- Email: [email protected]
Evaluation of patient preparedness for surgery: a randomized controlled trial
Accepted Manuscript Evaluation of Patient Preparedness for Surgery: A Randomized Controlled Trial Kristie A. Greene, MD, Allison M. Wyman, MD, Lauren A. Scott, MD, Stuart Hart, MD, Lennox Hoyte, MD, Renee Bassaly, DO PII:
S0002-9378(17)30518-5
DOI:
10.1016/j.ajog.2017.04.017
Reference:
YMOB 11621
To appear in:
American Journal of Obstetrics and Gynecology
Received Date: 5 January 2017 Revised Date:
28 March 2017
Accepted Date: 9 April 2017
Please cite this article as: Greene KA, Wyman AM, Scott LA, Hart S, Hoyte L, Bassaly R, Evaluation of Patient Preparedness for Surgery: A Randomized Controlled Trial, American Journal of Obstetrics and Gynecology (2017), doi: 10.1016/j.ajog.2017.04.017. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
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Title Page
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Evaluation of Patient Preparedness for Surgery: A Randomized Controlled Trial
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Kristie A. GREENE MD, Allison M. WYMAN MD, Lauren A. SCOTT MD, Stuart HART MD,
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Lennox HOYTE MD1, Renee BASSALY DO
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Division of Female Pelvic Medicine & Reconstructive Surgery
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Department of Obstetrics and Gynecology
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University of South Florida
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Tampa, FL
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Currently in private practice in Tampa, FL
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Corresponding Author:
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Kristie A. Greene, MD
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2 Tampa General Circle, STC 6th floor
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Tampa, FL 33606
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[email protected]
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Cell: 312-848-9343
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Fax: 813-259-8582
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Recently presented at the annual American Urogynecologic Society (AUGS) 2016 Meeting in Denver.
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https://clinicaltrials.gov clinical trial identification number: NCT02076360
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No funding was received for this work and all of the authors report no conflict of interest.
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Word count- Abstract: 390
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Main text: 2,622
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Short version of title: Patient Preparedness for Surgery
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Condensation: The addition of preoperative educational video does not improve level of
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preparedness of women undergoing sacrocolpopexy or decrease amount of time spent during
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physician-patient encounter.
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Abstract
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Background: Patient preparedness for pelvic reconstructive surgery has important implications
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for patient satisfaction and perception of improvement after surgery. The ideal method in which
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to optimally prepare patients for surgery has not been determined.
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Objective: To evaluate the impact of a preoperative patient education video on patient
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preparedness prior to sacrocolpopexy as measured by a preoperative preparedness questionnaire
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(PPQ).
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Study Design: We performed a single-blind, randomized stratified clinical trial at a single
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academic center evaluating the use of a preoperative patient education video as an adjunct to
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preoperative counseling on patient preparedness. Eligible patients presenting for their
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preoperative appointment prior to undergoing pelvic reconstructive surgery were randomized to
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watch a preoperative video vs. usual care. Preoperative questionnaires assessing patient
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preparedness, understanding, perception of time, and actual time spent with healthcare team were
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administered at the end of this visit. The primary outcome was patient preparedness for pelvic
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reconstructive surgery as measured by a preoperative preparedness questionnaire (PPQ).
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Secondary outcomes included actual time spent during physician-patient encounter, perception
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of time spent with healthcare team, and identification of patient factors associated with patient
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preparedness.
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Results: Of the total 100 recruited patients, 52 were randomized to the video group and 48 to the
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usual care group. The use of the video did not increase overall patient preparedness (71.1% with
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video vs. 68.8% usual care, p=0.79) prior to surgery. The use of the video did not decrease the
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amount of time spent during the physician-patient encounter (16.9± 5.6 min vs. 17.1±5.4 min,
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p=0.87). There was a significant association between patient preparedness and perception that
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the health care team spent sufficient time with the patient (89.5% vs. 10.5%; p < 0.001), but no
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association was observed between preparedness and actual time spent (17.4±5.4 min vs.16.5±
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5.5 min, p=0.47). Those with history of previous surgery (82.1% vs. 33.3%, p = 0.002) and
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those with more significant apical prolapse (0.6 ± 4.6 vs. -1.6 ± 3.9, p=0.05) were more likely to
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report feeling prepared for surgery.
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Conclusion: The majority of patients undergoing pelvic surgery at our institution felt prepared
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prior to undergoing surgery. The use of preoperative education video did not increase overall
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patient preparedness for surgery. Greater preparedness was associated with patient perception of
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how much time the health care team spent with the patient but not actual time spent.
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(Clinicaltrials.gov number NCT02076360).
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Key Words: educational video, patient preparedness, preoperative counseling
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Introduction Patient satisfaction is an increasingly important healthcare outcome and is often used as a
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component of quality assessment1. Recent studies have demonstrated that two areas central to
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patient satisfaction after reconstructive pelvic surgery are achievement of patient-centered goals2-
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did not feel adequately prepared for surgery were less likely to be satisfied postoperatively
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regardless of objective outcome.5 Furthermore, in a previous retrospective study, the same group
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demonstrated that both short and long-term dissatisfaction were strongly correlated with patients’
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feeling unprepared for surgery2.
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Despite the known significance of patient preparedness prior to surgery, the ideal means by
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which to ensure that patients are optimally prepared for surgery has not been demonstrated.
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Some surgical specialties have demonstrated potential benefits of a standardized educational
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videos on various postoperative outcome measures, specifically patient satisfaction,6-7
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preparedness for surgery,7 retention of procedure-related information,6 and quality of life scores.8
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To our knowledge, videos of this nature have not been studied in pelvic reconstructive surgery
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for preoperative counseling. The primary aim of this study was to determine the impact of a
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preoperative patient educational video on patient preparedness prior to pelvic reconstructive
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surgery. We secondarily sought to examine the impact of a preoperative video on patient
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understanding of the purpose, risks, benefits, alternatives, and complications of surgery, patient
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perception of time spent with the healthcare team, and the actual time spent during the
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preoperative visit. Lastly, we sought to determine factors associated with patient preparedness
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prior to surgery. We hypothesize that a statistically greater proportion of women randomized to
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watch the video will report feeling prepared for surgery compared to those randomized to usual
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and patient preparedness for surgery5. In this prospective study by Kenton et al, women who
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care. Furthermore, we hypothesize that the video may decrease the amount of time providers
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spend with the patient during the preoperative visit.
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Materials and Methods
This is a single-blind, randomized (1:1 allocation), stratified clinical trial at a tertiary referral teaching hospital evaluating the use of a preoperative patient education video as an
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adjunct to preoperative counseling on patient preparedness for surgery. The study was
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conducted from April 1, 2013–July 1, 2015. This protocol was written in accordance with
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CONSORT (Consolidated Standards of Reporting Trials) guidelines. IRB approval was
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obtained (Pro00013617) and the study was registered with clinicaltrials.gov (NCT02076360).
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Subjects were recruited from a single academic institution immediately prior to their preoperative visit at the Female Pelvic Medicine and Reconstructive Surgery (FPMRS) Clinic at
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a tertiary referral teaching hospital. Prior to this visit these patients were evaluated within the
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FPMRS division by an FPMRS faculty member, had undergone appropriate testing and
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counseling, and had been scheduled to undergo a sacrocolpopexy (robotic, laparoscopic, or
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open). Inclusion criteria included English-speaking females over the age of 18 presenting for
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their preoperative visit, scheduled to undergo sacrocolpopexy, and who were willing and able to
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provide informed consent. Concomitant procedures were permitted. We chose a single primary
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procedure (sacrocolpopexy) for inclusion in this study to simplify the content of the video and to
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help with standardization of the routine counseling.
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After obtaining informed consent, eligible patients were randomized with equal probability to Arm1 or Arm2 (video or usual care). Permuted block randomization with
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randomly varying block sizes were used. Patients were stratified by age into the following
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groups (age < 65, >65). Generation of allocation sequences was performed using a random-
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number table. The allocation sequence was generated by our statistician who was neither
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responsible for patient recruitment nor outcome assessment. Sequentially numbered opaque
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sealed envelopes were used for concealment of treatment allocation. All physicians on the
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healthcare team were blinded to the intervention received. A study nurse opened the sealed
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randomization envelope revealing the patient’s allocated intervention once the patient was in an
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exam room. The ten-minute education video was developed and agreed upon by the study team
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to ensure the information provided was similar to the routine preoperative counseling session
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however delivered in an alternative format. This included explanation and illustrations of pelvic
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organ prolapse, description of the surgical procedure, expectations regarding perioperative and
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postoperative care, and important postoperative instructions and precautions.
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video on an iPad and administered the routine preoperative packet (which includes bowel prep,
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pre- and postoperative instructions) that all patients undergoing surgery at our institution receive.
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Those randomized to the usual care group were given the routine preoperative packet and the
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iPad was left in the room to maintain provider blinding. The ipad had a locked 4-digit code to
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ensure that patients who were not randomized to the video could not view the video before the
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surgeon entered the room. The nurse alerted the physician after a ten-minute period so that the
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physician was not unblinded by entering the room while the patient was still watching the video.
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Subjects were asked not to divulge to any member of healthcare team whether or not they had
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watched the video. All subjects then received their routine preoperative visit by one of the
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FPMRS fellows, which is standard at our institution. Surgical counseling took place according
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to our routine clinic practice but included each of the bulleted points provided in (Figure 1) to
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ensure standardization amongst physicians. Standard counseling does include the use of a visual
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diagram of prolapse that is used to demonstrate where the mesh is placed during the procedure.
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The length of time the physician spent counseling (from the moment the physician walked in the
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room and began the counseling session until all questions were answered) was timed with a
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stopwatch and marked on the patient preoperative packet. The fellow pressed the start button
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when she entered the room and stopped the timer as she left the room.
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Immediately after the visit, patients were asked to complete a preoperative preparedness
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questionnaire (PPQ) assessing their knowledge and readiness for the planned procedure as
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illustrated in Figure 2). Although not fully validated, this is an 11-question questionnaire
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focusing on patient’s understanding surrounding risks, benefits, alternatives, potential
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complications, and expected outcomes of upcoming pelvic reconstructive surgery and has been
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previously reported in a population of women undergoing stress urinary incontinence (SUI)
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and/or pelvic organ prolapse surgery.5,9 The actual face-time between physician and patient
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during the counseling session was recorded.
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The primary outcome of this study was patient preparedness for pelvic reconstructive surgery as measured by preoperative patient questionnaire (PPQ) question 11. For purposes of
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analysis, women were categorized as “prepared” (those answering “strongly agree” on a 5-point
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Likert scale) and “unprepared” (all other responses) based on their responses to the question 11
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on the PPQ. We chose these definitions of preparedness as this was the scale used in a
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previously published study using this same questionnaire9. Secondary outcomes included patient
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understanding of the purpose, risks, benefits, alternatives, and complications of surgery, actual
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face-time spent between physician and patient during preoperative counseling session, patient
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perception of time spent with healthcare team in preparation for surgery as determined by
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question 10 on the PPQ, and identification of patients factors that may be associated with patient
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preparedness. We hypothesized that a greater proportion of women randomized to watch the
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preoperative educational video would consider themselves “prepared” for surgery compared to
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the usual care group. Additionally we hypothesized that the video may decrease the amount of
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time providers spend with the patient during preoperative visit.
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We performed a sample size analysis based on previously published data, which found that 58% of patients felt prepared for surgery5. Assuming 58% patients felt prepared for surgery
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in our unexposed group (usual care), and 80% of people felt prepared for surgery in our exposed
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group (after watching the video), using an alpha of 0.05 and a Beta of 0.20, we would need a
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total of 144 patients (72 in each group) to detect a difference between the groups with an 80%
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power. Data management and analyses were performed at our institution and conducted using
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SPSS version 19.0 for Windows (IBM) and Stata 13.1 (cite StataCorp. 2013. Stata Statistical
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Software: Release 13. College Station, TX: StataCorp LP). Baseline demographic and clinical
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characteristics are summarized as mean and standard deviation for continuous variables and
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percentages for categorical variables. These characteristics were compared by use of Student’s t
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tests or Wilcoxon rank-sum tests for continuous variables and Chi-square or Fisher exact tests for
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categorical variables. Paired t-test was used to compare pre-post continuous variables, while
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McNemar test was used to compare any pre-post categorical variables. Correlations were
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evaluated using Pearson correlations or Spearman’s rho correlations where appropriate. A p-
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value <0.05 was considered statistically significant.
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Results: Of the 156 women screened at our institution (Figure 3), 100 women during the study period were subsequently randomized. Four women were dropped from the study (3 in the video
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group and 1 in the usual care group) due to technical difficulties with iPad (2) and change in
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surgical procedure at time of preoperative visit (2). This rendered 96 subjects to undergo
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analysis (51 to the video group and 45 to the usual care group). However, for our primary
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endpoint of patient preparedness, the analysis was performed as intention-to-treat (52 to the
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video group and 48 to the usual care). At baseline, patient characteristics were not different
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between those who watched the video vs. those who did not as illustrated in Table 1. The vast
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majority were non-Hispanic, white, females in their sixties.
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Level of preoperative patient preparedness as defined by “strongly agreeing” with PPQ
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question # 11 was high overall amongst both groups, and the addition of the educational video
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did not improve patient preparedness (71.1% with video vs. 68.8% in usual care, p=0.79).
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Furthermore, addition of the preoperative video did not improve patient understanding of the
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risks, benefits, complications, alternatives, or purpose of the procedure as illustrated in Table 2.
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The actual time spent by the providers was similar between the two groups (17.1±5.4 min with
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video vs.16.9± 5.6 min with usual care, p=0.87). Furthermore, patient perception that the
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healthcare team spent sufficient time with them did not differ with addition of the video (69.2%
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with video vs. 68.8% with usual care, p=0.96).
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The perioperative events were similar in both groups as demonstrated in Table 3. The
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majority of patients underwent sacrocolpopexy via robotic approach (78%). About one third of
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patients underwent concomitant midurethral slings. Intraoperative and postoperative
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complication rates were similar between groups. Approximately 18% in the video group and
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33% in the usual care group went home with a catheter (p=0.14). Approximately half of patients
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felt prepared to cope with a catheter in the hospital (49% with video vs. 57% in usual care group,
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p=0.42) and at home (43% with video vs. 55% in usual care group, p=0.25) with no difference
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between groups.
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There was a significant association between patient preparedness and perception that health care
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team spent sufficient time preparing patient for surgery (89.5% vs. 10.5%; p < 0.001), but no
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significant association was observed between preparedness and actual time spent (17.4±5.4 min
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prepared vs. 16.5± 5.5 min unprepared, p=0.47). Furthermore, women who had a history of
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previous surgery were more likely to report feeling prepared for surgery than those with no
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previous surgical history (82.1% vs. 33.3%, p = 0.002). Finally, those with more significant
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apical prolapse were more likely to report feeling prepared than those with less severe prolapse
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as measured by point C on POPQ (pelvic organ prolapse quantification) examination (0.6 ± 4.6
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vs. -1.6 ± 3.9, p=0.05). Patient preparedness was not associated with age (p=0.36) or education
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(p=0.67).
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Comments:
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In our study, women undergoing pelvic reconstructive surgery overall reported a high
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rate of preoperative preparedness. Furthermore, the addition of an educational video did not
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improve patient preparedness or decrease the amount of time spent during the physician-patient
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encounter. Various surgical disciplines have demonstrated the benefit of supplemental
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education modules, including videos, in the preoperative setting.6-8,10 Although we did not find a
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statistical difference with the addition of the preoperative video in our study, patients’ overall
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preparedness prior to surgery was high in both groups. Furthermore, this level of preparedness
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denoted as “strongly agree that they felt prepared for surgery” was higher (68.8% in our
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unexposed group and 71.1% in our exposed group) than previously demonstrated in patients
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undergoing surgery for prolapse and stress urinary incontinence at other institutions (58% and
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48% respectively).5,9 High preoperative preparedness in our population may be due to the
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additional preoperative visit that all of our patients undergo with the fellows at our institution
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once they have agreed upon the surgical management plan with the FPMRS faculty. This gives
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the patients another opportunity to thoroughly discuss the events surrounding their surgery and
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have all their questions answered.
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Time was another important outcome in our study. In our study, approximately, 70% of patients strongly agreed that the healthcare team spent sufficient time with them. The addition of
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the video did not alter the actual amount of time the healthcare team spent counseling patients or
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the patients’ perception of how much time the healthcare team spent with them. This could be
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due to lack of power for this secondary outcome. It could also be that our fellows performed the
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exact same counseling for every patient and therefore demonstrated very little variation in time.
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However, similar to previous studies5, we found that patient perception that the healthcare team
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spent sufficient time with the patient was an important component of patient preparedness. This
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highlights the complex relationship between time and patient preparedness and that actual time
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spent and perception of time spent are not one in the same. Continuing to investigate this
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relationship will be particularly important as we continue to try to identify interventions that may
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improve patient preparedness.
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Furthermore, we demonstrated that patient preparedness prior to surgery was associated
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with patients having undergone surgery in past. It may be that having undergone a surgical
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procedure in the past eliminates some of the fear of the unknown. We also demonstrated
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correlation between higher preparedness and worse apical prolapse stage on POPQ. Other
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studies have shown that baseline symptom severity may be a contributing factor9 to patient
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preparedness such that those with more bothersome symptoms felt more prepared, where another
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smaller study showed no such association.5 Although we did not assess patient symptom
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severity scores using validated questionnaires, the association of preparedness with worse apical
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POPQ stages in our population may be indicative of those who have more bothersome prolapse
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and therefore feel more prepared to undergo surgical correction.
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Similar to results from Kenton’s study,5 we found that our lowest levels of preparedness scores surrounded the possibility of the patient requiring a catheter both in the hospital and at
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home. We think this may be more reflective of the wording of the question rather than a
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reflection of the patient’s actual preparedness. As most patients do not desire to go home with a
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catheter, they may not feel “mentally prepared” to do so regardless of the amount of preoperative
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counseling they receive. Although we do not address this in our current study, the authors are
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interested to investigate how preparedness is affected by surgical outcomes, postoperative
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complications, or expected but unwanted events, such as going home with a catheter. Future
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directions for this study would include a postoperative time point to determine whether
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satisfaction and preparedness would be affected by these outcomes. Additional future directions
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for this study include the addition of a knowledge/recall component of the study to determine
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whether comprehension and retention of knowledge is improved with the use of the video in
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pelvic reconstructive surgery as it has been in some of the general surgery literature, which again
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can impact patient feelings of preparedness6.
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Limitations of our study include that we did not reach our anticipated sample size
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because the study had to close prior to recruitment completion because the Primary Investigator
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of the study graduated from fellowship. Recruitment was unable to continue in the absence of
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the PI due to limited resources. However, we did collect important information to better plan for
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additional studies as the higher preoperative preparedness scores we found in our unexposed
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group at our institution (68.8% versus predicted 58%) would have required a significantly higher
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number of participants than initially calculated. Another limitation is that the manner in which
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our institution performs its preoperative counseling with fellows may not be widely
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generalizable. Many physicians may find it challenging to designate an additional preoperative
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visit in a busy clinical practice particularly if they don’t have fellows or other physician
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extenders. An educational video may actually be more beneficial in this type of clinical
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environment in which the use of the video could address the routine counseling allowing the
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physician to concentrate his time on answering patient questions. Finally, our population was
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homogenous in race, which again may limit the generalizability of our findings.
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Strengths of this study include the single-blind randomized study design, a well-defined surgical cohort, and the use of a novel, inexpensive and fairly simple intervention that has not yet
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been tested in Urogynecology. Further studies are warranted to test this intervention in a larger
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cohort that is fully powered and includes long-term follow-up to better determine its efficacy in
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other populations.
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In summary, patient preparedness is an important healthcare outcome and may be
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affected by many factors, some of which are unrelated to preoperative counseling. Future studies
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are needed to identify other potential approaches to optimize patient preparedness for surgery.
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And, given the time demands that many physicians face in a busy surgical practice, an approach
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that investigates and maximizes patients’ perception of time spent without increasing actual visit
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time may be particularly relevant.
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Hullfish K.L., Bovbjerg VE, Gibson J, Steers WD, Patient-centered goals for pelvic floor
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Table 1. Patient demographics, medical history, and prolapse measurements prior to undergoing sacrocolpopexy Age Race White African American Hispanic Native American Other
Usual care (n = 48) 62.98 ± 9.25
Video (n = 52) 64.52 ± 8.83
P value 0.419
33 (82.5) 1 (2.5) 3 (7.5) 1 (2.5) 2 (5)
46 (92) 0 (0) 1 (2) 1 (2) 2 (4)
0.565
355 356 357 358 359 360 361 362 363
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Ethnicity Non-Hispanic 37 (92.5) 47 (97.9) Hispanic 3 (6.7) 1 (2.1) 2 BMI (kg/m ) 28.98±5.32 26.25±4.47 Years education Elementary 0 (0) 3 (6.8) High school 19 (61.3) 21 (47.7) College 8 (25.8) 19 (42.3) Graduate 3 (9.7) 1 (2.3) Other 1 (3.2) 0 (0) Previous surgery 40 (97.6) 44 (88) Number medical 1 (0, 6) 1.5 (0, 5) comorbidities Ba 3 (-3, 8) 3.5 (-3, 8) Bp 0 (-3, 8) 1 (-3, 7) C 0 (-9, 8) 0 (-7, 8) * Data presented as n (%), mean ±s.d. or median [range]
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0.326 0.007
0.09
0.123 0.876 0.797 0.652 0.826
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Table 2. Patient responses on Preoperative Preparedness Questionnaire (PPQ)
n=48 (%)
n=52 (%)
Understanding of 29 (60.4) 28 (53.8) Alternatives Understanding of 34 (70.8) 37 (71.1) Purpose Understanding of 35 (72.9) 38 (73.1) Benefits Understanding of 32 (66.7) 34 (65.3) Risks Understanding of 30 (62.5) 32 (61.5) Complications Prepared hospital 28 (58.3) 32 (61.5) Prepared home 27 (56.5) 32 (61.5) Catheter in hospital 23 (47.9) 24 (46.1) Catheter at home 22 (45.8) 21 (40.4) Overall 33 (68.8) 37 (71.1) preparedness Patient perception 33 (68.8) 36 (69.2) of time Actual time spent 16.9± 5.6 min 17.1±5.4min *Data presented as n(%), mean ± s.d. or median [range]
P value
0.57
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Video
0.97 0.99 0.89
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Usual care
367 368 369 370 371 372 373 374 375 376 377
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0.92
0.74 0.59 0.86 0.58 0.79
0.96 0.87
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Table 3. Surgical procedures performed and perioperative events.
Postop complication: UTI Obstruction Nerve Incisional Leg
382 383 384 385 386 387 388 389 390 391 392
15 (37.5)
19 (38.8)
4 (10) 1 (2.5)
1 (2.1) 0 (0)
2 (5.1) 1 (2.6) 1 (2.6) 1 (2.6) 0 (0)
0 (0) 0 (0) 0 (0) 0 (0) 1 (2.1)
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1
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38 (77.6) 8 (16.3) 3 (6.1)
Home with catheter 13 (33.3) 9 (18.4) * Data presented as n (%), mean ± s.d. or median [range]
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31 (77.5) 7 (17.5) 2 (5)
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P value
0.902 0.108
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Approach: Robot Laparoscopic Open
Usual care (n = 45) Video (n = 51)
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0.08
0.139
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Figure Legends:
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Figure 1. Standardized preoperative checklist of items included in preoperative counseling sessions
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This is an outline of necessary items covered by the fellows during the preoperative surgical counseling session to ensure standardization amongst physicians.
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Figure 2. Preoperative Preparedness Questionnaire (PPQ)
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This is an 11-question questionnaire focusing on patient’s understanding surrounding risks, benefits, alternatives, potential complications, and expected outcomes of upcoming pelvic reconstructive surgery and has been previously reported in a population of women undergoing stress urinary incontinence (SUI) and/or pelvic organ prolapse surgery.5 Figure reprinted from Am J Obstet Gynecol, 197(6), Kenton K, Pham T, Mueller E, Brubaker L, Patient preparedness: an important predictor of surgical outcome, p. 654 e1-6 (2007) with permission from Elsevier.
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This is a flowchart as detailed in CONSORT guidelines of the numbers of participants who were randomly assigned to video and usual care groups, received intended treatment, and were analyzed for the primary outcome.
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Figure 3. CONSORT Diagram: Screening, Randomization, Treatment, and Follow-up
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S0002-9378(17)30518-5
DOI:
10.1016/j.ajog.2017.04.017
Reference:
YMOB 11621
To appear in:
American Journal of Obstetrics and Gynecology
Received Date: 5 January 2017 Revised Date:
28 March 2017
Accepted Date: 9 April 2017
Please cite this article as: Greene KA, Wyman AM, Scott LA, Hart S, Hoyte L, Bassaly R, Evaluation of Patient Preparedness for Surgery: A Randomized Controlled Trial, American Journal of Obstetrics and Gynecology (2017), doi: 10.1016/j.ajog.2017.04.017. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
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Title Page
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Evaluation of Patient Preparedness for Surgery: A Randomized Controlled Trial
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Kristie A. GREENE MD, Allison M. WYMAN MD, Lauren A. SCOTT MD, Stuart HART MD,
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Lennox HOYTE MD1, Renee BASSALY DO
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Division of Female Pelvic Medicine & Reconstructive Surgery
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Department of Obstetrics and Gynecology
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University of South Florida
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Tampa, FL
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Currently in private practice in Tampa, FL
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Corresponding Author:
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Kristie A. Greene, MD
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2 Tampa General Circle, STC 6th floor
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Tampa, FL 33606
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[email protected]
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Cell: 312-848-9343
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Fax: 813-259-8582
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Recently presented at the annual American Urogynecologic Society (AUGS) 2016 Meeting in Denver.
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https://clinicaltrials.gov clinical trial identification number: NCT02076360
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No funding was received for this work and all of the authors report no conflict of interest.
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Word count- Abstract: 390
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Main text: 2,622
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Short version of title: Patient Preparedness for Surgery
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Condensation: The addition of preoperative educational video does not improve level of
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preparedness of women undergoing sacrocolpopexy or decrease amount of time spent during
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physician-patient encounter.
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Abstract
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Background: Patient preparedness for pelvic reconstructive surgery has important implications
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for patient satisfaction and perception of improvement after surgery. The ideal method in which
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to optimally prepare patients for surgery has not been determined.
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Objective: To evaluate the impact of a preoperative patient education video on patient
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preparedness prior to sacrocolpopexy as measured by a preoperative preparedness questionnaire
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(PPQ).
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Study Design: We performed a single-blind, randomized stratified clinical trial at a single
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academic center evaluating the use of a preoperative patient education video as an adjunct to
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preoperative counseling on patient preparedness. Eligible patients presenting for their
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preoperative appointment prior to undergoing pelvic reconstructive surgery were randomized to
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watch a preoperative video vs. usual care. Preoperative questionnaires assessing patient
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preparedness, understanding, perception of time, and actual time spent with healthcare team were
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administered at the end of this visit. The primary outcome was patient preparedness for pelvic
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reconstructive surgery as measured by a preoperative preparedness questionnaire (PPQ).
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Secondary outcomes included actual time spent during physician-patient encounter, perception
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of time spent with healthcare team, and identification of patient factors associated with patient
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preparedness.
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Results: Of the total 100 recruited patients, 52 were randomized to the video group and 48 to the
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usual care group. The use of the video did not increase overall patient preparedness (71.1% with
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video vs. 68.8% usual care, p=0.79) prior to surgery. The use of the video did not decrease the
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amount of time spent during the physician-patient encounter (16.9± 5.6 min vs. 17.1±5.4 min,
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p=0.87). There was a significant association between patient preparedness and perception that
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the health care team spent sufficient time with the patient (89.5% vs. 10.5%; p < 0.001), but no
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association was observed between preparedness and actual time spent (17.4±5.4 min vs.16.5±
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5.5 min, p=0.47). Those with history of previous surgery (82.1% vs. 33.3%, p = 0.002) and
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those with more significant apical prolapse (0.6 ± 4.6 vs. -1.6 ± 3.9, p=0.05) were more likely to
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report feeling prepared for surgery.
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Conclusion: The majority of patients undergoing pelvic surgery at our institution felt prepared
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prior to undergoing surgery. The use of preoperative education video did not increase overall
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patient preparedness for surgery. Greater preparedness was associated with patient perception of
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how much time the health care team spent with the patient but not actual time spent.
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(Clinicaltrials.gov number NCT02076360).
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Key Words: educational video, patient preparedness, preoperative counseling
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Introduction Patient satisfaction is an increasingly important healthcare outcome and is often used as a
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component of quality assessment1. Recent studies have demonstrated that two areas central to
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patient satisfaction after reconstructive pelvic surgery are achievement of patient-centered goals2-
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4
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did not feel adequately prepared for surgery were less likely to be satisfied postoperatively
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regardless of objective outcome.5 Furthermore, in a previous retrospective study, the same group
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demonstrated that both short and long-term dissatisfaction were strongly correlated with patients’
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feeling unprepared for surgery2.
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Despite the known significance of patient preparedness prior to surgery, the ideal means by
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which to ensure that patients are optimally prepared for surgery has not been demonstrated.
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Some surgical specialties have demonstrated potential benefits of a standardized educational
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videos on various postoperative outcome measures, specifically patient satisfaction,6-7
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preparedness for surgery,7 retention of procedure-related information,6 and quality of life scores.8
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To our knowledge, videos of this nature have not been studied in pelvic reconstructive surgery
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for preoperative counseling. The primary aim of this study was to determine the impact of a
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preoperative patient educational video on patient preparedness prior to pelvic reconstructive
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surgery. We secondarily sought to examine the impact of a preoperative video on patient
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understanding of the purpose, risks, benefits, alternatives, and complications of surgery, patient
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perception of time spent with the healthcare team, and the actual time spent during the
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preoperative visit. Lastly, we sought to determine factors associated with patient preparedness
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prior to surgery. We hypothesize that a statistically greater proportion of women randomized to
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watch the video will report feeling prepared for surgery compared to those randomized to usual
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and patient preparedness for surgery5. In this prospective study by Kenton et al, women who
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care. Furthermore, we hypothesize that the video may decrease the amount of time providers
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spend with the patient during the preoperative visit.
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Materials and Methods
This is a single-blind, randomized (1:1 allocation), stratified clinical trial at a tertiary referral teaching hospital evaluating the use of a preoperative patient education video as an
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adjunct to preoperative counseling on patient preparedness for surgery. The study was
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conducted from April 1, 2013–July 1, 2015. This protocol was written in accordance with
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CONSORT (Consolidated Standards of Reporting Trials) guidelines. IRB approval was
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obtained (Pro00013617) and the study was registered with clinicaltrials.gov (NCT02076360).
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Subjects were recruited from a single academic institution immediately prior to their preoperative visit at the Female Pelvic Medicine and Reconstructive Surgery (FPMRS) Clinic at
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a tertiary referral teaching hospital. Prior to this visit these patients were evaluated within the
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FPMRS division by an FPMRS faculty member, had undergone appropriate testing and
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counseling, and had been scheduled to undergo a sacrocolpopexy (robotic, laparoscopic, or
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open). Inclusion criteria included English-speaking females over the age of 18 presenting for
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their preoperative visit, scheduled to undergo sacrocolpopexy, and who were willing and able to
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provide informed consent. Concomitant procedures were permitted. We chose a single primary
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procedure (sacrocolpopexy) for inclusion in this study to simplify the content of the video and to
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help with standardization of the routine counseling.
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After obtaining informed consent, eligible patients were randomized with equal probability to Arm1 or Arm2 (video or usual care). Permuted block randomization with
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randomly varying block sizes were used. Patients were stratified by age into the following
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groups (age < 65, >65). Generation of allocation sequences was performed using a random-
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number table. The allocation sequence was generated by our statistician who was neither
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responsible for patient recruitment nor outcome assessment. Sequentially numbered opaque
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sealed envelopes were used for concealment of treatment allocation. All physicians on the
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healthcare team were blinded to the intervention received. A study nurse opened the sealed
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randomization envelope revealing the patient’s allocated intervention once the patient was in an
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exam room. The ten-minute education video was developed and agreed upon by the study team
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to ensure the information provided was similar to the routine preoperative counseling session
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however delivered in an alternative format. This included explanation and illustrations of pelvic
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organ prolapse, description of the surgical procedure, expectations regarding perioperative and
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postoperative care, and important postoperative instructions and precautions.
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video on an iPad and administered the routine preoperative packet (which includes bowel prep,
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pre- and postoperative instructions) that all patients undergoing surgery at our institution receive.
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Those randomized to the usual care group were given the routine preoperative packet and the
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iPad was left in the room to maintain provider blinding. The ipad had a locked 4-digit code to
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ensure that patients who were not randomized to the video could not view the video before the
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surgeon entered the room. The nurse alerted the physician after a ten-minute period so that the
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physician was not unblinded by entering the room while the patient was still watching the video.
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Subjects were asked not to divulge to any member of healthcare team whether or not they had
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watched the video. All subjects then received their routine preoperative visit by one of the
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FPMRS fellows, which is standard at our institution. Surgical counseling took place according
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to our routine clinic practice but included each of the bulleted points provided in (Figure 1) to
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ensure standardization amongst physicians. Standard counseling does include the use of a visual
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diagram of prolapse that is used to demonstrate where the mesh is placed during the procedure.
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The length of time the physician spent counseling (from the moment the physician walked in the
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room and began the counseling session until all questions were answered) was timed with a
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stopwatch and marked on the patient preoperative packet. The fellow pressed the start button
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when she entered the room and stopped the timer as she left the room.
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Immediately after the visit, patients were asked to complete a preoperative preparedness
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questionnaire (PPQ) assessing their knowledge and readiness for the planned procedure as
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illustrated in Figure 2). Although not fully validated, this is an 11-question questionnaire
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focusing on patient’s understanding surrounding risks, benefits, alternatives, potential
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complications, and expected outcomes of upcoming pelvic reconstructive surgery and has been
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previously reported in a population of women undergoing stress urinary incontinence (SUI)
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and/or pelvic organ prolapse surgery.5,9 The actual face-time between physician and patient
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during the counseling session was recorded.
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The primary outcome of this study was patient preparedness for pelvic reconstructive surgery as measured by preoperative patient questionnaire (PPQ) question 11. For purposes of
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analysis, women were categorized as “prepared” (those answering “strongly agree” on a 5-point
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Likert scale) and “unprepared” (all other responses) based on their responses to the question 11
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on the PPQ. We chose these definitions of preparedness as this was the scale used in a
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previously published study using this same questionnaire9. Secondary outcomes included patient
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understanding of the purpose, risks, benefits, alternatives, and complications of surgery, actual
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face-time spent between physician and patient during preoperative counseling session, patient
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perception of time spent with healthcare team in preparation for surgery as determined by
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question 10 on the PPQ, and identification of patients factors that may be associated with patient
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preparedness. We hypothesized that a greater proportion of women randomized to watch the
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preoperative educational video would consider themselves “prepared” for surgery compared to
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the usual care group. Additionally we hypothesized that the video may decrease the amount of
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time providers spend with the patient during preoperative visit.
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We performed a sample size analysis based on previously published data, which found that 58% of patients felt prepared for surgery5. Assuming 58% patients felt prepared for surgery
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in our unexposed group (usual care), and 80% of people felt prepared for surgery in our exposed
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group (after watching the video), using an alpha of 0.05 and a Beta of 0.20, we would need a
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total of 144 patients (72 in each group) to detect a difference between the groups with an 80%
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power. Data management and analyses were performed at our institution and conducted using
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SPSS version 19.0 for Windows (IBM) and Stata 13.1 (cite StataCorp. 2013. Stata Statistical
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Software: Release 13. College Station, TX: StataCorp LP). Baseline demographic and clinical
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characteristics are summarized as mean and standard deviation for continuous variables and
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percentages for categorical variables. These characteristics were compared by use of Student’s t
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tests or Wilcoxon rank-sum tests for continuous variables and Chi-square or Fisher exact tests for
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categorical variables. Paired t-test was used to compare pre-post continuous variables, while
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McNemar test was used to compare any pre-post categorical variables. Correlations were
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evaluated using Pearson correlations or Spearman’s rho correlations where appropriate. A p-
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value <0.05 was considered statistically significant.
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Results: Of the 156 women screened at our institution (Figure 3), 100 women during the study period were subsequently randomized. Four women were dropped from the study (3 in the video
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group and 1 in the usual care group) due to technical difficulties with iPad (2) and change in
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surgical procedure at time of preoperative visit (2). This rendered 96 subjects to undergo
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analysis (51 to the video group and 45 to the usual care group). However, for our primary
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endpoint of patient preparedness, the analysis was performed as intention-to-treat (52 to the
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video group and 48 to the usual care). At baseline, patient characteristics were not different
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between those who watched the video vs. those who did not as illustrated in Table 1. The vast
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majority were non-Hispanic, white, females in their sixties.
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Level of preoperative patient preparedness as defined by “strongly agreeing” with PPQ
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question # 11 was high overall amongst both groups, and the addition of the educational video
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did not improve patient preparedness (71.1% with video vs. 68.8% in usual care, p=0.79).
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Furthermore, addition of the preoperative video did not improve patient understanding of the
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risks, benefits, complications, alternatives, or purpose of the procedure as illustrated in Table 2.
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The actual time spent by the providers was similar between the two groups (17.1±5.4 min with
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video vs.16.9± 5.6 min with usual care, p=0.87). Furthermore, patient perception that the
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healthcare team spent sufficient time with them did not differ with addition of the video (69.2%
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with video vs. 68.8% with usual care, p=0.96).
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The perioperative events were similar in both groups as demonstrated in Table 3. The
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majority of patients underwent sacrocolpopexy via robotic approach (78%). About one third of
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patients underwent concomitant midurethral slings. Intraoperative and postoperative
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complication rates were similar between groups. Approximately 18% in the video group and
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33% in the usual care group went home with a catheter (p=0.14). Approximately half of patients
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felt prepared to cope with a catheter in the hospital (49% with video vs. 57% in usual care group,
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p=0.42) and at home (43% with video vs. 55% in usual care group, p=0.25) with no difference
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between groups.
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There was a significant association between patient preparedness and perception that health care
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team spent sufficient time preparing patient for surgery (89.5% vs. 10.5%; p < 0.001), but no
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significant association was observed between preparedness and actual time spent (17.4±5.4 min
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prepared vs. 16.5± 5.5 min unprepared, p=0.47). Furthermore, women who had a history of
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previous surgery were more likely to report feeling prepared for surgery than those with no
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previous surgical history (82.1% vs. 33.3%, p = 0.002). Finally, those with more significant
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apical prolapse were more likely to report feeling prepared than those with less severe prolapse
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as measured by point C on POPQ (pelvic organ prolapse quantification) examination (0.6 ± 4.6
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vs. -1.6 ± 3.9, p=0.05). Patient preparedness was not associated with age (p=0.36) or education
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(p=0.67).
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Comments:
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In our study, women undergoing pelvic reconstructive surgery overall reported a high
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rate of preoperative preparedness. Furthermore, the addition of an educational video did not
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improve patient preparedness or decrease the amount of time spent during the physician-patient
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encounter. Various surgical disciplines have demonstrated the benefit of supplemental
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education modules, including videos, in the preoperative setting.6-8,10 Although we did not find a
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statistical difference with the addition of the preoperative video in our study, patients’ overall
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preparedness prior to surgery was high in both groups. Furthermore, this level of preparedness
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denoted as “strongly agree that they felt prepared for surgery” was higher (68.8% in our
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unexposed group and 71.1% in our exposed group) than previously demonstrated in patients
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undergoing surgery for prolapse and stress urinary incontinence at other institutions (58% and
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48% respectively).5,9 High preoperative preparedness in our population may be due to the
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additional preoperative visit that all of our patients undergo with the fellows at our institution
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once they have agreed upon the surgical management plan with the FPMRS faculty. This gives
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the patients another opportunity to thoroughly discuss the events surrounding their surgery and
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have all their questions answered.
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Time was another important outcome in our study. In our study, approximately, 70% of patients strongly agreed that the healthcare team spent sufficient time with them. The addition of
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the video did not alter the actual amount of time the healthcare team spent counseling patients or
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the patients’ perception of how much time the healthcare team spent with them. This could be
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due to lack of power for this secondary outcome. It could also be that our fellows performed the
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exact same counseling for every patient and therefore demonstrated very little variation in time.
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However, similar to previous studies5, we found that patient perception that the healthcare team
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spent sufficient time with the patient was an important component of patient preparedness. This
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highlights the complex relationship between time and patient preparedness and that actual time
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spent and perception of time spent are not one in the same. Continuing to investigate this
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relationship will be particularly important as we continue to try to identify interventions that may
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improve patient preparedness.
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Furthermore, we demonstrated that patient preparedness prior to surgery was associated
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with patients having undergone surgery in past. It may be that having undergone a surgical
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procedure in the past eliminates some of the fear of the unknown. We also demonstrated
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correlation between higher preparedness and worse apical prolapse stage on POPQ. Other
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studies have shown that baseline symptom severity may be a contributing factor9 to patient
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preparedness such that those with more bothersome symptoms felt more prepared, where another
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smaller study showed no such association.5 Although we did not assess patient symptom
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severity scores using validated questionnaires, the association of preparedness with worse apical
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POPQ stages in our population may be indicative of those who have more bothersome prolapse
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and therefore feel more prepared to undergo surgical correction.
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Similar to results from Kenton’s study,5 we found that our lowest levels of preparedness scores surrounded the possibility of the patient requiring a catheter both in the hospital and at
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home. We think this may be more reflective of the wording of the question rather than a
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reflection of the patient’s actual preparedness. As most patients do not desire to go home with a
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catheter, they may not feel “mentally prepared” to do so regardless of the amount of preoperative
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counseling they receive. Although we do not address this in our current study, the authors are
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interested to investigate how preparedness is affected by surgical outcomes, postoperative
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complications, or expected but unwanted events, such as going home with a catheter. Future
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directions for this study would include a postoperative time point to determine whether
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satisfaction and preparedness would be affected by these outcomes. Additional future directions
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for this study include the addition of a knowledge/recall component of the study to determine
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whether comprehension and retention of knowledge is improved with the use of the video in
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pelvic reconstructive surgery as it has been in some of the general surgery literature, which again
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can impact patient feelings of preparedness6.
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Limitations of our study include that we did not reach our anticipated sample size
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because the study had to close prior to recruitment completion because the Primary Investigator
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of the study graduated from fellowship. Recruitment was unable to continue in the absence of
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the PI due to limited resources. However, we did collect important information to better plan for
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additional studies as the higher preoperative preparedness scores we found in our unexposed
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group at our institution (68.8% versus predicted 58%) would have required a significantly higher
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number of participants than initially calculated. Another limitation is that the manner in which
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our institution performs its preoperative counseling with fellows may not be widely
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generalizable. Many physicians may find it challenging to designate an additional preoperative
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visit in a busy clinical practice particularly if they don’t have fellows or other physician
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extenders. An educational video may actually be more beneficial in this type of clinical
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environment in which the use of the video could address the routine counseling allowing the
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physician to concentrate his time on answering patient questions. Finally, our population was
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homogenous in race, which again may limit the generalizability of our findings.
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Strengths of this study include the single-blind randomized study design, a well-defined surgical cohort, and the use of a novel, inexpensive and fairly simple intervention that has not yet
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been tested in Urogynecology. Further studies are warranted to test this intervention in a larger
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cohort that is fully powered and includes long-term follow-up to better determine its efficacy in
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other populations.
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In summary, patient preparedness is an important healthcare outcome and may be
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affected by many factors, some of which are unrelated to preoperative counseling. Future studies
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are needed to identify other potential approaches to optimize patient preparedness for surgery.
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And, given the time demands that many physicians face in a busy surgical practice, an approach
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that investigates and maximizes patients’ perception of time spent without increasing actual visit
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time may be particularly relevant.
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Hullfish K.L., Bovbjerg VE, Gibson J, Steers WD, Patient-centered goals for pelvic floor
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Kenton K, Pham T, Mueller E, Brubaker L, Patient preparedness: an important predictor of surgical outcome. Am J Obstet Gynecol 2007; 197: 654 e1-6.
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dysfunction surgery: long-term follow-up. Am J Obstet Gynecol, 2004; 191:201-5.
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Hullfish K.L., V.E. Bovbjerg, and W.D. Steers, Patient-centered goals for pelvic floor
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Crabtree T.D., Puri V, Bell JM, et al, Outcomes and perception of lung surgery with implementation of a patient video education module: a prospective cohort study. J Am Coll Surg 2012; 214: 816-21 e2.
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Zieren J., C. Menenakos, and J.M. Mueller, Does an informative video before inguinal hernia surgical repair influence postoperative quality of life? Results of a prospective
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randomized study. Qual Life Res 2007; 16: 725-9.
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9.
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Brubaker L, Litman HJ, Rickey L, et al, Casiano E, Paraiso MFR, Ghetti C, Rahn DD, Kusek JW, Surgical preparation: are patients "ready" for stress incontinence surgery? Int
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Uroynecol J 2014; 25:41-46
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Nehme J, El-Khani U, Chow A, Hakky S, Ahmed AR, Purkayastha S, The use of multimedia consent programs for surgical procedures: a systematic review. Surg Innov.
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2013; 20:13-23.
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Table 1. Patient demographics, medical history, and prolapse measurements prior to undergoing sacrocolpopexy Age Race White African American Hispanic Native American Other
Usual care (n = 48) 62.98 ± 9.25
Video (n = 52) 64.52 ± 8.83
P value 0.419
33 (82.5) 1 (2.5) 3 (7.5) 1 (2.5) 2 (5)
46 (92) 0 (0) 1 (2) 1 (2) 2 (4)
0.565
355 356 357 358 359 360 361 362 363
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Ethnicity Non-Hispanic 37 (92.5) 47 (97.9) Hispanic 3 (6.7) 1 (2.1) 2 BMI (kg/m ) 28.98±5.32 26.25±4.47 Years education Elementary 0 (0) 3 (6.8) High school 19 (61.3) 21 (47.7) College 8 (25.8) 19 (42.3) Graduate 3 (9.7) 1 (2.3) Other 1 (3.2) 0 (0) Previous surgery 40 (97.6) 44 (88) Number medical 1 (0, 6) 1.5 (0, 5) comorbidities Ba 3 (-3, 8) 3.5 (-3, 8) Bp 0 (-3, 8) 1 (-3, 7) C 0 (-9, 8) 0 (-7, 8) * Data presented as n (%), mean ±s.d. or median [range]
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0.326 0.007
0.09
0.123 0.876 0.797 0.652 0.826
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Table 2. Patient responses on Preoperative Preparedness Questionnaire (PPQ)
n=48 (%)
n=52 (%)
Understanding of 29 (60.4) 28 (53.8) Alternatives Understanding of 34 (70.8) 37 (71.1) Purpose Understanding of 35 (72.9) 38 (73.1) Benefits Understanding of 32 (66.7) 34 (65.3) Risks Understanding of 30 (62.5) 32 (61.5) Complications Prepared hospital 28 (58.3) 32 (61.5) Prepared home 27 (56.5) 32 (61.5) Catheter in hospital 23 (47.9) 24 (46.1) Catheter at home 22 (45.8) 21 (40.4) Overall 33 (68.8) 37 (71.1) preparedness Patient perception 33 (68.8) 36 (69.2) of time Actual time spent 16.9± 5.6 min 17.1±5.4min *Data presented as n(%), mean ± s.d. or median [range]
P value
0.57
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Video
0.97 0.99 0.89
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Usual care
367 368 369 370 371 372 373 374 375 376 377
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0.92
0.74 0.59 0.86 0.58 0.79
0.96 0.87
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Table 3. Surgical procedures performed and perioperative events.
Postop complication: UTI Obstruction Nerve Incisional Leg
382 383 384 385 386 387 388 389 390 391 392
15 (37.5)
19 (38.8)
4 (10) 1 (2.5)
1 (2.1) 0 (0)
2 (5.1) 1 (2.6) 1 (2.6) 1 (2.6) 0 (0)
0 (0) 0 (0) 0 (0) 0 (0) 1 (2.1)
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38 (77.6) 8 (16.3) 3 (6.1)
Home with catheter 13 (33.3) 9 (18.4) * Data presented as n (%), mean ± s.d. or median [range]
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31 (77.5) 7 (17.5) 2 (5)
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P value
0.902 0.108
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Approach: Robot Laparoscopic Open
Usual care (n = 45) Video (n = 51)
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Figure Legends:
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Figure 1. Standardized preoperative checklist of items included in preoperative counseling sessions
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This is an outline of necessary items covered by the fellows during the preoperative surgical counseling session to ensure standardization amongst physicians.
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Figure 2. Preoperative Preparedness Questionnaire (PPQ)
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This is an 11-question questionnaire focusing on patient’s understanding surrounding risks, benefits, alternatives, potential complications, and expected outcomes of upcoming pelvic reconstructive surgery and has been previously reported in a population of women undergoing stress urinary incontinence (SUI) and/or pelvic organ prolapse surgery.5 Figure reprinted from Am J Obstet Gynecol, 197(6), Kenton K, Pham T, Mueller E, Brubaker L, Patient preparedness: an important predictor of surgical outcome, p. 654 e1-6 (2007) with permission from Elsevier.
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This is a flowchart as detailed in CONSORT guidelines of the numbers of participants who were randomly assigned to video and usual care groups, received intended treatment, and were analyzed for the primary outcome.
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Figure 3. CONSORT Diagram: Screening, Randomization, Treatment, and Follow-up
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