- Email: [email protected]
Improving completion of advance directives in the primary care setting: A randomized controlled trial
Improving Completion of Advance Directives in the Primary Care Setting: A Randomized Controlled Trial Heather Heiman, MD, David W. Bates, MD, MSc, David Fairchild, MD, Shimon Shaykevich, MS, Lisa Soleymani Lehmann, MD, PhD, MSc BACKGROUND: Since 1991, hospitals have asked patients whether they have advance directives, but few patients complete these documents. We assessed two simple interventions to improve completion of advance directives among elderly or chronically ill outpatients. METHODS: We conducted a cluster randomized controlled trial involving 1079 patients from five general medicine clinics that were affiliated with an academic medical center. Patients were either ⱖ70 years of age or ⱖ50 years old with a chronic illness. The study comprised three arms: physician reminders recommending documentation of advance directives, physician reminders plus mailing advance directives to patients together with educational literature, or neither intervention (control). The main outcome measure was completion of an advance directive. RESULTS: After 28 weeks, 1.5% (5/332) of patients in the phy-
sician reminder group, 14% (38/277) in the physician reminder plus patient mailing group, and 1.8% (5/286) in the control group had completed advance directives. In multivariate analyses, patients in the physician reminder plus patient mailing group were much more likely than controls to have completed advance directives (odds ratio [OR] ⫽ 5.9; 95% confidence interval [CI]: 1.5 to 22), whereas patients in the physician reminder– only group were no more likely than controls to have completed advance directives (OR ⫽ 0.88; 95% CI: 0.21 to 3.7). CONCLUSION: Mailing health care proxy and living will forms and literature to patients before an appointment at which their physicians received a reminder about advance directives yielded a small but significant improvement in completion of these documents. A physician reminder alone did not have an effect. Am J Med. 2004;117:318 –324. ©2004 by Elsevier Inc.
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of advance directives. The Joint Commission on Accreditation of Healthcare Organizations revised its hospital standards in 2002 to require that hospital-based ambulatory clinics be equipped to assist patients with advance directives (8). Several studies have tested interventions to increase the completion of advance directives among outpatients (9 –14). It is difficult to generalize the results of these studies to a busy primary care setting, however, because they either took place in geriatric clinics or required time-intensive interventions such as physician training sessions or patient visits with nurses or social workers. Simpler interventions such as computer-generated physician reminders have been shown to be effective in promoting preventive services such as blood pressure measurements and vaccinations (15), suggesting that such reminders can also help to increase the completion of advance directives. Dexter and colleagues found that computerized reminders to physicians were associated with up to a sixfold greater completion rate of advance directives as compared with no physician reminders (16). Patient mailings, another simple intervention, were shown to boost completion rates in two controlled trials that assessed the efficacy of mailings to older patients (17,18). One study (18) demonstrated that mailing the California Durable Power of Attorney for Healthcare led 18% of patients to complete an advance directive as compared with 0.4% of controls, whereas the other study
ore than a decade has passed since the Patient Self-Determination Act mandated that hospitals ask patients whether they have advance directives and make these documents available (1). Advance directives, which include health care proxies and living wills, are intended to promote patient autonomy and dignity at the end of life and to permit shared decision making between patients and doctors (2). Yet, despite support from providers and the public, only a minority of patients complete advance directives, and physicians are often unaware of the documents even when patients have executed them (3,4). Patient-physician discussions about patients’ wishes regarding future medical interventions may increase patients’ satisfaction with their physicians (5–7), and the primary care clinic may be the best setting for discussions From the Division of General Internal Medicine (HH), Feinberg School of Medicine, Northwestern University, Chicago, Illinois; Division of General Medicine and Primary Care (DWB, DF, SS, LSL), Brigham and Women’s Hospital, Boston, Massachusetts; and Department of Social Medicine (LSL), Division of Medical Ethics, Harvard Medical School, Boston, Massachusetts. This study was funded in part by a grant (HS11046) from the Agency for Healthcare Research and Quality, and by the Gretchen and Ed Fish Education Fund. Requests for reprints should be addressed to Lisa Soleymani Lehmann, MD, PhD, MSc, Brigham and Women’s Hospital, 1620 Tremont Street, Boston, Massachusetts 02120, or [email protected]. Manuscript submitted September 4, 2003, and accepted in revised form March 15, 2004. 318
© 2004 by Elsevier Inc. All rights reserved.
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showed that mailing written literature with or without a videotape increased the rate of completion from a baseline of 20% to 34% (17). We therefore aimed to determine whether the use of a patient mailing and a physician reminder would be synergistic in increasing the completion of advance directives by elderly or ill outpatients.
METHODS Setting and Patients Eligible clinics had to use a common electronic medical records system and distribute a computer-generated patient summary sheet to physicians before each patient visit. Summary sheets listed the patients’ medical problems, medications, health maintenance needs, and any reminders. We invited seven eligible primary care clinics affiliated with the Brigham and Women’s Hospital to participate, of which five agreed to participate. The main reason for nonparticipation was concern that the study would generate extra physician work. Only attending faculty physicians were included. Patient panels of two authors (HH, LSL) were excluded from the study. The human subjects committee of Partners HealthCare system in Boston, Massachusetts, approved the study. Eligible patients were either ⱖ70 years of age, or ⱖ50 years of age with one of the following chronic illnesses: acquired immunodeficiency syndrome or human immunodeficiency virus infection, cancer other than basal or squamous cell skin cancer, cardiomyopathy, pulmonary edema, cerebrovascular accident, cirrhosis, end-stage renal disease or chronic renal dysfunction, chronic pulmonary disease, paraplegia or quadriplegia, or amyotrophic lateral sclerosis. Eligible patients had a scheduled appointment with their primary physician within 6 months from the recruitment date. Patients were excluded if they spoke neither English nor Spanish, had met their physician fewer than two times, had documented dementia or psychosis, or had an advance directive documented in the electronic record. Patient information was obtained from the electronic medical record. Supplemental information about race was obtained from a follow-up survey. We met with physicians from each clinic to explain the study and invite participation. Participating physicians were sent an e-mail about how to document completion of advance directives in the electronic medical record.
Randomization The study contained three arms: a physician reminder arm, a physician reminder plus patient mailing arm, and a control arm. The unit of randomization was the clinic or, for larger clinics, the suite (a clinic subgroup with a separate waiting room). Each arm included at least one hospital-based and one community-based suite. To ensure approximately equal numbers of patients per group, clinics and suites were grouped together in a preassigned
fashion. A blinded programmer using a random number generator randomly assigned each group to one of the three study arms.
Blinding Physicians were not informed of their group assignments. The study investigator (HH) who assessed outcomes was not blinded. All patients were mailed a letter and a postcard 3 weeks before the start of the study and were asked to return the card within 14 days if they did not want to participate. The letter to the control and physician reminder groups informed patients that they would receive a follow-up survey, whereas the letter to the physician reminder plus patient mailing group indicated that patients would receive an initial mailing and a follow-up survey.
Sample We required 313 patients per study arm to have an 80% chance of detecting a 10% difference between the control and intervention groups, assuming a maximum rate of completion of 20% in the control group and 30% in the intervention groups. We assumed that 20% of patients would decline to participate or fail to keep their appointment, so we aimed to recruit 1128 patients. We recruited two sets of eligible patients. In June 2001, we recruited patients aged ⱖ75 years and those aged ⱖ50 years who had a comorbid disease as described above. To achieve a sufficient sample size, we lowered the eligible age for patients with no concomitant illnesses to 70 years in August 2001 and recruited all eligible patients.
Intervention The interventions took place between June 2001 and January 2002. Both intervention arms received computerized reminders. Computerized reminders were already in use at our institution for cervical cancer screening, mammography, cholesterol testing, and several other health maintenance interventions, and preliminary data have shown them to be effective. Advance directives could be entered in one of two linked electronic medical records. The reminder read: “Your patient is x years old with a history of y medical condition and is missing key information about advance directives.” It instructed physicians to enter data about discussion or completion of the living will and health care proxy in either the inpatient or outpatient electronic medical record. Reminders were printed at the bottom of patient summary sheets at every patient visit during the study period. Patients who were randomly assigned to the physician reminder plus mailed advance directive arm were sent a packet 1 to 6 weeks before their next scheduled primary care appointment. Mailed packets included a letter signed by the practice director and the study investigators, two educational brochures, a stamped envelope addressed to the practice, and a set of advance directives forms. The
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educational brochures were a short leaflet designed by the hospital (not available in Spanish) as well as a 15-page color booklet (19) (available in English and Spanish) that included definitions, a values history, and comments from patient experiences. The letter encouraged patients to return the completed directives by mail to the practice and advised patients to ask their physicians any questions about the forms. If a patient’s next appointment occurred before the end of the opt-out period, we chose the next scheduled appointment by scanning the appointment schedules regularly. We used the standard Brigham and Women’s Hospital health care proxy. We revised the standard hospital living will to present two options. Patients could indicate their “choice to limit life-sustaining treatment” or their “choice to use all life-sustaining treatment” within generally accepted medical standards. When original directives were returned to the practices, they were forwarded to the principal investigator, who photocopied them and returned the originals to the patients. We requested advance directives from the practice managers of the mailed packet intervention on a regular basis. A copy of the advance directive was kept for study records, and a copy was forwarded to the primary care physician. No changes were made in the electronic medical record by investigators.
Outcomes The primary study outcome was a completed advance directive. Completion was defined as either documentation of an advance directive in the electronic medical record or a written directive returned to the clinic and forwarded to the study investigators. Secondary outcomes were documented discussion or completion of an advance directive, completion of a living will, or completion of a health care proxy. We did not review individual visit notes for documentation of information about advance directives as such information is unlikely to be useful since it is not easily located.
Statistical Analysis Demographic and clinical characteristics of each trial arm were compared with controls using the chi-squared test for categorical data and the Wilcoxon rank-sum test for non-normally distributed continuous data (SAS 8.2; SAS Institute, Cary, North Carolina). We compared the frequency of outcomes in the intervention and control groups using the chi-squared test. To account for the fact that patients seeing the same physician may have correlated outcomes, we used SUDAAN software, version 8.0 (Research Triangle Institute, Research Triangle Park, North Carolina), to generate accurate standard errors for analyses of outcomes. Because we used a cluster randomized design, we examined whether differences in patient characteristics between groups were responsible for differences in outcomes by performing multivariable logis320
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tic regression. Demographic and clinical characteristics that were considered likely to be associated with completion of advance directives a priori or that differed between study arms were included in the regression model. Primary analyses were done using an intention-to-treat model. All tests of significance (P ⬍0.05) were two-sided.
RESULTS Five clinics agreed to participate. The two largest clinics were subdivided into two or three suites with separate waiting rooms. One clinic employed 3 physicians, but only 1 physician used the summary sheets; this physician was the sole representative from that clinic. The control group comprised 20 physicians from three clinics (15 women [75%]; mean [⫾ SD] age, 43 ⫾ 9 years), the reminder-only group comprised 11 physicians from two clinics (6 women [55%]; mean age, 47 ⫾ 11 years), and the reminder plus mailing group comprised 14 physicians from three clinics (6 women [43%]; mean age, 40 ⫾ 8 years) (Figure). No physician in the participating clinics refused to take part. Using a computer algorithm, we identified 1407 patients who met the study entry criteria (Figure). Fortyeight of these patients were later considered ineligible because they had some advance directive information within a comments section on manual review, and 280 patients (20%) opted not to participate. Compared with participants, nonparticipants were more likely to be older and white and to have private insurance. These differences were consistent across the three arms of the study. Of the 1079 subjects who agreed to participate, 895 received their assigned intervention. One hundred and eighty-four patients did not receive their assignment because they either failed to keep an appointment within the study period or, for 39 patients in the mailing arm, because we did not accurately identify an upcoming appointment to send the packet of advance directive information prior to the appointment. At baseline, there were differences in patient characteristics between the three arms (Table 1). Compared with controls, patients in the reminder-only arm were significantly more likely to be men, to have private insurance, and to have qualified for the study because of age alone and not because of chronic illness. Patients in the physician reminder plus patient mailing arm were significantly older and more likely to be men than patients in the control arm. In the intention-to-treat analysis (Table 2), patients in the physician reminder plus patient mailing arm were more likely to have completed a living will or health care proxy than were patients in the control group (odds ratio [OR] ⫽ 7.7; 95% confidence interval [CI]: 2.0 to 33), whereas patients in the reminder-only
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Figure. Flow of participants through cluster randomized trial.
group were not more likely to do so than were controls (OR ⫽ 0.87; 95% CI: 0.19 to 4.03). After adjustment for patient and physician characteristics, the physician reminder and patient mailing intervention remained associated significantly with a greater likelihood of completion of advance directives and with the combined outcome of advance directive discussion or completion (Table 3). The number of doctor visits was the only other variable in the multivariate model that was associated significantly with advance directive completion. Patient age, sex, race, insurance status, and number of comorbid illnesses, as well as physician age, sex, and practice size, did not affect the primary outcome. Older age was a significant predictor only of the combined outcome of discussion or completion of an advance directive. In the multivariate model, black patients were less likely than white patients to have completed a living will (OR ⫽ 0.27; 95% CI: 0.08 to 0.91). In an analysis that included only the 895 patients who received their assigned treatment, 1.8% (5/286) of patients in the control group, 1.5% (5/332) in the physician
reminder group, and 14% (38/277) in the physician reminder plus patient mailing group completed an advance directive. The likelihood of completion of an advance directive in the physician reminder plus patient mailing group increased (OR ⫽ 7.3; 95% CI: 1.9 to 28), while the physician reminder-only group showed no significant difference from controls. Of the 48 advance directives completed by patients from all groups, 43 were documented under the advance directive heading in the electronic medical record and five were returned to the study investigators but not documented in the chart. Of the 20 paper directives received by study investigators, 18 contained a formal living will. All contained a health care proxy. All living wills specified a preference for limitation of care in the event of terminal illness.
DISCUSSION We found that a combined intervention of a mailing to patients and a reminder to their physicians resulted in a
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Table 1. Demographic and Clinical Characteristics of the 1079 Participants Control (n ⫽ 334)
Characteristic
Physician Reminder (n ⫽ 385)
Physician Reminder ⫹ Patient Mailing (n ⫽ 360)
Number (%), Mean ⫾ SD, or Median (Range) Age (years) Female sex Race White Black Hispanic Other/unknown Privately insured‡ English-speaking Number of qualifying illnesses 0§ 1 ⱖ2 Number of visits
70.7 ⫾ 10.1 255 (76)
72.4 ⫾ 9.7 263 (68)*
72.9 ⫾ 9.6* 222 (62)†
193 (58) 80 (24) 9 (3) 52 (15) 242 (72) 324 (97)
244 (63) 68 (18) 5 (1) 68 (18) 322 (84)† 379 (99)
196 (54) 88 (24) 12 (3) 64 (18) 266 (74) 349 (97)
137 (41) 161 (48) 36 (11) 2 (0–11)
213 (55)† 150 (39) 22 (6) 2 (0–14)
171 (47) 151 (42) 38 (11) 2 (0–12)
* P ⱕ0.05 compared with control. † P ⬍0.01 compared with control. ‡ Of the 830 patients with private insurance, 72% (n ⫽ 602) had Medicare supplemental. § Only patients over age 70 years had no comorbid illnesses.
substantial increase in the completion of advance directives, although the absolute proportion of patients completing them was still low. After adjusting for clustering and demographic variables, the benefit of a mailing remained highly significant. In addition, delivery of a computerized reminder alone had no effect, suggesting that all of the benefit was related to the mailings. The study results are encouraging because our intervention was simple and low cost, and involved minimal work by physicians, a feasible option for an entire health care system. Indeed, the study suggests that a patientfocused intervention may be much more effective than a physician-focused intervention alone. Computerized reminders have been effective in many other settings (15). However, advance directives may be less amenable to such reminders because physicians perceive that discussions take too much time, have trouble
locating forms, or are uncomfortable bringing up end-oflife issues for fear of upsetting patients. Reminders in the study by Dexter et al (16) may have been more effective because they were more prominently displayed, they included space for physicians to respond to a question about advance directives, and physicians received prior training about advance directives. System interventions that improve reminders in general could also be helpful. After completion of this study, our institution began displaying reminders on the primary patient summary screen on the computer, making them more difficult to be overlooked. Computer-based reminder systems that make it easy for physicians to send advance directive materials to patients by mail, the Internet, or another modality might be more effective. Computerized record systems that are well equipped to process advance directives would be a valuable asset as they
Table 2. Unadjusted Rates of Completion and Discussion of Advance Directives
Variable
Control (n ⫽ 334)
Number (%) Completion of any advance directive Discussion or completion of advance directive Completion of health care proxy Completion of living will
5 (1.5) 9 (2.7) 5 (1.5) 3 (0.9)
5 (1.3) 7 (1.8) 5 (1.3) 2 (0.5)
* Compared with control. 322
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Physician Reminder ⫹ Patient Mailing (n ⫽ 360)
Physician Reminder (n ⫽ 385)
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P Value*
Number (%)
P Value*
0.85 0.48 0.85 0.59
38 (11) 46 (13) 37 (10) 28 (6)
0.005 0.003 0.004 0.007
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Table 3. Factors Associated with Actions on Advance Directives in Multivariate Analyses Completion of Advance Directives
Variable
Discussion About or Completion of Advance Directives
Odds Ratio (95% Confidence Interval) Physician reminder intervention Physician reminder plus patient mailing intervention Patient age (per 10 years) Female sex Black race Private insurance Comorbid conditions 1 ⱖ2 Three or more doctor visits Physician age (per 10 years) Female physician Physician practice size (per 100 patients)
0.88 (0.21–3.7) 5.9 (1.5–22)* 1.3 (0.70–2.4) 1.4 (0.81–2.4) 0.41 (0.12–1.4) 0.99 (0.49–2.0)
0.81 (0.29–2.3) 4.2 (1.9–9.5)† 1.6 (1.1–2.3)* 1.6 (0.96–2.5) 0.58 (0.27–1.3) 1.1 (0.60–1.9)
0.61 (0.25–1.5) 0.87 (0.30–2.5) 2.5 (1.6–3.9)† 0.86 (0.59–1.3) 0.62 (0.29–1.4) 0.98 (0.93–1.03)
0.61 (0.21–1.2) 1.6 (0.66–3.9) 2.1 (1.3–3.4)* 0.81 (0.58–1.1) 0.77 (0.40–1.5) 0.96 (0.92–1.01)
* P ⬍0.03. † P ⬍0.001.
could track completion of forms and allow dissemination and updating of these documents, especially as more patients begin to interact with their providers electronically. Physician reminders and patient mailings about advance directives have previously been studied separately (16 –18). Our results expand these findings by testing a combination of these two simple methods to promote completion of advance directives. Our mailing intervention also differed in that we coordinated it with a doctor visit. Ninety percent of advance directives completed during the study were entered into the medical record by providers. Our study has several limitations. Due to sample size needs, we were unable to include a “patient mailing only” arm to determine whether the physician reminder added any synergy to the patient mailing. We were only aware that an advance directive had been completed if a doctor documented it in the appropriate part of the record or if a patient returned it to us directly. We did not read individual visit notes or refer to the paper chart for the presence of an advance directive. We could have underestimated the number of directives completed if they were documented only on paper. We were also unable to mail a packet to every patient in the intervention group before their office appointment because of limitations in identifying appointments on time, which was partially done manually. These limitations, along with the fact that our intervention did not mandate a face-to-face interaction between providers and patients, probably account for the low rate of overall completion. Our study was also not designed to explore the cost-effectiveness of the intervention, and whether advance directives affect resource utilization at the end of life remains unclear (20 –22).
In conclusion, we found that mailing advance directives to older or chronically ill patients before a primary care office visit at which their physicians also received a reminder resulted in an increased rate of completion of advance directives. The computerized physician reminder on its own had no effect. The strategy of mailing advance directives costs relatively little and could be used more widely by health care organizations. Future research and quality improvement efforts should focus on encouraging patients to put advance directives on their agendas. Such patient-targeted interventions may help to ensure that the discussion of goals of care is not bypassed during a busy office encounter.
ACKNOWLEDGMENT The authors wish to acknowledge the contributions of Julie Fiskio, who provided programming expertise support; Joseph So, who diligently coordinated patient mailings; and Stephen Persell, MD, MPH, who assisted us with manuscript revision.
REFERENCES 1. Omnibus Reconciliation Act of 1990. Pub L No. 101-508, §4206, 4751. 2. Miles SH. Koepp R. Weber EP. Advance end-of-life treatment planning. A research review. Arch Intern Med. 1996;156:1062–1068. 3. Teno JM, Lynn J, Phillips RS, et al. Do formal advance directives affect resuscitation decisions and the use of resources for seriously ill patients? J Clin Ethics. 1994;5:23–30. 4. Bradley EH, Hallemeier AG, Fried TR, et al. Documentation of discussions about prognosis with terminally ill patients. Am J Med. 2001;111:218 –223. 5. Balaban RB. A physician’s guide to talking about end-of-life care. J Gen Intern Med. 2000;15:195–200.
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Completing Advance Directives in the Primary Care Setting/Heiman et al 6. Smucker WD, Ditto PH, Moore KA, et al. Elderly outpatients respond favorably to a physician-initiated advance directive discussion. J Am Board Fam Pract. 1993;6:473– 482. 7. Tierney WM, Dexter PR, Gramelspacher GP, et al. The effect of discussions about advance directives on patients’ satisfaction with primary care. J Gen Intern Med. 2001;16:32– 40. 8. Comprehensive Accreditation Manual for Hospitals: The Official Handbook. Oakbrook Terrace, Illinois: Joint Commission on Accreditation of Healthcare Organizations; 2003. Patients Rights and Organizational Ethics Standard (RI) 1.2.5. 9. Hare J, Nelson C. Will outpatients complete living wills? A comparison of two interventions. J Gen Intern Med. 1991;6:41– 46. 10. Sulmasy DP, Song KY, Marx ES, Mitchell JM. Strategies to promote the use of advance directives in a residency outpatient practice. J Gen Intern Med. 1996;11:657– 663. 11. Luptak MK, Boult C. A method for increasing elders’ use of advance directives. Gerontologist. 1994;34:409 – 412. 12. Meier DE, Gold G, Mertz K, et al. Enhancement of proxy appointment for older persons: physician counseling in the ambulatory setting. J Am Geriatr Soc. 1996;44:37– 43. 13. Sachs GA, Stocking CB, Miles SH. Empowerment of the older patient? A randomized controlled trial to increase discussion and use of advance directives. J Am Geriatr Soc. 1992;40:269 –273. 14. Richter KP, Langel S, Fawcett SB, et al. Promoting the use of advance directives. An empirical study. Arch Fam Med. 1995;4: 609 – 615.
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15. Johnston ME, Langton KB, Haynes RB, Mathieu A. Effects of computer-based clinical decision support systems on clinician performance and patient outcomes. A critical appraisal of research. Ann Intern Med. 1994;120:135–142. 16. Dexter PR, Wolinsky FD, Gramelspacher GP, et al. Effectiveness of computer-generated reminders for increasing discussions about advance directives and completion of advance directive forms. A randomized, controlled trial. Ann Intern Med. 1998;128:102–110. 17. Brown JB, Beck A, Moles M, Barrett P. Practical methods to increase use of advance medical directives. J Gen Intern Med. 1999;14: 21–26. 18. Rubin SM, Strull WM, Fialkow MF, Weiss SJ, Lo B. Increasing the completion of the durable power of attorney for health care. A randomized, controlled trial. JAMA. 1994;271:209 –212. 19. The StayWell Company. Advance Medical Directives. Your Wishes for Future Medical Care. San Bruno, California: The StayWell Company; 1999. 20. Emanuel EJ. Cost savings at the end of life. What do the data show? JAMA. 1996;276:1907–1914. 21. Chambers CV, Diamond JJ, Perkel RL, Lasch LA. Relationship of advance directives to hospital charges in a Medicare population. Arch Intern Med. 1994;154:541–547. 22. Schneiderman LJ, Kronick R, Kaplan RM, at al. Effects of offering advance directives on medical treatments and costs. Ann Intern Med. 1992;117:599 – 606.
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sician reminder group, 14% (38/277) in the physician reminder plus patient mailing group, and 1.8% (5/286) in the control group had completed advance directives. In multivariate analyses, patients in the physician reminder plus patient mailing group were much more likely than controls to have completed advance directives (odds ratio [OR] ⫽ 5.9; 95% confidence interval [CI]: 1.5 to 22), whereas patients in the physician reminder– only group were no more likely than controls to have completed advance directives (OR ⫽ 0.88; 95% CI: 0.21 to 3.7). CONCLUSION: Mailing health care proxy and living will forms and literature to patients before an appointment at which their physicians received a reminder about advance directives yielded a small but significant improvement in completion of these documents. A physician reminder alone did not have an effect. Am J Med. 2004;117:318 –324. ©2004 by Elsevier Inc.
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of advance directives. The Joint Commission on Accreditation of Healthcare Organizations revised its hospital standards in 2002 to require that hospital-based ambulatory clinics be equipped to assist patients with advance directives (8). Several studies have tested interventions to increase the completion of advance directives among outpatients (9 –14). It is difficult to generalize the results of these studies to a busy primary care setting, however, because they either took place in geriatric clinics or required time-intensive interventions such as physician training sessions or patient visits with nurses or social workers. Simpler interventions such as computer-generated physician reminders have been shown to be effective in promoting preventive services such as blood pressure measurements and vaccinations (15), suggesting that such reminders can also help to increase the completion of advance directives. Dexter and colleagues found that computerized reminders to physicians were associated with up to a sixfold greater completion rate of advance directives as compared with no physician reminders (16). Patient mailings, another simple intervention, were shown to boost completion rates in two controlled trials that assessed the efficacy of mailings to older patients (17,18). One study (18) demonstrated that mailing the California Durable Power of Attorney for Healthcare led 18% of patients to complete an advance directive as compared with 0.4% of controls, whereas the other study
ore than a decade has passed since the Patient Self-Determination Act mandated that hospitals ask patients whether they have advance directives and make these documents available (1). Advance directives, which include health care proxies and living wills, are intended to promote patient autonomy and dignity at the end of life and to permit shared decision making between patients and doctors (2). Yet, despite support from providers and the public, only a minority of patients complete advance directives, and physicians are often unaware of the documents even when patients have executed them (3,4). Patient-physician discussions about patients’ wishes regarding future medical interventions may increase patients’ satisfaction with their physicians (5–7), and the primary care clinic may be the best setting for discussions From the Division of General Internal Medicine (HH), Feinberg School of Medicine, Northwestern University, Chicago, Illinois; Division of General Medicine and Primary Care (DWB, DF, SS, LSL), Brigham and Women’s Hospital, Boston, Massachusetts; and Department of Social Medicine (LSL), Division of Medical Ethics, Harvard Medical School, Boston, Massachusetts. This study was funded in part by a grant (HS11046) from the Agency for Healthcare Research and Quality, and by the Gretchen and Ed Fish Education Fund. Requests for reprints should be addressed to Lisa Soleymani Lehmann, MD, PhD, MSc, Brigham and Women’s Hospital, 1620 Tremont Street, Boston, Massachusetts 02120, or [email protected]. Manuscript submitted September 4, 2003, and accepted in revised form March 15, 2004. 318
© 2004 by Elsevier Inc. All rights reserved.
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Completing Advance Directives in the Primary Care Setting/Heiman et al
showed that mailing written literature with or without a videotape increased the rate of completion from a baseline of 20% to 34% (17). We therefore aimed to determine whether the use of a patient mailing and a physician reminder would be synergistic in increasing the completion of advance directives by elderly or ill outpatients.
METHODS Setting and Patients Eligible clinics had to use a common electronic medical records system and distribute a computer-generated patient summary sheet to physicians before each patient visit. Summary sheets listed the patients’ medical problems, medications, health maintenance needs, and any reminders. We invited seven eligible primary care clinics affiliated with the Brigham and Women’s Hospital to participate, of which five agreed to participate. The main reason for nonparticipation was concern that the study would generate extra physician work. Only attending faculty physicians were included. Patient panels of two authors (HH, LSL) were excluded from the study. The human subjects committee of Partners HealthCare system in Boston, Massachusetts, approved the study. Eligible patients were either ⱖ70 years of age, or ⱖ50 years of age with one of the following chronic illnesses: acquired immunodeficiency syndrome or human immunodeficiency virus infection, cancer other than basal or squamous cell skin cancer, cardiomyopathy, pulmonary edema, cerebrovascular accident, cirrhosis, end-stage renal disease or chronic renal dysfunction, chronic pulmonary disease, paraplegia or quadriplegia, or amyotrophic lateral sclerosis. Eligible patients had a scheduled appointment with their primary physician within 6 months from the recruitment date. Patients were excluded if they spoke neither English nor Spanish, had met their physician fewer than two times, had documented dementia or psychosis, or had an advance directive documented in the electronic record. Patient information was obtained from the electronic medical record. Supplemental information about race was obtained from a follow-up survey. We met with physicians from each clinic to explain the study and invite participation. Participating physicians were sent an e-mail about how to document completion of advance directives in the electronic medical record.
Randomization The study contained three arms: a physician reminder arm, a physician reminder plus patient mailing arm, and a control arm. The unit of randomization was the clinic or, for larger clinics, the suite (a clinic subgroup with a separate waiting room). Each arm included at least one hospital-based and one community-based suite. To ensure approximately equal numbers of patients per group, clinics and suites were grouped together in a preassigned
fashion. A blinded programmer using a random number generator randomly assigned each group to one of the three study arms.
Blinding Physicians were not informed of their group assignments. The study investigator (HH) who assessed outcomes was not blinded. All patients were mailed a letter and a postcard 3 weeks before the start of the study and were asked to return the card within 14 days if they did not want to participate. The letter to the control and physician reminder groups informed patients that they would receive a follow-up survey, whereas the letter to the physician reminder plus patient mailing group indicated that patients would receive an initial mailing and a follow-up survey.
Sample We required 313 patients per study arm to have an 80% chance of detecting a 10% difference between the control and intervention groups, assuming a maximum rate of completion of 20% in the control group and 30% in the intervention groups. We assumed that 20% of patients would decline to participate or fail to keep their appointment, so we aimed to recruit 1128 patients. We recruited two sets of eligible patients. In June 2001, we recruited patients aged ⱖ75 years and those aged ⱖ50 years who had a comorbid disease as described above. To achieve a sufficient sample size, we lowered the eligible age for patients with no concomitant illnesses to 70 years in August 2001 and recruited all eligible patients.
Intervention The interventions took place between June 2001 and January 2002. Both intervention arms received computerized reminders. Computerized reminders were already in use at our institution for cervical cancer screening, mammography, cholesterol testing, and several other health maintenance interventions, and preliminary data have shown them to be effective. Advance directives could be entered in one of two linked electronic medical records. The reminder read: “Your patient is x years old with a history of y medical condition and is missing key information about advance directives.” It instructed physicians to enter data about discussion or completion of the living will and health care proxy in either the inpatient or outpatient electronic medical record. Reminders were printed at the bottom of patient summary sheets at every patient visit during the study period. Patients who were randomly assigned to the physician reminder plus mailed advance directive arm were sent a packet 1 to 6 weeks before their next scheduled primary care appointment. Mailed packets included a letter signed by the practice director and the study investigators, two educational brochures, a stamped envelope addressed to the practice, and a set of advance directives forms. The
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educational brochures were a short leaflet designed by the hospital (not available in Spanish) as well as a 15-page color booklet (19) (available in English and Spanish) that included definitions, a values history, and comments from patient experiences. The letter encouraged patients to return the completed directives by mail to the practice and advised patients to ask their physicians any questions about the forms. If a patient’s next appointment occurred before the end of the opt-out period, we chose the next scheduled appointment by scanning the appointment schedules regularly. We used the standard Brigham and Women’s Hospital health care proxy. We revised the standard hospital living will to present two options. Patients could indicate their “choice to limit life-sustaining treatment” or their “choice to use all life-sustaining treatment” within generally accepted medical standards. When original directives were returned to the practices, they were forwarded to the principal investigator, who photocopied them and returned the originals to the patients. We requested advance directives from the practice managers of the mailed packet intervention on a regular basis. A copy of the advance directive was kept for study records, and a copy was forwarded to the primary care physician. No changes were made in the electronic medical record by investigators.
Outcomes The primary study outcome was a completed advance directive. Completion was defined as either documentation of an advance directive in the electronic medical record or a written directive returned to the clinic and forwarded to the study investigators. Secondary outcomes were documented discussion or completion of an advance directive, completion of a living will, or completion of a health care proxy. We did not review individual visit notes for documentation of information about advance directives as such information is unlikely to be useful since it is not easily located.
Statistical Analysis Demographic and clinical characteristics of each trial arm were compared with controls using the chi-squared test for categorical data and the Wilcoxon rank-sum test for non-normally distributed continuous data (SAS 8.2; SAS Institute, Cary, North Carolina). We compared the frequency of outcomes in the intervention and control groups using the chi-squared test. To account for the fact that patients seeing the same physician may have correlated outcomes, we used SUDAAN software, version 8.0 (Research Triangle Institute, Research Triangle Park, North Carolina), to generate accurate standard errors for analyses of outcomes. Because we used a cluster randomized design, we examined whether differences in patient characteristics between groups were responsible for differences in outcomes by performing multivariable logis320
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tic regression. Demographic and clinical characteristics that were considered likely to be associated with completion of advance directives a priori or that differed between study arms were included in the regression model. Primary analyses were done using an intention-to-treat model. All tests of significance (P ⬍0.05) were two-sided.
RESULTS Five clinics agreed to participate. The two largest clinics were subdivided into two or three suites with separate waiting rooms. One clinic employed 3 physicians, but only 1 physician used the summary sheets; this physician was the sole representative from that clinic. The control group comprised 20 physicians from three clinics (15 women [75%]; mean [⫾ SD] age, 43 ⫾ 9 years), the reminder-only group comprised 11 physicians from two clinics (6 women [55%]; mean age, 47 ⫾ 11 years), and the reminder plus mailing group comprised 14 physicians from three clinics (6 women [43%]; mean age, 40 ⫾ 8 years) (Figure). No physician in the participating clinics refused to take part. Using a computer algorithm, we identified 1407 patients who met the study entry criteria (Figure). Fortyeight of these patients were later considered ineligible because they had some advance directive information within a comments section on manual review, and 280 patients (20%) opted not to participate. Compared with participants, nonparticipants were more likely to be older and white and to have private insurance. These differences were consistent across the three arms of the study. Of the 1079 subjects who agreed to participate, 895 received their assigned intervention. One hundred and eighty-four patients did not receive their assignment because they either failed to keep an appointment within the study period or, for 39 patients in the mailing arm, because we did not accurately identify an upcoming appointment to send the packet of advance directive information prior to the appointment. At baseline, there were differences in patient characteristics between the three arms (Table 1). Compared with controls, patients in the reminder-only arm were significantly more likely to be men, to have private insurance, and to have qualified for the study because of age alone and not because of chronic illness. Patients in the physician reminder plus patient mailing arm were significantly older and more likely to be men than patients in the control arm. In the intention-to-treat analysis (Table 2), patients in the physician reminder plus patient mailing arm were more likely to have completed a living will or health care proxy than were patients in the control group (odds ratio [OR] ⫽ 7.7; 95% confidence interval [CI]: 2.0 to 33), whereas patients in the reminder-only
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Figure. Flow of participants through cluster randomized trial.
group were not more likely to do so than were controls (OR ⫽ 0.87; 95% CI: 0.19 to 4.03). After adjustment for patient and physician characteristics, the physician reminder and patient mailing intervention remained associated significantly with a greater likelihood of completion of advance directives and with the combined outcome of advance directive discussion or completion (Table 3). The number of doctor visits was the only other variable in the multivariate model that was associated significantly with advance directive completion. Patient age, sex, race, insurance status, and number of comorbid illnesses, as well as physician age, sex, and practice size, did not affect the primary outcome. Older age was a significant predictor only of the combined outcome of discussion or completion of an advance directive. In the multivariate model, black patients were less likely than white patients to have completed a living will (OR ⫽ 0.27; 95% CI: 0.08 to 0.91). In an analysis that included only the 895 patients who received their assigned treatment, 1.8% (5/286) of patients in the control group, 1.5% (5/332) in the physician
reminder group, and 14% (38/277) in the physician reminder plus patient mailing group completed an advance directive. The likelihood of completion of an advance directive in the physician reminder plus patient mailing group increased (OR ⫽ 7.3; 95% CI: 1.9 to 28), while the physician reminder-only group showed no significant difference from controls. Of the 48 advance directives completed by patients from all groups, 43 were documented under the advance directive heading in the electronic medical record and five were returned to the study investigators but not documented in the chart. Of the 20 paper directives received by study investigators, 18 contained a formal living will. All contained a health care proxy. All living wills specified a preference for limitation of care in the event of terminal illness.
DISCUSSION We found that a combined intervention of a mailing to patients and a reminder to their physicians resulted in a
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Table 1. Demographic and Clinical Characteristics of the 1079 Participants Control (n ⫽ 334)
Characteristic
Physician Reminder (n ⫽ 385)
Physician Reminder ⫹ Patient Mailing (n ⫽ 360)
Number (%), Mean ⫾ SD, or Median (Range) Age (years) Female sex Race White Black Hispanic Other/unknown Privately insured‡ English-speaking Number of qualifying illnesses 0§ 1 ⱖ2 Number of visits
70.7 ⫾ 10.1 255 (76)
72.4 ⫾ 9.7 263 (68)*
72.9 ⫾ 9.6* 222 (62)†
193 (58) 80 (24) 9 (3) 52 (15) 242 (72) 324 (97)
244 (63) 68 (18) 5 (1) 68 (18) 322 (84)† 379 (99)
196 (54) 88 (24) 12 (3) 64 (18) 266 (74) 349 (97)
137 (41) 161 (48) 36 (11) 2 (0–11)
213 (55)† 150 (39) 22 (6) 2 (0–14)
171 (47) 151 (42) 38 (11) 2 (0–12)
* P ⱕ0.05 compared with control. † P ⬍0.01 compared with control. ‡ Of the 830 patients with private insurance, 72% (n ⫽ 602) had Medicare supplemental. § Only patients over age 70 years had no comorbid illnesses.
substantial increase in the completion of advance directives, although the absolute proportion of patients completing them was still low. After adjusting for clustering and demographic variables, the benefit of a mailing remained highly significant. In addition, delivery of a computerized reminder alone had no effect, suggesting that all of the benefit was related to the mailings. The study results are encouraging because our intervention was simple and low cost, and involved minimal work by physicians, a feasible option for an entire health care system. Indeed, the study suggests that a patientfocused intervention may be much more effective than a physician-focused intervention alone. Computerized reminders have been effective in many other settings (15). However, advance directives may be less amenable to such reminders because physicians perceive that discussions take too much time, have trouble
locating forms, or are uncomfortable bringing up end-oflife issues for fear of upsetting patients. Reminders in the study by Dexter et al (16) may have been more effective because they were more prominently displayed, they included space for physicians to respond to a question about advance directives, and physicians received prior training about advance directives. System interventions that improve reminders in general could also be helpful. After completion of this study, our institution began displaying reminders on the primary patient summary screen on the computer, making them more difficult to be overlooked. Computer-based reminder systems that make it easy for physicians to send advance directive materials to patients by mail, the Internet, or another modality might be more effective. Computerized record systems that are well equipped to process advance directives would be a valuable asset as they
Table 2. Unadjusted Rates of Completion and Discussion of Advance Directives
Variable
Control (n ⫽ 334)
Number (%) Completion of any advance directive Discussion or completion of advance directive Completion of health care proxy Completion of living will
5 (1.5) 9 (2.7) 5 (1.5) 3 (0.9)
5 (1.3) 7 (1.8) 5 (1.3) 2 (0.5)
* Compared with control. 322
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Physician Reminder ⫹ Patient Mailing (n ⫽ 360)
Physician Reminder (n ⫽ 385)
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P Value*
Number (%)
P Value*
0.85 0.48 0.85 0.59
38 (11) 46 (13) 37 (10) 28 (6)
0.005 0.003 0.004 0.007
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Table 3. Factors Associated with Actions on Advance Directives in Multivariate Analyses Completion of Advance Directives
Variable
Discussion About or Completion of Advance Directives
Odds Ratio (95% Confidence Interval) Physician reminder intervention Physician reminder plus patient mailing intervention Patient age (per 10 years) Female sex Black race Private insurance Comorbid conditions 1 ⱖ2 Three or more doctor visits Physician age (per 10 years) Female physician Physician practice size (per 100 patients)
0.88 (0.21–3.7) 5.9 (1.5–22)* 1.3 (0.70–2.4) 1.4 (0.81–2.4) 0.41 (0.12–1.4) 0.99 (0.49–2.0)
0.81 (0.29–2.3) 4.2 (1.9–9.5)† 1.6 (1.1–2.3)* 1.6 (0.96–2.5) 0.58 (0.27–1.3) 1.1 (0.60–1.9)
0.61 (0.25–1.5) 0.87 (0.30–2.5) 2.5 (1.6–3.9)† 0.86 (0.59–1.3) 0.62 (0.29–1.4) 0.98 (0.93–1.03)
0.61 (0.21–1.2) 1.6 (0.66–3.9) 2.1 (1.3–3.4)* 0.81 (0.58–1.1) 0.77 (0.40–1.5) 0.96 (0.92–1.01)
* P ⬍0.03. † P ⬍0.001.
could track completion of forms and allow dissemination and updating of these documents, especially as more patients begin to interact with their providers electronically. Physician reminders and patient mailings about advance directives have previously been studied separately (16 –18). Our results expand these findings by testing a combination of these two simple methods to promote completion of advance directives. Our mailing intervention also differed in that we coordinated it with a doctor visit. Ninety percent of advance directives completed during the study were entered into the medical record by providers. Our study has several limitations. Due to sample size needs, we were unable to include a “patient mailing only” arm to determine whether the physician reminder added any synergy to the patient mailing. We were only aware that an advance directive had been completed if a doctor documented it in the appropriate part of the record or if a patient returned it to us directly. We did not read individual visit notes or refer to the paper chart for the presence of an advance directive. We could have underestimated the number of directives completed if they were documented only on paper. We were also unable to mail a packet to every patient in the intervention group before their office appointment because of limitations in identifying appointments on time, which was partially done manually. These limitations, along with the fact that our intervention did not mandate a face-to-face interaction between providers and patients, probably account for the low rate of overall completion. Our study was also not designed to explore the cost-effectiveness of the intervention, and whether advance directives affect resource utilization at the end of life remains unclear (20 –22).
In conclusion, we found that mailing advance directives to older or chronically ill patients before a primary care office visit at which their physicians also received a reminder resulted in an increased rate of completion of advance directives. The computerized physician reminder on its own had no effect. The strategy of mailing advance directives costs relatively little and could be used more widely by health care organizations. Future research and quality improvement efforts should focus on encouraging patients to put advance directives on their agendas. Such patient-targeted interventions may help to ensure that the discussion of goals of care is not bypassed during a busy office encounter.
ACKNOWLEDGMENT The authors wish to acknowledge the contributions of Julie Fiskio, who provided programming expertise support; Joseph So, who diligently coordinated patient mailings; and Stephen Persell, MD, MPH, who assisted us with manuscript revision.
REFERENCES 1. Omnibus Reconciliation Act of 1990. Pub L No. 101-508, §4206, 4751. 2. Miles SH. Koepp R. Weber EP. Advance end-of-life treatment planning. A research review. Arch Intern Med. 1996;156:1062–1068. 3. Teno JM, Lynn J, Phillips RS, et al. Do formal advance directives affect resuscitation decisions and the use of resources for seriously ill patients? J Clin Ethics. 1994;5:23–30. 4. Bradley EH, Hallemeier AG, Fried TR, et al. Documentation of discussions about prognosis with terminally ill patients. Am J Med. 2001;111:218 –223. 5. Balaban RB. A physician’s guide to talking about end-of-life care. J Gen Intern Med. 2000;15:195–200.
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Completing Advance Directives in the Primary Care Setting/Heiman et al 6. Smucker WD, Ditto PH, Moore KA, et al. Elderly outpatients respond favorably to a physician-initiated advance directive discussion. J Am Board Fam Pract. 1993;6:473– 482. 7. Tierney WM, Dexter PR, Gramelspacher GP, et al. The effect of discussions about advance directives on patients’ satisfaction with primary care. J Gen Intern Med. 2001;16:32– 40. 8. Comprehensive Accreditation Manual for Hospitals: The Official Handbook. Oakbrook Terrace, Illinois: Joint Commission on Accreditation of Healthcare Organizations; 2003. Patients Rights and Organizational Ethics Standard (RI) 1.2.5. 9. Hare J, Nelson C. Will outpatients complete living wills? A comparison of two interventions. J Gen Intern Med. 1991;6:41– 46. 10. Sulmasy DP, Song KY, Marx ES, Mitchell JM. Strategies to promote the use of advance directives in a residency outpatient practice. J Gen Intern Med. 1996;11:657– 663. 11. Luptak MK, Boult C. A method for increasing elders’ use of advance directives. Gerontologist. 1994;34:409 – 412. 12. Meier DE, Gold G, Mertz K, et al. Enhancement of proxy appointment for older persons: physician counseling in the ambulatory setting. J Am Geriatr Soc. 1996;44:37– 43. 13. Sachs GA, Stocking CB, Miles SH. Empowerment of the older patient? A randomized controlled trial to increase discussion and use of advance directives. J Am Geriatr Soc. 1992;40:269 –273. 14. Richter KP, Langel S, Fawcett SB, et al. Promoting the use of advance directives. An empirical study. Arch Fam Med. 1995;4: 609 – 615.
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15. Johnston ME, Langton KB, Haynes RB, Mathieu A. Effects of computer-based clinical decision support systems on clinician performance and patient outcomes. A critical appraisal of research. Ann Intern Med. 1994;120:135–142. 16. Dexter PR, Wolinsky FD, Gramelspacher GP, et al. Effectiveness of computer-generated reminders for increasing discussions about advance directives and completion of advance directive forms. A randomized, controlled trial. Ann Intern Med. 1998;128:102–110. 17. Brown JB, Beck A, Moles M, Barrett P. Practical methods to increase use of advance medical directives. J Gen Intern Med. 1999;14: 21–26. 18. Rubin SM, Strull WM, Fialkow MF, Weiss SJ, Lo B. Increasing the completion of the durable power of attorney for health care. A randomized, controlled trial. JAMA. 1994;271:209 –212. 19. The StayWell Company. Advance Medical Directives. Your Wishes for Future Medical Care. San Bruno, California: The StayWell Company; 1999. 20. Emanuel EJ. Cost savings at the end of life. What do the data show? JAMA. 1996;276:1907–1914. 21. Chambers CV, Diamond JJ, Perkel RL, Lasch LA. Relationship of advance directives to hospital charges in a Medicare population. Arch Intern Med. 1994;154:541–547. 22. Schneiderman LJ, Kronick R, Kaplan RM, at al. Effects of offering advance directives on medical treatments and costs. Ann Intern Med. 1992;117:599 – 606.
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