Patient Education and Counseling 52 (2004) 107–112
Promoting patient participation in consultations: a randomised controlled trial to evaluate the effectiveness of three patient-focused interventions Jane Kidda,*, Theresa M. Marteaub, Stephen Robinsonc, Obioha C. Ukoumunned, Clare Tydemane a
Faculty of Medicine, Imperial College, 4th Floor, Patterson Center, 20 South Wharf Road, London W2 1PD, UK b GKT School of Medicine, London, UK c St. Mary’s Hospital NHS Trust, London, UK d GKT School of Medicine, London, UK e Faculty of Medicine, Imperial College, London, UK Received 15 May 2002; received in revised form 10 December 2002; accepted 27 December 2002
Abstract The aim of this experimental study was to evaluate the effectiveness of three patient-focused interventions designed to increase patient question asking in clinical consultations. Patients were randomly allocated to one of five conditions to receive either one of three interventions or to serve as an attention control group or a control group. The primary outcome measure was question asking by the patient of their physician. Participants in the intervention groups did not ask more questions than participants in the control groups. Immediately after the consultation participants in the intervention groups had higher levels of self-efficacy in asking questions. Three months after the index visit patients in the intervention groups were significantly more likely to be satisfied to some degree than patients in the control group. There was no difference in diabetic control. These results suggest that simple brief patient-focused interventions do not change patient behaviour in medical outpatient consultations. # 2003 Elsevier Science Ireland Ltd. All rights reserved. Keywords: Patient empowerment; Brief interventions; Doctor–patient communication
1. Introduction Emphasis is increasingly being placed on encouraging patients to play a more active part in their health care [1]. This has developed from a growing awareness that many patients are dissatisfied with the information they receive during medical consultations [2] and that there is an association between patient satisfaction, adherence and health status. One way of improving satisfaction is to give patients the information that they require. To do this in a patientcentred manner patients can be encouraged to ask their own questions. In this way information that is important to each individual patient can be identified. Several studies have tried to improve the information patients receive by attempting to alter the behaviour of one or both participants in the medical consultation [3–16]. There is evidence that complex interventions work [10,16]. For *
Corresponding author. Tel.: þ44-20-7886-1990; fax: þ44-20-7886-1995. E-mail address:
[email protected] (J. Kidd).
example, Roter’s intervention was 10 min in length; the patients wrote down the questions they wanted to ask; and, they took the list of questions into the consultation with them. There is some evidence that simple interventions may also work [13,17]. For example, Thompson et al. [13] gave patients a written message from the doctor encouraging patients to ask questions. The validity of the study is unknown as the outcome measure was patient self-report of question asking. While patient self-report can be a valid measure, in the context of a very specific outcome—number of questions asked—there are more valid ways of measuring outcome. Thompson et al. do not state that they report patient perception of number of questions asked but that the outcome measure is number of questions asked. These studies have worked with different study populations and within each study the patient population has been heterogeneous with regard to both demographic and disease related variables. These intervention studies have contained several elements: patients have received time to think about questions they really want to ask; they have been encouraged to write their questions down; they have had their questions clarified by an independent assistant; they have had
0738-3991/$ – see front matter # 2003 Elsevier Science Ireland Ltd. All rights reserved. doi:10.1016/S0738-3991(03)00018-1
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the opportunity to rehearse questions; they have taken their list of questions into the consultation; they have heard a statement of approval from the doctor that she/he likes patients to ask questions. The aim of the current study is to take a sample of patients similar to that represented in the work described above and replicate the earlier work using a valid measure of question asking. Each intervention contains only one component. This paper reports an intervention study designed to assess the impact of three components of earlier, successful patient-focused interventions which increased patient question asking in clinical consultations, patient satisfaction, and health status. Roter [10] identified enabling, predisposing and reinforcing factors as predictors of patient question asking. A complementary perspective involves identifying disabling factors or barriers to patients asking questions. These barriers can be divided into two categories: cognitive and affective. Cognitive disabling factors include the patients’ perceived lack of ability to ask questions, and their perception of time constraints on the consultation. They also include forgetting the question(s), and perceived unacceptability of asking questions. Affective barriers arise when patients anticipate feeling humiliated or embarrassed if they ask questions. The interventions (encouragement to ask questions, identifying questions and, identifying and rehearsing questions) were based on the work of Roter [10], Greenfield et al. [16] and Thompson et al. [13]. Each intervention was designed to overcome one or more of these barriers. The encouragement to ask questions was designed to address the barrier of unacceptability of asking questions of doctors. Identifying questions was designed to overcome the cognitive barrier of failing to recall questions. The third intervention: question identification and rehearsal; was designed to overcome the cognitive barriers of failing to recall questions and having the ability to ask questions together with the affective barrier of feeling embarrassed. Two hypotheses are tested: (1) patients in the intervention groups will ask more questions than those in the control groups, (2) as a function of the number of barriers being addressed by each intervention, participants in the ‘‘identify and rehearse questions’’ group will ask more questions than those in either the ‘‘encouragement to ask questions’’ or ‘‘identify questions’’ groups.
were all patients fluent in English who were attending the diabetic clinic at a London teaching hospital between August 1994 and the end of March 1995. 2.2. The interventions 2.2.1. Intervention 1: encouragement to ask questions A written message was designed to address the cognitive barrier of the unacceptability of asking questions of doctors. Patients were given a written message by the researcher which was signed by their doctor aimed at encouraging them to ask questions. The message, amended from Thompson et al. [13], read as follows: Good health care needs the doctor and patient to work well together. Most people have some questions about their health or their treatment. If you have any questions, please feel free to ask them when you see me today. 2.2.2. Intervention 2: question identification This intervention was designed to overcome the cognitive barrier of failing to recall questions. Before their appointment with the doctor, patients spent 5 min with a researcher. During this time, patients were helped to identify at least three questions that they wanted to ask of their doctor. 2.2.3. Intervention 3: question identification and rehearsal This intervention was designed to overcome the cognitive barriers of neither recalling questions nor having the ability to ask questions, and the affective barrier of feeling embarrassed. This intervention was the same as intervention 2, but in addition these patients were encouraged to rehearse their questions out loud with the researcher. 2.2.4. Control groups There were two control groups. The patients in the attention control group spent the same amount of time with the researcher discussing the layout of the hospital, the appointment system and routines of the diabetic clinic. The participants in the no treatment control group provided baseline data and data for comparisons immediately after the consultation and 3 months later. Consultations were recorded using a Sony professional audio-tape recorder, with an external microphone.
2. Method 2.3. Measures 2.1. Design Patients were randomly allocated to one of five conditions to receive either one of three interventions, to serve as an attention control group or to act as a control for the possible effects of non-experimental influences. Assessment of the independent variables was made prior to the intervention. Assessments of the dependent variables were made twice: immediately after the consultation and 3 months after the index visit. Those eligible for participation
2.3.1. Question asking The number of questions asked was counted from the transcripts of the audio-tape recordings independently by two raters blind to the group to which the patient had been allocated. 2.3.2. Self-efficacy in asking questions A two-item questionnaire measured and compared patients’ perceived ability to ask questions of (a) a known
J. Kidd et al. / Patient Education and Counseling 52 (2004) 107–112
and (b) an unknown hospital doctor in a clinical consultation. Patients responded to the question ‘‘How confident are you that you can ask questions in the following situations?’’ on a scale of 0 (not at all confident) to 100 (extremely confident). 2.3.3. Satisfaction with the consultation This was assessed using a single-item measure ‘‘Overall, how satisfied are you with the consultation?’’ Participants responded on an eight-point scale from zero—not at all satisfied to seven—extremely satisfied. This scale has a test– retest reliability of 0.86, with evidence of both concurrent and predictive validity [18]. For analysis, the variable was dichotomised by grouping together the first five categories labelled ‘‘less satisfied’’ and the last three categories, labelled satisfied. 2.3.4. Diabetic control The physical measure of health status was glycolated haemoglobin (HbA1c) which was used to examine how well patients’ diabetes was controlled between the time of entering the study and the time of the follow-up questionnaire, 3 months later. A lower value indicates better control. 2.3.5. Background data Patients provided information on their current age, age at onset of diabetes, gender, ethnicity, occupation, number of previous visits, number of years with diabetes and whether they were insulin dependent or not. 2.4. Statistical analysis and study power calculations Regression methods for hierarchical data [19] were used to adjust all analyses for the correlation in responses between patients who saw the same doctor. The random effects model extension of ordinary least squares regression was used to analyse the continuous outcomes number of questions asked, self efficacy in asking questions and the glycolated haemoglobin (HbA1c) measure of diabetic control. Logistic regression was used to analyse the dichotomous outcome whether or not the patients were satisfied, with robustified variance estimates used to adjust for correlated responses [20]. Although the outcomes are summarised by the five groups, most analyses compared the three intervention groups to the two control groups. The extent to which satisfaction immediately after the consultation was associated with diabetic control 3 months after the index visit was examined by comparing the mean glycolated haemoglobin levels between those who were and were not satisfied. Analyses were also implemented to identify the socio-demographic characteristics that were associated with question asking. A test of an interaction effect between age and ethnic group on question asking was implemented. All analyses were implemented using Stata [21]. It was originally intended that the primary outcome, mean number of questions asked, be compared
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between five groups using analysis of variance. The mean effect size for the work reported by Roter [10], Greenfield et al. [16] and Thompson et al. [13] was 39%. Cohen’s [22] tables for deriving the required sample size for analysis of variance tests indicated that 16 participants are required in each group to detect an effect size of 40% with 80% power at the 5% level of significance. 2.5. Procedure Ethical committee approval for the study was sought and granted. Patients were asked to participate in the study after they had booked in for their outpatient appointment at the diabetic clinic. They were informed that a study was being conducted examining information patients received during their consultations. Patients were informed that they would be randomly allocated to one of five groups and that they could not choose which group they would be in. They were also informed that their consultation would be audio-tape recorded and that if they did not wish this to be done then they should not agree to participate in the study. Those who agreed to participate gave informed, written consent and were then randomised. Random allocation was determined prior to data collection by a computer programmed to randomly select numbers one to five, representing the five groups in the study, for the required number of participants. The group allocation was passed on to the researcher in sealed envelopes. These were opened by the researcher in front of patients agreeing to participate in the trial. Participants were assured that it would not be possible to identify from whom the data were collected, either by questionnaire or by audio-tape.
3. Results 202 (61%) of the 332 patients approached, participated in the study; 93 refused to participate, and 37 were withdrawn from the study as they were called in for their consultation prior to being randomised to a group. Table 1 shows the demographic and disease characteristics of the sample. Randomisation was successful in that there were no differences between the five study groups on any of these variables. There was no difference between participants and those who declined in relation to whether or not they were insulin dependent or in the level of control they had over their diabetes at the start of the study (HbA1c level). Those agreeing to participate in the study were younger, more likely to be male and more likely to be white. Results for outcome by group are given in Table 2. A formal test of the number of questions asked revealed that there was no significant difference between the three intervention groups (P ¼ 0:44). Results of the analyses comparing the three intervention groups to the two control groups are given in Table 3. There
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Table 1 Demographic and disease characteristics of the sample (n ¼ 202) Variable
Mean (range)
Current age Age at onset No. of previous visits No. of years with diabetes HbA1c level at baseline
47 (17–78) 38 (4–74) 12 (1–200) 9 (1–42) 8.0 (4.7–13.6)
Gender (%) Male Female
56 44
Insulin dependency (%) Non-insulin dependent Insulin dependent
57 43
Ethnicity (%) White Black Asian Middle/Far East
64 17 13 6
Occupation (%) Working Retired Unemployed Student Housewife Registered disabled
50 20 13 8 6 3
Socio-economic group (%) 2 3 4 5 1
35 32 15 11 7
was no significant difference between intervention and control groups in respect of mean number of questions asked. Immediately after the consultation, participants in the intervention groups reported higher levels of self-efficacy
in asking questions of both known and unknown hospital doctors than did participants in the two control groups (see Table 3). The proportion of participants who said that they were satisfied to some degree immediately after the consultation was similar between the intervention and control groups (91% (100/110) versus 89% (76/85), respectively). The proportion of participants who said that they were satisfied at 3 months after the index visit was higher amongst the participants in the intervention groups (87% (83/95)) than amongst the control participants (74% (52/70)). A logistic regression analysis revealed that the intervention participants were significantly more likely to be satisfied than the control participants; odds ratio ¼ 2.39 (95% CI: 1.33–4.32). Satisfaction for the intervention groups remained almost the same between the two time points whereas it declined for the control groups. The mean HbA1c score was not significantly different between patients who were satisfied immediately after the consultation (mean (S.D.) 8.04 (1.48) and patients who were not satisfied (mean (S.D.) 8.33 (1.78)); adjusted mean difference and 95% CI, 0.29 (0.56 to 1.14). Examination of the demographic data revealed that question asking in the consultation was related to age (P ¼ 0:008) and ethnic group (P ¼ 0:003). Participants aged 45 and over asked significantly more questions than participants aged under 45 (mean (S.D.) 10.8 (7.9) versus 8.0 (5.6)). Patients who classified themselves as white (OPCS classification) asked significantly more questions than patients who classified themselves as belonging to other ethnic groups (mean (S.D.) 10.4 (7.8) versus 7.7 (4.7)). A test for an interaction effect between age group and ethnicity on question asking was significant (P ¼ 0:03) and revealed that increasing age is predictive of greater question asking only amongst white patients and not amongst patients from other ethnic groups (see Table 4). Gender was not significantly related to question asking (P ¼ 0:72).
Table 2 Outcomes by randomisation group
Number of questions asked Self-efficacy: known hospital doctor immediately after consultation Self-efficacy: unknown hospital doctor immediately after consultation Self-efficacy: known hospital doctor 3 months after index visit Self-efficacy: unknown hospital doctor 3 months after index visit Satisfaction immediately after consultation Satisfaction 3 months after index visit Diabetic control
Encouragement to ask questions (n ¼ 38): mean (S.D.)
Identification of questions (n ¼ 42): mean (S.D.)
Identification and rehearsal of questions (n ¼ 35): mean (S.D.)
Attention control (n ¼ 40): mean (S.D.)
Control (n ¼ 47): mean (S.D.)
10.4 (7.9) 89.5 (14.3)
8.8 (4.5) 88.2 (16.9)
10.6 (7.9) 87.5 (21.7)
9.3 (8.6) 83.3 (23.8)
8.9 (6.2) 77.3 (26.8)
78.3 (22.4)
78.2 (23.2)
73.6 (32.1)
75.8 (28.7)
57.9 (31.5)
91.7 (10.7)
86.0 (17.5)
85.5 (20.8)
86.0 (19.9)
78.9 (22.6)
77.2 (21.0)
73.8 (24.1)
71.5 (24.4)
75.8 (27.7)
66.2 (29.8)
6.0 (1.1) 5.3 (1.6) 7.8 (1.4)
5.8 (0.9) 5.6 (1.3) 8.2 (1.9)
6.1 (1.1) 5.7 (1.2) 8.3 (1.1)
5.9 (1.1) 5.3 (1.6) 7.9 (1.8)
5.9 (1.0) 5.0 (1.6) 8.3 (1.5)
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Table 3 Outcome by intervention-control status Outcome
Intervention (n ¼ 115): mean (S.D.)
Control (n ¼ 87): mean (S.D.)
Adjusted difference (95% confidence interval)
P-value
Number of questions asked Self-efficacy: known hospital doctors immediately after consultation Self-efficacy: unknown hospital doctors immediately after consultation Self-efficacy: known hospital doctors 3 months after index visit Self-efficacy: unknown hospital doctors 3 months after index visit Diabetic control
9.9 (6.8) 88.4 (17.8)
9.1 (7.4) 80.0 (25.5)
0.8 8.4
1.1 8.4
0.9 2.2
3.0 14.6
0.28 0.008
76.7 (26.1)
66.0 (31.4)
10.7
10.7
2.5
19.0
0.01
87.7 (16.9)
82.1 (21.6)
5.6
5.6
0.4
11.5
0.07
74.2 (23.1)
70.5 (29.1)
3.6
3.6
4.4
11.7
0.38
8.1 (1.5)
8.1 (1.7)
0.05
0.05
0.55
Table 4 Number of questions asked by age and ethnicity (mean (S.D.)) Ethnicity
Age under 45
n
45 and older
n
White Other ethnic groups
8.1 (5.8) 7.6 (5.2)
56 28
12.4 (8.9) 7.8 (4.4)
62 35
4. Discussion and conclusions None of the interventions was successful in increasing patient question asking in outpatient consultations. The interventions did, however, increase self-efficacy in question asking, immediately after the consultation. The interventions may have failed to change behaviour because the patients were already active in the consultation. The patients in the current study asked more questions in contrast to many earlier studies, when the mean number was lower at 4.3 (Roter) [10], 4.5 (Thompson et al.) [13] and 3.3 (McCann and Weinman) [15]. The relatively high number of questions asked in the current study compared to other studies may be explained if patient anxiety was high in the other intervention study populations. Patients in the current study reported relatively low levels of anxiety during the consultation but there was still a significant difference in anxiety level between those asking more than and those asking less than eight questions. In addition the participants in the current study reported high levels of self-efficacy in asking questions of both known and unknown hospital doctors. The current study worked with a heterogeneous group of patients and targeted hypothesised barriers to question asking but no attempt was made to target the barriers salient for each patient. Barriers salient to each patient divide into two categories: characteristics related to the disease and those related to the patient’s perception of their own barriers. A more patient-centred intervention might have been more successful, targeted at each patient’s perceived difficulties. A second possible reason for the failure of the interventions relates to the interventions themselves. The interventions were designed to be short, simple and patient-focused. Perhaps they were too short and simple. In the current study
Difference (intervention control)
Estimate
0.45
0.85
each intervention took around 5 min to complete. Greenfield et al. [16] reported an intervention of 20 min which patients received twice. Roter’s [10] experimental group received an intervention of 10 min duration and women entered their consultations with their list of questions. Alternatively it could be argued that these longer more successful interventions may be due to experimenter effect. Such an intervention would be more difficult to implement in daily practice. Thompson et al. [13] intervention was briefer but was not set in a chronic care clinic. In addition, it comprised only female participants and used a self-report assessment of the number of questions asked. Another study conducted in the UK with a brief intervention reported only a marginal difference between experimental and control groups [15]. Nonetheless, the interventions did increase self-efficacy to ask questions, which is an important precursor to behaviour [23]. This suggests that the interventions had the basis for behaviour change. Age and ethnicity predicted question asking. Patients who are older ask more questions. This finding is in contrast to work with cancer patients which reports that younger patients ask more questions [17,24]. In the context of the present study two explanations are possible. Older patients with a chronic condition have had more experience of health care and may feel more confident in asking questions. Alternatively they may be experiencing symptoms of late-onset diabetes for the first time and this may prompt question asking. Patients who describe themselves as white ask more questions than patients who describe themselves as belonging to any other ethnic group. Information on the impact of ethnicity on patient participation in consultations is seldom presented. Sixty-four percent of the participants in the current study described themselves as white and the majority of the doctors in the study were white; it may be that perceived similarity facilitates question asking. One possible explanation that covers both factors is that doctors may behave differently in consultations with patients who are older or white. Two further reasons for the interventions not being successful are related to the design of the study and can be amended in future work. Several patients saw the same
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doctor. Although the doctors were blind to the individual’s group they may not have been immune to the effects of the interventions. Thus, patients coming into the study later on would not need to ask questions as the information would be given spontaneously to the patient. Evidence against this explanation comes from examining the rates of question asking during the course of the trial: there was no correlation between the number of questions asked and when patients were recruited into the trial. One could argue that the outcome measure of number of questions asked is not appropriate as an outcome as it takes a very reductionist view of a consultation. The current study, however, was designed to replicate earlier work using the same outcome measure. 4.1. Conclusions The results of the current study together with those of McCann and Weinman [15] and Fleissig et al. [25] suggest that simple, brief, patient-focused interventions do not change patient behaviour in medical outpatient consultations. Simple, brief interventions to encourage patients to play a more active part in their health care increased their perceived ability to ask questions but did not change behaviour. Future studies would be advised to take a more in-depth analysis of consultations and to consider additional outcome measures. 4.2. Practice implications Interventions may need to be more patient-focused, addressing the barriers for the individual participant. In terms of possible interventions the research would not make assumptions about what barriers a patient might have but work with the patient to explore the barriers that they do have. Do they forget their questions and how could that be overcome? Do they feel embarrassed and what would help them to overcome that embarrassment? Alternatively doctors can be taught to expect patients to have questions and encouraged to ask every patient in a tone of interest and respect ‘‘What questions have you got for me?’’ Doctors can then acknowledge the questions and work with them.
Acknowledgements Funding: the study was funded by a grant from the Medical Research Council no. G9312973. T.M. Marteau is funded by The Wellcome Trust. Conflict of interest: none.
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