Trial Outcomes & Findings for The Effect of a Structured, Home-based Interview With a Patient on First-year Medical Students' Patient-centredness. (NCT NCT03722810)
NCT ID: NCT03722810
Last Updated: 2020-09-16
Results Overview
Change in students' PPOS-D12 scores from base-line (at the start of the academic year) to the end of their year-long primary care attachment. The PPOS-D12 is the validated German-language version of the Patient-Provider Orientation Scale (Kiessling C, Fabry G, Rudolf Fischer M, et al., 2014), a self-completed questionnaire to assess patient-centredness among medical students. PPOS-D12 scale scores can vary from a mean score per question of 1 (most doctor-centred) to 6 (most patient-centred). For the primary outcome measure, to adjust for a difference in baseline PPOS-D12 scores between the two intervention groups, and after exploration of the data suggested that the effect of the baseline scores was linear, we compared the mean difference in the study start and end PPOS-D12 scores for the active and sham intervention groups using analysis of covariance (ANCOVA).
COMPLETED
NA
317 participants
Between study start, 28th September 2018 and study completion, June 20, 2019, approximately 9 months.
2020-09-16
Participant Flow
More students agreed to participate in the study than we had expected.
Participant milestones
| Measure |
Active Comparator: Patient Interview
This intervention will be a structured in-depth interview with a patient with a chronic illness that has been chosen by the student's allocated GP teacher. The interview will be followed by a structured interview with the practice nurse and then a structured debriefing interview with the GP teacher.
Intervention: The intervention will be a structured in-depth interview with a patient with a chronic illness that has been chosen by the student's allocated GP teacher. These chronic diseases are the four conditions at the top of a list of diseases with high disability-adjusted life years (DALY) scores in Switzerland: ischaemic heart disease, low back pain, major depressive disorder and COPD.
GP teachers and students will be told that the students' intervention interviews need to be unaccompanied and at patients' own homes. The interview will be followed by a structured interview with the practice nurse and then a structured debriefing interview with the GP teacher.
|
Sham Comparator: Document
In this intervention, the student's allocated GP teacher will give the student time to read a document that gives information about consultation skills, and asks questions that the student will need to discuss with the GP teacher.
Sham comparator: In the sham comparator, the student's allocated GP teacher will be give the student time to read a document that gives information about consultation skills, and asks questions that the student will need to discuss with the GP teacher. The document is designed to have real educational value, and to complement BIHAM's department-based consultation skills teaching.
|
|---|---|---|
|
Overall Study
STARTED
|
157
|
160
|
|
Overall Study
COMPLETED
|
150
|
156
|
|
Overall Study
NOT COMPLETED
|
7
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Active Comparator: Patient Interview
n=157 Participants
This intervention will be a structured in-depth interview with a patient with a chronic illness that has been chosen by the student's allocated GP teacher. The interview will be followed by a structured interview with the practice nurse and then a structured debriefing interview with the GP teacher.
Intervention: The intervention will be a structured in-depth interview with a patient with a chronic illness that has been chosen by the student's allocated GP teacher. These chronic diseases are the four conditions at the top of a list of diseases with high disability-adjusted life years (DALY) scores in Switzerland: ischaemic heart disease, low back pain, major depressive disorder and COPD.
GP teachers and students will be told that the students' intervention interviews need to be unaccompanied and at patients' own homes. The interview will be followed by a structured interview with the practice nurse and then a structured debriefing interview with the GP teacher.
|
Sham Comparator: Document
n=160 Participants
In this intervention, the student's allocated GP teacher will give the student time to read a document that gives information about consultation skills, and asks questions that the student will need to discuss with the GP teacher.
Sham comparator: In the sham comparator, the student's allocated GP teacher will be give the student time to read a document that gives information about consultation skills, and asks questions that the student will need to discuss with the GP teacher. The document is designed to have real educational value, and to complement BIHAM's department-based consultation skills teaching.
|
Total
n=317 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=157 Participants
|
0 Participants
n=160 Participants
|
0 Participants
n=317 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
157 Participants
n=157 Participants
|
160 Participants
n=160 Participants
|
317 Participants
n=317 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=157 Participants
|
0 Participants
n=160 Participants
|
0 Participants
n=317 Participants
|
|
Sex: Female, Male
Female
|
92 Participants
n=157 Participants
|
103 Participants
n=160 Participants
|
195 Participants
n=317 Participants
|
|
Sex: Female, Male
Male
|
65 Participants
n=157 Participants
|
57 Participants
n=160 Participants
|
122 Participants
n=317 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Personal experience of a serious chronic illness,
|
55 Participants
n=157 Participants
|
47 Participants
n=160 Participants
|
102 Participants
n=317 Participants
|
PRIMARY outcome
Timeframe: Between study start, 28th September 2018 and study completion, June 20, 2019, approximately 9 months.Change in students' PPOS-D12 scores from base-line (at the start of the academic year) to the end of their year-long primary care attachment. The PPOS-D12 is the validated German-language version of the Patient-Provider Orientation Scale (Kiessling C, Fabry G, Rudolf Fischer M, et al., 2014), a self-completed questionnaire to assess patient-centredness among medical students. PPOS-D12 scale scores can vary from a mean score per question of 1 (most doctor-centred) to 6 (most patient-centred). For the primary outcome measure, to adjust for a difference in baseline PPOS-D12 scores between the two intervention groups, and after exploration of the data suggested that the effect of the baseline scores was linear, we compared the mean difference in the study start and end PPOS-D12 scores for the active and sham intervention groups using analysis of covariance (ANCOVA).
Outcome measures
| Measure |
Active Comparator: Patient Interview
n=150 Participants
This intervention will be a structured in-depth interview with a patient with a chronic illness that has been chosen by the student's allocated GP teacher. The interview will be followed by a structured interview with the practice nurse and then a structured debriefing interview with the GP teacher.
Intervention: The intervention will be a structured in-depth interview with a patient with a chronic illness that has been chosen by the student's allocated GP teacher. These chronic diseases are the four conditions at the top of a list of diseases with high disability-adjusted life years (DALY) scores in Switzerland: ischaemic heart disease, low back pain, major depressive disorder and COPD.
GP teachers and students will be told that the students' intervention interviews need to be unaccompanied and at patients' own homes. The interview will be followed by a structured interview with the practice nurse and then a structured debriefing interview with the GP teacher.
|
Sham Comparator: Document
n=156 Participants
In this intervention, the student's allocated GP teacher will give the student time to read a document that gives information about consultation skills, and asks questions that the student will need to discuss with the GP teacher.
Sham comparator: In the sham comparator, the student's allocated GP teacher will be give the student time to read a document that gives information about consultation skills, and asks questions that the student will need to discuss with the GP teacher. The document is designed to have real educational value, and to complement BIHAM's department-based consultation skills teaching.
|
|---|---|---|
|
Changes in Medical Students' Patient-centredness as Assessed by the PPOS-D12 Questionnaire
|
0.23 units on a scale
Standard Deviation 0.41
|
0.32 units on a scale
Standard Deviation 0.47
|
SECONDARY outcome
Timeframe: At baseline (start of academic year).Population: The two study arms are combined for this outcome because we were interested in the effect of students' gender on their pre-intervention levels of patient-centredness.
The effect of students' gender (female/male) on their levels of patient-centredness, as measured by their PPOS-D12 questionnaire administered before the intervention (at start of academic year). PPOS-D12 scale scores can vary from a mean score per question of 1 (most doctor-centred) to 6 (most patient-centred). To measure secondary outcomes, we used linear regression to determine the effect of students' baseline characteristics on PPOS-D12 scores before the intervention (at start of academic year).
Outcome measures
| Measure |
Active Comparator: Patient Interview
n=195 Participants
This intervention will be a structured in-depth interview with a patient with a chronic illness that has been chosen by the student's allocated GP teacher. The interview will be followed by a structured interview with the practice nurse and then a structured debriefing interview with the GP teacher.
Intervention: The intervention will be a structured in-depth interview with a patient with a chronic illness that has been chosen by the student's allocated GP teacher. These chronic diseases are the four conditions at the top of a list of diseases with high disability-adjusted life years (DALY) scores in Switzerland: ischaemic heart disease, low back pain, major depressive disorder and COPD.
GP teachers and students will be told that the students' intervention interviews need to be unaccompanied and at patients' own homes. The interview will be followed by a structured interview with the practice nurse and then a structured debriefing interview with the GP teacher.
|
Sham Comparator: Document
n=111 Participants
In this intervention, the student's allocated GP teacher will give the student time to read a document that gives information about consultation skills, and asks questions that the student will need to discuss with the GP teacher.
Sham comparator: In the sham comparator, the student's allocated GP teacher will be give the student time to read a document that gives information about consultation skills, and asks questions that the student will need to discuss with the GP teacher. The document is designed to have real educational value, and to complement BIHAM's department-based consultation skills teaching.
|
|---|---|---|
|
The Effect of Students' Gender on Their Levels of Patient-centredness as Assessed by the PPOS-D12 Questionnaire
|
4.25 score on a scale
Standard Deviation 0.43
|
4.08 score on a scale
Standard Deviation 0.51
|
SECONDARY outcome
Timeframe: At baseline (start of academic year).Population: The two study arms are combined for this outcome because we were interested in the effect of students' having previously studied another subject as an undergraduate on their pre-intervention levels of patient-centredness.
The effect of students' previous experience (presence or absence of previous university degrees) on their levels of patient-centredness, as measured by their PPOS-D12 questionnaire administered before the intervention (at start of academic year). PPOS-D12 scale scores can vary from a mean score per question of 1 (most doctor-centred) to 6 (most patient-centred). To measure secondary outcomes, we used linear regression to determine the effect of students' baseline characteristics on PPOS-D12 scores before the intervention (at start of academic year).
Outcome measures
| Measure |
Active Comparator: Patient Interview
n=36 Participants
This intervention will be a structured in-depth interview with a patient with a chronic illness that has been chosen by the student's allocated GP teacher. The interview will be followed by a structured interview with the practice nurse and then a structured debriefing interview with the GP teacher.
Intervention: The intervention will be a structured in-depth interview with a patient with a chronic illness that has been chosen by the student's allocated GP teacher. These chronic diseases are the four conditions at the top of a list of diseases with high disability-adjusted life years (DALY) scores in Switzerland: ischaemic heart disease, low back pain, major depressive disorder and COPD.
GP teachers and students will be told that the students' intervention interviews need to be unaccompanied and at patients' own homes. The interview will be followed by a structured interview with the practice nurse and then a structured debriefing interview with the GP teacher.
|
Sham Comparator: Document
n=270 Participants
In this intervention, the student's allocated GP teacher will give the student time to read a document that gives information about consultation skills, and asks questions that the student will need to discuss with the GP teacher.
Sham comparator: In the sham comparator, the student's allocated GP teacher will be give the student time to read a document that gives information about consultation skills, and asks questions that the student will need to discuss with the GP teacher. The document is designed to have real educational value, and to complement BIHAM's department-based consultation skills teaching.
|
|---|---|---|
|
The Effect of Students Having Previously Studied Another Subject as an Undergraduate.
|
4.37 units on a scale
Standard Deviation 0.54
|
4.17 units on a scale
Standard Deviation 0.46
|
SECONDARY outcome
Timeframe: At baseline (start of academic year).Population: The two study arms are combined for this outcome because we were interested in the effect of students' experience of a chronic illness in the themselves or a close relative on their pre-intervention levels of patient-centredness.
The effect of students' prior exposure to chronic illness (presence or absence of experience of serious chronic illness in the participant, a relative or a close friend) on their levels of patient-centredness, as measured by their PPOS-D12 questionnaire administered before the intervention (at start of academic year). PPOS-D12 scale scores can vary from a mean score per question of 1 (most doctor-centred) to 6 (most patient-centred). To measure secondary outcomes, we used linear regression to determine the effect of students' baseline characteristics on PPOS-D12 scores before the intervention (at start of academic year).
Outcome measures
| Measure |
Active Comparator: Patient Interview
n=102 Participants
This intervention will be a structured in-depth interview with a patient with a chronic illness that has been chosen by the student's allocated GP teacher. The interview will be followed by a structured interview with the practice nurse and then a structured debriefing interview with the GP teacher.
Intervention: The intervention will be a structured in-depth interview with a patient with a chronic illness that has been chosen by the student's allocated GP teacher. These chronic diseases are the four conditions at the top of a list of diseases with high disability-adjusted life years (DALY) scores in Switzerland: ischaemic heart disease, low back pain, major depressive disorder and COPD.
GP teachers and students will be told that the students' intervention interviews need to be unaccompanied and at patients' own homes. The interview will be followed by a structured interview with the practice nurse and then a structured debriefing interview with the GP teacher.
|
Sham Comparator: Document
n=55 Participants
In this intervention, the student's allocated GP teacher will give the student time to read a document that gives information about consultation skills, and asks questions that the student will need to discuss with the GP teacher.
Sham comparator: In the sham comparator, the student's allocated GP teacher will be give the student time to read a document that gives information about consultation skills, and asks questions that the student will need to discuss with the GP teacher. The document is designed to have real educational value, and to complement BIHAM's department-based consultation skills teaching.
|
|---|---|---|
|
The Effect of Students' Prior Exposure to Chronic Illness on Their Levels of Patient-centredness as Assessed by the PPOS-D12 Questionnaire.
|
4.22 units on a scale
Standard Deviation 0.48
|
4.18 units on a scale
Standard Deviation 0.47
|
OTHER_PRE_SPECIFIED outcome
Timeframe: GP teachers: end of primary care attachment. Students: Between study start, 28th September 2018 and study completion, June 20, 2019, approximately 9 months.Population: The two study arms are combined for this outcome because we were interested in the correlation between students' and teachers' PPOS-D12 scores regardless of which intervention group they were in.
A nested study measured the strength of association between the GP teachers' own levels of patient-centredness (at end of students' primary care attachment) and changes in their own students' levels over the year (from baseline, i.e. start of academic year, to end of primary care attachment, up to 12 months), as measured by their respective PPOS-D12 scores (PPOS-D12 change for the students, PPOS-D12 score for their GP teachers). PPOS-D12 scale scores can vary from a mean score per question of 1 (most doctor-centred) to 6 (most patient-centred). We used the Pearson correlation coefficient to measure the association between GP teachers' PPOS-D12 scores and changes in their students' scores.
Outcome measures
| Measure |
Active Comparator: Patient Interview
n=306 Participants
This intervention will be a structured in-depth interview with a patient with a chronic illness that has been chosen by the student's allocated GP teacher. The interview will be followed by a structured interview with the practice nurse and then a structured debriefing interview with the GP teacher.
Intervention: The intervention will be a structured in-depth interview with a patient with a chronic illness that has been chosen by the student's allocated GP teacher. These chronic diseases are the four conditions at the top of a list of diseases with high disability-adjusted life years (DALY) scores in Switzerland: ischaemic heart disease, low back pain, major depressive disorder and COPD.
GP teachers and students will be told that the students' intervention interviews need to be unaccompanied and at patients' own homes. The interview will be followed by a structured interview with the practice nurse and then a structured debriefing interview with the GP teacher.
|
Sham Comparator: Document
In this intervention, the student's allocated GP teacher will give the student time to read a document that gives information about consultation skills, and asks questions that the student will need to discuss with the GP teacher.
Sham comparator: In the sham comparator, the student's allocated GP teacher will be give the student time to read a document that gives information about consultation skills, and asks questions that the student will need to discuss with the GP teacher. The document is designed to have real educational value, and to complement BIHAM's department-based consultation skills teaching.
|
|---|---|---|
|
Correlation Between GP Teachers' Patient-centredness and Changes in Levels of Their Students Levels of Patient-centredness, as Assessed by the PPOS-D12 Questionnaire.
|
0.088 Correlation coefficient
|
—
|
Adverse Events
Active Comparator: Patient Interview
Sham Comparator: Document
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place