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The Effect of a Structured, Home-based Interview With a Patient on First-year Medical Students' Patient-centredness.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03722810
Recruitment Status : Completed
First Posted : October 29, 2018
Results First Posted : September 16, 2020
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
University of Bern

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Other
Condition Educational Techniques
Interventions Other: Intervention
Other: Sham comparator
Enrollment 317
Recruitment Details  
Pre-assignment Details More students agreed to participate in the study than we had expected.
Arm/Group Title Active Comparator: Patient Interview Sham Comparator: Document
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 157 160
Completed 150 156
Not Completed 7 4
Arm/Group Title Active Comparator: Patient Interview Sham Comparator: Document Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 157 160 317
Hide Baseline Analysis Population Description
As per assignment in Participant Flow.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 157 participants 160 participants 317 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
157
 100.0%
160
 100.0%
317
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 157 participants 160 participants 317 participants
Female
92
  58.6%
103
  64.4%
195
  61.5%
Male
65
  41.4%
57
  35.6%
122
  38.5%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Personal experience of a serious chronic illness,  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 157 participants 160 participants 317 participants
55
  35.0%
47
  29.4%
102
  32.2%
1.Primary Outcome
Title Changes in Medical Students' Patient-centredness as Assessed by the PPOS-D12 Questionnaire
Hide Description

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).

Time Frame Between study start, 28th September 2018 and study completion, June 20, 2019, approximately 9 months.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Comparator: Patient Interview Sham Comparator: Document
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 150 156
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.23  (0.41) 0.32  (0.47)
2.Secondary Outcome
Title The Effect of Students' Gender on Their Levels of Patient-centredness as Assessed by the PPOS-D12 Questionnaire
Hide Description

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).

Time Frame At baseline (start of academic year).
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Female Male
Hide Arm/Group Description:
Female participants
Male participants
Overall Number of Participants Analyzed 195 111
Mean (Standard Deviation)
Unit of Measure: score on a scale
4.25  (0.43) 4.08  (0.51)
3.Secondary Outcome
Title The Effect of Students Having Previously Studied Another Subject as an Undergraduate.
Hide Description

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).

Time Frame At baseline (start of academic year).
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Studied Another Subject as an Undergraduate Not Previously Studied Another Subject
Hide Arm/Group Description:
Previously studied another subject as an undergraduate
Not previously studied another subject as an undergraduate
Overall Number of Participants Analyzed 36 270
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.37  (0.54) 4.17  (0.46)
4.Secondary Outcome
Title The Effect of Students' Prior Exposure to Chronic Illness on Their Levels of Patient-centredness as Assessed by the PPOS-D12 Questionnaire.
Hide Description

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).

Time Frame At baseline (start of academic year).
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Experience of a Chronic Illness No Experience of a Chronic Illness
Hide Arm/Group Description:
Experience of a chronic illness in the students themselves or a close relative.
No experience of a chronic illness in the students themselves or a close relative
Overall Number of Participants Analyzed 102 55
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.22  (0.48) 4.18  (0.47)
5.Other Pre-specified Outcome
Title Correlation Between GP Teachers' Patient-centredness and Changes in Levels of Their Students Levels of Patient-centredness, as Assessed by the PPOS-D12 Questionnaire.
Hide Description

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.

Time Frame GP teachers: end of primary care attachment. Students: Between study start, 28th September 2018 and study completion, June 20, 2019, approximately 9 months.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Correlation Between Students' and Teachers' PPOS-D12 Scores
Hide Arm/Group Description:
Relationship between change in students' PPOS-D12 scores and their teachers' PPOS-D12 scores
Overall Number of Participants Analyzed 306
Measure Type: Number
Unit of Measure: Correlation coefficient
0.088
Time Frame Between study start, 28th September 2018 and study completion, June 20, 2019, approximately 9 months.
Adverse Event Reporting Description Adverse Events were monitored/assessed for this study. No adverse events were identified as having taken place.
 
Arm/Group Title Active Comparator: Patient Interview Sham Comparator: Document
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Active Comparator: Patient Interview Sham Comparator: Document
Affected / at Risk (%) Affected / at Risk (%)
Total   0/150 (0.00%)   0/156 (0.00%) 
Hide Serious Adverse Events
Active Comparator: Patient Interview Sham Comparator: Document
Affected / at Risk (%) Affected / at Risk (%)
Total   0/150 (0.00%)   0/156 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Active Comparator: Patient Interview Sham Comparator: Document
Affected / at Risk (%) Affected / at Risk (%)
Total   0/150 (0.00%)   0/156 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Prof. Michael Harris
Organization: BIHAM, University of Bern
Phone: +44 1761 241366
EMail: michael.harris@biham.unibe.ch
Publications:
Medical Protection Society. Medical Professionalism - What do we mean? London2017 [31 October 2017]. Available from: http://www.medicalprotection.org/uk/advice-booklets/professionalism-an-mps-guide/chapter-1-medical-professionalism-what-do-we-mean
McWhinney IR. The need for a transformed clinical method. In: Stuart M, Roter D, editors. Communicasting with medical patients. London: Sage; 1989.
de Silva D. Helping measure person-centred care. In: The Health Foundation, editor. London 2014.
Archer E, Bezuidenhout J, Kidd MR, et al. Making use of an existing questionnaire to measure patient-centred attitudes in undergraduate medical students: A case study. AJHPE. 2014;6(2):150-154.
Institute for Health Metrics and Evaluation. Global burden of diseases, injuries, and risk factors study 2010, Switzerland. University of Washington, USA; 2012.
Monrouxe V, Rees C. Healthcare Professionalism: Improving Practice through Reflections on Workplace Dilemmas. Wiley-Blackwell; 2017.
Layout table for additonal information
Responsible Party: University of Bern
ClinicalTrials.gov Identifier: NCT03722810    
Other Study ID Numbers: 1
First Submitted: October 20, 2018
First Posted: October 29, 2018
Results First Submitted: July 15, 2020
Results First Posted: September 16, 2020
Last Update Posted: September 16, 2020