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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

Brief Summary:

Background

Doctors are regarded as professionals, and specific teaching on professional behaviour is considered important in many countries. For medical students, early patient contact experiences were found to be an important way of learning about professionalism, and learning activities promoting critical reflection were particularly effective. Medical students consider that patient-centredness is one of the most important aspects of medical professionalism, and the PPOS questionnaire has been used extensively in measuring the attitudes of medical students towards patient-centredness. The PPOS-D12 questionnaire is a validated German version of that questionnaire.

The study aim is to assess how a structured, in-depth, home-based interview with a patient with a chronic illness affects first-year medical students' patient-centredness.

Methods

In this randomised controlled trial, medical students who are in the first year of their studies at the University of Bern will be randomised to either seeing a patient with a chronic illness for a structured, in-depth interview in their own home (the intervention), or to reading an educational document that gives information about consultation skills (the sham comparator).

Students will complete the PPOS-D12 survey before and after the interventions, so that changes in their scores can be calculated, and the mean scores of the two groups compared. Secondary outcomes will be the effect of students' gender and prior exposure to chronic illness in the participant or her/his close relatives and friends on their PPOS-D12 scores. A nested study will measure the strength of association between the GP teachers' own levels of patient/doctor-centredness and changes in their students' levels over the year.

Discussion

This research will consider the effect of an in-depth, structured interview with a patient with a chronic illness on changes in first-year medical students' levels of patient-centredness. There is existing evidence that medical students' levels of patient-centredness reduce over their student years, and this study will contribute to an understanding of how this reduction can be minimised or reversed.


Condition or disease Intervention/treatment Phase
Educational Techniques Other: Intervention Other: Sham comparator Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 317 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomised controlled trial, with sham control.
Masking: Single (Participant)
Primary Purpose: Other
Official Title: The Effect of a Structured, Home-based Interview With a Patient With a Chronic Illness on First-year Medical Students' Patient-centredness: a Randomised Controlled Trial.
Actual Study Start Date : September 28, 2018
Actual Primary Completion Date : June 20, 2019
Actual Study Completion Date : June 20, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
Other: 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.

Other Name: Active intervention

Sham Comparator: 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.
Other: 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.




Primary Outcome Measures :
  1. Changes in Medical Students' Patient-centredness as Assessed by the PPOS-D12 Questionnaire [ Time Frame: 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).



Secondary Outcome Measures :
  1. The Effect of Students' Gender on Their Levels of Patient-centredness as Assessed by the PPOS-D12 Questionnaire [ Time Frame: At baseline (start of academic year). ]

    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).


  2. The Effect of Students Having Previously Studied Another Subject as an Undergraduate. [ Time Frame: At baseline (start of academic year). ]

    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).


  3. The Effect of Students' Prior Exposure to Chronic Illness on Their Levels of Patient-centredness as Assessed by the PPOS-D12 Questionnaire. [ Time Frame: At baseline (start of academic year). ]

    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).



Other Outcome Measures:
  1. Correlation Between GP Teachers' Patient-centredness and Changes in Levels of Their Students Levels of Patient-centredness, as Assessed by the PPOS-D12 Questionnaire. [ 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. ]

    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.




Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Medical students who are in the first year of their studies (their first Bachelor year) at the University of Bern, Switzerland.

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03722810


Locations
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Switzerland
Berner Institut für Hausarztmedizin (BIHAM)
Bern, Kanton Bern, Switzerland, 3012
Sponsors and Collaborators
University of Bern
Investigators
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Principal Investigator: Michael F Harris, MB BS MMEd Employee
  Study Documents (Full-Text)

Documents provided by University of Bern:
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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Bern
ClinicalTrials.gov Identifier: NCT03722810    
Other Study ID Numbers: 1
First Posted: October 29, 2018    Key Record Dates
Results First Posted: September 16, 2020
Last Update Posted: September 16, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We may share all IPD that underlie results in a publication.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Starting 6 months after publication
Access Criteria: Emailed request to study lead (MH).

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Bern:
Medical Professionalism
Professionalism Education