NCT03722810

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
317

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 28, 2018

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

October 20, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 29, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2019

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

September 16, 2020

Completed
Last Updated

September 16, 2020

Status Verified

September 1, 2020

Enrollment Period

9 months

First QC Date

October 20, 2018

Results QC Date

July 15, 2020

Last Update Submit

September 11, 2020

Conditions

Keywords

Medical ProfessionalismProfessionalism Education

Outcome Measures

Primary Outcomes (1)

  • Changes in Medical Students' Patient-centredness as Assessed by the PPOS-D12 Questionnaire

    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).

    Between study start, 28th September 2018 and study completion, June 20, 2019, approximately 9 months.

Secondary Outcomes (3)

  • The Effect of Students' Gender on Their Levels of Patient-centredness as Assessed by the PPOS-D12 Questionnaire

    At baseline (start of academic year).

  • The Effect of Students Having Previously Studied Another Subject as an Undergraduate.

    At baseline (start of academic year).

  • The Effect of Students' Prior Exposure to Chronic Illness on Their Levels of Patient-centredness as Assessed by the PPOS-D12 Questionnaire.

    At baseline (start of academic year).

Other Outcomes (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.

    GP teachers: end of primary care attachment. Students: Between study start, 28th September 2018 and study completion, June 20, 2019, approximately 9 months.

Study Arms (2)

Active comparator: patient interview

ACTIVE COMPARATOR

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

Sham comparator: document

SHAM COMPARATOR

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

Interventions

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.

Also known as: Active intervention
Active comparator: patient interview

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.

Sham comparator: document

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Berner Institut für Hausarztmedizin (BIHAM)

Bern, Canton of Bern, 3012, Switzerland

Location

Related Publications (23)

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    BACKGROUND
  • Seif-Farshad M, Bazmi S, Amiri F, Fattahi F, Kiani M. Knowledge of medical professionalism in medical students and physicians at Shahid Beheshti University of Medical Sciences and affiliated hospitals-Iran. Medicine (Baltimore). 2016 Nov;95(45):e5380. doi: 10.1097/MD.0000000000005380.

    PMID: 27828869BACKGROUND
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    PMID: 22372211BACKGROUND
  • Swick HM. Toward a normative definition of medical professionalism. Acad Med. 2000 Jun;75(6):612-6. doi: 10.1097/00001888-200006000-00010.

    PMID: 10875505BACKGROUND
  • Sivalingam N. Teaching and learning of professionalism in medical schools. Ann Acad Med Singap. 2004 Nov;33(6):706-10.

    PMID: 15608822BACKGROUND
  • Goldie J, Dowie A, Cotton P, Morrison J. Teaching professionalism in the early years of a medical curriculum: a qualitative study. Med Educ. 2007 Jun;41(6):610-7. doi: 10.1111/j.1365-2923.2007.02772.x.

    PMID: 17518842BACKGROUND
  • Birden H, Glass N, Wilson I, Harrison M, Usherwood T, Nass D. Teaching professionalism in medical education: a Best Evidence Medical Education (BEME) systematic review. BEME Guide No. 25. Med Teach. 2013 Jul;35(7):e1252-66. doi: 10.3109/0142159X.2013.789132.

    PMID: 23829342BACKGROUND
  • Stockley AJ, Forbes K. Medical professionalism in the formal curriculum: 5th year medical students' experiences. BMC Med Educ. 2014 Nov 30;14:259. doi: 10.1186/s12909-014-0259-0.

    PMID: 25433816BACKGROUND
  • Levenstein JH, McCracken EC, McWhinney IR, Stewart MA, Brown JB. The patient-centred clinical method. 1. A model for the doctor-patient interaction in family medicine. Fam Pract. 1986 Mar;3(1):24-30. doi: 10.1093/fampra/3.1.24.

    PMID: 3956899BACKGROUND
  • McWhinney IR. The need for a transformed clinical method. In: Stuart M, Roter D, editors. Communicasting with medical patients. London: Sage; 1989.

    BACKGROUND
  • Bauman AE, Fardy HJ, Harris PG. Getting it right: why bother with patient-centred care? Med J Aust. 2003 Sep 1;179(5):253-6. doi: 10.5694/j.1326-5377.2003.tb05532.x.

    PMID: 12924973BACKGROUND
  • Institute of Medicine (US) Committee on Quality of Health Care in America. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington (DC): National Academies Press (US); 2001. Available from http://www.ncbi.nlm.nih.gov/books/NBK222274/

    PMID: 25057539BACKGROUND
  • de Silva D. Helping measure person-centred care. In: The Health Foundation, editor. London 2014.

    BACKGROUND
  • 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.

    BACKGROUND
  • Krupat E, Hiam CM, Fleming MZ, Freeman P. Patient-centeredness and its correlates among first year medical students. Int J Psychiatry Med. 1999;29(3):347-56. doi: 10.2190/DVCQ-4LC8-NT7H-KE0L.

    PMID: 10642908BACKGROUND
  • Tsimtsiou Z, Kerasidou O, Efstathiou N, Papaharitou S, Hatzimouratidis K, Hatzichristou D. Medical students' attitudes toward patient-centred care: a longitudinal survey. Med Educ. 2007 Feb;41(2):146-53. doi: 10.1111/j.1365-2929.2006.02668.x.

    PMID: 17269947BACKGROUND
  • Kiessling C, Fabry G, Rudolf Fischer M, Steiner C, Langewitz WA. [German translation and construct validation of the Patient-Provider-Orientation Scale (PPOS-D12)]. Psychother Psychosom Med Psychol. 2014 Mar;64(3-4):122-7. doi: 10.1055/s-0033-1341455. Epub 2013 Apr 19. German.

    PMID: 23606403BACKGROUND
  • Beattie A, Durham J, Harvey J, Steele J, McHanwell S. Does empathy change in first-year dental students? Eur J Dent Educ. 2012 Feb;16(1):e111-6. doi: 10.1111/j.1600-0579.2011.00683.x. Epub 2011 Mar 17.

    PMID: 22251333BACKGROUND
  • Ishikawa H, Son D, Eto M, Kitamura K, Kiuchi T. Changes in patient-centered attitude and confidence in communicating with patients: a longitudinal study of resident physicians. BMC Med Educ. 2018 Jan 25;18(1):20. doi: 10.1186/s12909-018-1129-y.

    PMID: 29370796BACKGROUND
  • Institute for Health Metrics and Evaluation. Global burden of diseases, injuries, and risk factors study 2010, Switzerland. University of Washington, USA; 2012.

    BACKGROUND
  • Mead N, Bower P. Patient-centredness: a conceptual framework and review of the empirical literature. Soc Sci Med. 2000 Oct;51(7):1087-110. doi: 10.1016/s0277-9536(00)00098-8.

    PMID: 11005395BACKGROUND
  • Monrouxe V, Rees C. Healthcare Professionalism: Improving Practice through Reflections on Workplace Dilemmas. Wiley-Blackwell; 2017.

    BACKGROUND
  • Harris M, Camenzind AL, Fankhauser R, Streit S, Hari R. Does a home-based interview with a chronically ill patient help medical students become more patient-centred? A randomised controlled trial. BMC Med Educ. 2020 Jul 11;20(1):217. doi: 10.1186/s12909-020-02136-y.

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Results Point of Contact

Title
Prof. Michael Harris
Organization
BIHAM, University of Bern

Study Officials

  • Michael F Harris, MB BS MMEd

    Employee

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Randomised controlled trial, with sham control.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2018

First Posted

October 29, 2018

Study Start

September 28, 2018

Primary Completion

June 20, 2019

Study Completion

June 20, 2019

Last Updated

September 16, 2020

Results First Posted

September 16, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will share

We may share all IPD that underlie results in a publication.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Starting 6 months after publication
Access Criteria
Emailed request to study lead (MH).

Locations