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.
Phase: NA
Conditions: Educational Techniques
Sponsor: University of Bern

The effect of a structured, home-based interview with a 
patient with a chronic illness on first-year medical 
students’ patient-centredness: protocol for a randomised 
controlled trial. 
19th October 2018 
NCT03722810 
 
Michael Harris, Anna-Lea Camenzind, Rita Fankhauser, Sven Streit, Roman Hari 
Protocol v2b (English language only) 
 
 

 
2 
Abstract 
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. 
Background 
Doctors are regarded as “professionals” both by the public and by their peers [1]. They are the 
most trusted profession among the public, and this has been the case for many years. Medical 
professionalism is not a new concept and has been present in the history of medicine in the 
form of a Hippocratic Oath taken by physicians [2]. However, medical professionalism is 
difficult to define and remains poorly understood [3]. While professionalism has become a 
widely emphasised subject in medical education and medical practice, there is still a lack of 
common understanding about the meaning of the concept. Discussions on the subject have 
thus been unsystematic, as the word “professionalism” has multiple meanings, complexities, 
and subtle differences  [2]. 
Professional healthcare groups have their own set of norms (codes) which guide members of 
that profession in terms of how they should behave professionally. [4] These are designed and 
implemented by the profession’s regulatory body, so differ according to different healthcare 
professions and countries. Over one hundred different dimensions of professionalism have 

 
3 
been identified. Swick [5] proposes that medical professionalism consists of specific 
behaviours (Table 1). 
 
Table 1: Specific behaviours that constitute medical professionalism [5] 
Physicians preferring others’ interests over their own. 
Physicians adhering to high ethical standards. 
Physicians responding to social needs and their behaviours, reflecting a social contract to 
serve the community. 
Physicians representing basic human values, including trustworthiness and honesty, 
compassion and sympathy, altruism and empathy, respect for others and trust. 
Physicians being accountable for their own and their colleagues’ actions. 
Physicians being committed to excellence. 
Physicians being committed to conducting research and updating their knowledge and 
using these in their professional field. 
Physicians dealing with high levels of complexity and uncertainty. 
Physicians reflecting on their actions and decisions. 
 
Concerns about professionalism in medicine have made the explicit teaching and learning of 
ethics, professionalism and personal development necessary. The General Medical Council in 
the UK, and other professional bodies in both Europe and the Americas, have emphasised the 
need to enhance the teaching and learning of professionalism in medical schools, particularly 
the development of good attitudes, appropriate and competent skills, and the inculcation of a 
value system that reflects the principles of professionalism in medicine [6]. 
A study investigating tutors' and students' perspectives of the delivery of professionalism in 
the early years of Glasgow's learner-centred, problem-based learning (PBL) medical 
curriculum found that [7]: early patient contact experiences were found to be particularly 
important, and that learning activities promoting critical reflection were most effective. 
However, a systematic review found no unifying theoretical or practical model to integrate the 
teaching of professionalism into the medical curriculum [8]. There is no consensus about how 
best to teach professionalism [9], and few studies have explored the effectiveness of different 
teaching and learning methods for professionalism [4].  
Research on students’ understandings of professionalism identified 19 dimensions [4]. Of 
these, patient-centredness was the second most discussed dimension (after ‘professionalism 
as rules’). Students’ ideas of patient-centred professionalism came from a variety of sources: 
formal lectures on ethics, informal learning through role models, and from formal 
assessments. In the patient-centred clinical method, both the physician’s and the patient’s 
agendas are addressed by the physician and any conflict between them dealt with by 
negotiation [10]. This means that the physician aims to gain an understanding of the patient 
as well as the disease, and it is in contrast to the disease-centred method in which only the 
doctor's agenda is addressed. Summarising patient-centeredness elegantly, McWhinney 
describes the patient-centred approach as one where the “physician tries to enter the 
patient’s world, to see the illness through the patient’s eyes” [11]. Evidence suggests that 
patient-centred care is associated with a number of favourable biomedical, psychological and 
social outcomes [12], and it has been recognised as an important aspect of quality in health 
care [13]. 

 
4 
There have been more than 900 papers published that measure patient-centred care or one of 
its components [14]. However, only two measurement instruments for attitudes towards 
patient-centredness in undergraduate medical students have been identified: the Doctor 
Orientation Scale and the Patient-Practitioner Orientation Scale (PPOS); of these two, the 
PPOS has been used much more extensively [15]. The PPOS was developed in 1999 to 
measure the attitudes of medical students towards patient-centredness [16]. It differentiates 
between patient-centred versus doctor-centred or disease-centred orientation, measuring 
attitudes along 2 dimensions: ‘sharing’ and ‘caring’ [17]. It has been used to assess attitude 
changes towards patient-centredness in medical student cohorts as they progress through the 
clinical curriculum.  
The PPOS is available in 13 languages. It has been translated into German and the degree of 
medical students' patient-centeredness assessed in 2 student samples in Freiburg, Germany 
and in Basel, Switzerland [18]. Construct validity was tested using factor analysis. Based on 
factor analysis and tests of internal consistency, a shortened version with 6 items for each of 
the 2 subscales "sharing" and "caring" was generated (PPOS-D12). PPOS-D12 (see English-
language version at Appendix 1) was found to be a reliable instrument to assess patient-
centeredness among medical students in German-speaking countries. 
In a longitudinal survey of medical students’ attitudes toward patient-centred care in Greece, 
students’ attitudes were significantly less patient-centred at the end of their studies compared 
to the beginning of their clinical curricula (mean score in year 4: 3.96; mean score in year 6: 
3.81; P < 0.001) [17]. In a South African study, medical students from all undergraduate six 
years took the PPOS survey. There was a decrease in mean scores (from 2.65 in first-year 
students to 2.25 in final-year students), with the most pronounced decrease in the first two 
years of study [15]. [19]. In a year-long study of resident physicians at a university hospital in 
Tokyo, PPOS scores reduced significantly over the year (mean score at start of year: 4.5, SD 
0.48; mean score at end of year: 4.39, SD 0.51; change: -0.11, SD 0.42) [20]. 
We have only identified one study that assessed the effect of an intervention on students’ 
levels of patient-centredness. In this uncontrolled UK study, first-year dental undergraduates 
were given an attitudinal questionnaire to complete before and after their behavioural science 
course. No significant difference was found between their mean pre- and post-course PPOS 
scores (pre-course mean scores: 3.44 SD 0.33; post-course mean score: 3.37, SD 0.19; P > 
0.05). We have found no controlled trials that test the effect of interventions on medical 
students’ levels of patient-centredness, and no trials that look at the effect of early patient 
contact in the form of an unaccompanied visit to a patient in their home.  
Aim of the study 
The aim of this study 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. 
A nested study will assess whether the GP’s level of patient/doctor-centredness affects 
changes in their student’s level over the year. 
Methods  
Study setting 
The study will take place in the Berner Institut für Hausarztmedizin (BIHAM) at the University 
of Bern, Switzerland, and a subset of the >700 General Practitioner (GP) teaching practices 
that are affiliated to it.  

 
5 
Study participants 
The population will be medical students who are in the first year of their studies (their first 
Bachelor year) at the University of Bern, during their longitudinal placements in primary care. 
The GP teachers are family doctors that are accredited by BIHAM to take medical students. 
Study design 
This will be a randomised controlled trial. During their first Bachelor year, each medical 
student will spend a series of six half-days at the practice of a GP teacher that she/he has been 
allocated to. Students will be randomly assigned to either the intervention or the sham 
comparator which will take place during their last half-day in their practices. All students will 
complete an on-line version of the PPOS-D12 questionnaire at the start of the academic year 
and once more after the last half-day at their GP teachers’ practices. 
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: ischemic heart disease, low back pain, major depressive disorder and 
COPD [21]. GP teachers who only see children are asked to choose a patient who has a chronic 
cardiac condition, a chronic lung disease, or another chronic illness that has a significant effect 
on the child’s quality of life, the interview to be carried out at the child’s home with one or 
both parents, and the child if she/he is old enough to take part in the interview.  
GP teachers and students will be told that the students’ intervention interviews need to be 
unaccompanied and at patients’ own homes, but in justified, exceptional cases, and after 
consultation with a member of the research team, the interview may take place in the GP 
teacher’s practice premises. 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 
In the sham comparator, the student’s the 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. The document is designed to have real 
educational value, and to complement BIHAM’s department-based consultation skills 
teaching. The use of this approach as the sham intervention is based on a study that found 
that a behavioural science course (including consultation skills teaching) had no effect on 
students’ PPOS scores [19]. 
Data collection 
At the start of the academic year (i.e. before the interventions), students will complete a 
SurveyMonkey questionnaire that asks for demographic information (gender, history of 
serious chronic illness in the participant, a friend or close relative, history of training or 
patient contact other than in medical school) and the PPOS D12 form.  
At the end of their GP attachment (i.e. after the interventions), students will complete a 
SurveyMonkey questionnaire that asks whether they had the intervention or sham 
comparator or neither (and if neither, why), and the PPOS D12 form. Consent to use these 
data for research will also be requested. 
At the end of their students’ attachments, their GP teachers will complete a SurveyMonkey 
questionnaire that asks them to complete the PPOS D12 form. Consent to use these data for 
research will also be requested. 

 
6 
Each of these questionnaires will ask for the participant’s name, so that pre-intervention, 
post-intervention, and GP’s data can be linked and compared. 
Outcome measures 
The primary outcome measure will be the 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.  
Secondary outcomes will be the effect of students’ gender, previous experience 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. 
Development of the intervention  
Following a literature review and discussion, RF, A-LC and MH developed a patient interview 
pro-forma which was designed to identify patients’ views on their illnesses, how it affects 
their lives in physical, psychological and social terms, and how their relationships with their 
GPs impacts on their lives. The sections of the interview pro-forma map across to Mead and 
Bower’s conceptual framework of patient-centredness given above [22].  
Six medical students who had been visiting their GP teachers for eight half-days per year since 
their first year of study agreed to pilot the intervention in November 2017. The GP teachers 
were asked to select a patient with a chronic illness for their students, and to organise 2.5-
hour interviews, half of the students at the patients’ home and in the other half in the teaching 
practices. Students were asked to use the questionnaire pro-forma. In addition, the students 
each had a 30-minute interview with a practice nurse to assess their perceptions of the effect 
of the illnesses on their patients, and finally a one-hour discussion with their GP teacher to 
reflect on their encounters with the patients, discuss their findings, and talk about any 
difficulties that may have arisen. 
Following this, RF conducted a focus group interview with the participating students. The 
discussion was recorded and transcribed in full. A-LC and MH analysed parts of each the 
transcript independently, then independently developed a coding frame. Their coding and 
thematic analysis was similar. The findings (the experiences, suggestions and criticisms of the 
piloting students) were used to make improvements in the organisation and in the 
information sheets for patients, students, MPAs and GPs.  
Three medical students then piloted the re-designed interview pro-forma with one of the 
researchers (A-LC) role-playing the patient), and they gave feedback with recommendations 
on how the pro-forma could be further improved. Following this, RF, A-LC and MH reviewed 
the pro-forma and designed the final version. The interview proforma and instructions on 
implementation of the intervention will be sent to students and their GP teachers before the 
students’ final visits to their teaching practices. 
Development of the sham comparator 
MH wrote an English-language ‘Communication skills for BIHAM medical students’ didactic 
document, which included sections on ‘Why should I learn about communication skills?’, 
‘What do patients want from a doctor?’, What information are patients looking for?’, What 
consultation skills should I use when I interview patients?’, ‘Do good communication skills 
really matter?’, ‘How can I learn good interpersonal and consultation skills?’, ‘How is a good 
consultation structured?’, and ‘Questions to discuss with your GP teacher’. This document was 
translated into German by A-LC. The resulting 1,850-word, 9-page document and instructions 
on implementation of the intervention will be sent to students and their GP teachers before 
the students’ final visits to their teaching practices. 

 
7 
Randomisation 
Participants will be allocated to intervention or sham intervention through random sequences 
generated in the SPSS statistical package. 
Blinding procedures  
This study will be partially blinded:  
• Screening and enrolment. A person blinded to the purpose of the interventions (i.e. 
that one is the intervention, the other is a sham comparator) will enrol participants 
and allocate them to their arm of the study. This person will work separately from the 
rest of the trial team and all team members will be asked to sign a form stating that 
they will not disclose the purpose of the interventions to this person.  
• Students. In a tailored informed consent procedure, students will be given a ‘high-level 
description’ of the study objectives with only superficial information on the study 
interventions, as accepted by ethics committees in similar studies. They will be 
informed that they are randomised to one of two study groups, without revealing that 
one is an intervention and the other is a sham comparator. The aim of this is to 
minimise performance and other reporting biases.  
• GP teachers. A similar approach with be taken with information for the GP teachers, so 
that they also have only a ‘high-level’ description of the study objectives. 
Statistical analysis 
Descriptive statistics will be used to describe the relationships between student 
demographics and PPOS scores. Mean pre- and post-test PPOS scores will be compared using 
paired t tests. Differences between PPOS scores in the intervention and control groups will be 
examined with unpaired t tests. For the nested study, GPs’ PPOS scores and changes in their 
students’ PPOS scores will be compared using paired t tests. 
The sample size calculation for the primary outcome was based on reported mean reduction 
of 0.11 in the PPOS score over one year in a group without any intervention [20], and a mean 
increase of 0.05 in the intervention group. We therefore assumed a mean difference 0.16, with 
a standard deviation of 0.42. The study was designed with a 5% level of significance and a 
90% power to reject the null hypothesis of equivalence between the two groups. To achieve 
this objective, 220 students would be required (110 for each group). Assuming a 20% drop-
out, we therefore aimed to enrol a total of 275 students. 
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.  
Strengths 
To our knowledge, this is the first randomised controlled trial that has been designed to study 
the effect of an intervention on medical students’ levels of patient-centredness. The 
intervention materials were carefully developed and piloted by GP teachers and medical 
students, and therefore grounded in their clinical and educational experience.  

 
8 
Limitations 
Although the research team will give participants information about the study in a 
presentation and in correspondence, there is a risk that fewer students than anticipated 
consent to take part in the study. While the researchers aim to blind participants to the nature 
of the comparison, i.e. that one intervention is the intervention and the other is a sham 
comparator, control intervention, participants may guess the researchers’ intentions, and this 
may result in bias in their responses. The power calculations have been based on data from 
other published studies, but these may not be directly comparable to our own study. Our 
control intervention has been chosen because of evidence that teaching dental students about 
communication skills does not affect their levels of patient-centredness, but it is possible that 
our communication skills intervention will indeed have an effect the levels of our medical 
students’ patient-centredness, and thus not be a truly inactive control. 
Expected impact 
One of the aims of BIHAM’s clerkships in primary care is to shift the medical students’ focus 
towards ‘professionalism’, and patient-centredness is an important aspect of professionalism. 
This study will assess whether a single in-depth structured interview with a patient, followed 
by a de-briefing interview with the patient’s GP, can contribute to achieving this aim. 
Quality assurance 
The study may be monitored or audited in accordance with the current approved protocol, 
relevant regulations and standard operating procedures. 
Confidentiality 
The research team will ensure that the participants’ anonymity is maintained.  As soon as each 
student’s pre- and post-intervention questionnaires have been matched with each other and 
those of their GP teachers, each participant will be identified only by a participant ID number 
on all study documents and any electronic database.  All documents will be stored securely 
and only accessible by study staff and authorised personnel. Under no circumstances will the 
identifiers be made available to individuals outside the research team. 
Dissemination 
Results will be published in peer-reviewed scientific journals as well as by conference 
presentations. The researchers will publicise the project findings within their university and 
the Swiss health system, for example in newsletters, websites, meetings and local journal 
publications. 
Funding 
This research receives no specific grant from any funding agency in the public, commercial or 
not-for-profit sectors. 
Availability of data and materials 
Only the research team at the University of Bern will have access to the data during the study. 
The datasets analysed during this study will be available from the corresponding author on 
reasonable request. 

 
9 
Ethics approval and consent to participate 
The research proposal was presented to the regional ethics committee (Kantonale 
Ethikkommission für die Forschung, Gesundheits- und Fürsorgedirektion des Kantons Bern) 
and a waiver was issued on Jan 24th 2018 stating that the study does not fall under the Swiss 
Human Research Act (BASEC-Nr. Req-2018-00059).  
Students and GP teachers will be sent an email with a link to the online survey, where they 
will be given information about the project, an assurance that their answers are confidential, 
and a request for their agreement to allow their data to be used in the study. Clicking on the 
‘agreement’ button will be considered as consent to participate in the study. Student and their 
GP teachers, as well as the selected patients in the intervention group, will be given 
information sheets about the study. 
Competing interests 
The authors declare that they have no competing interests. 
 
 

 
10 
Timetable 
 
 
Sep-
Dec 
17 Jan 
18 
Feb 
18 
Mar-
May 
18 
Jun 
18 
Jul 
18 
Aug 
18 
Sep 
18 
Oct 
18-
May 
19 
May-
July 
19 
Aug-
Sept 
19 
Pilot 1 
 
 
 
 
 
 
 
 
 
 
 
Ethics application 
 
 
 
 
 
 
 
 
 
 
 
Pilot 1 analysis 
 
 
 
 
 
 
 
 
 
 
 
Protocol 
 
 
 
 
 
 
 
 
 
 
 
Pilot 2 and analysis 
 
 
 
 
 
 
 
 
 
 
 
Finalise materials 
 
 
 
 
 
 
 
 
 
 
 
Data collection 
 
 
 
 
 
 
 
 
 
 
 
Write report 
 
 
 
 
 
 
 
 
 
 
 
Write paper 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
11 
 
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13 
Appendix 1. PPOS-D12 English translation 
Possible Likert-scale responses: ‘I completely agree’; ‘I agree’; ‘I agree slightly’; ‘I disagree slightly’; ‘I disagree’; ‘I completely disagree’. 
1. Although treating patients today is not so personal anymore, it is ultimately a small price for medical advancement. 
2. The most important part of the normal visit is the physical examination. 
3. Patients should rely on the knowledge of their doctors and not try to inform themselves about their condition. 
4. When doctors ask a lot of questions about a patient's personal situation, they are too involved in private matters. 
5. When doctors are really good at diagnosis and therapy, their treatment of patients is not so important. 
6. Many patients keep asking questions without really learning anything new. 
7. Patients tend to want to hear that everything is good, rather than real information about their health. 
8. When doctors first try to be open and make a warm-hearted impression, they will not be so terribly successful. 
9. If patients disagree with their doctors, it shows that they disrespect their doctors and do not trust them. 
10. The patient must always be aware that the doctor is responsible. 
11. It is not so important to know the cultural background of a patient and his life situation in order to treat his illness. 
12. When patients get their own medical information, it often confuses them more than it helps them.