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CommunicationNCT03965416

Influence of White Coat During Family Medicine Consultation: Interventional Study

A study testing White Coat and Without White Coat in people with Communication, run by University of Coimbra at 1 site in Portugal.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Introduction: The white coat is a physician attire worn since the antiquity time. Several studies in other countries have shown that it influences doctor-patient's relationship and that there is some kind of preference over what a doctor should wear. In Portugal there are few data on this subject. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Communication
What is being tested?
White Coat and Without White Coat
Could I receive a placebo?
No, everyone receives an active treatment
How many people
286 participants
Where
1 sitePortugal
Study dates
1 Nov 2018to 28 Feb 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • A sample of 286 patients, of both sexes, of different ages and from health centers in both urban and rural areas belonging to the ARS Center was studied.

Who cannot join

  • Age less than 18 years (in these cases the questionnaire can be answered by your companion).
  • Illiterate patients.
  • Patients whose general condition did not allow them to correctly answer the questionnaire presented.

Trial locations and contacts

1 site in 1 country.

Portugal1 site
  • ARS Centro

    Coimbra

Other trials in Portugal

About this study

Official title: Influence of White Coat on Communication During General and Family Medicine Consultation: Interventional Study

Introduction: The white coat is a physician attire worn since the antiquity time. Several studies in other countries have shown that it influences doctor-patient's relationship and that there is some kind of preference over what a doctor should wear. In Portugal there are few data on this subject.

Objectives: Investigate the influence of the white coat on satisfaction, confidence and empathy in relation to patients. Secondly, its impact on what patients perceive about medical knowledge, patients' opinions about medical clothing, and the level of satisfaction and comfort of physicians in consultation with or without the use of a white coat.

Methods: An interventional study with a quasi-randomized representative sample of the population attending the health centers belonging to ARS Centro, consisting of 286 participants. The investigators collaborated with 16 doctors, male and female and of different ages which usually wore white coat in their medical appointments. The investigators included the first and last patients in consultation every day for 10 consecutive days, and every other day the doctor consulted with the use of a white coat or without the use of a white coat. At the end of the consultation, a questionnaire was distributed to the patient. This questionnaire had simple questions with a Lickert scale response, the portuguese version of the scale "Trust in physician" to assess the trust in the physician, both globally and in the medical-patient's relationship and their medical competences, and the JSPPPE-VP scale to evaluate empathy. A questionnaire was also distributed to the physician in which the doctor indicated what type of attire that used on that appointment and how satisfied and comfortable was with the consultation.

Read the detailed description
  1. INTRODUCTION The white coat is a physician attire worn since the antiquity time. Several studies in other countries have shown that it influences doctor-patient's relationship and that there is some kind of preference over what a doctor should wear. In Portugal there are few data on this subject. Objectives: Investigate the influence of the white coat on satisfaction, confidence and empathy in relation to patients. Secondly, its impact on what patients perceive about medical knowledge, patients' opinions about medical clothing, and the level of satisfaction and comfort of physicians in consultation with or without the use of a white coat.
  2. METHODOLOGY

2.1 - Research characterization

An intervention study has been conducted evaluating the use or not of the white coat, in a quasi-random sample in the patient population attending health care centres in the central region of Portugal.

2.2 - Population, sample and exclusion criteria

The questionnaire was applied to a population sample calculated to represent, with a confidence interval of 90% and a margin of error of 5%, the population attending the consultations using the formula accessible at www.raosoft.com/samplesize.html (271 patients).

About 16 volunteer physicians were invited by the researchers to collaborate. These included both genders and different age ranges, from 10 primary health care units belonging to the ARS Centro [Regional Health Administration], from rural and urban areas.

Patients were selected semi-randomly as the first and last in consultation each day for 10 consecutive days of consultations (in order to avoid the bias of always having the same type of people), and on alternate days the physician consulted with or without the use of a white coat.

Exclusion criteria were considered as follows: under 18 years of age (in which case the questionnaire could be answered by the person accompanying him/her), illiterate patients and also patients whose general condition did not allow them to respond to the presented questionnaire. In the cases mentioned above, or in case of refusal, the physician could pass the questionnaire to the next patient (in case it was the first of the day) or to the first of the following day (if it was the last day), keeping the conditions aforementioned.

2.3 - Data collection instrument

The questionnaire addressed to the patient contained 2 scales duly translated and validated for the Portuguese language, whose authors gave the proper authorization for use in this study.

Each patient was asked about their age, gender, regular medication, literacy, level of education and professional activity. In the second part, they were asked about their satisfaction with the consultation and the medical knowledge perceived during the consultation, using a 0 to 4-point Likert scale. The "Trust in physician" scale - Portuguese version5, was applied, in which 11 items were presented, again using a 0 to 4-point Likert scale. This allows us to evaluate confidence in 3 aspects: the total trust of the physician, to which the 11 items correspond, trust in the relationship with the physician, to which only 6 items correspond (1, 4, 5, 7, 10 and 11) and finally the trust in the competence of the physician corresponding to 5 items (2,3,6,8 and 9). The JSPPPE-VP6 scale was applied in order to evaluate medical empathy, through 5 items to rank from 1 to 7 on a Likert scale. Finally, the patient's opinion on medical clothing was evaluated through 3 phrases: "1. Normal clothes worn by the physician make the environment more relaxed relative to the white coat. ", "2. It would be easier to communicate with a physician dressed in normal clothes. "e" 3. The white coat is the only attire acceptable for a physician.", with a scale equal to the previous one.

Regarding the questionnaire addressed to the physician, it was based on 2 simple yes/no questions with regard to having worn the white coat on a regular basis and 2 items related to his/her satisfaction and comfort during the consultation on a 0 to 4-point Likert scale.

2.4 - Data collection

The data collection took place from November 2018 to February 2019, in a period of 10 consecutive days, chosen by the physician. The questionnaire was delivered by the physician at the end of the consultation, after the patient signed the Informed Consent and filled out the self-completion questionnaire with the physician´s help in case of doubts or difficulties.

2.5 - Procedures prior to data collection

The study was authorized by the head of each health unit and the Ethics committee of the ARS do Centro [Regional Health Administration]

2.6 - Variables

The outcomes under study in this research, defined in protocol and unchanged after the field study, were as follows: Patient satisfaction, Total trust perceived by the patient, Confidence in the physician-patient relationship, Confidence in the physician's competences and Empathy perceived by the patient (main outcomes) and Knowledge perceived by the patient, Physician satisfaction and Physician comfort (secondary outcomes).

2.7- Statistical analysis

After a descriptive analysis, the normal distribution of numerical variables was tested using the Kolmogorov-Smirnov test. As the distribution of most variables was not normal, the non-parametric Mann-Whitney U tests were used to compare the numerical variables between the groups. The X2 test was used to compare the nominal variables. The value of p <0.05 was defined as statistically significant.

Conditions
Communication
Being tested
White Coat, Without White Coat
Keywords
White Coat, Communication, Physician - Patient Relationship, Satisfaction, Trust, Competence, Empathy, Knowledge
Medical subject headings
Communication, Personal Satisfaction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • White CoatOther

    We included the first and last patients in consultation every day for 10 consecutive days, and every other day the doctor consulted with the use of a white coat or without the use of a white coat.

  • Without White CoatOther

    We included the first and last patients in consultation every day for 10 consecutive days, and every other day the doctor consulted with the use of a white coat or without the use of a white coat.

Study groups in NCT03965416
Study groupRoleWhat they receive
Doctor with white coatExperimentalDoctor during consultation is wearing a white coat
Receives: Other: White Coat
Doctor without white coatExperimentalDoctor during consultation is not wearing a white coat
Receives: Other: Without White Coat

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient's satisfaction: rating

    A question about patient's satisfaction with the consultation rating from 0 to 4.

    Measured: 30 minutes

  2. Trust

    The use of the "Trust in physician" scale to evaluate patient trust in the medical-patient's relationship and in their medical competences.

    Measured: 30 minutes

  3. Empathy

    Empathy in the medical-patient's relationship evaluated through the Jefferson scale.

    Measured: 30 minutes

Secondary outcomes (3)
  1. Doctor's knowledge

    Medical knowledge perceived by the patient evaluated through a question.

    Measured: 30 minutes

  2. Doctor's satisfaction: question

    A question that evaluated the doctor's satisfaction with the consultation.

    Measured: 30 minutes

  3. Doctor's comfort: question

    A question that evaluated the doctor's comfort with the consultation.

    Measured: 30 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2019
  2. Study start1 Nov 2018
  3. Primary completion28 Feb 2019
  4. Study completion28 Feb 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
286 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03965416
Sponsor's protocol ID
2018.02
Status last verified
May 2019
First submitted
22 May 2019
Last updated
29 May 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Marques Caetano Carreira L, Dinis S, Correia A, Pereira A, Belo R, Madanelo I, Brito D, Gomes R, Monteiro L, Correia G, Maia C, Marques T, Sousa R, Abreu D, Matias C, Constantino L, Rosendo I. Does the white coat influence satisfaction, trust and empathy in the doctor-patient relationship in the General and Family Medicine consultation? Interventional study. BMJ Open. 2021 Dec 22;11(12):e031887. doi: 10.1136/bmjopen-2019-031887.

    PubMed 34937710

Questions about this trial

What is this clinical trial studying?

A study testing White Coat and Without White Coat in people with Communication, run by University of Coimbra at 1 site in Portugal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient's satisfaction: rating (time frame: 30 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03965416, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2019.

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