Patient ComplianceNCT02669355
Effect of Wearing of White Coat on Patient Satisfaction in Indian Out Patient Department (OPD) Setting
An observational study of Patient Compliance and Physician-Patient Relations, run by Columbia Asia at 1 site in India.
Trial summary
Doctor's attire acts as an important criteria in setting up good relationship between patient and physician. Recent evidence as well as strong viewpoints have highlighted the possible harm of wearing a white coat. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Compliance, Physician-Patient Relations
- How many people
- 123 participants
- Where
- 1 siteIndia
- Study dates
- Oct 2015to Jan 2016
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged above 18 years who come to consult in Rheumatalogy OPD in all three Columbia Asia Hospitals situated in Bangalore are taken into study.
Who may be able to join
- Patients aged equal to or greater than 18 years, attending the rheumatology OPD in Columbia Asia Hospitals,Bangalore.
Who cannot join
- Patient who have come only for diagnostic or therapeutic procedure or for second opinion.
- Patients without plan for follow up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Study to Determine the Effect of Wearing of White Coat on Patient Satisfaction in Indian Out Patient Department (OPD) Setting
Doctor's attire acts as an important criteria in setting up good relationship between patient and physician. Recent evidence as well as strong viewpoints have highlighted the possible harm of wearing a white coat. In order to get the patient's perspective on the same, this observational study is being conducted to determine the effect of wearing a white coat on patient satisfaction in an Indian setting , in patients who visit rheumatology outpatient department,in Columbia Asia Hospitals,Bangalore,India.
- Conditions
- Patient Compliance, Physician-Patient Relations
- Keywords
- White coat physician attire
- Medical subject headings
- Patient Compliance
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in patient satisfaction scores (if any) between patients visiting a rheumatologist for the first time based on the whether the physician dons an apron or not.
Measured: 50 days
Secondary outcomes (2)
Change in rate of compliance with medications between patients visiting a rheumatologist for the first time based on the whether the physician dons an apron or not.
Measured: 3 weeks to 1 month.
Change in rate of compliance with follow up visits (if any) between patients visiting a rheumatologist for the first time based on the whether the physician dons an apron or not.
Measured: 3 weeks to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2016 (estimated)
- Study startOct 2015
- Primary completionDec 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Patient ComplianceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia Asia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.Sharath Kumar, Columbia Asia
- Investigators
- Sharath Kumar, MBBS,MD,DNB, Principal investigator, Columbia Asia Hospitals,Bangalore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02669355
- Sponsor's protocol ID
- IEC/2015/RP/17
- Status last verified
- Jan 2016
- First submitted
- 28 Oct 2015
- Last updated
- 1 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Petrilli CM, Mack M, Petrilli JJ, Hickner A, Saint S, Chopra V. Understanding the role of physician attire on patient perceptions: a systematic review of the literature--targeting attire to improve likelihood of rapport (TAILOR) investigators. BMJ Open. 2015 Jan 19;5(1):e006578. doi: 10.1136/bmjopen-2014-006578.
PubMed 25600254Hughes LD, Done J, Young A. A 5 item version of the Compliance Questionnaire for Rheumatology (CQR5) successfully identifies low adherence to DMARDs. BMC Musculoskelet Disord. 2013 Oct 8;14:286. doi: 10.1186/1471-2474-14-286.
PubMed 24103582de Klerk E, van der Heijde D, Landewe R, van der Tempel H, van der Linden S. The compliance-questionnaire-rheumatology compared with electronic medication event monitoring: a validation study. J Rheumatol. 2003 Nov;30(11):2469-75.
PubMed 14677194Fernandes E. Doctors and medical students in India should stop wearing white coats. BMJ. 2015 Jul 21;351:h3855. doi: 10.1136/bmj.h3855. No abstract available.
PubMed 26198987
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study to Determine the Effect of Wearing of White Coat on Patient Satisfaction in Indian Out Patient Department (OPD) Setting
- ClinicalTrials.gov ID
- NCT02669355
- Acronym / sponsor ID
- IEC/2015/RP/17
- Conditions
- Patient Compliance, Physician-Patient Relations
- Keywords
- White coat physician attire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Columbia AsiaUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 1 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Doctor's attire acts as an important criteria in setting up good relationship between patient and physician. Recent evidence as well as strong viewpoints have highlighted the possible harm of wearing a white coat. In order to get the patient's perspective on the same, this observational study is being conducted to determine the effect of wearing a white coat on patient satisfaction in an Indian setting , in patients who visit rheumatology outpatient department,in Columbia Asia Hospitals,Bangalore,India.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged above 18 years who come to consult in Rheumatalogy OPD in all three Columbia Asia Hospitals situated in Bangalore are taken into study.
Key inclusion criteria (1 listed)
- Patients aged equal to or greater than 18 years, attending the rheumatology OPD in Columbia Asia Hospitals,Bangalore.
Key exclusion criteria (2 listed)
- Patient who have come only for diagnostic or therapeutic procedure or for second opinion.
- Patients without plan for follow up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in patient satisfaction scores (if any) between patients visiting a rheumatologist for the first time based on the whether the physician dons an apron or not.
Time frame: 50 days
2 secondary outcomes
Change in rate of compliance with medications between patients visiting a rheumatologist for the first time based on the whether the physician dons an apron or not.
Time frame: 3 weeks to 1 month.
Change in rate of compliance with follow up visits (if any) between patients visiting a rheumatologist for the first time based on the whether the physician dons an apron or not.
Time frame: 3 weeks to 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2016.
- Background: PubMed 25600254Petrilli CM, Mack M, Petrilli JJ, Hickner A, Saint S, Chopra V. Understanding the role of physician attire on patient perceptions: a systematic review of the literature--targeting attire to improve likelihood of rapport (TAILOR) investigators. BMJ Open. 2015 Jan 19;5(1):e006578. doi: 10.1136/bmjopen-2014-006578.
- Background: PubMed 24103582Hughes LD, Done J, Young A. A 5 item version of the Compliance Questionnaire for Rheumatology (CQR5) successfully identifies low adherence to DMARDs. BMC Musculoskelet Disord. 2013 Oct 8;14:286. doi: 10.1186/1471-2474-14-286.
- Background: PubMed 14677194de Klerk E, van der Heijde D, Landewe R, van der Tempel H, van der Linden S. The compliance-questionnaire-rheumatology compared with electronic medication event monitoring: a validation study. J Rheumatol. 2003 Nov;30(11):2469-75.
- Background: PubMed 26198987Fernandes E. Doctors and medical students in India should stop wearing white coats. BMJ. 2015 Jul 21;351:h3855. doi: 10.1136/bmj.h3855. No abstract available.
- The public statement by the Indian Medical Association to the BMJ(British Medical Journal) viewpointLink provided by the sponsor.
- Original feedback form of the General Medical Council of the UK (United Kingdom)which has been modified for this studyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharath Kumar, MBBS,MD,DNB principal investigator
Columbia Asia Hospitals,Bangalore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patient Compliance and Physician-Patient Relations, run by Columbia Asia at 1 site in India.
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 2 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 1 Feb 2016. 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 India. 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?
Change in patient satisfaction scores (if any) between patients visiting a rheumatologist for the first time based on the whether the physician dons an apron or not. (time frame: 50 days). 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 NCT02669355, which also lists 4 linked publications.
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 1 Feb 2016.