CTRI Number |
CTRI/2019/12/022460 [Registered on: 20/12/2019] Trial Registered Prospectively |
Last Modified On: |
19/12/2019 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Behavioral |
Study Design |
Other |
Public Title of Study
|
Doctor patient communication |
Scientific Title of Study
|
“Inculcating communication skills among healthcare professionals†|
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NA |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr SomuG |
Designation |
Professor |
Affiliation |
KMC Manipal |
Address |
Dept. of Hospital Administration
KMC Manipal, MAHE
Udupi
Udupi KARNATAKA 576104 India |
Phone |
|
Fax |
|
Email |
somu.g@manipal.edu |
|
Details of Contact Person Scientific Query
|
Name |
Dr SomuG |
Designation |
Professor |
Affiliation |
KMC Manipal |
Address |
Dept. of Hospital Administration
KMC Manipal, MAHE
Udupi
Udupi KARNATAKA 576104 India |
Phone |
|
Fax |
|
Email |
somu.g@manipal.edu |
|
Details of Contact Person Public Query
|
Name |
Dr SomuG |
Designation |
Professor |
Affiliation |
KMC Manipal |
Address |
Dept. of Hospital Administration
KMC Manipal, MAHE
Udupi
Udupi KARNATAKA 576104 India |
Phone |
|
Fax |
|
Email |
somu.g@manipal.edu |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
KH Manipal |
Address |
Dept of Hospital Administration, KMC Manipal |
Type of Sponsor |
Research institution and hospital |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Anand KM |
Kasturba hospital |
KMC Manipal Udupi KARNATAKA |
9844009873
anand.km@manipal.edu |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Kasturba Hospital Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
Health professionals and patients visiting OPD services |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Communication module will be developed and sensitized among the study population |
The outcome of the change in behavior/attitude will be assessed two times one after 3weeks & another after 6 weeks |
Intervention |
Questionnaire study |
Questionnaire will be distributed among the study participants and analysed |
|
Inclusion Criteria
|
Age From |
21.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
participants will be healthcare personnel and patients |
|
ExclusionCriteria |
Details |
Health care professionals with more than 20 years of experience and OPD patients not able to comprehend English language |
|
Method of Generating Random Sequence
|
Stratified block randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
change in the communication skill sets and behaviour of doctors towards patients and their response to this change |
This change will be seen after 6 weeks of intervention |
|
Secondary Outcome
|
Outcome |
TimePoints |
Reduced incidence of doctor patient violence. Positive image of doctors among the patient group |
After one year of intervention |
|
Target Sample Size
|
Total Sample Size="200" Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
23/12/2019 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
not yet published |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
In the evolution of medicine, an increasing number
of patients, in particular with chronic disease or illness, is requiring
treatment by healthcare providers from different disciplines. Two major trends
emerge. First, diagnostic workups and treatments are increasingly organized on
an outpatient basis, and, second, especially treatment and care is shifting
towards primary care. Both trends increase the need for sharing information
between specialists and general practitioners (GPs) to ensure continuity of
care, in an integrated transmural model1
Although a review of the literature revealed that
faceâ€toâ€face communication is recommended, in practice, written communication
remains the most usual means of communication between healthcare professionals.
Furthermore, there is a consensus about particular advantages of written
communication over faceâ€toâ€face communication.
Faceâ€toâ€face communication is essential to get the
full conversation. In faceâ€toâ€face communication, all involved parties can not
only hear what is being said but also they can see the body language and facial
expressions that provide key information so they can better understand the
meaning behind the words. In the past, this type of communication was only
possible in person, but as technology advances there are more ways to have
these faceâ€toâ€face conversations1
Violence erupts as a result of interacting factors
encompassing staff behavior, patient behavior, hospital setting, professional
roles, and waiting times. Patients and staff reported similar perceptions and
emotions regarding the episodes of violence in which they were involved
Half of the reasons stated by physicians and nurses
for violence eruption were related to patient dissatisfaction with the quality
of service, the degree of staff professionalism, or an unacceptable comment of
a staff member. In addition, data from the focus groups pointed to lack of
understanding of the hospital system on the part of patients, together with
poor communication between patients and providers and expectations gaps2
References:
- Vermeir, P., Vandijck, D., Degroote, S.,
Peleman, R., Verhaeghe, R., Mortier, E., Hallaert, G., Van Daele, S.,
Buylaert, W., … Vogelaers, D. (2015). Communication in healthcare: a
narrative review of the literature and practical recommendations.
International journal of clinical practice, 69(11), 1257-67.
- Shafran-Tikva,
S., Chinitz, D., Stern, Z., & Feder-Bubis, P. (2017). Violence against
physicians and nurses in a hospital: How does it happen? A mixed-methods
study. Israel journal of health policy research, 6(1), 59.
doi:10.1186/s13584-017-0183-y
|