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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  
Self sponsored 
 
Primary Sponsor  
Name  KH Manipal 
Address  Dept of Hospital Administration, KMC Manipal 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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 face‐to‐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 face‐to‐face communication.

 

Face‐to‐face communication is essential to get the full conversation. In face‐to‐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 face‐to‐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:

 

  1.  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.
  2. 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

 


 
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