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CTRI Number  CTRI/2021/03/032181 [Registered on: 22/03/2021] Trial Registered Prospectively
Last Modified On: 16/03/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A trial to assess the effectiveness of an electronic clinical decision support system technology in improving clinical practice among trained physicians 
Scientific Title of Study   A Cluster Randomized Controlled Trial to assess the effectiveness of an electronic clinical decision support(e-CDSS)system in enabling translation of clinical knowledge into practice among trained physicians 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Arun Pulikkottil Jose 
Designation  Senior Program Manager 
Affiliation  Public Health Foundation of India 
Address  Centre for Chronic Conditions and Injuries Public Health Foundation of India Plot No. 47, Sector 44 Institutional Area Gurugram – 122002, India

Gurgaon
HARYANA
122002
India 
Phone  8884837448  
Fax    
Email  arunp.jose@phfi.org  
 
Details of Contact Person
Scientific Query  
Name  Arun Pulikkottil Jose 
Designation  Senior Program Manager 
Affiliation  Public Health Foundation of India 
Address  Centre for Chronic Conditions and Injuries Public Health Foundation of India Plot No. 47, Sector 44 Institutional Area Gurugram – 122002, India

Gurgaon
HARYANA
122002
India 
Phone  8884837448  
Fax    
Email  arunp.jose@phfi.org  
 
Details of Contact Person
Public Query  
Name  Arun Pulikkottil Jose 
Designation  Senior Program Manager 
Affiliation  Public Health Foundation of India 
Address  Centre for Chronic Conditions and Injuries Public Health Foundation of India Plot No. 47, Sector 44 Institutional Area Gurugram – 122002, India

Gurgaon
HARYANA
122002
India 
Phone  8884837448  
Fax    
Email  arunp.jose@phfi.org  
 
Source of Monetary or Material Support  
Centre for Chronic Disease Control  
 
Primary Sponsor  
Name  Centre for Chronic Disease Control 
Address  C1/52, 2ND Floor, Safdarjung Development Area, New Delhi, India - 110016 
Type of Sponsor  Other [Non-government organization ] 
 
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 
Arun Pulikkottil Jose   Centre for Chronic Disease Control  C1/52, 2ND Floor, Safdarjung Development Area, New Delhi, India - 110016
New Delhi
DELHI 		 8884837448

arunp.jose@phfi.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Centre for Chronic Disease Control  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Physicians enrolled for Cycle 4 Certificate Course in Management of Hypertension (CCMH) at PHFI 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Electronic Clinical Decision Support System Technology   The m-power Electronic Clinical Decision Support System Technology will provide the trained physicians with clinical decision support. The timeline would be 1yr.  
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  All participants that successfully complete the CCMH-Cycle 4 (Certificate course in management of Hypertension) course  
 
ExclusionCriteria 
Details  withdrawal from the study and failure to complete the CCMH course (ineligibility for appearance in final examination (not attended minimum 7 out of 8 sessions or did not submit two interim assignments) and failure to secure minimum 50% marks in final examination).  
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the impact of an electronic clinical decision support system in the practical application of new knowledge from a large scale continuing medical education program.  10 months 
 
Secondary Outcome  
Outcome  TimePoints 
To identify enablers as well as barriers faced by the healthcare provider in implementing changes to clinical practice recommended by the electronic clinical decision support system and the continuing medical education program.  16 months 
 
Target Sample Size   Total Sample Size="600"
Sample Size from India="600" 
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   Phase 2 
Date of First Enrollment (India)   22/03/2021 
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="1"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Title: A Cluster Randomized Controlled Trial to Assess the effectiveness of an electronic clinical decision support system (e-CDSS) in enabling translation of clinical knowledge into practice among trained physicians

Objectives: Primary: To evaluate the impact of an e-CDSS in the practical application of new knowledge from a large scale continuing medical education program.

Secondary: To identify enablers as well as barriers faced by the healthcare provider in implementing changes to clinical practice recommended by the e-CDSS and the continuing medical education program.

Study Setting: The mPower is a knowledge-based Clinical Decision Support System designed to support healthcare providers in delivering evidence-based care to the patients. Certificate Course in Management of Hypertension (CCMH) is a unique initiative designed to enhance knowledge, skills and core competencies of Physicians in the management of hypertension. The fourth cycle of the CCMH program will launch in the month of January 2021 and aims to train approximately 165 physicians. A cluster randomized controlled trial will be done to assess the effectiveness of the e-CDSS in improving translation of knowledge imparted through the continuing medical education program. Anonymized electronic patient records will be analyzed to assess change in prescription patterns.

Study Outcomes:

1.       Initiation of pharmacotherapy in newly diagnosed hypertensives.

2.       Intensification of pharmacotherapy in known hypertensive with uncontrolled blood pressure

3.       Taking three blood pressure measurements in patients of unknown hypertension status or with first BP reading of systolic BP above 140 mmHg and/or diastolic BP above 90mmHg.

Inclusion criteria: All participants that enroll for CCMH Cycle 4 and give consent for the study will be enrolled for baseline evaluation.

Exclusion criteria: Withdrawal from the study after baseline evaluation; Failure to complete CCMH course [ineligibility for final examination (attended < the minimum 7/8 course sessions; did not submit two mandated interim assignments) and failure to secure minimum 50% marks in final examination].

Plan of Data Analysis:

Data in the control arm will be collected using REDCap. Data in the intervention arm will be collected on the mPower eCDSS. Data will be analyzed using SPSS Version 26. Appropriate themes and domains will be identified, and will be described accordingly.


 
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