| CTRI Number |
CTRI/2020/01/022723 [Registered on: 13/01/2020] Trial Registered Prospectively |
| Last Modified On: |
11/01/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Process of Care Changes |
| Study Design |
Other |
Public Title of Study
Modification(s)
|
Information Technology for Hypertension and Diabetes Care in Government Health System |
Scientific Title of Study
Modification(s)
|
“Integrated Tracking, Referral, and Electronic Decision Support, and Care Coordination- (I-TREC)"
|
|
Secondary IDs if Any
|
| Secondary ID |
Registry |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nikhil Tandon |
| Address |
Department of Endocrinology and Metabolism
Room No 312
3rd Floor
Biotechnology Block
AIIMS
Ansari Nagar
New Delhi
New Delhi
DELHI
110029
India |
| Phone |
011-26593433 |
| Fax |
|
| Email |
nikhil_tandon@hotmail.com |
|
Details Contact Person
Scientific Query
|
| Name |
Dr Nikhil Tandon |
| Address |
Department of Endocrinology and Metabolism
Room No 312
3rd Floor
Biotechnology Block
AIIMS
Ansari Nagar
New Delhi
New Delhi
DELHI
110029
India |
| Phone |
011-26593433 |
| Fax |
|
| Email |
nikhil_tandon@hotmail.com |
|
Details Contact Person
Public Query
|
| Name |
Dr Nikhil Tandon |
| Address |
Department of Endocrinology and Metabolism
Room No 312
3rd Floor
Biotechnology Block
AIIMS
Ansari Nagar
New Delhi
New Delhi
DELHI
110029
India |
| Phone |
011-26593433 |
| Fax |
|
| Email |
nikhil_tandon@hotmail.com |
|
|
Source of Monetary or Material Support
|
| National Heart Lung and Blood Institute of the National Institutes of Health, USA |
|
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Primary Sponsor
|
| Name |
All India Institute of Medical Sciences AIIMS |
| Address |
Ansari Nagar
New Delhi |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Centre for Chronic Disease Control CCDC |
C-1/52, 2nd Floor,
Safdarjung Development Area
New Delhi - 110 016, INDIA
|
| Emory University |
201 Dowman Dr, Atlanta, GA 30322, USA |
|
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Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Contact Person |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mohinder Singh |
CHC, Mukandpur Block |
Room no 3, Administration building
Nawanshahr
|
9815241406
nrhmmkdr.nsr518@gmail.com |
| Dr Harbansh Singh |
PHC Sujjon Block |
Senior Medical officer Room no 2
Nawanshahr
|
9780167787
nrhmsujn.nsr@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| All India Institute of Medical Sciences, Ansari Nagar, New Delhi. |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Diabetes mellitus |
| Patients |
Hypertensive diseases |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Active comparator : Control arm |
Delivery of healthcare at the all levels of facilities in the non-intervention comparison block will remain unchanged from their current status i.e comparison block will continue to receive the existing standard care and treatment for hypertension and diabetes . |
| Intervention |
I-TREC |
We are using a quasi-experimental design in which we are evaluating healthcare indicators in the community before and after the I-TREC facility-level IT intervention has been implemented. This is an implementation science study examining the following quality improvement activities applied within all government health care facilities comprising the public system in a single block :
(1) tracking system for individual patient progress through the various levels of the healthcare system; (2) use of mobile text messaging for referral and appointment reminders to promote patient retention in care and better adherence to lifestyle and medication recommendations; (3) provision of electronic clinical decision support system (DSS) to assist providers with tailoring guideline-based care to individual patient needs; and (5) training of designated individuals at each level of healthcare in care coordination strategies to improve continuity of hypertension and diabetes care in the Indian population.
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
This is not a traditional trial in which we will enroll patients. Instead, investigators will be provided with de-identified data of all patients who seek care for hypertension and/or diabetes in a government health facility within the intervention block. Because the data are collected in the course of providing routine care to patients, no additional criteria apply.1) All adults seeking diagnosis of, or care for, hypertension or diabetes at a public health facilities in the intervention block |
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| ExclusionCriteria |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Difference in the mean change in systolic blood pressure from baseline and at 3 year after intervention initiation at the community-level between the I-TREC and comparison block among patient with hypertension. Please note that these data will come from a strictly observational survey conducted in the community. |
2 i.e at baseline and at 3 years |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
Difference between I-TREC and comparison block at baseline and at 3 years after intervention initiation:
1. In the mean change in fasting plasma glucose at the community-level among patient with type-2 diabetes
2. Percent of individuals with hypertension and diabetes who have controlled blood pressure and blood sugar, respectively
3. In mean change in systolic blood pressure and fasting plasma glucose among patients who are observed more than once in the health facilities
|
2 i.e at baseline and at 3 year |
|
|
Target Sample Size
|
Total Sample Size="2544"
Sample Size from India="2544" |
|
Phase of Trial
|
N/A |
Date of First Enrollment (India)
Modification(s)
|
15/01/2020 |
| Date of First Enrollment (Global) |
No Date Specified |
Estimated Duration of Trial
Modification(s)
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
None yet |
|
Brief Summary
|
This is an observation trial
study to develop and implement an Integrated Tracking, Referral, Electronic
Decision Support and Care Coordination (I-TREC) package focused on hypertension
and diabetes management in India. We will use information technology (IT) to
create an integrated platform that (1) helps in universal screening for
hypertension and diabetes; (2) tracks
individual patient progress through the various levels of the healthcare system
and monitors community-level screening and treatment outcomes; (3) uses mobile text messaging for referral and
appointment reminders to promote patient retention in care and better
adherence to lifestyle and medication recommendations; (4) provides an electronic decision support system (DSS) to assist providers with
tailoring guideline-based care to individual patient needs; and (5) trains
designated individuals at each level of healthcare in care coordination strategies to improve continuity of hypertension and diabetes care in the Indian
population. Moreover, we will design this platform for implementation
within the existing public healthcare system, in collaboration with the
Department of Health in Punjab, a state in Northern India, in order to assure
cost-efficiency, scalability and longevity beyond this program.
AIM 1. (a) Establish an Advisory
Committee of local, national, and international stakeholders and experts to
provide inputs into developing a scalable and generalizable model of
coordinated healthcare delivery for hypertension and diabetes. This committee
will also advise on formulating best practices for technical capacity building
to ensure program sustainability. (b) Adapt our existing evidence-based tools
into an Integrated Tracking, Referral, and Electronic Decision Support, and
Care Coordination (I-TREC) package in collaboration with the Punjab State
Department of Health. Our goal is to contextually tailor proven single-level
interventions into a coordinated package within the healthcare system to track
and enhance hypertension and diabetes screening and care per the national
recommendations. We will conduct a mixed-methods gap analysis with stakeholders
(e.g., patients and providers) to (1) describe baseline health and healthcare
delivery indicators and (2) understand barriers to seeking and providing
effective hypertension and diabetes care.
AIM 2. Implement I-TREC in a
district of Punjab State, India. I-TREC will consist of an IT-enabled,
multi-component package to improve coordination of care across various levels
of the healthcare facility hierarchy and will include electronic data capture,
electronic DSS, and care coordination training for selected healthcare
professionals at each level of care; text messaging to patients for
appointments and disease management advice; facility level retrieval of patient
history and inventory needs, and health administration monitoring of data
across levels. We will implement the intervention in all 30 health facilities
within the healthcare system of a single block (sub-district administrative
unit) in Punjab covering a catchment area of ~1,00,000 lakh population.
AIM3. Evaluate I-TREC using a
mixed-methods, quasi-experimental design. We will estimate health and
healthcare changes in the intervention block with changes in a non-adjacent
comparison block (i.e., “difference-in-difference” measures). Community survey,
patient focus group discussion, provider interview, and the I-TREC platform
data will be used to evaluate RE-AIM indicators: Reach (e.g., %’s screened in
the community, tracked over time, and referred), Effectiveness (e.g., % with
controlled hypertension in the community), Adoption (e.g., % of facilities
using the I-TREC; provider reception to I-TREC), Implementation outcomes (e.g.,
concordance between facility paper registry I-TREC database; routine
operational costs per patient), and Maintenance (e.g., % providers using I-TREC
6 months after the active intervention).
The proposed T4 intervention promises to
consolidate previously proven strategies at single-levels of the healthcare
hierarchy into a scalable model for coordinated care delivery. Expert group
guidance and support from state and central government institutions assure
integration with existing local and national efforts, and great potential to
revolutionize care for deadly chronic diseases in the most vulnerable
hard-to-reach patients who rely primarily on the government healthcare system
in India and other similar settings. |
