| CTRI Number |
CTRI/2025/02/080572 [Registered on: 14/02/2025] Trial Registered Prospectively |
| Last Modified On: |
11/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive Screening Process of Care Changes Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
Strenghthening Outpatient Care Services for Non-Communicable Diseases |
|
Scientific Title of Study
|
STrengthening Ambulatory caRe
for Non Communicable Diseases-STAR NCD |
| Trial Acronym |
STAR NCD |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Roopa Shivashankar |
| Designation |
Scientist E |
| Affiliation |
Indian Council of Medical Research |
| Address |
Room number 204,
First floor,
V Ramalingaswami Bhawan
Indian Council of Medical Research
PO Box No 4911
Ansari Nagar
New Delhi
New Delhi DELHI 110029 India |
| Phone |
9312065025 |
| Fax |
|
| Email |
shivashankar.r@icmr.gov.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Roopa Shivashankar |
| Designation |
Scientist E |
| Affiliation |
Indian Council of Medical Research |
| Address |
Room number 204,
First floor,
V Ramalingaswami Bhawan
Indian Council of Medical Research
PO Box No 4911
Ansari Nagar
New Delhi
DELHI 110029 India |
| Phone |
9312065025 |
| Fax |
|
| Email |
shivashankar.r@icmr.gov.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Roopa Shivashankar |
| Designation |
Scientist E |
| Affiliation |
Indian Council of Medical Research |
| Address |
Room number 204,
First floor,
V Ramalingaswami Bhawan
Indian Council of Medical Research
PO Box No 4911
Ansari Nagar
New Delhi
DELHI 110029 India |
| Phone |
9312065025 |
| Fax |
|
| Email |
shivashankar.r@icmr.gov.in |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research Ansari Nagar NEW DELHI |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
Indian Council of Medical Research
V Ramalingaswami Bhawan
PO Box No 4911
Ansari Nagar
New Delhi 110029 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sumit Malhotra |
AIIMS, NEW DELHI |
Comprehensive Rural Health Services Project
Ballabgarh
Centre for Community Medicine
AIIMS
New Delhi Faridabad HARYANA |
011 26594125
drsumitaiims2012@gmail.com |
| Dr Dorothy Lall |
CMC Chittoor |
190 Ramapuram Village,
189 Kothapalle Post,
Gudipala Mandal, Chittoor - 517132,
Andhra Pradesh. Chittoor ANDHRA PRADESH |
9483604200
dorothy.lall@cmcvellore.ac.in |
| Dr Kamal Reang CMO Gomati |
Gomati |
office of Chief Medical Officer (CMO), Gomati, P.O.- Tepania Dist:-Gomati Tripura, Udaipur South Tripura TRIPURA |
94364 70771
cmo.gomati@gmail.com |
| Dr Akkilagunta Sujiv |
Nagpur |
Dept of Community Medicine, All India Institute of Medical Sciences Nagpur
Mihan, Nagpur, Maharashtra-441108
Nagpur MAHARASHTRA |
9626308793
sujiv.oh231@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 8 |
| Name of Committee |
Approval Status |
| AIIMS NAGPUR IEC |
Approved |
| Centre for Chronic Disease Control |
Approved |
| Centre for Chronic Disease Control IEC |
Approved |
| IEC AIIMS NEW DELHI |
Approved |
| IEC AIIMS NEW DELHI |
Approved |
| IRB CMC VELLORE |
Approved |
| NOC Gomati |
No Objection Certificate |
| NOC Nagpur |
No Objection Certificate |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E085||Diabetes mellitus due to underlying condition with circulatory complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Capacity Building |
The routine state and district level NCD trainers will be utilized for the training of facility level staff. We will use the blended method as a strategy for the training. We will develop pedagogically sound lesson plans clearly specifying the learning outcomes we hope to achieve and align the assessments to the outcomes specified. The online component will be self-paced, with periodic assessments and will be delivered on a learning management platform (LMS like Moodle that is open source and free). Online mode will be followed up by in person workshops of shorter duration that will reinforce online learnings as well as focus on skill building. This will enable a sustained engagement with staff undergoing training, provide updates and facilitate refresher training. |
| Intervention |
Ensuring use of evidence-based protocols |
To ensure quality and evidence-based care at the healthcare facilities, simple to implement treatment algorithms for diabetes, CVD, and COPD will be provided to the healthcare providers at all facility levels. These algorithms will be designed in accordance with the drug procurement and supply chain policies of the state and according to the level of healthcare facilities. Adoption of treatment protocols not only supports efficient treatment initiation, escalation, reducing clinical variability and decentralization of care, but it also helps in strengthening the supply chain system as fewer items to be procured and managed.
Additionally, an electronic Clinical Decision Support System (e-CDSS) will be initiated at the healthcare facilities to aid the health care providers in providing the evidence-based care to the patients visiting the healthcare facilities. |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
Strengthening NCD Governance mechanism (state and district level) |
It is recognized that effective NCDs prevention and control require leadership, coordinated multi-stakeholder engagement and multisectoral action for health at different levels with involvement of key decision makers and stakeholders.
A group of key stakeholders will be engaged at the state headquarters and the district levels for joint planning of project activities, administrative and financial approvals, review and monitoring of the project implementation progress, and ensuring sustainability of the implementation strategies.
|
| Intervention |
Strengthening referral linkages and access to specialist services |
To ensure continuum of care across different levels, bidirectional referrals will be imperative. Access to specialist services, complication screening and management, and getting a range of laboratory tests demand linkages with higher level facilities within the district health system. The Ministry of Health and Family Welfare launched India’s revolutionary telemedicine platform, ‘eSanjeevani’ to make healthcare more accessible and affordable for its people. To enhance the usage and benefits of telemedicine services, an assisted telemedicine model that would operate on the concept of task shifting and sharing is proposed. The trained healthcare provider (nurse, CHO, or ANM worker) can assist in recording a comprehensive medical history, documenting laboratory investigations, vitals, and physical examination findings on the platform before initiating the consultation. |
| Intervention |
Strengthening supply chain and procurement mechanisms |
Multiple strategies will be adopted to strengthen the supply chain, critical for providing quality care services.
a. The drugs (in different doses) as part of treatment protocols for managing NCDs will be included in the essential drug list of the state.
b. The “drug forecasting tool” will be used that will compute the requirement of drugs based on steady increase in patient enrolment and evidence on proportion of patients required to be treated at different steps of the treatment protocol. The tool will also help in forecasting the budget requirement for optimal planning.
c. Strengthening procurement efficiency
d.Setting up inventory norms and Patient load linked stock refilling
e. Last-mile delivery of drugs |
| Intervention |
Team based care with task redistribution at primary and secondary levels of health care in the district |
This intervention is aimed to overcome the gap in delivering high quality care – evidence based, patient centered, continuous, coordinated care. Team based care is known to improve outcomes of care especially for chronic conditions. There are several tasks that need to be completed in the care of a patient to ensure continuity and coordinated care and all of them cannot be completed by a solo provider. Tasks include counselling for lifestyle modification, self -management support, protocol-based regulation of medicines among others. With adequate capacity building and support it is possible for various members of a primary care team to be empowered to deliver specific tasks in patient care. A team approach also ensures responsiveness of the health care delivery system to the patients’ needs and context, where members in the facility work collaboratively with patients and their caregivers—to the extent preferred by each patient— to accomplish shared goals. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Community survey :
General population above 30 years
Exit interview:
Patients visiting public health facilities for Non communicable disease servicesFacility Assessment :
Primary-Health and Wellness Centre,Primary Health Centre,Upgarded Primary Health Centre and Urban Health Centre, Secondary-Community Health Centre, Sub District Hospital,Tertiary-District Hospital
Qualitative interviews and FGDs:
All health care providers who are directly involved in NCD delivery
Competency assessment:
ANM,Mid Level Health Provider,Community Health Officer
|
|
| ExclusionCriteria |
| Details |
Bedridden patients for exit interview |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Coverage, quality of service delivery, and equity |
6 months formative phase
2 iterations
One year and six months full scale implementation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Develop a model for improved delivery of NCD care at selected districts & iteratively implement the model & refine for scaling to the district |
For iterative model 15 months & 18 months after the project initiation |
| Determine the incremental cost implication for the health care delivery system in the context of the national program for NCDs |
Incremental cost at the end of three years project period |
|
|
Target Sample Size
|
Total Sample Size="16000" Sample Size from India="16000"
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)
|
01/03/2025 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The National Program for Non-Communicable Diseases (NP-NCDs) in India has been implemented within the public health facilities since 2008. The introduction of several components ranging from prevention, screening, case finding and management of NCDs have been phased and sequentially implemented with presence of NCD digital platform for data entry and recording. Currently, there are implementation gaps in reach, retention, and quality of ambulatory NCD care services in the country. This project is an implementation research study planned to develop a model to strengthen the ambulatory care for common NCDs (hypertension, diabetes, chronic obstructive pulmonary disease, and secondary prevention of coronary artery disease). The model developed will focus on improving coverage, quality, and equity within the scope of the national program for NCD (NP-NCD). The study will be done in four states with one district within each state namely Haryana (Jhajjar), Tripura (Gomati), Maharashtra (Nagpur), and Andhra Pradesh (Chittoor). The provisional implementation strategies include strengthening of NCD governance at the district/state level, patient empowerment, supportive supervision to facilities and providers, use of evidence -based protocols for management and referrals (including use of clinical decision support systems), ensuring drug and diagnostic supplies, team based and coordinated care, and use of information technology. However, the implementation strategies are subject to change based on the findings emerged during formative phase assessment. The study will have three phases- Phase 1 Formative, Phase 2 Co-design of implementation strategies, Iteration, and finalization Phase 3 Implementation of model at scale in district, measure outcomes and cost The total duration of the project will be three years. The first phase of the project will be the formative phase, in the first six months. The primary objective of this phase is to understand the context and current situation of implementation of the NP-NCD program in the study districts. An understanding of the context is an imperative to enable assessment of readiness within the study facilities to adopt the proposed implementation strategies that will be rolled out. We propose using a mixed methods approach collecting both quantitative and qualitative data concurrently and triangulating the data during analysis. Phase 2 will involve co-design of the implementation model. Stakeholders will be mapped and will be involved in shaping the model. Persons with NCDs are an important stakeholder often left out of delivery design. We will ensure the inclusion of patient groups in the co design process along with implementers and policymakers. Equity concerns will be embedded right from the beginning, keeping in mind inequalities that result from gender, age, location, and distance from health facilities that impedes access to care. Consultative workshops will be done with stakeholders block wise to co-create the 1st iteration of the model (Model 1). Additionally, we will also refine and develop treatment protocols engaging with experts and program officials. These protocols will be prepared as simple to follow algorithms for application at each level of health facility within the district health system, starting from sub center-HWC up to district hospital. We will monitor the implementation in 2 blocks (pilot) for 3 months and will iterate this model with stakeholders through a process of co analysis with stakeholders. Model 2 will be implemented in 4 blocks including the pilot districts for the next 3 months. At the end of 6 months a similar stakeholder consultation will be held for co analysis and a final model to scale will be developed. We will closely monitor processes and implementation through field level staff that will facilitate implementation and collect data once every month. We propose an interrupted time series design for the concurrent evaluation. The overarching design is a quasi-experimental design and includes a before and after cross-sectional community-based surveys (baseline and endline) and the interrupted time series for different outcome measurements. The survey design is used for assessment of change in the retention along the care cascade and impact of interventions on out-of-pocket expenditure and the interrupted time series for change in processes of care at facility level. We will use multiple methods to make inferences from triangulation of data -both qualitative and quantitative including routine reports, observations, exit interviews, prescription audits, observations, and qualitative interviews from various stakeholders. We also propose to conduct a costing of implementing the intervention calculating, additional cost per patient by the level of healthcare facilities (activity-based costing). In addition, we will perform a budget impact analysis and estimate additional resources required for scale-up at district- or state-level. The findings and learnings through the study will be disseminated through multiple modalities. Some of these will include writing policy briefs for advocacy and meetings with policy makers, media briefs, and stakeholder and community meetings. |