Integrated NCD Intervention in Rural Nepal

Study Overview
=================
Brief Summary
-----------------
We will test an NCD intervention bundle incorporating the World Health Organisation (WHO)'s Package for Essential Non-Communicable Disease Interventions (PEN) within an approximate population of 300,000 people in rural Nepal. This intervention integrates three evidence-based approaches for both facility- and community-based NCD care focused on the key areas of Clinical Practice, Counseling, and Technology for two tiers of non-physician healthcare worker - Mid-Level Providers and Community Health Workers: 1) Task-shifting of evidence-based medicine algorithms and clinical skills from PEN protocols to non-physician healthcare workers; 2) Delivering quality counseling based on the Motivational Interviewing Model to drive behavior change with respect to both treatment adherence (defined as medication adherence and follow-up completion) and risk factor modification (alcohol, tobacco, diet, physical activity); 3) Employing a facility- and community-based clinical decision support tool for effective integration of PEN protocols into non-physician healthcare worker workflow. This five-year study will initial test the acceptability and feasibility of the intervention (two years) followed by a type 2 hybrid effectiveness-implementation research trial (three years) to which we will apply the RE-AIM implementation evaluative framework of both outcomes and process indicators. Co-primary outcomes for the intervention bundle will be: a) disease-specific, evidence-based control metrics that measures clinical efficacy; b) qualitative evaluation of acceptability and feasibility that incorporates perspectives of patients, providers, and government stakeholders; and c) an implementation checklist of key intervention process measures.

Official Title
-----------------
An Integrated Intervention for Chronic Care Management in Rural Nepal: a Type 2 Hybrid Effectiveness-implementation Study

Conditions
-----------------
Noncommunicable Diseases, Hypertension, Chronic Obstructive Pulmonary Disease, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Other: Bundled NCD WHO PEN Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients aged 18 or older that screen into Nyaya Health Nepal/Possible's chronic disease program for the following conditions: Hypertension, Type II Diabetes Mellitus, COPD, and Asthma OR Adult patients aged 18 or older with end-organ pathology resulting from the aforementioned conditions including the following: Chronic Kidney Disease, Ischemic Heart Disease, Cerebrovascular Disease AND Healthcare staff; mid-level providers serving at district/primary health center-level facility; community health workers serving village clusters, Nyaya Health Nepal/Possible and Government of Nepal/Ministry of Health and Population employees involved in study design, program implementation, data collection, or data analysis processes. Note, study populations 1 and 2 must reside in either Achham or Dolakha (Nepal) districts. Patients must have a noncommunicable note in electronic medical record system at least twice (indicating at least one follow-up visit) and must have minimum 12 weeks in between baseline/endline clinical measures (indicating patients have been followed up for at least 3 months and have 3 months of exposure to intervention). Patients do not need to have been in study for all 3 years. Duration of exposure to intervention will depend on stepped implementation design. Patients may be identified at Bayalpata Hospital (Achham, Nepal) or Charikot Primary Health Center (Dolakha, Nepal) by facility clinicians. Community health workers can also identify hypertensive patients and refer them to the facility for diagnosis confirmation. Patient enrollment will not be restricted by economic status or caste. Patients will not be recruited exclusively to participate in the study but will undergo routine evaluations, entering the final diagnosis in electronic health record system, tracking progress at each patient contact, the frequency for which is determined by the clinician's recommendation per World Health Organization Package of Essential Noncommunicable disease intervention protocols and the patient's availability. Patients will receive longitudinal care via the community health workers at their homes and at the hospitals by mid-level providers and staff physicians. Their receipt of care is not contingent upon their enrollment in the study; they receive care per routine service delivery. Exclusion Criteria: Patients migrate from the study are before completion of any of the Package of Essential Noncommunicable disease interventions Patients explicitly request exclusion from the study and decline to consent to the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bundled NCD WHO PEN Intervention<br>Mixed-methods type 2 hybrid effectiveness-implementation study to evaluate an integrated NCD care management intervention | Other: Bundled NCD WHO PEN Intervention<br>* In the intervention includes the planned roll-out of the World Health Organization's Package of essential noncommunicable disease interventions (WHO PEN) for primary care in low resource settings by the Government of Nepal, Ministry of Health and Population. In addition, this intervention will include three evidence-based components: 1) non-communicable disease (NCD) care integration using mid-level practitioners (MLPs) and community healthcare workers (CHWs); 2) clinical decision support (CDS) tools to ensure quality care in accordance with best practices; and 3) training and supervision of MLPs to provide motivational interviewing (MI) techniques for modifiable risk factor optimization, with a specific focus on tobacco and alcohol use.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type II diabetes mellitus control measure | Percentage of enrolled type II diabetes patients achieving at goal status, at the completion of the study period (type II diabetes mellitus: Hemoglobin A1c < 7.5 OR fasting blood sugar <130 mg/dL) | 24 months | 
| Hypertension control measure | Percentage of enrolled hypertension patients achieving at goal status, at the completion of the study period (hypertension: blood pressure <130/80mm Hg or patient-tailored goal per risk stratification) | 24 months | 
| COPD control measure | Percentage of enrolled COPD patients achieving at goal status, at the completion of the study period (COPD: exacerbation status ≤1/3 Anthonisen criteria) | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tobacco use | Percentage of enrolled NCD patients who were using tobacco at enrollment who are non-users or who have reduced by >50% their tobacco intake, at the completion of the study period | 24 months | 
| Alcohol use | Percentage of enrolled NCD patients who were alcohol drinkers at enrollment who are non-drinkers or who have reduced by >50% alcohol intake, at the completion of the study period | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
implementation research, low- and middle-income countries, Nepal, Package of Essential Noncommunicable disease interventions for primary care in low-resource settings, task-shifting, non-physician health workers, digital tools, motivational interviewing