Clinical trial NCT04087369: Integrated NCD Intervention in Rural Nepal
Official title: An Integrated Intervention for Chronic Care Management in Rural Nepal: a Type 2 Hybrid Effectiveness-implementation Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Noncommunicable Diseases
Hypertension
Chronic Obstructive Pulmonary Disease
Diabetes Mellitus, Type 2
Keywords: 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
Lead sponsor: Possible
Sponsor class: OTHER
Collaborators: name: Nyaya Health Nepal
name: Ministry of Health and Population, Nepal
First posted: 2019-09-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: Inclusion Criteria:

1. 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
2. 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
3. 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:

1. Patients migrate from the study are before completion of any of the Package of Essential Noncommunicable disease interventions
2. Patients explicitly request exclusion from the study and decline to consent to the study.

Primary outcomes:
measure: Type II diabetes mellitus control measure
timeFrame: 24 months
measure: Hypertension control measure
timeFrame: 24 months
measure: COPD control measure
timeFrame: 24 months
Secondary outcomes:
measure: Tobacco use
timeFrame: 24 months
measure: Alcohol use
timeFrame: 24 months
Other outcomes:
measure: Home visit coverage (Reach)
timeFrame: 1 month
measure: Clinic visit coverage (Reach)
timeFrame: 1 month
measure: Demographic, geographic barriers and facilitators
timeFrame: 24 months
measure: Loss to follow-up (Reach)
timeFrame: 24 months
measure: Monthly patient touch-points (Effectiveness)
timeFrame: 1 month
measure: Evidence-based hypertension management (Effectiveness)
timeFrame: 3 months
measure: Evidence-based diabetes management (Effectiveness)
timeFrame: 3 months
measure: Evidence-based COPD management (Effectiveness)
timeFrame: 3 months
measure: Village cluster adoption (Adoption)
timeFrame: 24 months
measure: Timely adoption (Adoption)
timeFrame: 24 months
measure: CHW training adoption (Adoption)
timeFrame: 6 months
measure: CHW retention adoption (Adoption)
timeFrame: 24 months
measure: MLP training adoption (Adoption)
timeFrame: 24 months
measure: MLP retention adoption (Adoption)
timeFrame: 24 months
measure: Care integration (Implementation)
timeFrame: 1 month
measure: CHW supervision completion (Implementation)
timeFrame: 3 months
measure: CHW supervision review meeting completion (Implementation)
timeFrame: 3 months
measure: CHW home visit completion (Implementation)
timeFrame: 3 months
measure: CHW home visit fidelity (Implementation)
timeFrame: 3 months
measure: Referral fidelity (Implementation)
timeFrame: 3 months
measure: Referral completion (Implementation)
timeFrame: 3 months
measure: MLP supervision model (Implementation)
timeFrame: 3 months
measure: MLP visit fidelity (Implementation)
timeFrame: 1 month
measure: Total intervention cost (Maintenance)
timeFrame: 24 months
measure: Intervention initiation costs (Maintenance)
timeFrame: 24 months
measure: Intervention maintenance costs (Maintenance)
timeFrame: 24 months
measure: Facility vs. community costs (Maintenance)
timeFrame: 24 months
measure: Geographic cost variation (Maintenance)
timeFrame: 24 months
measure: Out-of-pocket patient costs (Maintenance)
timeFrame: 24 months
measure: Integrated intervention cost-effectiveness analysis (Maintenance)
timeFrame: 24 months
measure: Cost per unit patient (Maintenance)
timeFrame: 24 months
measure: Cost per capita (Maintenance)
timeFrame: 24 months
measure: Projected scale cost(Maintenance)
timeFrame: 24 months
Locations:
city: Sanfebagar-10
country: Nepal
facility: Bayalpata Hospital
state: Achham/Province 7
city: Charikot
country: Nepal
facility: Charikot Primary Health Center
state: Dolakha/Province 3
Study officials:
affiliation: Possible/Nyaya Health Nepal
name: Sabitri Sapkota, PhD, MPH
role: STUDY_DIRECTOR
References:
citation: Schwarz D, Dhungana S, Kumar A, Acharya B, Agrawal P, Aryal A, Baum A, Choudhury N, Citrin D, Dangal B, Dhimal M, Gauchan B, Gupta T, Halliday S, Karmacharya B, Kishore S, Koirala B, Kshatriya U, Levine E, Maru S, Rimal P, Sapkota S, Schwarz R, Shrestha A, Thapa A, Maru D. An integrated intervention for chronic care management in rural Nepal: protocol of a type 2 hybrid effectiveness-implementation study. Trials. 2020 Jan 29;21(1):119. doi: 10.1186/s13063-020-4063-3.