Integrated NCD Intervention in Rural Nepal

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Hypertension; Diabetes Mellitus, Type 2; Chronic Obstructive Pulmonary Disease; Noncommunicable Diseases
• Intervention / Treatment: Other: Bundled NCD WHO PEN Intervention

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Nepal
  • Achham/Province 7
    • Sanfebagar-10, Achham/Province 7, Nepal
      • Bayalpata Hospital
  • Dolakha/Province 3
    • Charikot, Dolakha/Province 3, Nepal
      • Charikot Primary Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Bundled NCD WHO PEN Intervention; Mixed-methods type 2 hybrid effectiveness-implementation study to evaluate an integrated NCD care management intervention

Other: Bundled NCD WHO PEN Intervention; 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.

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Home visit coverage (Reach)	Percentage of enrolled NCD patients having a CHW home visit	1 month
Clinic visit coverage (Reach)	Percentage of enrolled NCD patients having an MLP visit at the clinic, measured monthly according to the patients indicated to be seen that month based on protocol-based guidelines	1 month
Demographic, geographic barriers and facilitators	Percentage of enrolled NCD patients whose CHW has GPS-mapped their households, describing barriers/facilitators to individuals' access, and identifying contributors to variation/inequities	24 months
Loss to follow-up (Reach)	Percentage of patients, stratified by demographic data and NCD conditions, that are lost-to-follow-up after enrollment	24 months
Monthly patient touch-points (Effectiveness)	Number of monthly per-patient touch-points, including interactions by both MLPs and CHWs	1 month
Evidence-based hypertension management (Effectiveness)	Percentage of enrolled hypertension patients in accordance with evidence-based recommendations, as prescribed by clinical algorithms, assessed quarterly by EHR audits	3 months
Evidence-based diabetes management (Effectiveness)	Percentage of enrolled diabetes patients in accordance with evidence-based recommendations, as prescribed by clinical algorithms, assessed quarterly by EHR audits	3 months
Evidence-based COPD management (Effectiveness)	Percentage of enrolled COPD patients in accordance with evidence-based recommendations, as prescribed by clinical algorithms, assessed quarterly by EHR audits	3 months
Village cluster adoption (Adoption)	Percentage of intended village clusters receiving intervention	24 months
Timely adoption (Adoption)	Percentage of intended village clusters rolling-out intervention within 3 months of schedule, according to local governance decisions to roll-out the intervention	24 months
CHW training adoption (Adoption)	Percentage of CHWs trained in intervention implementation within first six months	6 months
CHW retention adoption (Adoption)	Percentage of of trained CHWs retained in their positions at the completion of the study period	24 months
MLP training adoption (Adoption)	Percentage of MLPs trained in intervention implementation	24 months
MLP retention adoption (Adoption)	Percentage of of trained MLPs retained in their positions at the completion of the study period	24 months
Care integration (Implementation)	Percentage of all NCD patients enrolled at the facilities seen by CHWs at home within first month	1 month
CHW supervision completion (Implementation)	Percentage of scheduled CHW supervision field visits completed, stratified by CHN and district	3 months
CHW supervision review meeting completion (Implementation)	Percentage of scheduled quarterly data review meetings held with CHWs and CHNs	3 months
CHW home visit completion (Implementation)	Percentage of enrolled NCD patients with 100% of algorithm-indicated home visits received	3 months
CHW home visit fidelity (Implementation)	Percentage of of topics included at each session as dictated by the condition-specific algorithms, assessed during the CHW supervision field visits by CHNs	3 months
Referral fidelity (Implementation)	Percentage of patients appropriately referred to MLP care as indicated by the clinical algorithms, assessed during the CHW supervision field visits by CHNs	3 months
Referral completion (Implementation)	Percentage of % of patients referred by CHWs seen by MLPs within the prescribed time window according to the clinical algorithms (e.g. 24hours, 72 hours, 1 week)	3 months
MLP supervision model (Implementation)	Percentage of enrolled NCD patients appropriately referred to see a physician by MLPs as indicated by the clinical algorithms, assessed during monthly physician supervision sessions	3 months
MLP visit fidelity (Implementation)	Percentage of of enrolled NCD patients with 100% of algorithm-indicated facility visits received, assessed during monthly physician supervision sessions	1 month
Total intervention cost (Maintenance)	Cost of each intervention component and total costs using the Joint Learning Network costing methodology	24 months
Intervention initiation costs (Maintenance)	Percentage breakdown of initial (one-time) costs for intervention (training, equipment, etc)	24 months
Intervention maintenance costs (Maintenance)	Percentage breakdown of maintenance (recurring) costs (on-going training, personnel, materials, and other)	24 months
Facility vs. community costs (Maintenance)	Percentage of costs of health care divided between facility level and community level	24 months
Geographic cost variation (Maintenance)	Variance in costs between village clusters and districts within the intervention catchment area	24 months
Out-of-pocket patient costs (Maintenance)	Percentage of costs of health care divided between facility level and community level	24 months
Integrated intervention cost-effectiveness analysis (Maintenance)	Pre/post intervention marginal effectiveness for primary outcomes	24 months
Cost per unit patient (Maintenance)	Intervention cost per enrolled patient	24 months
Cost per capita (Maintenance)	Intervention cost per capita	24 months
Projected scale cost(Maintenance)	Projected cost to scale intervention nationally	24 months

Collaborators and Investigators

• Sponsor: Possible
• Collaborators: Nyaya Health Nepal; Ministry of Health and Population, Nepal
• Investigators: Study Director: Sabitri Sapkota, PhD, MPH, Possible/Nyaya Health Nepal

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2019
• Primary Completion (ANTICIPATED): March 1, 2023
• Study Completion (ANTICIPATED): December 1, 2023

Study Registration Dates

• First Submitted: September 6, 2019
• First Submitted That Met QC Criteria: September 10, 2019
• First Posted (ACTUAL): September 12, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 25, 2021
• Last Update Submitted That Met QC Criteria: June 22, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: motivational interviewing; Nepal; low- and middle-income countries; digital tools; implementation research; Package of Essential Noncommunicable disease interventions for primary care in low-resource settings; task-shifting; non-physician health workers
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Respiratory Tract Diseases; Lung Diseases; Endocrine System Diseases; Disease Attributes; Diabetes Mellitus; Diabetes Mellitus, Type 2; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Noncommunicable Diseases
• Other Study ID Numbers: NCDnyaya

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No