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Integrated NCD Intervention in Rural Nepal

Primary Purpose

Noncommunicable Diseases, Hypertension, Chronic Obstructive Pulmonary Disease

Status
Withdrawn
Phase
Not Applicable
Locations
Nepal
Study Type
Interventional
Intervention
Bundled NCD WHO PEN Intervention
Sponsored by
Possible
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Noncommunicable Diseases focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Bayalpata Hospital
  • Charikot Primary Health Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bundled NCD WHO PEN Intervention

Arm Description

Mixed-methods type 2 hybrid effectiveness-implementation study to evaluate an integrated NCD care management intervention

Outcomes

Primary Outcome Measures

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)
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)
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)

Secondary Outcome Measures

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
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

Full Information

First Posted
September 6, 2019
Last Updated
June 22, 2021
Sponsor
Possible
Collaborators
Nyaya Health Nepal, Ministry of Health and Population, Nepal
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1. Study Identification

Unique Protocol Identification Number
NCT04087369
Brief Title
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

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Withdrawn
Why Stopped
This study was withdrawn prior to participant enrollment due to a lack of external funding, dedicated resources, and shifting organizational priorities among research collaborators
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Possible
Collaborators
Nyaya Health Nepal, Ministry of Health and Population, Nepal

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bundled NCD WHO PEN Intervention
Arm Type
Experimental
Arm Description
Mixed-methods type 2 hybrid effectiveness-implementation study to evaluate an integrated NCD care management intervention
Intervention Type
Other
Intervention Name(s)
Bundled NCD WHO PEN Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Type II diabetes mellitus control measure
Description
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)
Time Frame
24 months
Title
Hypertension control measure
Description
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)
Time Frame
24 months
Title
COPD control measure
Description
Percentage of enrolled COPD patients achieving "at goal" status, at the completion of the study period (COPD: exacerbation status ≤1/3 Anthonisen criteria)
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Tobacco use
Description
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
Time Frame
24 months
Title
Alcohol use
Description
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
Time Frame
24 months
Other Pre-specified Outcome Measures:
Title
Home visit coverage (Reach)
Description
Percentage of enrolled NCD patients having a CHW home visit
Time Frame
1 month
Title
Clinic visit coverage (Reach)
Description
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
Time Frame
1 month
Title
Demographic, geographic barriers and facilitators
Description
Percentage of enrolled NCD patients whose CHW has GPS-mapped their households, describing barriers/facilitators to individuals' access, and identifying contributors to variation/inequities
Time Frame
24 months
Title
Loss to follow-up (Reach)
Description
Percentage of patients, stratified by demographic data and NCD conditions, that are lost-to-follow-up after enrollment
Time Frame
24 months
Title
Monthly patient touch-points (Effectiveness)
Description
Number of monthly per-patient touch-points, including interactions by both MLPs and CHWs
Time Frame
1 month
Title
Evidence-based hypertension management (Effectiveness)
Description
Percentage of enrolled hypertension patients in accordance with evidence-based recommendations, as prescribed by clinical algorithms, assessed quarterly by EHR audits
Time Frame
3 months
Title
Evidence-based diabetes management (Effectiveness)
Description
Percentage of enrolled diabetes patients in accordance with evidence-based recommendations, as prescribed by clinical algorithms, assessed quarterly by EHR audits
Time Frame
3 months
Title
Evidence-based COPD management (Effectiveness)
Description
Percentage of enrolled COPD patients in accordance with evidence-based recommendations, as prescribed by clinical algorithms, assessed quarterly by EHR audits
Time Frame
3 months
Title
Village cluster adoption (Adoption)
Description
Percentage of intended village clusters receiving intervention
Time Frame
24 months
Title
Timely adoption (Adoption)
Description
Percentage of intended village clusters rolling-out intervention within 3 months of schedule, according to local governance decisions to roll-out the intervention
Time Frame
24 months
Title
CHW training adoption (Adoption)
Description
Percentage of CHWs trained in intervention implementation within first six months
Time Frame
6 months
Title
CHW retention adoption (Adoption)
Description
Percentage of of trained CHWs retained in their positions at the completion of the study period
Time Frame
24 months
Title
MLP training adoption (Adoption)
Description
Percentage of MLPs trained in intervention implementation
Time Frame
24 months
Title
MLP retention adoption (Adoption)
Description
Percentage of of trained MLPs retained in their positions at the completion of the study period
Time Frame
24 months
Title
Care integration (Implementation)
Description
Percentage of all NCD patients enrolled at the facilities seen by CHWs at home within first month
Time Frame
1 month
Title
CHW supervision completion (Implementation)
Description
Percentage of scheduled CHW supervision field visits completed, stratified by CHN and district
Time Frame
3 months
Title
CHW supervision review meeting completion (Implementation)
Description
Percentage of scheduled quarterly data review meetings held with CHWs and CHNs
Time Frame
3 months
Title
CHW home visit completion (Implementation)
Description
Percentage of enrolled NCD patients with 100% of algorithm-indicated home visits received
Time Frame
3 months
Title
CHW home visit fidelity (Implementation)
Description
Percentage of of topics included at each session as dictated by the condition-specific algorithms, assessed during the CHW supervision field visits by CHNs
Time Frame
3 months
Title
Referral fidelity (Implementation)
Description
Percentage of patients appropriately referred to MLP care as indicated by the clinical algorithms, assessed during the CHW supervision field visits by CHNs
Time Frame
3 months
Title
Referral completion (Implementation)
Description
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)
Time Frame
3 months
Title
MLP supervision model (Implementation)
Description
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
Time Frame
3 months
Title
MLP visit fidelity (Implementation)
Description
Percentage of of enrolled NCD patients with 100% of algorithm-indicated facility visits received, assessed during monthly physician supervision sessions
Time Frame
1 month
Title
Total intervention cost (Maintenance)
Description
Cost of each intervention component and total costs using the Joint Learning Network costing methodology
Time Frame
24 months
Title
Intervention initiation costs (Maintenance)
Description
Percentage breakdown of initial (one-time) costs for intervention (training, equipment, etc)
Time Frame
24 months
Title
Intervention maintenance costs (Maintenance)
Description
Percentage breakdown of maintenance (recurring) costs (on-going training, personnel, materials, and other)
Time Frame
24 months
Title
Facility vs. community costs (Maintenance)
Description
Percentage of costs of health care divided between facility level and community level
Time Frame
24 months
Title
Geographic cost variation (Maintenance)
Description
Variance in costs between village clusters and districts within the intervention catchment area
Time Frame
24 months
Title
Out-of-pocket patient costs (Maintenance)
Description
Percentage of costs of health care divided between facility level and community level
Time Frame
24 months
Title
Integrated intervention cost-effectiveness analysis (Maintenance)
Description
Pre/post intervention marginal effectiveness for primary outcomes
Time Frame
24 months
Title
Cost per unit patient (Maintenance)
Description
Intervention cost per enrolled patient
Time Frame
24 months
Title
Cost per capita (Maintenance)
Description
Intervention cost per capita
Time Frame
24 months
Title
Projected scale cost(Maintenance)
Description
Projected cost to scale intervention nationally
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sabitri Sapkota, PhD, MPH
Organizational Affiliation
Possible/Nyaya Health Nepal
Official's Role
Study Director
Facility Information:
Facility Name
Bayalpata Hospital
City
Sanfebagar-10
State/Province
Achham/Province 7
Country
Nepal
Facility Name
Charikot Primary Health Center
City
Charikot
State/Province
Dolakha/Province 3
Country
Nepal

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31996250
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.
Results Reference
derived

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Integrated NCD Intervention in Rural Nepal

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