Integrated NCD Intervention in Rural Nepal

Not Applicable

Withdrawn

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

• Registration Number: NCT04087369
• Lead Sponsor: Possible

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-06
• Study First Submitted QC: 2019-09-10
• Study First Posted: 2019-09-12
• Study Start: 2019-12-01
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-22
• Last Update Posted: 2021-06-25
• Primary Completion: 2023-03
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Type II diabetes mellitus control measure	24 months	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	24 months	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	24 months	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

Name	Time	Method
Tobacco use	24 months	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	24 months	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

Trial Locations

Locations (2)

Charikot Primary Health Center; 🇳🇵 Charikot, Dolakha/Province 3, Nepal

Bayalpata Hospital; 🇳🇵 Sanfebagar-10, Achham/Province 7, Nepal