Integrated NCD Intervention in Rural Nepal

NCT04087369 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-06-25

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Nyaya Health Nepal

    collaborator UNKNOWN
  • Ministry of Health and Population, Nepal

    collaborator OTHER_GOV
  • Possible

    lead OTHER

Principal Investigators

  • Sabitri Sapkota, PhD, MPH · Possible/Nyaya Health Nepal

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-01
Primary Completion
2023-03-31
Completion
2023-12-31

Countries

  • Nepal

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04087369 on ClinicalTrials.gov