Integrated NCD Intervention in Rural Nepal

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04087369
• Other study ID #: NCDnyaya
• Status: Withdrawn
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: December 2023

Study information

• Verified date: June 2021
• Source: Possible
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Diabetes Mellitus, Type 2
• Hypertension
• Lung Diseases, Obstructive
• Noncommunicable Diseases
• Pulmonary Disease, Chronic Obstructive

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.

Locations

Country	Name	City	State
Nepal	Charikot Primary Health Center	Charikot	Dolakha/Province 3
Nepal	Bayalpata Hospital	Sanfebagar-10	Achham/Province 7

Sponsors (3)

Lead Sponsor	Collaborator
Possible	Ministry of Health and Population, Nepal, Nyaya Health Nepal

Country where clinical trial is conducted

Nepal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Home visit coverage (Reach)	Percentage of enrolled NCD patients having a CHW home visit	1 month
Other	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
Other	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
Other	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
Other	Monthly patient touch-points (Effectiveness)	Number of monthly per-patient touch-points, including interactions by both MLPs and CHWs	1 month
Other	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
Other	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
Other	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
Other	Village cluster adoption (Adoption)	Percentage of intended village clusters receiving intervention	24 months
Other	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
Other	CHW training adoption (Adoption)	Percentage of CHWs trained in intervention implementation within first six months	6 months
Other	CHW retention adoption (Adoption)	Percentage of of trained CHWs retained in their positions at the completion of the study period	24 months
Other	MLP training adoption (Adoption)	Percentage of MLPs trained in intervention implementation	24 months
Other	MLP retention adoption (Adoption)	Percentage of of trained MLPs retained in their positions at the completion of the study period	24 months
Other	Care integration (Implementation)	Percentage of all NCD patients enrolled at the facilities seen by CHWs at home within first month	1 month
Other	CHW supervision completion (Implementation)	Percentage of scheduled CHW supervision field visits completed, stratified by CHN and district	3 months
Other	CHW supervision review meeting completion (Implementation)	Percentage of scheduled quarterly data review meetings held with CHWs and CHNs	3 months
Other	CHW home visit completion (Implementation)	Percentage of enrolled NCD patients with 100% of algorithm-indicated home visits received	3 months
Other	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
Other	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
Other	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
Other	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
Other	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
Other	Total intervention cost (Maintenance)	Cost of each intervention component and total costs using the Joint Learning Network costing methodology	24 months
Other	Intervention initiation costs (Maintenance)	Percentage breakdown of initial (one-time) costs for intervention (training, equipment, etc)	24 months
Other	Intervention maintenance costs (Maintenance)	Percentage breakdown of maintenance (recurring) costs (on-going training, personnel, materials, and other)	24 months
Other	Facility vs. community costs (Maintenance)	Percentage of costs of health care divided between facility level and community level	24 months
Other	Geographic cost variation (Maintenance)	Variance in costs between village clusters and districts within the intervention catchment area	24 months
Other	Out-of-pocket patient costs (Maintenance)	Percentage of costs of health care divided between facility level and community level	24 months
Other	Integrated intervention cost-effectiveness analysis (Maintenance)	Pre/post intervention marginal effectiveness for primary outcomes	24 months
Other	Cost per unit patient (Maintenance)	Intervention cost per enrolled patient	24 months
Other	Cost per capita (Maintenance)	Intervention cost per capita	24 months
Other	Projected scale cost(Maintenance)	Projected cost to scale intervention nationally	24 months
Primary	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
Primary	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
Primary	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	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
Secondary	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