FCHV-HTN Implementation Trail in Nepal

Study Overview
=================
Brief Summary
-----------------
The goal of this hybrid type III study incorporating a cluster-randomized trial is to assess the effect of a community health worker-led hypertension prevention and control program (CHPC) on the implementation outcomes and clinical outcomes among patient with hypertension in central Nepal. The main questions it aims to answer are: 1. What is the level of implementation outcomes, including reach, adoption, implementation fidelity, and maintenance of the CHPC implementation strategy at the patient, provider, and health system levels? 2: What is the effectiveness of the CHPC implementation strategy compared to facility-based intervention on systolic BP via a cluster randomized controlled trial. 3: What is the implementation cost and cost-effectiveness of the CHPC implementation strategy? Participants will receive counseling and blood pressure monitoring services at their home every four months for a year by a community health worker. Researchers will compare if there is a significant difference in systolic blood pressure between those who receive this intervention and those who do not receive the intervention in the same community.

Detailed Description
-----------------
INTRODUCTION HTN is a global public health challenge due to its high prevalence and concomitant increased risk of cardiovascular disease (CVD).About 13.5% of global total mortality is attributed to high blood pressure (BP) worldwide.3 In addition, about 54% of strokes and 47% of coronary heart disease worldwide were attributable to high BP. In Nepal, the adult HTN prevalence is 25%, similar to the global prevalence. Community Health Workers (CHWs) are the frontline pillars of community-based health programs in Nepal, that can be leveraged in support of HTN control efforts. CHWs play a pivotal role in Nepali culture - as role models and health leaders in their communities and are highly respected in society. Through CHW, investigators aim to influence HTN control and behavior change among adults and society at large. By providing a replicable model for increasing HTN awareness, treatment, and control in Nepal, investigators will accelerate the integration of effective intervention into practice, providing an example of amelioration of the well-documented delays in moving tested interventions to practice.To ensure relevance to policymakers, the investigators will follow the principles of 'practical trials that include: (a) implementing the strategy, (b) facilitating and evaluating the maintenance of the strategy beyond the implementation phase; (c) using multiple evaluation measures relevant to decision makers, including reach, adoption, and cost; and (d) evaluating effectiveness across multiple outcomes, with a plan to triangulate findings from across multiple data sources using both qualitative and quantitative measures. METHODS investigators will conduct a Hybrid type III effectiveness-implementation design focusing primarily on implementation outcomes while also collecting effectiveness outcomes as they relate to the uptake or fidelity of the intervention. The primary implementation outcomes (aim 1) - reach, adoption, implementation and maintenance - are selected to answer the central research question of this study and will be assessed using a non-inferiority design. Investigators will assess these outcomes in the intervention group using data from the process evaluation in intervention health facilities. For each outcome, the null hypothesis is that the percentages are equivalent to a set target or greater. Thus, if the program is successful, investigators will be able to say with 95% confidence that these high standards have been met. To measure the effectiveness (aim 2), Investigators will use a cluster-randomized design to assess effectiveness in decreasing mean systolic BP in the intervention group compared to the control group at 12 months after the intervention. Investigators will also measure cost and estimate incremental cost per participant with awareness on and control of high BP (aim 3). STUDY SETTING Investigators will include basic health facilities in the Sindhupalchowk and Kavrepalanchowk districts of Bagmati province. The reason is the need, these are hilly districts where there are geographic challenges to deliver services through health facilities only. So, the CHW program can have the highest impact by reaching a wider community to improve HTN awareness, treatment, and control. In Nepal's hierarchical government structure, the provincial government's commitment ensures high participation from health facilities. In the study districts, there are 171 basic health facilities, and approximately 1881 CHWs. These CHWs are female community health volunteers (FCHV) who provide basic health services in Nepal, particularly to women. Intervention (Implementation Strategies) Investigators will include reporting on the progress of this program in the quarterly health system review meetings to ensure continuous discussion of the program. For both training of healthcare providers (3 days) and CHWs (3 days) the training will focus on three objectives: (a) build knowledge of the package of essential non communicable disease (PEN) program protocols-1 and 2; (2) build skills to implement and maintain the program including effective communications, program promotion, engaging HTN patients; and reflecting on and evaluation progress and quality of implementation; and (3) build skills for barriers management, including strategies to address barriers to intervention delivery, such as defining and setting aside times for HTN patients to participate in discussing and addressing barriers to the successful implementation of HTN detection and control. After receiving the training, CHWs will conduct home visits in households in their catchment area and measure BP. Each CHW will take the high BP clients (>=140/90) to the nearest health center. They will enlist the individuals with HTN and conduct three follow-up visits to these participants, every four months. Using concepts from 'learning networks investigators will create information exchanges for both health care workers and CHWs leading to shared problem-solving, learning from each others' experiences, and support for program implementation. Data Sources, Measures, and Analysis by Specific Aim Community Survey: Investigators will conduct baseline and endline client surveys with a total of 2432 participants. Trained research assistants will collect the following data using a face-to-face interview technique: Sociodemographic data such as age (years), gender (male/female/other), marital status (married/unmarried/widow), highest education attained, occupation (government/ self-employed/ private/ unemployed), annual household and per capita income using validated questionnaire;(2) Lifestyle factors such as fruits and vegetable intake using diet quality questionnaire, physical using a global physical activity questionnaire, alcohol (drinks per week) and smoking (cigarettes per day), knowledge of hypertension, and medication. (3) Blood pressure will be taken during baseline and endline. an 'Omron' digital instrument three times in a resting position with an internal of at least 5 minutes. Health care workers survey: Healthcare workers in all health facilities will be asked to complete a survey assessing CHPC implementation, any HTN control efforts, and their BP and lifestyle status. (c) Process tracking: The process tracking system will also serve as a monitoring tool to support program implementation and maintenance. CHW will be asked by health care worker to complete a monthly checklist to capture completed intervention activities, including records of patients attended. Study staff will make monthly phone calls to healthcare workers to ensure collection of these data. (d) Focus group discussions: Investigators will conduct 6-9 FGDs with CHWs purposively at post-implementation and post-maintenance to identify key implementation facilitators and barriers. (e) Key informant interviews (KII): With provincial ministry of health and municipal officials in the selected municipality at two-time points (post-implementation and post-maintenance) investigators will explore factors influencing support for the program and their perceptions of barriers and facilitators to the program among 16 key informants expecting to reach data saturation. Data analysis for the primary aim: reach, adoption, implementation and maintenance Investigators will compute estimates of adoption, implementation, reach, and maintenance, with appropriate 95% confidence intervals. Investigators will conduct abductive analysis, using first inductive codes (e.g., emerging from the data) and transposing these into deductive consolidated framework for implementation research (CFIR) constructs. Investigators will compile codes and clear definitions of codes into a codebook and apply them to the data using Nvivo 12.0, with regular team meetings to ensure consistency across coders. Aim 2. Effectiveness To assess the effectiveness, investigators are planning for 2432 patients, 14 in the cluster to be enrolled over the period of 6 months. Power was set at 80% and level of significance at 5% to observe a minimum detectable mean difference between arms at 12 months of 3 mmHg systolic BP (primary outcome). There is evidence that 5 mmHg decrease in systolic BP at the population level reduces the risk of CVD by 10 percent. Investigators set the standard deviation of 17 mmHg for HTN based on a previous trial, assumed 10% loss to follow up, and intra-cluster coefficient (ICC) 0.015 to account for clustered design. The baseline characteristics of each arm will be presented as the mean (standard deviation) or, median (interquartile) for continuous; and frequency (%) for categorical variables. Primary analyses of the outcome, mean systolic BP at 12 months, will follow an intention-to-treat approach, by estimating the change in systolic BP between the intervention and control group using a generalized estimation equation (GEE ) with an identity, exchangeable working correlation, and robust variance. If a substantial baseline imbalance between randomized groups is identified, an additional adjusted sensitivity analysis will be performed including predefined variables (age, marital status, education) to assess the robustness of the primary analysis. Investigators will also use ANCOVA for clustered data to conduct difference-in-difference analysis. In the secondary 'per protocol' analyses, the participants will be excluded if they (i) received less than 2 home visits; or (ii) were found not eligible based on the inclusion and exclusion criteria after randomization and will be compared to all participants in the control group. Aim 3: Economic and Financial Sustainability Investigators will calculate the total costs of the implementation and maintenance years by summing the costs of the individual components. Investigators will determine associations for total and component costs with co-factors, rural/urban location, health facility catchment area, and CHW-to-beneficial ratio. The cost will be also be used for projecting the financial expenditures of implementation and maintenance, and ultimately, scale up across the estates over time, to facilitate budgetary planning and resource allocation at the level of municipality. Investigators will estimate the cost-effectiveness in terms of incremental cost per HTN awareness, and incremental cost per BP controlled client. The primary analysis will take a financial perspective and secondary analysis will take a societal perspective. Sensitivity analysis will be done using financial costs only - specifically by using the discounted medicine costs available to the program - to show difference in cost-effectiveness with and without full social costs accounted for.

Official Title
-----------------
Community Health Worker Led Hypertension Prevention and Control (CHPC) in Nepal: An Implementation Trial

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Behavioral: Community Health Worker Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -High blood pressure (BP) of 140/90 mmHg or higher. Exclusion Criteria: Severe illness requiring bed rest Pregnant women, due to their special health needs

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention arm<br>Community Health Worker Intervention | Behavioral: Community Health Worker Intervention<br>* After receiving the training, Community Health Workers (CHW) will conduct home visits using a locally adapted CHW's manual for hypertension management. They will visit households in their catchment area and measure BP. Each CHW will take the high BP clients (>=140/90) to the nearest health center. They will enlist the individuals with preHTN and HTN and conduct three follow-up visits to these participants, every four months. In the first visit (tentative 90 minutes), CHWs will explain the purpose of the home visit and discuss HTN and its consequences. CHWs will apply inductive questioning techniques to initiate dialogue and reflection regarding lifestyle modifications and choose lifestyle goals based on PEN protocol-2, BP monitoring, and antihypertensive medication use. In subsequent visits (approximately 60 minutes), the CHWs will measure BP and address ongoing problems.<br>|
| No Intervention: Control Group<br>Usual care that includes patients visit to health facility based on felt need | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic BP (mmHg) | Difference in mean systolic blood pressure | 12 months | 
| Reach | Percentage of CHWs implementing the program | 12 months | 
| Adoption | Percentage of the health facilities asked to participate in adopting the program | 12 months | 
| Program implementation | Percent of the health facility will implement a minimum standard to program implementation | 12 months | 
| Maintenance | Percentage of the health facility that will implement a minimum standard to program implementation during the maintenance period | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Costing | Total costs of the implementation and maintenance years by summing the costs of the individual components. | 24 months | 
| 2. Cost-effectiveness | cost-effectiveness in terms of incremental cost per HTN awareness, and incremental cost per BP controlled client. | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension, Community Health Worker, Implementation Trial