Table 1 Metrics for Specific Aim 1 (efficacy) and Specific Aim 2 (implementation)

Specific Aim 1: efficacy

Primary outcome: control of NCD conditions

Condition-specific “at-goal” metrics

% of enrolled NCD patients achieving “at-goal” status (Table 2), at completion of the study period

Secondary outcome 1: tobacco use

Tobacco use status

% of enrolled NCD patients who were using tobacco at enrollment who are nonusers or who have reduced by > 50% their tobacco intake, at completion of the study period

Secondary outcome 2: alcohol use

Alcohol use status

% of enrolled NCD patients who were alcohol drinkers at enrollment who are nondrinkers or who have reduced by > 50% alcohol intake, at completion of the study period

Specific Aim 2: implementation

Reach

Home visit coverage

% of enrolled NCD patients having a CHW home visit, measured monthly

Clinic visit coverage

% 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

Demographic, geographic barriers and facilitators

% of enrolled NCD patients whose CHW has GPS-mapped their households, describing barriers/facilitators to individuals’ access, and identifying contributors to variation/inequities

Loss to follow-up

% of patients, stratified by demographic data and NCD conditions, who are lost to follow-up after enrollment

Monthly patient touch-points

Number of monthly per-patient touch-points, including interactions by both MLPs and CHWs

Efficacy

Evidence-based hypertension management

% of enrolled hypertension patients in accordance with evidence-based recommendations, as prescribed by clinical algorithms, assessed quarterly by EHR audits

Evidence-based diabetes management

% of enrolled diabetes patients in accordance with evidence-based recommendations, as prescribed by clinical algorithms, assessed quarterly by EHR audits

Evidence-based COPD management

% of enrolled COPD patients in accordance with evidence-based recommendations, as prescribed by clinical algorithms, assessed quarterly by EHR audits

Adoption

Village-cluster adoption

% of intended village clusters receiving intervention

Timely adoption

% of intended village clusters rolling-out intervention within 3 months of schedule, according to local governance decisions to roll-out the intervention

CHW adoption

% of CHWs trained in intervention implementation within the first 6 months

% of trained CHWs retained in their positions at completion of the study period

MLP adoption

% of MLPs trained in intervention implementation

% of trained MLPs retained in their positions at completion of the study period

Implementation

Care integration

% of all NCD patients enrolled at the facilities seen by CHWs at home within the first month

CHW supervision model

% of scheduled CHW supervision field visits completed, stratified by CHN and district, measured quarterly

% of scheduled quarterly data review meetings held with CHWs and CHNs, measured quarterly

CHW home visit fidelity

% of enrolled NCD patients with 100% of algorithm-indicated home visits received

% of topics included at each session as dictated by the condition-specific algorithms, assessed during the CHW supervision field visits by CHNs, measured quarterly

Referrals

% of patients appropriately referred to MLP care as indicated by the clinical algorithms, assessed during the CHW supervision field visits by CHNs, measured quarterly

% of patients referred by CHWs seen by MLPs within the prescribed time window according to the clinical algorithms (e.g., 24 h, 72 h, 1 week), measured quarterly

MLP supervision model

% of enrolled NCD patients appropriately referred to see a physician by MLPs as indicated by the clinical algorithms, assessed during monthly physician supervision sessions, measured quarterly

MLP visit fidelity

% of enrolled NCD patients with 100% of algorithm-indicated facility visits received, assessed during monthly physician supervision sessions, measured quarterly

% of diagnostic, treatment, and counseling topics included at each session as dictated by the condition-specific algorithms, assessed during monthly physician supervision sessions, measured quarterly

Implementation challenges

Exploratory and hypothesis-generating as revealed through FGDs and KIIs with CHWs, CHNs, MLPs, physicians, patients, and other relevant community stakeholders

Maintenance

Total intervention cost

Cost of each intervention component and total costs using the Joint Learning Network costing methodology

Intervention initiation costs

% breakdown of initial (one-time) costs for intervention (training, equipment, etc.)

Intervention maintenance costs

% breakdown of maintenance (recurring) costs (ongoing training, personnel, materials, and other)

Facility vs. community costs

% of costs of healthcare divided between facility level and community level

Geographic cost variation

Characterization of variance in costs between village clusters and districts within the intervention catchment area

Out-of-pocket patient costs

% costs of healthcare divided between facility level and community level

Integrated intervention cost-effectiveness analysis

Pre/post-intervention marginal effectiveness for primary outcomes

Cost per unit

Intervention cost per enrolled patient

Intervention cost per capita

Projected cost to scale intervention nationally, based on known incidence and prevalence of each condition