Table 1.
Implementation outcomes to be assessed
| RE-AIM dimension | Definition | Assessment measure | Data source | Timepoint |
|---|---|---|---|---|
| Reach | The number of people and percent of the target population who are impacted, and the extent to which those reached are representative and include those at most risk | Size of the target population | PHC records | Study end |
| Number of women enrolled in the study and the number receiving the intervention | SHP app | Study end | ||
| Comparison of characteristics of the individuals enrolled in the study to the target population | SHP app; district records | Study end | ||
| Effectiveness | A measure of the impact on health individual-level primary outcome including positive, negative and unintended consequences |
The proportion of women with anaemia as measured by capillary test at 12 months after birth The proportion of women with follow-up blood pressure measurement or blood glucose tests during the 12 months after birth following a pregnancy affected hypertension or diabetes |
Endline CRF | Study end |
|
The proportion of screening visits performed per protocol (maximum 7 SHP visits) The proportion of visits conducted in person and by phone The proportion of visits performed at the stated time in the protocol |
Intervention group only: SHP app | Study end | ||
| Self-report rating of health outcome (WHO-5 quality of life) | Endline CRF | Study end | ||
| Self-report rating of health behaviour (WHO infant feeding questionnaire) | Endline CRF | Study end | ||
| Quantitative comparison of outcomes across subgroups (family income, caste stratification, parity, rural/semi-rural, private/ government delivery) with qualitative exploration | Endline CRF, interviews and FGDs | Study end | ||
| Adoption | The number and percent of settings/providers/interventionists who participate, and the extent to which these are representative of those who the target population will use or visit | Number of PHCs invited and the number that participate at the start of the study | Baseline study information | Study initiation |
| Number of participating PHCs at the end of the study | Endline study information | Study end | ||
| Comparison of participating PHCs to non-participating PHCs in the district (size, location, number of pregnant women per year, sociodemographic indicators) | Local records | Study end | ||
| Implementation | Level of adherence to programme delivery as intended, including extent to which elements are implemented and/or adapted. Cost of delivering the programme | Ethnological observation to determine fidelity to SHP intervention delivery at different timepoints throughout the programme and different study visits | Interviews and FGDs | 12 months and study end |
| Proportion of intervention elements delivered as intended as measured by a checklist of essential elements | Checklists; Interviews and FGDs | 12 months and study end | ||
| Extent and number of adaptations to original protocol (fieldnotes, protocol amendments, app changes, additional trainings) | Checklists; Interviews and FGDs | Study end | ||
| Cost of programme delivery (cost of intervention, training, materials, time-based activity costing) | Costing proforma | Study end | ||
| Maintenance | The degree to which the programme is sustained to the end of the trial (at the setting level) and to which the effects of the programme are maintained (at the individual level) | Level of intent to continue programme delivery (setting) as determined by in depth interviews with key stakeholders (PHC leads, other policy makers/local leaders) and Likert scale to community health workers and PHC doctors | Surveys; Interviews | 12 months and study end |
|
Number of health workers trained to use the intervention Number of health workers who continue to use the intervention to study end Reasons for health worker drop outs |
Intervention group only: SHP app, interviews | Study end |