The Effect of Digitally Enabled District (DED 2.0) Ecosystem on the Completeness and Timeliness of Maternal and Neonatal Services in Primary Health Care

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorSummit Institute for Development, Indonesia

About this trial

DED 2.0 is a stepped-wedge cluster-randomized trial testing whether an integrated digital health ecosystem (KuApps, a service-monitoring dashboard, AI-assisted OCR for handwritten records, two-way WhatsApp-based health communication, and an automated worker-support tool) improves the completeness and timeliness of maternal and neonatal primary health care services, delivered through 45 Puskesmas in Garut Regency, West Java, Indonesia.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Mothers residing within the catchment area of a participating Puskesmas in Garut Regency during their pregnancy

Pregnancy registered in the maternal health records of a participating Puskesmas within the study catchment area in Garut Regency

The pregnant woman provides informed consent to participate in the study.

Disqualifiers

Puskesmas had fully implemented the DED ecosystem in daily practice before the study baseline period

Puskesmas lacks adequate routine service data for outcome measurement throughout the study period

Trial design

Design model

Sequential

Treatments tested in this trial

  • Digitally Enabled District (DED)

    Device

    The research adopts a stepped-wedge cluster-randomized design. Puskesmas are randomized sequentially to receive the intervention. Following a one-month baseline (retrospective data of Aug-Sept, taken in October), an additional set of 15 clusters begins the intervention at the start of each three-month step: step one covers randomisation and digital-readiness training for that wave, and the remainder of the step is given over to monitoring utilisation of the digital platform. Three successive steps of three months each follow this pattern until the full sample is covered, within a 9-month rollout-and-monitoring window.

Treatment groups

10,800 Participants
are divided into 2 treatment groups
Group A: DED Intervention Group (Ecosystem of DED)Experimental treatment 1 intervention
Group B: Control Group (non-DED)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

Completeness of Antenatal Care (ANC) Services within the Gestational-Age Window

Completeness of ANC services within the gestational-age window, in accordance with the recommended schedule and standard: Trimester 1 (1 visit, 1 ultrasound, 1 physician examination); Trimester 2 (2 visits); Trimester 3 (3 visits, 1 ultrasound, 1 physician examination). Binary, individual-level: 1 = received all scheduled ANC contacts within the nationally recommended gestational-age windows; 0 = otherwise. Denominator = all eligible pregnant women registered at the cluster in that cluster-period. Analysed via generalised linear mixed model with a cluster random effect and categorical calendar period as a fixed effect (Hussey \& Hughes, 2007). This is the study's single registered primary outcome; ANC "12T" completeness, PNC completeness, and PNC standard-assessment completeness are secondary outcomes.

Time frame
From first ANC contact up to 40 weeks gestation, assessed up to 9 months

Secondary outcomes

1

Proportion of Participants with Timely ANC Contacts

Proportion of pregnant women for whom mandated ANC visits are documented within the correct gestational-age window (per trimester schedule) in routine facility records (KuApps and Legacy Apps). Coded 1 = Timely; 0 = Not timely

Time frame
Assessed at each gestational-age window, up to 40 weeks gestation
2

Proportion of Participants with Complete Postnatal Care (PNC)

Proportion of postpartum women for whom all four scheduled PNC contacts are documented by a health worker in routine facility records (KuApps and Legacy Apps): PNC1 (6 hours-2 days), PNC2 (3-7 days), PNC3 (8-28 days), PNC4 (29-42 days). Coded 0 = Incomplete, 1 = Complete.

Time frame
From delivery through 42 days postpartum
3

Proportion of Participants with a Complete Standard PNC Assessment

Proportion of postpartum women with all 14 mandated components of the Book of KIA standard PNC assessment, documented in routine facility records (KuApps and Legacy Apps). Components include breast examination (assessment of lactation/breastfeeding), bleeding assessment, examination of the birth canal/perineum, Vitamin A administration, postpartum family planning, mental health screening, counselling, and case management. Documented in routine facility records (KuApps and Legacy Apps)

Time frame
From delivery through 42 days postpartum
4

Proportion of Neonates with Complete Neonatal Visits

Proportion of neonates for whom all three neonatal visits (KN1, KN2, and KN3) fully documented in routine facility records (KuApps and Legacy Apps). Classified as incomplete if one or more visits are not documented. Coded 0 = Incomplete, 1 = Complete.

Time frame
From birth through 28 days of age

Other outcomes

Sponsors and contacts

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Summit Institute for Development, Indonesia

Lead sponsor

Bill and Melinda Gates Foundation

Collaborator

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