Implementing an Integrated RMNCH Intervention by Community Health Workers in Achham and Dolakha: National Pilot

Possible

Status: Unknown

Conditions: Integrated, Community-Health Systems; Reproductive, Maternal, Newborn, and Child Health

Treatments: Other: Continuous Surveillance; Other: Community Health Worker; Other: CB-Integrated Management of Newborn and Childhood Illness; Other: Balanced Post-Partum Contraceptive Counseling; Other: Group Antenatal and Postnatal Care

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; NIH

Identifiers

NCT03371186

AID-OAA-A-11-0001 (Other Grant/Funding Number)

1DP5OD019894-01 (U.S. NIH Grant/Contract)

RMNCHnyaya

Details and patient eligibility

About

The investigators will conduct a cluster-controlled, stepped wedge implementation science trial of a bundled reproductive, maternal, neonatal, and child healthcare (RMNCH) delivery intervention within an approximate population of 300,000 people in rural Nepal. This intervention integrates five evidence-based approaches for reproductive, maternal, newborn, and child health focused on the "golden 1000 days" from conception through age two: 1) Community Health Worker model of home-based care to monitor and increase utilization of services, maternal and neonatal health knowledge, self-efficacy, social support, and emergency planning among mothers; 2) Continuous surveillance of all pregnancies and children via an integrated electronic medical record; 3) Delivering community-based integrated management of newborn and childhood illness (CB-IMNCI) via CHWs; 4) Group antenatal and postnatal care to improve care delivery and reduce mortality during the "golden 1000 days" from conception to age two; and 5) Balanced counseling to increase post-partum contraception.

Enrollment: 12,000 estimated patients

Sex: Female

Ages: 15 to 49 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Reproductive aged women 15-49;
2. Reproductive aged women 15-49; recently delivered in past two years;
3. Reproductive aged women 15-49; active pregnancy during study period and identified by a CHW serving their village
4. Children aged 0-2; children of recently-delivered mothers (population #2 or #3 above);
5. Healthcare staff; CHWs serving village clusters, CHW Leaders serving one of the village clusters, Nyaya Health Nepal and Government of Nepal employees involved in study design, program implementation, data collection, or data analysis processes; and
6. Must reside in either Achham or Dolakha District, Nepal.

Exclusion criteria

Patients meeting inclusion criteria and consenting to study enrollment, as stated above, will be included in the study unless 1) patients migrate from the study are before completion of any of the bundled interventions; 2) patients request exclusion from the study at any point during the bundled intervention.

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12,000 participants in 1 patient group

Bundled RMNCH Intervention

Experimental group

Description:

Stepped wedge, cluster-controlled implementation science trial of 5 bundled intervention components (1. Community Health Worker, 2, Continuous Surveillance, 3. CB-Integrated Management of Newborn and Childhood Illness, 4. Group Antenatal and Postnatal Care, and 5. Balanced Post-Partum Contraceptive Counseling) implemented across 40 village clusters in Achham District, Nepal and 40 village clusters in Dolakha District, Nepal (covering a total population of approximately 300,000) in coordination with district authorities and study staff. The investigators anticipate the experimental arm will enroll approximately 12,000 women and their children over the 18mo enrollment period.

Treatment:

Other: Community Health Worker

Other: Continuous Surveillance

Other: Group Antenatal and Postnatal Care

Other: CB-Integrated Management of Newborn and Childhood Illness

Other: Balanced Post-Partum Contraceptive Counseling