Clinical trial NCT03371186: Implementing an Integrated RMNCH Intervention by Community Health Workers in Achham and Dolakha: National Pilot
Official title: Implementing an Integrated RMNCH Intervention by Community Health Workers in Achham and Dolakha: National Pilot
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Reproductive, Maternal, Newborn, and Child Health
Integrated, Community-Health Systems
Keywords: Implementation Research
Maternal Mortality and Morbidity
Neonatal Mortality and Morbidity
Infant Mortality and Morbidity
Child Mortality and Morbidity
Community Health Workers
Health Systems Strengthening
Lead sponsor: Possible
Sponsor class: OTHER
Collaborators: name: United States Agency for International Development (USAID)
name: National Institutes of Health (NIH)
name: Ministry of Health and Population, Nepal
name: Planned Parenthood League of Massachusetts
First posted: 2017-12-13
Enrollment: 12000
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Stepped wedge, cluster-controlled implementation science trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Institutional Birth Rate
timeFrame: 3 years
measure: Under-Two Mortality Rate
timeFrame: 3 years
measure: Post-Partum Contraceptive Prevalence Rate
timeFrame: 3 years
Secondary outcomes:
measure: Home Visit Coverage
timeFrame: 3 months
measure: Group Care Content Fidelity
timeFrame: 3 months
measure: Group Participation
timeFrame: 3 months
measure: Session Completion
timeFrame: 3 months
measure: First-Trimester Pregnancies Identified
timeFrame: 3 months
measure: Antenatal Care Completion
timeFrame: 3 months
measure: Pediatric Pneumonia Incidence
timeFrame: 1 month
measure: Pediatric Diarrhea Incidence
timeFrame: 1 month
measure: Pediatric Stunting Prevalence
timeFrame: 1 month
measure: Exclusive Breastfeeding Prevalence
timeFrame: 1 month
measure: Percent of postpartum women with unmet need for contraception
timeFrame: 3 years
measure: Contraceptive Method Mix
timeFrame: 3 months
measure: Total Intervention Cost
timeFrame: 3 years
measure: Cost-Effectiveness of Bundled Intervention
timeFrame: 3 years
Other outcomes:
Locations:
city: Sanfebagar
country: Nepal
facility: Bayalpata Hospital
state: Achham
city: Bhimeshwor
country: Nepal
facility: Charikot Primary Health Center
state: Dolakha
Study officials:
affiliation: Possible
name: Sheela Maru, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Ministry of Health and Population, Nepal
name: Pushpa Chaudhari, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Maru S, Nirola I, Thapa A, Thapa P, Kunwar L, Wu WJ, Halliday S, Citrin D, Schwarz R, Basnett I, Kc N, Karki K, Chaudhari P, Maru D. An integrated community health worker intervention in rural Nepal: a type 2 hybrid effectiveness-implementation study protocol. Implement Sci. 2018 Mar 29;13(1):53. doi: 10.1186/s13012-018-0741-x.