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

NCT03371186 | Unknown

• 3 other identifiers: RMNCHnyaya1DP5OD019894-01AID-OAA-A-11-0001
• Study Type: interventional
• Target: 12,000
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (3)

• Institutional Birth Rate

  The percentage of births in a healthcare facility with a healthcare professional present.

  3 years

• Under-Two Mortality Rate

  The under-2 mortality rate is the probability (expressed as a rate per 1,000 live births) of a child born in a specified year dying before reaching the age of two if subject to current age-specific mortality rates.

  3 years

• Post-Partum Contraceptive Prevalence Rate

  The post-partum contraceptive prevalence rate is number of married reproductive aged women (15-49) in the study population who delivered in the past two years who are using a modern contraceptive method out of the total number of married reproductive aged women (15-49) in the study population who delivered in the past two years.

  3 years

Secondary Outcomes (14)

• Home Visit Coverage

  3 months

• Group Care Content Fidelity

  3 months

• Group Participation

  3 months

• Session Completion

  3 months

• First-Trimester Pregnancies Identified

  3 months

Study Arms (1)

Bundled RMNCH Intervention

EXPERIMENTAL

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.

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

Interventions

Community Health Worker OTHER

The intervention is designed to address these primary drivers of underutilization of reproductive, maternal, newborn, and child health services in rural Nepal, namely: poverty, lack of social support, and poor birth planning. The investigators have worked with a cadre of Community Healthcare Workers who, in addition to the responsibilities of local community health volunteers, have added responsibilities, training, and managerial support. These women support their community members in their homes to identify and overcome social barriers and plan for emergency healthcare needs. The goals are to increase utilization of services, maternal and neonatal health knowledge, self-efficacy, social support, and emergency planning among mothers

Bundled RMNCH Intervention

Continuous Surveillance OTHER

Each patient identified by a Community Health Worker will undergo a complete diagnostic evaluation by the hospital-based clinicians and will be enrolled in the study only if they are identified as currently pregnant, have recently given birth, or have a child under the age of 24 months. Continuous surveillance systems ensure that the entire population is surveyed every three months and has a three month touchpoint with a Community Health Worker.

Bundled RMNCH Intervention

CB-Integrated Management of Newborn and Childhood Illness OTHER

Safe delivery care; effective neonatal resuscitation; management of childhood diarrhea, malnutrition, and pneumonia; and treatment of traumatic and congenital surgical conditions can reduce child mortality. Community Based Integrated Management of Newborn and Child Illness (CB-IMNCI) has shown substantial reductions in neonatal and early child mortality. Community Health Workers will use CB-IMNCI as the clinical protocol for ongoing care to the community.

Bundled RMNCH Intervention

Group Antenatal and Postnatal Care OTHER

The proposed model will change antenatal and pediatric care in three major ways: 1) conduct care in a group setting, 2) provide expert and facilitated peer counseling, and 3) incorporate emergency planning. The group setting is designed to create a supportive social network among women facing similar challenges. The opportunity for counseling beyond the current standard will promote detailed emergency planning and the sharing of context-specific advice from peers to overcome barriers to access care. This intervention draws on the strength within communities of women to change health-seeking behaviors.

Bundled RMNCH Intervention

Balanced Post-Partum Contraceptive Counseling OTHER

Research on interventions to improve postpartum contraception suggest strategies that bridge the continuum of reproductive health care-antenatal care, labor and delivery, postnatal care, and infant care-are more effective than short term, stand-alone counseling sessions. The structured counseling module incorporated in the intervention will be partially adapted from the Balanced Counseling Strategy, an interactive contraceptive counseling method developed by the Population Council in accordance with the World Health Organization's tiered effectiveness guidelines. Prior studies in clinical settings in Nepal have demonstrated increased uptake of modern contraceptive methods, especially of long-acting reversible contraceptives with use of balanced counseling.

Bundled RMNCH Intervention

Eligibility Criteria

• Age: 15 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Reproductive aged women 15-49;
• Reproductive aged women 15-49; recently delivered in past two years;
• Reproductive aged women 15-49; active pregnancy during study period and identified by a CHW serving their village
• Children aged 0-2; children of recently-delivered mothers (population #2 or #3 above);
• 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
• Must reside in either Achham or Dolakha District, Nepal.

Sponsors & Collaborators

• Possible: lead
• United States Agency for International Development (USAID): collaborator
• National Institutes of Health (NIH): collaborator
• Ministry of Health and Population, Nepal: collaborator
• Planned Parenthood League of Massachusetts: collaborator

Study Sites (2)

Bayalpata Hospital

Sanfebagar, Achham, Nepal

RECRUITING

Charikot Primary Health Center

Bhimeshwor, Dolakha, Nepal

RECRUITING

Related Publications (1)

• 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.

  PMID: 29598824 DERIVED

MeSH Terms

Conditions

Maternal Death; Infant Death

Interventions

Community Health Workers; Postnatal Care

Condition Hierarchy (Ancestors)

Parental Death; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Allied Health Personnel; Health Personnel; Health Care Facilities Workforce and Services; Perinatal Care; Patient Care; Therapeutics; Maternal Health Services; Community Health Services; Health Services

Study Officials

• Sheela Maru, MD, MPH

  Possible

  PRINCIPAL INVESTIGATOR

• Pushpa Chaudhari, MD

  Ministry of Health and Population, Nepal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Duncan Maru, MD, PhD

CONTACT

duncan@possiblehealth.org

Scott Halliday, MS

CONTACT

scott@possiblehealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Stepped wedge, cluster-controlled implementation science trial

Study Record Dates

• First Submitted: December 4, 2017
• First Posted: December 13, 2017
• Study Start: February 1, 2016
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2021
• Last Updated: September 10, 2019

Record last verified: 2019-09

Locations

NE (2)