Implementing an Integrated RMNCH Intervention by Community Health Workers in Achham and Dolakha: National Pilot
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 12,000
- 试验地点
- 2
- 主要终点
- Institutional Birth Rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 49 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Bundled RMNCH Intervention
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.
干预措施: Community Health Worker (Other)
Bundled RMNCH Intervention
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.
干预措施: Continuous Surveillance (Other)
Bundled RMNCH Intervention
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.
干预措施: CB-Integrated Management of Newborn and Childhood Illness (Other)
Bundled RMNCH Intervention
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.
干预措施: Group Antenatal and Postnatal Care (Other)
Bundled RMNCH Intervention
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.
干预措施: Balanced Post-Partum Contraceptive Counseling (Other)
结局指标
主要结局
Institutional Birth Rate
时间窗: 3 years
The percentage of births in a healthcare facility with a healthcare professional present.
Under-Two Mortality Rate
时间窗: 3 years
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.
Post-Partum Contraceptive Prevalence Rate
时间窗: 3 years
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.
次要结局
- Home Visit Coverage(3 months)
- Group Care Content Fidelity(3 months)
- Group Participation(3 months)
- Session Completion(3 months)
- Pediatric Stunting Prevalence(1 month)
- First-Trimester Pregnancies Identified(3 months)
- Contraceptive Method Mix(3 months)
- Antenatal Care Completion(3 months)
- Pediatric Diarrhea Incidence(1 month)
- Total Intervention Cost(3 years)
- Cost-Effectiveness of Bundled Intervention(3 years)
- Pediatric Pneumonia Incidence(1 month)
- Exclusive Breastfeeding Prevalence(1 month)
- Percent of postpartum women with unmet need for contraception(3 years)