Improving Maternal and Child Health in India: Evaluating Demand and Supply Side Strategies (IMATCHINE)
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Purpose
The study evaluates the impact of a new conditional cash transfer (CCT) program (Thayi Bhagya Yojana) to promote child birth in obstetric facilities in the state of Karnataka, India in order to determine its policy value and to guide efforts to improve maternal and infant health outcomes nationally. In addition, the study includes a large cluster randomized evaluation of performance-based incentive payments to providers to improve quality of medical care provided during delivery and actual health improvement in the catchment areas served by the providers.
| Condition | Intervention |
|---|---|
|
Obstetric Labor Complications Post-partum Hemorrhage Sepsis Neonatal Infection |
Other: Experimental: Treatment 1 Other: Experimental: Treatment 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research |
| Official Title: | Improving Maternal and Child Health in India: Evaluating Demand and Supply Side Strategies |
- Increase institutional deliveries and improve maternal and infant health outcomes in the population. [ Time Frame: Baseline, Endline (1 year) ] [ Designated as safety issue: No ]Rates of deliveries in hospitals and maternal health complications such as obstetric fistulas, post-partum hemorrhage, sepsis, as well as neonatal outcomes.
- Effectiveness of financial incentives to maternity care private providers for improvements in the clinical quality of services in the catchment areas served by the providers. [ Time Frame: 1 Year ] [ Designated as safety issue: No ]Indicators of quality of services include monitoring of the fetal heartbeat, active management of labor, and monitoring of cervical dilation and effacement.
- Effectiveness of financial incentives to maternity care private providers for improvements in maternal and infant health outcomes in the catchment areas served by the providers. [ Time Frame: 1 Year ] [ Designated as safety issue: No ]Indicators of improvements in maternal and neonatal health outcomes include reduced incidence of maternal morbidity outcomes such as obstetric fistulas, excessive post partum bleeding, sepsis, hospital readmission, as well as neonatal outcomes.
- Effectiveness of financial incentives to maternity care providers for reductions in neonatal mortality in the catchment area served by the provider [ Time Frame: 1 Year ] [ Designated as safety issue: No ]Indicator of reductions in neonatal mortality is reduced incidence of neonatal death among newborns within 1-2 weeks of birth
| Estimated Enrollment: | 36600 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: Mothers at baseline
Data collected on new mothers (one to two weeks after childbirth) in 165 clusters with 100 mothers in each cluster at baseline
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No Intervention: Mothers at endline
Data collected on new mothers (two weeks after childbirth)in 180 clusters with 100 mothers in each cluster at endline
|
|
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Experimental: Treatment 1
Data collected on providers with incentives for clinical improvements in quality of maternity care in the catchment areas served by the providers.
|
Other: Experimental: Treatment 1
Physicians will receive financial incentives for improving the quality of obstetric and neonatal care provided to mothers and newborns as reported by mothers at follow-up.
|
|
Experimental: Treatment 2
Data collected on providers with incentives for improvement in maternal and infant health outcomes in the catchment areas served by the providers
|
Other: Experimental: Treatment 2
Physicians will receive financial incentives for improving maternal and neonatal health outcomes as reported by mothers at follow-up.
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No Intervention: Control
Data collected on providers with no incentives
|
Detailed Description:
The evaluation study will first provide new evidence on the effectiveness of demand-side strategies to increase institutional deliveries and improve childbirth outcomes. Second, the study will analyze one of the first implementations of direct rewards to providers for health improvement in a developing country. Third, the study will provide critical new insight into dynamics between demand and supply-side incentives in improving population health outcomes as either complements or substitutes.
The study uses household survey to collect data from mothers on socio-economic, human capital, quality of life variables (including BPL index components) and as well as information about deliveries, fertility histories, morbidity and mortality (for mothers, infants, and children), birth related complications, health service use and spending. Additionally, provider surveys will collect data on infrastructure, staffing, provider qualifications, provider knowledge and process measures of provider performance.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Households with new mothers (one to two weeks after childbirth)
- Rural private sector maternity care providers who are listed on the Karnataka government's legitimate provider list.
Exclusion Criteria:
- Households without children
- Households where mothers gave birth > 2 weeks ago
- Public sector maternity care providers
- Private sector maternity care providers serving in towns with large public providers such as Community Health Centers (CHCs)
Contacts and Locations| Contact: Manveen Kohli, MA | 919-321-8111 | manveen.kohli@duke.edu |
| Contact: Manoj Mohanan, PhD, MPH | 919-613-6127 | manoj.mohanan@duke.edu |
| India | |
| Imatchine | Recruiting |
| Bangalore, Karnataka, India | |
| Principal Investigator: Manveen Kohli, MA | |
| Principal Investigator: | Manoj Mohanan, PhD, MPH | Duke University |
More Information
No publications provided
| Responsible Party: | Duke University |
| ClinicalTrials.gov Identifier: | NCT01480544 History of Changes |
| Other Study ID Numbers: | Pro00031046 |
| Study First Received: | November 8, 2011 |
| Last Updated: | May 2, 2013 |
| Health Authority: | United States: Institutional Review Board India: Society for the Promotion of Ethical Clinical Trials - Ethical Review Board (SPECT-ERB) |
Keywords provided by Duke University:
|
Institutional Deliveries Maternal Health Infant Health Private Medical Providers |
Provider Incentives Cluster Randomized Control Trial |
Additional relevant MeSH terms:
|
Obstetric Labor Complications Hemorrhage Postpartum Hemorrhage Sepsis Pathologic Processes Pregnancy Complications |
Puerperal Disorders Uterine Hemorrhage Infection Systemic Inflammatory Response Syndrome Inflammation |
ClinicalTrials.gov processed this record on May 21, 2013