Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01345695
Other study ID # Pro00027527
Secondary ID
Status Completed
Phase N/A
First received April 25, 2011
Last updated December 14, 2015
Start date May 2011
Est. completion date October 2015

Study information

Verified date December 2015
Source Duke University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review BoardIndia: Institutional Review Board
Study type Observational

Clinical Trial Summary

This study will conduct an evaluation of the World Health Partners (WHP) private provider project to see if the social franchising and telemedicine project has an impact on health outcomes in treatment vs. control areas. The evaluation will also estimate specific parameters of the WHP program that can be used to maximize financial sustainability and replicability/scalability of the program.


Description:

In 2011, World Health Partners (WHP) will launch a large social franchising program of healthcare delivery in Bihar, India, with funding from the Bill and Melinda Gates Foundation (BMGF). The WHP project is particularly innovative in integrating a social franchising delivery model with a telemedicine platform. Although social franchising models of delivery are becoming increasingly common, to our knowledge, none of these efforts has been rigorously evaluated.

COHESIVE-India plans to undertake an evaluation of the BMGF-financed WHP project. The overarching focus of the evaluation project (called Bihar Evaluation of Social Franchising and Telemedicine (BEST)) is to provide evidence on the performance and effectiveness of the WHP program. In addition to studying the overall impact and effectiveness of the social franchising and telemedicine program, the evaluation will estimate how the WHP model influences outcomes related to two target diseases of interest to BMGF: childhood diarrhea and childhood pneumonia.

The Evaluation Design The core objective of the evaluation is to estimate the causal impact of the WHP program on BMGF target disease outcomes as well as other indicators of its primary health care success. The key design feature of the evaluation is that it relies on the franchisee network model of the WHP program. The evaluation design involves identifying villages in Bihar that have asymmetric digital subscriber line (ADSL) connectivity where WHP is likely to find providers who would participate in the program. The areas surrounding these villages that form catchment areas for providers will be identified; 360 such areas will be randomly sampled from the list and divided into 180 treatment and 180 control areas for implementation of the WHP program.

The study also includes a detailed costing component to estimate the costs associated with the target diseases and the benefits from the program intervention. In doing so, the evaluation strategy addresses specific policy-relevant questions about sustainability, affordability, replicability, and future Government support for privately provided healthcare options in Bihar as well as in other parts of India.

In addition, COHESIVE-India, with funding from external sources also plans to conduct studies that will provide insights on how to improve the effectiveness of the WHP model, as well as its financial sustainability. These studies include the distribution of vouchers for WHP services to estimate household's willingness to pay for them, as well experiments on financial incentives to learn how to improve the performance of network providers.

This evaluation is closely aligned with the objectives of the Government of Bihar to reduce the burden of disease. Through a rigorous evaluation of the WHP program, this study will provide evidence on whether this model of rural health service delivery is efficient and whether it can be scaled up. The stated goals of the WHP program indicate the many potential health and economic benefits to the people of Bihar. The evaluation will provide an empirical and objective assessment of the impact of WHP's effort on quality of care available in rural areas (the program anticipates a significant improvement), increases in access to healthcare providers and improved drug supply, reductions in time lapse between onset of disease and optimal care, as well as reductions in unnecessary healthcare expenditures.


Recruitment information / eligibility

Status Completed
Enrollment 106380
Est. completion date October 2015
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Households with children age < 60 months

- Persons with tuberculosis or visceral leishmaniasis

- Rural private sector medical providers

Exclusion Criteria:

- Households without children

- Households with children aged > 60 months

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
India BEST Patna Bihar

Sponsors (6)

Lead Sponsor Collaborator
Duke University Institute of Socio-Economic Research in Development and Democracy (ISERDD), Public Health Foundation of India (PHFI), Sambodhi Research and Communication Pvt., Ltd., Stanford University, University College, London

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary Improvements in population based health outcomes Improvements in population based health outcomes in the treatment vs. the control areas Baseline; 3 years No
Secondary Improvements in population based health outcomes for childhood diarrhea Proportion of children with diarrhea in the last two weeks who were treated with zinc Baseline; 3 years No
Secondary Improvements in population based health outcomes for childhood pneumonia Proportion of children with suspected pneumonia in the past two weeks who received a full course of antibiotics (five days) Baseline; 3 years No
Secondary Cost-effectiveness of the service model Through micro-experiments, we hope to gain insights on how to improve the cost effectiveness of the WHP model, as well as evaluate its financial sustainability. We will also evaluate whether the are overall improvements in the population level health indicators in the treatment vs. the control areas. Baseline; 3 years No
See also
  Status Clinical Trial Phase
Terminated NCT00732732 - A Controlled Trial of Plantain Powder in Infantile Diarrhea N/A
Not yet recruiting NCT03598010 - Safety, Tolerability and Preliminary Efficacy of Lenodiar Pediatric in Diarrhea N/A
Recruiting NCT04654832 - IVC Index in Patient With Diarrhea and Dehydration And How It Affects Its Management
Completed NCT04061538 - Efficiency and Safety of Zinc Sulphate to Reduce the Duration of Acute Diarrheal Disease Between 6 and 59 Months of Age N/A
Completed NCT05322655 - PAthogen Transmission and Health Outcome Models of Enteric Disease
Recruiting NCT02870751 - Human Challenge Model With ST-only Enterotoxigenic Escherichia Coli Phase 1
Recruiting NCT04528303 - Whole Genome Sequencing Versus Whole Exome Sequencing for Congenital Diarrhea and Enteropahty N/A
Completed NCT04335877 - Effect of Prompting the Supply of Zinc/LO-ORS Co-packs in the Private Sector Plus BCI on Childhood Diarrhea Treatment N/A
Active, not recruiting NCT03012048 - Effectiveness of Point-of-use Water Treatment Technologies to Prevent Stunting Among Children in South Africa N/A
Completed NCT04677296 - Efficacy and Safety of "VS002A" With the Standard WHO-ORS in Non-cholera Acute Watery Diarrhea in Infants and Young Children N/A
Completed NCT04209751 - Descriptive Study of Pathogens Involved in Summer Diarrhea in Children Leading to Pediatric Emergency Room Visits (PE-DIA)
Completed NCT00447161 - Preventing Antibiotic-Associated DiarRhea Using Erceflora Phase 4
Recruiting NCT05766826 - Coupons for Safe Water Project N/A
Terminated NCT04628819 - Effect and Tolerability of Lactobacillus Rhamnosus GG LA801 for the Preventive Nutritional Care of Nosocomial Diarrhea in Children N/A
Completed NCT03473561 - Study to Evaluate the Efficacy and Safety of Racecadotril in Children Aged 3 to 60 Months Suffering From Acute Diarrhea Phase 3