Bihar Evaluation of Social Franchising and Telemedicine (BEST)

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Stanford University
University College, London
Sambodhi Research and Communication Pvt., Ltd.
Public Health Foundation of India (PHFI)
Institute of Socio-Economic Research in Development and Democracy (ISERDD)
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01345695
First received: April 25, 2011
Last updated: June 19, 2013
Last verified: June 2013
  Purpose

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.


Condition
Diarrhea, Infantile
Childhood Pneumonia
Tuberculosis (TB)
Visceral Leishmaniasis (VL)

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Bihar Evaluation of Social Franchising and Telemedicine in India

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Improvements in population based health outcomes [ Time Frame: Baseline; 2 years; 4 years ] [ Designated as safety issue: No ]
    Improvements in population based health outcomes in the treatment vs. the control areas


Secondary Outcome Measures:
  • Improvements in population based health outcomes for childhood diarrhea [ Time Frame: Baseline; 2 years; 4 years ] [ Designated as safety issue: No ]
    Proportion of children with diarrhea in the last two weeks who were treated with zinc

  • Improvements in population based health outcomes for childhood pneumonia [ Time Frame: Baseline; 2 years; 4 years ] [ Designated as safety issue: No ]
    Proportion of children with suspected pneumonia in the past two weeks who received a full course of antibiotics (five days)

  • Improvements in health outcomes for tuberculosis [ Time Frame: Baseline; 2 years; 4 years ] [ Designated as safety issue: No ]
    Median number of days from symptom onset to treatment

  • Improvements in health outcomes for visceral leishmaniasis (VL) [ Time Frame: Baseline; 2 years; 4 years ] [ Designated as safety issue: No ]
    Proportion of individuals that completed appropriate treatment for VL

  • Cost-effectiveness of the service model [ Time Frame: Baseline; 2 years; 4 years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 106380
Study Start Date: May 2011
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Treatment
Data collected on persons living in the catchment area for a WHP telemedicine center
Control
Data collected on persons living in the catchment area where there is not a WHP telemedicine center

Detailed 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 a rigorous 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 experimental 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 four target diseases of interest to BMGF: childhood diarrhea, childhood pneumonia, tuberculosis (TB), and visceral leishmaniasis (VL).

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 a prospective randomized evaluation that relies on the franchisee network model of the WHP program, which naturally lends itself to a cluster randomization design. 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 four 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 impact evaluation project 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Randomly selected residents of 12 districts in Bihar State, India.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01345695

Locations
India
BEST
Patna, Bihar, India
Sponsors and Collaborators
Duke University
Stanford University
University College, London
Sambodhi Research and Communication Pvt., Ltd.
Public Health Foundation of India (PHFI)
Institute of Socio-Economic Research in Development and Democracy (ISERDD)
Investigators
Principal Investigator: Manoj Mohanan, PhD, MPH Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01345695     History of Changes
Other Study ID Numbers: Pro00027527
Study First Received: April 25, 2011
Last Updated: June 19, 2013
Health Authority: United States: Institutional Review Board
India: Institutional Review Board

Keywords provided by Duke University:
Childhood diarrhea
childhood pneumonia
tuberculosis (TB)
visceral leishmaniasis (VL)
telemedicine
cluster
randomized
treatment-control trial

Additional relevant MeSH terms:
Diarrhea
Diarrhea, Infantile
Leishmaniasis
Leishmaniasis, Visceral
Pneumonia
Tuberculosis
Signs and Symptoms, Digestive
Signs and Symptoms
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on July 26, 2014