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Diarrhea, InfantileBESTNCT01345695

Bihar Evaluation of Social Franchising and Telemedicine

An observational study of Diarrhea, Infantile and Childhood Pneumonia, run by Duke University at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Diarrhea, Infantile, Childhood Pneumonia
How many people
106,380 participants
Where
1 siteIndia
Study dates
May 2011to Oct 2015
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

  • Households with children age < 60 months
  • Persons with tuberculosis or visceral leishmaniasis
  • Rural private sector medical providers

Who cannot join

  • Households without children
  • Households with children aged > 60 months

Trial locations and contacts

1 site in 1 country.

India1 site
  • BEST

    Patna, Bihar

Other trials in India

About this study

Official title: Bihar Evaluation of Social Franchising and Telemedicine in India

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.

Read the 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 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.

Keywords
Childhood diarrhea, childhood pneumonia, telemedicine, cluster, treatment-control trial
Medical subject headings
Diarrhea, Infantile

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01345695
Study groupRoleWhat they receive
TreatmentData collected on persons living in the catchment area for a WHP telemedicine center
ControlData collected on persons living in the catchment area where there is not a WHP telemedicine center

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Improvements in population based health outcomes

    Improvements in population based health outcomes in the treatment vs. the control areas

    Measured: Baseline; 3 years

Secondary outcomes (3)
  1. Improvements in population based health outcomes for childhood diarrhea

    Proportion of children with diarrhea in the last two weeks who were treated with zinc

    Measured: Baseline; 3 years

  2. 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)

    Measured: Baseline; 3 years

  3. 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.

    Measured: Baseline; 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 May 2011 (estimated)
  2. Study startMay 2011
  3. Primary completionDec 2014
  4. Study completionOct 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
106,380 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01345695
Sponsor's protocol ID
Pro00027527
Acronym
BEST
Status last verified
Dec 2015
First submitted
25 Apr 2011
Last updated
16 Dec 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Diarrhea, Infantile and Childhood Pneumonia, run by Duke University at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Improvements in population based health outcomes (time frame: Baseline; 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2015.

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