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.
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.
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.
- Conditions
- Diarrhea, Infantile, Childhood Pneumonia
- 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 group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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.
- First posted2 May 2011 (estimated)
- Study startMay 2011
- Primary completionDec 2014
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diarrhea, InfantileStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University, University College, London, Sambodhi Research and Communications Pvt. Ltd., Public Health Foundation of India, Institute of Socio-Economic Research in Development and Democracy (ISERDD)
- Responsible party
- Sponsor
- Investigators
- Manoj Mohanan, PhD, MPH, Principal investigator, Duke University
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bihar Evaluation of Social Franchising and Telemedicine in India
- ClinicalTrials.gov ID
- NCT01345695
- Acronym / sponsor ID
- BEST / Pro00027527
- Conditions
- Diarrhea, Infantile, Childhood Pneumonia
- Keywords
- Childhood diarrhea, childhood pneumonia, telemedicine, cluster, treatment-control trial
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106,380 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Stanford University, University College, London, Sambodhi Research and Communications Pvt. Ltd., Public Health Foundation of India, Institute of Socio-Economic Research in Development and Democracy (ISERDD)
- Study start
- May 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 2 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Randomly selected residents of 12 districts in Bihar State, India.
Key inclusion criteria (3 listed)
- Households with children age < 60 months
- Persons with tuberculosis or visceral leishmaniasis
- Rural private sector medical providers
Key exclusion criteria (2 listed)
- Households without children
- Households with children aged > 60 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Improvements in population based health outcomes
Time frame: Baseline; 3 years
Improvements in population based health outcomes in the treatment vs. the control areas
3 secondary outcomes
Improvements in population based health outcomes for childhood diarrhea
Time frame: Baseline; 3 years
Improvements in population based health outcomes for childhood pneumonia
Time frame: Baseline; 3 years
Cost-effectiveness of the service model
Time frame: Baseline; 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manoj Mohanan, PhD, MPH principal investigator
Duke University
1 site in 1 country: see every site and its status.
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.