Infectious DiseaseDESHNCT01003587
Promoting Evidence-Based Decision-Making in India: District Evaluation Study on Health
A study testing District health information package in people with Infectious Disease and Cardiovascular Disease, run by Unity Health Toronto at 2 sites in 2 countries.
Trial summary
The purpose of this study is to assess the impact of disseminating information on comparative performance, along with actionable messages on how to improve health outcomes, to district-level decision-makers in India using a randomized, controlled design. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infectious Disease, Cardiovascular Disease
- What is being tested?
- District health information package
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 594 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jul 2009to Jul 2016
- Phase
- Interventional
- 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
Who may be able to join
- All districts in India in existence in 2001
- Members of Parliament (MPs) who sit in the Lok Sabha (Lower House of Parliament) and represent constituencies that are contained within or overlap study districts
- Members of Legislative Assembly (MLAs) who represent constituencies that are contained within study districts
- District Collectors (DCs) who administrate study districts
- Zilla Parishad Chief Executive Officers (ZPCEOs) who administrate study districts
- District Health Officers (DHOs) who work in study districts
Who cannot join
- All districts in India created after 2001
- MPs who sit in the Rajya Sabha (Upper House of Parliament), Lok Sabha MPs who represent constituencies not contained within or overlapping study districts, Lok Sabha MPs who represent constituencies that overlap both experimental and control study districts
- MLAs who represent constituencies not contained within study districts
- DCs who administrate non-study districts
- ZPCEOs who administrate non-study districts
- DHOs who work in non-study districts
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Canada1 site
Centre for Global Health Research, St. Michael's Hospital
Toronto, Ontario, M5C 1N8
About this study
Official title: Improving Use of Evidence in Policy: District Evaluation Study on Health
The purpose of this study is to assess the impact of disseminating information on comparative performance, along with actionable messages on how to improve health outcomes, to district-level decision-makers in India using a randomized, controlled design. This information should improve prioritization of health services by district health officers, budget allocation for health, and implementation of priority health services at the district level.
Read the detailed description
Use of evidence in policy is uneven, leading to frequent waste of resources. However, the best way to promote evidence uptake in policy formulation and implementation is unclear. Information on disease control priorities based on India's disease burden and health system capacity has been produced to help focus government efforts during a period of increased spending and decentralization.
This study tests the impact of sending information on comparative performance (using district report cards) and actionable messages (on how to reduce disease burden) to district-level decision-makers on uptake of disease control priority recommendations in India. Using a cluster-randomized design, districts will be randomized to receive either the mailed information package or no intervention. The sample includes all 594 Indian districts in existence in 2001. The intervention will target key district level decision-makers: parliamentarians (Members of Parliament, Members of Legislative Assembly), bureaucrats (District Collectors), technocrats (District Health Officers), and local government officials (Zilla Parishad CEOs).
Study outcome data will be collected using sequential national surveys of health service availability and utilization, including relevant rounds of the District Level Health and Facility Surveys and the Annual Health Surveys. This study tests an inexpensive, pragmatic strategy on a large scale and will provide information on effective methods of knowledge translation to policy-makers.
- Conditions
- Infectious Disease, Cardiovascular Disease
- Being tested
- District health information package
- Keywords
- India, evidence-based policy, knowledge translation, disease control priorities, decision-makers, health spending, health services delivery, maternal and child health, policy making, delivery of health care
- Medical subject headings
- Communicable Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
District health information packageBehavioural
The intervention package consists of:
- A report on disease burden, disease control priorities and health system performance in India
- Condensed fact sheet based on the report
- District health report cards (DRCs) comparing performance on key health indicators with other districts, information on causes of death in each district, and actionable messages to reduce deaths in the district
- Customized speech for district level officials detailing key actions to reduce deaths
- Reminder materials including poster version of the DRCs and video on key points and actionable messages
| Study group | Role | What they receive |
|---|---|---|
| District health information package | Experimental | Not described Receives: Behavioral: District health information package |
| No Intervention | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage children 12-23 months vaccinated against measles
Measured: Five years
Percentage children <3 yrs with diarrhea in past 2 weeks given oral rehydration solution
Measured: Five years
Percentage facility-based births for the last child since 2007
Measured: Five years
Secondary outcomes (5)
Percentage last child >3 yrs breast fed within 1 hr of birth
Measured: Five years
Percentage women given advice on breastfeeding and newborn thermal care during antenatal care
Measured: Five years
Percentage subcenters with oral rehydration solution available on day of survey and no stockouts for more than 10 days in last month
Measured: Five years
Percentage community health centres with at least 1 surgeon or ob/gyn
Measured: Five years
Percentage public health centres with reagents, light microscope and lab technician for malaria blood smear
Measured: Five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2009 (estimated)
- Study startJul 2009
- Primary completionMar 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infectious DiseaseStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 594 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian International Development Agency, Lombard Insurance Global Poverty Action Lab, St. John's Research Institute
- Responsible party
- Sponsor
- Investigators
- Onil Bhattacharyya, MD, PhD, Principal investigator, Unity Health TorontoPrabhat Jha, MD, PhD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01003587
- Sponsor's protocol ID
- SMH 09-049
- Acronym
- DESH
- Status last verified
- Jun 2015
- First submitted
- 28 Oct 2009
- Last updated
- 4 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Use of Evidence in Policy: District Evaluation Study on Health
- ClinicalTrials.gov ID
- NCT01003587
- Acronym / sponsor ID
- DESH / SMH 09-049
- Conditions
- Infectious Disease, Cardiovascular Disease
- Keywords
- India, evidence-based policy, knowledge translation, disease control priorities, decision-makers, health spending, health services delivery, maternal and child health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 594 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- Canadian International Development Agency, Lombard Insurance Global Poverty Action Lab, St. John's Research Institute
- Study start
- Jul 2009
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 29 Oct 2009 (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.
The purpose of this study is to assess the impact of disseminating information on comparative performance, along with actionable messages on how to improve health outcomes, to district-level decision-makers in India using a randomized, controlled design. This information should improve prioritization of health services by district health officers, budget allocation for health, and implementation of priority health services at the district level.
Detailed description
Use of evidence in policy is uneven, leading to frequent waste of resources. However, the best way to promote evidence uptake in policy formulation and implementation is unclear. Information on disease control priorities based on India's disease burden and health system capacity has been produced to help focus government efforts during a period of increased spending and decentralization.
This study tests the impact of sending information on comparative performance (using district report cards) and actionable messages (on how to reduce disease burden) to district-level decision-makers on uptake of disease control priority recommendations in India. Using a cluster-randomized design, districts will be randomized to receive either the mailed information package or no intervention. The sample includes all 594 Indian districts in existence in 2001. The intervention will target key district level decision-makers: parliamentarians (Members of Parliament, Members of Legislative Assembly), bureaucrats (District Collectors), technocrats (District Health Officers), and local government officials (Zilla Parishad CEOs).
Study outcome data will be collected using sequential national surveys of health service availability and utilization, including relevant rounds of the District Level Health and Facility Surveys and the Annual Health Surveys. This study tests an inexpensive, pragmatic strategy on a large scale and will provide information on effective methods of knowledge translation to policy-makers.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| District health information package | Experimental | Behavioral: District health information package |
| No Intervention | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- All districts in India in existence in 2001
- Members of Parliament (MPs) who sit in the Lok Sabha (Lower House of Parliament) and represent constituencies that are contained within or overlap study districts
- Members of Legislative Assembly (MLAs) who represent constituencies that are contained within study districts
- District Collectors (DCs) who administrate study districts
- Zilla Parishad Chief Executive Officers (ZPCEOs) who administrate study districts
Key exclusion criteria (6 listed)
- All districts in India created after 2001
- MPs who sit in the Rajya Sabha (Upper House of Parliament), Lok Sabha MPs who represent constituencies not contained within or overlapping study districts, Lok Sabha MPs who represent constituencies that overlap both experimental and control study districts
- MLAs who represent constituencies not contained within study districts
- DCs who administrate non-study districts
- ZPCEOs who administrate non-study districts
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| District health information packageThe intervention package consists of: * A report on disease burden, disease control priorities and health system performance in India * Condensed fact sheet based on the report * District health report cards (DRCs) comparing performance on key health indicators with other districts, information on causes of death in each district, and actionable messages to reduce deaths in the district * Customized speech for district level officials detailing key actions to reduce deaths * Reminder materials including poster version of the DRCs and video on key points and actionable messages | Behavioural | District health information package |
Primary outcome
Percentage children 12-23 months vaccinated against measles
Time frame: Five years
Percentage children <3 yrs with diarrhea in past 2 weeks given oral rehydration solution
Time frame: Five years
Percentage facility-based births for the last child since 2007
Time frame: Five years
5 secondary outcomes
Percentage last child >3 yrs breast fed within 1 hr of birth
Time frame: Five years
Percentage women given advice on breastfeeding and newborn thermal care during antenatal care
Time frame: Five years
Percentage subcenters with oral rehydration solution available on day of survey and no stockouts for more than 10 days in last month
Time frame: Five years
Percentage community health centres with at least 1 surgeon or ob/gyn
Time frame: Five years
Percentage public health centres with reagents, light microscope and lab technician for malaria blood smear
Time frame: Five years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2015.
- Centre for Global Health ResearchLink provided by the sponsor.
- St. John's Research InstituteLink provided by the sponsor.
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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.
Onil Bhattacharyya, MD, PhD principal investigator
Unity Health Toronto
Prabhat Jha, MD, PhD principal investigator
Unity Health Toronto
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing District health information package in people with Infectious Disease and Cardiovascular Disease, run by Unity Health Toronto at 2 sites in 2 countries.
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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 4 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada, 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?
Results are not available in the source record.
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?
Percentage children 12-23 months vaccinated against measles (time frame: Five years). The study lists 3 primary outcomes in all. 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 4 Jun 2015.