Promoting Evidence-Based Decision-Making in India: District Evaluation Study on Health (DESH)

June 3, 2015 updated by: Unity Health Toronto

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
594

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5C 1N8
        • Centre for Global Health Research, St. Michael's Hospital
  • India
    • Karnataka
      • Bangalore, Karnataka, India, 560034
        • St. John's Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria (Districts):

  • All districts in India in existence in 2001

Exclusion Criteria (Districts):

  • All districts in India created after 2001

Inclusion Criteria (District Officials):

  • 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

Exclusion Criteria (District Officials):

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: No Intervention
Experimental: District health information package
Behavioral: District health information package

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Percentage children 12-23 months vaccinated against measles
Time Frame: Five years
Five years
Percentage children <3 yrs with diarrhea in past 2 weeks given oral rehydration solution
Time Frame: Five years
Five years
Percentage facility-based births for the last child since 2007
Time Frame: Five years
Five years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Percentage last child >3 yrs breast fed within 1 hr of birth
Time Frame: Five years
Five years
Percentage women given advice on breastfeeding and newborn thermal care during antenatal care
Time Frame: Five years
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
Five years
Percentage community health centres with at least 1 surgeon or ob/gyn
Time Frame: Five years
Five years
Percentage public health centres with reagents, light microscope and lab technician for malaria blood smear
Time Frame: Five years
Five years

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Differences in any of primary and secondary outcomes between Empowered Action Group and Assam (EAGA) states and non-EAGA states
Time Frame: Five years
Five years
Differences in any of primary and secondary outcomes between measles-focus states and non-measles-focus states
Time Frame: Five years
Five years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Unity Health Toronto

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
St. John's Research Institute
Canadian International Development Agency
Lombard Insurance Global Poverty Action Lab

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Onil Bhattacharyya, MD, PhD, Unity Health Toronto
  • Principal Investigator: Prabhat Jha, MD, PhD, Unity Health Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2009

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2016

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 28, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 28, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 29, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 4, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SMH 09-049

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cardiovascular Disease

Clinical Trials on District health information package

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings