- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01307228
Effects of an Evidence Service on Health System Policymakers' Use of Research Evidence
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background Health system policymakers need timely access to synthesized research evidence to inform the policymaking process. No efforts to address this need have been evaluated using an experimental quantitative design. The investigators developed an evidence service that draws inputs from Health Systems Evidence, which is a database of policy relevant systematic reviews. The reviews have been: 1) categorized by topic and type of review; 2) coded by the last year searches for studies were conducted and by the countries in which included studies were conducted; 3) rated for quality; and 4) linked to available user-friendly summaries, scientific abstracts, and full-text reports. The goal is to evaluate whether a "full-serve" evidence service increases the use of synthesized research evidence by policy analysts and advisors in the Ontario Ministry of Health and Long-Term Care (MOHLTC) as compared to a "self-serve" evidence service.
Methods/design: The investigators will conduct a two-arm randomized controlled trial (RCT), along with a follow-up qualitative process study in order to explore the findings in greater depth. For the RCT, all policy analysts and policy advisors (n=168) in a single division of the MOHLTC will be invited to participate. Using a stratified randomized design, participants will be randomized to receive either the "full-serve" evidence service (database access, monthly e-mail alerts, and full-text article availability) or the "self-serve" evidence service (database access only). The trial duration will be ten months (two-month baseline period, six-month intervention period, and two month cross-over period). The primary outcome will be the mean number of site visits/month/user between baseline and the end of the intervention period. The secondary outcome will be participants' intention to use research evidence. For the qualitative study, 15 participants from each trial arm (n=30) will be purposively sampled. One-on-one semi-structured interviews will be conducted by telephone on their views about and their experiences with the evidence service they received, how helpful it was in their work, why it was helpful (or not helpful), what aspects were most and least helpful and why, and recommendations for next steps.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ontario
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Hamilton, Ontario, Canada, L8S 4K1
- McMaster Health Forum Impact Lab
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All policy analysts and policy advisors from one purposively selected division of one Canadian provincial Ministry of Health.
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Full-serve evidence service
The "full-serve" evidence service consists of:
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Health Systems Evidence (HSE) contains over 1400 research syntheses about governance, financial and delivery arrangements within health systems and about implementation strategies relevant to health systems.
The syntheses have been: 1) categorized by topic, type of synthesis, and type of question addressed; 2) coded by the last year in which searches for studies were conducted and by the countries in which included studies were conducted; 3) rated for quality; and 4) linked to publicly available user-friendly summaries, scientific abstracts, and full-text reviews.
We identified systematic reviews in HSE that are not accessible to study participants and developed a mechanism to reimburse publishers for full-text downloads of these reviews.
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Active Comparator: Self-serve evidence service
Participants allocated to the "self-serve" evidence service will receive only database access, which is already publicly available at www.healthsystemsevidence.org
|
Health Systems Evidence (HSE) contains over 1400 research syntheses about governance, financial and delivery arrangements within health systems and about implementation strategies relevant to health systems.
The syntheses have been: 1) categorized by topic, type of synthesis, and type of question addressed; 2) coded by the last year in which searches for studies were conducted and by the countries in which included studies were conducted; 3) rated for quality; and 4) linked to publicly available user-friendly summaries, scientific abstracts, and full-text reviews.
We identified systematic reviews in HSE that are not accessible to study participants and developed a mechanism to reimburse publishers for full-text downloads of these reviews.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
number of logins/month/participant
Time Frame: 10 months
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The investigators will track utilization of the evidence service by calculating the mean number of logins/month/participant
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10 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intention to use research evidence
Time Frame: Baseline and follow-up (after delivery of 6-month intervention)
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The investigators will use the theory of planned behaviour to measure participants' intention to use research evidence.
Using a manual designed to construct measures based on the theory, colleagues have developed and sought preliminary feedback on a data-collection instrument by first assessing face validity through interviews with key informants and then pilot testing it with 28 policymakers and researchers who completed it after participating in a knowledge translation intervention.
In addition, colleagues found the data-collection instrument to have moderate test-retest reliability.
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Baseline and follow-up (after delivery of 6-month intervention)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: John N Lavis, MD, PhD, McMaster University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- HHS/FHS REB 10-267
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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.
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