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Effects of an Evidence Service on Health System Policymakers' Use of Research Evidence

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ClinicalTrials.gov Identifier: NCT01307228
Recruitment Status : Withdrawn (Insufficient participants recruited for the trial)
First Posted : March 2, 2011
Last Update Posted : March 23, 2017
Sponsor:
Collaborator:
Ontario Ministry of Health and Long Term Care
Information provided by (Responsible Party):
John Lavis, McMaster University

Tracking Information
First Submitted Date  ICMJE February 28, 2011
First Posted Date  ICMJE March 2, 2011
Last Update Posted Date March 23, 2017
Actual Study Start Date  ICMJE December 2010
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 1, 2011)
number of logins/month/participant [ Time Frame: 10 months ]
The investigators will track utilization of the evidence service by calculating the mean number of logins/month/participant
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 1, 2011)
Intention to use research evidence [ Time Frame: Baseline and follow-up (after delivery of 6-month intervention) ]
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of an Evidence Service on Health System Policymakers' Use of Research Evidence
Official Title  ICMJE Effects of an Evidence Service on Health System Policymakers' Use of Research Evidence
Brief Summary The investigators have developed an online database called 'Health Systems Evidence,' which contains synthesized research evidence and additional details about this evidence that can make it easier for health system policymakers to use the included research evidence. The investigators have also developed an e-mail alerting service that brings to the attention of health system policymakers any new additions to Health Systems Evidence. This study will evaluate whether a "full-serve" version of Health Systems Evidence increases the use of research evidence by policy analysts and advisors in the Ontario government as compared to a "self-serve" version. The "full-serve" version comprises: 1) access to Health Systems Evidence; 2) monthly e-mail alerts about new additions to Health Systems Evidence; and 3) access to full-text articles that are cited in Health Systems Evidence. The "self-serve" version only provides access to Health Systems Evidence. The investigators will also interview study participants to obtain feedback about Health Systems Evidence, including 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 improving it.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Other
Condition  ICMJE Use of Research Evidence
Intervention  ICMJE Other: Health Systems Evidence
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.
Study Arms  ICMJE
  • Experimental: Full-serve evidence service

    The "full-serve" evidence service consists of:

    1. database (Health Systems Evidence) access;
    2. monthly e-mail alerts; and
    3. full-text article availability.
    Intervention: Other: Health Systems Evidence
  • 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
    Intervention: Other: Health Systems Evidence
Publications * Lavis JN, Wilson MG, Grimshaw JM, Haynes RB, Hanna S, Raina P, Gruen R, Ouimet M. Effects of an evidence service on health-system policy makers' use of research evidence: a protocol for a randomised controlled trial. Implement Sci. 2011 May 27;6:51. doi: 10.1186/1748-5908-6-51.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: March 21, 2017)
0
Original Estimated Enrollment  ICMJE
 (submitted: March 1, 2011)
100
Actual Study Completion Date  ICMJE February 2013
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • All policy analysts and policy advisors from one purposively selected division of one Canadian provincial Ministry of Health.

Exclusion Criteria:

  • None
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01307228
Other Study ID Numbers  ICMJE HHS/FHS REB 10-267
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Not applicable - trial was terminated due to insufficient enrollment and no data was collected.
Responsible Party John Lavis, McMaster University
Study Sponsor  ICMJE McMaster University
Collaborators  ICMJE Ontario Ministry of Health and Long Term Care
Investigators  ICMJE
Principal Investigator: John N Lavis, MD, PhD McMaster University
PRS Account McMaster University
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP