Use of Research EvidenceNCT01307228
Effects of an Evidence Service on Health System Policymakers' Use of Research Evidence
A study testing Health Systems Evidence in people with Use of Research Evidence, run by McMaster University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Use of Research Evidence
- What is being tested?
- Health Systems Evidence
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2010to Feb 2013
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All policy analysts and policy advisors from one purposively selected division of one Canadian provincial Ministry of Health.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Use of Research Evidence
- Being tested
- Health Systems Evidence
- Keywords
- Knowledge translation, Policymakers, Health systems
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Systems EvidenceOther
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 group | Role | What they receive |
|---|---|---|
| Full-serve evidence service | Experimental | The "full-serve" evidence service consists of:
1. database (Health Systems Evidence) access;
2. monthly e-mail alerts; and
3. full-text article availability. Receives: Other: Health Systems Evidence |
| Self-serve evidence service | Active comparator | Participants allocated to the "self-serve" evidence service will receive only database access, which is already publicly available at www.healthsystemsevidence.org Receives: Other: Health Systems Evidence |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of logins/month/participant
The investigators will track utilization of the evidence service by calculating the mean number of logins/month/participant
Measured: 10 months
Secondary outcomes (1)
Intention to use research evidence
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.
Measured: Baseline and follow-up (after delivery of 6-month intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2011 (estimated)
- Study startDec 2010
- Primary completionApr 2011
- Study completionFeb 2013
Why it stopped: Insufficient participants recruited for the trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Use of Research EvidenceStudies of the same condition, open and under way.
- More trials run by McMaster 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Ministry of Health and Long Term Care
- Responsible party
- Principal investigator, John Lavis, McMaster University
- Investigators
- John N Lavis, MD, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01307228
- Sponsor's protocol ID
- HHS/FHS REB 10-267
- Status last verified
- Mar 2017
- First submitted
- 28 Feb 2011
- Last updated
- 23 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Not applicable - trial was terminated due to insufficient enrollment and no data was collected.
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.
PubMed 21619621
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Evidence Service on Health System Policymakers' Use of Research Evidence
- ClinicalTrials.gov ID
- NCT01307228
- Acronym / sponsor ID
- HHS/FHS REB 10-267
- Conditions
- Use of Research Evidence
- Keywords
- Knowledge translation, Policymakers, Health systems
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Insufficient participants recruited for the trial
- Enrolment
- 0 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Ontario Ministry of Health and Long Term Care
- Study start
- Dec 2010 (actual)
- Primary completion
- Apr 2011 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 2 Mar 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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Full-serve evidence service | Experimental | Other: Health Systems EvidenceThe "full-serve" evidence service consists of: 1. database (Health Systems Evidence) access; 2. monthly e-mail alerts; and 3. full-text article availability. |
| Self-serve evidence service | Active comparator | Other: Health Systems EvidenceParticipants allocated to the "self-serve" evidence service will receive only database access, which is already publicly available at www.healthsystemsevidence.org |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All policy analysts and policy advisors from one purposively selected division of one Canadian provincial Ministry of Health.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Health Systems EvidenceHealth 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. | Other | Full-serve evidence service, Self-serve evidence service |
Primary outcome
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
1 secondary outcome
Intention to use research evidence
Time frame: Baseline and follow-up (after delivery of 6-month intervention)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2017.
- Derived from this study: PubMed 21619621Lavis 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.
- Individual participant dataSharing planned: No. Not applicable - trial was terminated due to insufficient enrollment and no data was collected.
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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.
John N Lavis, MD, PhD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Systems Evidence in people with Use of Research Evidence, run by McMaster University at 1 site in Canada.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 23 Mar 2017. 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 Canada. 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 was withdrawn before enrolling participants, so there are no results.
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?
number of logins/month/participant (time frame: 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01307228, which also lists 1 linked publication.
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 23 Mar 2017.