Uptake of Systematic Review EvidenceNCT03041454
Testing New Formats for the Presentation of Research Evidence to Health Care Managers and Policy Makers
A study testing Novel systematic review format in people with Uptake of Systematic Review Evidence, run by Unity Health Toronto at 1 site in Canada.
Trial summary
The purpose of this project is to identify and use our knowledge on the barriers and facilitators to using systematic reviews (SR) by health care managers (HCM) and policy markers (PM) to develop and test a novel format for presentation of SR for HCM and PM. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Uptake of Systematic Review Evidence
- What is being tested?
- Novel systematic review format
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 257 participants
- Where
- 1 siteCanada
- Study dates
- 16 May 2017to 30 Nov 2019
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Health care managers from the Alberta SCNs, CAHO in Ontario, the RHAs and AQESSS in Quebec and RHAs from BC will be invited to participate.
- Policy makers/analysts from the Ontario, BC, Alberta and Quebec Ministries of Health
Who cannot join
- Health care managers or policy makers who are unwilling or unable to give informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Trial to Compare the Effects of a Novel Versus Traditional Systematic Review Format on the Ability of Health Care Managers and Policy Makers to Understand and Apply Evidence
The purpose of this project is to identify and use our knowledge on the barriers and facilitators to using systematic reviews (SR) by health care managers (HCM) and policy markers (PM) to develop and test a novel format for presentation of SR for HCM and PM. We will invite HCM and PM from hospitals and regional authorities in Ontario, Alberta, and British Columbia to participate in a randomized-control trial. Participants will receive a link to an online consent survey, and then be randomly allocated to receive access to a novel SR or its traditional presentation. There is no time limit to completing the task, and participants are able to save their responses and finish later. Participants are able to withdraw from the study by not completing the task.
Read the detailed description
Despite advances in the conduct and reporting of traditional systematic reviews, current evidence suggests that they are used infrequently by health care managers and policy makers in decision making. Managers and policy makers have suggested that concise presentation positively affects the use of systematic reviews. The purpose of this randomized controlled trial is to assess the impact of a traditional systematic review format compared with the innovative format on the ability of health care managers and policy makers to understand the evidence in the review and apply it to a relevant health care decision making scenario.
The two end-user groups have different formatting needs and we will therefore run 2 parallel studies, randomizing each group separately. Once participants have consented to participate, a computer generated randomization process will allocate them to one of 2 arms (1:1 ratio). Participants will either receive either a traditional format or a novel format. Unequal block randomization will be used and allocation will be concealed through central assignment. Outcomes assessors will be blinded and participants will be blinded to the citation of the review so that the traditional version will not be easily accessible in its original format from the relevant journal.
This study will be the first study to engage health care managers and policy makers in the testing of formats for presentation of research evidence relevant to their needs. The results of the project will help increase the uptake of systematic review results in health care management policy decision-making, ultimately leading to informed decision making and positively impacting the health of Canadians.
- Conditions
- Uptake of Systematic Review Evidence
- Being tested
- Novel systematic review format
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel systematic review formatOther
A 2-page summary of systematic review content that has been designed in collaboration with policy makers and health care managers.
| Study group | Role | What they receive |
|---|---|---|
| Novel systematic review format | Experimental | A 2-page summary of systematic review content that has been designed in collaboration with policy makers and health care managers. Participants receiving the intervention will be asked to read and answer questions using a novel systematic review format. Receives: Other: Novel systematic review format |
| Traditional systematic review format | No intervention | Control participants will be asked to read and answer questions using a traditional systematic review format. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants (health care managers or policy makers) who appropriately consider and apply the evidence from each systematic review format
The proportion of participants (health care managers or policy makers) who appropriately consider and apply the evidence from each systematic review format to the scenario as measured by agreement with an expert panel's recommendation. A panel of 4 health care managers or policy makers from our research team and 2 content experts. Their answers will provide the definition of appropriate application of the evidence. Two investigators who will be blind to allocation will independently determine if the participant's answer agrees with that from the expert panel. Disagreements will be resolved by a third investigator, independently. Agreement between investigators will be reported using the kappa statistic.
Measured: This measure will be assessed at the particular time the intervention is administered (i.e., at the time the participant reads the systematic review format, an average of 2 hours).
Secondary outcomes (4)
Comprehension of the review
Comprehension of the review - defined as the proportion of participants (health care managers or policy makers) who accurately define the bottom line from the systematic review as defined by an expert panel. A panel of 4 health care managers or policy makers from our research team and 2 content experts. Their answers will provide the definition of the bottom line from the systematic review. Two investigators who will be blind to allocation will independently determine if the participant's answer agrees with that from the expert panel. Disagreements will be resolved by a third investigator, independently. Agreement between investigators will be reported using the kappa statistic.
Measured: This measures will be assessed at the particular time the intervention is administered (i.e., at the time the participant reads the systematic review format, an average of 2 hours).
Intention to use evidence
Intention to use evidence - collected through a 12-item likert scale survey. The survey has good face validity amongst policy makers and managers. The mean and SD of each item in the survey will be reported and we will provide a summary score of all items and convert it to a percentage.
Measured: This measures will be assessed at the particular time the intervention is administered (i.e., at the time the participant reads the systematic review format, an average of 2 hours).
Perceived tentativeness of research findings
Perceived tentativeness of research findings - collected through a 6-item likert scale survey. This has been pre-tested to make sure that the items are intelligible to people and to achieve high levels of face validity and reliability. The mean and SD of each item in the survey will be reported and we will provide a summary score of all items and convert it to a percentage.
Measured: This measures will be assessed at the particular time the intervention is administered (i.e., at the time the participant reads the systematic review format, an average of 2 hours).
Provisional opinion about the intervention
Provisional opinion about the intervention - collected through a 14-item likert scale survey. This has been pre-tested to make sure that the items are intelligible to people and to achieve high levels of face validity and reliability. The mean and SD of each item in the survey will be reported and we will provide a summary score of all items and convert it to a percentage.
Measured: This measures will be assessed at the particular time the intervention is administered (i.e., at the time the participant reads the systematic review format, an average of 2 hours).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2017 (estimated)
- Study start16 May 2017
- Primary completion30 Nov 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uptake of Systematic Review EvidenceStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 257 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sharon e Straus, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03041454
- Sponsor's protocol ID
- SMH-312381
- Status last verified
- May 2020
- First submitted
- 5 Jan 2017
- Last updated
- 7 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial to Compare the Effects of a Novel Versus Traditional Systematic Review Format on the Ability of Health Care Managers and Policy Makers to Understand and Apply Evidence
- ClinicalTrials.gov ID
- NCT03041454
- Acronym / sponsor ID
- SMH-312381
- Conditions
- Uptake of Systematic Review Evidence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 257 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- 16 May 2017 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 2 Feb 2017 (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 project is to identify and use our knowledge on the barriers and facilitators to using systematic reviews (SR) by health care managers (HCM) and policy markers (PM) to develop and test a novel format for presentation of SR for HCM and PM. We will invite HCM and PM from hospitals and regional authorities in Ontario, Alberta, and British Columbia to participate in a randomized-control trial. Participants will receive a link to an online consent survey, and then be randomly allocated to receive access to a novel SR or its traditional presentation. There is no time limit to completing the task, and participants are able to save their responses and finish later. Participants are able to withdraw from the study by not completing the task.
Detailed description
Despite advances in the conduct and reporting of traditional systematic reviews, current evidence suggests that they are used infrequently by health care managers and policy makers in decision making. Managers and policy makers have suggested that concise presentation positively affects the use of systematic reviews. The purpose of this randomized controlled trial is to assess the impact of a traditional systematic review format compared with the innovative format on the ability of health care managers and policy makers to understand the evidence in the review and apply it to a relevant health care decision making scenario.
The two end-user groups have different formatting needs and we will therefore run 2 parallel studies, randomizing each group separately. Once participants have consented to participate, a computer generated randomization process will allocate them to one of 2 arms (1:1 ratio). Participants will either receive either a traditional format or a novel format. Unequal block randomization will be used and allocation will be concealed through central assignment. Outcomes assessors will be blinded and participants will be blinded to the citation of the review so that the traditional version will not be easily accessible in its original format from the relevant journal.
This study will be the first study to engage health care managers and policy makers in the testing of formats for presentation of research evidence relevant to their needs. The results of the project will help increase the uptake of systematic review results in health care management policy decision-making, ultimately leading to informed decision making and positively impacting the health of Canadians.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Novel systematic review format | Experimental | Other: Novel systematic review formatA 2-page summary of systematic review content that has been designed in collaboration with policy makers and health care managers. Participants receiving the intervention will be asked to read and answer questions using a novel systematic review format. |
| Traditional systematic review format | No intervention | –Control participants will be asked to read and answer questions using a traditional systematic review format. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Health care managers from the Alberta SCNs, CAHO in Ontario, the RHAs and AQESSS in Quebec and RHAs from BC will be invited to participate.
- Policy makers/analysts from the Ontario, BC, Alberta and Quebec Ministries of Health
Key exclusion criteria (1 listed)
- Health care managers or policy makers who are unwilling or unable to give informed consent.
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 |
|---|---|---|
| Novel systematic review formatA 2-page summary of systematic review content that has been designed in collaboration with policy makers and health care managers. | Other | Novel systematic review format |
Primary outcome
Proportion of participants (health care managers or policy makers) who appropriately consider and apply the evidence from each systematic review format
Time frame: This measure will be assessed at the particular time the intervention is administered (i.e., at the time the participant reads the systematic review format, an average of 2 hours).
The proportion of participants (health care managers or policy makers) who appropriately consider and apply the evidence from each systematic review format to the scenario as measured by agreement with an expert panel's recommendation. A panel of 4 health care managers or policy makers from our research team and 2 content experts. Their answers will provide the definition of appropriate application of the evidence. Two investigators who will be blind to allocation will independently determine if the participant's answer agrees with that from the expert panel. Disagreements will be resolved by a third investigator, independently. Agreement between investigators will be reported using the kappa statistic.
4 secondary outcomes
Comprehension of the review
Time frame: This measures will be assessed at the particular time the intervention is administered (i.e., at the time the participant reads the systematic review format, an average of 2 hours).
Intention to use evidence
Time frame: This measures will be assessed at the particular time the intervention is administered (i.e., at the time the participant reads the systematic review format, an average of 2 hours).
Perceived tentativeness of research findings
Time frame: This measures will be assessed at the particular time the intervention is administered (i.e., at the time the participant reads the systematic review format, an average of 2 hours).
Provisional opinion about the intervention
Time frame: This measures will be assessed at the particular time the intervention is administered (i.e., at the time the participant reads the systematic review format, an average of 2 hours).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2020.
- Individual participant dataSharing planned: No
Related trials for Uptake of Systematic Review Evidence
Recruiting
Place Activation in Urban Peripheries: the 'Comunidades y Espacios Activos" Project (CEA)
Uptake of Systematic Review Evidence
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.
Sharon e Straus principal investigator
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Novel systematic review format in people with Uptake of Systematic Review Evidence, run by Unity Health Toronto 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 2 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: finished, as of the sponsor's last update on 7 May 2020. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of participants (health care managers or policy makers) who appropriately consider and apply the evidence from each systematic review format (time frame: This measure will be assessed at the particular time the intervention is administered (i.e., at the time the participant reads the systematic review format, an average of 2 hours).). 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 7 May 2020.