Testing New Formats for the Presentation of Research Evidence to Health Care Managers and Policy Makers

May 5, 2020 updated by: Unity Health Toronto

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.

Study Overview

Status

Status

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

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

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 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.
257

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, M5B 1W8
        • St. Michael's Hospital

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Health care managers or policy makers who are unwilling or unable to give informed consent.

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: Double

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.
Experimental: Novel systematic review format
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.
Other: Novel systematic review format
A 2-page summary of systematic review content that has been designed in collaboration with policy makers and health care managers.
No Intervention: Traditional systematic review format
Control participants will be asked to read and answer questions using a traditional systematic review format.

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
Measure Description
Time Frame
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.
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 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
Measure Description
Time Frame
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).
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.
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).
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.
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).
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.
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).
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.
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).

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

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: Sharon e Straus, Unity Health Toronto

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 (Actual)

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.
May 16, 2017

Primary Completion (Actual)

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.
November 30, 2019

Study Completion (Actual)

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.
November 30, 2019

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).
January 5, 2017

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.
February 1, 2017

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.
February 2, 2017

Study Record Updates

Last Update Posted (Actual)

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.
May 7, 2020

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.
May 5, 2020

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.
May 1, 2020

More Information

Terms related to this study

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-312381

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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