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Knowledge Mobilization Activities to Support Decision-Making by Youth, Parents and Adults: Study Protocol (eCOVID-PLR)

Primary Purpose

COVID-19

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Plain Language Recommendation (PLR)
Standard Language Version (SLV)
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for COVID-19 focused on measuring electronic Coronavirus Disease Recommendation Map (eCOVID RecMap), Plain Language Recommendation, Standard Language Versions, Public Engagement, Knowledge Mobilization

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • For youth population: be between the ages of 15 to 24 years
  • For parents population: be 18 years and above and making decisions with or for their children (parent, caregiver, the legal guardian of a child < 18 years)
  • For adults: be 21 years of age or older
  • Need to be able to complete the survey in English

Exclusion Criteria:

  • Individuals not fitting any of the above age categories or language requirement

Sites / Locations

  • McMaster University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Plain Language Recommendation (PLR)

Standard Language Version (SLV)

Arm Description

New easy to read COVID-19 recommendations available on the COVID19 Living Map of Recommendations and Gateway to Contextualization (RecMap).

Original recommendation as initially published by the guideline organization.

Outcomes

Primary Outcome Measures

Understanding with Multiple Choice Questions
The primary outcome is understanding. Understanding is defined as the correct comprehension of key guideline content (year of publication, intent of the recommendation, direction of recommendation, etc.). This outcome will be measured with seven multiple-choice questions about key concepts in the recommendation with four to six response options for each question and only one correct answer (total minimum score of 0, maximum score of 7).

Secondary Outcome Measures

Accessibility and Usability on a Seven-Point Likert Scale
Accessibility and Usability is defined as the ability to find/access, and use the presented information. This outcome considers the three following domains: (1) how easy it was to find information, (2) how easy it was to understand the information (perception), and (3) whether the information was presented in a way that could be helpful for making an informed health decision. Participants will have to indicate the degree of agreement with six statements, measured using the original 7-point Likert scale (1 being strongly disagree, 4 being neutral, and 7 being strongly agree). The outcome 'overall accessibility of information' will be measured using the 7-point Likert-type scale.
Satisfaction on a Seven-Point Likert Scale
Satisfaction is defined as participants' impression of the recommendation's presentation. This will be measured using questions related to participants' level of satisfaction with the different features of the format (e.g. feature of explaining the certainty of the evidence). Participants will have to indicate the degree of satisfaction with three questions measured using the original 7-point Likert-type scale (11 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neutral, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied). Participants will also have to answer three open-ended questions to get their input on what they liked and disliked in the format.
Intended Behavior on a Seven-Point Likert Scale and Multiple Choice Questions
Intended behavior is defined as participants' intention in adopting and following the shared recommendation. Participants will answer a question on whether they have already followed and implemented the recommendation in their jurisdiction and have them respond with yes, no, unsure, or not applicable. Subsequently, they will be asked how likely it is that they will follow and share the recommendation through two questions measured using a 7-point Likert-scale (1 = very unlikely, 2 = unlikely, 3 = somewhat unlikely, 4 = neutral, 5 = somewhat likely, 6 = likely, 7 = very likely.
Preference on a Seven-Point Likert-Scale
Preference is defined as a greater liking of one format over the other (PLR or SLV). All participants will get to compare the optimized PLR and the SLV; after having completed the tasks in the group they were randomized to, participants will review the alternative format and indicate their preference for one of the two formats using a 7-point Likert-type scale (1 = strongly prefer SLV, 2 = prefer SLV, 3 = somewhat prefer SLV, 4 = same preference for SLV and PLR, 5 = somewhat prefer PLR, 6 = prefer PLR, 7 = strongly prefer PLR).

Full Information

First Posted
April 28, 2022
Last Updated
December 12, 2022
Sponsor
McMaster University
Collaborators
Western University, The Hospital for Sick Children, University of Alberta
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1. Study Identification

Unique Protocol Identification Number
NCT05358990
Brief Title
Knowledge Mobilization Activities to Support Decision-Making by Youth, Parents and Adults: Study Protocol
Acronym
eCOVID-PLR
Official Title
Knowledge Mobilization Activities to Support Decision-making by Youth, Parents and Adults Using a Systematic and Living Map of Evidence and Recommendations on Coronavirus Disease (COVID-19)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
May 25, 2022 (Actual)
Primary Completion Date
October 25, 2022 (Actual)
Study Completion Date
October 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McMaster University
Collaborators
Western University, The Hospital for Sick Children, University of Alberta

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Coronavirus Disease (COVID-19) recommendations are usually developed for healthcare professionals (for example Doctors, health organizations, etc.). It is important to make sure that these recommendations can be used and understood by everyone. This study aims to make COVID-19 recommendations more accessible and understandable for parents and caregivers, adults, and youth.
Detailed Description
This is a two-arm superiority randomized controlled trial. The primary objective is to compare the understanding of key guideline information between the Plain Language Recommendation (PLR) (intervention) and the Standard Language Version (SLV- original recommendation as available in the published guideline) (comparison). Secondary outcomes include accessibility and usability of the information, satisfaction with the presentation, intended behavior to follow the information in the recommendation, and preference toward one of the two presentations. Recruitment will be global for the three populations (youth, parents, and adults), using three different online links. Data will be collected using a survey with 1:1 randomization to the intervention and subsequent demographic questions. Superiority will be declared if a minimal difference of 10% in understanding is achieved between the two groups (an average difference of 1 correct answer).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
electronic Coronavirus Disease Recommendation Map (eCOVID RecMap), Plain Language Recommendation, Standard Language Versions, Public Engagement, Knowledge Mobilization

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
997 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Plain Language Recommendation (PLR)
Arm Type
Experimental
Arm Description
New easy to read COVID-19 recommendations available on the COVID19 Living Map of Recommendations and Gateway to Contextualization (RecMap).
Arm Title
Standard Language Version (SLV)
Arm Type
Active Comparator
Arm Description
Original recommendation as initially published by the guideline organization.
Intervention Type
Other
Intervention Name(s)
Plain Language Recommendation (PLR)
Intervention Description
New easy to read COVID-19 recommendations available on the COVID19 Living Map of Recommendations and Gateway to Contextualization (RecMap).
Intervention Type
Other
Intervention Name(s)
Standard Language Version (SLV)
Intervention Description
Original recommendation as initially published by the guideline organization.
Primary Outcome Measure Information:
Title
Understanding with Multiple Choice Questions
Description
The primary outcome is understanding. Understanding is defined as the correct comprehension of key guideline content (year of publication, intent of the recommendation, direction of recommendation, etc.). This outcome will be measured with seven multiple-choice questions about key concepts in the recommendation with four to six response options for each question and only one correct answer (total minimum score of 0, maximum score of 7).
Time Frame
Duration of survey (approximately 25 minutes) at baseline
Secondary Outcome Measure Information:
Title
Accessibility and Usability on a Seven-Point Likert Scale
Description
Accessibility and Usability is defined as the ability to find/access, and use the presented information. This outcome considers the three following domains: (1) how easy it was to find information, (2) how easy it was to understand the information (perception), and (3) whether the information was presented in a way that could be helpful for making an informed health decision. Participants will have to indicate the degree of agreement with six statements, measured using the original 7-point Likert scale (1 being strongly disagree, 4 being neutral, and 7 being strongly agree). The outcome 'overall accessibility of information' will be measured using the 7-point Likert-type scale.
Time Frame
Duration of survey (approximately 25 minutes) at baseline
Title
Satisfaction on a Seven-Point Likert Scale
Description
Satisfaction is defined as participants' impression of the recommendation's presentation. This will be measured using questions related to participants' level of satisfaction with the different features of the format (e.g. feature of explaining the certainty of the evidence). Participants will have to indicate the degree of satisfaction with three questions measured using the original 7-point Likert-type scale (11 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neutral, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied). Participants will also have to answer three open-ended questions to get their input on what they liked and disliked in the format.
Time Frame
Duration of survey (approximately 25 minutes) at baseline
Title
Intended Behavior on a Seven-Point Likert Scale and Multiple Choice Questions
Description
Intended behavior is defined as participants' intention in adopting and following the shared recommendation. Participants will answer a question on whether they have already followed and implemented the recommendation in their jurisdiction and have them respond with yes, no, unsure, or not applicable. Subsequently, they will be asked how likely it is that they will follow and share the recommendation through two questions measured using a 7-point Likert-scale (1 = very unlikely, 2 = unlikely, 3 = somewhat unlikely, 4 = neutral, 5 = somewhat likely, 6 = likely, 7 = very likely.
Time Frame
Duration of survey (approximately 25 minutes) at baseline
Title
Preference on a Seven-Point Likert-Scale
Description
Preference is defined as a greater liking of one format over the other (PLR or SLV). All participants will get to compare the optimized PLR and the SLV; after having completed the tasks in the group they were randomized to, participants will review the alternative format and indicate their preference for one of the two formats using a 7-point Likert-type scale (1 = strongly prefer SLV, 2 = prefer SLV, 3 = somewhat prefer SLV, 4 = same preference for SLV and PLR, 5 = somewhat prefer PLR, 6 = prefer PLR, 7 = strongly prefer PLR).
Time Frame
Duration of survey (approximately 25 minutes) at baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: For youth population: be between the ages of 15 to 24 years For parents population: be 18 years and above and making decisions with or for their children (parent, caregiver, the legal guardian of a child < 18 years) For adults: be 21 years of age or older Need to be able to complete the survey in English Exclusion Criteria: Individuals not fitting any of the above age categories or language requirement
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Holger J Schunemann, MD, PHD
Organizational Affiliation
McMaster University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Kevin Pottie
Organizational Affiliation
Western University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Martin Offringa
Organizational Affiliation
The Hospital for Sick Children Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nancy Butcher
Organizational Affiliation
The Hospital for Sick Children Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lisa Hartling
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 4L8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Knowledge Mobilization Activities to Support Decision-Making by Youth, Parents and Adults: Study Protocol

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