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

COVID-19 Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05358990
• Other study ID #: 3856
• Status: Completed
• Phase: N/A
• Start date: May 25, 2022
• Est. completion date: October 25, 2022

Study information

• Verified date: December 2022
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 997
• Est. completion date: October 25, 2022
• Est. primary completion date: October 25, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Other:
• Plain Language Recommendation (PLR)
New easy to read COVID-19 recommendations available on the COVID19 Living Map of Recommendations and Gateway to Contextualization (RecMap).
• Standard Language Version (SLV)
Original recommendation as initially published by the guideline organization.

Locations

Country	Name	City	State
Canada	McMaster University	Hamilton	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
McMaster University	The Hospital for Sick Children, University of Alberta, Western University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Duration of survey (approximately 25 minutes) at baseline
Secondary	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.	Duration of survey (approximately 25 minutes) at baseline
Secondary	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.	Duration of survey (approximately 25 minutes) at baseline
Secondary	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.	Duration of survey (approximately 25 minutes) at baseline
Secondary	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).	Duration of survey (approximately 25 minutes) at baseline