Developing a Tool to Support Shared Decision Making Post-Concussion Between Adolescents, Parents and Clinicians
Primary Purpose
Concussion, Brain
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Decision Aid
Sponsored by
About this trial
This is an interventional health services research trial for Concussion, Brain
Eligibility Criteria
Participants in the clinical trial component of this study will be adolescents, parents, and healthcare providers:
Adolescent Inclusion Criteria:
- Age 13-17
- Sustained at least 1 concussion and is scheduled for a concussion injury visit
Parent Inclusion Criteria:
- Age 18 or older
- Parent of a child between the age of 13 and 17 (inclusive) who has sustained at least 1 concussion and is scheduled for a concussion injury visit
Healthcare Provider Inclusion Criteria:
- Age 18 or older
- Seattle Children's affiliated healthcare provider who provides patient care to youth with concussion
Sites / Locations
- Seattle Children's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Usual Care
Decision Aid
Arm Description
Usual care, plus introduction of a decision aid
Outcomes
Primary Outcome Measures
Decisional Regret
We will use the 5-item Decisional Regret Scale to measure personal perceptions of regret when considering the decision previously made about sports participation post-concussion. Responses are on a 5-point Likert scale, from (1) strongly agree to (5) strongly disagree.
Change in Quality of Choice Made
We will use the 10-item Decisional Conflict Scale-Low Literacy version to measure parent and adolescent perceptions of certainty in making the decision to return to sports after concussion recovery.
Decision Self-Efficacy
We will use the 12-item Decision Self-Efficacy Scale to measure parent and adolescent perceptions that they are informed about options, risks, and benefits in making the decision to return to sport post-concussion.
Patient-Parent-Provider Engagement
We will use the 19-item Decision Making Involvement Scale to assess engagement and perceived support in the decision making process.
Secondary Outcome Measures
Change in Adolescent Psychosocial Functioning
We will use the Pediatric Quality of Life Inventory, Physical and Psychosocial subscales (PEDS-QL) to measure adolescent physical, emotional, social, and school functioning.
Change in Adolescent Physical Activity
We will use the International Physical Activity Questionnaire (IPAQ-SF) to assess adolescent physical activity post-concussion.
Full Information
NCT ID
NCT04777864
First Posted
February 23, 2021
Last Updated
March 1, 2023
Sponsor
Seattle Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04777864
Brief Title
Developing a Tool to Support Shared Decision Making Post-Concussion Between Adolescents, Parents and Clinicians
Official Title
Developing a Tool to Support Shared Decision Making Post-Concussion Between Adolescents, Parents and Clinicians
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 30, 2021 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seattle Children's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Investigators will conduct a pilot efficacy test of a decision aid about contact sport participation post-concussion.
Detailed Description
The clinical trial portion of this study will enroll 40 adolescents and their parent/caregiver who are seen in the Sports Medicine clinic with a diagnosis of concussion. 20 will receive usual care, and 20 will receive a decision aid to facilitate the decision making process about sport participation post-concussion. Adolescents and their parent/caregiver will complete separate surveys at a minimum of three timepoints: before their initial clinic visit, after each clinic visit (up until a decision regarding sports participation post-concussion is made), and three months after their first clinic visit. The study team will also conduct qualitative interviews with clinicians about their experiences with implementation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Concussion, Brain
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Usual Care
Arm Type
No Intervention
Arm Title
Decision Aid
Arm Type
Experimental
Arm Description
Usual care, plus introduction of a decision aid
Intervention Type
Behavioral
Intervention Name(s)
Decision Aid
Intervention Description
In addition to usual care, participants (parents and adolescents) receive the newly developed decision aid as part of their clinic visit(s). Clinicians receive an implementation guide to facilitate use of the decision aid.
Primary Outcome Measure Information:
Title
Decisional Regret
Description
We will use the 5-item Decisional Regret Scale to measure personal perceptions of regret when considering the decision previously made about sports participation post-concussion. Responses are on a 5-point Likert scale, from (1) strongly agree to (5) strongly disagree.
Time Frame
3 months after initial Sports Medicine visit
Title
Change in Quality of Choice Made
Description
We will use the 10-item Decisional Conflict Scale-Low Literacy version to measure parent and adolescent perceptions of certainty in making the decision to return to sports after concussion recovery.
Time Frame
1 week before Sports Medicine visit, Immediately after Sports Medicine visit
Title
Decision Self-Efficacy
Description
We will use the 12-item Decision Self-Efficacy Scale to measure parent and adolescent perceptions that they are informed about options, risks, and benefits in making the decision to return to sport post-concussion.
Time Frame
1 week before Sports Medicine visit
Title
Patient-Parent-Provider Engagement
Description
We will use the 19-item Decision Making Involvement Scale to assess engagement and perceived support in the decision making process.
Time Frame
Immediately after Sports Medicine clinic visit
Secondary Outcome Measure Information:
Title
Change in Adolescent Psychosocial Functioning
Description
We will use the Pediatric Quality of Life Inventory, Physical and Psychosocial subscales (PEDS-QL) to measure adolescent physical, emotional, social, and school functioning.
Time Frame
1 week before Sports Medicine visit, Immediately after Sports Medicine visit, 3 months after initial Sports Medicine visit
Title
Change in Adolescent Physical Activity
Description
We will use the International Physical Activity Questionnaire (IPAQ-SF) to assess adolescent physical activity post-concussion.
Time Frame
Immediately after Sports Medicine visit, 3 months after initial Sports Medicine visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Participants in the clinical trial component of this study will be adolescents, parents, and healthcare providers:
Adolescent Inclusion Criteria:
Age 13-17
Sustained at least 1 concussion and is scheduled for a concussion injury visit
Parent Inclusion Criteria:
Age 18 or older
Parent of a child between the age of 13 and 17 (inclusive) who has sustained at least 1 concussion and is scheduled for a concussion injury visit
Healthcare Provider Inclusion Criteria:
Age 18 or older
Seattle Children's affiliated healthcare provider who provides patient care to youth with concussion
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emily Kroshus, Principal Investigator
Phone
206-884-5326
Email
emily.kroshus@seattlechildrens.org
Facility Information:
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily Kroshus
Phone
206-884-5326
Email
emily.kroshus@seattlechildrens.org
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Developing a Tool to Support Shared Decision Making Post-Concussion Between Adolescents, Parents and Clinicians
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