Developing a Tool to Support Shared Decision Making Post-Concussion Between Adolescents, Parents and Clinicians
- Conditions
- Concussion, Brain
- Interventions
- Behavioral: Decision Aid
- Registration Number
- NCT04777864
- Lead Sponsor
- Seattle Children's Hospital
- 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 surveys with clinicians about their experiences with implementation.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 106
- Age 11-17
- 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 11 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
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Decision Aid Decision Aid Usual care, plus introduction of a decision aid
- Primary Outcome Measures
Name Time Method Decisional Regret 3 months after initial clinic visit 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 1 week before clinic visit, Immediately after clinic visit 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 1 week before clinic visit 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 Immediately after clinic visit We will use the 19-item Decision Making Involvement Scale to assess engagement and perceived support in the decision making process.
- Secondary Outcome Measures
Name Time Method Change in Adolescent Psychosocial Functioning 1 week before clinic visit, Immediately after clinic visit(s), 3 months after initial clinic visit 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 1 week before clinic visit, Immediately after clinic visit(s), 3 months after initial clinic visit We will use the International Physical Activity Questionnaire (IPAQ-SF) to assess adolescent physical activity post-concussion.
Trial Locations
- Locations (1)
Seattle Children's Hospital
🇺🇸Seattle, Washington, United States