Developing a Tool to Support Shared Decision Making Post-Concussion Between Adolescents, Parents and Clinicians

Study Overview
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Brief Summary
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Investigators will conduct a pilot efficacy test of a decision aid about contact sport participation post-concussion.

Detailed Description
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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.

Official Title
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Developing a Tool to Support Shared Decision Making Post-Concussion Between Adolescents, Parents and Clinicians

Conditions
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Concussion, Brain

Intervention / Treatment
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* Behavioral: Decision Aid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care<br> | |
| Experimental: Decision Aid<br>Usual care, plus introduction of a decision aid | Behavioral: Decision Aid<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 months after initial Sports Medicine visit | 
| 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. | 1 week before Sports Medicine visit, Immediately after Sports Medicine visit | 
| 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. | 1 week before Sports Medicine visit | 
| 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. | Immediately after Sports Medicine clinic visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 week before Sports Medicine visit, Immediately after Sports Medicine visit, 3 months after initial Sports Medicine visit | 
| Change in Adolescent Physical Activity | We will use the International Physical Activity Questionnaire (IPAQ-SF) to assess adolescent physical activity post-concussion. | Immediately after Sports Medicine visit, 3 months after initial Sports Medicine visit |