Developing a Tool to Support Shared Decision Making Post-Concussion Between Adolescents, Parents and Clinicians
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Concussion, Brain
- Sponsor
- Seattle Children's Hospital
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- Decisional Regret
- Status
- Completed
- Last Updated
- 8 months ago
Overview
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.
Investigators
Emily Kroshus
Research Assistant Professor
Seattle Children's Hospital
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Decisional Regret
Time Frame: 3 months after initial clinic visit
We used 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. Two positively worded items were reverse scored. Responses were averaged to create a decisional regret score with a possible range of 1 to 5, with higher scores indicating greater regret.
Change in Quality of Choice Made
Time Frame: Baseline: Within 1 week prior to the index clinic visit (i.e., the participant's first visit after they enrolled in the study), Post-Index Visit: Within 24 hours after the index visit (typically occurs 1-2 weeks after enrollment),
We used 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. Respondents answered 10 items using a 3-point scale scored as 0 = "yes," 2 = "unsure," and 4 = "no." Item scores were summed, divided by 10, and then multiplied by 25 to produce a total decisional conflict score ranging from 0 to 100, with higher scores indicating greater decisional conflict and lower decision certainty.
Decision Self-Efficacy
Time Frame: Baseline: Within 1 week prior to the index clinic visit (i.e., first visit after enrolled in the study)
We used a 12-item Decision Self-Efficacy Scale to measure parent and adolescent confidence in making health-related decisions. Participants responded using a 5-point scale scored from 0 = "not at all confident" to 4 = "very confident." Item scores were summed, divided by 12, and then multiplied by 25 to produce a total decision self-efficacy score ranging from 0 to 100, with higher scores indicating greater confidence in decision-making. The scale included an additional item: "Let my child/my parent(s) know what I think is best for them/me."
Patient-Parent-Provider Engagement
Time Frame: Post-Index Visit: Within 24 hours after the index visit (typically occurs 1-2 weeks after enrollment),
We used the 19-item Decision Making Involvement Scale to assess engagement and perceived support in the decision making process, divided into two subscales: Within Family Engagement and Family-Provider Engagement. Participants rated their agreement with items on a 4-point Likert scale from 1 (strongly disagree) to 4 (strongly agree). Subscale scores are calculated by averaging the item responses within each subscale. Each subscale score ranges from 1 to 4, with higher scores indicating more engagement or involvement.
Secondary Outcomes
- Change in Adolescent Physical Activity(Baseline: Within 1 week prior to the index clinic visit (i.e., first visit after enrolled in the study), Post-Index Visit: Within 24 hours after the index visit (typically occurs 1-2 weeks after enrollment), 3 months after initial clinic visit)
- Change in Adolescent Psychosocial Functioning(Baseline: Within 1 week prior to the index clinic visit (i.e., first visit after enrolled in the study), Post-Index Visit: Within 24 hours after the index visit (typically occurs 1-2 weeks after enrollment), 3 months after initial clinic visit.)