Developing a Tool to Support Shared Decision Making Post-Concussion Between Adolescents, Parents and Clinicians
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Seattle Children's Hospital
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- Decisional Regret
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 11 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Usual Care
Decision Aid
Usual care, plus introduction of a decision aid
Intervention: Decision Aid (Behavioral)
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.
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.)
Investigators
Emily Kroshus
Research Assistant Professor
Seattle Children's Hospital