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

Concussion, Brain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04777864
• Other study ID #: STUDY00002334
• Status: Completed
• Phase: N/A
• Start date: August 30, 2021
• Est. completion date: April 1, 2024

Study information

• Verified date: May 2024
• Source: Seattle Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: April 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Concussion
• Concussion, Brain

Intervention

Behavioral:
• Decision Aid
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.

Locations

Country	Name	City	State
United States	Seattle Children's Hospital	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Seattle Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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