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

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

Study Overview

• Status: Recruiting
• Conditions: Concussion, Brain
• Intervention / Treatment: Behavioral: Decision Aid

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 qualitative interviews with clinicians about their experiences with implementation.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emily Kroshus, Principal Investigator; Phone Number: 206-884-5326; Email: emily.kroshus@seattlechildrens.org

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98105
      • Recruiting
      • Seattle Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care
Experimental: Decision Aid; Usual care, plus introduction of a decision aid	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Seattle Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2021
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: February 23, 2021
• First Submitted That Met QC Criteria: March 1, 2021
• First Posted (Actual): March 2, 2021

Study Record Updates

• Last Update Posted (Estimate): March 3, 2023
• Last Update Submitted That Met QC Criteria: March 1, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Brain Injuries, Traumatic; Brain Concussion
• Other Study ID Numbers: STUDY00002334

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No