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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-30

Study Completion Date

2024-04-01

Brief Summary

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

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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 surveys with clinicians about their experiences with implementation.

Conditions

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Concussion, Brain

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Usual Care

Group Type NO_INTERVENTION

No interventions assigned to this group

Decision Aid

Usual care, plus introduction of a decision aid

Group Type EXPERIMENTAL

Decision Aid

Intervention Type BEHAVIORAL

In addition to usual care, participants (parents and adolescents) receive the newly developed decision aid prior to their clinic visit(s). Clinicians receive a summary to review and use to help facilitate the decision making process.

Interventions

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Decision Aid

In addition to usual care, participants (parents and adolescents) receive the newly developed decision aid prior to their clinic visit(s). Clinicians receive a summary to review and use to help facilitate the decision making process.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Age 11-17
* Sustained at least 1 concussion and is scheduled for a concussion injury visit

* 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

* Age 18 or older
* Seattle Children's affiliated healthcare provider who provides patient care to youth with concussion

Minimum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes