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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04777864
Enrollment
110
Registered
2021-03-02
Start date
2021-08-30
Completion date
2024-04-01
Last updated
2025-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Concussion, Brain

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.

Interventions

BEHAVIORALDecision 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.

Sponsors

Seattle Children's Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
11 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Participants in the clinical trial component of this study will be adolescents, parents, and healthcare providers: Adolescent 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

Design outcomes

Primary

MeasureTime frameDescription
Decisional Regret3 months after initial clinic visitWe 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 MadeBaseline: 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-EfficacyBaseline: 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 EngagementPost-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

MeasureTime frameDescription
Change in Adolescent Physical ActivityBaseline: 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 visitWe used the International Physical Activity Questionnaire (IPAQ-SF) to assess adolescent physical activity post-concussion. Participants reported the number of days and minutes spent on vigorous, moderate, and walking activities. These values were converted to MET-minutes per week (MMW) using standard MET values (vigorous = 8, moderate = 4, walking = 3.3). The total physical activity score was calculated by summing the MMW for all activities.
Change in Adolescent Psychosocial FunctioningBaseline: 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.We used the Pediatric Quality of Life Inventory, Psychosocial subscale (PEDS-QL) to measure adolescent emotional functioning. Participants rated items on a 5-point Likert scale, with higher scores reflecting better emotional functioning. To ensure ease of interpretation, items were reverse scored and then transformed to a 0-100 scale, where higher scores indicate better emotional health.

Countries

United States

Participant flow

Recruitment details

We recruited a sample of adolescents (ages 11-17) and their parent/caregiver who were seen in the Sports Medicine clinic with a diagnosis of concussion. After dyads enrolled, the parent or guardian and adolescent were emailed and/or texted separate surveys to complete before the upcoming appointment.

Pre-assignment details

All participants were assigned to the control or intervention condition. There were 10 dyads (n=20 participants) enrolled in the intervention that did not complete the intervention prior to their index visit. These dyads were excluded from analyses. 24 dyads (48 participants) were included in the control condition and 21 dyads (42 participants) were included in the intervention condition. The protocol enrollment number represents the number of individual participants enrolled in each condition.

Participants by arm

ArmCount
Usual Care
Participants received post-concussion care as usual.
46
Decision Aid
Usual care, plus introduction of a decision aid 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.
42
Total88

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up819

Baseline characteristics

CharacteristicUsual CareDecision AidTotal
Age, Continuous
Adolescent
15.56 years
STANDARD_DEVIATION 1.4
15.59 years
STANDARD_DEVIATION 1.75
15.57 years
STANDARD_DEVIATION 1.55
Age, Continuous
Parent
47.11 years
STANDARD_DEVIATION 4.61
46.05 years
STANDARD_DEVIATION 3.9
46.55 years
STANDARD_DEVIATION 4.23
Ethnicity (NIH/OMB)
Adolescent
Hispanic or Latino
1 Participants3 Participants4 Participants
Ethnicity (NIH/OMB)
Adolescent
Not Hispanic or Latino
21 Participants18 Participants39 Participants
Ethnicity (NIH/OMB)
Adolescent
Unknown or Not Reported
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Parent
Hispanic or Latino
1 Participants1 Participants2 Participants
Ethnicity (NIH/OMB)
Parent
Not Hispanic or Latino
21 Participants20 Participants41 Participants
Ethnicity (NIH/OMB)
Parent
Unknown or Not Reported
2 Participants0 Participants2 Participants
Race (NIH/OMB)
Adolescent
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Adolescent
Asian
2 Participants0 Participants2 Participants
Race (NIH/OMB)
Adolescent
Black or African American
2 Participants0 Participants2 Participants
Race (NIH/OMB)
Adolescent
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Adolescent
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Adolescent
Unknown or Not Reported
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Adolescent
White
18 Participants20 Participants38 Participants
Race (NIH/OMB)
Parent
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Parent
Asian
2 Participants1 Participants3 Participants
Race (NIH/OMB)
Parent
Black or African American
1 Participants0 Participants1 Participants
Race (NIH/OMB)
Parent
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Parent
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Parent
Unknown or Not Reported
2 Participants1 Participants3 Participants
Race (NIH/OMB)
Parent
White
19 Participants19 Participants38 Participants
Sex/Gender, Customized
Adolescent
Female
12 Participants11 Participants23 Participants
Sex/Gender, Customized
Adolescent
Male
9 Participants10 Participants19 Participants
Sex/Gender, Customized
Adolescent
Non-binary
1 Participants0 Participants1 Participants
Sex/Gender, Customized
Parent
Female
14 Participants19 Participants33 Participants
Sex/Gender, Customized
Parent
Male
8 Participants2 Participants10 Participants
Sex/Gender, Customized
Parent
Non-binary
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 240 / 210 / 240 / 21
other
Total, other adverse events
0 / 240 / 210 / 240 / 21
serious
Total, serious adverse events
0 / 240 / 210 / 240 / 21

Outcome results

Primary

Change in Quality of Choice Made

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.

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),

Population: The number analyzed in one or more rows differs from the overall number because results are reported separately by group (Parent, Child) and timepoint (Baseline, Post-Index Visit). The number reported for each timepoint includes only those participants who responded at that timepoint and, for the Post-Index Visit timepoint, also reported that they made a decision.

ArmMeasureGroupValue (MEAN)Dispersion
Usual CareChange in Quality of Choice MadeParent: Baseline43.81 Score on a scaleStandard Deviation 18.43
Usual CareChange in Quality of Choice MadeAdolescent: Baseline20.91 Score on a scaleStandard Deviation 21.02
Usual CareChange in Quality of Choice MadeParent: Post-Index Visit15.00 Score on a scaleStandard Deviation 19.31
Usual CareChange in Quality of Choice MadeAdolescent: Post-Index Visit7.62 Score on a scaleStandard Deviation 18.07
Decision AidChange in Quality of Choice MadeAdolescent: Post-Index Visit7.75 Score on a scaleStandard Deviation 13.81
Decision AidChange in Quality of Choice MadeParent: Baseline42.62 Score on a scaleStandard Deviation 21.83
Decision AidChange in Quality of Choice MadeParent: Post-Index Visit13.81 Score on a scaleStandard Deviation 16.87
Decision AidChange in Quality of Choice MadeAdolescent: Baseline20.95 Score on a scaleStandard Deviation 26.06
Comparison: Parent: Post-Index Visitp-value: 0.975Regression, Linear
Comparison: Adolescent: Post-Index Visitp-value: 0.854Regression, Linear
Primary

Decisional Regret

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.

Time frame: 3 months after initial clinic visit

Population: The number analyzed in one or more rows differs from the overall number analyzed because only participants who completed the scale at 3-month follow-up survey were included in the analyses. Outcomes are also reported separately by subgroup (parent, child).

ArmMeasureGroupValue (MEAN)Dispersion
Usual CareDecisional RegretParents1.68 Score on a scaleStandard Deviation 0.64
Usual CareDecisional RegretAdolescents1.80 Score on a scaleStandard Deviation 1.09
Decision AidDecisional RegretParents2.00 Score on a scaleStandard Deviation 0.83
Decision AidDecisional RegretAdolescents1.77 Score on a scaleStandard Deviation 0.69
Comparison: Parent group onlyp-value: 0.18t-test, 2 sided
Comparison: Adolescent group onlyp-value: 0.91t-test, 2 sided
Primary

Decision Self-Efficacy

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.

Time frame: Baseline: Within 1 week prior to the index clinic visit (i.e., first visit after enrolled in the study)

Population: The number analyzed in one or more rows differs from the overall number because results are reported separately by group (Parent, Adolescent).

ArmMeasureGroupValue (MEAN)Dispersion
Usual CareDecision Self-EfficacyParent80.41 score on a scaleStandard Deviation 15.09
Usual CareDecision Self-EfficacyAdolescent77.91 score on a scaleStandard Deviation 14.01
Decision AidDecision Self-EfficacyParent77.29 score on a scaleStandard Deviation 17.62
Decision AidDecision Self-EfficacyAdolescent79.90 score on a scaleStandard Deviation 17.17
Primary

Patient-Parent-Provider Engagement

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.

Time frame: Post-Index Visit: Within 24 hours after the index visit (typically occurs 1-2 weeks after enrollment),

Population: Analyses only include participants who reported that they made a decision after their first visit. Outcomes are reported separately by subgroup (parent, child) and subscale (within family engagement and family-clinician engagement).

ArmMeasureGroupValue (MEAN)Dispersion
Usual CarePatient-Parent-Provider EngagementParent: Within family engagement2.83 score on a scaleStandard Deviation 0.6
Usual CarePatient-Parent-Provider EngagementAdolescent: Within family engagement2.68 score on a scaleStandard Deviation 0.84
Usual CarePatient-Parent-Provider EngagementParent: Family-clinician engagement2.94 score on a scaleStandard Deviation 0.43
Usual CarePatient-Parent-Provider EngagementAdolescent: Family-clinician engagement3.20 score on a scaleStandard Deviation 0.36
Decision AidPatient-Parent-Provider EngagementAdolescent: Family-clinician engagement3.25 score on a scaleStandard Deviation 0.39
Decision AidPatient-Parent-Provider EngagementParent: Within family engagement2.76 score on a scaleStandard Deviation 0.55
Decision AidPatient-Parent-Provider EngagementParent: Family-clinician engagement2.87 score on a scaleStandard Deviation 0.55
Decision AidPatient-Parent-Provider EngagementAdolescent: Within family engagement3.07 score on a scaleStandard Deviation 0.49
Secondary

Change in Adolescent Physical Activity

We used the International Physical Activity Questionnaire (IPAQ-SF) to assess adolescent physical activity post-concussion. Participants reported the number of days and minutes spent on vigorous, moderate, and walking activities. These values were converted to MET-minutes per week (MMW) using standard MET values (vigorous = 8, moderate = 4, walking = 3.3). The total physical activity score was calculated by summing the MMW for all activities.

Time frame: 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

Population: The number analyzed in one or more rows differs from the overall number because these analyses include only adolescent participants.

ArmMeasureGroupValue (MEAN)Dispersion
Usual CareChange in Adolescent Physical ActivityPost-Index Visit466 total mmwStandard Deviation 581.02
Usual CareChange in Adolescent Physical Activity3 Month Follow-up2141.39 total mmwStandard Deviation 1111.35
Decision AidChange in Adolescent Physical ActivityPost-Index Visit1220.79 total mmwStandard Deviation 1440.68
Decision AidChange in Adolescent Physical Activity3 Month Follow-up1775.11 total mmwStandard Deviation 1378.9
Comparison: Post-Index Visitp-value: 0.03t-test, 2 sided
Comparison: 3 months after initial clinic visitp-value: 0.21t-test, 2 sided
Secondary

Change in Adolescent Psychosocial Functioning

We used the Pediatric Quality of Life Inventory, Psychosocial subscale (PEDS-QL) to measure adolescent emotional functioning. Participants rated items on a 5-point Likert scale, with higher scores reflecting better emotional functioning. To ensure ease of interpretation, items were reverse scored and then transformed to a 0-100 scale, where higher scores indicate better emotional health.

Time frame: 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.

Population: The number analyzed in one or more rows differs from the overall number because results are reported separately by timepoint (Baseline, Post-Index Visit, 3 Month Follow-up). The number reported for each timepoint includes only those participants who responded at that timepoint .

ArmMeasureGroupValue (MEAN)Dispersion
Usual CareChange in Adolescent Psychosocial FunctioningBaseline81.14 Score on a scaleStandard Deviation 16.1
Usual CareChange in Adolescent Psychosocial FunctioningPost-Index Visit84.05 Score on a scaleStandard Deviation 14.97
Usual CareChange in Adolescent Psychosocial Functioning3-Month Follow-up84.05 Score on a scaleStandard Deviation 14.96
Decision AidChange in Adolescent Psychosocial FunctioningBaseline79.52 Score on a scaleStandard Deviation 18.43
Decision AidChange in Adolescent Psychosocial FunctioningPost-Index Visit83.81 Score on a scaleStandard Deviation 15.56
Decision AidChange in Adolescent Psychosocial Functioning3-Month Follow-up83.81 Score on a scaleStandard Deviation 15.56
Comparison: Baselinep-value: 0.76t-test, 2 sided
Comparison: Post-Index Visitp-value: 0.96t-test, 2 sided
Comparison: 3 months after initial clinic visitp-value: 0.96t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026