Concussion, Brain
Conditions
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
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
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Decisional Regret | 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 | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| 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. | 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
| Arm | Count |
|---|---|
| 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 |
| Total | 88 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 8 | 19 |
Baseline characteristics
| Characteristic | Usual Care | Decision Aid | Total |
|---|---|---|---|
| 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 Participants | 3 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Adolescent Not Hispanic or Latino | 21 Participants | 18 Participants | 39 Participants |
| Ethnicity (NIH/OMB) Adolescent Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Parent Hispanic or Latino | 1 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Parent Not Hispanic or Latino | 21 Participants | 20 Participants | 41 Participants |
| Ethnicity (NIH/OMB) Parent Unknown or Not Reported | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Adolescent American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Adolescent Asian | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Adolescent Black or African American | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Adolescent More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Adolescent Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Adolescent Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Adolescent White | 18 Participants | 20 Participants | 38 Participants |
| Race (NIH/OMB) Parent American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Parent Asian | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Parent Black or African American | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Parent More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Parent Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Parent Unknown or Not Reported | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Parent White | 19 Participants | 19 Participants | 38 Participants |
| Sex/Gender, Customized Adolescent Female | 12 Participants | 11 Participants | 23 Participants |
| Sex/Gender, Customized Adolescent Male | 9 Participants | 10 Participants | 19 Participants |
| Sex/Gender, Customized Adolescent Non-binary | 1 Participants | 0 Participants | 1 Participants |
| Sex/Gender, Customized Parent Female | 14 Participants | 19 Participants | 33 Participants |
| Sex/Gender, Customized Parent Male | 8 Participants | 2 Participants | 10 Participants |
| Sex/Gender, Customized Parent Non-binary | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 21 | 0 / 24 | 0 / 21 |
| other Total, other adverse events | 0 / 24 | 0 / 21 | 0 / 24 | 0 / 21 |
| serious Total, serious adverse events | 0 / 24 | 0 / 21 | 0 / 24 | 0 / 21 |
Outcome results
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | Change in Quality of Choice Made | Parent: Baseline | 43.81 Score on a scale | Standard Deviation 18.43 |
| Usual Care | Change in Quality of Choice Made | Adolescent: Baseline | 20.91 Score on a scale | Standard Deviation 21.02 |
| Usual Care | Change in Quality of Choice Made | Parent: Post-Index Visit | 15.00 Score on a scale | Standard Deviation 19.31 |
| Usual Care | Change in Quality of Choice Made | Adolescent: Post-Index Visit | 7.62 Score on a scale | Standard Deviation 18.07 |
| Decision Aid | Change in Quality of Choice Made | Adolescent: Post-Index Visit | 7.75 Score on a scale | Standard Deviation 13.81 |
| Decision Aid | Change in Quality of Choice Made | Parent: Baseline | 42.62 Score on a scale | Standard Deviation 21.83 |
| Decision Aid | Change in Quality of Choice Made | Parent: Post-Index Visit | 13.81 Score on a scale | Standard Deviation 16.87 |
| Decision Aid | Change in Quality of Choice Made | Adolescent: Baseline | 20.95 Score on a scale | Standard Deviation 26.06 |
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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | Decisional Regret | Parents | 1.68 Score on a scale | Standard Deviation 0.64 |
| Usual Care | Decisional Regret | Adolescents | 1.80 Score on a scale | Standard Deviation 1.09 |
| Decision Aid | Decisional Regret | Parents | 2.00 Score on a scale | Standard Deviation 0.83 |
| Decision Aid | Decisional Regret | Adolescents | 1.77 Score on a scale | Standard Deviation 0.69 |
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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | Decision Self-Efficacy | Parent | 80.41 score on a scale | Standard Deviation 15.09 |
| Usual Care | Decision Self-Efficacy | Adolescent | 77.91 score on a scale | Standard Deviation 14.01 |
| Decision Aid | Decision Self-Efficacy | Parent | 77.29 score on a scale | Standard Deviation 17.62 |
| Decision Aid | Decision Self-Efficacy | Adolescent | 79.90 score on a scale | Standard Deviation 17.17 |
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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | Patient-Parent-Provider Engagement | Parent: Within family engagement | 2.83 score on a scale | Standard Deviation 0.6 |
| Usual Care | Patient-Parent-Provider Engagement | Adolescent: Within family engagement | 2.68 score on a scale | Standard Deviation 0.84 |
| Usual Care | Patient-Parent-Provider Engagement | Parent: Family-clinician engagement | 2.94 score on a scale | Standard Deviation 0.43 |
| Usual Care | Patient-Parent-Provider Engagement | Adolescent: Family-clinician engagement | 3.20 score on a scale | Standard Deviation 0.36 |
| Decision Aid | Patient-Parent-Provider Engagement | Adolescent: Family-clinician engagement | 3.25 score on a scale | Standard Deviation 0.39 |
| Decision Aid | Patient-Parent-Provider Engagement | Parent: Within family engagement | 2.76 score on a scale | Standard Deviation 0.55 |
| Decision Aid | Patient-Parent-Provider Engagement | Parent: Family-clinician engagement | 2.87 score on a scale | Standard Deviation 0.55 |
| Decision Aid | Patient-Parent-Provider Engagement | Adolescent: Within family engagement | 3.07 score on a scale | Standard Deviation 0.49 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | Change in Adolescent Physical Activity | Post-Index Visit | 466 total mmw | Standard Deviation 581.02 |
| Usual Care | Change in Adolescent Physical Activity | 3 Month Follow-up | 2141.39 total mmw | Standard Deviation 1111.35 |
| Decision Aid | Change in Adolescent Physical Activity | Post-Index Visit | 1220.79 total mmw | Standard Deviation 1440.68 |
| Decision Aid | Change in Adolescent Physical Activity | 3 Month Follow-up | 1775.11 total mmw | Standard Deviation 1378.9 |
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 .
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | Change in Adolescent Psychosocial Functioning | Baseline | 81.14 Score on a scale | Standard Deviation 16.1 |
| Usual Care | Change in Adolescent Psychosocial Functioning | Post-Index Visit | 84.05 Score on a scale | Standard Deviation 14.97 |
| Usual Care | Change in Adolescent Psychosocial Functioning | 3-Month Follow-up | 84.05 Score on a scale | Standard Deviation 14.96 |
| Decision Aid | Change in Adolescent Psychosocial Functioning | Baseline | 79.52 Score on a scale | Standard Deviation 18.43 |
| Decision Aid | Change in Adolescent Psychosocial Functioning | Post-Index Visit | 83.81 Score on a scale | Standard Deviation 15.56 |
| Decision Aid | Change in Adolescent Psychosocial Functioning | 3-Month Follow-up | 83.81 Score on a scale | Standard Deviation 15.56 |