Concussion, Brain
Conditions
Brief summary
Investigators will conduct a hybrid implementation-effectiveness evaluation of an educational intervention that supports communication with families post-concussion in the emergency department. Primary outcomes will be parent self-report of specific concussion management behaviors two weeks post-visit. Investigators will also explore whether successful implementation is associated with (1) improved parent knowledge and self-efficacy related to helping their child adhere to CDC guidelines for returning to daily activities, school and sports, and (2) decreased disparity in knowledge and self-efficacy between high and low health literacy parents.
Detailed description
Parents can play an important role in evidence-based concussion management by (1) monitoring their child's activity and level of stimulation, (2) communicating with school personnel about potential need for short-term academic accommodations, and (3) ensuring their child does not return to contact or collision sport prematurely and risk greater injury. However, not all parents follow these evidence-based guidelines, in part due to health literacy deficits, and further compounded by the poor fit and inconsistent implementation of educational materials. The initial medical encounter following a concussion provides an important opportunity for evidence-based knowledge translation to parents. Families at risk of low health literacy most often seek initial post-concussion care in emergency departments (ED) and often do not follow-up with a primary care provider or concussion specialist. Knowledge translation to parents in the ED is often inconsistent in terms of content and delivery, and existing approaches often do not meet the needs of families with low health literacy. The Agency for Healthcare Research and Quality's (AHRQ) Re-Engineered Discharge (RED) Toolkit provides an evidence-based approach to supporting the implementation of parent education that has not as yet been adapted for use post-concussion in the ED setting. Investigators will work with stakeholders to develop toolkit to support evidence-based parent education post-concussion in the ED. Guided by the Consolidated Framework for Implementation Research, investigators will adapt the AHRQ RED Toolkit to facilitate post-concussion parent education in the ED. The evidence-based parent education to be shared will be an asynchronous text-based intervention, adapted to meet learning needs of parents with low health literacy and limited English proficiency. Investigators will use parent and provider interviews to iteratively develop the implementation toolkit in consultation with an advisory board comprised of parents. The clinical trial component of the study will be a hybrid implementation-effectiveness evaluation of the educational intervention. Primary outcomes will be parent self-report of specific concussion management behaviors two weeks post-visit. Investigators will also explore whether successful implementation is associated with (1) improved parent knowledge and self-efficacy related to helping their child adhere to CDC guidelines for returning to daily activities, school and sports, and (2) decreased disparity in knowledge and self-efficacy between high and low health literacy parents. Achieving these aims will result in a scalable approach to the implementation of the developed parent education toolkit in the pediatric ED post-concussion. If parents are better able to follow evidence-based guidelines for concussion, they will better advocate and care for their children, and this should improve outcomes for all youth. More broadly, achieving these aims will provide a model for engaging low health literacy parents in adapting evidence-based educational practices for implementation in ED settings.
Interventions
BEHAVIORALPost-concussion education for families
An educational intervention for families will be developed based on the CDC guidelines for returning to daily activities, school, and sports, adapted with stakeholder feedback to meet the learning needs of low health literacy parents.
Sponsors
Seattle Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Consecutive cohort design with randomization
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Parent/guardian of a child between the ages of 5 and 17 who presented to the Seattle Children's Hospital Emergency Department and was treated for closed head injury. * Child for whom care was sought was not admitted for inpatient care * Parent/guardian of child without chronic disease or with non-complex chronic disease * Parent/guardian with a preferred language for medical care of English or Spanish * Parent/guardian present in the ED is child's legal guardian
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Concussion Management Behaviors: Communication | Timepoint 3 [Two weeks post-visit] | Parent self-report of specific emotionally supportive concussion management behaviors in the home setting using the emotionally supportive behaviors index. This index is comprised of three communication practices: whether they had talked to their child about how they are feeling emotionally (e.g., sadness, anxiety), the time it takes to recover from a head injury can be different from person to person, and their concerns about their recovery from head injury. Responses were summed to create a communication index with a possible range of 3 to 9, with higher scores indicating more supportive communication with their child during recovery (Cronbach's alpha=0.59). |
| Change in Concussion Management Behaviors: Supportive/Rehabilitation-related | Timepoint 3 [Two weeks post-visit] | Parent self-report of specific instrumentally-supportive concussion management behaviors in the home setting using the instrumentally supportive behaviors index. This index was comprised of three rehabilitation-related behaviors: helped child do more physical activity as symptoms improved, allowed child to return to normal media use as symptoms improved, and helped child adjust bedtime or sleep environment. Responses were summed to create an instrumental support behavioral index with a possible range of 3 to 9, with higher scores indicating more supportive/rehabilitation-related behaviors (Cronbach's alpha=0.55). |
| Change in Concussion Management Behaviors: Follow-up Appointment | Timepoint 3 [Two weeks post-visit] | Percentage of participants who reported they had scheduled a follow-up appointment for their child. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Concussion Management Self-efficacy: Communication | Timepoint 1 [At ED visit], Timepoint 3 [Two weeks post-visit] | Self-report of parent confidence in their ability to engage in specific emotionally supportive concussion management behaviors in the home setting using the communication self-efficacy scale. For each of the behaviors, parents were asked to report how challenging it would be to engage in each. Responses were obtained on a 5-point scale where higher scores indicate that performing the behavior would be more challenging (i.e., they have lower self-efficacy). For each domain-specific measure, item level means were calculated, meaning there was a possible range of 1 to 5. In this sample, internal consistency reliability was adequate for the communication subscale (Cronbach's alpha=0.90). |
| Change in Concussion Knowledge | Timepoint 1 [At ED visit], Timepoint 3 [Two weeks post-visit] | Self-report of parent knowledge about the benefits of engaging in specific concussion management behaviors in the home setting was measured using the concussion knowledge index. This index was comprised of 10 true or false questions reflecting the knowledge parents need to perform the targeted guideline-consistent communication, rehabilitation, and external engagement behaviors. The index has a potential range of 0-10, with higher scores indicating greater knowledge. |
| Change in Concussion Management Self-efficacy: Supportive/Rehabilitation-related | Timepoint 1 [At ED visit], Timepoint 3 [Two weeks post-visit] | Self-report of parent confidence in their ability to engage in specific instrumentally-supportive concussion management behaviors in the home setting using the rehabilitation self-efficacy scale. For each of the parenting behaviors, parents were asked to report how challenging it would be to engage in each. Responses were obtained on a 5-point scale where higher scores indicate that performing the behavior would be more challenging (i.e., they have lower self-efficacy). For each domain-specific measure, item level means were calculated, meaning there was a possible range of 1 to 5. In this sample, internal consistency reliability was adequate for the rehabilitation subscale (Cronbach's alpha=0.79). |
| Change in Concussion Management Self-efficacy: Follow-up | Timepoint 1 [At ED visit], Timepoint 3 [Two weeks post-visit] | Parent self-report of how challenging it would be to make a follow-up appointment for their child. Responses were obtained on a 5-point scale, where higher scores indicate that performing the behavior would be more challenging (i.e., they have lower self-efficacy). Item level means were calculated, meaning there was a possible range of 1 to 5. |
Countries
United States
Participant flow
Recruitment details
Participants were parents in a large pediatric emergency department (ED) whose child (aged 5-17) had sustained a closed head injury in the previous 3 days, was not admitted for inpatient care, and was being discharged. Families waiting for discharge were provided with information about the study. A sequential cohort design (initially control only and then randomization to intervention or control) was used to collect data. The period table presented is for the overall study.
Pre-assignment details
N/a. All enrolled participants were assigned to the control or intervention condition.
Participants by arm
| Arm | Count |
|---|---|
| Education as Usual Participants receive education/healthcare provider communication as usual during their visit to the ED for concussion care. | 75 |
| New Education Participants receive the newly developed educational intervention.
Post-concussion education for families: An educational intervention for families will be developed based on the CDC guidelines for returning to daily activities, school, and sports, adapted with stakeholder feedback to meet the learning needs of low health literacy parents. | 23 |
| Total | 98 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 13 | 9 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | New Education | Total | Education as Usual |
|---|---|---|---|
| Age, Continuous | 41.36 Years STANDARD_DEVIATION 4.41 | 40.68 Years STANDARD_DEVIATION 4.64 | 39.42 Years STANDARD_DEVIATION 4.98 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 13 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants | 84 Participants | 63 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 7 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 5 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 12 Participants | 10 Participants |
| Race (NIH/OMB) White | 15 Participants | 67 Participants | 52 Participants |
| Sex: Female, Male Female | 16 Participants | 70 Participants | 54 Participants |
| Sex: Female, Male Male | 7 Participants | 27 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 75 | 0 / 23 |
| other Total, other adverse events | 0 / 75 | 0 / 23 |
| serious Total, serious adverse events | 0 / 75 | 0 / 23 |
Outcome results
Primary
Change in Concussion Management Behaviors: Communication
Parent self-report of specific emotionally supportive concussion management behaviors in the home setting using the emotionally supportive behaviors index. This index is comprised of three communication practices: whether they had talked to their child about how they are feeling emotionally (e.g., sadness, anxiety), the time it takes to recover from a head injury can be different from person to person, and their concerns about their recovery from head injury. Responses were summed to create a communication index with a possible range of 3 to 9, with higher scores indicating more supportive communication with their child during recovery (Cronbach's alpha=0.59).
Time frame: Timepoint 3 [Two weeks post-visit]
Population: All participants who responded to concussion management behavior items two weeks post-visit \[Cohorts 1 and 2.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Education as Usual | Change in Concussion Management Behaviors: Communication | 5.49 Score on a scale | Standard Deviation 1.68 |
| New Education | Change in Concussion Management Behaviors: Communication | 6.71 Score on a scale | Standard Deviation 2.02 |
p-value: 0.021Regression, Linear
Primary
Change in Concussion Management Behaviors: Follow-up Appointment
Percentage of participants who reported they had scheduled a follow-up appointment for their child.
Time frame: Timepoint 3 [Two weeks post-visit]
Population: All participants who responded to concussion management behavior items two weeks post-visit \[Cohorts 1 and 2\].
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Education as Usual | Change in Concussion Management Behaviors: Follow-up Appointment | Yes | 22 Participants |
| Education as Usual | Change in Concussion Management Behaviors: Follow-up Appointment | No | 39 Participants |
| New Education | Change in Concussion Management Behaviors: Follow-up Appointment | Yes | 7 Participants |
| New Education | Change in Concussion Management Behaviors: Follow-up Appointment | No | 7 Participants |
p-value: 0.33895% CI: [0.55, 5.72]Regression, Logistic
Primary
Change in Concussion Management Behaviors: Supportive/Rehabilitation-related
Parent self-report of specific instrumentally-supportive concussion management behaviors in the home setting using the instrumentally supportive behaviors index. This index was comprised of three rehabilitation-related behaviors: helped child do more physical activity as symptoms improved, allowed child to return to normal media use as symptoms improved, and helped child adjust bedtime or sleep environment. Responses were summed to create an instrumental support behavioral index with a possible range of 3 to 9, with higher scores indicating more supportive/rehabilitation-related behaviors (Cronbach's alpha=0.55).
Time frame: Timepoint 3 [Two weeks post-visit]
Population: All participants who responded to concussion management behavior items two weeks post-visit \[Cohorts 1 and 2\].
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Education as Usual | Change in Concussion Management Behaviors: Supportive/Rehabilitation-related | 7.35 Score on a scale | Standard Deviation 1.51 |
| New Education | Change in Concussion Management Behaviors: Supportive/Rehabilitation-related | 7.57 Score on a scale | Standard Deviation 1.87 |
p-value: 0.638Regression, Linear
Secondary
Change in Concussion Knowledge
Self-report of parent knowledge about the benefits of engaging in specific concussion management behaviors in the home setting was measured using the concussion knowledge index. This index was comprised of 10 true or false questions reflecting the knowledge parents need to perform the targeted guideline-consistent communication, rehabilitation, and external engagement behaviors. The index has a potential range of 0-10, with higher scores indicating greater knowledge.
Time frame: Timepoint 1 [At ED visit], Timepoint 3 [Two weeks post-visit]
Population: All participants who responded to concussion knowledge index items at Timepoint 1 and Timepoint 3
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Education as Usual | Change in Concussion Knowledge | Timepoint 1 | 6.05 Score on a scale | Standard Deviation 1.43 |
| Education as Usual | Change in Concussion Knowledge | Timepoint 3 | 6.45 Score on a scale | Standard Deviation 1.68 |
| New Education | Change in Concussion Knowledge | Timepoint 1 | 6.22 Score on a scale | Standard Deviation 1.68 |
| New Education | Change in Concussion Knowledge | Timepoint 3 | 7.29 Score on a scale | Standard Deviation 1.54 |
p-value: 0.128Regression, Linear
Secondary
Change in Concussion Management Self-efficacy: Communication
Self-report of parent confidence in their ability to engage in specific emotionally supportive concussion management behaviors in the home setting using the communication self-efficacy scale. For each of the behaviors, parents were asked to report how challenging it would be to engage in each. Responses were obtained on a 5-point scale where higher scores indicate that performing the behavior would be more challenging (i.e., they have lower self-efficacy). For each domain-specific measure, item level means were calculated, meaning there was a possible range of 1 to 5. In this sample, internal consistency reliability was adequate for the communication subscale (Cronbach's alpha=0.90).
Time frame: Timepoint 1 [At ED visit], Timepoint 3 [Two weeks post-visit]
Population: All participants who responded to the self-efficacy scale items at Timepoint 1 and Timepoint 3 \[Cohort 2 only\].
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Education as Usual | Change in Concussion Management Self-efficacy: Communication | Timepoint 1 | 4.69 Score on a scale | Standard Deviation 0.57 |
| Education as Usual | Change in Concussion Management Self-efficacy: Communication | Timepoint 3 | 4.80 Score on a scale | Standard Deviation 0.42 |
| New Education | Change in Concussion Management Self-efficacy: Communication | Timepoint 1 | 4.71 Score on a scale | Standard Deviation 0.56 |
| New Education | Change in Concussion Management Self-efficacy: Communication | Timepoint 3 | 4.81 Score on a scale | Standard Deviation 0.53 |
p-value: 0.606Regression, Linear
Secondary
Change in Concussion Management Self-efficacy: Follow-up
Parent self-report of how challenging it would be to make a follow-up appointment for their child. Responses were obtained on a 5-point scale, where higher scores indicate that performing the behavior would be more challenging (i.e., they have lower self-efficacy). Item level means were calculated, meaning there was a possible range of 1 to 5.
Time frame: Timepoint 1 [At ED visit], Timepoint 3 [Two weeks post-visit]
Population: All participants who responded to the self-efficacy items at Timepoint 1 and Timepoint 3 \[Cohort 2 only\]
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Education as Usual | Change in Concussion Management Self-efficacy: Follow-up | Timepoint 1 | 4.83 Score on a scale | Standard Deviation 0.53 |
| Education as Usual | Change in Concussion Management Self-efficacy: Follow-up | Timepoint 3 | 4.70 Score on a scale | Standard Deviation 0.48 |
| New Education | Change in Concussion Management Self-efficacy: Follow-up | Timepoint 1 | 4.77 Score on a scale | Standard Deviation 0.43 |
| New Education | Change in Concussion Management Self-efficacy: Follow-up | Timepoint 3 | 5.00 Score on a scale | Standard Deviation 0 |
p-value: 0.042Regression, Linear
Secondary
Change in Concussion Management Self-efficacy: Supportive/Rehabilitation-related
Self-report of parent confidence in their ability to engage in specific instrumentally-supportive concussion management behaviors in the home setting using the rehabilitation self-efficacy scale. For each of the parenting behaviors, parents were asked to report how challenging it would be to engage in each. Responses were obtained on a 5-point scale where higher scores indicate that performing the behavior would be more challenging (i.e., they have lower self-efficacy). For each domain-specific measure, item level means were calculated, meaning there was a possible range of 1 to 5. In this sample, internal consistency reliability was adequate for the rehabilitation subscale (Cronbach's alpha=0.79).
Time frame: Timepoint 1 [At ED visit], Timepoint 3 [Two weeks post-visit]
Population: All participants who responded to the self-efficacy items at Timepoint 1 and Timepoint 3 \[Cohort 2 only\]
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Education as Usual | Change in Concussion Management Self-efficacy: Supportive/Rehabilitation-related | Timepoint 1 | 3.39 Score on a scale | Standard Deviation 0.55 |
| Education as Usual | Change in Concussion Management Self-efficacy: Supportive/Rehabilitation-related | Timepoint 3 | 3.28 Score on a scale | Standard Deviation 0.34 |
| New Education | Change in Concussion Management Self-efficacy: Supportive/Rehabilitation-related | Timepoint 1 | 3.48 Score on a scale | Standard Deviation 0.44 |
| New Education | Change in Concussion Management Self-efficacy: Supportive/Rehabilitation-related | Timepoint 3 | 3.41 Score on a scale | Standard Deviation 0.55 |
p-value: 0.508Regression, Linear