Concussion, BrainNCT04112914
Developing an Implementation Strategy for Post-concussion Communication With Low Health Literacy Parents in the Emergency Department
A study testing Post-concussion education for families in people with Concussion, Brain, run by Seattle Children's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Concussion, Brain
- What is being tested?
- Post-concussion education for families
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2021to 27 Jul 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Seattle Children's Hospital Emergency Department
Seattle, Washington, 98105
About this study
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.
Read the 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.
- Conditions
- Concussion, Brain
- Being tested
- Post-concussion education for families
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post-concussion education for familiesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Education as usual | No intervention | Participants receive education/healthcare provider communication as usual during their visit to the ED for concussion care. |
| New education | Experimental | Participants receive the newly developed educational intervention. Receives: Behavioral: Post-concussion education for families |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Timepoint 3 [Two weeks post-visit]
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).
Measured: Timepoint 3 [Two weeks post-visit]
Change in Concussion Management Behaviors: Follow-up Appointment
Percentage of participants who reported they had scheduled a follow-up appointment for their child.
Measured: Timepoint 3 [Two weeks post-visit]
Secondary outcomes (4)
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).
Measured: Timepoint 1 [At ED visit], Timepoint 3 [Two weeks post-visit]
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).
Measured: Timepoint 1 [At ED visit], Timepoint 3 [Two weeks post-visit]
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.
Measured: Timepoint 1 [At ED visit], Timepoint 3 [Two weeks post-visit]
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.
Measured: Timepoint 1 [At ED visit], Timepoint 3 [Two weeks post-visit]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2019
- Study start5 Jan 2021
- Primary completion27 Jul 2022
- Study completion27 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Concussion, BrainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Consecutive cohort design with randomization
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emily Kroshus, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04112914
- Sponsor's protocol ID
- R21NS111065
- Status last verified
- Apr 2024
- First submitted
- 29 Jul 2019
- Last updated
- 29 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing an Implementation Strategy for Post-concussion Communication With Low Health Literacy Parents in the Emergency Department
- ClinicalTrials.gov ID
- NCT04112914
- Acronym / sponsor ID
- R21NS111065
- Conditions
- Concussion, Brain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Study start
- 5 Jan 2021 (actual)
- Primary completion
- 27 Jul 2022 (actual)
- Study completion
- 27 Jul 2022 (actual)
- First posted
- 2 Oct 2019 (actual)
- Results
- Posted 29 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Consecutive cohort design with randomization
| Arm | Type | Receives |
|---|---|---|
| Education as usual | No intervention | –Participants receive education/healthcare provider communication as usual during their visit to the ED for concussion care. |
| New education | Experimental | Behavioral: Post-concussion education for familiesParticipants receive the newly developed educational intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Post-concussion education for familiesAn 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. | Behavioural | New education |
Primary outcome
Change in Concussion Management Behaviors: Communication
Time frame: 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
Time frame: 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
Time frame: Timepoint 3 [Two weeks post-visit]
Percentage of participants who reported they had scheduled a follow-up appointment for their child.
4 secondary outcomes
Change in Concussion Management Self-efficacy: Communication
Time frame: Timepoint 1 [At ED visit], Timepoint 3 [Two weeks post-visit]
Change in Concussion Management Self-efficacy: Supportive/Rehabilitation-related
Time frame: Timepoint 1 [At ED visit], Timepoint 3 [Two weeks post-visit]
Change in Concussion Management Self-efficacy: Follow-up
Time frame: Timepoint 1 [At ED visit], Timepoint 3 [Two weeks post-visit]
Change in Concussion Knowledge
Time frame: Timepoint 1 [At ED visit], Timepoint 3 [Two weeks post-visit]
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Post-concussion education for families in people with Concussion, Brain, run by Seattle Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Concussion Management Behaviors: Communication (time frame: Timepoint 3 [Two weeks post-visit]). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2024.