Trial Outcomes & Findings for Developing an Implementation Strategy for Post-concussion Communication With Low Health Literacy Parents in the Emergency Department (NCT NCT04112914)
NCT ID: NCT04112914
Last Updated: 2024-04-29
Results Overview
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).
COMPLETED
NA
98 participants
Timepoint 3 [Two weeks post-visit]
2024-04-29
Participant Flow
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.
N/a. All enrolled participants were assigned to the control or intervention condition.
Participant milestones
| Measure |
Education as Usual
Participants receive education/healthcare provider communication as usual during their visit to the ED for concussion care.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
75
|
23
|
|
Overall Study
COMPLETED
|
61
|
14
|
|
Overall Study
NOT COMPLETED
|
14
|
9
|
Reasons for withdrawal
| Measure |
Education as Usual
Participants receive education/healthcare provider communication as usual during their visit to the ED for concussion care.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
13
|
9
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
One participant did not provide sex/gender information.
Baseline characteristics by cohort
| Measure |
Education as Usual
n=75 Participants
Participants receive education/healthcare provider communication as usual during their visit to the ED for concussion care.
|
New Education
n=23 Participants
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.
|
Total
n=98 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.42 Years
STANDARD_DEVIATION 4.98 • n=75 Participants
|
41.36 Years
STANDARD_DEVIATION 4.41 • n=23 Participants
|
40.68 Years
STANDARD_DEVIATION 4.64 • n=98 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=74 Participants • One participant did not provide sex/gender information.
|
16 Participants
n=23 Participants • One participant did not provide sex/gender information.
|
70 Participants
n=97 Participants • One participant did not provide sex/gender information.
|
|
Sex: Female, Male
Male
|
20 Participants
n=74 Participants • One participant did not provide sex/gender information.
|
7 Participants
n=23 Participants • One participant did not provide sex/gender information.
|
27 Participants
n=97 Participants • One participant did not provide sex/gender information.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=75 Participants
|
2 Participants
n=23 Participants
|
13 Participants
n=98 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
63 Participants
n=75 Participants
|
21 Participants
n=23 Participants
|
84 Participants
n=98 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=75 Participants
|
0 Participants
n=23 Participants
|
1 Participants
n=98 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=75 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=98 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=75 Participants
|
3 Participants
n=23 Participants
|
7 Participants
n=98 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=75 Participants
|
1 Participants
n=23 Participants
|
2 Participants
n=98 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=75 Participants
|
0 Participants
n=23 Participants
|
5 Participants
n=98 Participants
|
|
Race (NIH/OMB)
White
|
52 Participants
n=75 Participants
|
15 Participants
n=23 Participants
|
67 Participants
n=98 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=75 Participants
|
2 Participants
n=23 Participants
|
5 Participants
n=98 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=75 Participants
|
2 Participants
n=23 Participants
|
12 Participants
n=98 Participants
|
PRIMARY outcome
Timeframe: Timepoint 3 [Two weeks post-visit]Population: All participants who responded to concussion management behavior items two weeks post-visit \[Cohorts 1 and 2.
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).
Outcome measures
| Measure |
Education as Usual
n=61 Participants
Participants receive education/healthcare provider communication as usual during their visit to the ED for concussion care.
|
New Education
n=14 Participants
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.
|
|---|---|---|
|
Change in Concussion Management Behaviors: Communication
|
5.49 Score on a scale
Standard Deviation 1.68
|
6.71 Score on a scale
Standard Deviation 2.02
|
PRIMARY outcome
Timeframe: Timepoint 3 [Two weeks post-visit]Population: All participants who responded to concussion management behavior items two weeks post-visit \[Cohorts 1 and 2\].
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).
Outcome measures
| Measure |
Education as Usual
n=61 Participants
Participants receive education/healthcare provider communication as usual during their visit to the ED for concussion care.
|
New Education
n=14 Participants
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.
|
|---|---|---|
|
Change in Concussion Management Behaviors: Supportive/Rehabilitation-related
|
7.35 Score on a scale
Standard Deviation 1.51
|
7.57 Score on a scale
Standard Deviation 1.87
|
PRIMARY outcome
Timeframe: Timepoint 3 [Two weeks post-visit]Population: All participants who responded to concussion management behavior items two weeks post-visit \[Cohorts 1 and 2\].
Percentage of participants who reported they had scheduled a follow-up appointment for their child.
Outcome measures
| Measure |
Education as Usual
n=61 Participants
Participants receive education/healthcare provider communication as usual during their visit to the ED for concussion care.
|
New Education
n=14 Participants
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.
|
|---|---|---|
|
Change in Concussion Management Behaviors: Follow-up Appointment
Yes
|
22 Participants
|
7 Participants
|
|
Change in Concussion Management Behaviors: Follow-up Appointment
No
|
39 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 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 \[Cohort 2 only\].
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).
Outcome measures
| Measure |
Education as Usual
n=10 Participants
Participants receive education/healthcare provider communication as usual during their visit to the ED for concussion care.
|
New Education
n=14 Participants
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.
|
|---|---|---|
|
Change in Concussion Management Self-efficacy: Communication
Timepoint 1
|
4.69 Score on a scale
Standard Deviation 0.57
|
4.71 Score on a scale
Standard Deviation 0.56
|
|
Change in Concussion Management Self-efficacy: Communication
Timepoint 3
|
4.80 Score on a scale
Standard Deviation 0.42
|
4.81 Score on a scale
Standard Deviation 0.53
|
SECONDARY outcome
Timeframe: 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 \[Cohort 2 only\]
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).
Outcome measures
| Measure |
Education as Usual
n=10 Participants
Participants receive education/healthcare provider communication as usual during their visit to the ED for concussion care.
|
New Education
n=14 Participants
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.
|
|---|---|---|
|
Change in Concussion Management Self-efficacy: Supportive/Rehabilitation-related
Timepoint 1
|
3.39 Score on a scale
Standard Deviation 0.55
|
3.48 Score on a scale
Standard Deviation 0.44
|
|
Change in Concussion Management Self-efficacy: Supportive/Rehabilitation-related
Timepoint 3
|
3.28 Score on a scale
Standard Deviation 0.34
|
3.41 Score on a scale
Standard Deviation 0.55
|
SECONDARY outcome
Timeframe: 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 \[Cohort 2 only\]
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.
Outcome measures
| Measure |
Education as Usual
n=10 Participants
Participants receive education/healthcare provider communication as usual during their visit to the ED for concussion care.
|
New Education
n=14 Participants
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.
|
|---|---|---|
|
Change in Concussion Management Self-efficacy: Follow-up
Timepoint 1
|
4.83 Score on a scale
Standard Deviation 0.53
|
4.77 Score on a scale
Standard Deviation 0.43
|
|
Change in Concussion Management Self-efficacy: Follow-up
Timepoint 3
|
4.70 Score on a scale
Standard Deviation 0.48
|
5.00 Score on a scale
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Education as Usual
n=61 Participants
Participants receive education/healthcare provider communication as usual during their visit to the ED for concussion care.
|
New Education
n=14 Participants
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.
|
|---|---|---|
|
Change in Concussion Knowledge
Timepoint 1
|
6.05 Score on a scale
Standard Deviation 1.43
|
6.22 Score on a scale
Standard Deviation 1.68
|
|
Change in Concussion Knowledge
Timepoint 3
|
6.45 Score on a scale
Standard Deviation 1.68
|
7.29 Score on a scale
Standard Deviation 1.54
|
Adverse Events
Education as Usual
New Education
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Emily Kroshus
Seattle Children's Research Institute
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place