Developing an Implementation Strategy for Post-concussion Communication With Low Health Literacy Parents in the Emergency Department

NCT04112914 | Completed Results

• 1 other identifier: R21NS111065
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Concussion, Brain

Outcome Measures

Primary Outcomes (3)

• 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).

  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).

  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.

  Timepoint 3 [Two weeks post-visit]

Secondary Outcomes (4)

• Change in Concussion Management Self-efficacy: Communication

  Timepoint 1 [At ED visit], Timepoint 3 [Two weeks post-visit]

• Change in Concussion Management Self-efficacy: Supportive/Rehabilitation-related

  Timepoint 1 [At ED visit], Timepoint 3 [Two weeks post-visit]

• Change in Concussion Management Self-efficacy: Follow-up

  Timepoint 1 [At ED visit], Timepoint 3 [Two weeks post-visit]

• Change in Concussion Knowledge

  Timepoint 1 [At ED visit], Timepoint 3 [Two weeks post-visit]

Study Arms (2)

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.

Behavioral: Post-concussion education for families

Interventions

Post-concussion education for families BEHAVIORAL

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.

New education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Seattle Children's Hospital: lead

Study Sites (1)

Seattle Children's Hospital Emergency Department

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Results Point of Contact

• Title: Dr. Emily Kroshus
• Organization: Seattle Children's Research Institute

Emily.Kroshus@seattlechildrens.org

206-884-5326

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Model Details: Consecutive cohort design with randomization

Study Record Dates

• First Submitted: July 29, 2019
• First Posted: October 2, 2019
• Study Start: January 5, 2021
• Primary Completion: July 27, 2022
• Study Completion: July 27, 2022
• Last Updated: April 29, 2024
• Results First Posted: April 29, 2024

Record last verified: 2024-04

Locations

US (1)