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

NCT ID: NCT04112914

Last Updated: 2024-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-05
• Study Completion Date: 2022-07-27

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.

Conditions

Concussion, Brain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Education as usual

Participants receive education/healthcare provider communication as usual during their visit to the ED for concussion care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

New education

Participants receive the newly developed educational intervention.

Group Type: EXPERIMENTAL

Post-concussion education for families

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Seattle Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Emily Kroshus

Research Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Seattle Children's Hospital Emergency Department

Seattle, Washington, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form: Cohort 2

View Document

Document Type: Informed Consent Form: Cohort 1

View Document

Other Identifiers

R21NS111065

Identifier Type: NIH

Identifier Source: org_study_id

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