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

Primary Purpose

Concussion, Brain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Post-concussion education for families
Sponsored by
Seattle Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Concussion, Brain

Eligibility Criteria

5 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Seattle Children's Hospital Emergency Department

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Education as usual

New education

Arm Description

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

Participants receive the newly developed educational toolkit

Outcomes

Primary Outcome Measures

Change in concussion management behavior
Parent self-report of specific concussion management behaviors in the home setting (monitor child's symptoms/functioning, contact medical provider when appropriate, interface with school personnel about academic accommodations, prohibit activities with risk of contact or collision until child has obtained medical clearance, discuss return to sport decision with child).

Secondary Outcome Measures

Change in concussion management self-efficacy
Self-report survey of parent confidence in their ability to engage in specific concussion management behaviors in the home setting (monitor child's symptoms/functioning, contact medical provider when appropriate, interface with school personnel about academic accommodations, prohibit activities with risk of contact or collision until child has obtained medical clearance, discuss return to sport decision with child).
Change in concussion knowledge
Self-report survey of parent knowledge about the benefits of engaging in specific concussion management behaviors in the home setting (monitor child's symptoms/functioning, contact medical provider when appropriate, interface with school personnel about academic accommodations, prohibit activities with risk of contact or collision until child has obtained medical clearance, discuss return to sport decision with child).

Full Information

First Posted
July 29, 2019
Last Updated
December 1, 2022
Sponsor
Seattle Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04112914
Brief Title
Developing an Implementation Strategy for Post-concussion Communication With Low Health Literacy Parents in the Emergency Department
Official Title
Developing an Implementation Strategy for Post-concussion Communication With Low Health Literacy Parents in the Emergency Department
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
January 5, 2021 (Actual)
Primary Completion Date
July 27, 2022 (Actual)
Study Completion Date
July 27, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seattle Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Investigators will conduct a hybrid implementation-effectiveness evaluation of an implementation toolkit 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Concussion, Brain

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Consecutive cohort design with randomization
Masking
None (Open Label)
Allocation
Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Education as usual
Arm Type
No Intervention
Arm Description
Participants receive education/healthcare provider communication as usual during their visit to the ED for concussion care.
Arm Title
New education
Arm Type
Experimental
Arm Description
Participants receive the newly developed educational toolkit
Intervention Type
Behavioral
Intervention Name(s)
Post-concussion education for families
Intervention Description
An educational resource 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. An implementation toolkit will be developed, adapting the AHRQ RED Toolkit, to support communication about the educational resource and other best-practices for communication with families, including low health literacy families.
Primary Outcome Measure Information:
Title
Change in concussion management behavior
Description
Parent self-report of specific concussion management behaviors in the home setting (monitor child's symptoms/functioning, contact medical provider when appropriate, interface with school personnel about academic accommodations, prohibit activities with risk of contact or collision until child has obtained medical clearance, discuss return to sport decision with child).
Time Frame
Two weeks post-visit
Secondary Outcome Measure Information:
Title
Change in concussion management self-efficacy
Description
Self-report survey of parent confidence in their ability to engage in specific concussion management behaviors in the home setting (monitor child's symptoms/functioning, contact medical provider when appropriate, interface with school personnel about academic accommodations, prohibit activities with risk of contact or collision until child has obtained medical clearance, discuss return to sport decision with child).
Time Frame
Immediately post-visit
Title
Change in concussion knowledge
Description
Self-report survey of parent knowledge about the benefits of engaging in specific concussion management behaviors in the home setting (monitor child's symptoms/functioning, contact medical provider when appropriate, interface with school personnel about academic accommodations, prohibit activities with risk of contact or collision until child has obtained medical clearance, discuss return to sport decision with child).
Time Frame
Immediately post-visit, two weeks post-visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Seattle Children's Hospital Emergency Department
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States

12. IPD Sharing Statement

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

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