Emergency Department Healthcare Education Assessment and Response for Teen Relationships: A Pilot Feasibility Study (ED-HEART)

Children's Mercy Hospital Kansas City

Status: Completed

Conditions: Abuse Physical; Emergency Department; Abuse Verbal; Abuse Mental; Adolescent Behavior; Intimate Partner Violence; HEART; Abuse Domestic

Treatments: Behavioral: ED-HEART

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05194202

K23HD098299 (U.S. NIH Grant/Contract)

STUDY00001967

Details and patient eligibility

About

This is a single-site, randomized, controlled trial. Investigators will evaluate feasibility of the Emergency Department Healthcare Education Assessment and Response for Teen Relationships (ED-HEART) intervention among adolescents age 14-19 years receiving care in the Children's Mercy emergency department.

Full description

This study is a mixed methods feasibility evaluation that will use a randomized controlled trial to assess feasibility of Emergency Department Healthcare Education Assessment and Response for Teen Relationships (ED-HEART) (intervention arm: ED-HEART + teen resource list; control arm: enhanced standard care [standard care + teen resource list]). Adolescents age 14-19 years will be recruited and enrolled during an emergency department visit. Investigators will evaluate feasibility using the eight Bowen model feasibility constructs: acceptability, demand, implementation, practicality, adaptation, integration, expansion, and limited-efficacy testing. Investigators will also examine theory of planned behavior constructs (attitudes, beliefs, perceived behavioral control, intention) to facilitate exploratory analysis of factors that may contribute to differential outcomes.

Enrollment: 175 patients

Sex: All

Ages: 14 to 19 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• emergency department (ED) patient 14-19 years of age.

Exclusion criteria

• Developmental delay, severe illness, or cognitive impairment precluding informed consent/assent or completion of study activities, as determined by ED team or study team.
• Current ED evaluation for acute sexual assault/abuse.
• Current mental or behavioral health symptoms precluding completion of study activities, as determined by ED team or study team.
• Caregiver declines to step out to allow assent/consent in private or adolescent declines for caregiver to step out to allow assent/consent or participation in private.
• Adolescent is non-English speaking.
• Parent is non-English or non-Spanish speaking.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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175 participants in 2 patient groups

ED-HEART (Intervention Arm)

Experimental group

Description:

All adolescents take a baseline survey in the Emergency Department (ED), receive Emergency Department Healthcare Education Assessment and Response for Teen Relationships (ED HEART) by a trained health educator, complete an exit survey while in the ED, complete a 6-week check-in to confirm contact information and aid retention, and complete a 12-week follow up survey.

Treatment:

Behavioral: ED-HEART

Enhanced Standard Care (Control Arm)

No Intervention group

Description:

All adolescents take a baseline survey in the Emergency Department (ED), receive enhanced standard care (i.e., standard care + teen resource list), complete a 6-week check in to confirm contact information and aid retention, and complete a 12-week follow up survey.