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

Sponsor

Children's Mercy Hospital Kansas City (Other)

Overall Status

Recruiting

CT.gov ID

NCT05194202

Collaborator

National Institutes of Health (NIH) (NIH)

174

Enrollment

Location

Arms

18.2

Anticipated Duration (Months)

9.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Adolescent Behavior Emergency Department Abuse Physical Abuse Mental Abuse Verbal Abuse Domestic HEART Intimate Partner Violence	Behavioral: ED-HEART	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

174 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Adolescents will be enrolled in one of two arms: Emergency Department Healthcare Education Assessment and Response for Teen Relationships (ED-HEART) (intervention arm) or Enhanced Usual Care (control arm). Adolescents will complete study surveys at baseline (Baseline Survey; intervention and control arms), immediately post-intervention (Exit Survey, intervention arm), and 12 weeks after intervention delivery (Follow-up Survey, intervention and control arms).Adolescents will be enrolled in one of two arms: Emergency Department Healthcare Education Assessment and Response for Teen Relationships (ED-HEART) (intervention arm) or Enhanced Usual Care (control arm). Adolescents will complete study surveys at baseline (Baseline Survey; intervention and control arms), immediately post-intervention (Exit Survey, intervention arm), and 12 weeks after intervention delivery (Follow-up Survey, intervention and control arms).

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Promoting Healthy Relationships Among At-Risk Adolescents: A Feasibility Trial in the Emergency Department

Actual Study Start Date :

Dec 9, 2021

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Jun 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ED-HEART (Intervention Arm) 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.	Behavioral: ED-HEART Behavioral intervention that assesses 1) healthy and unhealthy relationship behaviors, 2) conversation with partners around boundaries within relationships, 3) harm reduction strategies, and 4) resources for Adolescent Relationship Abuse (ARA) and related concerns, including Point of Care (POC) Reproductive and Sexual Health (RSH) harm reduction resources.
No Intervention: Enhanced Standard Care (Control Arm) 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.

Arm

Intervention/Treatment

Experimental: ED-HEART (Intervention Arm)

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.

Behavioral: ED-HEART

Behavioral intervention that assesses 1) healthy and unhealthy relationship behaviors, 2) conversation with partners around boundaries within relationships, 3) harm reduction strategies, and 4) resources for Adolescent Relationship Abuse (ARA) and related concerns, including Point of Care (POC) Reproductive and Sexual Health (RSH) harm reduction resources.

No Intervention: Enhanced Standard Care (Control Arm)

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.

Outcome Measures

Primary Outcome Measures

Number/proportion of participants reporting Emergency Department Healthcare Education Assessment and Response for Teen Relationships (ED-HEART) as acceptable. [12 weeks]
2 survey items on acceptability, rated using 5-point Likert scale. Answers dichotomized to strongly/agree-agree vs. neutral/disagree/strongly disagree.

Secondary Outcome Measures

Number/proportion of participants reporting of adolescent relationship abuse (ARA) victimization [12 weeks]
Report of ARA will be considered positive for any positive answer to one or more of six survey items assessing ARA
Participant recognition of abusive behaviors as assessed by survey [12 weeks]
19 survey items using 5-point Likert scale to categorize each behavior from not abusive to extremely abusive.

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years to 19 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Mercy Hospitals and Clinics	Kansas City	Missouri	United States	64108

Sponsors and Collaborators

Children's Mercy Hospital Kansas City
National Institutes of Health (NIH)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kimberly Randell, Physician, MD, Children's Mercy Hospital Kansas City

ClinicalTrials.gov Identifier:

NCT05194202

Other Study ID Numbers:

STUDY00001967

First Posted:

Jan 18, 2022

Last Update Posted:

Jan 18, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Emergencies

Study Results

No Results Posted as of Jan 18, 2022