Communication Intervention for Traumatic Stress Disorders

(EFTI Trial)

Overseen By Victoria M. Parente, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Child abuse/neglect evaluation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

90 Participants Needed

Trial Summary

What is the purpose of this trial?

Development and pilot testing of a clinician coaching communication intervention to improve communication between medical teams and caregivers (parents, family members) of children in the hospital. Our team is specifically focused on improving partnership, respect, and collaboration with Black and Latinx caregivers of children in the hospital by incorporating elements from trauma-informed care and racial equity into a communication intervention. The investigators will explore the impact of this intervention on communication quality, caregiver trust, caregiver satisfaction, and hospital readmissions.

Research Team

Victoria M. Parente, MD

Principal Investigator

Duke University

Eligibility Criteria

This trial is for English or Spanish-speaking adults who are the primary caregivers of hospitalized Black or Latino children at Duke Children's Hospital. It excludes those involved in child abuse/neglect cases or when family-centered rounds aren't suitable.

Inclusion Criteria

I can understand and agree to the study's details.

I am a pediatrician providing care at Duke Children's Hospital.

I do not provide care to children in a hospital setting on the general pediatrics team.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Development

Co-development and refinement of a clinician coaching communication intervention with feedback from caregivers and clinicians

Not specified

Intervention Implementation

Clinicians receive the communication intervention, including didactics, audio-recorded clinical encounters, feedback sessions, and post-intervention interviews

Up to 12 months

8 audio-recorded clinical encounters, 4 feedback sessions

Follow-up

Participants are monitored for the impact of the intervention on communication quality, caregiver trust, caregiver satisfaction, and hospital readmissions

Up to 12 months

Treatment Details

Interventions

• Equity Focused and Trauma-Informed Communication Intervention

Trial Overview The study tests a communication intervention aimed to enhance interactions between medical teams and caregivers during hospital rounds, focusing on partnership, respect, and collaboration with an emphasis on trauma-informed care and racial equity.

Participant Groups

Group I: Clinician Coaching Wait-List Control Arm-- Caregivers Experimental Treatment 1 Intervention

Clinicians in the wait-list control arm will initially serve as the control arm then receive the intervention to provide feasibility and acceptability data. The clinicians randomized the control arm will undergo didactics and feedback once their pre-intervention audio-recordings are complete. Caregivers of hospitalized children will not know if their clinician has yet received the communication intervention. The investigators will recruit 40 caregivers in this arm prior to clinicians receiving the intervention.

Group II: Clinician Coaching Immediate Intervention Arm-- Caregivers Active Control 1 Intervention

Clinicians who receive the intervention will participate for up to 12 months, which includes completion of didactics, 8 audio-recorded clinical encounters, 4 feedback sessions, and completion of a post-intervention brief interview and survey. After completing didactic training elements, clinicians will receive coaching and professional feedback on their communication with caregivers of children in the hospital. The investigators will provide clinicians with illustrative examples from their encounters to prompt discussion and self-reflection. Caregivers of hospitalized children will not know if their clinician has received the communication intervention. The investigators will recruit 40 caregivers in this arm.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+