CompletedNot Applicable

Pilot Testing of an Equity Focused and Trauma-informed Communication Intervention During Family-centered Rounds

United States51 participantsStarted 2024-02-01

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Eligibility criteria for caregivers: * Adults (18 years of age or older) * Proficient in English or Spanish * Capable of providing informed consent * Identified as a primary caregiver (parent or guardian) of a hospitalized Black or Latino(a/x) child on the general pediatrics team. * We will exclude caregivers of children undergoing evaluation for child abuse/neglect or other cases in which the medical team believes family-centered rounds are not appropriate. Eligibility criteria for clinicians: * pediatric attending physicians who provide hospital care to children at Duke Children's Hospital. * Capable of providing informed consent * We will exclude clinicians who do not provide hospital care to children on the general pediatrics team.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Feasibility Measured by Enrollment Rate of Clinicians and Caregivers

Timeframe: Up to 12 months

Feasibility Measured by the Rate of Complete Data Collection by Caregivers

Timeframe: Up to 12 months

Fidelity Measured by the Rate of Intervention Elements Completed Per Encounter by Clinicians

Timeframe: Up to 12 months

Acceptability of the Intervention as Measured by the Acceptability of Intervention Measure (AIM)

Timeframe: Up to 12 months following the coaching intervention for each arm

Feasibility Measured by the Feasibility of Intervention Measure (FIM)

Timeframe: Up to 12 months following the coaching intervention for each arm

Number of Clinician Rapport-building Statements

Timeframe: Up to 12 months

Number of Clinician Partnership-building Statements

Timeframe: Up to 12 months

Trial details

NCT IDNCT05618652

SponsorDuke University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-29

Results submitted2026-03-27

View on ClinicalTrials.gov More Hospitalism in Children trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Feasibility Measured by Enrollment Rate of Clinicians and Caregivers

Timeframe: Up to 12 months

Feasibility Measured by the Rate of Complete Data Collection by Caregivers

Timeframe: Up to 12 months

Fidelity Measured by the Rate of Intervention Elements Completed Per Encounter by Clinicians

Timeframe: Up to 12 months

Acceptability of the Intervention as Measured by the Acceptability of Intervention Measure (AIM)

Timeframe: Up to 12 months following the coaching intervention for each arm

Feasibility Measured by the Feasibility of Intervention Measure (FIM)

Timeframe: Up to 12 months following the coaching intervention for each arm

Number of Clinician Rapport-building Statements

Timeframe: Up to 12 months

Number of Clinician Partnership-building Statements

Timeframe: Up to 12 months