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Completed

NCT Number: NCT05618652

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

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.

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Key information

Conditions

Hospitalism in Children Mental Disorders Post Traumatic Stress Disorder Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Health Sustem

Durham, North Carolina, 27710, United States

About this study

When admitted to the hospital, Black and Latino(a/x) children are at greater risk of medical errors, surgical complications, longer, more-costly hospital stays, and mortality compared to White children. Although many factors play a role, poor clinician communication likely contributes to these disparities in health outcomes. Across settings, including our preliminary work in the inpatient pediatric environment, Black and Latino(a/x) patients have been shown to experience worse communication quality as evidenced by less patient and family-centered, empathic, and respectful communication as compared to White patients. Poor communication can make the hospital stay more stressful for caregivers, with implications for caregiver and child health and recovery from illness. While prior experiences of discrimination and trauma can negatively affect clinician-caregiver communication, current best practices in clinician communication fail to incorporate equity and trauma-informed principles. In this study the investigators will test the feasibility, acceptability, and preliminary efficacy of a pilot randomized waitlist control trial of an equity focused and trauma-informed clinician coaching communication intervention that aims to teach clinicians skills to improve communication in areas where inequities are known to exist (i.e. respect, partnership) and incorporate principles of equity (i.e affirmation) and trauma-informed care. To do this, first the investigators will co-develop and refine a clinician coaching communication intervention with iterative feedback from Black and Latino(a/x) caregivers as well as clinicians of children in the hospital. Second, the investigators will examine the feasibility, acceptability and preliminary efficacy of the intervention. The investigators will randomize 10 clinicians to an intervention or waitlist group; clinicians in the intervention group will receive the intervention immediately, while clinicians in the waitlist group will initially serve as the control arm then receive the intervention to provide feasibility and acceptability data. The investigators will assess the feasibility of recruiting and collecting data as well as acceptability of the intervention by clinicians. The investigators will explore preliminary efficacy for the effect of the intervention on communication, caregiver satisfaction, caregiver trust, and hospital readmissions.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Equity Focused and Trauma-Informed Communication Intervention

Behavioral

Clinician communication intervention that includes didactic training and real-time feedback on communication behaviors during clinical encounters.

Primary outcomes

  1. Feasibility Measured by Enrollment Rate of Clinicians and Caregivers

    Time frame: Up to 12 months

  2. Feasibility Measured by the Rate of Complete Data Collection by Caregivers

    Time frame: Up to 12 months

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

    Time frame: Up to 12 months

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

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

    The AIM has 4 items, each with a response on 5 point Likert scale (1=completely disagree to 5=completely agree). The score will be averaged for all items for a total score range of 1 to 5, where a higher score indicates great acceptability. Reported for all hospital clinicians after receiving the intervention (i.e., both clinicians assigned to immediately receive the intervention and the waitlist group).

  5. Feasibility Measured by the Feasibility of Intervention Measure (FIM)

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

    The FIM has 4 items, each with a response on 5 point Likert scale (1=completely disagree to 5=completely agree). The score will be averaged for all items for a total score range of 1 to 5, where a higher score indicates great feasibility. Reported for all hospital clinicians after receiving the intervention (i.e., both clinicians assigned to immediately receive the intervention and the waitlist group).

  6. Number of Clinician Rapport-building Statements

    Time frame: Up to 12 months

    Clinician communication behaviors measured via audio-recorded hospital encounters.

  7. Number of Clinician Partnership-building Statements

    Time frame: Up to 12 months

    Clinician communication behaviors measured via audio-recorded hospital encounters.

  8. Number of Times Team Interrupted the Caregiver

    Time frame: Up to 12 months

    Clinician communication behaviors measured via audio-recorded hospital encounters.

  9. Number of Times the Team Praised the Caregiver

    Time frame: Up to 12 months

    Clinician communication behaviors measured via audio-recorded hospital encounters.

  10. Number of Times the Team Asked Permission

    Time frame: Up to 12 months

    Clinician communication behaviors measured via audio-recorded hospital encounters.

  11. Caregiver Satisfaction Measured by Survey

    Time frame: Up to 12 months

    Satisfaction was measured with a single item. Response options: 1=Not at all satisfied, 2= A little satisfied, 3= Satisfied, 4=Extremely Satisfied.

  12. Caregiver Trust in Their Childs Doctors Measured by the Wake Forest Physician Trust Scale

    Time frame: Up to 12 months

    Trust was measured using a validated 5-item measure, the Wake Forest Physician Trust Scale. Responses to each item were a 5-point Likert scale, which was averaged together for these analyses for a total score range of 1 to 5, where a higher score indicates greater trust.

  13. Caregiver Reported Communication Quality Measured by the Interpersonal Processes of Care Short Form (IPC-18)

    Time frame: Up to 12 months

    All IPC items use an identical set of response options: 1='never'; 2='rarely'; 3='sometimes'; 4='usually'; 5='always.' Scale scores are calculated as the mean of non-missing responses to the corresponding items (i.e., item responses are averaged, not summed). Domains of hurried and discrimination were reverse coded so that higher scores represented better communication.

  14. Caregiver Reported Communication Quality Measured by the Interpersonal Processes of Care Short Form (IPC-18)

    Time frame: Up to 12 months

    All IPC items use an identical set of response options: 1='never'; 2='rarely'; 3='sometimes'; 4='usually'; 5='always.' Scale scores are calculated as the mean of non-missing responses to the corresponding items (i.e., item responses are averaged, not summed). Lower scores represent better communication.

Secondary outcomes

  1. Change in Caregiver Salivary Cortisol

    Time frame: 30-60 minutes before and 20-30 minutes after FCR

    The investigators will assess for reductions in caregiver salivary cortisol following interactions with clinical teams. The investigators will collect saliva samples from caregivers at two time points: 30-60 minutes before and 20-30 minutes after family-centered rounds (FCR). The investigators anticipate lower salivary cortisol levels in the intervention compared to control arm at 20-30 minutes following FCR. The investigators will also compare differences in the change in cortisol from before and after FCR for each caregiver; the investigators hypothesize caregivers in the intervention arm will have a smaller change from baseline following FCR.

  2. Number of Caregiver Participatory Behaviors

    Time frame: Up to 12 months

    The investigators will measure caregiver participation during clinical encounters by counting the number of times caregivers (1) ask a question, (2) state a preference and (3) express an emotion per clinician encounter. These three behaviors will be summed together and analyzed in aggregate as a count of caregiver participatory behaviors.

  3. Percentage of Caregivers Who Correctly Identify Child's Diagnosis

    Time frame: Up to 12 months

    Using validated approach described by Lion et al. the caregiver description of "the main condition child was admitted for" will be compared to the diagnoses listed by the child's doctors in the electronic health record.

  4. Percentage of Participants With Hospital Readmission at 30 Days

    Time frame: Up to 30 days after discharge

    Child unplanned hospital readmission

Other outcomes

  1. Percentage of Participants With Hospital Readmission at 90 Days

    Time frame: Up to 90 days after discharge

    Child unplanned hospital readmission

  2. Appropriateness Measured by the Intervention Appropriateness Measure (IAM)

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

    The IAM has 4 items, each with a response on 5 point Likert scale (1=completely disagree to 5=completely agree). The score will be averaged for all items for a total score range of 1 to 5, where a higher score indicates great appropriateness. Reported for all hospital clinicians after receiving the intervention (i.e., both clinicians assigned to immediately receive the intervention and the waitlist group).

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study title

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

Acronym: EFTI

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 16, 2022
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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