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

Development and 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.

Study Overview

• Status: Completed
• Conditions: Post Traumatic Stress Disorder; Hospitalism in Children
• Intervention / Treatment: Behavioral: Equity Focused and Trauma-Informed Communication Intervention

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Health Sustem

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Clinician Coaching Immediate Intervention Arm-- Caregivers; 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.	Behavioral: Equity Focused and Trauma-Informed Communication Intervention; Clinician communication intervention that includes didactic training and real-time feedback on communication behaviors during clinical encounters.
Other: Clinician Coaching Wait-List Control Arm-- Caregivers; 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.	Behavioral: Equity Focused and Trauma-Informed Communication Intervention; Clinician communication intervention that includes didactic training and real-time feedback on communication behaviors during clinical encounters.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility measured by enrollment rate of clinicians and caregivers combined		Up to 12 months
Feasibility measured by the rate of complete data collection by caregivers		Up to 12 months
Fidelity measured by the rate of intervention elements completed per encounter by clinicians		Up to 12 months
Acceptability of the intervention as measured by the Acceptability of Intervention Measure (AIM)	The AIM has 4 items. Each with response of 5 point likert scale (completely disagree to completely agree). The Investigator will assign a score of 1 to completely disagree and a 5 to completely agree for each item. To calculate the AIM the Investigator average together the responses to the 4 items.	Up to 12 months
Appropriateness measured by the Intervention Appropriateness Measure (IAM)	The IAM has 4 items. Each with response of 5 point likert scale (completely disagree to completely agree). The Investigator will assign a score of 1 to completely disagree and a 5 to completely agree for each item. To calculate the AIM the Investigator average together the responses to the 4 items.	Up to 12 months
Feasibility measured by the Feasibility of Intervention Measure (FIM)	The FIM has 4 items. Each with response of 5 point likert scale (completely disagree to completely agree). The Investigator will assign a score of 1 to completely disagree and a 5 to completely agree for each item. To calculate the AIM the Investigator average together the responses to the 4 items.	Up to 12 months
Number of Clinician rapport-building statements	Clinician communication behaviors measured via audio-recorded hospital encounters.	Up to 12 months
Number of Clinician partnership-building statements	Clinician communication behaviors measured via audio-recorded hospital encounters.	Up to 12 months
Number of Clinician interruptions	Clinician communication behaviors measured via audio-recorded hospital encounters.	Up to 12 months
Number of Clinician praise statements	Clinician communication behaviors measured via audio-recorded hospital encounters.	Up to 12 months
Number of Clinician permission asking	Clinician communication behaviors measured via audio-recorded hospital encounters.	Up to 12 months
Caregiver Satisfaction measured by survey	1 item question on the post-rounds caregiver survey. Response choices will include: not at all satisfied, a little satisfied, satisfied, and extremely satisfied.	Up to 12 months
Caregiver Trust in their Childs Doctors measured by the Wake Forest Physician Trust Scale	The Wake Forest Physician Trust Scale is a validated 5 item instrument on the post-rounds caregiver survey. Responses to the 5 items are summed together and can vary from a score of 5-25. A higher score indicates a more positive outcome.	Up to 12 months
Caregiver Reported Communication Quality measured by the Interpersonal Processes of Care Short Form	The interpersonal processes of care measure has 18 items on the short form, each with response of Never (score=1), Rarely (Score=2), Sometimes (Score=3), Usually (Score=4), Always(Score=5). The Investigator will average together responses from the 18 items to give a value from 1-5 for each domain.	Up to 12 months
Caregiver Stress	Measured by salivary cortisol levels	Timeframe up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in caregiver Salivary Cortisol	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.	30-60 minutes before and 20-30 minutes after FCR
Number of participants with Hospital Readmission at 30 days	Child unplanned hospital readmission	30 days after discharge
Number of participants with Hospital Readmission at 90 days	Child unplanned hospital readmission	90 days after discharge
Number of Caregiver Participatory Behaviors	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.	Up to 12 months
Caregiver ability to correctly identify child's diagnosis	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.	Up to 12 months

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Institute on Minority Health and Health Disparities (NIMHD)
• Investigators: Principal Investigator: Victoria M. Parente, MD, Duke University

Publications and helpful links

General Publications

• Parente VM, Khan A, Robles JM. Belonging on Rounds: Translating Research Into Inclusive Practices for Families With Limited English Proficiency to Promote Safety, Equity, and Quality. Hosp Pediatr. 2022 May 1;12(5):e171-e173. doi: 10.1542/hpeds.2022-006581. No abstract available.
• Parente V, Stark A, Key-Solle M, Olsen M, Sanders LL, Bartlett KW, Pollak KI. Caregiver Inclusivity and Empowerment During Family-Centered Rounds. Hosp Pediatr. 2022 Feb 1;12(2):e72-e77. doi: 10.1542/hpeds.2021-006034.
• Khan A, Parente V, Baird JD, Patel SJ, Cray S, Graham DA, Halley M, Johnson T, Knoebel E, Lewis KD, Liss I, Romano EM, Trivedi S, Spector ND, Landrigan CP; Patient and Family Centered I-PASS SCORE Scientific Oversight Committee; Bass EJ, Calaman S, Fegley AE, Knighton AJ, O'Toole JK, Sectish TC, Srivastava R, Starmer AJ, West DC. Association of Patient and Family Reports of Hospital Safety Climate With Language Proficiency in the US. JAMA Pediatr. 2022 Aug 1;176(8):776-786. doi: 10.1001/jamapediatrics.2022.1831.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Actual): March 29, 2025
• Study Completion (Actual): March 29, 2025

Study Registration Dates

• First Submitted: October 25, 2022
• First Submitted That Met QC Criteria: November 9, 2022
• First Posted (Actual): November 16, 2022

Study Record Updates

• Last Update Posted (Actual): June 3, 2025
• Last Update Submitted That Met QC Criteria: May 28, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: Pro00111356; 1K23MD018433 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will only be available to individuals on the Institutional Review Board protocol. We will share study protocol documents including intervention didactic materials and outcome measure assessments.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No