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

Post Traumatic Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05618652
• Other study ID #: Pro00111356
• Secondary ID: 1K12HD105253-01
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: January 2025

Study information

• Verified date: February 2024
• Source: Duke University
• Contact: Victoria M. Parente, MD
• Phone: 631-806-4695
• Email: victoria.parente[@]duke.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 child and caregiver mental health both in the hospital and 90 days after discharge.

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 child adjustment to hospitalization and caregiver post-discharge stress. The investigators hypothesize that our intervention will reduce caregiver stress in the hospital leading to greater participation in hospital care as well as better child adjustment and caregiver mental health after discharge. The investigators will explore the effect of the intervention on child 30 and 90 day readmission.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hospitalism in Children
• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

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.

Locations

Country	Name	City	State
United States	Duke University Health Sustem	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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 — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Caregiver Post-Traumatic Stress Symptoms as measured by the Impact of Events Scale at 30 days	The investigators will use the Impact of Events Scale- Revised (IES-R) a 22-item questionnaire that assesses post-traumatic stress symptoms and is a widely used measure. The investigators will administer this in a telephone survey of caregivers 30 and 90 days after discharge. Scores range from 0 to 88 with anything above 24 raising a concern for Post-Traumatic Stress Disorder. The investigators hypothesize caregivers in the intervention arm to have a lower IES-R score.	30 days after discharge
Primary	Caregiver Post-Traumatic Stress Symptoms as measured by the Impact of Events Scale at 90 days	The investigators will use the Impact of Events Scale- Revised (IES-R) a 22-item questionnaire that assesses post-traumatic stress symptoms and is a widely used measure. The investigators will administer this in a telephone survey of caregivers 30 and 90 days after discharge. Scores range from 0 to 88 with anything above 24 raising a concern for Post-Traumatic Stress Disorder. The investigators hypothesize caregivers in the intervention arm to have a lower IES-R score.	90 days after discharge
Primary	Child Post-Traumatic Stress Symptoms as measured by the Behavioral Assessment System for Children at 30 days	The BASC is a comprehensive measure of both adaptive and problem behaviors that has previously been used to evaluate the impact of illness and hospitalization on children. The BASC measure is available in English and Spanish. The BASC measure comes with scoring software that provides a T-score and percentile in 5 domains with cutoff points for population norms. Higher scores indicate a child is at risk for developing behavioral, emotion, and social problems.	30 days after discharge
Primary	Child Post-Traumatic Stress Symptoms as measured by the Behavioral Assessment System for Children at 90 days	The BASC is a comprehensive measure of both adaptive and problem behaviors that has previously been used to evaluate the impact of illness and hospitalization on children. The BASC measure is available in English and Spanish. The BASC measure comes with scoring software that provides a T-score and percentile in 5 domains with cutoff points for population norms. Higher scores indicate a child is at risk for developing behavioral, emotion, and social problems.	90 days after discharge
Secondary	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
Secondary	Number of participants with Hospital Readmission at 30 days	Child unplanned hospital readmission	30 days after discharge
Secondary	Number of participants with Hospital Readmission at 90 days	Child unplanned hospital readmission	90 days after discharge
Secondary	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.	During hospitalization