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

NCT05618652 | Completed DMC

• 2 other identifiers: Pro001113561K23MD018433
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hospitalism in Children; Post Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (15)

• 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 Outcomes (5)

• Number of Caregiver Participatory Behaviors

  Up to 12 months

• Number of participants with Hospital Readmission at 30 days

  30 days after discharge

• Number of participants with Hospital Readmission at 90 days

  90 days after discharge

• Caregiver ability to correctly identify child's diagnosis

  Up to 12 months

• Change in caregiver Salivary Cortisol

  30-60 minutes before and 20-30 minutes after FCR

Study Arms (2)

Clinician Coaching Immediate Intervention Arm-- Caregivers

ACTIVE COMPARATOR

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 Coaching Wait-List Control Arm-- Caregivers

OTHER

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

Interventions

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.

Clinician Coaching Immediate Intervention Arm-- Caregivers; Clinician Coaching Wait-List Control Arm-- Caregivers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Duke University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Duke University Health Sustem

Durham, North Carolina, 27710, United States

Location

Related Publications (3)

• 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.

  PMID: 35411380 BACKGROUND

• 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.

  PMID: 35696195 RESULT

• 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.

  PMID: 35079809 RESULT

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Victoria M. Parente, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients and their caregivers will not know whether their clinical team has received or not yet received the communication intervention. Additionally, team members who assess outcomes (coding of audio-recorded transcripts) will be blinded to the clinical team intervention status.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The investigators will test the intervention in a randomized pilot with intervention and waitlist control arms. Half the clinical teams will receive the clinician communication intervention immediately upon enrollment and half will receive the intervention after 6 months. The investigators will assess recruitment, enrollment, and data collection feasibility as well as intervention fidelity to evaluate feasibility of implementation and skill uptake using audio-recordings of rounds. The investigators will develop a semi-structured interview and survey to assess acceptability as well as facilitators/barriers to implementation.

Study Record Dates

• First Submitted: October 25, 2022
• First Posted: November 16, 2022
• Study Start: February 1, 2024
• Primary Completion: March 29, 2025
• Study Completion: March 29, 2025
• Last Updated: June 3, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)