Clinical trial NCT05618652: Pilot Testing of an Equity Focused and Trauma-informed Communication Intervention During Family-centered Rounds
Official title: Development and Pilot Testing of an Equity-focused and Trauma-informed Communication Intervention During Family-centered Rounds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hospitalism in Children
Post Traumatic Stress Disorder
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2022-11-16
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility measured by enrollment rate of clinicians and caregivers combined
timeFrame: Up to 12 months
measure: Feasibility measured by the rate of complete data collection by caregivers
timeFrame: Up to 12 months
measure: Fidelity measured by the rate of intervention elements completed per encounter by clinicians
timeFrame: Up to 12 months
measure: Acceptability of the intervention as measured by the Acceptability of Intervention Measure (AIM)
timeFrame: Up to 12 months
measure: Appropriateness measured by the Intervention Appropriateness Measure (IAM)
timeFrame: Up to 12 months
measure: Feasibility measured by the Feasibility of Intervention Measure (FIM)
timeFrame: Up to 12 months
measure: Number of Clinician rapport-building statements
timeFrame: Up to 12 months
measure: Number of Clinician partnership-building statements
timeFrame: Up to 12 months
measure: Number of Clinician interruptions
timeFrame: Up to 12 months
measure: Number of Clinician praise statements
timeFrame: Up to 12 months
measure: Number of Clinician permission asking
timeFrame: Up to 12 months
measure: Caregiver Satisfaction measured by survey
timeFrame: Up to 12 months
measure: Caregiver Trust in their Childs Doctors measured by the Wake Forest Physician Trust Scale
timeFrame: Up to 12 months
measure: Caregiver Reported Communication Quality measured by the Interpersonal Processes of Care Short Form
timeFrame: Up to 12 months
measure: Caregiver Stress
timeFrame: Timeframe up to 12 months
Secondary outcomes:
measure: Number of Caregiver Participatory Behaviors
timeFrame: Up to 12 months
measure: Number of participants with Hospital Readmission at 30 days
timeFrame: 30 days after discharge
measure: Number of participants with Hospital Readmission at 90 days
timeFrame: 90 days after discharge
measure: Caregiver ability to correctly identify child's diagnosis
timeFrame: Up to 12 months
measure: Change in caregiver Salivary Cortisol
timeFrame: 30-60 minutes before and 20-30 minutes after FCR
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Health Sustem
state: North Carolina
Study officials:
affiliation: Duke University
name: Victoria M. Parente, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.