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Clinical Trials/NCT05618652
NCT05618652
Completed
Not Applicable

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

Duke University1 site in 1 country90 target enrollmentFebruary 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hospitalism in Children
Sponsor
Duke University
Enrollment
90
Locations
1
Primary Endpoint
Feasibility measured by enrollment rate of clinicians and caregivers combined
Status
Completed
Last Updated
11 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2024
End Date
March 29, 2025
Last Updated
11 months ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Feasibility measured by enrollment rate of clinicians and caregivers combined

Time Frame: Up to 12 months

Feasibility measured by the rate of complete data collection by caregivers

Time Frame: Up to 12 months

Fidelity measured by the rate of intervention elements completed per encounter by clinicians

Time Frame: Up to 12 months

Acceptability of the intervention as measured by the Acceptability of Intervention Measure (AIM)

Time Frame: Up to 12 months

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.

Appropriateness measured by the Intervention Appropriateness Measure (IAM)

Time Frame: Up to 12 months

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.

Feasibility measured by the Feasibility of Intervention Measure (FIM)

Time Frame: Up to 12 months

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.

Number of Clinician rapport-building statements

Time Frame: Up to 12 months

Clinician communication behaviors measured via audio-recorded hospital encounters.

Number of Clinician partnership-building statements

Time Frame: Up to 12 months

Clinician communication behaviors measured via audio-recorded hospital encounters.

Number of Clinician interruptions

Time Frame: Up to 12 months

Clinician communication behaviors measured via audio-recorded hospital encounters.

Number of Clinician praise statements

Time Frame: Up to 12 months

Clinician communication behaviors measured via audio-recorded hospital encounters.

Number of Clinician permission asking

Time Frame: Up to 12 months

Clinician communication behaviors measured via audio-recorded hospital encounters.

Caregiver Satisfaction measured by survey

Time Frame: Up to 12 months

1 item question on the post-rounds caregiver survey. Response choices will include: not at all satisfied, a little satisfied, satisfied, and extremely satisfied.

Caregiver Trust in their Childs Doctors measured by the Wake Forest Physician Trust Scale

Time Frame: Up to 12 months

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.

Caregiver Reported Communication Quality measured by the Interpersonal Processes of Care Short Form

Time Frame: Up to 12 months

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.

Caregiver Stress

Time Frame: Timeframe up to 12 months

Measured by salivary cortisol levels

Secondary Outcomes

  • 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 Sites (1)

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