- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05618652
Pilot Testing of an Equity Focused and Trauma-informed Communication Intervention During Family-centered Rounds
Development and Pilot Testing of an Equity-focused and Trauma-informed Communication Intervention During Family-centered Rounds
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Victoria M. Parente, MD
- Phone Number: 631-806-4695
- Email: victoria.parente@duke.edu
Study Locations
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-
North Carolina
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Durham, North Carolina, United States, 27710
- Recruiting
- Duke University Health Sustem
-
Contact:
- Victoria M. Parente
- Phone Number: 631-806-4695
- Email: victoria.parente@duke.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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. |
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. |
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 |
---|---|---|
Caregiver Post-Traumatic Stress Symptoms as measured by the Impact of Events Scale at 30 days
Time Frame: 30 days after discharge
|
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
|
Caregiver Post-Traumatic Stress Symptoms as measured by the Impact of Events Scale at 90 days
Time Frame: 90 days after discharge
|
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
|
Child Post-Traumatic Stress Symptoms as measured by the Behavioral Assessment System for Children at 30 days
Time Frame: 30 days after discharge
|
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
|
Child Post-Traumatic Stress Symptoms as measured by the Behavioral Assessment System for Children at 90 days
Time Frame: 90 days after discharge
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in caregiver Salivary Cortisol
Time Frame: 30-60 minutes before and 20-30 minutes after FCR
|
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
Time Frame: 30 days after discharge
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Child unplanned hospital readmission
|
30 days after discharge
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Number of participants with Hospital Readmission at 90 days
Time Frame: 90 days after discharge
|
Child unplanned hospital readmission
|
90 days after discharge
|
Number of Caregiver Participatory Behaviors
Time Frame: During hospitalization
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
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)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00111356
- 1K12HD105253-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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