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

Primary Purpose

Hospitalism in Children, Post Traumatic Stress Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Equity Focused and Trauma-Informed Communication Intervention
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hospitalism in Children

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Other

    Arm Label

    Clinician Coaching Immediate Intervention Arm-- Caregivers

    Clinician Coaching Wait-List Control Arm-- Caregivers

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.
    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.

    Secondary Outcome Measures

    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.
    Number of participants with Hospital Readmission at 30 days
    Child unplanned hospital readmission
    Number of participants with Hospital Readmission at 90 days
    Child unplanned hospital readmission
    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.

    Full Information

    First Posted
    October 25, 2022
    Last Updated
    September 7, 2023
    Sponsor
    Duke University
    Collaborators
    Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05618652
    Brief Title
    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

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 1, 2023 (Anticipated)
    Primary Completion Date
    January 2025 (Anticipated)
    Study Completion Date
    January 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Duke University
    Collaborators
    Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hospitalism in Children, Post Traumatic Stress Disorder

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    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.
    Masking
    ParticipantOutcomes Assessor
    Masking Description
    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.
    Allocation
    Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Clinician Coaching Immediate Intervention Arm-- Caregivers
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Clinician Coaching Wait-List Control Arm-- Caregivers
    Arm Type
    Other
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Equity Focused and Trauma-Informed Communication Intervention
    Intervention Description
    Clinician communication intervention that includes didactic training and real-time feedback on communication behaviors during clinical encounters.
    Primary Outcome Measure Information:
    Title
    Caregiver Post-Traumatic Stress Symptoms as measured by the Impact of Events Scale at 30 days
    Description
    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.
    Time Frame
    30 days after discharge
    Title
    Caregiver Post-Traumatic Stress Symptoms as measured by the Impact of Events Scale at 90 days
    Description
    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.
    Time Frame
    90 days after discharge
    Title
    Child Post-Traumatic Stress Symptoms as measured by the Behavioral Assessment System for Children at 30 days
    Description
    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.
    Time Frame
    30 days after discharge
    Title
    Child Post-Traumatic Stress Symptoms as measured by the Behavioral Assessment System for Children at 90 days
    Description
    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.
    Time Frame
    90 days after discharge
    Secondary Outcome Measure Information:
    Title
    Change in caregiver Salivary Cortisol
    Description
    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.
    Time Frame
    30-60 minutes before and 20-30 minutes after FCR
    Title
    Number of participants with Hospital Readmission at 30 days
    Description
    Child unplanned hospital readmission
    Time Frame
    30 days after discharge
    Title
    Number of participants with Hospital Readmission at 90 days
    Description
    Child unplanned hospital readmission
    Time Frame
    90 days after discharge
    Title
    Number of Caregiver Participatory Behaviors
    Description
    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.
    Time Frame
    During hospitalization

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Victoria M. Parente, MD
    Phone
    631-806-4695
    Email
    victoria.parente@duke.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Victoria M. Parente, MD
    Organizational Affiliation
    Duke University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Data will only be available to individuals on the Institutional Review Board protocol. We will share study protocol documents including intervention didactic materials and outcome measure assessments.
    Citations:
    PubMed Identifier
    35411380
    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.
    Results Reference
    background
    PubMed Identifier
    35696195
    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.
    Results Reference
    result
    PubMed Identifier
    35079809
    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.
    Results Reference
    result

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

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