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临床试验/NCT05618652
NCT05618652已完成不适用

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

Duke University2 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2024年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
51
试验地点
2
主要终点
Feasibility measured by enrollment rate of clinicians and caregivers combined

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Health Services Research
盲法
Double (Participant, Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 未提供

研究组 & 干预措施

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.

干预措施: Equity Focused and Trauma-Informed Communication Intervention (Behavioral)

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.

干预措施: Equity Focused and Trauma-Informed Communication Intervention (Behavioral)

结局指标

主要结局

Feasibility measured by enrollment rate of clinicians and caregivers combined

时间窗: Up to 12 months

Feasibility measured by the rate of complete data collection by caregivers

时间窗: Up to 12 months

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

时间窗: Up to 12 months

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

时间窗: 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)

时间窗: 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)

时间窗: 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

时间窗: Up to 12 months

Clinician communication behaviors measured via audio-recorded hospital encounters.

Number of Clinician partnership-building statements

时间窗: Up to 12 months

Clinician communication behaviors measured via audio-recorded hospital encounters.

Number of Clinician interruptions

时间窗: Up to 12 months

Clinician communication behaviors measured via audio-recorded hospital encounters.

Number of Clinician praise statements

时间窗: Up to 12 months

Clinician communication behaviors measured via audio-recorded hospital encounters.

Number of Clinician permission asking

时间窗: Up to 12 months

Clinician communication behaviors measured via audio-recorded hospital encounters.

Caregiver Satisfaction measured by survey

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: Timeframe up to 12 months

Measured by salivary cortisol levels

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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