Improving Family Meetings in the Pediatric Cardiac Intensive Care Unit
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 451
- 试验地点
- 2
- 主要终点
- Participant Consent Rates
研究概览
简要总结
This study aims to improve communication between medical teams, patients, and families in the pediatric cardiac intensive care unit. The researchers hypothesize that both improving interprofessional teamwork when preparing for family meeting and preparing families for these meetings will improve team and family satisfaction with communication. The study will involve bringing together a group of medical professionals and parents of patients to collaboratively design an intervention. In addition, the researchers will study feasibility and acceptability of the intervention and whether it impacts family and team outcomes.
详细描述
Context:
A large proportion of children with advanced heart disease (AHD) die in the pediatric cardiac intensive care unit (CICU), where parents describe obtaining a realistic understanding that their child had a life-limiting disease only 2 days prior to death. Delayed or inadequate communication within teams or with families may contribute to this lack of understanding (as shown in children with other serious illnesses), while interactions with pediatric palliative care specialists (PPCS) have been shown to improve communication and understanding of prognosis. The limited number of PPCS, however, means that all clinicians in the CICU must have the skills to support parental decision-making, including giving bad news and eliciting parental goals for their child.
Objectives:
- To develop a communication skills training (CST) program for interprofessional teams in the pediatric CICU via a co-design process.
- To evaluate CICU clinicians' perceived feasibility and acceptability of the CST.
- To evaluate CST impact on communication skills and team function in actual family meetings.
- To describe and evaluate parents' communication challenges in the CICU and their satisfaction with communication.
- To determine the parents' perceived acceptability of the parent-facing aspects of the CST program.
- Evaluate clinician fidelity to intervention plan.
Study Design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants in Co-design:
- •Clinicians including attending physicians, front line clinicians (fellows, nurse practitioners, or physician assistants), bedside nurses, and social workers working at CHOP or parents of children previously hospitalized in an ICU at CHOP.
- •Clinicians Participating in Intervention:
- •Pediatric CICU clinicians (attending intensivists, cardiologists, cardiac surgeons, front line clinicians, bedside nurses, and social workers) at CHOP who volunteer to undergo communication skills training.
- •Clinicians Not Participating in Intervention:
- •Clinicians who plan to participate in family meetings in the pediatric CICU that will be observed by the research team.
- •Parent-patient Dyads Participating in the Survey or Interview:
- •Parent must be the legal decision maker of a patient who has been admitted to the CHOP CICU for at least 7 days.
- •Patient has been admitted to the CICU at CHOP for ≥7 days following onset of study and the medical team believes the patient will remain in the CICU for at least 7 more days OR the patient has already been admitted to the CICU for 14 days.
- •Parent/guardian ≥ 18 years old.
- •Child < 18 years old at time of enrollment.
- •Parent/guardian is English-speaking.
- •Parent/guardian has no cognitive impairments that prevent them from being a surrogate decision maker.
排除标准
- •Participants in Co-design:
- •Clinicians Participating in Intervention:
- •Clinicians who will not participate in CHOP's CICU chronic care meeting in the following year.
- •Clinicians Not Participating in Intervention:
- •Parent-patient Dyads Participating in the Survey or Interview:
- •Parent is not the legal decision maker of a patient who has been admitted to the CHOP CICU for at least 7 days.
- •The medical team does not believe the patient will remain in the CICU for at least 7 more days.
- •Parent/guardian < 18 years old.
- •Child is ≥ 18 years old at time of enrollment.
- •Parent/guardian is not English-speaking.
- •Parent/guardian has cognitive impairments that prevent them from being a surrogate decision maker.
结局指标
主要结局
Participant Consent Rates
时间窗: 3.5 years
Consent rates will be tracked over time by comparing numbers of consenting subjects to numbers of subjects who do not consent to participate
Duration of Meetings Between Teams and Families
时间窗: 3.5 years
Meetings will be audio-recorded and the length of each meeting measured automatically as part of analysis with NVivo qualitative coding software
Rates of Missing Data From Parents and Team Subjects
时间窗: 3.5 years
Percent of missing data from parent and CICU team member reported survey data will be tracked throughout the study. All participants should have had data collected, therefore denominator is number of participants and the numerator is the number of participants that we received survey data from.
Feasibility of Enrollment and Retention of Participants
时间窗: 2 years
Were we able to enroll clinicians in the intervention portion of the study and parents in the study and to what extent were they retained throughout the duration of the study.
Perceived Acceptability Comparison of CICU TALC by CICU Providers Immediately After Completion of Intervention: Satisfaction Survey
时间窗: 5 months
Acceptability of the study will be evaluated with 1 item from the Satisfaction with and Impact of the Course survey. The item is whether the training would be recommended to colleagues scored using a 4-point Likert scale (1=strongly agree to 4=strongly disagree), therefore a lower score indicates more acceptability.
Summary Rating of CICU TALC Intervention by Parent Participants in Intervention
时间窗: 2 years
Overall parent participant perception of the intervention will be assessed with the summary rating of intervention item from the Patient Ratings of Shared Decision Making Program scale. Response options range from 1-5 on a 5-point Likert scale (1=very positive, generally positive, neutral, somewhat positive, 5=very negative).
Percent of Family Meetings Adhering to Intervention Protocol
时间窗: 2 years
For the 30 family meetings which were intended to receive the intervention (CST) we will assess the percent of those meetings which met the threshold of adhering to the intervention protocol. The denominator is the total number of observed MEETINGS in the post-intervention phase and the numerator is the number of meeting that meet the adherence threshold.
Participant Retention Rates
时间窗: 3.5 years
Retention rates will be tracked over time by comparing numbers of enrolled/retained subjects to numbers of those who decline to enroll or disenroll
Amount of Information Provided by CICU TALC as Perceived by Parent Participants in Intervention
时间窗: 2 years
Parent participant perception of acceptability of the amount of information included in the intervention will be assessed with the amount of information item from the Patient Ratings of Shared Decision Making Program scale. Response options range from 1-3 on a 3-point Likert scale (1=less than wanted, about right, 3=more than wanted).
Perceived Clarity of Intervention Materials of CICU TALC by Parent Participants in Intervention
时间窗: 2 years
Parent participant perception of clarity of intervention materials will be assessed with the clarity item from the Patient Ratings of Shared Decision Making Program scale. Response options range from 1-3 on a 3-point Likert scale (1=everything clear, most things clear, 3=some/many things unclear).
Percent of Team Meetings Adhering to Intervention Schedule and Protocol: Observation of Meeting
时间窗: 2 years
Percent of Team interactions post-intervention will be monitored to assess the adherence to the intervention schedule and protocol.
次要结局
- Changes in CICU Providers' Use of Explicit Statements of Empathy During Family Meetings(2 years)
- Changes in CICU Team Function for Communication(2 years)