Clinical trial NCT03749330: Improving Family Meetings in the Pediatric Cardiac Intensive Care Unit
Official title: Improving Family Meetings in the Pediatric Cardiac Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Communication
Critical Illness
Keywords: cardiac intensive care unit
pediatrics
medical communication
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2018-11-21
Enrollment: 451
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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:

1. To develop a communication skills training (CST) program for interprofessional teams in the pediatric CICU via a co-design process.
2. To evaluate CICU clinicians' perceived feasibility and acceptability of the CST.
3. To evaluate CST impact on communication skills and team function in actual family meetings.
4. To describe and evaluate parents' communication challenges in the CICU and their satisfaction with communication.
5. To determine the parents' perceived acceptability of the parent-facing aspects of the CST program.
6. Evaluate clinician fidelity to intervention plan.

Study Design:

Prospective cohort study with pre and post assessments around an intervention.

Setting/Participants:

Clinicians at the Children's Hospital of Philadelphia (CHOP) and parents of children previously hospitalized in the ICU will be invited to participate in the co-design portion of the study to develop the team and family based intervention. A separate group of volunteer attending intensivists, cardiologists, cardiac surgeons, front line clinicians, bedside nurses, and social workers from the pediatric CICU at the Children's Hospital of Philadelphia (CHOP) will undergo the intervention and participate in observed family meetings before and after the intervention. Other clinicians who are participating in an observed family meeting will also be enrolled. Parents or legal guardians and their children in the CICU who have been there for at least 7 days and are expected to stay at least another 7 days will also be consented and enrolled.

Study Interventions and Measures:

Intervention:

The intervention includes both an interprofessional team training that will include practice in communication skills of giving bad news and building team collaboration and a family oriented intervention to prepare them for family meetings.

Measures:

The Co-design process to develop the intervention will have focus groups to evaluate the interventions' content and perceived feasibility.

The impact of the intervention on CICU clinicians' perceived usefulness and satisfaction with the training will be measured with post-intervention survey and follow-up interviews.

For the actual family meetings, assessment of the impact of the intervention on communication and team function in actual family meetings pre and post-intervention will be done by coding audio recordings with validated tools and qualitative coding of content. Collaboration will be measured using the amount of time different members of different disciplines speak, and team member perception and satisfaction with collaboration will be measured using a validated tool. Fidelity of the intervention implementation will be measured by documenting behaviors of clinicians post-intervention in meetings and in chart documentation.

Parents' experiences in family meetings and perspectives on communication with the clinical team will be measured with a pre-intervention survey measuring parental mood, affect, and satisfaction with communication or with semi-structured interview. Parental perception of the CST will be measured in post-intervention surveys and acceptability interviews.

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

Participants in Co-design:

- None.

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:

- None.

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.

Primary outcomes:
measure: Perceived Acceptability Comparison of CICU TALC by CICU Providers Immediately After Completion of Intervention: Satisfaction Survey
timeFrame: 5 months
measure: Participant Retention Rates
timeFrame: 3.5 years
measure: Participant Consent Rates
timeFrame: 3.5 years
measure: Rates of Missing Data From Parents and Team Subjects
timeFrame: 3.5 years
measure: Duration of Meetings Between Teams and Families
timeFrame: 3.5 years
measure: Amount of Information Provided by CICU TALC as Perceived by Parent Participants in Intervention
timeFrame: 2 years
measure: Perceived Clarity of Intervention Materials of CICU TALC by Parent Participants in Intervention
timeFrame: 2 years
measure: Summary Rating of CICU TALC Intervention by Parent Participants in Intervention
timeFrame: 2 years
measure: Percent of Family Meetings Adhering to Intervention Protocol
timeFrame: 2 years
measure: Percent of Team Meetings Adhering to Intervention Schedule and Protocol: Observation of Meeting
timeFrame: 2 years
measure: Feasibility of Enrollment and Retention of Participants
timeFrame: 2 years
Secondary outcomes:
measure: Changes in CICU Providers' Use of Explicit Statements of Empathy During Family Meetings
timeFrame: 2 years
measure: Changes in CICU Team Function for Communication
timeFrame: 2 years
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Jennifer K Walter, MD, PhD, MS
role: PRINCIPAL_INVESTIGATOR
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