Improving Family Meetings in the Pediatric Cardiac Intensive Care Unit

Not Applicable

Completed

Conditions: Critical Illness
Communication

Interventions: Behavioral: CICU Team And Loved Ones Communicating (CICU TALC)

Registration Number: NCT03749330

Lead Sponsor: Children's Hospital of Philadelphia

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 451

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CHOP CICU	CICU Team And Loved Ones Communicating (CICU TALC)	CICU Team And Loved Ones Communicating (CICU TALC)

Primary Outcome Measures

Name	Time	Method
Participant Consent Rates	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	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	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	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	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	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	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	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	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	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	2 years	Percent of Team interactions post-intervention will be monitored to assess the adherence to the intervention schedule and protocol.

Secondary Outcome Measures

Name	Time	Method
Changes in CICU Providers' Use of Explicit Statements of Empathy During Family Meetings	2 years	A proportion of empathic terminator statements provided by a clinician after a parental expression of negative emotion will be calculated pre and post intervention. The denominator of the proportion will be all the expressions of negative emotion by a parent and the numerator will be the instances in which a clinician responds without a statement of empathy. Because there will be a proportion calculated for all 58 meetings, we will then calculate the median proportion pre-intervention and post-intervention with an interquartile range. Empathic terminators are not desirable and therefore a lower proportion is considered a better outcome.
Changes in CICU Team Function for Communication	2 years	Team function communication will be measured by changes in the Performance Assessment for Communication and Teamwork Toolset - Novice (PACT-Novice) scores. The PACT-Novice communication item is scored on a 5-point Likert scale (1-poor, 3=average, 5-excellent). Higher scores are better. We analyzed the median (IQR) differences in pre-intervention vs. Post-intervention PACT novice item "communication" scores using wilcoxon rank sum tests.