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Improving Family Meetings in the Pediatric Cardiac Intensive Care Unit

Improving Family Meetings in the Pediatric Cardiac Intensive Care Unit

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03749330
Enrollment
451
Registered
2018-11-21
Start date
2018-12-19
Completion date
2022-09-20
Last updated
2024-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Communication, Critical Illness

Keywords

cardiac intensive care unit, pediatrics, medical communication

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.

Interventions

BEHAVIORALCICU Team And Loved Ones Communicating (CICU TALC)

When the necessary pre-intervention clinical encounters are completed, clinicians will go through the interprofessional team training to improve communication skills and teamwork in developing care plans and communicating with families in family meetings. The first step in the study is co-design of the intervention, so it will evolve as the study continues.

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
Children's Hospital of Philadelphia
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Percent of Team Meetings Adhering to Intervention Schedule and Protocol: Observation of Meeting2 yearsPercent of Team interactions post-intervention will be monitored to assess the adherence to the intervention schedule and protocol.
Summary Rating of CICU TALC Intervention by Parent Participants in Intervention2 yearsOverall 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 Protocol2 yearsFor 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.
Feasibility of Enrollment and Retention of Participants2 yearsWere 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 Survey5 monthsAcceptability 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.
Participant Retention Rates3.5 yearsRetention rates will be tracked over time by comparing numbers of enrolled/retained subjects to numbers of those who decline to enroll or disenroll
Participant Consent Rates3.5 yearsConsent rates will be tracked over time by comparing numbers of consenting subjects to numbers of subjects who do not consent to participate
Rates of Missing Data From Parents and Team Subjects3.5 yearsPercent 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.
Duration of Meetings Between Teams and Families3.5 yearsMeetings will be audio-recorded and the length of each meeting measured automatically as part of analysis with NVivo qualitative coding software
Amount of Information Provided by CICU TALC as Perceived by Parent Participants in Intervention2 yearsParent 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 Intervention2 yearsParent 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).

Secondary

MeasureTime frameDescription
Changes in CICU Team Function for Communication2 yearsTeam 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.
Changes in CICU Providers' Use of Explicit Statements of Empathy During Family Meetings2 yearsA 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.

Countries

United States

Participant flow

Pre-assignment details

There are many different aspects of this NIH funded study which are not a clinical trial. I have included a full participant count for the funded project although there is only a subset are in the clinical trial. The clinical trial includes 2 groups: 1) Parents of hospitalized children who were in the pre and post-intervention. 2) CICU Clinicians who participated in the intervention training. Only these groups are in the participant flow and the outcome measures.

Participants by arm

ArmCount
Parents Participating in Clinical Trial (CST Intervention)
Parents of hospitalized child enrolled in the pre and post-intervention arms of the study
60
CICU Clinicians Participating in Intervention Training (CST)
Interprofessional clinicians who participated in intervention training
24
Clinicians Not Participating in Intervention Training (Not CST)
Clinicians who were enrolled in the study because they participated in an observed team or family meeting but did not participate in the intervention training and so there are no outcome measures collected for them.
202
Pre-intervention Parents Who Participated Only in the Survey or Interview, Not the CST
Pre-intervention parents who completed a one time survey or interview and were enrolled in the study for that purpose but did not participate in the family meeting that was observed as part of the intervention and therefore we have no outcome measures collected for them related to the CST.
45
Participants in Codesign
Clinicians and Parents who participated in the codesign (development) of the intervention and therefore there are no outcomes measures for them.
21
Children Patients of Parents Who Participated in Study
Patients who are the children of whom participated in the study. There are no outcome measures for the patient data.
99
Total451

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004FG005
Overall StudyClinicians left work in the CICU020000

Baseline characteristics

CharacteristicTotalParents Participating in Clinical Trial (CST Intervention)CICU Clinicians Participating in Intervention Training (CST)Clinicians Not Participating in Intervention Training (Not CST)Pre-intervention Parents Who Participated Only in the Survey or Interview, Not the CSTParticipants in CodesignChildren Patients of Parents Who Participated in Study
Age, Categorical
<=18 years
99 Participants0 Participants0 Participants0 Participants0 Participants0 Participants99 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
352 Participants60 Participants24 Participants202 Participants45 Participants21 Participants0 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
51 Participants11 Participants1 Participants10 Participants7 Participants1 Participants21 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
330 Participants46 Participants22 Participants134 Participants37 Participants20 Participants71 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
70 Participants3 Participants1 Participants58 Participants1 Participants0 Participants7 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
36 Participants3 Participants2 Participants26 Participants1 Participants1 Participants3 Participants
Race (NIH/OMB)
Black or African American
47 Participants13 Participants2 Participants5 Participants7 Participants1 Participants19 Participants
Race (NIH/OMB)
More than one race
12 Participants7 Participants0 Participants3 Participants0 Participants0 Participants2 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
58 Participants2 Participants1 Participants49 Participants0 Participants0 Participants6 Participants
Race (NIH/OMB)
White
298 Participants35 Participants19 Participants119 Participants37 Participants19 Participants69 Participants
Region of Enrollment
United States
451 participants60 participants24 participants202 participants45 participants21 participants99 participants
Sex: Female, Male
Female
290 Participants41 Participants19 Participants144 Participants28 Participants19 Participants39 Participants
Sex: Female, Male
Male
161 Participants19 Participants5 Participants58 Participants17 Participants2 Participants60 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 600 / 24
other
Total, other adverse events
0 / 600 / 24
serious
Total, serious adverse events
0 / 600 / 24

Outcome results

Primary

Amount of Information Provided by CICU TALC as Perceived by Parent Participants in Intervention

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).

Time frame: 2 years

Population: participants who completed survey data about intervention handout. CICU clinicians were not asked this outcome measure.

ArmMeasureValue (MEAN)Dispersion
CICU Clinicians Participating in Intervention Training for Clinical Trial (Single Arm)Amount of Information Provided by CICU TALC as Perceived by Parent Participants in Intervention2.2 score on a scaleStandard Deviation 0.4
Primary

Duration of Meetings Between Teams and Families

Meetings will be audio-recorded and the length of each meeting measured automatically as part of analysis with NVivo qualitative coding software

Time frame: 3.5 years

Population: Analysis of length of meeting between team and family

ArmMeasureValue (MEAN)Dispersion
CICU Clinicians Participating in Intervention Training for Clinical Trial (Single Arm)Duration of Meetings Between Teams and Families50 minutes of meetingStandard Deviation 20
Parents Participating in the Intervention (Single Arm)Duration of Meetings Between Teams and Families50 minutes of meetingStandard Deviation 20
Primary

Feasibility of Enrollment and Retention of Participants

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.

Time frame: 2 years

Population: Clinicians who were enrolled in the intervention and parents who were enrolled in the pre and post-intervention clinical trial. This outcome was only measured for the subjects that participated in the CST. Therefore there is no data for all other group/arms

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
CICU Clinicians Participating in Intervention Training for Clinical Trial (Single Arm)Feasibility of Enrollment and Retention of Participants60 Participants
Parents Participating in the Intervention (Single Arm)Feasibility of Enrollment and Retention of Participants22 Participants
Primary

Participant Consent Rates

Consent rates will be tracked over time by comparing numbers of consenting subjects to numbers of subjects who do not consent to participate

Time frame: 3.5 years

Population: percent of all parents screened eligible for enrollment and approached who enrolled

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
CICU Clinicians Participating in Intervention Training for Clinical Trial (Single Arm)Participant Consent Rates60 Participants
Parents Participating in the Intervention (Single Arm)Participant Consent Rates24 Participants
Primary

Participant Retention Rates

Retention rates will be tracked over time by comparing numbers of enrolled/retained subjects to numbers of those who decline to enroll or disenroll

Time frame: 3.5 years

Population: Parents enrolled and retained in study

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
CICU Clinicians Participating in Intervention Training for Clinical Trial (Single Arm)Participant Retention Rates60 Participants
Parents Participating in the Intervention (Single Arm)Participant Retention Rates22 Participants
Primary

Perceived Acceptability Comparison of CICU TALC by CICU Providers Immediately After Completion of Intervention: Satisfaction Survey

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.

Time frame: 5 months

Population: Only clinicians were asked this question. This question was not asked of parents because it was in reference to being trained in the intervention, which only clinicians were.

ArmMeasureValue (MEAN)Dispersion
CICU Clinicians Participating in Intervention Training for Clinical Trial (Single Arm)Perceived Acceptability Comparison of CICU TALC by CICU Providers Immediately After Completion of Intervention: Satisfaction Survey1.4 score on a scaleStandard Deviation 0.5
Primary

Perceived Clarity of Intervention Materials of CICU TALC by Parent Participants in Intervention

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).

Time frame: 2 years

Population: parents who completed survey questions post-intervention. CICU Clinicians were not asked this outcome measure as it was not relevant to them.

ArmMeasureValue (MEAN)Dispersion
CICU Clinicians Participating in Intervention Training for Clinical Trial (Single Arm)Perceived Clarity of Intervention Materials of CICU TALC by Parent Participants in Intervention1.48 score on a scaleStandard Deviation 0.57
Primary

Percent of Family Meetings Adhering to Intervention Protocol

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.

Time frame: 2 years

Population: 30 family meeting processes were observed to determine percent of them that met a threshold of fidelity to intervention

ArmMeasureValue (NUMBER)
CICU Clinicians Participating in Intervention Training for Clinical Trial (Single Arm)Percent of Family Meetings Adhering to Intervention Protocol93 percentage of meetings with fidelity
Parents Participating in the Intervention (Single Arm)Percent of Family Meetings Adhering to Intervention Protocol93 percentage of meetings with fidelity
Primary

Percent of Team Meetings Adhering to Intervention Schedule and Protocol: Observation of Meeting

Percent of Team interactions post-intervention will be monitored to assess the adherence to the intervention schedule and protocol.

Time frame: 2 years

Population: Percent of team meetings that strictly adhered to intervention schedule and protocol. There were no families observed in these meetings so no data is entered.

ArmMeasureValue (NUMBER)
CICU Clinicians Participating in Intervention Training for Clinical Trial (Single Arm)Percent of Team Meetings Adhering to Intervention Schedule and Protocol: Observation of Meeting28 percentage of total family meetings
Primary

Rates of Missing Data From Parents and Team Subjects

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.

Time frame: 3.5 years

Population: parents and clinicians who were supposed to complete survey data

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
CICU Clinicians Participating in Intervention Training for Clinical Trial (Single Arm)Rates of Missing Data From Parents and Team Subjects59 Participants
Parents Participating in the Intervention (Single Arm)Rates of Missing Data From Parents and Team Subjects22 Participants
Primary

Summary Rating of CICU TALC Intervention by Parent Participants in Intervention

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).

Time frame: 2 years

Population: parents who completed post-intervention survey about intervention. Clinicians were not given this measure since it was not relevant to their experience of the intervention.

ArmMeasureValue (MEAN)Dispersion
CICU Clinicians Participating in Intervention Training for Clinical Trial (Single Arm)Summary Rating of CICU TALC Intervention by Parent Participants in Intervention1.76 score on a scaleStandard Deviation 0.76
Secondary

Changes in CICU Providers' Use of Explicit Statements of Empathy During Family Meetings

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.

Time frame: 2 years

Population: 42 clinicians who participated in a total of 58 family meetings pre and post intervention. Parents were not analyzed for this outcome.

ArmMeasureGroupValue (MEDIAN)
CICU Clinicians Participating in Intervention Training for Clinical Trial (Single Arm)Changes in CICU Providers' Use of Explicit Statements of Empathy During Family Meetingspre-intervention0.5 proportion of empathic terminators
CICU Clinicians Participating in Intervention Training for Clinical Trial (Single Arm)Changes in CICU Providers' Use of Explicit Statements of Empathy During Family Meetingspost-intervention0.27 proportion of empathic terminators
Secondary

Changes in CICU Team Function for Communication

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.

Time frame: 2 years

Population: analyzed the median (IQR) differences in pre-intervention vs. Post-intervention PACT novice item communication scores using wilcoxon rank sum tests. These scores were not assigned to parents.

ArmMeasureGroupValue (MEDIAN)
CICU Clinicians Participating in Intervention Training for Clinical Trial (Single Arm)Changes in CICU Team Function for Communicationpre-intervention3 score on a scale
CICU Clinicians Participating in Intervention Training for Clinical Trial (Single Arm)Changes in CICU Team Function for Communicationpost-intervention5 score on a scale
p-value: <0.05Wilcoxon (Mann-Whitney)

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026