Trial Outcomes & Findings for Improving Family Meetings in the Pediatric Cardiac Intensive Care Unit (NCT NCT03749330)

NCT ID: NCT03749330

Last Updated: 2024-01-18

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 451 participants
• Primary outcome timeframe: 2 years
• Results posted on: 2024-01-18

Participant Flow

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.

Participant milestones

Measure	Parents Participating in Clinical Trial (Single Arm) Parents of hospitalized children enrolled in the pre and post-intervention arms of the study	Clinicians Participating in Intervention Training (Single Arm) Interprofessional clinicians participated in intervention training to deploy the intervention	Clinicians Not Participating in Intervention Training (Not CST) Clinicians Not participating in Intervention Training (not CST) but were observed in a team or family meeting and so were enrolled in the study under the same IRB.	Pre-intervention Parents Who Only Did Interview/Survey Parents who were enrolled in the CICU prior to the intervention who did not participate in the intervention and only completed a one time survey or interview and therefore are not considered part of the clinical trial	Participants in the Codesign Clinicians and parents who participated in the codesign of the intervention but did not participate in the intervention and therefore are not part of the clinical trial	Children Patients of the Parents Enrolled in the Study Because we collected clinical data from the medical record of patients who were children of parents enrolled in the study, these are considered enrolled participants under the IRB protocol although they did not participate in the intervention.
Overall Study STARTED	60	24	202	45	21	99
Overall Study COMPLETED	60	22	202	45	21	99
Overall Study NOT COMPLETED	0	2	0	0	0	0

Reasons for withdrawal

Measure	Parents Participating in Clinical Trial (Single Arm) Parents of hospitalized children enrolled in the pre and post-intervention arms of the study	Clinicians Participating in Intervention Training (Single Arm) Interprofessional clinicians participated in intervention training to deploy the intervention	Clinicians Not Participating in Intervention Training (Not CST) Clinicians Not participating in Intervention Training (not CST) but were observed in a team or family meeting and so were enrolled in the study under the same IRB.	Pre-intervention Parents Who Only Did Interview/Survey Parents who were enrolled in the CICU prior to the intervention who did not participate in the intervention and only completed a one time survey or interview and therefore are not considered part of the clinical trial	Participants in the Codesign Clinicians and parents who participated in the codesign of the intervention but did not participate in the intervention and therefore are not part of the clinical trial	Children Patients of the Parents Enrolled in the Study Because we collected clinical data from the medical record of patients who were children of parents enrolled in the study, these are considered enrolled participants under the IRB protocol although they did not participate in the intervention.
Overall Study Clinicians left work in the CICU	0	2	0	0	0	0

Baseline Characteristics

Improving Family Meetings in the Pediatric Cardiac Intensive Care Unit

Baseline characteristics by cohort

Measure	Parents Participating in Clinical Trial (CST Intervention) n=60 Participants Parents of hospitalized child enrolled in the pre and post-intervention arms of the study	CICU Clinicians Participating in Intervention Training (CST) n=24 Participants Interprofessional clinicians who participated in intervention training	Clinicians Not Participating in Intervention Training (Not CST) n=202 Participants 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.	Pre-intervention Parents Who Participated Only in the Survey or Interview, Not the CST n=45 Participants 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.	Participants in Codesign n=21 Participants Clinicians and Parents who participated in the codesign (development) of the intervention and therefore there are no outcomes measures for them.	Children Patients of Parents Who Participated in Study n=99 Participants Patients who are the children of whom participated in the study. There are no outcome measures for the patient data.	Total n=451 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	99 Participants n=10 Participants	99 Participants n=115 Participants
Age, Categorical Between 18 and 65 years	60 Participants n=5 Participants	24 Participants n=7 Participants	202 Participants n=5 Participants	45 Participants n=4 Participants	21 Participants n=21 Participants	0 Participants n=10 Participants	352 Participants n=115 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Sex: Female, Male Female	41 Participants n=5 Participants	19 Participants n=7 Participants	144 Participants n=5 Participants	28 Participants n=4 Participants	19 Participants n=21 Participants	39 Participants n=10 Participants	290 Participants n=115 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	5 Participants n=7 Participants	58 Participants n=5 Participants	17 Participants n=4 Participants	2 Participants n=21 Participants	60 Participants n=10 Participants	161 Participants n=115 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants n=5 Participants	1 Participants n=7 Participants	10 Participants n=5 Participants	7 Participants n=4 Participants	1 Participants n=21 Participants	21 Participants n=10 Participants	51 Participants n=115 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	46 Participants n=5 Participants	22 Participants n=7 Participants	134 Participants n=5 Participants	37 Participants n=4 Participants	20 Participants n=21 Participants	71 Participants n=10 Participants	330 Participants n=115 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	1 Participants n=7 Participants	58 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	7 Participants n=10 Participants	70 Participants n=115 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	2 Participants n=7 Participants	26 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	3 Participants n=10 Participants	36 Participants n=115 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Black or African American	13 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants	7 Participants n=4 Participants	1 Participants n=21 Participants	19 Participants n=10 Participants	47 Participants n=115 Participants
Race (NIH/OMB) White	35 Participants n=5 Participants	19 Participants n=7 Participants	119 Participants n=5 Participants	37 Participants n=4 Participants	19 Participants n=21 Participants	69 Participants n=10 Participants	298 Participants n=115 Participants
Race (NIH/OMB) More than one race	7 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=10 Participants	12 Participants n=115 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	49 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	6 Participants n=10 Participants	58 Participants n=115 Participants
Region of Enrollment United States	60 participants n=5 Participants	24 participants n=7 Participants	202 participants n=5 Participants	45 participants n=4 Participants	21 participants n=21 Participants	99 participants n=10 Participants	451 participants n=115 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	CICU Clinicians Participating in Intervention Training for Clinical Trial (Single Arm) n=22 Participants CICU Clinicians completed intervention training to enhance their conduct of family meetings.	Parents Participating in the Intervention (Single Arm) Parents of hospitalized children participating in the pre and post intervention
Perceived Acceptability Comparison of CICU TALC by CICU Providers Immediately After Completion of Intervention: Satisfaction Survey	1.4 score on a scale Standard Deviation 0.5	—

PRIMARY outcome

Timeframe: 3.5 years

Population: Parents enrolled and retained in study

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

Outcome measures

Measure	CICU Clinicians Participating in Intervention Training for Clinical Trial (Single Arm) n=60 Participants CICU Clinicians completed intervention training to enhance their conduct of family meetings.	Parents Participating in the Intervention (Single Arm) n=24 Participants Parents of hospitalized children participating in the pre and post intervention
Participant Retention Rates	60 Participants	22 Participants

PRIMARY outcome

Timeframe: 3.5 years

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

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

Outcome measures

Measure	CICU Clinicians Participating in Intervention Training for Clinical Trial (Single Arm) n=63 Participants CICU Clinicians completed intervention training to enhance their conduct of family meetings.	Parents Participating in the Intervention (Single Arm) n=25 Participants Parents of hospitalized children participating in the pre and post intervention
Participant Consent Rates	60 Participants	24 Participants

PRIMARY outcome

Timeframe: 3.5 years

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

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.

Outcome measures

Measure	CICU Clinicians Participating in Intervention Training for Clinical Trial (Single Arm) n=60 Participants CICU Clinicians completed intervention training to enhance their conduct of family meetings.	Parents Participating in the Intervention (Single Arm) n=24 Participants Parents of hospitalized children participating in the pre and post intervention
Rates of Missing Data From Parents and Team Subjects	59 Participants	22 Participants

PRIMARY outcome

Timeframe: 3.5 years

Population: Analysis of length of meeting between team and family

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

Outcome measures

Measure	CICU Clinicians Participating in Intervention Training for Clinical Trial (Single Arm) n=58 meetings CICU Clinicians completed intervention training to enhance their conduct of family meetings.	Parents Participating in the Intervention (Single Arm) n=58 meetings Parents of hospitalized children participating in the pre and post intervention
Duration of Meetings Between Teams and Families	50 minutes of meeting Standard Deviation 20	50 minutes of meeting Standard Deviation 20

PRIMARY outcome

Timeframe: 2 years

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

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).

Outcome measures

Measure	CICU Clinicians Participating in Intervention Training for Clinical Trial (Single Arm) n=25 Participants CICU Clinicians completed intervention training to enhance their conduct of family meetings.	Parents Participating in the Intervention (Single Arm) Parents of hospitalized children participating in the pre and post intervention
Amount of Information Provided by CICU TALC as Perceived by Parent Participants in Intervention	2.2 score on a scale Standard Deviation 0.4	—

PRIMARY outcome

Timeframe: 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.

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).

Outcome measures

Measure	CICU Clinicians Participating in Intervention Training for Clinical Trial (Single Arm) n=25 Participants CICU Clinicians completed intervention training to enhance their conduct of family meetings.	Parents Participating in the Intervention (Single Arm) Parents of hospitalized children participating in the pre and post intervention
Perceived Clarity of Intervention Materials of CICU TALC by Parent Participants in Intervention	1.48 score on a scale Standard Deviation 0.57	—

PRIMARY outcome

Timeframe: 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.

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).

Outcome measures

Measure	CICU Clinicians Participating in Intervention Training for Clinical Trial (Single Arm) n=25 Participants CICU Clinicians completed intervention training to enhance their conduct of family meetings.	Parents Participating in the Intervention (Single Arm) Parents of hospitalized children participating in the pre and post intervention
Summary Rating of CICU TALC Intervention by Parent Participants in Intervention	1.76 score on a scale Standard Deviation 0.76	—

PRIMARY outcome

Timeframe: 2 years

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

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.

Outcome measures

Measure	CICU Clinicians Participating in Intervention Training for Clinical Trial (Single Arm) n=30 meetings CICU Clinicians completed intervention training to enhance their conduct of family meetings.	Parents Participating in the Intervention (Single Arm) n=30 meetings Parents of hospitalized children participating in the pre and post intervention
Percent of Family Meetings Adhering to Intervention Protocol	93 percentage of meetings with fidelity	93 percentage of meetings with fidelity

PRIMARY outcome

Timeframe: 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.

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

Outcome measures

Measure	CICU Clinicians Participating in Intervention Training for Clinical Trial (Single Arm) n=30 meetings CICU Clinicians completed intervention training to enhance their conduct of family meetings.	Parents Participating in the Intervention (Single Arm) Parents of hospitalized children participating in the pre and post intervention
Percent of Team Meetings Adhering to Intervention Schedule and Protocol: Observation of Meeting	28 percentage of total family meetings	—

PRIMARY outcome

Timeframe: 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

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.

Outcome measures

Measure	CICU Clinicians Participating in Intervention Training for Clinical Trial (Single Arm) n=60 Participants CICU Clinicians completed intervention training to enhance their conduct of family meetings.	Parents Participating in the Intervention (Single Arm) n=24 Participants Parents of hospitalized children participating in the pre and post intervention
Feasibility of Enrollment and Retention of Participants	60 Participants	22 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	CICU Clinicians Participating in Intervention Training for Clinical Trial (Single Arm) n=58 meetings CICU Clinicians completed intervention training to enhance their conduct of family meetings.	Parents Participating in the Intervention (Single Arm) Parents of hospitalized children participating in the pre and post intervention
Changes in CICU Providers' Use of Explicit Statements of Empathy During Family Meetings pre-intervention	0.5 proportion of empathic terminators Interval 0.25 to 0.75	—
Changes in CICU Providers' Use of Explicit Statements of Empathy During Family Meetings post-intervention	0.27 proportion of empathic terminators Interval 0.0 to 0.6	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	CICU Clinicians Participating in Intervention Training for Clinical Trial (Single Arm) n=58 meetings CICU Clinicians completed intervention training to enhance their conduct of family meetings.	Parents Participating in the Intervention (Single Arm) Parents of hospitalized children participating in the pre and post intervention
Changes in CICU Team Function for Communication pre-intervention	3 score on a scale Interval 2.0 to 4.0	—
Changes in CICU Team Function for Communication post-intervention	5 score on a scale Interval 5.0 to 5.0	—

Adverse Events

Parent-Patient Dyads Participating in Clinical Trial

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

CICU Clinicians Participating in the Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jennifer Walter, MD, PhD, MS Associate Professor of Pediatrics

Children's Hospital of Philadelphia

Phone: 215-590-1000

Email: walterj1@chop.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place