Communication, Critical Illness
Conditions
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
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
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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 |
| 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 |
| 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. |
| 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 |
| 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
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
| Arm | Count |
|---|---|
| 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 |
| Total | 451 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Clinicians left work in the CICU | 0 | 2 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | Parents 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 CST | Participants in Codesign | Children Patients of Parents Who Participated in Study |
|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 99 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 99 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 352 Participants | 60 Participants | 24 Participants | 202 Participants | 45 Participants | 21 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 51 Participants | 11 Participants | 1 Participants | 10 Participants | 7 Participants | 1 Participants | 21 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 330 Participants | 46 Participants | 22 Participants | 134 Participants | 37 Participants | 20 Participants | 71 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 70 Participants | 3 Participants | 1 Participants | 58 Participants | 1 Participants | 0 Participants | 7 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 36 Participants | 3 Participants | 2 Participants | 26 Participants | 1 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 47 Participants | 13 Participants | 2 Participants | 5 Participants | 7 Participants | 1 Participants | 19 Participants |
| Race (NIH/OMB) More than one race | 12 Participants | 7 Participants | 0 Participants | 3 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 58 Participants | 2 Participants | 1 Participants | 49 Participants | 0 Participants | 0 Participants | 6 Participants |
| Race (NIH/OMB) White | 298 Participants | 35 Participants | 19 Participants | 119 Participants | 37 Participants | 19 Participants | 69 Participants |
| Region of Enrollment United States | 451 participants | 60 participants | 24 participants | 202 participants | 45 participants | 21 participants | 99 participants |
| Sex: Female, Male Female | 290 Participants | 41 Participants | 19 Participants | 144 Participants | 28 Participants | 19 Participants | 39 Participants |
| Sex: Female, Male Male | 161 Participants | 19 Participants | 5 Participants | 58 Participants | 17 Participants | 2 Participants | 60 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 60 | 0 / 24 |
| other Total, other adverse events | 0 / 60 | 0 / 24 |
| serious Total, serious adverse events | 0 / 60 | 0 / 24 |
Outcome results
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.
| Arm | Measure | Value (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 Intervention | 2.2 score on a scale | Standard Deviation 0.4 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CICU Clinicians Participating in Intervention Training for Clinical Trial (Single Arm) | Duration of Meetings Between Teams and Families | 50 minutes of meeting | Standard Deviation 20 |
| Parents Participating in the Intervention (Single Arm) | Duration of Meetings Between Teams and Families | 50 minutes of meeting | Standard Deviation 20 |
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CICU Clinicians Participating in Intervention Training for Clinical Trial (Single Arm) | Feasibility of Enrollment and Retention of Participants | 60 Participants |
| Parents Participating in the Intervention (Single Arm) | Feasibility of Enrollment and Retention of Participants | 22 Participants |
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CICU Clinicians Participating in Intervention Training for Clinical Trial (Single Arm) | Participant Consent Rates | 60 Participants |
| Parents Participating in the Intervention (Single Arm) | Participant Consent Rates | 24 Participants |
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CICU Clinicians Participating in Intervention Training for Clinical Trial (Single Arm) | Participant Retention Rates | 60 Participants |
| Parents Participating in the Intervention (Single Arm) | Participant Retention Rates | 22 Participants |
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.
| Arm | Measure | Value (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 Survey | 1.4 score on a scale | Standard Deviation 0.5 |
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.
| Arm | Measure | Value (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 Intervention | 1.48 score on a scale | Standard Deviation 0.57 |
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CICU Clinicians Participating in Intervention Training for Clinical Trial (Single Arm) | Percent of Family Meetings Adhering to Intervention Protocol | 93 percentage of meetings with fidelity |
| Parents Participating in the Intervention (Single Arm) | Percent of Family Meetings Adhering to Intervention Protocol | 93 percentage of meetings with fidelity |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CICU Clinicians Participating in Intervention Training for Clinical Trial (Single Arm) | Percent of Team Meetings Adhering to Intervention Schedule and Protocol: Observation of Meeting | 28 percentage of total family meetings |
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CICU Clinicians Participating in Intervention Training for Clinical Trial (Single Arm) | Rates of Missing Data From Parents and Team Subjects | 59 Participants |
| Parents Participating in the Intervention (Single Arm) | Rates of Missing Data From Parents and Team Subjects | 22 Participants |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CICU Clinicians Participating in Intervention Training for Clinical Trial (Single Arm) | Summary Rating of CICU TALC Intervention by Parent Participants in Intervention | 1.76 score on a scale | Standard Deviation 0.76 |
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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| CICU Clinicians Participating in Intervention Training for Clinical Trial (Single Arm) | Changes in CICU Providers' Use of Explicit Statements of Empathy During Family Meetings | pre-intervention | 0.5 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 Meetings | post-intervention | 0.27 proportion of empathic terminators |
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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| CICU Clinicians Participating in Intervention Training for Clinical Trial (Single Arm) | Changes in CICU Team Function for Communication | pre-intervention | 3 score on a scale |
| CICU Clinicians Participating in Intervention Training for Clinical Trial (Single Arm) | Changes in CICU Team Function for Communication | post-intervention | 5 score on a scale |