Improving Family Meetings in the Pediatric Cardiac Intensive Care Unit

Study Overview
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Brief Summary
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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
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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: To develop a communication skills training (CST) program for interprofessional teams in the pediatric CICU via a co-design process. To evaluate CICU clinicians' perceived feasibility and acceptability of the CST. To evaluate CST impact on communication skills and team function in actual family meetings. To describe and evaluate parents' communication challenges in the CICU and their satisfaction with communication. To determine the parents' perceived acceptability of the parent-facing aspects of the CST program. 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.

Official Title
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Improving Family Meetings in the Pediatric Cardiac Intensive Care Unit

Conditions
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Communication, Critical Illness

Intervention / Treatment
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* Behavioral: CICU Team And Loved Ones Communicating (CICU TALC)


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: CHOP CICU<br>CICU Team And Loved Ones Communicating (CICU TALC) | Behavioral: CICU Team And Loved Ones Communicating (CICU TALC)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived acceptability comparison of CICU TALC by CICU providers immediately after completion of intervention: satisfaction survey | Acceptability of the study will be evaluated with the Satisfaction with and Impact of the Course survey. The post-intervention survey consists of 8 questions about training effectiveness, enjoyability, usefulness, whether it would be recommended to colleagues, and whether the time/cost was worth it, scored using a 4-point Likert scale (1=strongly agree to 4=strongly disagree). | 5 months | 
| 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 | 4 years | 
| 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 | 4 years | 
| Rates of missing data from parents and team subjects | Rates of missing data from parent and CICU team member reported survey data will be tracked throughout the study | 4 years | 
| 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 | 4 years | 
| 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). | 2 years | 
| 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). | 2 years | 
| 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). | 2 years | 
| Rate of adherence to intervention protocol: observation of intervention | Intervention will be observed to characterize whether intervention protocol was adhered to. | 2 years | 
| Adherence to intervention schedule and protocol:observation of meetings | Team interactions post-intervention will be monitored to assess the adherence to the intervention schedule and protocol. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in CICU providers' SPIKES skills acquisition | SPIKES is an acronym that stands for setting, perception, invitation, knowledge, emotion, and summary. It is a stepwise approach for giving bad news by preparing the setting; assessing the patient's perception; making an invitation to disclose the news; sharing the knowledge about the news; responding to the patient's emotion; and summarizing the plan. Skills acquisition will be assessed by the SCOPE tool, which is a modified VitalTalk coding scheme, applied during qualitative coding. Evaluation of individual and combined SPIKES skills will involve tallying the number of times each skill appears. | 2 years | 
| Changes in CICU providers' NURSE skills acquisition | NURSE is an acronym that stands for naming, understanding, respect, support, and exploring. It measures clinicians' use of verbal empathetic expressions by how they name emotions; express understanding; show respect or praise for a patient's behavior; articulate support for the patient; and explore the patient's emotional state. Skills acquisition will be assessed by the SCOPE tool, which is a modified VitalTalk coding scheme, applied during qualitative coding. Evaluation of individual and combined NURSE skills will involve tallying the number of times each skill appears. | 2 years | 
| Changes in CICU team function | Team function will be analyzed by comparing the change in the number of minutes clinicians from each discipline speak in pre- and post-intervention meetings using linear regression and controlling for the length of the meetings. | 4 years | 
| Changes in CICU team function | Team function will be measured by changes in the Performance Assessment for Communication and Teamwork Toolset - Novice (PACT-Novice) scores. PACT-Novice is scored on a 5-point Likert scale (1-poor, 3=average, 5-excellent). Scores are separately reported for the scale's 5 subdomains, each of which is a separate item: team structure, leadership, situation monitoring, mutual support, and communication. | 4 years | 
| Changes in parental perspectives about communication challenges in the CICU | In-person interviews will assess parents' experiences in communicating in the CICU with the clinical team. A constructivist grounded theory approach will guide qualitative analysis of interview transcripts. | 4 years | 
| Changes in parental anxiety and depression in the CICU | Parental anxiety and depressed will be assessed with the Hospital Anxiety and Depression Scale (HAD), a self-assessment tool that has been validated for screening for mood disorders. The tool has a scoring range of 0-21. Scores between 0-7 are considered normal, between 8-10 are considered borderline, and between 11-21 are considered abnormal. | 4 years | 
| Changes in parental stress responses | Changes in parental stress responses will be measured by use of the Impact of Event Scale-Revised (IES-R), a validated self-report measure that maps onto the diagnostic criteria for Post-Traumatic Stress Disorder (PTSD). The tool has a scoring range of 0-88. Scores of 24 or more indicate that PTSD is a clinical concern. Scores 33 and above indicate a probable diagnosis of PTSD. | 4 years | 
| Changes in parental trust in physicians | Changes in parental trust in physicians will be evaluated with the Trust in Physician Scale, an 11-item, single-score, validated self-report tool. The measure uses a five point scale (1=Strongly Disagree to 5= Strongly Agree). A summary measure of trust is obtained by taking the un- weighted mean of the responses to the 11 questions and transforming that value to a 0-100 scale. Higher scores reflect greater trust. | 4 years | 
| Changes in parental satisfaction with communication in the CICU | Changes in parental satisfaction with communication in the CICU will be evaluated with the Pediatric Family Satisfaction with Care in the Intensive Care Unit (PFS-ICU 24) survey, which has been validated for use with parents/caregivers of critically ill children. The pFS-ICU 24 survey has 24 Likert-scale questions divided in two domains; satisfaction with care (14 questions) and satisfaction with medical decision-making (10 questions). Scores range from 0-100, with 0 representing the lowest satisfaction and 100 representing the highest satisfaction. | 4 years | 
| Changes in parental perspectives about communication satisfaction in the CICU | Changes in parental perspectives about and satisfaction with communication in the CICU will be evaluated using the Communication Assessment Tool-Team (CAT-T), a validated patient survey focused on the quality of communication received from a medical team. The tool consists of 15 items on a 5-point response scale (1 = poor, to 5 = excellent). Scores for the 5 assessed quality areas are calculated as percentage scores. | 4 years | 
| Changes in staff retention | Changes in staff retention will be evaluated by tracking staff retention over time via staff leaving positions within unit. Human Resources and/or unit records will be used for this purpose. | 4 years | 
| Changes in clinician burnout | Changes will be evaluated with the Maslach Burnout Inventory, a self-report validated measure of the three areas of burnout: emotional exhaustion (EE), depersonalization (DP), and personal accomplishment (PA). 22 items are divided into three subscales. Answers, related to how frequently respondents experience specified feelings, range from 0=never to 6=every day. Scores for each subscale are considered separately. The 8-item PA scale measures feelings of competence and successful achievement in one's work with people. Lower scores on the PA scale correspond to greater experienced burnout. The 5-item DP scale measures an unfeeling and impersonal response toward recipients of one's service, care, treatment, or instruction. Higher scores on the DP scale correspond to greater degrees of experienced burnout. The 9-item EE scale measures feelings of being emotionally overextended and exhausted at one's work. Higher scores on the EE scale correspond to greater experienced burnout. | 4 years | 
| Perceived acceptability of intervention by CICU TaLC clinician participants in the intervention: Qualitative interview | A semi-structured interview with clinicians reviewing their experience of the intervention process including what worked well and what they would recommend changing. Emphasis will be placed on virtual aspects of the training given the novelty of the implementation due to the COVID-19 pandemic. | 1 year | 
| Demographics of clinician participants | The following data will be collected regarding clinician subjects: discipline, age, gender, ethnicity, race, number of years in practice, estimated number of family meetings conducted in a week, estimated average time spent on conducting family meetings, previous experience with communication skills training. | 4 years | 
| Changes in Team member perception and satisfaction with collaboration | The Baggs CSACD-N tool will measure team member perception and satisfaction with collaboration both pre- and post-intervention. Clinicians will rate their level of agreement for 9 items on a 7-point Likert-type scale from Strongly disagree to Strongly agree. This tool will capture each discipline's experience with collaboration with other team members and satisfaction with care decisions. | 4 years | 
| Demographics of parent-patient dyads | The following baseline data will be collected regarding parent-patient dyads: age, gender, ethnicity, race, education level, and health literacy. | 4 years | 
| Parental preference for decision making control | The Control Preferences Scale for Pediatrics (CPS-P) is a 5-item sorting measure of parent preferences for participation in treatment decision making | 4 years | 
| Parental feelings about communication with the clinical team | myICU is an 11 item tool adapted by the authors of the tool to assess a surrogate's perceptions of how comfortable the surrogate feels discussing potential concerns they have with their child's medical team regarding their child's care in the ICU. | 4 years | 
| Patient clinical characteristics | Collected from Epic electronic medical record and PC4 database, the clinical characteristics including (but not limited to) diagnoses, procedures, complications, clinical consultation services, mortality and confirmation of demographics. | 4 years | 
| Parental acceptability of intervention: Qualitative interviews | The interviews will assess parents' acceptability of the parent-facing elements of the intervention, including preparing for the meeting and their perception of the written summary after the family meeting. | 1 year | 
| Clinician perceptions of communication changes due to COVID-19 | A novel survey was designed to better understand the methods of communication utilized during COVID-19 restrictions in the hospital compared to prior to the pandemic and the impact of those restrictions on clinician's perceptions of communication effectiveness. | 1 year | 
| Demographics of Co-Design Participants | Role in the co-design, gender, race | 1.5 years | 
| Perception of co-design process and level of engagement | Modified version of Coalition Effectiveness Inventory that consists of one 14-item section measuring participants' perceptions of the Co-design leader's effectiveness and one 10-item section measuring participants' perceptions of their own involvement and commitment to the Co-design process. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiac intensive care unit, pediatrics, medical communication