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Improving Family Meetings in the Pediatric Cardiac Intensive Care Unit

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ClinicalTrials.gov Identifier: NCT03749330
Recruitment Status : Recruiting
First Posted : November 21, 2018
Last Update Posted : January 9, 2019
Sponsor:
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

Brief Summary:
This study aims to improve communication between medical teams, patients, and families in the pediatric cardiac intensive care unit. The researchers hypothesize that both improving interprofessional teamwork when preparing for family meeting and preparing families for these meetings will improve team and family satisfaction with communication. The study will involve bringing together a group of medical professionals and parents of patients to collaboratively design an intervention. In addition, the researchers will study feasibility and acceptability of the intervention and whether it impacts family and team outcomes.

Condition or disease Intervention/treatment Phase
Communication Critical Illness Behavioral: CICU Team And Loved Ones Communicating (CICU TALC) Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 386 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Improving Family Meetings in the Pediatric Cardiac Intensive Care Unit
Actual Study Start Date : December 19, 2018
Estimated Primary Completion Date : November 2023
Estimated Study Completion Date : November 2023

Arm Intervention/treatment
CHOP CICU
CICU Team And Loved Ones Communicating (CICU TALC)
Behavioral: CICU 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.




Primary Outcome Measures :
  1. Perceived acceptability comparison of CICU TALC by CICU providers immediately after completion of intervention: satisfaction survey [ Time Frame: 5 months ]
    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).

  2. Participant retention rates [ Time Frame: 4 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

  3. Participant consent rates [ Time Frame: 4 years ]
    Consent rates will be tracked over time by comparing numbers of consenting subjects to numbers of subjects who do not consent to participate

  4. Rates of missing data from parents and team subjects [ Time Frame: 4 years ]
    Rates of missing data from parent and CICU team member reported survey data will be tracked throughout the study

  5. Duration of meetings between teams and families [ Time Frame: 4 years ]
    Meetings will be audio-recorded and the length of each meeting measured automatically as part of analysis with NVivo qualitative coding software

  6. Amount of information provided by CICU TALC as perceived by Parent participants in intervention [ Time Frame: 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).

  7. Perceived clarity of intervention materials of CICU TALC by Parent participants in intervention [ Time Frame: 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).

  8. Summary rating of CICU TALC intervention by Parent participants in intervention [ Time Frame: 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).

  9. Rate of adherence to intervention protocol: observation of intervention [ Time Frame: 2 years ]
    Intervention will be observed to characterize whether intervention protocol was adhered to.

  10. Adherence to intervention schedule and protocol:observation of meetings [ Time Frame: 2 years ]
    Team interactions post-intervention will be monitored to assess the adherence to the intervention schedule and protocol.


Secondary Outcome Measures :
  1. Changes in CICU providers' SPIKES skills acquisition [ Time Frame: 2 years ]
    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. Changes in CICU providers' NURSE skills acquisition [ Time Frame: 2 years ]
    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.

  3. Changes in CICU team function [ Time Frame: 4 years ]
    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. Changes in CICU team function [ Time Frame: 4 years ]
    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.

  5. Changes in parental perspectives about communication challenges in the CICU [ Time Frame: 4 years ]
    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.

  6. Changes in parental anxiety and depression in the CICU [ Time Frame: 4 years ]
    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."

  7. Changes in parental stress responses [ Time Frame: 4 years ]
    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.

  8. Changes in parental trust in physicians [ Time Frame: 4 years ]
    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.

  9. Changes in parental satisfaction with communication in the CICU [ Time Frame: 4 years ]
    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.

  10. Changes in parental perspectives about communication satisfaction in the CICU [ Time Frame: 4 years ]
    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.

  11. Changes in staff retention [ Time Frame: 4 years ]
    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.

  12. Changes in clinician burnout [ Time Frame: 4 years ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03749330


Contacts
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Contact: Jennifer K Walter, MD, PhD, MS 2674267466 walterj1@email.chop.edu
Contact: Theodore E Schall, MSW, MBE 2674263940 schallt@email.chop.edu

Locations
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United States, Pennsylvania
The Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19146
Contact: Jennifer K Walter, MD, PhD, MS    215-590-1000    walterj1@email.chop.edu   
Sponsors and Collaborators
Children's Hospital of Philadelphia
Investigators
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Principal Investigator: Jennifer K Walter, MD, PhD, MS Children's Hospital of Philadelphia

Publications:

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Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT03749330     History of Changes
Other Study ID Numbers: 15-012274
First Posted: November 21, 2018    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Children's Hospital of Philadelphia:
cardiac intensive care unit
pediatrics
medical communication
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes