<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03749330</url>
  </required_header>
  <id_info>
    <org_study_id>15-012274</org_study_id>
    <secondary_id>K23HL141700</secondary_id>
    <nct_id>NCT03749330</nct_id>
  </id_info>
  <brief_title>Improving Family Meetings in the Pediatric Cardiac Intensive Care Unit</brief_title>
  <official_title>Improving Family Meetings in the Pediatric Cardiac Intensive Care Unit</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Hospital of Philadelphia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Children's Hospital of Philadelphia</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to improve communication between medical teams, patients, and families in the&#xD;
      pediatric cardiac intensive care unit. The researchers hypothesize that both improving&#xD;
      interprofessional teamwork when preparing for family meeting and preparing families for these&#xD;
      meetings will improve team and family satisfaction with communication. The study will involve&#xD;
      bringing together a group of medical professionals and parents of patients to collaboratively&#xD;
      design an intervention. In addition, the researchers will study feasibility and acceptability&#xD;
      of the intervention and whether it impacts family and team outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Context:&#xD;
&#xD;
      A large proportion of children with advanced heart disease (AHD) die in the pediatric cardiac&#xD;
      intensive care unit (CICU), where parents describe obtaining a realistic understanding that&#xD;
      their child had a life-limiting disease only 2 days prior to death. Delayed or inadequate&#xD;
      communication within teams or with families may contribute to this lack of understanding (as&#xD;
      shown in children with other serious illnesses), while interactions with pediatric palliative&#xD;
      care specialists (PPCS) have been shown to improve communication and understanding of&#xD;
      prognosis. The limited number of PPCS, however, means that all clinicians in the CICU must&#xD;
      have the skills to support parental decision-making, including giving bad news and eliciting&#xD;
      parental goals for their child.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
        1. To develop a communication skills training (CST) program for interprofessional teams in&#xD;
           the pediatric CICU via a co-design process.&#xD;
&#xD;
        2. To evaluate CICU clinicians' perceived feasibility and acceptability of the CST.&#xD;
&#xD;
        3. To evaluate CST impact on communication skills and team function in actual family&#xD;
           meetings.&#xD;
&#xD;
        4. To describe and evaluate parents' communication challenges in the CICU and their&#xD;
           satisfaction with communication.&#xD;
&#xD;
        5. To determine the parents' perceived acceptability of the parent-facing aspects of the&#xD;
           CST program.&#xD;
&#xD;
        6. Evaluate clinician fidelity to intervention plan.&#xD;
&#xD;
      Study Design:&#xD;
&#xD;
      Prospective cohort study with pre and post assessments around an intervention.&#xD;
&#xD;
      Setting/Participants:&#xD;
&#xD;
      Clinicians at the Children's Hospital of Philadelphia (CHOP) and parents of children&#xD;
      previously hospitalized in the ICU will be invited to participate in the co-design portion of&#xD;
      the study to develop the team and family based intervention. A separate group of volunteer&#xD;
      attending intensivists, cardiologists, cardiac surgeons, front line clinicians, bedside&#xD;
      nurses, and social workers from the pediatric CICU at the Children's Hospital of Philadelphia&#xD;
      (CHOP) will undergo the intervention and participate in observed family meetings before and&#xD;
      after the intervention. Other clinicians who are participating in an observed family meeting&#xD;
      will also be enrolled. Parents or legal guardians and their children in the CICU who have&#xD;
      been there for at least 7 days and are expected to stay at least another 7 days will also be&#xD;
      consented and enrolled.&#xD;
&#xD;
      Study Interventions and Measures:&#xD;
&#xD;
      Intervention:&#xD;
&#xD;
      The intervention includes both an interprofessional team training that will include practice&#xD;
      in communication skills of giving bad news and building team collaboration and a family&#xD;
      oriented intervention to prepare them for family meetings.&#xD;
&#xD;
      Measures:&#xD;
&#xD;
      The Co-design process to develop the intervention will have focus groups to evaluate the&#xD;
      interventions' content and perceived feasibility.&#xD;
&#xD;
      The impact of the intervention on CICU clinicians' perceived usefulness and satisfaction with&#xD;
      the training will be measured with post-intervention survey and follow-up interviews.&#xD;
&#xD;
      For the actual family meetings, assessment of the impact of the intervention on communication&#xD;
      and team function in actual family meetings pre and post-intervention will be done by coding&#xD;
      audio recordings with validated tools and qualitative coding of content. Collaboration will&#xD;
      be measured using the amount of time different members of different disciplines speak, and&#xD;
      team member perception and satisfaction with collaboration will be measured using a validated&#xD;
      tool. Fidelity of the intervention implementation will be measured by documenting behaviors&#xD;
      of clinicians post-intervention in meetings and in chart documentation.&#xD;
&#xD;
      Parents' experiences in family meetings and perspectives on communication with the clinical&#xD;
      team will be measured with a pre-intervention survey measuring parental mood, affect, and&#xD;
      satisfaction with communication or with semi-structured interview. Parental perception of the&#xD;
      CST will be measured in post-intervention surveys and acceptability interviews.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 19, 2018</start_date>
  <completion_date type="Actual">September 20, 2022</completion_date>
  <primary_completion_date type="Actual">September 20, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Perceived acceptability comparison of CICU TALC by CICU providers immediately after completion of intervention: satisfaction survey</measure>
    <time_frame>5 months</time_frame>
    <description>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).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Participant retention rates</measure>
    <time_frame>4 years</time_frame>
    <description>Retention rates will be tracked over time by comparing numbers of enrolled/retained subjects to numbers of those who decline to enroll or disenroll</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Participant consent rates</measure>
    <time_frame>4 years</time_frame>
    <description>Consent rates will be tracked over time by comparing numbers of consenting subjects to numbers of subjects who do not consent to participate</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rates of missing data from parents and team subjects</measure>
    <time_frame>4 years</time_frame>
    <description>Rates of missing data from parent and CICU team member reported survey data will be tracked throughout the study</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Duration of meetings between teams and families</measure>
    <time_frame>4 years</time_frame>
    <description>Meetings will be audio-recorded and the length of each meeting measured automatically as part of analysis with NVivo qualitative coding software</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Amount of information provided by CICU TALC as perceived by Parent participants in intervention</measure>
    <time_frame>2 years</time_frame>
    <description>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).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Perceived clarity of intervention materials of CICU TALC by Parent participants in intervention</measure>
    <time_frame>2 years</time_frame>
    <description>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).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Summary rating of CICU TALC intervention by Parent participants in intervention</measure>
    <time_frame>2 years</time_frame>
    <description>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).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of adherence to intervention protocol: observation of intervention</measure>
    <time_frame>2 years</time_frame>
    <description>Intervention will be observed to characterize whether intervention protocol was adhered to.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adherence to intervention schedule and protocol:observation of meetings</measure>
    <time_frame>2 years</time_frame>
    <description>Team interactions post-intervention will be monitored to assess the adherence to the intervention schedule and protocol.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in CICU providers' SPIKES skills acquisition</measure>
    <time_frame>2 years</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in CICU providers' NURSE skills acquisition</measure>
    <time_frame>2 years</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in CICU team function</measure>
    <time_frame>4 years</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in CICU team function</measure>
    <time_frame>4 years</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in parental perspectives about communication challenges in the CICU</measure>
    <time_frame>4 years</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in parental anxiety and depression in the CICU</measure>
    <time_frame>4 years</time_frame>
    <description>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 &quot;normal,&quot; between 8-10 are considered &quot;borderline,&quot; and between 11-21 are considered &quot;abnormal.&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in parental stress responses</measure>
    <time_frame>4 years</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in parental trust in physicians</measure>
    <time_frame>4 years</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in parental satisfaction with communication in the CICU</measure>
    <time_frame>4 years</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in parental perspectives about communication satisfaction in the CICU</measure>
    <time_frame>4 years</time_frame>
    <description>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 = &quot;poor,&quot; to 5 = &quot;excellent&quot;). Scores for the 5 assessed quality areas are calculated as percentage scores.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in staff retention</measure>
    <time_frame>4 years</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in clinician burnout</measure>
    <time_frame>4 years</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived acceptability of intervention by CICU TaLC clinician participants in the intervention: Qualitative interview</measure>
    <time_frame>1 year</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Demographics of clinician participants</measure>
    <time_frame>4 years</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Team member perception and satisfaction with collaboration</measure>
    <time_frame>4 years</time_frame>
    <description>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 &quot;Strongly disagree&quot; to &quot;Strongly agree.&quot; This tool will capture each discipline's experience with collaboration with other team members and satisfaction with care decisions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Demographics of parent-patient dyads</measure>
    <time_frame>4 years</time_frame>
    <description>The following baseline data will be collected regarding parent-patient dyads: age, gender, ethnicity, race, education level, and health literacy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parental preference for decision making control</measure>
    <time_frame>4 years</time_frame>
    <description>The Control Preferences Scale for Pediatrics (CPS-P) is a 5-item sorting measure of parent preferences for participation in treatment decision making</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parental feelings about communication with the clinical team</measure>
    <time_frame>4 years</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient clinical characteristics</measure>
    <time_frame>4 years</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parental acceptability of intervention: Qualitative interviews</measure>
    <time_frame>1 year</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinician perceptions of communication changes due to COVID-19</measure>
    <time_frame>1 year</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Demographics of Co-Design Participants</measure>
    <time_frame>1.5 years</time_frame>
    <description>Role in the co-design, gender, race</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perception of co-design process and level of engagement</measure>
    <time_frame>1 year</time_frame>
    <description>Modified version of &quot;Coalition Effectiveness Inventory&quot; 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.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">451</enrollment>
  <condition>Communication</condition>
  <condition>Critical Illness</condition>
  <arm_group>
    <arm_group_label>CHOP CICU</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>CICU Team And Loved Ones Communicating (CICU TALC)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>CICU Team And Loved Ones Communicating (CICU TALC)</intervention_name>
    <description>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.</description>
    <arm_group_label>CHOP CICU</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Participants in Co-design:&#xD;
&#xD;
        - Clinicians including attending physicians, front line clinicians (fellows, nurse&#xD;
        practitioners, or physician assistants), bedside nurses, and social workers working at CHOP&#xD;
        or parents of children previously hospitalized in an ICU at CHOP.&#xD;
&#xD;
        Clinicians Participating in Intervention:&#xD;
&#xD;
        - Pediatric CICU clinicians (attending intensivists, cardiologists, cardiac surgeons, front&#xD;
        line clinicians, bedside nurses, and social workers) at CHOP who volunteer to undergo&#xD;
        communication skills training.&#xD;
&#xD;
        Clinicians Not Participating in Intervention:&#xD;
&#xD;
        - Clinicians who plan to participate in family meetings in the pediatric CICU that will be&#xD;
        observed by the research team.&#xD;
&#xD;
        Parent-patient Dyads Participating in the Survey or Interview:&#xD;
&#xD;
          -  Parent must be the legal decision maker of a patient who has been admitted to the CHOP&#xD;
             CICU for at least 7 days.&#xD;
&#xD;
          -  Patient has been admitted to the CICU at CHOP for ≥7 days following onset of study and&#xD;
             the medical team believes the patient will remain in the CICU for at least 7 more days&#xD;
             OR the patient has already been admitted to the CICU for 14 days.&#xD;
&#xD;
          -  Parent/guardian ≥ 18 years old.&#xD;
&#xD;
          -  Child &lt; 18 years old at time of enrollment.&#xD;
&#xD;
          -  Parent/guardian is English-speaking.&#xD;
&#xD;
          -  Parent/guardian has no cognitive impairments that prevent them from being a surrogate&#xD;
             decision maker.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Participants in Co-design:&#xD;
&#xD;
        - None.&#xD;
&#xD;
        Clinicians Participating in Intervention:&#xD;
&#xD;
        - Clinicians who will not participate in CHOP's CICU chronic care meeting in the following&#xD;
        year.&#xD;
&#xD;
        Clinicians Not Participating in Intervention:&#xD;
&#xD;
        - None.&#xD;
&#xD;
        Parent-patient Dyads Participating in the Survey or Interview:&#xD;
&#xD;
          -  Parent is not the legal decision maker of a patient who has been admitted to the CHOP&#xD;
             CICU for at least 7 days.&#xD;
&#xD;
          -  The medical team does not believe the patient will remain in the CICU for at least 7&#xD;
             more days.&#xD;
&#xD;
          -  Parent/guardian &lt; 18 years old.&#xD;
&#xD;
          -  Child is ≥ 18 years old at time of enrollment.&#xD;
&#xD;
          -  Parent/guardian is not English-speaking.&#xD;
&#xD;
          -  Parent/guardian has cognitive impairments that prevent them from being a surrogate&#xD;
             decision maker.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jennifer K Walter, MD, PhD, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's Hospital of Philadelphia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Children's Hospital of Philadelphia</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19146</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Mercer LM, Tanabe P, Pang PS, Gisondi MA, Courtney DM, Engel KG, Donlan SM, Adams JG, Makoul G. Patient perspectives on communication with the medical team: pilot study using the Communication Assessment Tool-Team (CAT-T). Patient Educ Couns. 2008 Nov;73(2):220-3. doi: 10.1016/j.pec.2008.07.003.</citation>
    <PMID>18703306</PMID>
  </reference>
  <reference>
    <citation>Pyke-Grimm KA, Degner L, Small A, Mueller B. Preferences for participation in treatment decision making and information needs of parents of children with cancer: a pilot study. J Pediatr Oncol Nurs. 1999 Jan;16(1):13-24. doi: 10.1177/104345429901600103.</citation>
    <PMID>9989013</PMID>
  </reference>
  <reference>
    <citation>Snaith RP, Zigmond AS. The hospital anxiety and depression scale. Br Med J (Clin Res Ed). 1986 Feb 1;292(6516):344. doi: 10.1136/bmj.292.6516.344. No abstract available.</citation>
    <PMID>3080166</PMID>
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  <reference>
    <citation>Creamer M, Bell R, Failla S. Psychometric properties of the Impact of Event Scale - Revised. Behav Res Ther. 2003 Dec;41(12):1489-96. doi: 10.1016/j.brat.2003.07.010.</citation>
    <PMID>14705607</PMID>
  </reference>
  <reference>
    <citation>Anderson LA, Dedrick RF. Development of the Trust in Physician scale: a measure to assess interpersonal trust in patient-physician relationships. Psychol Rep. 1990 Dec;67(3 Pt 2):1091-100. doi: 10.2466/pr0.1990.67.3f.1091.</citation>
    <PMID>2084735</PMID>
  </reference>
  <reference>
    <citation>Epstein D, Unger JB, Ornelas B, Chang JC, Markovitz BP, Moromisato DY, Dodek PM, Heyland DK, Gold JI. Psychometric evaluation of a modified version of the family satisfaction in the ICU survey in parents/caregivers of critically ill children*. Pediatr Crit Care Med. 2013 Oct;14(8):e350-6. doi: 10.1097/PCC.0b013e3182917705.</citation>
    <PMID>23863815</PMID>
  </reference>
  <reference>
    <citation>Back AL, Arnold RM, Baile WF, Fryer-Edwards KA, Alexander SC, Barley GE, Gooley TA, Tulsky JA. Efficacy of communication skills training for giving bad news and discussing transitions to palliative care. Arch Intern Med. 2007 Mar 12;167(5):453-60. doi: 10.1001/archinte.167.5.453.</citation>
    <PMID>17353492</PMID>
  </reference>
  <reference>
    <citation>Dechairo-Marino AE, Jordan-Marsh M, Traiger G, Saulo M. Nurse/physician collaboration: action research and the lessons learned. J Nurs Adm. 2001 May;31(5):223-32. doi: 10.1097/00005110-200105000-00002.</citation>
    <PMID>11388158</PMID>
  </reference>
  <reference>
    <citation>Baggs JG. Development of an instrument to measure collaboration and satisfaction about care decisions. J Adv Nurs. 1994 Jul;20(1):176-82. doi: 10.1046/j.1365-2648.1994.20010176.x.</citation>
    <PMID>7930118</PMID>
  </reference>
  <reference>
    <citation>Barry MJ, Fowler FJ Jr, Mulley AG Jr, Henderson JV Jr, Wennberg JE. Patient reactions to a program designed to facilitate patient participation in treatment decisions for benign prostatic hyperplasia. Med Care. 1995 Aug;33(8):771-82. doi: 10.1097/00005650-199508000-00003.</citation>
    <PMID>7543639</PMID>
  </reference>
  <reference>
    <citation>Clayton JM, Adler JL, O'Callaghan A, Martin P, Hynson J, Butow PN, Laidsaar-Powell RC, Arnold RM, Tulsky JA, Back AL. Intensive communication skills teaching for specialist training in palliative medicine: development and evaluation of an experiential workshop. J Palliat Med. 2012 May;15(5):585-91. doi: 10.1089/jpm.2011.0292. Epub 2012 Mar 20.</citation>
    <PMID>22433021</PMID>
  </reference>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>November 1, 2018</study_first_submitted>
  <study_first_submitted_qc>November 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>November 14, 2022</last_update_submitted>
  <last_update_submitted_qc>November 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cardiac intensive care unit</keyword>
  <keyword>pediatrics</keyword>
  <keyword>medical communication</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Critical Illness</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03749330
org study id: 15-012274
secondary id: K23HL141700
nct id: NCT03749330
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Perceived acceptability comparison of CICU TALC by CICU providers immediately after completion of intervention: satisfaction survey
time frame: 5 months
description: 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).
measure: Participant retention rates
time frame: 4 years
description: Retention rates will be tracked over time by comparing numbers of enrolled/retained subjects to numbers of those who decline to enroll or disenroll
measure: Participant consent rates
time frame: 4 years
description: Consent rates will be tracked over time by comparing numbers of consenting subjects to numbers of subjects who do not consent to participate
measure: Rates of missing data from parents and team subjects
time frame: 4 years
description: Rates of missing data from parent and CICU team member reported survey data will be tracked throughout the study
measure: Duration of meetings between teams and families
time frame: 4 years
description: Meetings will be audio-recorded and the length of each meeting measured automatically as part of analysis with NVivo qualitative coding software
measure: Amount of information provided by CICU TALC as perceived by Parent participants in intervention
time frame: 2 years
description: 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).
measure: Perceived clarity of intervention materials of CICU TALC by Parent participants in intervention
time frame: 2 years
description: 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).
measure: Summary rating of CICU TALC intervention by Parent participants in intervention
time frame: 2 years
description: 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).
measure: Rate of adherence to intervention protocol: observation of intervention
time frame: 2 years
description: Intervention will be observed to characterize whether intervention protocol was adhered to.
measure: Adherence to intervention schedule and protocol:observation of meetings
time frame: 2 years
description: Team interactions post-intervention will be monitored to assess the adherence to the intervention schedule and protocol.
measure: Changes in CICU providers' SPIKES skills acquisition
time frame: 2 years
description: 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.
measure: Changes in CICU providers' NURSE skills acquisition
time frame: 2 years
description: 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.
measure: Changes in CICU team function
time frame: 4 years
description: 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.
measure: Changes in CICU team function
time frame: 4 years
description: 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.
measure: Changes in parental perspectives about communication challenges in the CICU
time frame: 4 years
description: 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.
measure: Changes in parental anxiety and depression in the CICU
time frame: 4 years
description: 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."
measure: Changes in parental stress responses
time frame: 4 years
description: 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.
measure: Changes in parental trust in physicians
time frame: 4 years
description: 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.
measure: Changes in parental satisfaction with communication in the CICU
time frame: 4 years
description: 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.
measure: Changes in parental perspectives about communication satisfaction in the CICU
time frame: 4 years
description: 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.
measure: Changes in staff retention
time frame: 4 years
description: 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.
measure: Changes in clinician burnout
time frame: 4 years
description: 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.
measure: Perceived acceptability of intervention by CICU TaLC clinician participants in the intervention: Qualitative interview
time frame: 1 year
description: 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.
measure: Demographics of clinician participants
time frame: 4 years
description: 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.
measure: Changes in Team member perception and satisfaction with collaboration
time frame: 4 years
description: 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.
measure: Demographics of parent-patient dyads
time frame: 4 years
description: The following baseline data will be collected regarding parent-patient dyads: age, gender, ethnicity, race, education level, and health literacy.
measure: Parental preference for decision making control
time frame: 4 years
description: The Control Preferences Scale for Pediatrics (CPS-P) is a 5-item sorting measure of parent preferences for participation in treatment decision making
measure: Parental feelings about communication with the clinical team
time frame: 4 years
description: 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.
measure: Patient clinical characteristics
time frame: 4 years
description: 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.
measure: Parental acceptability of intervention: Qualitative interviews
time frame: 1 year
description: 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.
measure: Clinician perceptions of communication changes due to COVID-19
time frame: 1 year
description: 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.
measure: Demographics of Co-Design Participants
time frame: 1.5 years
description: Role in the co-design, gender, race
measure: Perception of co-design process and level of engagement
time frame: 1 year
description: 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.
arm group label: CHOP CICU
arm group type: Other
description: CICU Team And Loved Ones Communicating (CICU TALC)
intervention type: Behavioral
intervention name: CICU Team And Loved Ones Communicating (CICU TALC)
description: 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.
arm group label: CHOP CICU
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Jennifer K Walter, MD, PhD, MS
role: Principal Investigator
affiliation: Children's Hospital of Philadelphia
facility: 
country: United States
citation: Mercer LM, Tanabe P, Pang PS, Gisondi MA, Courtney DM, Engel KG, Donlan SM, Adams JG, Makoul G. Patient perspectives on communication with the medical team: pilot study using the Communication Assessment Tool-Team (CAT-T). Patient Educ Couns. 2008 Nov;73(2):220-3. doi: 10.1016/j.pec.2008.07.003.
PMID: 18703306
citation: Pyke-Grimm KA, Degner L, Small A, Mueller B. Preferences for participation in treatment decision making and information needs of parents of children with cancer: a pilot study. J Pediatr Oncol Nurs. 1999 Jan;16(1):13-24. doi: 10.1177/104345429901600103.
PMID: 9989013
citation: Snaith RP, Zigmond AS. The hospital anxiety and depression scale. Br Med J (Clin Res Ed). 1986 Feb 1;292(6516):344. doi: 10.1136/bmj.292.6516.344. No abstract available.
PMID: 3080166
citation: Creamer M, Bell R, Failla S. Psychometric properties of the Impact of Event Scale - Revised. Behav Res Ther. 2003 Dec;41(12):1489-96. doi: 10.1016/j.brat.2003.07.010.
PMID: 14705607
citation: Anderson LA, Dedrick RF. Development of the Trust in Physician scale: a measure to assess interpersonal trust in patient-physician relationships. Psychol Rep. 1990 Dec;67(3 Pt 2):1091-100. doi: 10.2466/pr0.1990.67.3f.1091.
PMID: 2084735
citation: Epstein D, Unger JB, Ornelas B, Chang JC, Markovitz BP, Moromisato DY, Dodek PM, Heyland DK, Gold JI. Psychometric evaluation of a modified version of the family satisfaction in the ICU survey in parents/caregivers of critically ill children*. Pediatr Crit Care Med. 2013 Oct;14(8):e350-6. doi: 10.1097/PCC.0b013e3182917705.
PMID: 23863815
citation: Back AL, Arnold RM, Baile WF, Fryer-Edwards KA, Alexander SC, Barley GE, Gooley TA, Tulsky JA. Efficacy of communication skills training for giving bad news and discussing transitions to palliative care. Arch Intern Med. 2007 Mar 12;167(5):453-60. doi: 10.1001/archinte.167.5.453.
PMID: 17353492
citation: Dechairo-Marino AE, Jordan-Marsh M, Traiger G, Saulo M. Nurse/physician collaboration: action research and the lessons learned. J Nurs Adm. 2001 May;31(5):223-32. doi: 10.1097/00005110-200105000-00002.
PMID: 11388158
citation: Baggs JG. Development of an instrument to measure collaboration and satisfaction about care decisions. J Adv Nurs. 1994 Jul;20(1):176-82. doi: 10.1046/j.1365-2648.1994.20010176.x.
PMID: 7930118
citation: Barry MJ, Fowler FJ Jr, Mulley AG Jr, Henderson JV Jr, Wennberg JE. Patient reactions to a program designed to facilitate patient participation in treatment decisions for benign prostatic hyperplasia. Med Care. 1995 Aug;33(8):771-82. doi: 10.1097/00005650-199508000-00003.
PMID: 7543639
citation: Clayton JM, Adler JL, O'Callaghan A, Martin P, Hynson J, Butow PN, Laidsaar-Powell RC, Arnold RM, Tulsky JA, Back AL. Intensive communication skills teaching for specialist training in palliative medicine: development and evaluation of an experiential workshop. J Palliat Med. 2012 May;15(5):585-91. doi: 10.1089/jpm.2011.0292. Epub 2012 Mar 20.
PMID: 22433021
responsible party type: Sponsor
mesh term: Critical Illness