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CommunicationNCT03749330

Improving Family Meetings in the Pediatric Cardiac Intensive Care Unit

A study testing CICU Team And Loved Ones Communicating (CICU TALC) in people with Communication and Critical Illness, run by Children's Hospital of Philadelphia at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Any age
Conditions the study is for
Communication, Critical Illness
What is being tested?
CICU Team And Loved Ones Communicating (CICU TALC)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
451 participants
Where
1 siteUnited States
Study dates
19 Dec 2018to 20 Sep 2022
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.
Show all 13Show fewer
  • 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.

Who cannot join

  • 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.
Show all 13Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • The Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19146

Other trials in United States

About this study

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.

Read the detailed description

Context:

A large proportion of children with advanced heart disease (AHD) die in the pediatric cardiac intensive care unit (CICU), where parents describe obtaining a realistic understanding that their child had a life-limiting disease only 2 days prior to death. Delayed or inadequate communication within teams or with families may contribute to this lack of understanding (as shown in children with other serious illnesses), while interactions with pediatric palliative care specialists (PPCS) have been shown to improve communication and understanding of prognosis. The limited number of PPCS, however, means that all clinicians in the CICU must have the skills to support parental decision-making, including giving bad news and eliciting parental goals for their child.

Objectives:

  1. To develop a communication skills training (CST) program for interprofessional teams in the pediatric CICU via a co-design process.
  2. To evaluate CICU clinicians' perceived feasibility and acceptability of the CST.
  3. To evaluate CST impact on communication skills and team function in actual family meetings.
  4. To describe and evaluate parents' communication challenges in the CICU and their satisfaction with communication.
  5. To determine the parents' perceived acceptability of the parent-facing aspects of the CST program.
  6. Evaluate clinician fidelity to intervention plan.

Study Design:

Prospective cohort study with pre and post assessments around an intervention.

Setting/Participants:

Clinicians at the Children's Hospital of Philadelphia (CHOP) and parents of children previously hospitalized in the ICU will be invited to participate in the co-design portion of the study to develop the team and family based intervention. A separate group of volunteer attending intensivists, cardiologists, cardiac surgeons, front line clinicians, bedside nurses, and social workers from the pediatric CICU at the Children's Hospital of Philadelphia (CHOP) will undergo the intervention and participate in observed family meetings before and after the intervention. Other clinicians who are participating in an observed family meeting will also be enrolled. Parents or legal guardians and their children in the CICU who have been there for at least 7 days and are expected to stay at least another 7 days will also be consented and enrolled.

Study Interventions and Measures:

Intervention:

The intervention includes both an interprofessional team training that will include practice in communication skills of giving bad news and building team collaboration and a family oriented intervention to prepare them for family meetings.

Measures:

The Co-design process to develop the intervention will have focus groups to evaluate the interventions' content and perceived feasibility.

The impact of the intervention on CICU clinicians' perceived usefulness and satisfaction with the training will be measured with post-intervention survey and follow-up interviews.

For the actual family meetings, assessment of the impact of the intervention on communication and team function in actual family meetings pre and post-intervention will be done by coding audio recordings with validated tools and qualitative coding of content. Collaboration will be measured using the amount of time different members of different disciplines speak, and team member perception and satisfaction with collaboration will be measured using a validated tool. Fidelity of the intervention implementation will be measured by documenting behaviors of clinicians post-intervention in meetings and in chart documentation.

Parents' experiences in family meetings and perspectives on communication with the clinical team will be measured with a pre-intervention survey measuring parental mood, affect, and satisfaction with communication or with semi-structured interview. Parental perception of the CST will be measured in post-intervention surveys and acceptability interviews.

Being tested
CICU Team And Loved Ones Communicating (CICU TALC)
Keywords
cardiac intensive care unit, pediatrics, medical communication
Medical subject headings
Communication, Critical Illness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CICU Team And Loved Ones Communicating (CICU TALC)Behavioural

    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.

Study groups in NCT03749330
Study groupRoleWhat they receive
CHOP CICUOtherCICU Team And Loved Ones Communicating (CICU TALC)
Receives: Behavioral: CICU Team And Loved Ones Communicating (CICU TALC)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Perceived Acceptability Comparison of CICU TALC by CICU Providers Immediately After Completion of Intervention: Satisfaction Survey

    Acceptability of the study will be evaluated with 1 item from the Satisfaction with and Impact of the Course survey. The item is whether the training would be recommended to colleagues scored using a 4-point Likert scale (1=strongly agree to 4=strongly disagree), therefore a lower score indicates more acceptability.

    Measured: 5 months

  2. 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

    Measured: 3.5 years

  3. 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

    Measured: 3.5 years

  4. Rates of Missing Data From Parents and Team Subjects

    Percent of missing data from parent and CICU team member reported survey data will be tracked throughout the study. All participants should have had data collected, therefore denominator is number of participants and the numerator is the number of participants that we received survey data from.

    Measured: 3.5 years

  5. 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

    Measured: 3.5 years

  6. 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).

    Measured: 2 years

  7. 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).

    Measured: 2 years

  8. 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).

    Measured: 2 years

  9. Percent of Family Meetings Adhering to Intervention Protocol

    For the 30 family meetings which were intended to receive the intervention (CST) we will assess the percent of those meetings which met the threshold of adhering to the intervention protocol. The denominator is the total number of observed MEETINGS in the post-intervention phase and the numerator is the number of meeting that meet the adherence threshold.

    Measured: 2 years

  10. Percent of Team Meetings Adhering to Intervention Schedule and Protocol: Observation of Meeting

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

    Measured: 2 years

  11. Feasibility of Enrollment and Retention of Participants

    Were we able to enroll clinicians in the intervention portion of the study and parents in the study and to what extent were they retained throughout the duration of the study.

    Measured: 2 years

Secondary outcomes (2)

  1. Changes in CICU Providers' Use of Explicit Statements of Empathy During Family Meetings

    A proportion of empathic terminator statements provided by a clinician after a parental expression of negative emotion will be calculated pre and post intervention. The denominator of the proportion will be all the expressions of negative emotion by a parent and the numerator will be the instances in which a clinician responds without a statement of empathy. Because there will be a proportion calculated for all 58 meetings, we will then calculate the median proportion pre-intervention and post-intervention with an interquartile range. Empathic terminators are not desirable and therefore a lower proportion is considered a better outcome.

    Measured: 2 years

  2. Changes in CICU Team Function for Communication

    Team function communication will be measured by changes in the Performance Assessment for Communication and Teamwork Toolset - Novice (PACT-Novice) scores. The PACT-Novice communication item is scored on a 5-point Likert scale (1-poor, 3=average, 5-excellent). Higher scores are better. We analyzed the median (IQR) differences in pre-intervention vs. Post-intervention PACT novice item "communication" scores using wilcoxon rank sum tests.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2018
  2. Study start19 Dec 2018
  3. Primary completion20 Sep 2022
  4. Study completion20 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
451 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03749330
Sponsor's protocol ID
15-012274
Other IDs
K23HL141700
Status last verified
Dec 2023
First submitted
1 Nov 2018
Last updated
18 Jan 2024
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 18703306

  • 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.

    PubMed 9989013

  • 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.

    PubMed 3080166

  • 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.

    PubMed 14705607

  • 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.

    PubMed 2084735

  • 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.

    PubMed 23863815

  • 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.

    PubMed 17353492

  • 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.

    PubMed 11388158

  • 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.

    PubMed 7930118

  • 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.

    PubMed 7543639

  • 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.

    PubMed 22433021

Questions about this trial

What is this clinical trial studying?

A study testing CICU Team And Loved Ones Communicating (CICU TALC) in people with Communication and Critical Illness, run by Children's Hospital of Philadelphia at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Perceived Acceptability Comparison of CICU TALC by CICU Providers Immediately After Completion of Intervention: Satisfaction Survey (time frame: 5 months). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03749330, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2024.

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