Improving Family Meetings in the Pediatric Cardiac Intensive Care Unit
NCT ID: NCT03749330
Last Updated: 2024-01-18
Study Results
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COMPLETED
NA
451 participants
INTERVENTIONAL
2018-12-19
2022-09-20
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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CHOP CICU
CICU Team And Loved Ones Communicating (CICU TALC)
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
\- Clinicians including attending physicians, front line clinicians (fellows, nurse practitioners, or physician assistants), bedside nurses, and social workers working at CHOP or parents of children previously hospitalized in an ICU at CHOP.
Clinicians Participating in Intervention:
\- Pediatric CICU clinicians (attending intensivists, cardiologists, cardiac surgeons, front line clinicians, bedside nurses, and social workers) at CHOP who volunteer to undergo communication skills training.
Clinicians Not Participating in Intervention:
\- Clinicians who plan to participate in family meetings in the pediatric CICU that will be observed by the research team.
Parent-patient Dyads Participating in the Survey or Interview:
* Parent must be the legal decision maker of a patient who has been admitted to the CHOP CICU for at least 7 days.
* Patient has been admitted to the CICU at CHOP for ≥7 days following onset of study and the medical team believes the patient will remain in the CICU for at least 7 more days OR the patient has already been admitted to the CICU for 14 days.
* Parent/guardian ≥ 18 years old.
* Child \< 18 years old at time of enrollment.
* Parent/guardian is English-speaking.
* Parent/guardian has no cognitive impairments that prevent them from being a surrogate decision maker.
Exclusion Criteria
\- 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.
ALL
No
Sponsors
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National Institutes of Health (NIH)
NIH
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Children's Hospital of Philadelphia
OTHER
Responsible Party
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Principal Investigators
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Jennifer K Walter, MD, PhD, MS
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Philadelphia
Locations
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The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form: Parent consent
Document Type: Informed Consent Form: Clinician consent
Other Identifiers
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15-012274
Identifier Type: -
Identifier Source: org_study_id
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