Clinical Trials Directory

Trials / Completed

CompletedNCT03749330

Improving Family Meetings in the Pediatric Cardiac Intensive Care Unit

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
451 (actual)
Sponsor
Children's Hospital of Philadelphia · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

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.

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALCICU 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.

Timeline

Start date
2018-12-19
Primary completion
2022-09-20
Completion
2022-09-20
First posted
2018-11-21
Last updated
2024-01-18
Results posted
2024-01-18

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03749330. Inclusion in this directory is not an endorsement.