Improving Family Meetings in the Pediatric Cardiac Intensive Care Unit

Critical Illness Clinical Trial

Official title:

Improving Family Meetings in the Pediatric Cardiac Intensive Care Unit

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03749330
• Other study ID #: 15-012274
• Secondary ID: K23HL141700
• Status: Completed
• Phase: N/A
• Start date: December 19, 2018
• Est. completion date: September 20, 2022

Study information

• Verified date: December 2023
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 451
• Est. completion date: September 20, 2022
• Est. primary completion date: September 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Participants in Co-design:

• Clinicians including attending physicians, front line clinicians (fellows, nurse practitioners, or physician assistants), bedside nurses, and social workers working at CHOP or parents of children previously hospitalized in an ICU at CHOP.

Clinicians Participating in Intervention:

• Pediatric CICU clinicians (attending intensivists, cardiologists, cardiac surgeons, front line clinicians, bedside nurses, and social workers) at CHOP who volunteer to undergo communication skills training.

Clinicians Not Participating in Intervention:

• Clinicians who plan to participate in family meetings in the pediatric CICU that will be observed by the research team.

Parent-patient Dyads Participating in the Survey or Interview:

• Parent must be the legal decision maker of a patient who has been admitted to the CHOP CICU for at least 7 days.

• Patient has been admitted to the CICU at CHOP for =7 days following onset of study and the medical team believes the patient will remain in the CICU for at least 7 more days 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:

Participants in Co-design:

• None.

Clinicians Participating in Intervention:

• Clinicians who will not participate in CHOP's CICU chronic care meeting in the following year.

Clinicians Not Participating in Intervention:

• None.

Parent-patient Dyads Participating in the Survey or Interview:

• Parent is not the legal decision maker of a patient who has been admitted to the CHOP CICU for at least 7 days.

• The medical team does not believe the patient will remain in the CICU for at least 7 more days.

• Parent/guardian < 18 years old.

• Child is = 18 years old at time of enrollment.

• Parent/guardian is not English-speaking.

• Parent/guardian has cognitive impairments that prevent them from being a surrogate decision maker.

Related Conditions & MeSH terms

• Communication
• Critical Illness

Intervention

Behavioral:
• CICU Team And Loved Ones Communicating (CICU TALC)
When the necessary pre-intervention clinical encounters are completed, clinicians will go through the interprofessional team training to improve communication skills and teamwork in developing care plans and communicating with families in family meetings. The first step in the study is co-design of the intervention, so it will evolve as the study continues.

Locations

Country	Name	City	State
United States	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (11)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	5 months
Primary	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	3.5 years
Primary	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	3.5 years
Primary	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.	3.5 years
Primary	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	3.5 years
Primary	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).	2 years
Primary	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).	2 years
Primary	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).	2 years
Primary	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.	2 years
Primary	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.	2 years
Primary	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.	2 years
Secondary	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.	2 years
Secondary	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.	2 years