Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04298281 |
| Other study ID # |
2020-3240 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 30, 2020 |
| Est. completion date |
December 2021 |
Study information
| Verified date |
December 2020 |
| Source |
Ann & Robert H Lurie Children's Hospital of Chicago |
| Contact |
Jairo Chavez |
| Phone |
7738163198 |
| Email |
jachavez[@]luriechildrens.org |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Multidisciplinary experts from two Pediatric Intensive Care Units (PICUs), used an iterative
modified Delphi process to develop and refine criteria for determining PICU patients for whom
a family care conference would be beneficial. In this study the investigators will assess the
use of those criteria as a trigger to offer parents of PICU patients a family care
conference.
Description:
Multidisciplinary experts from two Pediatric Intensive Care Units (PICUs) used an iterative
modified Delphi process to develop and refine criteria for determining PICU patients for whom
a family care conference would be beneficial. A preliminary set of criteria were developed
with expert input and review of the literature. The investigators then assessed the
preliminary criteria by retrospectively reviewing PICU patient's medical records at the two
participating sites. Making revisions as needed the investigators then assessed the
reliability of the family care conference criteria by prospectively reviewing the medical
records of two months of PICU patient admissions at both participating sites. Based on these
efforts, the investigators have described a set of family care conference criteria that will
be studied in this investigation.
Primary Aim: Assess the inclusivity of the developed Family care conference criteria (FCC).
Secondary Aim: Describe parents' views of PICU family care conferences (FCC) and factors
associated with having PICU family care conferences.
Methods: Taking an implementation science approach, the investigators will use
plan-do-study-act cycles to optimize the goal of offering an FCC to all parent(s) of patients
with any FCC criteria. The implementation aim statement is, within 6 months, healthcare team
members will offer an FCC to the parent(s) of >95% of patients who have at least one FCC
criteria.
- Planning (Plan). Development teams at participating institutions have determined how to
inform PICU healthcare team members (HTMs) when a patient has an FCC criterion. A
one-page information sheet (written at a 6th-grade level) describing FCCs, their
potential role and value will be used when offering families a FCC. The development
teams have also created an electronic health record (EHR) note template to document
offering and conducting FCCs.
- Implementation (Do). Each weekday, a study team member at each site will review the EHR
to identify patients who have one FCC criteria. A study team member will inform the PICU
team when a patient has at least one FCC criteria and request that an HTM give the
parent(s) the FCC information sheet, offer the parent(s) an FCC, and document the
conversation with the parent(s) in the EHR. The processes for organizing and conducting
FCCs will occur according to the PICU teams' discretion.
- Data collection (Study). The investigators will track the occurrence of FCCs by
reviewing the EHR and obtaining input from PICU HTMs. For patients meeting at least one
FCC criteria, but for whom an FCC was not documented, a study team member will ask the
patient's PICU team (either resident, fellow, APRN, or attending) if an FCC occurred
while the patient was admitted. For patients meeting FCC criteria, but for whom an FCC
did not occur, study team members will also document if an FCC was offered by reviewing
the EHR. If there is no EHR documentation about offering parent(s) an FCC, a study team
member will ask the patient's PICU team (within a week of informing them that a patient
met an FCC criteria) if the parent(s) were offered an FCC and if not why the parent(s)
were not offered and FCC. Using input from HTMs, the investigators will record reasons
for not offering an FCC and ascertain why parents opted out of an FCC. In addition to
data about the FCC criteria, the investigators will extract the follow patient data from
the EHR: age; sex; Pediatric Index of Mortality 3 (PIM3) score (measures of PICU
admission illness severity) indication for PICU admission; need for intubation; need for
pressors/vasoactive medications; number of subspecialty teams consulted; and use of
ECMO.
- Revise implementation plan (Act). The development teams will meet every other week x 4,
then monthly x 4, then every two months to review the data, assess implementation, and
modify the process as needed.
To describe parents' views of PICU FCCs and factors associated with having PICU FCCs, the
investigators will enroll English- and Spanish-speaking (materials will be available in
Spanish) parents (one or both) of PICU patients <18 years old for whom an FCC occurred or
whose child had at least one FCC criteria. English- and Spanish-speaking parents (one or
both) of PICU patients < 18 years old whose child did not have an FCC criteria and who did
not have an FCC will also be eligible until the investigators have enrolled 100 parents. the
investigators will invite eligible parents to complete a post-FCC Survey within three days of
an FCC (for those that have an FCC). The investigators will invite all eligible parents to
complete a post-PICU Survey and participate in a one-on-one interview within three days of
PICU discharge.
The Post-FCC Survey will ask for information about parent characteristics and feedback on the
FCC. The variables related to parent characteristics will include demographics, family
relationship style (using the Family Apgar), informational support (using the Informational
Support SF4a), and mental health (using the two-item PROMIS® mental health scale) and global
physical health (using the two-item PROMIS® global physical health scale). Items asking for
feedback about the FCC (adapted from previous work) will assess: overall FCC utility; the
topics discussed and their importance to the parents; what was useful and what could be
improved; and whether the parent would like to have another FCC in the future. The post-PICU
Survey will include the same items asking about family characteristics as in the Post-FCC
Survey (not included for parents who completed a post-FCC Survey). The post-PICU Survey will
also include items asking about the utility of other modes of PICU communication (daily
rounds, electronic patient portals, written information, bedside and phone interactions with
physicians/APRNs and bedside nurses, and communication with social workers, chaplains, and
case managers). Finally, the post-PICU Survey will ask if an FCC was offered, request
feedback on FCCs (see above) that occurred (not included if a post-FCC Survey was completed),
and ask why offered FCCs did not occur. All non-validated survey items were reviewed by the
study team, for face validity. Parents of patients who die in the PICU will receive the
post-PICU Survey by mail or email 3-5 weeks after their child's death, as the investigators
and others have done previously. Parents will complete surveys electronically on a tablet
using REDCap. Audio-recorded one-on-one interviews will be conducted by a study team member
using an interview guide that focuses on the following content areas: perceptions of PICU
communications overall; specific modes of communication; why an FCC occurred or did not
occur; and perceptions of FCC utility.
