Clinical trial NCT06039501: The Family Perspectives Project Pilot Trial
Official title: The Family Perspectives Project Pilot Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Respiratory Failure
Family Support
Physician-Patient Relations
Critical Illness
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
Collaborators: name: National Palliative Care Research Center
First posted: 2023-09-15
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of the study is to conduct a pilot randomized trial of a program designed to enhance equitable communication and emotional support for families of critically ill patients in order to determine feasibility, acceptability, and participant experience with the program.

The primary study procedures include: chart abstraction, questionnaires, meetings with ICU support counselors, meetings with ICU physicians and care team, audio recordings of these meetings (optional), and interviews with study participants (optional).

Study participants include: 70 critically ill patients with acute respiratory failure (enrolled with the consent of their Legally Authorized Representative) and their primary surrogate decision makers as well as ICU support counselors and ICU care teams (physicians, nurses, social workers).


Eligibility criteria: Inclusion Criteria:

* Patient inclusion criteria:

  * Individuals 18 years old or older.
  * Individuals admitted to the medical intensive care unit (MICU) at Cedars-Sinai Medical Center.
  * Individuals with acute respiratory failure, defined as \>24 hours of invasive mechanical ventilation.
  * Individuals who received invasive mechanical ventilation within 24 hours of admission to the MICU.
  * Individuals expected to need invasive mechanical ventilation for \>72 hours total, as determined by the patient's intensivist physician (fellow or attending).
* Primary surrogate decision maker inclusion criteria:

  o Individuals 18 years old or older.
  * Individual who self-identifies as the most responsible for making decisions for the enrolled patient (can be either family member or close friend).
  * Proficiency in English language.
* ICU support counselor inclusion criteria:

  * Individuals 18 years old or older.
  * Individuals who work as hospital chaplains in the MICU.
* Physician (intensivist) inclusion criteria:

  * Individuals 18 years old or older.
  * Individuals who work as critical care physicians in the MICU (fellow or attending).
* Nurse inclusion criteria:

  * Individuals 18 years old or older.
  * Individuals who work as bedside nurses in the MICU.
* Social worker inclusion criteria:

  * Individuals 18 years old or older.
  * Individuals work as social workers in the MICU.

Exclusion Criteria:

* Patient exclusion criteria:

  o Any records flagged "break the glass" or "research opt out."

  o Individuals expected to die within 24 hours of potential enrollment, as determined by the patient's intensivist physician (fellow or attending).

  o Individuals on comfort care protocol or with clear preference for comfort care, as determined by the patient's intensivist physician (fellow or attending).
  * Individuals who are chronically dependent on a ventilator prior to admission.
  * Individuals with acute on chronic neuromuscular disease-related respiratory failure (e.g., Guillain Barre, Muscular Dystrophy, Myasthenia Gravis, etc.).
  * Individuals imminently awaiting organ transplant, as determined by the patient's intensivist physician (fellow or attending).
  * Individuals with decisional capacity, as determined by the patient's intensivist physician (fellow or attending).
  * Individuals who are unrepresented (i.e., patient has no surrogate decision maker).
  * Individuals whose potential enrolled family member (primary surrogate decision maker) is not proficient in English.
  * Individuals whose attending physician is the PI on this study at the time of potential enrollment.
  * Individuals who are cared for by intensivist physicians (fellow and attending) who do not agree to participate in the study.
  * Individuals who have a pre-existing relationship with a hospital chaplain who does not agree to participate in the study, as determined by that chaplain.
* Primary surrogate decision maker exclusion criteria:

  o Not proficient in English language. (Rationale: materials and intervention are not adapted in other languages.)
* ICU support counselor exclusion criteria:

  o None
* Physician (intensivist) exclusion criteria:

  o None
* Nurse exclusion criteria:

  o None
* Social worker exclusion criteria:

  * None

Primary outcomes:
measure: Feasibility of implementing the program for families of patients with acute respiratory failure.
timeFrame: 6 months
Secondary outcomes:
measure: Feasibility of collecting data from families
timeFrame: 6 months
measure: Feasibility of collecting data from ICU support counselors
timeFrame: 6 months
measure: Feasibility of collecting data from ICU care team members
timeFrame: 6 months
measure: ICU support counselor perception of feasibility of implementing the program
timeFrame: 6 months
measure: ICU care team member perception of feasibility of implementing the program
timeFrame: 6 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Matthew Modes, MD, MPP, MS
role: PRINCIPAL_INVESTIGATOR
References: