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The Family Perspectives Project Pilot Trial

ConditionsRespiratory FailureFamily SupportPhysician-Patient RelationsCritical Illness
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMatthew Modes

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Family Perspective Program

    Behavioral

    The program involves regular meetings between families and an ICU support counselor. The ICU support counselor is a trained expert in providing culturally competent emotional and/or spiritual support. The ICU support counselor will support families and also learn and summarize family perspectives in a standardized report. ICU care team members will be prompted to perspective take as they review reports prior to regular routine meetings between families and the ICU care team.

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Family Perspective ProgramExperimental treatment 1 intervention
Group B: Usual CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Feasibility of implementing the program for families of patients with acute respiratory failure.

The proportion of enrolled primary surrogate decision makers randomized to the program who receive all program components. The study will be declared "feasible" if at least 70% of primary surrogate decision makers receive all program components (meeting with ICU support counselors, ICU support counselors generating standardized reports, reports being reviewed by ICU care team members prior to meeting with families).

Time frame
6 months

Secondary outcomes

1

Feasibility of collecting data from families

The proportion of enrolled primary surrogate decision makers completing all questionnaires (enrollment, after meetings with ICU care team, 1-month post-enrollment, and 6 months post-enrollment) in each arm.

Time frame
6 months
2

Feasibility of collecting data from ICU support counselors

The proportion of questionnaires (enrollment, after each meeting with a primary surrogate decision maker) completed by ICU support counselors.

Time frame
6 months
3

Feasibility of collecting data from ICU care team members

The proportion of questionnaires (enrollment, after each meeting with a primary surrogate decision maker) completed by ICU care team members (physicians, nurses, social workers) in each arm.

Time frame
6 months
4

ICU support counselor perception of feasibility of implementing the program

Mean score on the validated 4-item Feasibility of Intervention Measure

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Matthew Modes

Lead sponsor

Cedars-Sinai Medical Center

Sponsor institution

National Palliative Care Research Center

Collaborator

Source ClinicalTrials.gov
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