Critical Illness, Family Support, Physician-Patient Relations, Respiratory Failure
Conditions
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).
Interventions
BEHAVIORALFamily Perspective Program
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.
Sponsors
National Palliative Care Research Center
Matthew Modes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of implementing the program for families of patients with acute respiratory failure. | 6 months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of collecting data from families | 6 months | 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. |
| Feasibility of collecting data from ICU support counselors | 6 months | The proportion of questionnaires (enrollment, after each meeting with a primary surrogate decision maker) completed by ICU support counselors. |
| Feasibility of collecting data from ICU care team members | 6 months | 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. |
| ICU support counselor perception of feasibility of implementing the program | 6 months | Mean score on the validated 4-item Feasibility of Intervention Measure |
| ICU care team member perception of feasibility of implementing the program | 6 months | Mean score on the validated 4-item Feasibility of Intervention Measure |
Countries
United States
Contacts
Primary ContactMatthew Modes, MD, MPP, MS
Outcome results
None listed