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| Name | Class |
|---|---|
| National Palliative Care Research Center | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Family Perspective Program | Experimental | Families of critically ill patients will receive a program designed to enhance equitable communication and emotional support. Questionnaires will be completed by primary surrogate decision makers, ICU support counselors, and ICU care team members (physicians, nurses, social workers). Meetings between families and ICU support counselors will be audio recorded (optional). Meetings between families and ICU care teams will be audio recorded (optional). Interviews with participants will be completed (optional). |
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| Usual Care | No Intervention | Families of critically ill patients will receive usual care, which involves regular and routine meetings between families and the ICU care team. Questionnaires will be completed by primary surrogate decision makers and ICU care team members (physicians, nurses, social workers). Meetings between families and ICU care teams will be audio recorded (optional). Interviews with participants will be completed (optional). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Feasibility of collecting data from ICU support counselors |
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Inclusion Criteria:
Patient inclusion criteria:
Primary surrogate decision maker inclusion criteria:
o Individuals 18 years old or older.
ICU support counselor inclusion criteria:
Physician (intensivist) inclusion criteria:
Nurse inclusion criteria:
Social worker inclusion criteria:
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).
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Matthew Modes, MD, MPP, MS | Contact | 310-423-9017 | matthew.modes@cshs.org |
| Name | Affiliation | Role |
|---|---|---|
| Matthew Modes, MD, MPP, MS | Cedars-Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Recruiting | Los Angeles | California | 90048 | United States |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
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|
The proportion of questionnaires (enrollment, after each meeting with a primary surrogate decision maker) completed by ICU support counselors. |
| 6 months |
| 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. | 6 months |
| ICU support counselor perception of feasibility of implementing the program | Mean score on the validated 4-item Feasibility of Intervention Measure | 6 months |
| ICU care team member perception of feasibility of implementing the program | Mean score on the validated 4-item Feasibility of Intervention Measure | 6 months |
| D013568 | Pathological Conditions, Signs and Symptoms |