Multi-component Family Support Tool Intervention (FST)

Critical Illness Clinical Trial

— FST  

Official title:

Randomized Trial of a Scalable, Interactive Tool to Support Surrogate Decision-makers of Critically Ill Older Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05019261
• Other study ID #: STUDY20110367
• Secondary ID: R01AG066731-01
• Status: Recruiting
• Phase: N/A
• Start date: November 11, 2021
• Est. completion date: April 30, 2026

Study information

• Verified date: March 2024
• Source: University of Pittsburgh
• Contact: Douglas B White, MD, MAS
• Phone: 412-864-3757
• Email: douglas.white[@]pitt.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The National Academy of Medicine and the National Institutes of Health have called for urgent action to improve the care delivered to the nearly 1,000,000 older Americans who die in intensive care units (ICUs) annually or survive with substantial impairments. These patients often die with distressing symptoms and may receive more invasive, life-prolonging treatment than they would choose for themselves. Moreover, their family members acting as surrogate decision-makers often experience lasting psychological distress from the ICU experience. We will conduct a multicenter randomized trial among 370 incapacitated, critically ill older adult patients at high risk of death or severe functional impairment, their surrogate decision-makers, and their ICU clinicians to determine whether a multi-component family support intervention can improve the patient- and family-centeredness of care (primary outcome), as well as positively impact a variety of other patient, family, and healthcare delivery outcomes. The multicomponent intervention involves: Proactive family meetings scheduled within 48 hours of ICU admission and approximately every 5-7 days after that.

Surrogates will have access (computer, tablet, or mobile phone) to the interactive web-based Family Support Tool. The tool will familiarize families with the ICU and prepare them for their interactions with the clinical team by completing specific sections of the Family Support Tool upon study enrollment, before family meetings, and any other time they wish. The ICU team will receive a tool-generated summary of information about the family before each family meeting, including their main questions and concerns, information about the patient's values and preferences, prognostic expectations, and unmet psychological needs.

Description:

The Family Support Tool intervention is designed to help families navigate the emotional, psychological, and cognitive complexities of being a surrogate for an incapacitated critically ill patient and also to enhance the timeliness and quality of clinician-family communication. The intervention consists of three components:

1. Proactive clinician-family meetings within 48 hours of enrollment and every 5-7 days thereafter.

2. Family members complete sections of an interactive web-based tool upon study enrollment, before family meetings, and any other time they wish. Family members can access the tool anywhere via computer, tablet, or mobile phone. The first section of the tool is completed on the first day of study enrollment and contains: video messages supporting families including stories from other families and their experiences and coping strategies, tips on self-care and links to hospital resources. The second and third sections of the FST are completed before scheduled clinician-family meetings on study day 2-3 and again 5-7 days later. These sections of the tool contain: videos detailing what to expect during family meetings, interactive exercises and prompts about patient values, prognosis, care expectations and treatment leanings to help prepare for family meetings. The study team will provide families a printed summary sheet of their main questions for the ICU team that they are encouraged to bring to the family meeting.

3. Before each scheduled family meeting the ICU team receives a written report that summarizes the family's main questions and concerns, information about the patient's values and preferences, surrogates' prognostic expectations, and a visual display of their unmet PC needs.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1163
• Est. completion date: April 30, 2026
• Est. primary completion date: April 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

INCLUSION

Patient

1. Age =50

2. Lack of decision-making capacity as determined by clinical examination by the attending physician or designee

3. Clinical indication of at least 50% risk of death or =50% chance of new, severe long-term functional impairment (needs assistance with = 2 ADLs), as judged by the patient's attending physician or designee

Surrogate

1. The primary surrogate is determined by the patient's advance directive or, if no directive exists, by following the hierarchy of surrogates codified in state law.

2. Up to 3 additional surrogates

Clinician

1. Patient's primary attending (or their designee)

EXCLUSION

Patient

1. Lack of a surrogate decision maker

2. Family not available for study

3. Imminent death (within 24 hours); goals of care are already "comfort measures only"; decision to withdraw life support has already been made

4. Currently participating in a competing research study that does not allow co-enrollment

5. Incarcerated or on an involuntary hold

6. Died prior to enrollment

7. Discharged prior to enrollment

8. Regained capacity prior to enrollment

9. Physician declined patient's participation

10. Physician and designee declined own participation

11. Patient does not meet inclusion criteria within 3 days of ICU admission

12. MD expects transfer orders will be written or the patient will be transferred within 36 hours of screening

Surrogate

1. Age <18 years

2. Cannot read or understand English

3. Cannot complete questionnaires due to physical or cognitive limitations

4. Has no access to or cannot travel to access the internet

Related Conditions & MeSH terms

• Critical Illness

Intervention

Other:
• Multi-component Family Support Intervention
The multi-component intervention is designed to enhance the quality of clinician-family communication and help families manage the emotional and cognitive complexities of surrogate decision-making. It involves: 1) proactive clinician-family meetings; 2) use by surrogates of an interactive web-based tool throughout the ICU stay which is narrated by family members of ICU patients and includes stories and experiences from other families, self-care strategies, brief videos explaining what to expect during family meetings, a question prompt list, an interactive values clarification exercise, and an explanation of different treatment pathways for critically ill patients. 3. Prior to the proactive family meetings, the ICU team is provided with a summary of the family's main questions/concerns, their prognostic expectations, a summary of the patient's values and preferences, and surrogates' current ratings of the extent to which their psychosocial needs are being addressed in the ICU.

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Duke University	Durham	North Carolina
United States	NYC Health + Hospitals/Lincoln Hospital	New York	New York
United States	Pittsburgh VA Medical Center	Pittsburgh	Pennsylvania
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Oregon Health and Science University	Portland	Oregon
United States	Baystate Medical Center	Springfield	Massachusetts

Sponsors (8)

Lead Sponsor	Collaborator
University of Pittsburgh	Baystate Medical Center, Duke University, National Institute on Aging (NIA), New York City Health and Hospitals Corporation, Oregon Health and Science University, Pittsburgh VA Medical Center-University Drive, University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient hospital survival	The vital status of the patient will be assessed at the conclusion of index hospitalization	6 months after hospital discharge
Other	Duration of survival from hospital discharge through 6-month follow-up	This will be measured as a time-to-event variable, with time 0 being the date of hospital discharge. All death dates will be confirmed by querying the SSDMF or institutional death indices at the completion of the trial.	6 months after hospital discharge
Other	Days alive outside healthcare facilities	We will calculate the number of days a patient was alive from discharge to 6 months, then subtract that from the number of days the patient was in a hospital, LTAC, SNF, rehab facility, or hospice.	6 months after hospital discharge
Other	Patients' functional status	Assessed using the Katz Index of Independence in Activities of Daily Living, a validated and widely-used scale to quantify patients' functional status. Katz is a 6-item (1 or 0 point) scale measuring independency in older adults. Lower scores indicate a greater level of dependence for measured skills.	6 months after hospital discharge
Primary	Patient and family centeredness of care	12-item Patient Perceived Patient-Centeredness of Care Scale (PPPC), previously modified for use by surrogates, completed at 3-month telephone follow-up of surrogates.	3 months after hospital discharge
Secondary	Composite measure of goal-concordant care	Assessed by surrogates at 3-month telephone follow-up using an 8-item composite measure of goal-concordant care.	3 months after hospital discharge
Secondary	Satisfaction with ICU care	Assessed using the Family Satisfaction in the ICU (FS-ICU) instrument at 3-month telephone follow-up of surrogates. The FS-ICU is a 24-item scale concerning satisfaction with care, communication, and decision-making in the ICU.	3 months after hospital discharge
Secondary	Unmet palliative care needs	Measured using the adapted Needs of Social Nature, Existential Concerns, Symptoms, and Therapeutic Interaction (NEST) scale administered to surrogates on day 5 post-randomization. The adapted NEST scale is designed for ICU use; it is a 13-item instrument developed to identify unmet social, emotional, physical, and care-system needs in serious illness.	Measured at day 5 post-randomization
Secondary	Surrogates' prognostic awareness	Assessed on study day 5 using the validated Clinician-Surrogate Concordance Scale (CSCS), which our research team developed. The single item CSCS has excellent test-retest reliability (r =0.91). It has established criterion validity and responsiveness to change.	Measured at day 5 post-randomization
Secondary	Surrogates' clarity about patient values and preferences	Assessed by surrogates after family meetings on study day 5 using the "informed" and "values clarity" subscales, 6 items out of the 16-item Decisional Conflict Scale (DCS). The scale has established responsiveness to change, test-retest reliability (r=0.81), internal consistency (a=0.92), and discriminant validity.	Measured at day 5 post-randomization
Secondary	Clinician-family conflict	A brief survey (measured by both surrogates and ICU clinicians) to determine the level of family-clinician conflict during index hospitalization	Measured at day 5 post-randomization
Secondary	Perceived effectiveness of Family Support Tool	A brief survey asking (intervention only) surrogate participants perceived effectiveness of the FST intervention	Measured at day 5 post-randomization
Secondary	Risk of post-traumatic stress disorder	Assessed using the Impact of Events Scale-revised (IES-R) at 6 months. The IES-R is a valid, reliable, and responsive 22 -item instrument measuring symptoms of avoidance and intrusive thoughts. A score 33 indicates a high risk of PTSD. It has been used successfully among ICU surrogates.	6 months after hospital discharge
Secondary	Surrogates' symptoms of anxiety and depression	The HADS is a 14-item, two-domain (anxiety, depression) instrument with established reliability and validity among ICU surrogates that is recommended by consensus guidelines for use among ICU surrogates. Assessed at 6-month telephone follow-up.	6 months after hospital discharge
Secondary	Resource utilization	Among hospital survivors we will perform interviews with surrogates at 3-months and 6-months to identify patient's post-discharge healthcare utilization (e.g. hospital admissions, ED visits, skilled-nursing facility use, hospice use, etc.), assigning costs using validated methods.	3 months and 6 months after hospital discharge
Secondary	Proportion of patients with new DNR order during index hospitalization and time to first DNR order during index hospitalization		6 months after hospital discharge
Secondary	Proportion of patients who received comfort-focused care during the index hospitalization and time to comfort-focused care		6 months after hospital discharge
Secondary	Proportion of patients enrolled in hospice during index hospitalization		6 months after hospital discharge
Secondary	ICU and hospital length of stay	Duration of time patient spent in ICU and hospital	6 months after hospital discharge
Secondary	Duration of mechanical ventilation	Duration of time patient spent on mechanical ventilation during index hospitalization	6 months after hospital discharge
Secondary	Cost of index hospitalization	Assigning costs using validated methods, the cost of index hospitalization will be calculated	6 months after hospital discharge
Secondary	Time to hospice	time in days from enrollment to hospice	6 months after hospital discharge