Clinical trial NCT05019261: Multi-component Family Support Tool Intervention (FST)
Official title: Randomized Trial of a Scalable, Interactive Tool to Support Surrogate Decision-makers of Critically Ill Older Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Critical Illness
Keywords: Patient centeredness of care
Psychological Distress
End of Life Care
Critical Illness
Surrogate Decision Making
Goal Concordant Care
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Duke University
name: Baystate Medical Center
name: Oregon Health and Science University
name: National Institute on Aging (NIA)
name: New York City Health and Hospitals Corporation
name: University of North Carolina, Chapel Hill, NC, USA
name: VA Pittsburgh Healthcare System
First posted: 2021-08-24
Enrollment: 1163
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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.

Eligibility criteria: INCLUSION

Patient

1. Age ≥18
2. Lack of decision-making capacity as determined by clinical examination by the attending physician or designee
3. Clinical indication of at least 40% risk of death or ≥40% 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 5 days of ICU admission
12. MD expects transfer orders will be written or the patient will be transferred within 36 hours of screening
13. Greater than 5 ICU days during the current hospitalization

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

Primary outcomes:
measure: Patient and family centeredness of care
timeFrame: 3 months after hospital discharge
Secondary outcomes:
measure: Composite measure of goal-concordant care
timeFrame: 3 months after hospital discharge
measure: Satisfaction with ICU care
timeFrame: 3 months after hospital discharge
measure: Unmet palliative care needs
timeFrame: Measured at day 5 post-randomization
measure: Surrogates' prognostic awareness
timeFrame: Measured at day 5 post-randomization
measure: Surrogates' clarity about patient values and preferences
timeFrame: Measured at day 5 post-randomization
measure: Clinician-family conflict
timeFrame: Measured at day 5 post-randomization
measure: Perceived effectiveness of Family Support Tool
timeFrame: Measured at day 5 post-randomization
measure: Risk of post-traumatic stress disorder
timeFrame: 6 months after hospital discharge
measure: Surrogates' symptoms of anxiety and depression
timeFrame: 6 months after hospital discharge
measure: Resource utilization
timeFrame: 3 months and 6 months after hospital discharge
measure: Proportion of patients with new DNR order during index hospitalization and time to first DNR order during index hospitalization
timeFrame: 6 months after hospital discharge
measure: Proportion of patients who received comfort-focused care during the index hospitalization and time to comfort-focused care
timeFrame: 6 months after hospital discharge
measure: Proportion of patients enrolled in hospice during index hospitalization
timeFrame: 6 months after hospital discharge
measure: ICU and hospital length of stay
timeFrame: 6 months after hospital discharge
measure: Duration of mechanical ventilation
timeFrame: 6 months after hospital discharge
measure: Cost of index hospitalization
timeFrame: 6 months after hospital discharge
measure: Time to hospice
timeFrame: 6 months after hospital discharge
Other outcomes:
measure: Patient hospital survival
timeFrame: 6 months after hospital discharge
measure: Duration of survival from hospital discharge through 6-month follow-up
timeFrame: 6 months after hospital discharge
measure: Days alive outside healthcare facilities
timeFrame: 6 months after hospital discharge
measure: Patients' functional status
timeFrame: 6 months after hospital discharge
Locations:
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
city: New York
country: United States
facility: NYC Health + Hospitals/Lincoln Hospital
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Pittsburgh VA Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Douglas B White, MD, MAS
role: PRINCIPAL_INVESTIGATOR
References: