Multi-component Family Support Tool Intervention (FST)

N/AActive Not RecruitingNCT05019261

University of Pittsburgh1,163 enrolled

Overview

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.

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.

Interventions

Multi-component Family Support InterventionOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (7)

Baystate Medical Center

Springfield, Massachusetts, United States

NYC Health + Hospitals/Lincoln Hospital

New York, New York, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Duke University

Durham, North Carolina, United States

Oregon Health and Science University

Portland, Oregon, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Pittsburgh VA Medical Center

Pittsburgh, Pennsylvania, United States

Outcomes

Primary Outcomes

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.

Time frame: 3 months after hospital discharge

Secondary Outcomes

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.

Time frame: 3 months after hospital discharge

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.

Time frame: 3 months after hospital discharge

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.

Time frame: Measured at day 5 post-randomization

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.

Time frame: Measured at day 5 post-randomization

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 (α=0.92), and discriminant validity.

Time frame: Measured at day 5 post-randomization

Clinician-family conflict

A brief survey (measured by both surrogates and ICU clinicians) to determine the level of family-clinician conflict during index hospitalization

Time frame: Measured at day 5 post-randomization

Perceived effectiveness of Family Support Tool

A brief survey asking (intervention only) surrogate participants perceived effectiveness of the FST intervention

Time frame: Measured at day 5 post-randomization

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.