Multi-component Family Support Tool Intervention (FST)
- Conditions
- Critical Illness
- Interventions
- Other: Multi-component Family Support Intervention
- Registration Number
- NCT05019261
- Lead Sponsor
- University of Pittsburgh
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1163
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Multi-component Family Support Intervention Multi-component Family Support Intervention
- Primary Outcome Measures
Name Time Method Patient and family centeredness of care 3 months after hospital discharge 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.
- Secondary Outcome Measures
Name Time Method Resource utilization 3 months and 6 months after hospital discharge 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.
Proportion of patients enrolled in hospice during index hospitalization 6 months after hospital discharge Satisfaction with ICU care 3 months after hospital discharge 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.
Unmet palliative care needs Measured at day 5 post-randomization 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.
Proportion of patients who received comfort-focused care during the index hospitalization and time to comfort-focused care 6 months after hospital discharge ICU and hospital length of stay 6 months after hospital discharge Duration of time patient spent in ICU and hospital
Duration of mechanical ventilation 6 months after hospital discharge Duration of time patient spent on mechanical ventilation during index hospitalization
Clinician-family conflict Measured at day 5 post-randomization A brief survey (measured by both surrogates and ICU clinicians) to determine the level of family-clinician conflict during index hospitalization
Perceived effectiveness of Family Support Tool Measured at day 5 post-randomization A brief survey asking (intervention only) surrogate participants perceived effectiveness of the FST intervention
Risk of post-traumatic stress disorder 6 months after hospital discharge 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.
Cost of index hospitalization 6 months after hospital discharge Assigning costs using validated methods, the cost of index hospitalization will be calculated
Surrogates' clarity about patient values and preferences Measured at day 5 post-randomization 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.
Surrogates' symptoms of anxiety and depression 6 months after hospital discharge 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.
Time to hospice 6 months after hospital discharge time in days from enrollment to hospice
Composite measure of goal-concordant care 3 months after hospital discharge Assessed by surrogates at 3-month telephone follow-up using an 8-item composite measure of goal-concordant care.
Surrogates' prognostic awareness Measured at day 5 post-randomization 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.
Proportion of patients with new DNR order during index hospitalization and time to first DNR order during index hospitalization 6 months after hospital discharge
Trial Locations
- 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