Critical IllnessFSTNCT05019261
Multi-component Family Support Tool Intervention (FST)
A study testing Multi-component Family Support Intervention in people with Critical Illness, run by University of Pittsburgh at 7 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Critical Illness
- What is being tested?
- Multi-component Family Support Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,039 participants
- Where
- 7 sitesUnited States
- Study dates
- 11 Nov 2021to 30 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient
- Age ≥18
- Lack of decision-making capacity as determined by clinical examination by the attending physician or designee
- 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
- 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.
Show all 9Show fewer
- Up to 3 additional surrogates
- Clinician
- 1. Patient's primary attending (or their designee)
Who cannot join
- Patient
- Lack of a surrogate decision maker
- Family not available for study
- Imminent death (within 24 hours); goals of care are already "comfort measures only"; decision to withdraw life support has already been made
- Currently participating in a competing research study that does not allow co-enrollment
- Incarcerated or on an involuntary hold
Show all 19Show fewer
- Died prior to enrollment
- Discharged prior to enrollment
- Regained capacity prior to enrollment
- Physician declined patient's participation
- Physician and designee declined own participation
- Patient does not meet inclusion criteria within 5 days of ICU admission
- MD expects transfer orders will be written or the patient will be transferred within 36 hours of screening
- Greater than 5 ICU days during the current hospitalization
- Surrogate
- Age <18 years
- Cannot read or understand English
- Cannot complete questionnaires due to physical or cognitive limitations
- Has no access to or cannot travel to access the internet
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Duke University
Durham, North Carolina, 27710
NYC Health + Hospitals/Lincoln Hospital
New York, New York, 10451
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Pittsburgh VA Medical Center
Pittsburgh, Pennsylvania, 15240
Oregon Health and Science University
Portland, Oregon, 97239
Baystate Medical Center
Springfield, Massachusetts, 01199
About this study
Official title: Randomized Trial of a Scalable, Interactive Tool to Support Surrogate Decision-makers of Critically Ill Older Adults
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.
Read the 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:
- Proactive clinician-family meetings within 48 hours of enrollment and every 5-7 days thereafter.
- 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.
- 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.
- Conditions
- Critical Illness
- Being tested
- Multi-component Family Support Intervention
- Keywords
- Patient centeredness of care, Psychological Distress, End of Life Care, Critical Illness, Surrogate Decision Making, Goal Concordant Care
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Multi-component Family Support Intervention Receives: Other: Multi-component Family Support Intervention |
| Control | No intervention | Usual ICU care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months after hospital discharge
Secondary outcomes (17)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 6 months after hospital discharge
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.
Measured: 6 months after hospital discharge
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.
Measured: 3 months and 6 months after hospital discharge
Proportion of patients with new DNR order during index hospitalization and time to first DNR order during index hospitalization
Measured: 6 months after hospital discharge
Proportion of patients who received comfort-focused care during the index hospitalization and time to comfort-focused care
Measured: 6 months after hospital discharge
Proportion of patients enrolled in hospice during index hospitalization
Measured: 6 months after hospital discharge
ICU and hospital length of stay
Duration of time patient spent in ICU and hospital
Measured: 6 months after hospital discharge
Duration of mechanical ventilation
Duration of time patient spent on mechanical ventilation during index hospitalization
Measured: 6 months after hospital discharge
Cost of index hospitalization
Assigning costs using validated methods, the cost of index hospitalization will be calculated
Measured: 6 months after hospital discharge
Time to hospice
time in days from enrollment to hospice
Measured: 6 months after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study start11 Nov 2021
- Primary completion30 Jan 2026
- Study completion30 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,039 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Duke University, Baystate Medical Center, Oregon Health and Science University, National Institute on Aging (NIA), New York City Health and Hospitals Corporation, VA Pittsburgh Healthcare System, University of North Carolina, Chapel Hill
- Responsible party
- Principal investigator, Douglas White, University of Pittsburgh
- Investigators
- Douglas B White, MD, MAS, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05019261
- Sponsor's protocol ID
- STUDY20110367
- Other IDs
- R01AG066731-01
- Acronym
- FST
- Status last verified
- Apr 2026
- First submitted
- 30 Jul 2021
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Raw data and derived datasets will be made available to external investigators and the public on a case-by-case basis, to be approved by the PI and in accordance with institutional, HIPAA, state and federal regulations. A data-sharing agreement may be instituted, depending upon the data to be shared. All data that is shared will be de-identified to protect participant privacy and confidentiality. Data and datasets will be retained and available to share for at least three years following completion of the project, in accordance with NIH regulations.
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of a Scalable, Interactive Tool to Support Surrogate Decision-makers of Critically Ill Older Adults
- ClinicalTrials.gov ID
- NCT05019261
- Acronym / sponsor ID
- FST / STUDY20110367
- Conditions
- Critical Illness
- Keywords
- Patient centeredness of care, Psychological Distress, End of Life Care, Critical Illness, Surrogate Decision Making, Goal Concordant Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,039 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Duke University, Baystate Medical Center, Oregon Health and Science University, National Institute on Aging (NIA), New York City Health and Hospitals Corporation, VA Pittsburgh Healthcare System, University of North Carolina, Chapel Hill
- Study start
- 11 Nov 2021 (actual)
- Primary completion
- 30 Jan 2026 (actual)
- Study completion
- 30 Jan 2026 (actual)
- First posted
- 24 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Proactive clinician-family meetings within 48 hours of enrollment and every 5-7 days thereafter.
- 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.
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Multi-component Family Support InterventionMulti-component Family Support Intervention |
| Control | No intervention | –Usual ICU care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient
- Age ≥18
- Lack of decision-making capacity as determined by clinical examination by the attending physician or designee
- 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
Key exclusion criteria (19 listed)
- Patient
- Lack of a surrogate decision maker
- Family not available for study
- Imminent death (within 24 hours); goals of care are already "comfort measures only"; decision to withdraw life support has already been made
- Currently participating in a competing research study that does not allow co-enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-component Family Support InterventionThe 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. | Other | Intervention |
Primary outcome
Patient and family centeredness of care
Time frame: 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.
17 secondary outcomes
Composite measure of goal-concordant care
Time frame: 3 months after hospital discharge
Satisfaction with ICU care
Time frame: 3 months after hospital discharge
Unmet palliative care needs
Time frame: Measured at day 5 post-randomization
Surrogates' prognostic awareness
Time frame: Measured at day 5 post-randomization
Surrogates' clarity about patient values and preferences
Time frame: Measured at day 5 post-randomization
Clinician-family conflict
Time frame: Measured at day 5 post-randomization
Perceived effectiveness of Family Support Tool
Time frame: Measured at day 5 post-randomization
Risk of post-traumatic stress disorder
Time frame: 6 months after hospital discharge
Surrogates' symptoms of anxiety and depression
Time frame: 6 months after hospital discharge
Resource utilization
Time frame: 3 months and 6 months after hospital discharge
Proportion of patients with new DNR order during index hospitalization and time to first DNR order during index hospitalization
Time frame: 6 months after hospital discharge
Proportion of patients who received comfort-focused care during the index hospitalization and time to comfort-focused care
Time frame: 6 months after hospital discharge
Proportion of patients enrolled in hospice during index hospitalization
Time frame: 6 months after hospital discharge
ICU and hospital length of stay
Time frame: 6 months after hospital discharge
Duration of mechanical ventilation
Time frame: 6 months after hospital discharge
Cost of index hospitalization
Time frame: 6 months after hospital discharge
Time to hospice
Time frame: 6 months after hospital discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: Yes. Raw data and derived datasets will be made available to external investigators and the public on a case-by-case basis, to be approved by the PI and in accordance with institutional, HIPAA, state and federal regulations. A data-sharing agreement may be instituted, depending upon the data to be shared. All data that is shared will be de-identified to protect participant privacy and confidentiality. Data and datasets will be retained and available to share for at least three years following completion of the project, in accordance with NIH regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Douglas B White, MD, MAS principal investigator
University of Pittsburgh
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-component Family Support Intervention in people with Critical Illness, run by University of Pittsburgh at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient and family centeredness of care (time frame: 3 months after hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.