Family Support Tool Intervention for Critical Illness

(FST Trial)

Recruiting at6 trial locations

Overseen by Douglas B White, MD, MAS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Pittsburgh

Disqualifiers: No surrogate, Imminent death, Incarcerated, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests a program that helps families of critically ill older adults by offering meetings with doctors and an online tool. It aims to improve communication, help families make informed decisions, and reduce their stress.

Will I have to stop taking my current medications?

The trial protocol does not specify whether participants must stop taking their current medications.

What data supports the effectiveness of the Family Support Tool Intervention (FST) treatment for critical illness?

Research shows that family-centered care interventions in the ICU can improve outcomes, suggesting that the Family Support Tool Intervention may help improve family experiences and reduce stress during critical illness. ^{1 2 3 4 5}

Is the Family Support Tool Intervention safe for humans?

The available research does not provide specific safety data for the Family Support Tool Intervention, but it generally involves support and communication strategies, which are typically safe for humans. ^{1 3 6 7 8}

How is the Family Support Tool Intervention unique compared to other treatments for critical illness?

The Family Support Tool Intervention is unique because it focuses on providing structured support to the families of critically ill patients, helping them cope and function better during the crisis, which is not typically addressed by standard medical treatments for critical illness. ^{3 6 9 10 11}

Research Team

Douglas B White, MD, MAS

Principal Investigator

University of Pittsburgh

Eligibility Criteria

This trial is for critically ill older adults (age ≥60) in the ICU with a high risk of death or severe long-term impairment, and their family surrogates. Patients must lack decision-making capacity and have at least a 50% chance of dying or needing significant help with daily activities. Surrogates must be adults, speak English, able to use the internet, and not involved in conflicting studies.

Inclusion Criteria

Clinician: Patient's primary attending (or their designee)

Up to 3 additional surrogates

I am 50 years old or older.

Exclusion Criteria

Surrogate cannot read or understand English

I have recovered from my previous condition.

My doctor and their team have chosen not to participate.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

Intervention

Proactive 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.

6 months

Multiple virtual interactions and in-person meetings

Follow-up

Participants are monitored for patient and family-centeredness of care, functional status, and other outcomes at 3 and 6 months after hospital discharge.

6 months

3-month and 6-month follow-up assessments

Treatment Details

Interventions

• Multi-component Family Support Intervention (Behavioural Intervention)

Trial Overview The study tests if a multi-component family support tool can improve care for ICU patients by scheduling proactive family meetings and providing an interactive web-based tool to prepare families for discussions about patient values, preferences, and needs.

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

Multi-component Family Support Intervention

Group II: Control Active Control 1 Intervention

Usual ICU care

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

David Apelian

University of Pittsburgh

Chief Executive Officer since 2019

PhD in Molecular Biology from Rutgers University, MD from the University of Medicine and Dentistry of New Jersey, MBA from Quinnipiac University

Pamela D. Garzone

University of Pittsburgh

Chief Medical Officer

PhD in Clinical Science from the University of Pittsburgh

University of North Carolina, Chapel Hill, NC, USA

Collaborator

Trials

2

Recruited

3,200+

VA Pittsburgh Healthcare System

Collaborator

Trials

36

Recruited

15,900+

Pittsburgh VA Medical Center-University Drive

Collaborator

Trials

1

Recruited

1,200+

Oregon Health and Science University

Collaborator

Trials

1,024

Recruited

7,420,000+

John Hunter

Oregon Health and Science University

Chief Medical Officer since 2024

MD, specific details unavailable

Ann Madden Rice

Oregon Health and Science University

Chief Executive Officer

FACHE certification, extensive leadership experience in academic health centers

Baystate Medical Center

Collaborator

Trials

67

Recruited

44,500+

Peter Banko

Baystate Medical Center

Chief Executive Officer

MBA from Stanford University

Dr. Yvonne Cheung

Baystate Medical Center

Chief Medical Officer since 2024

MD from Columbia University, MPH from Harvard School of Public Health, MBA from University of Massachusetts Amherst

Duke University

Collaborator

Trials

2,495

Recruited

5,912,000+

Mary E. Klotman

Duke University

Chief Executive Officer since 2017

MD from Duke University School of Medicine

Michelle McMurry-Heath

Duke University

Chief Medical Officer since 2020

MD from Duke University School of Medicine

New York City Health and Hospitals Corporation

Collaborator

Trials

33

Recruited

8,500+

University of North Carolina, Chapel Hill

Collaborator

Trials

1,588

Recruited

4,364,000+

Dr. Peggy P. McNaull

University of North Carolina, Chapel Hill

Chief Medical Officer

MD from Louisiana State University School of Medicine

Dr. Lynne Fiscus

University of North Carolina, Chapel Hill

Chief Executive Officer since 2020

MD from Georgetown University, MPH from UNC

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Dr. Richard J. Hodes

National Institute on Aging (NIA)

Chief Executive Officer since 1993

MD from Harvard Medical School

Dr. Marie Bernard

National Institute on Aging (NIA)

Chief Medical Officer

MD from Harvard Medical School

Findings from Research

The nurse-led family support intervention in the intensive care unit was viewed as essential by both families and healthcare staff, enhancing the overall care experience.

This intervention improved communication between staff and families, allowing for better relationship-building and support, indicating its potential value in critical care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family and health professional experience with a nurse-led family support intervention in ICU: A qualitative evaluation study. Naef, R., Massarotto, P., Petry, H.[2021]

The study identifies specific support interventions that significantly benefit the families of critically ill patients, highlighting the importance of addressing their needs during such challenging times.

It recommends targeted nursing actions to effectively meet the support needs of these families, emphasizing the role of healthcare providers in enhancing family well-being in critical care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family perceptions of support interventions in the intensive care unit. De Jong, MJ., Beatty, DS.[2019]

The implementation of a standardized family stress screening tool in a pediatric intensive care unit (PICU) led to a significant increase in stress screenings from 0% to 100% over 18 months, ensuring that all families received timely support.

Parent satisfaction regarding emotional support improved significantly, with scores rising from 81.7 to 87.0, and the number of security calls for distressed families decreased by 50%, indicating a reduction in family crises.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Co-designed PICU Family Stress Screening and Response System to Improve Experience, Quality, and Safety. Liaw, KR., Cho, J., Devins, L., et al.[2023]

Patient- and family-centered care interventions in the ICU led to a significant reduction in the length of stay by an average of 1.21 days, based on a meta-analysis of high-quality randomized studies involving 46 total studies.

While these interventions did not significantly affect mortality rates, they were associated with improvements in various important outcomes such as family satisfaction, patient experience, and mental health, indicating their potential benefits in the ICU setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of Patient- and Family-Centered Care Interventions in the ICU: A Systematic Review and Meta-Analysis. Goldfarb, MJ., Bibas, L., Bartlett, V., et al.[2022]

Family-centered outcomes in critical care, such as satisfaction with care and psychological distress, are crucial for improving communication and support for families during and after a loved one's critical illness.

New measures like decisional conflict and caregiver burden can help better understand and address the significant emotional and psychological challenges faced by families in the ICU.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family-centered outcomes during and after critical illness: current outcomes and opportunities for future investigation. Long, AC., Kross, EK., Curtis, JR.[2020]

A systematic review of 20 studies on interventions to promote family involvement in adult critical care revealed moderate to weak evidence, highlighting the need for more effective strategies.

Six categories of interventions were identified, with outcomes showing improvements in communication, decision-making, and family well-being, suggesting that tailored, multilayered approaches could enhance family engagement in critical care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions to promote family member involvement in adult critical care settings: a systematic review. Xyrichis, A., Fletcher, S., Philippou, J., et al.[2022]

In a study involving 532 family members of critically ill patients, those who accessed an educational website reported significantly higher satisfaction with care, as measured by the Critical Care Family Needs Inventory.

Family members who used the website also experienced a lower prevalence of clinical anxiety, with a prevalence ratio of 0.35, indicating a substantial reduction in anxiety symptoms compared to those who did not access the site.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does an educational website improve psychological outcomes and satisfaction among family members of intensive care unit patients? Haack, TDSR., Rosa, RG., Teixeira, C., et al.[2023]

Research has highlighted the importance of developing and testing interventions to support family members after a critical illness, indicating a need for targeted strategies in this area.

Critical care nurses play a vital role in providing support to families during these challenging times, suggesting that their involvement can significantly improve family outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family member interventions: research challenges. Leske, JS.[2006]

The guidelines developed by an international team of 29 experts provide 23 evidence-based recommendations for optimizing family-centered care in the ICU, focusing on communication, family presence, and support, based on a systematic review of 238 relevant studies.

All recommendations were classified as weak, indicating that while there is a growing body of research, more studies are needed to determine the most effective strategies for supporting families of critically ill patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guidelines for Family-Centered Care in the Neonatal, Pediatric, and Adult ICU. Davidson, JE., Aslakson, RA., Long, AC., et al.[2022]

The Family Health Conversation Intervention, involving reflective discussions facilitated by nurses, significantly improved family functioning among participants, as evidenced by enhanced understanding and concern for each other after three and twelve months.

Families reported feeling closer and more open in their communication, which helped them navigate the challenges of having a critically ill member, ultimately supporting healthier family dynamics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family Health Conversations create awareness of family functioning. Ahlberg, M., Hollman Frisman, G., Berterö, C., et al.[2020]

Families of critically ill patients develop strategies such as awareness, dialogue, and comfort to cope with their situation, as revealed through qualitative interviews.

Nurses play a crucial role in providing cognitive and emotional support to families, facilitating their interactions with the healthcare team, which helps families better understand and discuss their circumstances.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Critical health-disease transition in the family: Nursing intervention in the lived experience. Mendes, AP.[2022]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Family and health professional experience with a nurse-led family support intervention in ICU: A qualitative evaluation study. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Family perceptions of support interventions in the intensive care unit. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Co-designed PICU Family Stress Screening and Response System to Improve Experience, Quality, and Safety. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Outcomes of Patient- and Family-Centered Care Interventions in the ICU: A Systematic Review and Meta-Analysis. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Family-centered outcomes during and after critical illness: current outcomes and opportunities for future investigation. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Interventions to promote family member involvement in adult critical care settings: a systematic review. [2022]

7. Brazil pubmed.ncbi.nlm.nih.gov

Does an educational website improve psychological outcomes and satisfaction among family members of intensive care unit patients? [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Family member interventions: research challenges. [2006]

9. United States pubmed.ncbi.nlm.nih.gov

Guidelines for Family-Centered Care in the Neonatal, Pediatric, and Adult ICU. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Family Health Conversations create awareness of family functioning. [2020]

11. Brazil pubmed.ncbi.nlm.nih.gov

Critical health-disease transition in the family: Nursing intervention in the lived experience. [2022]