Family Support Tool Intervention for Critical Illness

(FST Trial)

Not currently recruiting at 6 trial locations

Overseen By Vidya Menon, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: No surrogate, Imminent death, Incarcerated, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve the experience for older adults who are critically ill in the ICU and their families. It tests a new family support intervention, the Multi-component Family Support Intervention, which includes scheduled family meetings and an online tool to help families understand the ICU environment and communicate better with the medical team. The goal is to make care more patient- and family-centered and to reduce stress for both patients and their surrogate decision-makers. This trial may suit critically ill patients who cannot make decisions themselves and have a high risk of severe health issues, as well as their family members who assist in medical decision-making. As an unphased trial, this study offers a unique opportunity to contribute to innovative care strategies that could significantly enhance patient and family experiences in the ICU.

Will I have to stop taking my current medications?

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

What prior data suggests that this family support intervention is safe for critically ill patients and their families?

Research shows that supporting families in intensive care units (ICUs) can be beneficial. A review of studies found that nearly two-thirds of these efforts improved patient outcomes in adult ICUs. However, family members might also face mental health challenges. Studies indicate that 20-60% of family members could experience stress-related symptoms like anxiety or depression during or after their loved one's ICU stay.

These efforts aim to enhance communication and care quality, but they can also impact emotions. Despite this, the primary goal is to support both patients and their families, making the ICU experience more focused on their needs and preferences. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Multi-component Family Support Intervention for critical illness because it offers a holistic approach that goes beyond the usual ICU care. Unlike standard treatments that primarily focus on the medical needs of the patient, this intervention actively involves family members by providing tools and support to help them cope with their loved one's critical condition. The unique feature of this approach is its emphasis on improving communication and emotional support, potentially leading to better outcomes for both patients and their families. By addressing the emotional and informational needs of the family, this intervention could transform the way we manage critical illness in the ICU.

What evidence suggests that this multi-component family support intervention is effective for improving patient- and family-centeredness of care in critical illness?

Research shows that family support programs can be helpful in ICU settings. A review of studies found that about two-thirds of these programs improved patient outcomes. In this trial, participants in the intervention arm will receive the Multi-component Family Support Intervention, designed to help families understand the ICU and prepare for discussions with doctors. These programs aim to make care more patient- and family-focused, potentially reducing stress and improving decision-making. Meanwhile, the control arm will receive usual ICU care. In another study, a nurse-led family support program slightly increased family satisfaction. ^{1 2 3 5 6}

Who Is on the Research Team?

Douglas B White, MD, MAS

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Multi-component Family Support 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.

How Is the Trial Designed?

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+

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+

Baystate Medical Center

Collaborator

Trials

67

Recruited

44,500+

Duke University

Collaborator

Trials

2,495

Recruited

5,912,000+

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+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

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]

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]

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 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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9235279/

A multicomponent family support intervention in intensive care ... This trial will examine the effectiveness of the family support intervention and generate knowledge of its implementability.

2. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2836585

Nurse-Led Family Support Intervention for ... The nurse-led, multicomponent family support intervention for families of critically ill adults slightly improved family satisfaction with ...

3. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-024-08351-y

statistical analysis plan for the cluster-randomized controlled ... The FICUS trial is a cluster-randomized superiority trial to determine the effectiveness of a nurse-led, interprofessional family support intervention (FSI)

4. sciencedirect.com sciencedirect.com/science/article/pii/S0883944124003162

A systematic review of randomized controlled trials The systematic review found that nearly two-thirds of randomized clinical trials of family-centered interventions in the adult ICU improved patient outcomes.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35761343/

study protocol for a multicenter cluster-randomized trial ... This trial will examine the effectiveness of the family support intervention and generate knowledge of its implementability.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05280691

Family Support Intervention in Intensive Care Units The primary study endpoint is quality of family care, operationalized as family members' satisfaction with ICU care at discharge. Secondary endpoints include ...