Family Support Program for Critical Illness

Overseen By Matthew Modes, MD, MPP, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Matthew Modes

Disqualifiers: Comfort care, Ventilator dependent, Organ transplant, others

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

Compensation: Varies

Number of Visits: 1

Duration: 6 months

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new program to improve communication and emotional support for families of critically ill ICU patients. It compares usual care with the Family Perspective Program, which aims to help families feel more supported. Eligible patients must have acute respiratory failure and be on a ventilator, with a primary decision-maker, such as a close family member, who speaks English. Participants will fill out questionnaires and attend meetings with ICU staff, which may be recorded. As an unphased trial, this study allows families to contribute to innovative care improvements in the ICU setting.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether participants need to stop taking their current medications. It seems unlikely that medication changes are required, as the study focuses on communication and support for families of critically ill patients.

What prior data suggests that this program is safe for families of critically ill patients?

Research has shown that family-centered programs in the ICU can enhance the well-being of both patients and their families. Studies have found that these programs often lead to better patient outcomes.

The Family Perspective Program supports families of critically ill patients by enhancing communication and providing emotional support. This non-invasive program does not involve medical procedures or medications. Instead, it centers on conversations and support sessions with ICU staff.

Because the program focuses on communication and emotional support, it does not cause physical side effects like those from drugs or medical treatments, resulting in very low safety concerns. Participants mainly engage in meetings and complete questionnaires, which are safe activities.

Overall, the Family Perspective Program is well-received for its emphasis on discussions and emotional support. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Family Perspective Program is unique because it focuses on enhancing communication and emotional support for families of critically ill patients, going beyond the usual care, which typically involves routine meetings with the ICU care team. Researchers are excited about this program because it aims to create a more equitable dialogue between families and healthcare providers, potentially improving decision-making and emotional well-being for families during highly stressful times. By incorporating ICU support counselors and providing additional resources, this approach could lead to better support systems compared to the standard care practices.

What evidence suggests that the Family Perspective Program is effective for enhancing communication and emotional support?

Research has shown that involving families in the care of adults in the ICU can improve patient outcomes. A review of studies found that almost two-thirds of these family-focused programs had a positive impact. In this trial, the Family Perspective Program serves as one of the treatment arms, aiming to enhance communication and provide emotional support to families of critically ill patients. Although no single program has been proven to help every family, this approach shows promise. Families often encounter emotional and social challenges, and programs like this aim to offer better support during difficult times. ^{3 6 7 8 9}

Who Is on the Research Team?

Matthew Modes, MD, MPP, MS

Principal Investigator

Cedars-Sinai Medical Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 in the MICU at Cedars-Sinai with acute respiratory failure needing a ventilator for more than 24 hours. It includes their primary decision-makers and ICU staff. Participants must speak English. Those not expected to need extended ventilation or unable to consent are excluded.

Inclusion Criteria

You are required to demonstrate proficiency in English language for this study.

I have been on a breathing machine for more than 24 hours.

I was put on a breathing machine within 24 hours of being admitted to the intensive care unit.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a program designed to enhance equitable communication and emotional support, including meetings with ICU support counselors and care teams, and completing questionnaires.

6 months

Regular meetings with ICU support counselors and care teams

Follow-up

Participants are monitored for feasibility and effectiveness of the program, including completion of questionnaires and interviews.

6 months

Questionnaires and interviews at 1-month and 6-month post-enrollment

What Are the Treatments Tested in This Trial?

Interventions

• Family Perspective Program

Trial Overview The Family Perspectives Program aims to improve communication and support between families of critically ill patients, ICU counselors, and care teams through meetings, questionnaires, optional audio recordings of discussions, and interviews.

How Is the Trial Designed?

Group I: Family Perspective Program Experimental Treatment 1 Intervention

Families of critically ill patients will receive a program designed to enhance equitable communication and emotional support. Questionnaires will be completed by primary surrogate decision makers, ICU support counselors, and ICU care team members (physicians, nurses, social workers). Meetings between families and ICU support counselors will be audio recorded (optional). Meetings between families and ICU care teams will be audio recorded (optional). Interviews with participants will be completed (optional).

Group II: Usual Care Active Control 1 Intervention

Families of critically ill patients will receive usual care, which involves regular and routine meetings between families and the ICU care team. Questionnaires will be completed by primary surrogate decision makers and ICU care team members (physicians, nurses, social workers). Meetings between families and ICU care teams will be audio recorded (optional). Interviews with participants will be completed (optional).

Who Is Running the Clinical Trial?

Matthew Modes

Lead Sponsor

Trials

1

Recruited

70+

Icahn School of Medicine at Mount Sinai

Collaborator

Trials

933

Recruited

579,000+

National Palliative Care Research Center

Collaborator

Trials

3

Recruited

190+

Published Research Related to This Trial

Critical care nurses play a vital role in providing care that considers the entire family system, recognizing that illness affects not just the patient but the family as a whole.

The article outlines strategies and mechanisms that can be implemented to enhance family-focused care in critical settings, emphasizing the importance of nurse-family relationships in managing stress during illness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing family-focused care. Titler, MG., Bombei, C., Schutte, DL.[2004]

A national survey of 41 intensive care units in Denmark revealed that 78% of responding nurses actively involved patients and families in daily care, highlighting the importance of engagement in improving care quality and safety.

While most units had strategies for patient and family engagement, only 4 out of 41 had established dedicated engagement panels, indicating a need for more structured approaches to enhance participation in care and research processes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient and family engagement in Danish intensive care units: A national survey. Oxenbøll Collet, M., Albertsen, H., Egerod, I.[2023]

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 structured family intervention program in a Medical Intensive Care Unit (MICU) was positively received by most participating families, highlighting its effectiveness in providing emotional support during a crisis.

The program improved nurses' knowledge and sensitivity to the needs of families with critically ill patients, suggesting that coordinated care can enhance support for families in distress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A collaborative project: initiating a family intervention program in a medical intensive care unit. Cray, L.[2016]

A review of 20 studies highlighted that family members' perceptions of patient safety in the ICU are significantly influenced by four key factors: family visiting policies, effective communication and information sharing, the level of care provided, and the professional competence of the healthcare staff.

The findings suggest that improving these factors can enhance family members' feelings of safety, which is crucial for overall healthcare quality in intensive care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors influencing family member perspectives on safety in the intensive care unit: a systematic review. Coombs, MA., Statton, S., Endacott, CV., et al.[2021]

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]

Caregivers of children in the PICU emphasized the importance of self-care, communication, and active engagement with their child to improve their experience during critical illness, based on interviews with 26 caregivers.

A satisfactory PICU experience is characterized by trustful caregiver-provider relationships, supportive hospital environments, and preparation for transitions in care, suggesting that targeted support can enhance family well-being and potentially improve long-term outcomes for critically ill children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supporting families during pediatric critical illness: Opportunities identified in a multicenter, qualitative study. Jarvis, JM., Huntington, T., Perry, G., et al.[2023]

Interviews with 11 families of patients in intensive care revealed that families desire regular communication and support from nurses during critical illness, highlighting the importance of family-centered care.

The study supports the implementation of scheduled nurse-family meetings, which can facilitate meaningful conversations and address the emotional needs of families, ultimately improving their experience during a loved one's critical illness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The essence of the family critical illness experience and nurse-family meetings. Nelms, TP., Eggenberger, SK.[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 randomized controlled trial involving 104 family members of ICU patients found that providing a rehabilitation program with information about recovery did not significantly reduce psychological distress, such as depression, anxiety, or PTSD symptoms, after 6 months.

Despite the intervention, 49% of relatives still reported concerning levels of psychological distress, indicating a strong correlation between the distress experienced by patients and their family members.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-traumatic stress disorder-related symptoms in relatives of patients following intensive care. Jones, C., Skirrow, P., Griffiths, RD., et al.[2022]

A review of 52 randomized controlled trials in adult ICUs found that family-centered interventions significantly improved family-centered outcomes, with 67% of studies reporting at least one positive result.

Interventions focused on communication and meeting family needs were particularly effective, with 60% of studies showing improvements in mental health outcomes for families, while patient-centered and healthcare worker outcomes showed less consistent benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of Randomized Family-Centered Interventions on Family-Centered Outcomes in the Adult Intensive Care Unit: A Systematic Review. Wang, G., Antel, R., Goldfarb, M.[2023]

Survivors of critical illness often have vivid, hallucinatory experiences during their illness, leading to a disconnect between their memories and those of their family members, who have a more factual recall of events.

The study emphasizes the importance of establishing a rehabilitation infrastructure to support both survivors and their families, as they face challenges in readjusting to life after critical care, highlighting the need for early conversations about their experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Constructing a grounded theory of critical illness survivorship: The dualistic worlds of survivors and family members. Page, P., Simpson, A., Reynolds, L.[2019]

Family members of patients with severe traumatic brain injury in the ICU face significant unmet needs, particularly regarding communication with healthcare providers, which can lead to feelings of uncertainty and anxiety.

The scoping review identified three main themes from the experiences of families: the importance of clear communication with the clinical team, the uncertainty surrounding their loved one's condition, and the desire for involvement in care, highlighting areas where targeted support interventions could be developed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the Experiences of Family Members When a Patient Is Admitted to the ICU with a Severe Traumatic Brain Injury: A Scoping Review. Hayes, K., Harding, S., Buckley, K., et al.[2023]

Citations

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Integrating Perspectives on Family Caregiving After Critical ... To date, no intervention has definitively improved outcomes for families of critical illness survivors. An integrated perspective on ...

2. 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.

3. link.springer.com link.springer.com/article/10.1007/s00134-025-08072-z

a scoping review | Intensive Care Medicine Family members of critically ill patients are known to experience short and longer term challenges, including emotional and social problems.

4. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-022-06454-y

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.

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Integrating Perspectives on Family Caregiving After Critical ... To date, no intervention has definitively improved outcomes for families of critical illness survivors. An integrated perspective on ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12405393/

What measures have been used to explore the outcomes ... Family members of critically ill patients are known to experience short and longer term challenges, including emotional and social problems.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12415862/

Family Support Strategies During Intensive Care Unit In the field of nursing, we identified 3 crucial conceptual perspectives regarding the situation of families of critically ill adult patients ...

8. bmcnurs.biomedcentral.com bmcnurs.biomedcentral.com/articles/10.1186/s12912-024-02103-8

The experiences of the families of patients admitted to the ... The admission of close family members to intensive care units can cause significant stress and anxiety for both patients and their families.

9. sciencedirect.com sciencedirect.com/science/article/pii/S0964339725000254

Family involvement in the intensive care unit, moving to ... Up to half of adult former patients in the intensive care unit (ICU) experience long-term consequences after critical illness, including physical, ...