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

Trial Summary

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 data supports the effectiveness of the Family Perspective Program treatment?

Research shows that family-centered interventions in the ICU, which include improving communication and meeting family needs, can lead to better outcomes for families. About two-thirds of studies found improvements in family-centered outcomes, and many showed positive effects on mental health. ^{1 2 3 4 5}

Is the Family Support Program for Critical Illness safe for participants?

The research highlights the importance of family engagement in intensive care units, which can improve patient safety and care quality. While specific safety data for the Family Support Program is not detailed, involving families in care is generally seen as beneficial and safe. ^{6 7 8 9 10}

How does the Family Support Program for Critical Illness differ from other treatments for critical illness?

The Family Support Program for Critical Illness is unique because it focuses on providing emotional and structured support to the families of critically ill patients, rather than directly treating the illness itself. This program involves coordinated efforts by healthcare teams to address the emotional needs of families, which is not typically a focus of standard medical treatments for critical illness. ^{4 5 11 12 13}

What is the purpose of this trial?

The purpose of the study is to conduct a pilot randomized trial of a program designed to enhance equitable communication and emotional support for families of critically ill patients in order to determine feasibility, acceptability, and participant experience with the program. The primary study procedures include: chart abstraction, questionnaires, meetings with ICU support counselors, meetings with ICU physicians and care team, audio recordings of these meetings (optional), and interviews with study participants (optional). Study participants include: 70 critically ill patients with acute respiratory failure (enrolled with the consent of their Legally Authorized Representative) and their primary surrogate decision makers as well as ICU support counselors and ICU care teams (physicians, nurses, social workers).

Research Team

Matthew Modes, MD, MPP, MS

Principal Investigator

Cedars-Sinai Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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]

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 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]

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]

References

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

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

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

Post-traumatic stress disorder-related symptoms in relatives of patients following intensive care. [2022]

3. United States 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. [2023]

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

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

5. Brazil pubmed.ncbi.nlm.nih.gov

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

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

Factors influencing family member perspectives on safety in the intensive care unit: a systematic review. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Patient and family engagement in Danish intensive care units: A national survey. [2023]

8. Switzerland 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. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Supporting families during pediatric critical illness: Opportunities identified in a multicenter, qualitative study. [2023]

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

Constructing a grounded theory of critical illness survivorship: The dualistic worlds of survivors and family members. [2019]

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

Developing family-focused care. [2004]

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

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

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

The essence of the family critical illness experience and nurse-family meetings. [2022]