Family Support Program for Critical Illness

Recruiting at 2 trial locations

Overseen By Rosario Costas-Muñiz, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Cognitive impairment, Suicidal ideation, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 7

172 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to better support those making medical decisions for loved ones in the ICU, aiming to reduce feelings of grief and PTSD. It compares two approaches: EMPOWER (Enhancing and Mobilizing the Potential for Wellness and Resilience), which involves guided sessions with an expert, and general supportive conversations. The goal is to determine which method more effectively eases emotional stress and aligns care with patients' values. Suitable participants include decision-makers for patients in intensive care who experience high levels of pre-loss grief. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to meaningful advancements in emotional support strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on supporting decision-makers rather than changing medication regimens.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the EMPOWER program relies on proven therapy methods, using effective techniques to reduce stress for patients and their caregivers. Studies have found that this type of therapy is generally easy for people to handle, with participants likely experiencing few side effects or discomfort. However, as this is a Phase 2 study, researchers are still learning about the treatment's safety and effectiveness for the specific group under study.

The EMPOWER approach targets individuals making decisions for critically ill patients. Previous studies have not reported any major unexpected medical problems with this kind of program. Participants often find it helpful and supportive. Since EMPOWER involves talking to a trained professional over several sessions, it is considered a low-risk treatment option. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Family Support Program for Critical Illness because it introduces a novel approach to supporting families during critical care. The EMPOWER treatment is unique because it provides structured, one-on-one modules with a trained interventionist, focusing on skill-building and empowerment, which is different from the usual supportive conversations that do not include specific skill development. By offering tailored interventions that are both personal and structured, the program aims to improve family resilience and coping mechanisms in a way that traditional support systems may not fully address. This could potentially lead to better psychological outcomes for families navigating the challenges of critical illness.

What evidence suggests that the EMPOWER intervention could be effective for reducing grief and PTSD symptoms?

Research shows that the EMPOWER program, available to participants in this trial, may help reduce stress and emotional distress for patients and caregivers. Studies indicate that it uses proven therapy methods to address stress during difficult times. Early results suggest it might lessen feelings of grief and PTSD for those involved in serious illness situations. EMPOWER also aims to align care with patients' values, potentially leading to better outcomes. Overall, the treatment is practical and well-received, making it a promising option for those facing the emotional challenges of serious illness. ^{1 3 4 6 7}

Who Is on the Research Team?

Wendy Lichtenthal, PhD

Principal Investigator

University of Miami

Holly Prigerson, PhD

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

This trial is for adult surrogate decision-makers of critically ill ICU patients near end-of-life. They must speak English, be able to use a device with internet, and live where the interventionist is licensed. Participants need to show significant pre-loss grief or distress but can't have cognitive impairments or recent suicidal ideation.

Inclusion Criteria

Surrogate decision-makers whom physicians or advance practice providers indicate as the designated health care proxy or decision-making patient surrogates, or who are listed as such in the patient's medical charts or by self-report of the surrogate

Surrogate decision-makers will need to be willing to utilize a device (computer, tablet, phone) with internet

Surrogate decision-makers must report 'syndromal' levels of pre-loss grief (PG-12 score ≥ 25) or peritraumatic distress (PDI ≥ 23)

Exclusion Criteria

Surrogate-decision makers who endorse suicidal ideation in the past month based on responses to the Columbia Suicide Severity Rating Scale

Surrogate-decision makers who are unable to access a functional device for videoconferencing and decline the offer to use a study loner device

Patients and surrogate decision-makers who do not meet the eligibility criteria

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the EMPOWER intervention or Supportive Conversation over a period of 3 months

3 months

Up to 4 visits (in-person and by phone)

Follow-up

Participants are monitored for changes in symptoms of PTSD, PGD, and other outcomes

12 months

Assessments at 3 months and 12 months post-intervention

What Are the Treatments Tested in This Trial?

Interventions

• EMPOWER
• Supportive Conversation

Trial Overview The study tests if the EMPOWER program better reduces symptoms of grief and PTSD in surrogates compared to just having supportive conversations. It also looks at depression, regrets, and how well patient care matches their values over time.

How Is the Trial Designed?

Group I: EMPOWER arm Experimental Treatment 1 Intervention

The EMPOWER arm includes six 15 minute modules delivered in a 1-on-1 format with the same interventionist, and 2 boosters (approximately 45 minutes each) conducted by phone. Subjects who meet eligibility criteria will receive up to 4 sequential assessments before and after the EMPOWER intervention within 3 months conducted in person and by phone.

Group II: Supportive Conversation arm Placebo Group 1 Intervention

The Supportive Conversation (SC) arm includes a supportive, empathic encounter without specific skill-building for approximately the same amount of time as EMPOWER. Subjects who meet eligibility criteria will receive up to 4 sequential assessments before and after SC within 3 months conducted in person and by phone.

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Published Research Related to This Trial

Caregivers of ICU survivors reported significant unmet needs for support after discharge, highlighting a general inadequacy in post-ICU care across multiple countries.

Effective support systems identified by caregivers included structured programs like post-discharge calls, home health services, and peer support groups, as well as accessible educational resources, which are crucial for improving recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing Critical Illness Recovery: Perspectives and Solutions From the Caregivers of ICU Survivors. Sevin, CM., Boehm, LM., Hibbert, E., et al.[2022]

The COPE program significantly improved mothers' ability to support their critically ill children during medical procedures, leading to better emotional support and reduced parental stress.

Mothers who participated in the COPE program reported fewer post-traumatic stress symptoms and less change in their parental roles four weeks after their child's hospitalization, highlighting the program's effectiveness in helping families cope with the stress of critical illness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Helping mothers cope with a critically ill child: a pilot test of the COPE intervention. Melnyk, BM., Alpert-Gillis, LJ., Hensel, PB., et al.[2019]

The COPE program, an educational-behavioral intervention for mothers of critically ill children, significantly reduced parental stress and improved participation in their children's care, leading to better emotional outcomes for both mothers and children.

Children whose mothers participated in the COPE program exhibited fewer behavioral problems and adjustment issues up to 12 months after discharge compared to those in the control group, suggesting that early intervention can help mitigate long-term mental health risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Creating opportunities for parent empowerment: program effects on the mental health/coping outcomes of critically ill young children and their mothers. Melnyk, BM., Alpert-Gillis, L., Feinstein, NF., et al.[2022]

The Nurses' Empowerment Scale for Intensive Care Unit Patients' Families (NESIPF) was developed through a rigorous four-phase process, including expert consensus and testing for reliability and validity, demonstrating strong internal consistency (Cronbach's α = 0.92).

This tool can effectively assess the empowerment status of families of critically ill patients, which is crucial for addressing their psychological needs and enhancing their ability to support patients during recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nurses' Empowerment Scale for ICU patients' families: an instrument development study. Li, H., Liu, YL., Qiu, L., et al.[2019]

A 30-day multicomponent intervention for critical illness survivors significantly reduced rehospitalization and mortality rates over 12 months compared to usual care, highlighting the importance of structured recovery support.

Integrating health and social care for critical care survivors improved health-related quality of life and self-efficacy at 12 months, suggesting that comprehensive support systems are beneficial for recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Healthcare delivery and recovery after critical illness. Hope, AA., McPeake, J.[2023]

A study involving interviews with 29 relatives of ICU patients revealed that they find empowerment crucial for coping with the stress of having a loved one in critical care, emphasizing the need for both internal confidence and external support.

Relatives expressed that trust in themselves, encounters with kindness, and professional care are essential for feeling supported, highlighting the importance of healthcare professionals being sensitive to their needs and providing appropriate social support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What is supportive when an adult next-of-kin is in critical care? Johansson, I., Fridlund, B., Hildingh, C.[2022]

A study involving 35 survivors of critical illness and their relatives revealed that current hospital discharge practices often prioritize speed over individual needs, which can hinder a positive transition experience.

Key barriers identified include feelings of being overlooked and disqualified, while enablers for a smoother transition included empowerment, support from empathetic professionals, and family engagement, highlighting the need for more personalized discharge planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survivors of Critical Illness and Their Relatives. A Qualitative Study on Hospital Discharge Experience. Major, ME., van Nes, F., Ramaekers, S., et al.[2020]

The EMPOWER intervention, a cognitive-behavioral and acceptance-based program, aims to improve mental health outcomes for surrogate decision-makers in the ICU, addressing their peritraumatic stress and potentially enhancing the quality of life for patients.

The study will evaluate the effectiveness of EMPOWER through a randomized controlled trial involving 60 participants, assessing its impact on mental health symptoms and patient care outcomes, with feedback from clinicians and caregivers used to refine the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing & Mobilizing the POtential for Wellness & Emotional Resilience (EMPOWER) among Surrogate Decision-Makers of ICU Patients: study protocol for a randomized controlled trial. Prigerson, HG., Viola, M., Brewin, CR., et al.[2021]

The EMPOWER intervention, designed for surrogate decision-makers of critically ill patients, was found to be feasible and acceptable, with 100% of participants completing all modules and high ratings of effectiveness.

Participants showed significant improvements in psychological symptoms, including reductions in anxiety and prolonged grief, with notable effects lasting up to three months after the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and preliminary evaluation of EMPOWER for surrogate decision-makers of critically ill patients. Lichtenthal, WG., Viola, M., Rogers, M., et al.[2022]

A study involving 38 family members of critically ill patients compared two types of follow-up interventions, revealing that both interventions increased hope and improved health-related quality of life.

The family health conversation intervention, which included the patient, showed significantly better outcomes in family functioning and hope compared to the support group conversation that excluded the patient.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family health conversations versus support group conversations when a family member has been critically ill: A mixed methods study. Ahlberg, M., Persson, C., Berterö, C., et al.[2021]

Citations

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Enhancing & Mobilizing the POtential for Wellness & ... The EMPOWER study is unique in its application of evidence-based psychotherapy targeting peritraumatic stress to improve patient and caregiver ...

2. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-019-3515-0

Enhancing & Mobilizing the POtential for Wellness ... - Trials The EMPOWER study is unique in its application of evidence-based psychotherapy targeting peritraumatic stress to improve patient and caregiver ...

3. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/59/NCT03276559/Prot_SAP_001.pdf

Enhancing & Mobilizing the Potential for Wellness & ... Examine the effects of EMPOWER on patient outcomes, including intensity of care and quality of life/quality of. Page 6. Enhancing & Mobilizing the Potential for ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11110718/

EMPOWER: A Multi-Site Pilot Trial to Reduce Distress in ... The aim of this study was to determine the feasibility, acceptability, and preliminary efficacy of EMPOWER (Enhancing and Mobilizing the POtential for Wellness ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0885392424006584

EMPOWER: A Multi-Site Pilot Trial to Reduce Distress in ... The aim of this study was to determine the feasibility, acceptability, and preliminary efficacy of EMPOWER (Enhancing and Mobilizing the POtential for Wellness ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03276559

Enhancing & Mobilizing the POtential for Wellness & Emotional ... 1: Develop EMPOWER for surrogate decision-makers of critically ill patients who are at risk of becoming incapacitated or are currently unable to communicate in ...

7. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2019-06081

Enhancing & Mobilizing the POtential for Wellness & ... Specifically, investigators aim to: - 1: Develop EMPOWER for surrogate decision-makers of critically ill patients who are at risk of becoming incapacitated or ...