The Four Supports Study: Family Support Intervention in Intensive Care Units

NCT ID: NCT01982877

Last Updated: 2020-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 546 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2019-04-19

Brief Summary

The purpose of this study is to test the effectiveness of a multi-faceted communication intervention for family members of critically ill patients to reduce the family members' long-term symptoms of depression and anxiety.

Detailed Description

One in four elderly Americans die in or shortly after discharge from an intensive care unit. An expanding body of literature documents that physician-family communication and end-of-life care is poor in intensive care units. These deficiencies are associated with high rates of adverse psychological outcomes among surrogates, physician-family conflict, and life support decisions that may be inconsistent with patients' goals and preferences. There is a lack of information on practical, generalizable interventions that effectively improve this important aspect of care for elderly patients and their families.

The primary aim of this study is to evaluate the effectiveness of a multifaceted communication intervention as compared to an educational control to improve psychological outcomes among family members of critically ill patients, using a randomized, controlled trial design.

This randomized controlled trial involves adding a Family Support Specialist (FSS) to the clinical team to provide four types of support to the families of patients with advanced critical illness: emotional support, communication support (between the clinical team and the family), decisional support (education about the role of a surrogate decision maker) and anticipatory grief support.

The overall aim of the study is to improve the long-term psychological outcomes for family members of critically ill patients, to improve the quality of communication and decision-making between physicians and families, and to improve the patient-centeredness of care.

What happens in the study?

Patient is randomized to one of two groups:

1. INTERVENTION GROUP: Family Support Specialist is added to the clinical team to provide emotional support to the family and facilitate frequent communication with the clinical team.

2. CONTROL GROUP: Receives usual care with the addition of two educational sessions provided by the FSS to teach family members about the ICU environment.

What do participants need to do?

Family Members: Interact with the Family Support Specialist daily. Family Support Specialist addresses family needs and ensures that their questions are addressed.

Physicians: Collaborate with the Family Support Specialist to determine how best to support the family as well as attending clinician-family meetings.

Sample size: With a sample size of 300 patients (450 surrogates), the study is well powered to detect small and clinically important differences in the primary outcome measure Hospital Anxiety and Depression Score (HADS).The trial's original sample size of 400 patients (600 surrogates) was chosen to maximize the power to detect differences in a secondary outcome measure (costs) that required a substantially larger sample size than the primary outcome (HADS). Since the original power calculations were conducted, new data were published which indicated that cost analysis in this context will require an even larger sample size based one effect modification from whether the patient lived or died. Therefore, the Data and Safety Monitoring Board recommended revising the sample size to power the trial on the primary outcome (HADS), which required 300 patients (450 surrogates).

Conditions

Critically Ill Intensive Care Unit Patients; Physician-Family Communication in Intensive Care Units; Surrogate Decision-making for Critically Ill Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Family Support Intervention

Multifaceted family support intervention as well as ICU educational component.

Group Type: EXPERIMENTAL

Four Supports Intervention

Intervention Type: BEHAVIORAL

The Four Supports Intervention is a multi-faceted intervention involving the addition of a trained nurse/social worker interventionist to the patient's care team who delivers four kinds of support: emotional support, communication support, decision support, and anticipatory grief support.

Educational Control Intervention

Intervention Type: BEHAVIORAL

In addition to usual care, enrolled surrogates will receive two 15-minute education sessions about critical illness and mechanical ventilation on days 2 and 5, delivered by a research staff coordinator with education in critical care nursing.

Educational Control

ICU educational component

Group Type: EXPERIMENTAL

Educational Control Intervention

Intervention Type: BEHAVIORAL

In addition to usual care, enrolled surrogates will receive two 15-minute education sessions about critical illness and mechanical ventilation on days 2 and 5, delivered by a research staff coordinator with education in critical care nursing.

Interventions

Four Supports Intervention

The Four Supports Intervention is a multi-faceted intervention involving the addition of a trained nurse/social worker interventionist to the patient's care team who delivers four kinds of support: emotional support, communication support, decision support, and anticipatory grief support.

Intervention Type: BEHAVIORAL

Educational Control Intervention

In addition to usual care, enrolled surrogates will receive two 15-minute education sessions about critical illness and mechanical ventilation on days 2 and 5, delivered by a research staff coordinator with education in critical care nursing.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. age ≥21,

2. lack of decision making capacity as determined by clinical examination by the attending physician,

3. APACHE II score ≥ 22, AND/OR

4. > 40% risk of death in hospital or >40% chance of severe long term functional impairment as judged by the patient's attending physician.

1. age ≥ 18 years,

2. self-identify as being involved in surrogate decision-making for the patient, up to a total of four family/surrogates.

3. able to give full informed consent, and

4. able to complete written questionnaires.

1) Eligible physicians will be the patient's primary attending or his/her designee. If an enrolled patient is cared for by more than one attending physician during their ICU stay, each will be consented.

Exclusion Criteria

1. lack of a surrogate decision maker and

2. impending organ transplantation.

3. decisions regarding care and treatment already made

4. not currently participating in competing research study

5. Discharged prior to enrollment

6. Incarcerated.

1. age <18 years old,

2. unable to read and understand English, and

3. unable to complete questionnaires due to physical or cognitive limitations.

1) Study investigators will be excluded as participants.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Douglas White

MD, MAS Vice Chair and Professor of Critical Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Countries

United States

References

Butler RA, Seaman JB, Felman K, Stonehouse W, San Pedro R, Morse JQ, Chang CH, Lincoln T, Reynolds CF 3rd, Landefeld S, Happ MB, Song MK, Angus DC, Arnold RM, White DB. Randomized Clinical Trial of the Four Supports Intervention for Surrogate Decision-Makers in Intensive Care Units. Am J Respir Crit Care Med. 2025 Mar;211(3):370-380. doi: 10.1164/rccm.202405-0931OC.

Reference Type: DERIVED

PMID: 39586017 (View on PubMed)

Seaman JB, Arnold RM, Buddadhumaruk P, Shields AM, Gustafson RM, Felman K, Newdick W, SanPedro R, Mackenzie S, Morse JQ, Chang CH, Happ MB, Song MK, Kahn JM, Reynolds CF 3rd, Angus DC, Landefeld S, White DB. Protocol and Fidelity Monitoring Plan for Four Supports. A Multicenter Trial of an Intervention to Support Surrogate Decision Makers in Intensive Care Units. Ann Am Thorac Soc. 2018 Sep;15(9):1083-1091. doi: 10.1513/AnnalsATS.201803-157SD.

Reference Type: DERIVED

PMID: 30088971 (View on PubMed)

Other Identifiers

1R01AG045176-01

Identifier Type: NIH

Identifier Source: org_study_id

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