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

University of Pittsburgh

Status: Completed

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

Treatments: Behavioral: Four Supports Intervention; Behavioral: Educational Control Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01982877

1R01AG045176-01

Details and patient eligibility

About

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.

Full 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).

Enrollment: 546 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Patient 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.

Patient 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.

Surrogate Inclusion criteria:

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.

Surrogate Exclusion Criteria:

1. age <18 years old,
2. unable to read and understand English, and
3. unable to complete questionnaires due to physical or cognitive limitations.

Physician Inclusion criteria:

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.

Physician Exclusion Criteria:

1. Study investigators will be excluded as participants.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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546 participants in 2 patient groups

Family Support Intervention

Experimental group

Description:

Multifaceted family support intervention as well as ICU educational component.

Treatment:

Behavioral: Educational Control Intervention

Behavioral: Four Supports Intervention

Educational Control

Experimental group

Description:

ICU educational component

Treatment:

Behavioral: Educational Control Intervention