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

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).

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.