Clinical trial NCT01107704: Family Support Intervention in Intensive Care Units (The Four Supports Study)
Official title: A Randomized Controlled Trial to Test the Effectiveness of a Multi-faceted Communication Intervention for Family Members of Critically Ill Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physician-Family Communication in Intensive Care Units
Surrogate Decision-making for Critically Ill Patients
Keywords: Intensive Care Units
Surrogates
Family Members
Physicians
Critically Ill
Depression
Anxiety
Emotional
Support
Multi-faceted communication
Grief
Prognosis
Family Support Counselor
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2010-04-21
Enrollment: 159
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 on 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 to improve psychological outcomes among family members of critically ill patients, using a randomized, controlled trial design.

Eligibility criteria: Inclusion Criteria for ICU Patients:

* must be unable to make treatment decisions for him/herself, as determined by the patient's physicians.
* must have have either an APACHE II score of ≥ 25 or, for patients with a primary neurologic diagnosis (e.g. intracranial hemorrhage, subdural hemorrhage, or subarachnoid hemorrhage), physician estimate that the patient has at least a 50% risk of long term, severe functional impairment
* must be 50 years old or greater.

Exclusion Criteria for ICU Patients:

* Patients who do not have surrogates or at least one family member who is willing to participate in the study.
* Patients awaiting organ transplantation.

Primary outcomes:
measure: Family Outcome: Family members' depressive symptoms
timeFrame: Three months following patient death or discharge from the ICU.
measure: Patient Outcome: Patient centeredness of care
timeFrame: Three months following patient death or discharge from the ICU.
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center (UPMC)
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Douglas B. White, MD, MAS
role: PRINCIPAL_INVESTIGATOR
References: