Family Support Intervention in Intensive Care Units (The Four Supports Study)

A Randomized Controlled Trial to Test the Effectiveness of a Multi-faceted Communication Intervention for Family Members of Critically Ill Patients.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01107704

Enrollment

159

Registered

2010-04-21

Start date

2010-04-30

Completion date

2013-08-31

Last updated

2014-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

BEHAVIORALFamily Support Intervention

Multifaceted family support intervention

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Family Outcome: Family members' depressive symptoms	Three months following patient death or discharge from the ICU.
Patient Outcome: Patient centeredness of care	Three months following patient death or discharge from the ICU.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026