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

Not Applicable

Completed

• Conditions: Surrogate Decision-making for Critically Ill Patients; Physician-Family Communication in Intensive Care Units
• Interventions: Behavioral: Family Support Intervention

• Registration Number: NCT01107704
• Lead Sponsor: University of Pittsburgh

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.

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-04-19
• Study First Submitted QC: 2010-04-19
• Study First Posted: 2010-04-21
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-23
• Last Update Posted: 2014-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 159

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Family Support Intervention	Family Support Intervention	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of Pittsburgh Medical Center (UPMC); 🇺🇸 Pittsburgh, Pennsylvania, United States