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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01107704
Recruitment Status : Completed
First Posted : April 21, 2010
Last Update Posted : January 27, 2014
National Institute on Aging (NIA)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Physician-Family Communication in Intensive Care Units Surrogate Decision-making for Critically Ill Patients Behavioral: Family Support Intervention Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 159 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Randomized Controlled Trial to Test the Effectiveness of a Multi-faceted Communication Intervention for Family Members of Critically Ill Patients.
Study Start Date : April 2010
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Arm Intervention/treatment
Experimental: Family Support Intervention Behavioral: Family Support Intervention
Multifaceted family support intervention

No Intervention: Control Group

Primary Outcome Measures :
  1. Family Outcome: Family members' depressive symptoms [ Time Frame: Three months following patient death or discharge from the ICU. ]
  2. Patient Outcome: Patient centeredness of care [ Time Frame: Three months following patient death or discharge from the ICU. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01107704

United States, Pennsylvania
University of Pittsburgh Medical Center (UPMC)
Pittsburgh, Pennsylvania, United States, 15213-2582
Sponsors and Collaborators
University of Pittsburgh
National Institute on Aging (NIA)
Principal Investigator: Douglas B. White, MD, MAS University of Pittsburgh

Responsible Party: University of Pittsburgh Identifier: NCT01107704     History of Changes
Other Study ID Numbers: K23AG032875 ( U.S. NIH Grant/Contract )
K23AG032875 ( U.S. NIH Grant/Contract )
First Posted: April 21, 2010    Key Record Dates
Last Update Posted: January 27, 2014
Last Verified: January 2014

Keywords provided by University of Pittsburgh:
Intensive Care Units
Family Members
Critically Ill
Multi-faceted communication
Family Support Counselor

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes