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Completed

NCT Number: NCT01107704

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

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh Medical Center (UPMC)

Pittsburgh, Pennsylvania, 15213-2582, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Family Support Intervention

Behavioral

Multifaceted family support intervention

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Apr 21, 2010
Registry last updated
Jan 27, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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