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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01107704
First received: April 19, 2010
Last updated: January 23, 2014
Last verified: January 2014
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Family Outcome: Family members' depressive symptoms [ Time Frame: Three months following patient death or discharge from the ICU. ] [ Designated as safety issue: No ]
  • Patient Outcome: Patient centeredness of care [ Time Frame: Three months following patient death or discharge from the ICU. ] [ Designated as safety issue: No ]

Enrollment: 159
Study Start Date: April 2010
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Family Support Intervention Behavioral: Family Support Intervention
Multifaceted family support intervention
No Intervention: Control Group

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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01107704

Locations
United States, Pennsylvania
University of Pittsburgh Medical Center (UPMC)
Pittsburgh, Pennsylvania, United States, 15213-2582
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Douglas B. White, MD, MAS University of Pittsburgh
  More Information

No publications provided

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01107704     History of Changes
Other Study ID Numbers: K23AG032875, K23AG032875
Study First Received: April 19, 2010
Last Updated: January 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Intensive Care Units
Surrogates
Family Members
Physicians
Critically Ill
Depression
Anxiety
Emotional
Support
Multi-faceted communication
Grief
Prognosis
Family Support Counselor

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on November 20, 2014