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

Physician-Family Communication in Intensive Care Units Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01107704
• Other study ID #: K23AG032875
• Secondary ID: K23AG032875
• Status: Completed
• Phase: N/A
• First received: April 19, 2010
• Last updated: January 23, 2014
• Start date: April 2010
• Est. completion date: August 2013

Study information

• Verified date: January 2014
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Critical Illness
• Physician-Family Communication in Intensive Care Units
• Surrogate Decision-making for Critically Ill Patients

Intervention

Behavioral:
• Family Support Intervention
Multifaceted family support intervention

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center (UPMC)	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Family Outcome: Family members' depressive symptoms		Three months following patient death or discharge from the ICU.	No
Primary	Patient Outcome: Patient centeredness of care		Three months following patient death or discharge from the ICU.	No