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

Primary Purpose

Physician-Family Communication in Intensive Care Units, Surrogate Decision-making for Critically Ill Patients

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Family Support Intervention
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Physician-Family Communication in Intensive Care Units focused on measuring Intensive Care Units, Surrogates, Family Members, Physicians, Critically Ill, Depression, Anxiety, Emotional, Support, Multi-faceted communication, Grief, Prognosis, Family Support Counselor

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Pittsburgh Medical Center (UPMC)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Family Support Intervention

Control Group

Arm Description

Outcomes

Primary Outcome Measures

Family Outcome: Family members' depressive symptoms
Patient Outcome: Patient centeredness of care

Secondary Outcome Measures

Full Information

First Posted
April 19, 2010
Last Updated
January 23, 2014
Sponsor
University of Pittsburgh
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT01107704
Brief Title
Family Support Intervention in Intensive Care Units (The Four Supports Study)
Official Title
A Randomized Controlled Trial to Test the Effectiveness of a Multi-faceted Communication Intervention for Family Members of Critically Ill Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pittsburgh
Collaborators
National Institute on Aging (NIA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physician-Family Communication in Intensive Care Units, Surrogate Decision-making for Critically Ill Patients
Keywords
Intensive Care Units, Surrogates, Family Members, Physicians, Critically Ill, Depression, Anxiety, Emotional, Support, Multi-faceted communication, Grief, Prognosis, Family Support Counselor

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
159 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Family Support Intervention
Arm Type
Experimental
Arm Title
Control Group
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Family Support Intervention
Intervention Description
Multifaceted family support intervention
Primary Outcome Measure Information:
Title
Family Outcome: Family members' depressive symptoms
Time Frame
Three months following patient death or discharge from the ICU.
Title
Patient Outcome: Patient centeredness of care
Time Frame
Three months following patient death or discharge from the ICU.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas B. White, MD, MAS
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh Medical Center (UPMC)
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213-2582
Country
United States

12. IPD Sharing Statement

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

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