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CompletedNCT01107704Updated Jan 27, 2014

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

An interventional study of Family Support Intervention in Physician-Family Communication in Intensive Care Units and Surrogate Decision-making for Critically Ill Patients, sponsored by University of Pittsburgh. Completed at 1 site in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2014-01-27.

Sponsored by University of Pittsburgh · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
159
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

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Keywords

  • Intensive Care Units
  • Surrogates
  • Family Members
  • Physicians
  • Critically Ill
  • Depression
  • Anxiety
  • Emotional
  • Support
  • Multi-faceted communication
  • Grief
  • Prognosis
  • Family Support Counselor
03

In context

Critical Illness

1,881 studies on the registry are indexed under Critical Illness; 462 are open to participants now.

This study's enrollment of 159 is above the median of 90 across 979 interventional studies indexed under Critical Illness.

Browse Critical Illness studies →

Lead sponsor

University of Pittsburgh is the lead sponsor of 1,385 studies on the registry; 167 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
159 participants (actual)

Study arms

  • Experimental
    Family Support Intervention

    Behavioral: Family Support Intervention

  • No intervention
    Control Group

Interventions

  • BehavioralFamily Support Intervention

    Multifaceted family support intervention

06

What researchers measure

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.

07

Study locations

1 site
  • University of Pittsburgh Medical Center (UPMC)
    Pittsburgh, Pennsylvania 15213-2582, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 27, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01107704
Lead sponsor
University of Pittsburgh
Collaborators
National Institute on Aging (NIA)
Responsible party
Sponsor
First posted
Apr 21, 2010
Start date
Apr 2010
Primary completion
Aug 2013
Completion
Aug 2013
Last update
Jan 27, 2014

Study contacts

Douglas B. White, MD, MAS
principal investigator · University of Pittsburgh

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.

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