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

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University of Pittsburgh

Status

Completed

Conditions

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

Treatments

Behavioral: Family Support Intervention

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT01107704
K23AG032875 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

159 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

159 participants in 2 patient groups

Family Support Intervention
Experimental group
Treatment:
Behavioral: Family Support Intervention
Control Group
No Intervention group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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