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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

159 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2013-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Family Support Intervention

Group Type EXPERIMENTAL

Family Support Intervention

Intervention Type BEHAVIORAL

Multifaceted family support intervention

Control Group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Family Support Intervention

Multifaceted family support intervention

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

* Patients who do not have surrogates or at least one family member who is willing to participate in the study.
* Patients awaiting organ transplantation.

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No