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The Four Supports Study: Family Support Intervention in Intensive Care Units

NCT01982877 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 546

Last updated 2020-01-14

No results posted yet for this 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.

Conditions

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

Interventions

BEHAVIORAL

Four Supports Intervention

The Four Supports Intervention is a multi-faceted intervention involving the addition of a trained nurse/social worker interventionist to the patient's care team who delivers four kinds of support: emotional support, communication support, decision support, and anticipatory grief support.

BEHAVIORAL

Educational Control Intervention

In addition to usual care, enrolled surrogates will receive two 15-minute education sessions about critical illness and mechanical ventilation on days 2 and 5, delivered by a research staff coordinator with education in critical care nursing.

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH

  • University of Pittsburgh

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2019-04-19
Completion
2019-04-19

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01982877 on ClinicalTrials.gov