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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University of Pittsburgh
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01982877
First received: October 30, 2013
Last updated: February 25, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Critically Ill Intensive Care Unit Patients
Physician-Family Communication in Intensive Care Units
Surrogate Decision-making for Critically Ill Patients
Behavioral: Four Supports Intervention
Behavioral: Educational Control Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Trial to Improve Surrogate Decision-Making for Critically Ill Older Adults

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Family Outcome [ Time Frame: participants will be followed six months following the patient's death or discharge from hospital, an expected average of 195 days ] [ Designated as safety issue: No ]
    Family members' depressive symptoms measured by the Hospital Anxiety and Depression Scale (HADS) and the Impact of Events Scale (IES)

  • Patient Outcome [ Time Frame: participants will be followed six months following the patient's death or discharge from hospital, an expected average of 195 days ] [ Designated as safety issue: No ]
    Patient centeredness of care measured by the Patient Centeredness of Care Scale (PCC)


Estimated Enrollment: 400
Study Start Date: January 2014
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Family Support Intervention
Multifaceted family support intervention as well as ICU educational component.
Behavioral: Four Supports Intervention
The Four Supports Intervention is a multi-faceted intervention involving the addition of a trained nurse 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 separate research nurse with a background in critical care nursing.
Experimental: Educational Control
ICU educational component
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 separate research nurse with a background in critical care nursing.

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 of 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 as compared to an educational control to improve psychological outcomes among family members of critically ill patients, using a randomized, controlled trial design.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 ≥ 27 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 21 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01982877

Locations
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15216
Contact: Douglas B White, MD, MAS    412-864-3757    whitedb@upmc.edu   
Contact: Anne-Marie Shields, RN, BSN, MSN    412-647-9102    shieldsa@upmc.edu   
Principal Investigator: Douglas B White, MD, MAS         
Sponsors and Collaborators
University of Pittsburgh
  More Information

No publications provided

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01982877     History of Changes
Other Study ID Numbers: 1RO1AG045176-01
Study First Received: October 30, 2013
Last Updated: February 25, 2014
Health Authority: United States: Data and Safety Monitoring Board University of Pittsburgh
United States: Institutional Review Board University of Pittsburgh

Keywords provided by University of Pittsburgh:
decision making
values elicitation
patient centered care
Four Supports
Family Support

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on November 27, 2014