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

This study is currently recruiting participants.
Verified October 2016 by Douglas White, University of Pittsburgh
Sponsor:
ClinicalTrials.gov Identifier:
NCT01982877
First Posted: November 13, 2013
Last Update Posted: October 21, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Douglas White, University of Pittsburgh
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Trial to Improve Surrogate Decision-Making for Critically Ill Older Adults

Further study details as provided by Douglas White, 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 ]
    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 ]
    Patient centeredness of care measured by the Patient Centeredness of Care Scale (PCC)


Estimated Enrollment: 300
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/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.
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 research staff coordinator with education 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.

The trial's original sample size of 400 was chosen to maximize the ability to detect differences based on a secondary outcome measure (costs) that required a substantially larger sample size than the primary outcome. The trial was initially overpowered for the primary outcome. Even with the sample size of 400, the study had limited power to detect small but clinically important differences in the secondary outcome of costs. Since the original power calculations were conducted, new data were published which indicated that cost analysis in this context will require an even larger sample size based one effect modification from whether the patient lived or died. Enrollment was initially slow due to regional changes in admission patterns. Subsequently, the study team has added study ICUs and we have re-allocated resources to maximize screening and enrolling, which has come at a risk of compromising the quality of the data and other aspects of the study that are getting comparably less attention. With a sample size of 300, the study is well powered to detect small and clinically important differences in the primary outcome measure Hospital Anxiety and Depression Score (HADS). The Data and Safety Monitoring Board recommended decreasing the sample size based on the considerations outlined above.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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 ≥ 22 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 40% risk of long term severe functional impairment or 40% risk of in-hospital mortality
  • 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
National Institute on Aging (NIA)
  More Information

Responsible Party: Douglas White, MD, MAS Vice Chair and Professor of Critical Medicine, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01982877     History of Changes
Other Study ID Numbers: 1R01AG045176-01 ( U.S. NIH Grant/Contract )
First Submitted: October 30, 2013
First Posted: November 13, 2013
Last Update Posted: October 21, 2016
Last Verified: October 2016

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

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes