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ICU Family Communication Study

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. Read our disclaimer for details. Identifier: NCT00720200
Recruitment Status : Completed
First Posted : July 22, 2008
Last Update Posted : September 16, 2014
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
J. Randall Curtis, University of Washington

Brief Summary:
The purpose of this study is to improve care in the Intensive Care Unit (ICU) by focusing on communication with family members of patients who are too sick to make decisions about their own care while they are in the ICU. The randomized trial will test the efficacy of a communication intervention designed to improve communication between families and clinicians through the use of a facilitator. Outcome evaluation occurs at the level of the individual family with surveys completed by families and clinicians.

Condition or disease Intervention/treatment Phase
Depression Depressive Symptoms Anxiety Stress Disorders, Post-Traumatic ICU Hospitalization Care and Treatment in ICU Behavioral: Facilitator-Based intervention Behavioral: Usual Care Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 593 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Randomized Trial of an Interdisciplinary Communication Intervention to Improve Patient and Family Outcomes in the Intensive Care Unit
Study Start Date : June 2008
Actual Primary Completion Date : March 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1 Behavioral: Facilitator-Based intervention
Family Members receiving facilitator-based intervention

Active Comparator: 2 Behavioral: Usual Care
Family Members receiving usual care/clinical interaction

Primary Outcome Measures :
  1. Patient Health Questionaire (PHQ-9) [ Time Frame: At 3- and 6- months following the death of the patient ]
    Family symptoms of depression after the patient dies or is discharged from ICU as assessed by a survey

Secondary Outcome Measures :
  1. Post-Traumatic Stress Disorder Checklist (PCL) [ Time Frame: At 3- and 6- months following the death of the patient ]
    Symptoms of PTSD

  2. Generalized Anxiety Disorder (GAD-7) Survey [ Time Frame: At 3- and 6- months following the death of the patient ]

  3. Quality of Dying and Death Questionaire [ Time Frame: Following death of patient ]
  4. Evaluate length of stay in ICU/hospital [ Time Frame: During hospital stay ]
  5. Costs during ICU stay including estimated costs of intervention [ Time Frame: During ICU length of stay ]
  6. Families' ratings of the quality of communication generally and specifically in the family conference [ Time Frame: During ICU length of stay ]
  7. Clinicians' ratings of the quality of clinician-family in the family conference [ Time Frame: During ICU length of stay ]
  8. Clinicians' ratings of nurse-physician collaboration [ Time Frame: During ICU length of stay ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients, family members, clinicians attending ICU family conferences, and nurses evaluating the quality of care.
  • All ICU patients are eligible if they meet the age criteria, have been in the ICU for at least 12 hours, have acute respiratory failure requiring mechanical ventilation at the time of enrollment, and have an APACHE II score/SOFA score or other diagnosis that predicts a 30-50% or greater risk of mortality.
  • Eligible family members and/or friends may include any of the following: legal guardians, durable power of attorney for healthcare, spouses, adult children, parents, siblings, domestic partners, other relatives, and friends; if they meet the age criteria, and understand English well enough to complete informed consent and study materials.
  • Eligible clinicians include those who are present during a family conference and may include physicians, nurses, nurse practitioners, physician assistants, social workers, respiratory therapists, and clergy.
  • All critical care nurses are eligible to participate in the evaluation if they have provided care to a patient on or before the shift in which he or she died or was discharged from the ICU.

Exclusion Criteria:

  • Legal or risk management concerns (as determined by the attending physician or via hospital record designation);
  • Psychological illness or morbidity; and
  • Physical or mental limitations preventing ability to complete questionnaires.
  • Patients will be excluded if they do not have at least one family member who is eligible and willing to participate in the study.
  • A patient who is readmitted to the ICU, if the patient was enrolled and discharged previously, will not be eligible.
  • Post-operative patients who have been admitted to the ICU after a scheduled surgery without complications will be excluded. These patients may meet other eligibility criteria (ventilation, APACHE scores, etc.) within the first 12 to 48 hours of admission, but will usually improve quite rapidly after that period.

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 identifier (NCT number): NCT00720200

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United States, Washington
Valley Medical Center
Renton, Washington, United States, 98058
Harborview Medical Center
Seattle, Washington, United States, 98104
Sponsors and Collaborators
University of Washington
National Institute of Nursing Research (NINR)
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Principal Investigator: J. Randall Curtis, MD, MPH University of Washington, Division of Pulmonary and Critical Care Medicine
Principal Investigator: Ruth A Engelberg, PhD University of Washington, Division of Pulmonary and Critical Care Medicine

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: J. Randall Curtis, Professor of Medicine, University of Washington Identifier: NCT00720200     History of Changes
Other Study ID Numbers: 33584-C
2R01NR005226 ( U.S. NIH Grant/Contract )
First Posted: July 22, 2008    Key Record Dates
Last Update Posted: September 16, 2014
Last Verified: September 2014
Keywords provided by J. Randall Curtis, University of Washington:
Intensive Care Units
Palliative Care
End-of-Life Issues
Talking with Your Doctor
Coping with Chronic Illness
Additional relevant MeSH terms:
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Stress Disorders, Post-Traumatic
Behavioral Symptoms
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders