ICU Family Communication Study

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
J. Randall Curtis, University of Washington
ClinicalTrials.gov Identifier:
NCT00720200
First received: July 18, 2008
Last updated: February 6, 2014
Last verified: February 2014
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Patient Health Questionaire (PHQ-9) [ Time Frame: At 3- and 6- months following the death of the patient ] [ Designated as safety issue: No ]
    Family symptoms of depression after the patient dies or is discharged from ICU as assessed by a survey


Secondary Outcome Measures:
  • Post-Traumatic Stress Disorder Checklist (PCL) [ Time Frame: At 3- and 6- months following the death of the patient ] [ Designated as safety issue: No ]
    Symptoms of PTSD

  • Generalized Anxiety Disorder (GAD-7) Survey [ Time Frame: At 3- and 6- months following the death of the patient ] [ Designated as safety issue: No ]
    Anxiety

  • Quality of Dying and Death Questionaire [ Time Frame: Following death of patient ] [ Designated as safety issue: No ]
  • Evaluate length of stay in ICU/hospital [ Time Frame: During hospital stay ] [ Designated as safety issue: No ]
  • Costs during ICU stay including estimated costs of intervention [ Time Frame: During ICU length of stay ] [ Designated as safety issue: No ]
  • Families' ratings of the quality of communication generally and specifically in the family conference [ Time Frame: During ICU length of stay ] [ Designated as safety issue: No ]
  • Clinicians' ratings of the quality of clinician-family in the family conference [ Time Frame: During ICU length of stay ] [ Designated as safety issue: No ]
  • Clinicians' ratings of nurse-physician collaboration [ Time Frame: During ICU length of stay ] [ Designated as safety issue: No ]

Estimated Enrollment: 6500
Study Start Date: June 2008
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 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.
  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: NCT00720200

Locations
United States, Washington
Valley Medical Center
Renton, Washington, United States, 98058
Harborview Medical Center
Seattle, Washington, United States, 98104
Swedish Medical Center
Seattle, Washington, United States, 98122
Virginia Mason Medical Center
Seattle, Washington, United States, 98104
University of Washington Medical Center
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
Investigators
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
  More Information

No publications provided by University of Washington

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: J. Randall Curtis, Professor of Medicine, University of Washington
ClinicalTrials.gov Identifier: NCT00720200     History of Changes
Other Study ID Numbers: 33584-C, 2R01NR005226
Study First Received: July 18, 2008
Last Updated: February 6, 2014
Health Authority: United States: Federal Government

Keywords provided by University of Washington:
Communication
Intensive Care Units
Palliative Care
End-of-Life Issues
Talking with Your Doctor
Coping with Chronic Illness

Additional relevant MeSH terms:
Anxiety Disorders
Depression
Depressive Disorder
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Mental Disorders
Behavioral Symptoms
Mood Disorders

ClinicalTrials.gov processed this record on August 28, 2014