Full Text View
Tabular View
No Study Results Posted
Related Studies
ICU Family Communication Study
This study is currently recruiting participants.
Verified by National Institute of Nursing Research (NINR), July 2009
First Received: July 18, 2008   Last Updated: July 13, 2009   History of Changes
Sponsored by: National Institute of Nursing Research (NINR)
Information provided by: National Institute of Nursing Research (NINR)
ClinicalTrials.gov Identifier: NCT00720200
  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
ICU Hospitalization
Care and Treatment in ICU
Behavioral: Facilitator-Based intervention
Behavioral: Usual Care
Phase III

Study Type: Interventional
Study Design: Supportive Care, Randomized, Open Label, Placebo Control, Parallel Assignment
Official Title: A Randomized Trial of an Interdisciplinary Communication Intervention to Improve Patient and Family Outcomes in the Intensive Care Unit

Further study details as provided by National Institute of Nursing Research (NINR):

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

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 ]
  • Generalized Anxiety Disorder (GAD-7) Survey [ Time Frame: At 3- and 6- months following the death of the patient ] [ Designated as safety issue: No ]
  • 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 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Behavioral: Facilitator-Based intervention
Family Members receiving facilitator-based intervention
2: Active Comparator 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 or SOFA score 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00720200

Contacts
Contact: J. Randall Curtis, MD, MPH 206-744-3356 jrc@u.washington.edu
Contact: Ruth A Engelberg, PhD 206-744-9523 rengle@u.washington.edu

Locations
United States, Washington
Valley Medical Center Recruiting
Renton, Washington, United States, 98058
Harborview Medical Center Recruiting
Seattle, Washington, United States, 98104
Swedish Medical Center Recruiting
Seattle, Washington, United States, 98122
Sponsors and Collaborators
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

Responsible Party: University of Washington, Division of Pulmonary and Critical Care Medicine ( J. Randall Curtis, MD, MPH / Ruth A. Engelberg )
Study ID Numbers: 2R01NR005226
Study First Received: July 18, 2008
Last Updated: July 13, 2009
ClinicalTrials.gov Identifier: NCT00720200     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institute of Nursing Research (NINR):
End-of-Life issues
Talking with your doctor
Coping with chronic illness

Study placed in the following topic categories:
Chronic Disease

ClinicalTrials.gov processed this record on September 09, 2009