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Sponsored by: |
National Institute of Nursing Research (NINR) |
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Information provided by: | National Institute of Nursing Research (NINR) |
ClinicalTrials.gov Identifier: | NCT00720200 |
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 |
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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 |
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 |
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1: Experimental |
Behavioral: Facilitator-Based intervention
Family Members receiving facilitator-based intervention
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2: Active Comparator |
Behavioral: Usual Care
Family Members receiving usual care/clinical interaction
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
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 |
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 |
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 |
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