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| Sponsor: | University of Washington |
|---|---|
| Collaborator: |
National Institute of Nursing Research (NINR) |
| Information provided by: | University of Washington |
| 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 |
|---|---|---|
|
Depression Depressive Symptoms Anxiety Stress Disorders, Post-Traumatic ICU Hospitalization Care and Treatment in ICU |
Behavioral: Facilitator-Based intervention Behavioral: Usual Care |
Phase III |
| 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 |
| 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 |
|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: J. Randall Curtis, MD, MPH | 206-744-3356 | jrc@u.washington.edu |
| Contact: Ruth A Engelberg, PhD | 206-744-9523 | rengel@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 | Active, not recruiting |
| Seattle, Washington, United States, 98122 | |
| Virginia Mason Medical Center | Not yet recruiting |
| Seattle, Washington, United States, 98104 | |
| University of Washington Medical Center | Not yet recruiting |
| Seattle, Washington, United States, 98195 | |
| 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
| Responsible Party: | J. Randall Curtis, MD, MPH / Ruth A. Engelberg, PhD, University of Washington, Division of Pulmonary and Critical Care Medicine |
| ClinicalTrials.gov Identifier: | NCT00720200 History of Changes |
| Other Study ID Numbers: | 33587-C, 2R01NR005226 |
| Study First Received: | July 18, 2008 |
| Last Updated: | March 24, 2011 |
| Health Authority: | United States: Federal Government |
|
Communication Intensive Care Units Palliative Care |
End-of-Life Issues Talking with Your Doctor Coping with Chronic Illness |
|
Anxiety Disorders Depression Depressive Disorder Stress Disorders, Post-Traumatic |
Stress Disorders, Traumatic Mental Disorders Behavioral Symptoms Mood Disorders |