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Integrating Palliative and Critical Care (IPACC) Study (IPACC)

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.
 
ClinicalTrials.gov Identifier: NCT00685893
Recruitment Status : Completed
First Posted : May 29, 2008
Last Update Posted : June 27, 2013
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
J. Randall Curtis, University of Washington

Study Description
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Brief Summary:
The purpose of this research study is to evaluate an intervention to improve the care given to patients who are dying in the intensive care unit (ICU) and their families. This study is a multi-center randomized trial of a multi-faceted quality improvement intervention designed to improve the quality of palliative and end-of-life care in the ICU setting. The intervention targets the hospital and the outcome evaluation occurs at the level of the individual patient and family with surveys completed by family members and nurses as well as standardized medical record review.

Condition or disease Intervention/treatment Phase
Any Disease Causing Death in the ICU or Within 24 Hours of Discharge From the ICU Behavioral: Education Behavioral: Local Champions Behavioral: Institution Feedback Behavioral: Academic Detailing Behavioral: Institutional Forms Phase 3

Detailed Description:
Because of the severity of illness, the intensive care unit (ICU) is a setting where death is prevalent and where the majority of deaths involve decisions to withhold or withdraw life-sustaining therapies. There is substantial data to suggest that the quality of end-of-life care in the ICU is poor. Many patients die with moderate to severe pain, physicians are often unaware of patients' wishes regarding end-of-life care, and the care patients' receive is often not consistent with their treatment preferences. Our study aims to evaluate the effectiveness of a multi-faceted intervention to improve the quality of care for patients dying in, or shortly after a stay in, the ICU using a randomized controlled study of 12 hospitals. In addition we plan to examine the variability in, and predictors of, the quality of dying and end-of-life care in community hospital ICUs with the purpose of identifying the current quality of end-of-life care and the institutional, clinician, and patient factors associated with the quality of this care. We will evaluate the successful and unsuccessful components of the intervention and describe the institutional and clinician facilitators and barriers to the intervention's implementation, with a focus on identifying interventions to improve care for the dying at other sites.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3498 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: An ICU Intervention to Improve End-of-Life Care
Study Start Date : June 2003
Actual Primary Completion Date : March 2008
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
No Intervention: Control Arm
6 Community hospital ICUs receiving delayed intervention activities after the completion of the randomized trial
Experimental: Intervention Arm
6 community hospital ICUs receiving 5-component intervention.
 Behavioral: Education
We include information about end-of-life decision-making, communication skills, pain and symptom management, and withdrawal of life support. The primary methods of delivery will be a grand rounds lecture by one of the physician investigators and the viewing of an educational video for nurses and respiratory therapists. The content of the educational components will be structured to cover four topics: the principles of decision-making about end-of-life care in the ICU; communication with patients, families and the ICU team; pain and symptom management; and, the principles and practice of withdrawal of life support.

Behavioral: Local Champions
We identify physicians, nurses and other clinicians from each hospital to serve as the local champions. The role of the local champions is to help implement the intervention and be a role model for end-of-life care in the ICU. Local champions participate in interactive education and training sessions with the investigators and the other local champions from their institution to discuss barriers to good end-of-life care at their location and to strategize about how to overcome those barriers.

Behavioral: Institution Feedback
We provide feedback to the institution from the hospital specific family satisfaction data we collect. All feedback is presented as aggregated data for the institution without any personal identifiers.

Behavioral: Academic Detailing
Study staff meet with ICU directors with 4 goals. The first goal is to familiarize the director with the educational content of the intervention. Secondly, the results of the family satisfaction data collected are shared without identifying information. The aggregated results of the other participating hospitals are disclosed, also without identifiers. Third, we elicit and discuss the institution-specific barriers to providing high quality end-of-life care in the ICU. Lastly, we hope that by educating the directors we can engage these clinical leaders to serve as role models in their institutions.

Behavioral: Institutional Forms
We have developed a set of orders that encompass the various aspects of withdrawing life support from patients. Individual department directors at each hospital will decide if they want to implement a similar order form at their institution and whether they want to modify the form to fit their specific institutional needs. In addition to the order forms, we encourage hospitals to develop a family pamphlets and resources that can be given to families to provide education about the intensive care unit experience.


Outcome Measures
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Primary Outcome Measures :
  1. Total Score on a survey: the Quality of Dying and Death (QODD) as assessed by family members. [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Total score of the QODD, as assessed by nurses [ Time Frame: 5 years ]
  2. Satisfaction with care, as assessed by a survey called Family Satisfaction with the ICU (FS-ICU) as assessed by family members [ Time Frame: 5 years ]
  3. Indicators of quality of end-of-life care as assessed by standardized medical record review. [ Time Frame: 5 years ]

Eligibility Criteria
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Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Inclusion Criteria:

  • patients, family members, nurses, and clinician evaluators

Patients are eligible if they are:

  • in the ICU for a minimum of 6 hours AND,
  • if they die in an ICU or within 24 hours of transfer out of the ICU.

Family members or significant others are eligible if:

  • they were involved with the patient who has died.

Nurses are eligible if:

  • they cared for an eligible patient on either the shift during which the patient died or the shift preceding the death.

Clinicians are eligible to evaluate the intervention components if they:

  • work in a study ICU AND
  • participate in any of the intervention components.

Exclusion Criteria:

  • Inability to read English well enough to complete the surveys
  • Under 18 years of age.
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00685893


Locations
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United States, Washington
Overlake Hospital Medical Center
Bellevue, Washington, United States, 98004
Harrison Memorial Hospital
Bremerton, Washington, United States, 98310
Highline Medical Center
Burien, Washington, United States, 98166
Stevens Hospital
Edmonds, Washington, United States, 98056
Evergreen Hospital Medical Center
Kirkland, Washington, United States, 98034
Valley Medical Center
Renton, Washington, United States, 98058
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
University of Washington; Harborview Medical Center
Seattle, Washington, United States, 98104
Swedish Medical Center; Ballard Campus
Seattle, Washington, United States, 98107
Veteran's Affairs Puget Sound HCS
Seattle, Washington, United States, 98108
Swedish Medical Center; Cherry Hill Campus
Seattle, Washington, United States, 98112
Swedish Medical Center; First Hill Campus
Seattle, Washington, United States, 98122
Northwest Hospital Medical Center
Seattle, Washington, United States, 98133
University of Washington; UW Medical Center
Seattle, Washington, United States, 98195
Saint Joseph Hospital
Tacoma, Washington, United States, 98405
Sponsors and Collaborators
University of Washington
National Institute of Nursing Research (NINR)
Investigators
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Principal Investigator: J. Randall Curtis, MD, MPH University of Washington; Division of Pulmonary and Critical Care
More Information
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Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: J. Randall Curtis, Professor of Medicine, University of Washington
ClinicalTrials.gov Identifier: NCT00685893    
Other Study ID Numbers: 23503-G
R01NR005226 ( U.S. NIH Grant/Contract )
First Posted: May 29, 2008    Key Record Dates
Last Update Posted: June 27, 2013
Last Verified: June 2013
Keywords provided by J. Randall Curtis, University of Washington:
End-of-life issues
Talking with your doctor
Coping with chronic illness