Integrating Palliative and Critical Care (IPACC) Study - Full Text View

Purpose

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	Intervention	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care
Official Title:	An ICU Intervention to Improve End-of-Life Care

Resource links provided by NLM:

MedlinePlus related topics: Critical Care Hospice Care

U.S. FDA Resources

Further study details as provided by University of Washington:

Primary Outcome Measures:

Total Score on a survey: the Quality of Dying and Death (QODD) as assessed by family members. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Total score of the QODD, as assessed by nurses [ Time Frame: 5 years ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Indicators of quality of end-of-life care as assessed by standardized medical record review. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Enrollment:	3498
Study Start Date:	June 2003
Study Completion Date:	October 2010
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Arms

Assigned Interventions

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.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00685893

Locations

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
University of Washington; UW Medical Center
Seattle, Washington, United States, 98195
Veteran's Affairs Puget Sound HCS
Seattle, Washington, United States, 98108
University of Washington; Harborview Medical Center
Seattle, Washington, United States, 98104
Swedish Medical Center; Ballard Campus
Seattle, Washington, United States, 98107
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
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Saint Joseph Hospital
Tacoma, Washington, United States, 98405

Sponsors and Collaborators

University of Washington

National Institute of Nursing Research (NINR)

Investigators

Principal Investigator:

J. Randall Curtis, MD, MPH

University of Washington; Division of Pulmonary and Critical Care

More Information

Publications:

Curtis JR, Nielsen EL, Treece PD, Downey L, Dotolo D, Shannon SE, Back AL, Rubenfeld GD, Engelberg RA. Effect of a Quality-Improvement Intervention on End-of-Life Care in the Intensive Care Unit: A Randomized Trial. Am J Respir Crit Care Med. 2010 Sep 10; [Epub ahead of print]

Treece PD, Engelberg RA, Shannon SE, Nielsen EL, Braungardt T, Rubenfeld GD, Steinberg KP, Curtis JR. Integrating palliative and critical care: description of an intervention. Crit Care Med. 2006 Nov;34(11 Suppl):S380-7.

Curtis JR, Treece PD, Nielsen EL, Downey L, Shannon SE, Braungardt T, Owens D, Steinberg KP, Engelberg RA. Integrating palliative and critical care: evaluation of a quality-improvement intervention. Am J Respir Crit Care Med. 2008 Aug 1;178(3):269-75. Epub 2008 May 14.

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

Kross EK, Nielsen EL, Curtis JR, Engelberg RA. Survey burden for family members surveyed about end-of-life care in the intensive care unit. J Pain Symptom Manage. 2012 Nov;44(5):671-80. doi: 10.1016/j.jpainsymman.2011.11.008. Epub 2012 Jul 3.

Osborn TR, Curtis JR, Nielsen EL, Back AL, Shannon SE, Engelberg RA. Identifying elements of ICU care that families report as important but unsatisfactory: decision-making, control, and ICU atmosphere. Chest. 2012 Nov;142(5):1185-92.

Kross EK, Engelberg RA, Shannon SE, Curtis JR. Potential for response bias in family surveys about end-of-life care in the ICU. Chest. 2009 Dec;136(6):1496-502. Epub 2009 Jul 17.

Responsible Party:	J. Randall Curtis, Professor of Medicine, University of Washington
ClinicalTrials.gov Identifier:	NCT00685893 History of Changes
Other Study ID Numbers:	23503-G, R01NR005226
Study First Received:	May 27, 2008
Last Updated:	January 21, 2013
Health Authority:	United States: Federal Government

Keywords provided by University of Washington:

End-of-life issues
Talking with your doctor
Coping with chronic illness

ClinicalTrials.gov processed this record on May 16, 2013