Clinical trial NCT00685893: Integrating Palliative and Critical Care (IPACC) Study
Official title: An ICU Intervention to Improve End-of-Life Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Any Disease Causing Death in the ICU or Within 24 Hours of Discharge From the ICU
Keywords: End-of-life issues
Talking with your doctor
Coping with chronic illness
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2008-05-29
Enrollment: 3498
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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 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.

Primary outcomes:
measure: Total Score on a survey: the Quality of Dying and Death (QODD) as assessed by family members.
timeFrame: 5 years
Secondary outcomes:
measure: Total score of the QODD, as assessed by nurses
timeFrame: 5 years
measure: Satisfaction with care, as assessed by a survey called Family Satisfaction with the ICU (FS-ICU) as assessed by family members
timeFrame: 5 years
measure: Indicators of quality of end-of-life care as assessed by standardized medical record review.
timeFrame: 5 years
Other outcomes:
Locations:
city: Bellevue
country: United States
facility: Overlake Hospital Medical Center
state: Washington
city: Bremerton
country: United States
facility: Harrison Memorial Hospital
state: Washington
city: Burien
country: United States
facility: Highline Medical Center
state: Washington
city: Edmonds
country: United States
facility: Stevens Hospital
state: Washington
city: Kirkland
country: United States
facility: Evergreen Hospital Medical Center
state: Washington
city: Renton
country: United States
facility: Valley Medical Center
state: Washington
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Seattle
country: United States
facility: University of Washington; Harborview Medical Center
state: Washington
city: Seattle
country: United States
facility: Swedish Medical Center; Ballard Campus
state: Washington
city: Seattle
country: United States
facility: Veteran's Affairs Puget Sound HCS
state: Washington
city: Seattle
country: United States
facility: Swedish Medical Center; Cherry Hill Campus
state: Washington
city: Seattle
country: United States
facility: Swedish Medical Center; First Hill Campus
state: Washington
city: Seattle
country: United States
facility: Northwest Hospital Medical Center
state: Washington
city: Seattle
country: United States
facility: University of Washington; UW Medical Center
state: Washington
city: Tacoma
country: United States
facility: Saint Joseph Hospital
state: Washington
Study officials:
affiliation: University of Washington; Division of Pulmonary and Critical Care
name: J. Randall Curtis, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1097/01.CCM.0000237045.12925.09.
citation: 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. doi: 10.1164/rccm.200802-272OC. Epub 2008 May 14.
citation: 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. 2011 Feb 1;183(3):348-55. doi: 10.1164/rccm.201006-1004OC. Epub 2010 Sep 10.
citation: Brown CE, Engelberg RA, Nielsen EL, Curtis JR. Palliative Care for Patients Dying in the Intensive Care Unit with Chronic Lung Disease Compared with Metastatic Cancer. Ann Am Thorac Soc. 2016 May;13(5):684-9. doi: 10.1513/AnnalsATS.201510-667OC.
citation: Ramos KJ, Downey L, Nielsen EL, Treece PD, Shannon SE, Curtis JR, Engelberg RA. Using Nurse Ratings of Physician Communication in the ICU To Identify Potential Targets for Interventions To Improve End-of-Life Care. J Palliat Med. 2016 Mar;19(3):292-9. doi: 10.1089/jpm.2015.0155. Epub 2015 Dec 18.
citation: Lee JJ, Long AC, Curtis JR, Engelberg RA. The Influence of Race/Ethnicity and Education on Family Ratings of the Quality of Dying in the ICU. J Pain Symptom Manage. 2016 Jan;51(1):9-16. doi: 10.1016/j.jpainsymman.2015.08.008. Epub 2015 Sep 16.
citation: Johnson JR, Engelberg RA, Nielsen EL, Kross EK, Smith NL, Hanada JC, Doll O'Mahoney SK, Curtis JR. The association of spiritual care providers' activities with family members' satisfaction with care after a death in the ICU*. Crit Care Med. 2014 Sep;42(9):1991-2000. doi: 10.1097/CCM.0000000000000412.
citation: Kross EK, Engelberg RA, Downey L, Cuschieri J, Hallman MR, Longstreth WT Jr, Tirschwell DL, Curtis JR. Differences in end-of-life care in the ICU across patients cared for by medicine, surgery, neurology, and neurosurgery physicians. Chest. 2014 Feb;145(2):313-321. doi: 10.1378/chest.13-1351.
citation: DeCato TW, Engelberg RA, Downey L, Nielsen EL, Treece PD, Back AL, Shannon SE, Kross EK, Curtis JR. Hospital variation and temporal trends in palliative and end-of-life care in the ICU. Crit Care Med. 2013 Jun;41(6):1405-11. doi: 10.1097/CCM.0b013e318287f289.
citation: 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.
citation: 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):1185-1192. doi: 10.1378/chest.11-3277.
citation: Muni S, Engelberg RA, Treece PD, Dotolo D, Curtis JR. The influence of race/ethnicity and socioeconomic status on end-of-life care in the ICU. Chest. 2011 May;139(5):1025-1033. doi: 10.1378/chest.10-3011. Epub 2011 Feb 3.
citation: Gries CJ, Engelberg RA, Kross EK, Zatzick D, Nielsen EL, Downey L, Curtis JR. Predictors of symptoms of posttraumatic stress and depression in family members after patient death in the ICU. Chest. 2010 Feb;137(2):280-7. doi: 10.1378/chest.09-1291. Epub 2009 Sep 17.
citation: 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):1496-1502. doi: 10.1378/chest.09-0589. Epub 2009 Jul 17.