Integrating Palliative and Critical Care (IPACC) Study

NCT00685893 | Completed Phase 3 DMC

• 2 other identifiers: 23503-GR01NR005226
• Study Type: interventional
• Target: 3,498
• Locations: 1 country
• Sites: 15

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.

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

Outcome Measures

Primary Outcomes (1)

• Total Score on a survey: the Quality of Dying and Death (QODD) as assessed by family members.

  5 years

Secondary Outcomes (3)

• Total score of the QODD, as assessed by nurses

  5 years

• Satisfaction with care, as assessed by a survey called Family Satisfaction with the ICU (FS-ICU) as assessed by family members

  5 years

• Indicators of quality of end-of-life care as assessed by standardized medical record review.

  5 years

Study Arms (2)

Control Arm

NO INTERVENTION

6 Community hospital ICUs receiving delayed intervention activities after the completion of the randomized trial

Intervention Arm

EXPERIMENTAL

6 community hospital ICUs receiving 5-component intervention.

Behavioral: Education; Behavioral: Local Champions; Behavioral: Institution Feedback; Behavioral: Academic Detailing; Behavioral: Institutional Forms

Interventions

Education BEHAVIORAL

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.

Intervention Arm

Local Champions BEHAVIORAL

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.

Intervention Arm

Institution Feedback BEHAVIORAL

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.

Intervention Arm

Academic Detailing BEHAVIORAL

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.

Intervention Arm

Institutional Forms BEHAVIORAL

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.

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Inability to read English well enough to complete the surveys
• Under 18 years of age.

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (15)

Overlake Hospital Medical Center

Bellevue, Washington, 98004, United States

Location

Harrison Memorial Hospital

Bremerton, Washington, 98310, United States

Location

Highline Medical Center

Burien, Washington, 98166, United States

Location

Stevens Hospital

Edmonds, Washington, 98056, United States

Location

Evergreen Hospital Medical Center

Kirkland, Washington, 98034, United States

Location

Valley Medical Center

Renton, Washington, 98058, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

University of Washington; Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Swedish Medical Center; Ballard Campus

Seattle, Washington, 98107, United States

Location

Veteran's Affairs Puget Sound HCS

Seattle, Washington, 98108, United States

Location

Swedish Medical Center; Cherry Hill Campus

Seattle, Washington, 98112, United States

Location

Swedish Medical Center; First Hill Campus

Seattle, Washington, 98122, United States

Location

Northwest Hospital Medical Center

Seattle, Washington, 98133, United States

Location

University of Washington; UW Medical Center

Seattle, Washington, 98195, United States

Location

Saint Joseph Hospital

Tacoma, Washington, 98405, United States

Location

Related Publications (14)

• 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.

  PMID: 17057602 BACKGROUND

• 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.

  PMID: 18480429 BACKGROUND

• 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.

  PMID: 20833820 RESULT

• 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.

  PMID: 26784137 DERIVED

• 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.

  PMID: 26685082 DERIVED

• 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.

  PMID: 26384556 DERIVED

• 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.

  PMID: 24797373 DERIVED

• 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.

  PMID: 24114410 DERIVED

• 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.

  PMID: 23518869 DERIVED

• 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.

  PMID: 22762964 DERIVED

• 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.

  PMID: 22661455 DERIVED

• 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.

  PMID: 21292758 DERIVED

• 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.

  PMID: 19762549 DERIVED

• 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.

  PMID: 19617402 DERIVED

MeSH Terms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• J. Randall Curtis, MD, MPH

  University of Washington; Division of Pulmonary and Critical Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: May 27, 2008
• First Posted: May 29, 2008
• Study Start: June 1, 2003
• Primary Completion: March 1, 2008
• Study Completion: October 1, 2010
• Last Updated: June 27, 2013

Record last verified: 2013-06

Locations

US (15)