Ignite Creation Date:
2025-12-25 @ 1:08 AM
Ignite Modification Date:
2026-01-03 @ 8:42 PM
Study NCT ID:
NCT00685893
Status:
COMPLETED
Last Update Posted:
2013-06-27
First Post:
2008-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Integrating Palliative and Critical Care (IPACC) Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004522', 'term': 'Educational Status'}], 'ancestors': [{'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3498}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-25', 'studyFirstSubmitDate': '2008-05-27', 'studyFirstSubmitQcDate': '2008-05-27', 'lastUpdatePostDateStruct': {'date': '2013-06-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Score on a survey: the Quality of Dying and Death (QODD) as assessed by family members.', 'timeFrame': '5 years'}], 'secondaryOutcomes': [{'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'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['End-of-life issues', 'Talking with your doctor', 'Coping with chronic illness'], 'conditions': ['Any Disease Causing Death in the ICU or Within 24 Hours of Discharge From the ICU']}, 'referencesModule': {'references': [{'pmid': '17057602', 'type': 'BACKGROUND', '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.'}, {'pmid': '18480429', 'type': 'BACKGROUND', '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.'}, {'pmid': '20833820', 'type': 'RESULT', '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.'}, {'pmid': '26784137', 'type': 'DERIVED', '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.'}, {'pmid': '26685082', 'type': 'DERIVED', '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.'}, {'pmid': '26384556', 'type': 'DERIVED', '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.'}, {'pmid': '24797373', 'type': 'DERIVED', '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."}, {'pmid': '24114410', 'type': 'DERIVED', '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.'}, {'pmid': '23518869', 'type': 'DERIVED', '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.'}, {'pmid': '22762964', 'type': 'DERIVED', '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.'}, {'pmid': '22661455', 'type': 'DERIVED', '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.'}, {'pmid': '21292758', 'type': 'DERIVED', '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.'}, {'pmid': '19762549', 'type': 'DERIVED', '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.'}, {'pmid': '19617402', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients, family members, nurses, and clinician evaluators\n\nPatients are eligible if they are:\n\n* in the ICU for a minimum of 6 hours AND,\n* if they die in an ICU or within 24 hours of transfer out of the ICU.\n\nFamily members or significant others are eligible if:\n\n* they were involved with the patient who has died.\n\nNurses are eligible if:\n\n* they cared for an eligible patient on either the shift during which the patient died or the shift preceding the death.\n\nClinicians are eligible to evaluate the intervention components if they:\n\n* work in a study ICU AND\n* participate in any of the intervention components.\n\nExclusion Criteria:\n\n* Inability to read English well enough to complete the surveys\n* Under 18 years of age.'}, 'identificationModule': {'nctId': 'NCT00685893', 'acronym': 'IPACC', 'briefTitle': 'Integrating Palliative and Critical Care (IPACC) Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'An ICU Intervention to Improve End-of-Life Care', 'orgStudyIdInfo': {'id': '23503-G'}, 'secondaryIdInfos': [{'id': 'R01NR005226', 'link': 'https://reporter.nih.gov/quickSearch/R01NR005226', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control Arm', 'description': '6 Community hospital ICUs receiving delayed intervention activities after the completion of the randomized trial'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention Arm', 'description': '6 community hospital ICUs receiving 5-component intervention.', 'interventionNames': ['Behavioral: Education', 'Behavioral: Local Champions', 'Behavioral: Institution Feedback', 'Behavioral: Academic Detailing', 'Behavioral: Institutional Forms']}], 'interventions': [{'name': 'Education', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Intervention Arm']}, {'name': 'Local Champions', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Intervention Arm']}, {'name': 'Institution Feedback', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Intervention Arm']}, {'name': 'Academic Detailing', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Intervention Arm']}, {'name': 'Institutional Forms', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Intervention Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98004', 'city': 'Bellevue', 'state': 'Washington', 'country': 'United States', 'facility': 'Overlake Hospital Medical Center', 'geoPoint': {'lat': 47.61038, 'lon': -122.20068}}, {'zip': '98310', 'city': 'Bremerton', 'state': 'Washington', 'country': 'United States', 'facility': 'Harrison Memorial Hospital', 'geoPoint': {'lat': 47.56732, 'lon': -122.63264}}, {'zip': '98166', 'city': 'Burien', 'state': 'Washington', 'country': 'United States', 'facility': 'Highline Medical Center', 'geoPoint': {'lat': 47.47038, 'lon': -122.34679}}, {'zip': '98056', 'city': 'Edmonds', 'state': 'Washington', 'country': 'United States', 'facility': 'Stevens Hospital', 'geoPoint': {'lat': 47.81065, 'lon': -122.37736}}, {'zip': '98034', 'city': 'Kirkland', 'state': 'Washington', 'country': 'United States', 'facility': 'Evergreen Hospital Medical Center', 'geoPoint': {'lat': 47.68149, 'lon': -122.20874}}, {'zip': '98058', 'city': 'Renton', 'state': 'Washington', 'country': 'United States', 'facility': 'Valley Medical Center', 'geoPoint': {'lat': 47.48288, 'lon': -122.21707}}, {'zip': '98101', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Virginia Mason Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington; Harborview Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98107', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Swedish Medical Center; Ballard Campus', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98108', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': "Veteran's Affairs Puget Sound HCS", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98112', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Swedish Medical Center; Cherry Hill Campus', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98122', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Swedish Medical Center; First Hill Campus', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98133', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Northwest Hospital Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington; UW Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98405', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'Saint Joseph Hospital', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}], 'overallOfficials': [{'name': 'J. Randall Curtis, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington; Division of Pulmonary and Critical Care'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Nursing Research (NINR)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'J. Randall Curtis', 'investigatorAffiliation': 'University of Washington'}}}}