Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2025-12-27 @ 6:31 AM
Study NCT ID:
NCT01844492
Status:
COMPLETED
Last Update Posted:
2018-03-20
First Post:
2013-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Patient and Family Centered Care in Advanced Critical Illness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D003643', 'term': 'Death'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Sample size listed is for patients (n=1420), for whom 809 surrogates completed long-term follow-up'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1420}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2016-02-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-16', 'studyFirstSubmitDate': '2013-04-19', 'studyFirstSubmitQcDate': '2013-04-26', 'lastUpdatePostDateStruct': {'date': '2018-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-05-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Mortality', 'timeFrame': 'At 6 months', 'description': 'Hospital mortality and 6-month mortality using hospital administrative records, and the 6-month follow-up with surrogates.'}, {'measure': 'Katz Activities of Daily Living Scale', 'timeFrame': 'At 6 months', 'description': 'Functional status of the patient using the validated Katz Activities of Daily Living Scale at 6 months.'}, {'measure': 'Hospital Length of Stay', 'timeFrame': 'Participants will be followed for duration of hosptial stay, an expected average of 4 weeks.', 'description': 'We will assess hospital length of stay.'}, {'measure': '6-month health care utilization', 'timeFrame': 'inclusive of index hospitalization and 6 months follow up', 'description': 'We will assess patient health care utilization using hospital records and through standardized interviews with surrogates at 6 months.'}], 'primaryOutcomes': [{'measure': 'Hospital Anxiety and Depression Scale', 'timeFrame': 'At 6 months', 'description': 'Symptom burden of anxiety and depression in family members in a telephone interview 6 months after enrollment using the validated 14-item Hospital Anxiety and Depression scale (HADS).'}], 'secondaryOutcomes': [{'measure': 'Quality of Communication (QOC) scale', 'timeFrame': 'At 6 months', 'description': 'Quality of communication in family members in a telephone interview 6 months after enrollment using the validated19 item Quality of Communication Scale.'}, {'measure': 'Patient-and Family Centeredness of Care Scale', 'timeFrame': 'At 6 months', 'description': 'Patient and Family -Centeredness of Care, using the 12-item Patient-Perceived Patient-Centeredness of Care Scale (PPPC) adapted for use by surrogates.'}, {'measure': 'Intensive Care Unit Length of Stay', 'timeFrame': 'Participants will be followed for duration of ICU stay, an expected average of 21 days.', 'description': 'Intensive Care Unit length of stay as assessed by abstraction of this information from hospital administrative records.'}, {'measure': 'Total Hospitalization costs', 'timeFrame': 'Duration of hospital stay, an expected average of 4 weeks', 'description': "Total hospitalization costs by aggregating each patient's total service specific costs, generated from hospital administrative records. We will stratify this analysis by the patient's vital status at hospital discharge."}, {'measure': 'Impact of Events Scale of Care Scale', 'timeFrame': 'At 6 months', 'description': 'We will assess symptoms of post-traumatic stress in family members in a telephone interview 6 months after enrollment using the validated 22 item Impact of Events Scale.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['decision making for incapacitated patients', 'intensive care', 'surrogate decision making', 'patient centered care', 'Palliative Care', 'End of Life', 'Quality of Communication'], 'conditions': ['Anxiety', 'Depression']}, 'referencesModule': {'references': [{'pmid': '15090940', 'type': 'BACKGROUND', 'citation': 'Angus DC, Barnato AE, Linde-Zwirble WT, Weissfeld LA, Watson RS, Rickert T, Rubenfeld GD; Robert Wood Johnson Foundation ICU End-Of-Life Peer Group. Use of intensive care at the end of life in the United States: an epidemiologic study. Crit Care Med. 2004 Mar;32(3):638-43. doi: 10.1097/01.ccm.0000114816.62331.08.'}, {'pmid': '9769276', 'type': 'BACKGROUND', 'citation': 'Prendergast TJ, Claessens MT, Luce JM. A national survey of end-of-life care for critically ill patients. Am J Respir Crit Care Med. 1998 Oct;158(4):1163-7. doi: 10.1164/ajrccm.158.4.9801108.'}, {'pmid': '15665319', 'type': 'BACKGROUND', 'citation': 'Azoulay E, Pochard F, Kentish-Barnes N, Chevret S, Aboab J, Adrie C, Annane D, Bleichner G, Bollaert PE, Darmon M, Fassier T, Galliot R, Garrouste-Orgeas M, Goulenok C, Goldgran-Toledano D, Hayon J, Jourdain M, Kaidomar M, Laplace C, Larche J, Liotier J, Papazian L, Poisson C, Reignier J, Saidi F, Schlemmer B; FAMIREA Study Group. Risk of post-traumatic stress symptoms in family members of intensive care unit patients. Am J Respir Crit Care Med. 2005 May 1;171(9):987-94. doi: 10.1164/rccm.200409-1295OC. Epub 2005 Jan 21.'}, {'pmid': '21357911', 'type': 'BACKGROUND', 'citation': 'Wendler D, Rid A. Systematic review: the effect on surrogates of making treatment decisions for others. Ann Intern Med. 2011 Mar 1;154(5):336-46. doi: 10.7326/0003-4819-154-5-201103010-00008.'}, {'pmid': '9005760', 'type': 'BACKGROUND', 'citation': 'Lynn J, Teno JM, Phillips RS, Wu AW, Desbiens N, Harrold J, Claessens MT, Wenger N, Kreling B, Connors AF Jr. Perceptions by family members of the dying experience of older and seriously ill patients. SUPPORT Investigators. Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments. Ann Intern Med. 1997 Jan 15;126(2):97-106. doi: 10.7326/0003-4819-126-2-199701150-00001.'}, {'pmid': '8302322', 'type': 'BACKGROUND', 'citation': "Murphy DJ, Burrows D, Santilli S, Kemp AW, Tenner S, Kreling B, Teno J. The influence of the probability of survival on patients' preferences regarding cardiopulmonary resuscitation. N Engl J Med. 1994 Feb 24;330(8):545-9. doi: 10.1056/NEJM199402243300807."}, {'pmid': '9624023', 'type': 'BACKGROUND', 'citation': "Weeks JC, Cook EF, O'Day SJ, Peterson LM, Wenger N, Reding D, Harrell FE, Kussin P, Dawson NV, Connors AF Jr, Lynn J, Phillips RS. Relationship between cancer patients' predictions of prognosis and their treatment preferences. JAMA. 1998 Jun 3;279(21):1709-14. doi: 10.1001/jama.279.21.1709."}, {'pmid': '20148984', 'type': 'BACKGROUND', 'citation': 'Riley GF, Lubitz JD. Long-term trends in Medicare payments in the last year of life. Health Serv Res. 2010 Apr;45(2):565-76. doi: 10.1111/j.1475-6773.2010.01082.x. Epub 2010 Feb 9.'}, {'pmid': '11463076', 'type': 'BACKGROUND', 'citation': "Hogan C, Lunney J, Gabel J, Lynn J. Medicare beneficiaries' costs of care in the last year of life. Health Aff (Millwood). 2001 Jul-Aug;20(4):188-95. doi: 10.1377/hlthaff.20.4.188."}, {'pmid': '11932474', 'type': 'BACKGROUND', 'citation': 'Fried TR, Bradley EH, Towle VR, Allore H. Understanding the treatment preferences of seriously ill patients. N Engl J Med. 2002 Apr 4;346(14):1061-6. doi: 10.1056/NEJMsa012528.'}, {'pmid': '20713793', 'type': 'BACKGROUND', 'citation': 'Sudore RL, Fried TR. Redefining the "planning" in advance care planning: preparing for end-of-life decision making. Ann Intern Med. 2010 Aug 17;153(4):256-61. doi: 10.7326/0003-4819-153-4-201008170-00008.'}, {'pmid': '12952998', 'type': 'BACKGROUND', 'citation': 'Schneiderman LJ, Gilmer T, Teetzel HD, Dugan DO, Blustein J, Cranford R, Briggs KB, Komatsu GI, Goodman-Crews P, Cohn F, Young EW. Effect of ethics consultations on nonbeneficial life-sustaining treatments in the intensive care setting: a randomized controlled trial. JAMA. 2003 Sep 3;290(9):1166-72. doi: 10.1001/jama.290.9.1166.'}, {'pmid': '17267907', 'type': 'BACKGROUND', 'citation': 'Lautrette A, Darmon M, Megarbane B, Joly LM, Chevret S, Adrie C, Barnoud D, Bleichner G, Bruel C, Choukroun G, Curtis JR, Fieux F, Galliot R, Garrouste-Orgeas M, Georges H, Goldgran-Toledano D, Jourdain M, Loubert G, Reignier J, Saidi F, Souweine B, Vincent F, Barnes NK, Pochard F, Schlemmer B, Azoulay E. A communication strategy and brochure for relatives of patients dying in the ICU. N Engl J Med. 2007 Feb 1;356(5):469-78. doi: 10.1056/NEJMoa063446.'}, {'pmid': '38954149', 'type': 'DERIVED', 'citation': 'Andersen SK, Chang CH, Arnold RM, Pidro C, Darby JM, Angus DC, White DB; Pairing Re-engineered Intensive Care Teams with Nurse-driven Emotional Support, Relationship building (PARTNER) Investigators. Impact of a family support intervention on hospitalization costs and hospital readmissions among ICU patients at high risk of death or severe functional impairment. Ann Intensive Care. 2024 Jul 2;14(1):103. doi: 10.1186/s13613-024-01344-9.'}, {'pmid': '29791247', 'type': 'DERIVED', 'citation': 'White DB, Angus DC, Shields AM, Buddadhumaruk P, Pidro C, Paner C, Chaitin E, Chang CH, Pike F, Weissfeld L, Kahn JM, Darby JM, Kowinsky A, Martin S, Arnold RM; PARTNER Investigators. A Randomized Trial of a Family-Support Intervention in Intensive Care Units. N Engl J Med. 2018 Jun 21;378(25):2365-2375. doi: 10.1056/NEJMoa1802637. Epub 2018 May 23.'}]}, 'descriptionModule': {'briefSummary': 'One in five deaths in the U.S. occurs in or shortly after discharge from an intensive care unit (ICU), typically following decisions made by surrogate decision makers to forego life prolonging treatment. A large body of empirical research has identified deficiencies in care processes that contribute to three important problems: 1) family members often experience poor quality communication with ICU clinicians, leading to lasting psychological distress associated with the ICU experience; 2) patients near the end of life frequently receive invasive, expensive treatment that is inconsistent with their values and preferences, and 3) end-of-life care is a major contributor to health care costs.\\[8, 9\\] Although advance care planning can prevent some unwanted treatment, many patients wish for a trial of intensive treatment when the prognosis is uncertain, and therefore it seems likely that the need for interventions to improve "in-the-moment" decisions by surrogates will persist.\\[10, 11\\]\n\nIn a pilot project, the investigators developed the PARTNER intervention (PAiring Re-engineered ICU Teams with Nurse-driven Emotional Support and Relationship-building), an interdisciplinary intervention that 1) gives new responsibilities and advanced communication skills training to existing ICU staff (local nurse leaders and social work members of the ICU team); 2) changes care "defaults" to ensure frequent clinician-family meetings; and 3) adds protocolized, nurse-administered coaching and emotional support of surrogates before and during clinician-family meetings. The objective of this proposal is to conduct a stepped wedge randomized controlled trial testing the PARTNER intervention in 5 ICUs among 1000 patients with advanced critical illness and their surrogates.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 18 years of age or older\n* Surrogate decision maker for ICU patient in one of 5 UPMC ICU's\n\nExclusion Criteria:\n\n* Non-English Speaking\n* Surrogate's loved one is for organ transplantation\n* Not physically able to participate in family meeting"}, 'identificationModule': {'nctId': 'NCT01844492', 'acronym': 'PARTNER', 'briefTitle': 'Improving Patient and Family Centered Care in Advanced Critical Illness', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Improving Patient and Family Centered Care in Advanced Critical Illness', 'orgStudyIdInfo': {'id': 'PRO13020304'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ICU Usual Care Control', 'description': 'described below', 'interventionNames': ['Other: ICU Usual Care Control']}, {'type': 'EXPERIMENTAL', 'label': 'The PARTNER Intervention', 'description': 'described below', 'interventionNames': ['Behavioral: The PARTNER Intervention']}], 'interventions': [{'name': 'The PARTNER Intervention', 'type': 'BEHAVIORAL', 'description': 'The PARTNER intervention (PAiring Re-engineered ICU Teams with Nurse-driven Emotional Support and Relationship-building) consists of: 1) institution of a clinical pathway for family support overseen by ICU staff nurses; 2) advanced communication skills training for ICU staff nurses; 3) a multifaceted strategy to support implementation of the clinical pathway for family support.', 'armGroupLabels': ['The PARTNER Intervention']}, {'name': 'ICU Usual Care Control', 'type': 'OTHER', 'description': 'The control group will receive usual care, in which the frequency and content of clinician-family communication is determined by the clinical team according to their usual practice. No study ICU has a protocolized approach to family communication and instead clinicians determine the timing and frequency of communication with families. All sites have palliative care services.', 'armGroupLabels': ['ICU Usual Care Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15261', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Medical Centers', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Douglas B. White, MD,MAS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Douglas White', 'investigatorAffiliation': 'University of Pittsburgh'}}}}