Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2026-02-23 @ 11:34 AM
Study NCT ID:
NCT02680327
Status:
UNKNOWN
Last Update Posted:
2016-02-11
First Post:
2016-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Advance Care Planning (ACP) in Elderly Cardiac Surgery Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 35}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2016-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-02-10', 'studyFirstSubmitDate': '2016-01-29', 'studyFirstSubmitQcDate': '2016-02-10', 'lastUpdatePostDateStruct': {'date': '2016-02-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-02-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Successful study completion', 'timeFrame': '1 month', 'description': 'To estimate the proportion of patients who successfully completed all the study tasks;'}, {'measure': 'Time frame', 'timeFrame': '1 month', 'description': 'To evaluate the time frame required to enroll and complete the study for 35 patients;'}, {'measure': 'Gait test', 'timeFrame': '1 month', 'description': 'To evaluate the length of time required perform the gait test (in minutes);'}, {'measure': 'patient retention', 'timeFrame': '1 month', 'description': 'To evaluate patient retention (percent of patients who complete the study);'}, {'measure': 'Screen failure rate', 'timeFrame': '1 month', 'description': 'To evaluate the screen failure rate'}], 'secondaryOutcomes': [{'measure': 'Overall satisfaction', 'timeFrame': '1 month', 'description': "To assess the patient's overall satisfaction with goals of care communication (question 1 of CANHELP questionnaire; (5 point Likert scale));"}, {'measure': 'Prevalence of ACP', 'timeFrame': '1 month', 'description': 'To determine, from the perspective of the acutely ill patient, the prevalence of Advanced Care Planning (ACP) directives;'}, {'measure': 'Percentage of frail patients', 'timeFrame': '1 month', 'description': 'To evaluate proportion of patients evaluated as frail using the 5-meter walk test;'}, {'measure': 'Level of correlation between "level of frailty" and "satisfaction with decision making".', 'timeFrame': '1 month', 'description': 'To evaluate the level of correlation between "satisfaction with decision making" and level of frailty.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Advanced Care Planning']}, 'referencesModule': {'references': [{'pmid': '12622581', 'type': 'RESULT', 'citation': 'Pfisterer M, Buser P, Osswald S, Allemann U, Amann W, Angehrn W, Eeckhout E, Erne P, Estlinbaum W, Kuster G, Moccetti T, Naegeli B, Rickenbacher P; Trial of Invasive versus Medical therapy in Elderly patients (TIME) Investigators. Outcome of elderly patients with chronic symptomatic coronary artery disease with an invasive vs optimized medical treatment strategy: one-year results of the randomized TIME trial. JAMA. 2003 Mar 5;289(9):1117-23. doi: 10.1001/jama.289.9.1117.'}, {'pmid': '10716477', 'type': 'RESULT', 'citation': 'Alexander KP, Anstrom KJ, Muhlbaier LH, Grosswald RD, Smith PK, Jones RH, Peterson ED. Outcomes of cardiac surgery in patients > or = 80 years: results from the National Cardiovascular Network. J Am Coll Cardiol. 2000 Mar 1;35(3):731-8. doi: 10.1016/s0735-1097(99)00606-3.'}, {'pmid': '12021224', 'type': 'RESULT', 'citation': 'Graham MM, Ghali WA, Faris PD, Galbraith PD, Norris CM, Knudtson ML; Alberta Provincial Project for Outcomes Assessment in Coronary Heart Disease (APPROACH) Investigators. Survival after coronary revascularization in the elderly. Circulation. 2002 May 21;105(20):2378-84. doi: 10.1161/01.cir.0000016640.99114.3d.'}, {'pmid': '21050978', 'type': 'RESULT', 'citation': 'Afilalo J, Eisenberg MJ, Morin JF, Bergman H, Monette J, Noiseux N, Perrault LP, Alexander KP, Langlois Y, Dendukuri N, Chamoun P, Kasparian G, Robichaud S, Gharacholou SM, Boivin JF. Gait speed as an incremental predictor of mortality and major morbidity in elderly patients undergoing cardiac surgery. J Am Coll Cardiol. 2010 Nov 9;56(20):1668-76. doi: 10.1016/j.jacc.2010.06.039.'}, {'pmid': '23545563', 'type': 'RESULT', 'citation': 'Heyland DK, Barwich D, Pichora D, Dodek P, Lamontagne F, You JJ, Tayler C, Porterfield P, Sinuff T, Simon J; ACCEPT (Advance Care Planning Evaluation in Elderly Patients) Study Team; Canadian Researchers at the End of Life Network (CARENET). Failure to engage hospitalized elderly patients and their families in advance care planning. JAMA Intern Med. 2013 May 13;173(9):778-87. doi: 10.1001/jamainternmed.2013.180.'}, {'pmid': '19571280', 'type': 'RESULT', 'citation': 'Ehlenbach WJ, Barnato AE, Curtis JR, Kreuter W, Koepsell TD, Deyo RA, Stapleton RD. Epidemiologic study of in-hospital cardiopulmonary resuscitation in the elderly. N Engl J Med. 2009 Jul 2;361(1):22-31. doi: 10.1056/NEJMoa0810245.'}, {'pmid': '18840840', 'type': 'RESULT', 'citation': 'Wright AA, Zhang B, Ray A, Mack JW, Trice E, Balboni T, Mitchell SL, Jackson VA, Block SD, Maciejewski PK, Prigerson HG. Associations between end-of-life discussions, patient mental health, medical care near death, and caregiver bereavement adjustment. JAMA. 2008 Oct 8;300(14):1665-73. doi: 10.1001/jama.300.14.1665.'}, {'pmid': '23857860', 'type': 'RESULT', 'citation': 'You JJ, Fowler RA, Heyland DK; Canadian Researchers at the End of Life Network (CARENET). Just ask: discussing goals of care with patients in hospital with serious illness. CMAJ. 2014 Apr 1;186(6):425-32. doi: 10.1503/cmaj.121274. Epub 2013 Jul 15. No abstract available.'}, {'pmid': '20605850', 'type': 'RESULT', 'citation': 'Heyland DK, Cook DJ, Rocker GM, Dodek PM, Kutsogiannis DJ, Skrobik Y, Jiang X, Day AG, Cohen SR; Canadian Researchers at the End of Life Network. The development and validation of a novel questionnaire to measure patient and family satisfaction with end-of-life care: the Canadian Health Care Evaluation Project (CANHELP) Questionnaire. Palliat Med. 2010 Oct;24(7):682-95. doi: 10.1177/0269216310373168. Epub 2010 Jul 6.'}, {'pmid': '20921249', 'type': 'RESULT', 'citation': 'Heyland DK, Cook DJ, Rocker GM, Dodek PM, Kutsogiannis DJ, Skrobik Y, Jiang X, Day AG, Cohen SR; Canadian Researchers at the End of Life Network (CARENET). Defining priorities for improving end-of-life care in Canada. CMAJ. 2010 Nov 9;182(16):E747-52. doi: 10.1503/cmaj.100131. Epub 2010 Oct 4.'}, {'pmid': '17087693', 'type': 'RESULT', 'citation': 'Purser JL, Kuchibhatla MN, Fillenbaum GG, Harding T, Peterson ED, Alexander KP. Identifying frailty in hospitalized older adults with significant coronary artery disease. J Am Geriatr Soc. 2006 Nov;54(11):1674-81. doi: 10.1111/j.1532-5415.2006.00914.x.'}, {'pmid': '16181165', 'type': 'RESULT', 'citation': 'Cesari M, Kritchevsky SB, Penninx BW, Nicklas BJ, Simonsick EM, Newman AB, Tylavsky FA, Brach JS, Satterfield S, Bauer DC, Visser M, Rubin SM, Harris TB, Pahor M. Prognostic value of usual gait speed in well-functioning older people--results from the Health, Aging and Body Composition Study. J Am Geriatr Soc. 2005 Oct;53(10):1675-80. doi: 10.1111/j.1532-5415.2005.53501.x.'}, {'pmid': '19903980', 'type': 'RESULT', 'citation': 'Dumurgier J, Elbaz A, Ducimetiere P, Tavernier B, Alperovitch A, Tzourio C. Slow walking speed and cardiovascular death in well functioning older adults: prospective cohort study. BMJ. 2009 Nov 10;339:b4460. doi: 10.1136/bmj.b4460.'}]}, 'descriptionModule': {'briefSummary': 'This is a prospective epidemiological pilot study to evaluate the feasibility of recruiting and retaining patients in a large multicenter study that will audit Advanced Care Planning (ACP) practices and satisfaction with End Of Life (EOL) communication and decision-making in patients undergoing cardiac surgery using the current validated questionnaires and methodology.', 'detailedDescription': 'Study Procedures:\n\nOnce patients have signed an informed consent they will be asked to complete the ACP evaluation questionnaire. Their level of frailty will be assessed with the 5-meter walk test. Two weeks after discharge (+ or - 7 days) they will be contacted by phone in order to complete 3 sections of the CANHELP questionnaire.\n\nStudy Tools\n\nPatient questionnaires:\n\n1. ACP Evaluation questionnaire: 5 questions about advance care planning on admission to hospital from CANHELP study (time predicted 10 minutes)\n2. CANHELP questionnaire (sections relationship with doctors, communication and decision making) 2 weeks after discharge (time predicted 25 minutes)\n\nPatient test:\n\n1. 5-minute gait speed\n\n Patient Assessment Data\n2. Standard Demographics\n3. Anthropometric data\n4. Cardiac variables\n5. Comorbidities\n6. Lab Values\n7. Frailty (assessed using 5-meter gait speed)\n\nPost-surgical outcome data (will be sought in the chart after 30 days post-surgery)\n\n1. Outcome\n2. Complications'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '70 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients 70 years of age and over admitted for cardiac surgery that requires a general anesthetic (either via median sternotomy, minimally invasive or percutaneous approach);', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age and over 70 years\n* Admitted for cardiac surgery;\n* Able to speak English or French;\n\nExclusion Criteria:\n\n* Age under 70 years;\n* Unable to participate in the follow-up telephone survey;\n* Unable to speak English or French.'}, 'identificationModule': {'nctId': 'NCT02680327', 'acronym': 'DIMAN', 'briefTitle': 'Advance Care Planning (ACP) in Elderly Cardiac Surgery Patients', 'organization': {'class': 'OTHER', 'fullName': 'Montreal Heart Institute'}, 'officialTitle': 'A Feasibility Study on: Advance Care Planning (ACP) in Elderly Cardiac Surgery Patients', 'orgStudyIdInfo': {'id': 'ICM 15-1875'}}, 'contactsLocationsModule': {'locations': [{'zip': 'H1T 1C8', 'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Jennifer Cogan, MD, FRCPC', 'role': 'CONTACT', 'email': 'jennifer.cogan@gmail.com', 'phone': '514-376-3330', 'phoneExt': '3732'}], 'facility': 'Montreal Heart Institute', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'centralContacts': [{'name': 'Jennifer Cogan, MD, FRCPC', 'role': 'CONTACT', 'email': 'jennifer.cogan@gmail.com', 'phone': '514-376-3330', 'phoneExt': '3732'}], 'overallOfficials': [{'name': 'Jennifer Cogan, MD, FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Montreal Heart Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Montreal Heart Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, MSc, MD, FRCPC,', 'investigatorFullName': 'Jennifer Cogan', 'investigatorAffiliation': 'Montreal Heart Institute'}}}}