Advance Care Planning (ACP) in Elderly Cardiac Surgery Patients

NCT02680327 | Unknown

• 1 other identifier: ICM 15-1875
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Advanced Care Planning

Outcome Measures

Primary Outcomes (5)

• Successful study completion

  To estimate the proportion of patients who successfully completed all the study tasks;

  1 month

• Time frame

  To evaluate the time frame required to enroll and complete the study for 35 patients;

  1 month

• Gait test

  To evaluate the length of time required perform the gait test (in minutes);

  1 month

• patient retention

  To evaluate patient retention (percent of patients who complete the study);

  1 month

• Screen failure rate

  To evaluate the screen failure rate

  1 month

Secondary Outcomes (4)

• Overall satisfaction

  1 month

• Prevalence of ACP

  1 month

• Percentage of frail patients

  1 month

• Level of correlation between "level of frailty" and "satisfaction with decision making".

  1 month

Eligibility Criteria

• Age: 70 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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);

You may qualify if:

• Age and over 70 years
• Admitted for cardiac surgery;
• Able to speak English or French;

You may not qualify if:

• Age under 70 years;
• Unable to participate in the follow-up telephone survey;
• Unable to speak English or French.

Sponsors & Collaborators

• Montreal Heart Institute: lead

Study Sites (1)

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

RECRUITING

Related Publications (13)

• 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: 12622581 RESULT

• 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: 10716477 RESULT

• 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: 12021224 RESULT

• 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: 21050978 RESULT

• 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: 23545563 RESULT

• 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: 19571280 RESULT

• 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: 18840840 RESULT

• 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: 23857860 RESULT

• 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: 20605850 RESULT

• 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: 20921249 RESULT

• 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: 17087693 RESULT

• 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: 16181165 RESULT

• 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.

  PMID: 19903980 RESULT

Study Officials

• Jennifer Cogan, MD, FRCPC

  Montreal Heart Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Cogan, MD, FRCPC

CONTACT

514-376-3330; jennifer.cogan@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, MSc, MD, FRCPC,

Study Record Dates

• First Submitted: January 29, 2016
• First Posted: February 11, 2016
• Study Start: October 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: July 1, 2016
• Last Updated: February 11, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)