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Advanced Care PlanningDIMANNCT02680327

Advance Care Planning (ACP) in Elderly Cardiac Surgery Patients

An observational study of Advanced Care Planning, run by Montreal Heart Institute at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 70 to 95 years
Conditions the study is for
Advanced Care Planning
How many people
35 participants
Where
1 siteCanada
Study dates
Oct 2015to Jul 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 to 95 years
  • All sexes
  • No healthy volunteers
  • Older adult

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);

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Jennifer Cogan, MD, FRCPC contact

514-376-3330 ext. 3732

jennifer.cogan@gmail.com

Canada1 site, 1 recruiting

  • Montreal Heart Institute

    Montreal, Quebec, H1T 1C8

    Jennifer Cogan, MD, FRCPC, 514-376-3330 ext. 3732, jennifer.cogan@gmail.com

    Recruiting

Other trials in Canada

About this study

Official title: A Feasibility Study on: Advance Care Planning (ACP) in Elderly Cardiac Surgery Patients

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.

Read the detailed description

Study Procedures:

Once 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.

Study Tools

Patient questionnaires:

  1. ACP Evaluation questionnaire: 5 questions about advance care planning on admission to hospital from CANHELP study (time predicted 10 minutes)
  2. CANHELP questionnaire (sections relationship with doctors, communication and decision making) 2 weeks after discharge (time predicted 25 minutes)

Patient test:

  1. 5-minute gait speed Patient Assessment Data
  2. Standard Demographics
  3. Anthropometric data
  4. Cardiac variables
  5. Comorbidities
  6. Lab Values
  7. Frailty (assessed using 5-meter gait speed)

Post-surgical outcome data (will be sought in the chart after 30 days post-surgery)

  1. Outcome
  2. Complications

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Successful study completion

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

    Measured: 1 month

  2. Time frame

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

    Measured: 1 month

  3. Gait test

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

    Measured: 1 month

  4. patient retention

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

    Measured: 1 month

  5. Screen failure rate

    To evaluate the screen failure rate

    Measured: 1 month

Secondary outcomes (4)

  1. Overall satisfaction

    To assess the patient's overall satisfaction with goals of care communication (question 1 of CANHELP questionnaire; (5 point Likert scale));

    Measured: 1 month

  2. Prevalence of ACP

    To determine, from the perspective of the acutely ill patient, the prevalence of Advanced Care Planning (ACP) directives;

    Measured: 1 month

  3. Percentage of frail patients

    To evaluate proportion of patients evaluated as frail using the 5-meter walk test;

    Measured: 1 month

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

    To evaluate the level of correlation between "satisfaction with decision making" and level of frailty.

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2016 (estimated)
  2. Study startOct 2015
  3. Primary completionApr 2016 (estimated)
  4. Study completionJul 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
35 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02680327
Sponsor's protocol ID
ICM 15-1875
Acronym
DIMAN
Status last verified
Feb 2016
First submitted
29 Jan 2016
Last updated
11 Feb 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 12622581

  • 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.

    PubMed 10716477

  • 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.

    PubMed 12021224

  • 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.

    PubMed 21050978

  • 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.

    PubMed 23545563

  • 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.

    PubMed 19571280

  • 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.

    PubMed 18840840

  • 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.

    PubMed 23857860

  • 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.

    PubMed 20605850

  • 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.

    PubMed 20921249

  • 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.

    PubMed 17087693

  • 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.

    PubMed 16181165

  • 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.

    PubMed 19903980

Questions about this trial

What is this clinical trial studying?

An observational study of Advanced Care Planning, run by Montreal Heart Institute at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jennifer Cogan, MD, FRCPC (514-376-3330 ext. 3732, jennifer.cogan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Successful study completion (time frame: 1 month). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02680327, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2016.

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