Advance Care Planning (ACP) in Elderly Cardiac Surgery Patients

Advanced Care Planning Clinical Trial

— DIMAN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02680327
• Other study ID #: ICM 15-1875
• Status: Recruiting
• Phase: N/A
• First received: January 29, 2016
• Last updated: February 10, 2016
• Start date: October 2015
• Est. completion date: July 2016

Study information

• Verified date: February 2016
• Source: Montreal Heart Institute
• Contact: Jennifer Cogan, MD, FRCPC
• Phone: 514-376-3330
• Email: jennifer.cogan[@]gmail.com
• Is FDA regulated: No
• Health authority: Canada: Institutional Review Board
• Study type: Observational

Clinical 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 the current validated questionnaires and methodology.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: July 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years to 95 Years

Eligibility

Inclusion Criteria:

• Age and over 70 years

• Admitted for cardiac surgery;

• Able to speak English or French;

Exclusion Criteria:

• Age under 70 years;

• Unable to participate in the follow-up telephone survey;

• Unable to speak English or French.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Advanced Care Planning

Locations

Country	Name	City	State
Canada	Montreal Heart Institute	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Montreal Heart Institute

Country where clinical trial is conducted

Canada, 

References & Publications (13)

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 — View 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. — View 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 Heal — View Citation

Dumurgier J, Elbaz A, Ducimetière P, Tavernier B, Alpérovitch 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. — View 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. — View 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; — View 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 en — View 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 — View 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-o — View 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 patie — View 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. — View 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. JA — View 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. Review — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful study completion	To estimate the proportion of patients who successfully completed all the study tasks;	1 month	No
Primary	Time frame	To evaluate the time frame required to enroll and complete the study for 35 patients;	1 month	No
Primary	Gait test	To evaluate the length of time required perform the gait test (in minutes);	1 month	No
Primary	patient retention	To evaluate patient retention (percent of patients who complete the study);	1 month	No
Primary	Screen failure rate	To evaluate the screen failure rate	1 month	No
Secondary	Overall satisfaction	To assess the patient's overall satisfaction with goals of care communication (question 1 of CANHELP questionnaire; (5 point Likert scale));	1 month	No
Secondary	Prevalence of ACP	To determine, from the perspective of the acutely ill patient, the prevalence of Advanced Care Planning (ACP) directives;	1 month	No
Secondary	Percentage of frail patients	To evaluate proportion of patients evaluated as frail using the 5-meter walk test;	1 month	No
Secondary	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.	1 month	No