Advance Care Planning (ACP) in Elderly Cardiac Surgery Patients

• Conditions: Advanced Care Planning

• Registration Number: NCT02680327
• Lead Sponsor: Montreal Heart Institute

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.

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

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2016-01-29
• Status Verified: 2016-02
• Study First Submitted QC: 2016-02-10
• Last Update Submitted: 2016-02-10
• Study First Posted: 2016-02-11
• Last Update Posted: 2016-02-11
• Primary Completion: 2016-04
• Study Completion: 2016-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 35

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Successful study completion	1 month	To estimate the proportion of patients who successfully completed all the study tasks;
Time frame	1 month	To evaluate the time frame required to enroll and complete the study for 35 patients;
Gait test	1 month	To evaluate the length of time required perform the gait test (in minutes);
patient retention	1 month	To evaluate patient retention (percent of patients who complete the study);
Screen failure rate	1 month	To evaluate the screen failure rate

Secondary Outcome Measures

Name	Time	Method
Overall satisfaction	1 month	To assess the patient's overall satisfaction with goals of care communication (question 1 of CANHELP questionnaire; (5 point Likert scale));
Prevalence of ACP	1 month	To determine, from the perspective of the acutely ill patient, the prevalence of Advanced Care Planning (ACP) directives;
Percentage of frail patients	1 month	To evaluate proportion of patients evaluated as frail using the 5-meter walk test;
Level of correlation between "level of frailty" and "satisfaction with decision making".	1 month	To evaluate the level of correlation between "satisfaction with decision making" and level of frailty.

Trial Locations

Locations (1)

Montreal Heart Institute; 🇨🇦 Montreal, Quebec, Canada