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DIMAN: Advance Care Planning (ACP) in Elderly Cardiac Surgery Patients

Sponsor
Montreal Heart Institute (Other)
Overall Status
Unknown status
CT.gov ID
NCT02680327
Collaborator
(none)
35
Enrollment
1
Location
9
Duration (Months)
3.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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

    1. Standard Demographics

    2. Anthropometric data

    3. Cardiac variables

    4. Comorbidities

    5. Lab Values

    6. 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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    35 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Feasibility Study on: Advance Care Planning (ACP) in Elderly Cardiac Surgery Patients
    Study Start Date :
    Oct 1, 2015
    Anticipated Primary Completion Date :
    Apr 1, 2016
    Anticipated Study Completion Date :
    Jul 1, 2016

    Outcome Measures

    Primary Outcome Measures

    1. Successful study completion [1 month]

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

    2. Time frame [1 month]

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

    3. Gait test [1 month]

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

    4. patient retention [1 month]

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

    5. Screen failure rate [1 month]

      To evaluate the screen failure rate

    Secondary Outcome Measures

    1. 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));

    2. Prevalence of ACP [1 month]

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

    3. Percentage of frail patients [1 month]

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

    4. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    70 Years to 95 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Montreal Heart Institute Montreal Quebec Canada H1T 1C8

    Sponsors and Collaborators

    • Montreal Heart Institute

    Investigators

    • Principal Investigator: Jennifer Cogan, MD, FRCPC, Montreal Heart Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jennifer Cogan, Associate Professor, MSc, MD, FRCPC,, Montreal Heart Institute
    ClinicalTrials.gov Identifier:
    NCT02680327
    Other Study ID Numbers:
    • ICM 15-1875
    First Posted:
    Feb 11, 2016
    Last Update Posted:
    Feb 11, 2016
    Last Verified:
    Feb 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No

    Study Results

    No Results Posted as of Feb 11, 2016