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

February 10, 2016 updated by: Jennifer Cogan, Montreal Heart Institute

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H1T 1C8
        • Recruiting
        • Montreal Heart Institute
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years to 95 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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);

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montreal Heart Institute

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Anticipated)

April 1, 2016

Study Completion (Anticipated)

July 1, 2016

Study Registration Dates

First Submitted

January 29, 2016

First Submitted That Met QC Criteria

February 10, 2016

First Posted (Estimate)

February 11, 2016

Study Record Updates

Last Update Posted (Estimate)

February 11, 2016

Last Update Submitted That Met QC Criteria

February 10, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • ICM 15-1875

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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