Viewing Study NCT02680327


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Study NCT ID: NCT02680327
Status: UNKNOWN
Last Update Posted: 2016-02-11
First Post: 2016-01-29
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Advance Care Planning (ACP) in Elderly Cardiac Surgery Patients
Sponsor: Montreal Heart Institute
Organization:

Study Overview

Official Title: A Feasibility Study on: Advance Care Planning (ACP) in Elderly Cardiac Surgery Patients
Status: UNKNOWN
Status Verified Date: 2016-02
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: DIMAN
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 Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: