Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06616129
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-19
Brief Title:
A Study Protocol for Research Investigating How Geriatric Risk Assessment and Shared Decision-making Conversations Affect Treatment Decisions and Quality of Life in Patients Eligible for Open-heart Surgery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Preoperative RIsk Assessment and Shared Decision-Making in Patients Eligible for Cardiac Surgery PRIME-study a Study Protocol for a Single Center Non-randomized Prospective Trial
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRIME
Brief Summary:
The goal of this study is to determine whether intervention by the PRIME clinic influences cardiac treatment decisions as well as patients quality of life and healthcare utilization
The main questions this study aims to answer are
Does PRIME consultation influence treatment recommendations
Does a personalized treatment plan for cardiac patients influence health-related quality of life
Does a personalized treatment plan influence healthcare costs in terms of quality-adjusted life years
Participants will
Visit the PRIME clinic once
Complete quality of life questionnaires twice
Track their healthcare usage over the course of a year and complete a corresponding questionnaire four times
The main questions this study aims to answer are
Does PRIME consultation influence treatment recommendations
Does a personalized treatment plan for cardiac patients influence health-related quality of life
Does a personalized treatment plan influence healthcare costs in terms of quality-adjusted life years
Participants will
Visit the PRIME clinic once
Complete quality of life questionnaires twice
Track their healthcare usage over the course of a year and complete a corresponding questionnaire four times
Detailed Description:
The primary outcome of this study is the difference between treatment recommendations the first treatment recommendation the decision before the patient visits the outpatient clinic will be compared with the treatment recommendation after the assessment at the outpatient clinic
Secondary and other outcomes that will be collected are baseline demographic data including age gender body mass index education level European System for Cardiac Operative Risk Evaluation II EuroSCORE II and co-morbidities such as stroke reduced cognitive function chronic obstructive pulmonary disease COPD GOLD III or IV renal failure a reduced renal function prior to surgery with a kreatinine level 150mmolL a reduced left ventricular function reduced mobility cardiac reoperation and type of surgical procedure CABG valve replacement or repair surgery of the thoracic aorta or a combination of several procedures
Data will be collected using several questionnaires
Health-related Quality of Life the RAND-36 questionnaire
The Katz Index of Independence in Activities of Daily Living to assess functional status
The Cognitive Impairment Test
The Timed Up and Go Test
Outcome Prioritization Tool to assess the most important goals of treatment The RAND-36 and KATZ-ADL will be completed by all patients including those receiving standard care
Secondary and other outcomes that will be collected are baseline demographic data including age gender body mass index education level European System for Cardiac Operative Risk Evaluation II EuroSCORE II and co-morbidities such as stroke reduced cognitive function chronic obstructive pulmonary disease COPD GOLD III or IV renal failure a reduced renal function prior to surgery with a kreatinine level 150mmolL a reduced left ventricular function reduced mobility cardiac reoperation and type of surgical procedure CABG valve replacement or repair surgery of the thoracic aorta or a combination of several procedures
Data will be collected using several questionnaires
Health-related Quality of Life the RAND-36 questionnaire
The Katz Index of Independence in Activities of Daily Living to assess functional status
The Cognitive Impairment Test
The Timed Up and Go Test
Outcome Prioritization Tool to assess the most important goals of treatment The RAND-36 and KATZ-ADL will be completed by all patients including those receiving standard care
Study Oversight
Has Oversight DMC:
None
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?:
None