Clinical trial NCT06616129: 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.
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Frail Elderly Persons
Cardiac Surgery
Keywords: cardiothoracic surgery
decision-making
quality of life
frailty
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
Collaborators: name: Hanze University of Applied Sciences Groningen
First posted: 2024-09-27
Enrollment: 70
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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 ≥150mmol/L), 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.

Eligibility criteria: Inclusion Criteria:

* Age 70 years and older
* Eligible for cardiac surgery
* Having two or more risk factors: stroke; reduced cognitive function; Chronic Obstructive Pulmonary Disease (COPD); obesity; reduced left ventricular ejection fraction; renal failure; reduced mobility; cardiac reoperation; and the complexity of the procedure.

Exclusion Criteria:

* Unable to read or understand Dutch

Primary outcomes:
measure: The difference between the treatment recommendation provided by the multidisciplinary Heart Team prior to the patients visit to the PRIME-clinic and the treatment advice from the Heart Team after the patients visit to the PRIME-clinic.
timeFrame: From enrollment to the second treatment advice of the heart team, typically within 8 weeks. .
Secondary outcomes:
measure: Health related quality of life, SF-36
timeFrame: From enrollment to one year after
measure: The cost-effectiveness ratio, an analysis that combines both the EQ-5D-5L (for health gains) and the Medical Cost Questionnaire (for costs)
timeFrame: From enrollment to one year after
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: University Medical Center Groningen
name: Prof. dr. Mariani
role: PRINCIPAL_INVESTIGATOR
References: