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. (PRIME)

University Medical Center Groningen (UMCG)

Status

Enrolling

Conditions

Cardiac Surgery

Frail Elderly Persons

Treatments

Diagnostic Test: Geriatric assessment

Other: Shared decision-making conversation

Study type

Interventional

Funder types

Other

Identifiers

NCT06616129

RR number: 202100724

Details and patient eligibility

About

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.

Full 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.

Enrollment

70 estimated patients

Sex

All

Ages

70+ years old

Volunteers

No Healthy Volunteers

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