Preoperative Risk Assessment and Shared Decision-Making in Patients Eligible for Cardiac Surgery (PRIME-study): a Single Center Non-randomized Prospective Trial

What this Trial Is About

Researchers are evaluating the impact of the PRIME clinic's intervention on treatment decisions, quality of life, and healthcare use in elderly patients eligible for cardiac surgery. The study focuses on whether consultation at the PRIME clinic influences treatment recommendations, personalized treatment plans, and healthcare costs measured by quality-adjusted life years. Participants will visit the PRIME clinic once, where a geriatric assessment gathers detailed information on physical, social, psychological, and functional health using validated tests like the Cognitive Impairment Test and the Timed Up and Go Test. They will also engage in a shared decision-making conversation to discuss treatment options and personal goals using the Outcome Prioritization Tool. The study compares treatment recommendations before and after the clinic visit and includes a control group receiving standard care. During the study, participants complete quality of life questionnaires twice and track their healthcare usage over a year with four questionnaires. Researchers collect baseline data on demographics, co-morbidities, and surgical details. The primary outcome is the change in treatment recommendations within about eight weeks. Secondary outcomes include health-related quality of life and cost-effectiveness measured over one year, with assessments like the RAND-36 and Katz Index of Independence in Activities of Daily Living used for evaluation.

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.