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RECRUITING
NCT06616129
NA

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: University Medical Center Groningen

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

70 Years - Any

Study Type

INTERVENTIONAL

Enrollment

70

Start Date

2022-04-04

Completion Date

2025-12-31

Last Updated

2024-09-27

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Geriatric assessment

At the clinic further information on the somatic, social, psychological and functional domain will be gathered by the nurse and two validated tests to map the vulnerability and resilience of the patient will be used; the Cognitive Impairment Test and the timed Up and Go Test.

OTHER

Shared decision-making conversation

The nurse and nurse practitioner together will talk with the patient and their partner about possible treatment options as well as patients' expectations, preferences and their life in general. During the conversation the OPT (Outcome Prioritization Tool) will be used to clarify the most important goals of treatment for the patient. The OPT exists of four universal treatment goals rated on a visual analogue scale from 0 to 100. The goals represented are: life extension, maintaining independence, reducing pain and reducing other symptoms. The goals will be explained and the patient will be asked to rate each outcome according to the trade-off principle meaning that two outcomes cannot be rated equally.

Locations (1)

University Medical Center Groningen

Groningen, Provincie Groningen, Netherlands