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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.

Study acronym: PRIME
StatusUnknown
PhaseNot applicable
Started
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Record status
This record was last updated September 27, 2024 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Recruiting
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06616129
Lead Sponsor University Medical Center Groningen
Collaborators: Hanze University of Applied Sciences Groningen
Conditions Frail Elderly Persons, Cardiac Surgery
Enrollment 70 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov