MedTrace Logo

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.

NCT06616129 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2024-09-27

No results posted yet for this study

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.

Conditions

  • Frail Elderly Persons
  • Cardiac Surgery

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.

Sponsors & Collaborators

  • Hanze University of Applied Sciences Groningen

    collaborator OTHER

  • University Medical Center Groningen

    lead OTHER

Principal Investigators

  • Prof. dr. Mariani · University Medical Center Groningen

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-04
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Netherlands

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06616129 on ClinicalTrials.gov