Investigating how geriatric assessments and shared decision-making affect treatment for elderly heart surgery patients
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
NA · University Medical Center Groningen · NCT06616129
This study is testing if talking about health risks and making decisions together can improve treatment choices and quality of life for older patients needing heart surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 70 Years and up |
| Sex | All |
| Sponsor | University Medical Center Groningen (other) |
| Locations | 1 site (Groningen, Provincie Groningen) |
| Trial ID | NCT06616129 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the impact of geriatric risk assessments and shared decision-making conversations on treatment decisions and quality of life for elderly patients eligible for open-heart surgery. Participants will visit the PRIME clinic for an assessment, after which their treatment recommendations will be compared to those made prior to the visit. The study will also track healthcare utilization and quality of life over the course of a year using various questionnaires. Key outcomes include changes in treatment recommendations, health-related quality of life, and healthcare costs.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 70 and older who are eligible for cardiac surgery and have multiple risk factors.
Not a fit: Patients who are unable to read or understand Dutch will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment decisions and enhanced quality of life for elderly patients undergoing cardiac surgery.
How similar studies have performed: Other studies have shown that personalized treatment plans and shared decision-making can positively influence patient outcomes, suggesting a promising approach in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
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: * Unable to read or understand Dutch
Where this trial is running
Groningen, Provincie Groningen
- University Medical Center Groningen — Groningen, Provincie Groningen, Netherlands (RECRUITING)
Study contacts
- Principal investigator: Prof. dr. Mariani — University Medical Center Groningen
- Study coordinator: dr. Fredrike Zwiers-Blokzijl
- Email: f.zwiers-blokzijl@umcg.nl
- Phone: +31 50 361 56 17
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Frail Elderly Persons, Cardiac Surgery, cardiothoracic surgery, decision-making, quality of life, frailty