Study on How Geriatric Risk Assessment and Shared Decision-Making Affect Treatment and Quality of Life in Older Adults Eligible for Cardiac Surgery
Led by University Medical Center Groningen · Updated on 2024-09-27
70
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the impact of the PRIME clinics 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.
CONDITIONS
Brief Title
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.
Research Team
D
dr. Fredrike Zwiers-Blokzijl
M
Milou S.H. van Dieen
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Have 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; or complex surgical procedure
You will not qualify if you...
Unable to read or understand Dutch
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Geriatric Assessment and Shared Decision-Making Conversation
Duration - Within 8 weeks after enrollment
Participants undergo a geriatric assessment and participate in a shared decision-making conversation about treatment options and personal goals.
1 visit (in-person)
Follow-up for Quality of Life and Cost-Effectiveness
Duration - Up to 1 year after enrollment
Participants' health-related quality of life and cost-effectiveness are monitored for up to one year after enrollment.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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Published Research Related To This Trial
Preoperative Risk Assessment and Shared Decision-Making in Older Patients Eligible for Cardiac Surgery: Protocol for a Non-Randomized Prospective Study.
Milou S H van Dieën, Fredrike Blokzijl, Michiel Kuijpers...