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.

Официальное название

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

Обзор

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.

Подробное описание

The primary outcome of this study is the difference between treatment recommendations; the first treatment recommendation (the decision before the patient visits the outpatient clinic) will be compared with the treatment recommendation after the assessment at the outpatient clinic.

Secondary and other outcomes that will be collected are baseline demographic data including age, gender, body mass index, education level, European System for Cardiac Operative Risk Evaluation II (EuroSCORE II) and co-morbidities such as stroke, reduced cognitive function, chronic obstructive pulmonary disease (COPD) GOLD III or IV, renal failure (a reduced renal function prior to surgery with a kreatinine level ≥150mmol/L), a reduced left ventricular function, reduced mobility, cardiac reoperation and type of surgical procedure (CABG, valve replacement or repair, surgery of the thoracic aorta or a combination of several procedures).

Data will be collected using several questionnaires:

* Health-related Quality of Life (the RAND-36 questionnaire) * The Katz Index of Independence in Activities of Daily Living to assess functional status * The Cognitive Impairment Test * The Timed Up and Go Test * Outcome Prioritization Tool to assess the most important goals of treatment The RAND-36 and KATZ-ADL will be completed by all patients, including those receiving standard care.

Вмешательства

• Диагностический тест 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.
• Другое 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

Первичные конечные точки

• The difference between the treatment recommendation provided by the multidisciplinary Heart Team prior to the patients visit to the PRIME-clinic and the treatment advice from the Heart Team after the patients visit to the PRIME-clinic. [Срок оценки: From enrollment to the second treatment advice of the heart team, typically within 8 weeks. .]

Вторичные конечные точки (2)

• Health related quality of life, SF-36 [Срок оценки: From enrollment to one year after]
• The cost-effectiveness ratio, an analysis that combines both the EQ-5D-5L (for health gains) and the Medical Cost Questionnaire (for costs) [Срок оценки: From enrollment to one year after]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• Unable to read or understand Dutch

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Нидерланды · 1 центр

• University Medical Center Groningen — Groningen

Публикации

• Dieen MSHV, Blokzijl F, Kuijpers M, Paans W, Bayon MA, Festen S, Dieperink W, Bouma W, Rienstra M, Mariani MA. Preoperative Risk Assessment and Shared Decision-Making in Older Patients Eligible for Cardiac Surgery: Protocol for a Non-Randomized Prospective Study. Healthcare (Basel). 2026 Jun 30;14(13):1900. doi: 10.3390/healthcare14131900. PMID 42450909

Идентификаторы

NCT: NCT06616129 · RR number: 202100724

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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