AI Insight
This is a study protocol for a multicenter randomized controlled trial that will evaluate whether a 2-week multimodal multicomponent prehabilitation program (MMPP) can reduce hospital length of stay and improve outcomes in older adults (65+ years) with chronic limb-threatening ischemia scheduled for revascularization. The trial will randomize 300 patients to either standard preoperative care or an MMPP that includes physiotherapy and targeted interventions such as geriatric assessment, nutritional support, smoking cessation, iron infusion, or pre-arranged home care based on individual screening results. Primary outcome is length of stay, with secondary outcomes including complications, mortality, quality of life for patients and caregivers, and cost-effectiveness.
Why it matters
This will be the first randomized controlled trial to assess comprehensive prehabilitation in older vascular surgery patients, a growing population facing high morbidity and mortality rates. Results could inform whether multimodal prehabilitation should become standard practice to improve surgical outcomes and reduce healthcare burden in this vulnerable patient group.
Understand the Science
by Seline Verbaan, Miriam C. Faes, Elke T. A. M. van Delft, Alexander L. Kooiman, Patrick W. H. E. Vriens, Hidde Jongsma, Ewout W. Steyerberg, Wilbert B. van den Hout, Lijckle van der Laan, on behalf of the POCI-study group
Chronic limb threatening ischemia (CLTI) in older adults is associated with severe morbidity and high mortality. The rising prevalence is largely driven by the aging population and confronts healthcare systems with challenges like increasing demand for chronic care, staff shortage and rising healthcare costs. To improve post-operative outcomes and reduce the burden on healthcare systems, multimodal prehabilitation has gained interest and has the potential to improve post operative outcomes. However, evidence of the effect in older adults with CLTI remains scarce. The aim of this study is to determine whether a multimodal multicomponent prehabilitation program (MMPP) reduces length of stay and improves clinical, patient-reported and economic outcomes of older adults with CLTI. We developed a multicenter randomized controlled trial, with embedded cost-effectiveness analyses.. CLTI-patients aged 65 years or older, planned for revascularization, and their primary informal caregiver (IC) will be eligible. A total of 300 patients will be randomized to receive either standard preoperative care or a 2-week MMPP. All patients receive a general health screening. The MMPP includes physiotherapy and, if indicated, referral to a geriatrician, dietician or smoking-cessation coach, ferric carboxymaltose infusion or pre-arranged homecare. The primary outcome is length of stay. Exploratory secondary outcomes include minor complications, quality of life of patient and IC and health related quality of life. Descriptive secondary outcomes include 30-day and 6-month mortality, major complications, readmissions, burden on the IC, cost-effectiveness; and experiences and preferences regarding shared decision making. To the best of our knowledge, this is the first randomized controlled trial to evaluate the effect of an MMPP within older CLTI-patients. Findings will inform healthcare professionals whether an MMPP should be implemented in routine vascular surgical practice to reduce length of stay and improve clinical and patient-centered outcomes. The study is registered at the International Clinical Trials Registry Platform (NL-OMON58069).