Improvement of perioperative care of the elderly patient (PeriAge): protocol of a controlled interventional feasibility study
Autor: | Rainer Kiefmann, Levente Kriston, Lili Plümer, Cynthia Olotu, Alwin E. Goetz, Lisa Lebherz, Anna Mende, Christian Zöllner, Martin Härter |
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Rok vydání: | 2019 |
Předmět: |
instrumental activities of daily life
medicine.medical_specialty perioperative care post-operative complications Prehabilitation elderly law.invention Helsinki declaration Anaesthesia 03 medical and health sciences Postoperative Complications 0302 clinical medicine Quality of life (healthcare) complex interventions Randomized controlled trial law Health care Protocol Clinical endpoint medicine Humans Prospective Studies 030212 general & internal medicine Aged Protocol (science) business.industry General Medicine Perioperative process evaluation geriatric anaesthesia quality of life patient-reported outcomes Physical therapy Feasibility Studies Controlled Clinical Trials as Topic business anaesthesiology 030217 neurology & neurosurgery feasibility |
Zdroj: | BMJ Open |
ISSN: | 2044-6055 |
Popis: | IntroductionGeriatric patients have a pronounced risk to suffer from postoperative complications. While effective risk-specific perioperative measures have been studied in controlled experimental settings, they are rarely found in routine healthcare. This study aims (1) to implement a multicomponent preoperative and intraoperative intervention, and investigate its feasibility, and (2) exploratorily assess the effectiveness of the intervention in routine healthcare.Methods and analysisFeasibility and exploratory effectiveness of the intervention will be investigated in a monocentric, prospective, non-randomised, controlled trial. The intervention includes systematic information for patients and family about measures to prevent postoperative complications; preoperative screening for frailty, malnutrition, strength and mobility with nutrient supplementation and physical exercise (prehabilitation) as needed. Further components focus on potentially inadequate medication, patient blood-management and carbohydrate loading prior to surgery, retainment of orientation aids in the operating room and a geriatric anaesthesia concept. Data will successively be collected from control, implementation and intervention groups. Patients aged 65+ with impending surgery will be included. A sample size of 240, n=80 per group, is planned. Assessments will take place at inclusion and 2, 30 and 180 days after surgery. Mixed-methods analyses will be performed. Exploratory effectiveness will be assessed using mixed segmented regressions. The primary endpoint is functional status. Secondary endpoints include cognitive performance, health-related quality of life, length of inpatient stay and occurrence of postoperative complications. Feasibility will be assessed through semi-structured interviews with staff and patients and quantitative analyses of the data quality, focussing on practicability, acceptance, adoption and fidelity to protocol.Ethics and disseminationThe study will be carried out in accordance with the Helsinki Declaration and to principles of good scientific practice. The Ethics Committee of the Medical Association Hamburg, Germany, approved the protocol (study ID: PV5596). Results will be disseminated in scientific journals and healthcare conferences.Trial registration numberClinicalTrials.gov Identifier: NCT03325413. |
Databáze: | OpenAIRE |
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