Patient safety, cost-effectiveness, and quality of life: reduction of delirium risk and postoperative cognitive dysfunction after elective procedures in older adults—study protocol for a stepped-wedge cluster randomized trial (PAWEL Study)

Abstract

BackgroundPostoperative delirium is a common disorder in older adults that is associated with higher morbidity and mortality, prolonged cognitive impairment, development of dementia, higher institutionalization rates, and rising healthcare costs. The probability of delirium after surgery increases with patients’ age, with pre-existing cognitive impairment, and with comorbidities, and its diagnosis and treatment is dependent on the knowledge of diagnostic criteria, risk factors, and treatment options of the medical staff. In this study, we will investigate whether a cross-sectoral and multimodal intervention for preventing delirium can reduce the prevalence of delirium and postoperative cognitive decline (POCD) in patients older than 70 years undergoing elective surgery. Additionally, we will analyze whether the intervention is cost-effective.MethodsThe study will be conducted at five medical centers (with two or three surgical departments each) in the southwest of Germany. The study employs a stepped-wedge design with cluster randomization of the medical centers. Measurements are performed at six consecutive points: preadmission, preoperative, and postoperative with daily delirium screening up to day 7 and POCD evaluations at 2, 6, and 12 months after surgery. Recruitment goals are to enroll 1500 patients older than 70 years undergoing elective operative procedures (cardiac, thoracic, vascular, proximal big joints and spine, genitourinary, gastrointestinal, and general elective surgery procedures).DiscussionResults of the trial should form the basis of future standards for preventing delirium and POCD in surgical wards. Key aims are the improvement of patient safety and quality of life, as well as the reduction of the long-term risk of conversion to dementia. Furthermore, from an economic perspective, we expect benefits and decreased costs for hospitals, patients, and healthcare insurances.Trial registrationGerman Clinical Trials Register, DRKS00013311. Registered on 10 November 2017.Electronic supplementary materialThe online version of this article (10.1186/s13063-018-3148-8) contains supplementary material, which is available to authorized users.

<p>Diverging Awareness of Postoperative Delirium and Cognitive Dysfunction in German Health Care Providers</p>

“…This qualitative study is part of a German multicenter trial in tertiary care hospitals, which aims to decrease the prevalence of POCD after elective surgery for patients over 75. 26 Next to evaluating a multifaceted inpatient intervention and defining effective screening instruments, the goal of the part presented here is to describe how care providers of the entire process care for patients at risk of POD/POCD.…”

“…2 Accordingly, one of the aims of the PAWEL-consortium was to establish an appropriate delirium risk screening tool. 26 Missing Implementation of (Comprehensive) Concepts…”

“…8,24 In order to implement preventive or therapeutic procedures, patients at risk of delirium and cognitive dysfunction should be identified through screening on a regular basis, before but especially also after surgery to detect early signs of cognitive dysfunction. 25 There are evaluated risk screening tools 26 as well as delirium monitoring instruments 27 available; however, up to now, they do not appear well integrated into clinical care processes. 26,[28][29][30] To understand hurdles for the broader implementation of improved care processes for these patients, we aim to clarify perceptions and concepts around POD/POCD management in Germany.…”

“…25 There are evaluated risk screening tools 26 as well as delirium monitoring instruments 27 available; however, up to now, they do not appear well integrated into clinical care processes. 26,[28][29][30] To understand hurdles for the broader implementation of improved care processes for these patients, we aim to clarify perceptions and concepts around POD/POCD management in Germany.…”

Is the bispectral index monitoring protective against postoperative cognitive decline? A systematic review with meta-analysis

“…By definition, POD is an acute deterioration in cognitive function, a disturbance of consciousness. It develops in the early days postoperatively [2,6,7,10,11]. POCD is one of the adverse effects of anaesthesia which develops in the later postoperative period and manifests as a decline in a patient's cognitive abilities [2,6,7,10].…”