Reduction of care-relevant risks to older patients during and after acute hospital care (ReduRisk) - study protocol of a cluster randomized efficacy trial in a stepped wedge design.

BACKGROUND: Older patients are at an increased risk of hospitalization, negatively affecting their health and quality of life. Such patients also experience a lack of physical activity during their inpatient stay, as well as being at increased risk of delirium and inappropriate prescribing. These risk factors can accumulate, promoting a degree of morbidity and the development of cognitive impairment. METHODS: Through the ReduRisk-program, patients at risk of functional impairment, immobility, falls, delirium or re-hospitalization shortly after hospital discharge, will be identified via risk-screening. These patients will receive an individually tailored, multicomponent and risk-adjusted prevention program. The trial will compare the effectiveness of the ReduRisk-program against usual care in a stepped-wedge-design, with quarterly cluster randomization of six university hospital departments into intervention and control groups. 612 older adults aged 70 years or more are being recruited. Patients in the intervention cluster (n = 357) will receive the ReduRisk-program, comprising risk-adjusted delirium management, structured mobility training and digitally supported planning of post-inpatient care, including polypharmacy management. This study will evaluate the impact of the ReduRisk-program on the primary outcomes of activities of daily living and mobility, and the secondary outcomes of delirium, cognition, falls, grip strength, health-related quality of life, potentially inappropriate prescribing, health care costs and re-hospitalizations. Assessments will be conducted at inpatient admission (t0), at discharge (t1) and at six months post-discharge (t2). In the six-month period following discharge, a health-economic evaluation will be carried out based on routine health insurance data (t3). DISCUSSION: Despite the importance of multicomponent, risk-specific approaches to managing older patients, guidelines on their effectiveness are lacking. This trial will seek to provide evidence for the effectiveness of a multicomponent, risk-adjusted prevention program for older patients at risk of functional impairment, immobility, falls, delirium and re-hospitalization. Positive study results would support efforts to improve multicomponent prevention and the management of older patients. TRIAL REGISTRATION: German Clinical Trials Register, DRKS00025594, date of registration: 09/08/2021.

Anticholinergic Drug Exposure Increases the Risk of Delirium in Older Patients Undergoing Elective Surgery.

Introduction: Postoperative delirium (POD) is a common and serious adverse event of surgery in older people. Because of its great impact on patients' safety and quality of life, identification of modifiable risk factors could be useful. Although preoperative medication intake is assumed to be an important modifiable risk factor, the impact of anticholinergic drugs on the occurrence of POD seems underestimated in elective surgery. The aim of this study was to investigate the association between preoperative anticholinergic burden and POD. We hypothesized that a high preoperative anticholinergic burden is an independent, potentially modifiable predisposing and precipitating factor of POD in older people. Methods: Between November 2017 and April 2019, 1,470 patients of 70 years and older undergoing elective orthopedic, general, cardiac, or vascular surgery were recruited in the randomized, prospective, multicenter PAWEL trial. Anticholinergic burden of a sub-cohort of 899 patients, who did not receive a multimodal intervention for preventing POD, was assessed by two different tools at hospital admission: The established Anticholinergic Risk Scale (ARS) and the recently developed Anticholinergic Burden Score (ABS). POD was detected by confusion assessment method (CAM) and a validated post discharge medical record review. Logistic regression analyses were performed to evaluate the association between anticholinergic burden and POD. Results: POD was observed in 210 of 899 patients (23.4%). Both ARS and ABS were independently associated with POD. The association persisted after adjustment for relevant confounding factors such as age, sex, comorbidities, preoperative cognitive and physical status, number of prescribed drugs, surgery time, type of surgery and anesthesia, usage of heart-lung-machine, and treatment in intensive care unit. If a patient was taking one of the 56 drugs listed in the ABS, risk for POD was 2.7-fold higher (OR = 2.74, 95% CI = 1.55-4.94) and 1.5-fold higher per additional point on the ARS (OR = 1.54, 95% CI = 1.15-2.02). Conclusion: Preoperative anticholinergic drug exposure measured by ARS or ABS was independently associated with POD in older patients undergoing elective surgery. Therefore, identification, discontinuation or substitution of anticholinergic medication prior to surgery may be a promising approach to reduce the risk of POD in older patients.

Presurgical Screening Improves Risk Prediction for Delirium in Elective Surgery of Older Patients: The PAWEL RISK Study.

Introduction: The number of elective surgeries for patients who are over 70 years of age is continuously growing. At the same time, postoperative delirium (POD) is common in older patients (5-60%) depending on predisposing risk factors, such as multimorbidity, cognitive impairment, neurodegenerative disorders and other dementing disorders, and precipitating factors, such as duration of surgery. Knowledge of individual risk profiles prior to elective surgery may help to identify patients at increased risk for development of POD. In this study, clinical and cognitive risk factors for POD were investigated in patients undergoing various elective cardiac and non-cardiac surgeries. Methods: The PAWEL study is a prospective, interventional trial on delirium prevention. At baseline, 880 inpatients at five surgical centers were recruited for sub-sample PAWEL-R. Multimodal assessments included clinical renal function, medication, American Society of Anesthesiologists (ASA) Physical Status Classification System, geriatric and cognitive assessments, which comprised the Montreal Cognitive Assessment Scale (MoCA), Trail-making Test, and Digit Span backward. Delirium incidence was monitored postoperatively by the Confusion Assessment Method (CAM) and a chart review for up to a week or until discharge. Multivariate regression models and Chi-square Automatic Interaction Detectors (CHAID) analyses were performed using delirium incidence as the primary outcome. Results: Eighteen risk factors were investigated in elective cardiovascular and orthopedic or general surgery. A total of 208 out of 880 patients (24%) developed POD. A global regression model that included all risk variables predicted delirium incidence with high accuracy (AUC = 0.81; 95% CI 0.77, 0.85). A simpler model (clinical and cognitive variables; model CLIN-COG) of 10 factors that only included surgery type, multimorbidity, renal failure, polypharmacy, ASA, cut-to-suture time, and cognition (MoCA, Digit Span backward, and preexisting dementia), however, exhibited similar predictive accuracy (AUC = 0.80; 95% CI 0.76, 0.84). Conclusion: The risk of developing POD can be estimated by preoperative assessments, such as ASA classification, expected cut-to-suture time, and short cognitive screenings. This rather efficient approach predicted POD risk over all types of surgery. Thus, a basic risk assessment including a cognitive screen can help to stratify patients at low, medium, or high POD risk to provide targeted prevention and/or management strategies for patients at risk.

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).

BACKGROUND: Postoperative 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. METHODS: The 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). DISCUSSION: Results 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 REGISTRATION: German Clinical Trials Register, DRKS00013311 . Registered on 10 November 2017.

Patient-related complexity of care: a challenge or overwhelming burden for nurses - a qualitative study.

BACKGROUND: Patient-related complexity of nursing care in acute care hospitals has increased in recent years, in part due to shorter hospital stays and the increase in multimorbid patients. However, little research has been conducted on how nurses experience complex nursing care situations. AIMS: The aim of this study was to gain a better understanding of how nurses experience complex nursing care situations in Swiss acute care hospitals. METHODS: This qualitative study utilised focus group interviews and thematic analysis. Focus groups facilitate different perspectives of the topic. Thematic analysis is suitable for the analysis of everyday stories. Participants were 24 Registered Nurses with experience in their field, from four Swiss hospitals. The evaluation was performed in six steps according to themes. Participation was voluntary. This study was part of a multicentre research project that had been approved by the responsible ethics committees. RESULTS: Three main themes regarding the experience of complex nursing care situations were found: complexity as a challenge, complexity as an overwhelming burden and mediating factors. Mediating factors included time resources and teamwork and interprofessional collaboration as contextual conditions. Additionally, nurses' individual characteristics such as their professional experience and expertise, as well as their personal and professional values and beliefs were considered as mediating factors. These mediating factors may determine whether complex nursing care situations are experienced as challenging or overwhelming. LIMITATIONS: The findings from this study are limited as only experienced nurses participated in the study. CONCLUSIONS: Nurses are ambivalent with regard to how they experience complex nursing care situations. The contextual conditions and the nurses' personal characteristics play a key role in whether nurses perceive complex nursing care situations as positive challenges or overwhelming burdens. These findings are important for managers, as they can support nurses to master complex nursing care situations.