Development of a complex intervention to prevent delirium in older hospitalized patients by optimizing discharge and transfer processes and involving caregivers: A multi-method study.

BACKGROUND: Delirium is a common yet challenging condition in older hospitalized patients, associated with various adverse outcomes. Environmental factors, such as room changes, may contribute to the development or severity of delirium. Most previous research has focused on preventing and reducing this condition by addressing risk factors and facilitating reorientation during hospital stay. OBJECTIVE: We aimed to systematically develop a complex intervention to prevent delirium in older hospitalized patients by optimizing discharge and transfer processes and involving caregivers during and after these procedures. The intervention combines stakeholder and expert opinions, evidence, and theory. This article provides guidance and inspiration to research groups in developing complex interventions according to the recommendations in the Medical Research Council framework for complex interventions. DESIGN AND METHODS: A stepwise multi-method study was conducted. The preparation phase included analysis of the context and current practice via focus groups. Based on these results, an expert workshop was organized, followed by a Delphi survey. Finally, the intervention was modeled and a program theory was developed, including a logic model. RESULTS: A complex intervention was developed in an iterative process, involving healthcare professionals, delirium experts, researchers, as well as caregiver and patient representatives. The key intervention component is an 8-point-program, which provides caregivers with recommendations for preventing delirium during the transition phase and in the post-discharge period. Information materials (flyers, handbook, videos, posters, defined "Dos and Don'ts", discharge checklist), training for healthcare professionals, and status analyses are used as implementation strategies. In addition, roles were established for gatekeepers to act as leaders, and champions to serve as knowledge multipliers and trainers for the multi-professional team in the hospitals. CONCLUSIONS: This study serves as an example of how to develop a complex intervention. In an additional step, the intervention and implementation strategies will be investigated for feasibility and acceptability in a pilot study with an accompanying process evaluation. TWEETABLE ABSTRACT: Delirium prevention can benefit from optimizing discharge and transfer processes and involving caregivers of older patients in these procedures. STUDY REGISTRATION: DRKS00017828, German Register of Clinical Studies, date of registration 17.09.2019.

Frailty index and its association with the onset of postoperative delirium in older adults undergoing elective surgery.

BACKGROUND: The association of frailty based on the accumulation of deficits with postoperative delirium (POD) has been poorly examined. We aimed to analyze this association in older patients undergoing elective surgery. METHODS: Preoperative data was used to build a 30-item frailty index (FI) for participants of the PAWEL-study. Delirium was defined by a combination of I-CAM and chart review. Using logistic regressions models we analysed the association between frailty and POD adjusting for age, sex, smoking, alcohol consumption, education and type of surgery. RESULTS: Among 701 participants (mean age 77.1, 52.4% male) median FI was 0.27 (Q1 0.20| Q3 0.34), with 528 (75.3%) frail participants (FI ≥ 0.2). Higher median FI were seen in orthopedic than cardiac surgery patients (0.28 versus 0.23), and in women (0.28 versus 0.25 in men). Frail participants showed a higher POD incidence proportion (25.4% versus 17.9% in non-frail). An increased odds for POD was observed in frail versus non-frail participants (OR 2.14 [95% CI 1.33, 3.44], c-statistic 0.71). A 0.1 increment of FI was associated with OR 1.57 [95% CI 1.30, 1.90] (c-statistic 0.72) for POD. No interaction with sex or type of surgery was detected. Adding timed-up-and-go-test and handgrip strength to the FI did not improve discrimination. CONCLUSION: Our data showed a significant association between frailty defined through a 30-item FI and POD among older adults undergoing elective surgery. Adding functional measures to the FI did not improve discrimination. Hence, our preoperative 30-item FI can help to identify patients with increased odds for POD. TRIAL REGISTRATION: PAWEL and PAWEL-R (sub-) study were registered on the German Clinical Trials Register (number DRKS00013311 and DRKS00012797).

The Effectiveness of Assistive Technologies for Older Adults and the Influence of Frailty: Systematic Literature Review of Randomized Controlled Trials.

BACKGROUND: The use of assistive technologies (ATs) to support older people has been fueled by the demographic change and technological progress in many countries. These devices are designed to assist seniors, enable independent living at home or in residential facilities, and improve quality of life by addressing age-related difficulties. OBJECTIVE: We aimed to evaluate the effectiveness of ATs on relevant outcomes with a focus on frail older adults. METHODS: A systematic literature review of randomized controlled trials evaluating ATs was performed according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. The Ovid Medline, PsycINFO, SocIndex, CINAHL (Cumulative Index to Nursing and Allied Health Literature), CENTRAL (Cochrane Central Register of Controlled Trials), and IEEEXplore databases were searched from January 1, 2009, to March 15, 2019. ATs were included when aiming to support the domains autonomy, communication, or safety of older people with a mean age ≥65 years. Trials performed within a laboratory setting were excluded. Studies were retrospectively categorized according to the physical frailty status of participants. RESULTS: A total of 19 trials with a high level of heterogeneity were included in the analysis. Six device categories were identified: mobility, personal disease management, medication, mental support, hearing, and vision. Eight trials showed significant effectiveness in all or some of the primary outcome measures. Personal disease management devices seem to be the most effective, with four out of five studies showing significant improvement of disease-related outcomes. Frailty could only be assessed for seven trials. Studies including participants with significant or severe impairment showed no effectiveness. CONCLUSIONS: Different ATs show some promising results in well-functioning but not in frail older adults, suggesting that the evaluated ATs might not (yet) be suitable for this subgroup. The uncertainty of the effectiveness of ATs and the lack of high-quality research for many promising supportive devices were confirmed in this systematic review. Large studies, also including frail older adults, and clear standards are needed in the future to guide professionals, older users, and their relatives. TRIAL REGISTRATION: PROSPERO CRD42019130249; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=130249.

Comparison of delirium detection tools in acute care : A rapid review.

BACKGROUND: Delirium is a frequent psychopathological syndrome in geriatric patients. It is sometimes the only symptom of acute illness and bears a high risk for complications. Therefore, feasible assessments are needed for delirium detection. OBJECTIVE AND METHODS: Rapid review of available delirium assessments based on a current Medline search and cross-reference check with a special focus on those implemented in acute care hospital settings. RESULTS: A total of 75 delirium detection tools were identified. Many focused on inattention as well as acute onset and/or fluctuating course of cognitive changes as key features for delirium. A range of assessments are based on the confusion assessment method (CAM) that has been adapted for various clinical settings. The need for a collateral history, time resources and staff training are major challenges in delirium assessment. Latest tests address these through a two-step approach, such as the ultrabrief (UB) CAM or by optional assessment of temporal aspects of cognitive changes (4 As test, 4AT). Most delirium screening assessments are validated for patient interviews, some are suitable for monitoring delirium symptoms over time or diagnosing delirium based on collateral history only. CONCLUSION: Besides the CAM the 4AT has become well-established in acute care because of its good psychometric properties and practicability. There are several other instruments extending and improving the possibilities of delirium detection in different clinical settings.

Outcomes of a Delirium Prevention Program in Older Persons After Elective Surgery: A Stepped-Wedge Cluster Randomized Clinical Trial.

Importance: Delirium significantly worsens elective surgery outcomes and costs. Delirium risk is highest in elderly populations, whose surgical health care resource consumption (50%) exceeds their demographic proportion (15% to 18%) in high-resource countries. Effective nonpharmacologic delirium prevention could safely improve care in these vulnerable patients, but data from procedure-specific studies are insufficiently compelling to drive changes in practice. Delirium prevention approaches applicable to different surgical settings remain unexplored. Objective: To examine whether a multifaceted prevention intervention is effective in reducing postoperative delirium incidence and prevalence after various major surgical procedures. Design, Setting, and Participants: This stepped-wedge cluster randomized trial recruited 1470 patients 70 years and older undergoing elective orthopedic, general, or cardiac surgery from November 2017 to April 2019 from 5 German tertiary medical centers. Data were analyzed from December 2019 to July 2021. Interventions: First, structured delirium education was provided to clinical caregivers at each site. Then, the study delirium prevention team assessed patient delirium risk factors and symptoms daily. Prevention was tailored to individual patient needs and could include: cognitive, motor, and sensory stimulation; meal companionship; accompaniment during diagnostic procedures; stress relaxation; and sleep promotion. Main Outcomes and Measures: Postoperative delirium incidence and duration. Results: Of 1470 included patients, 763 (51.9%) were male, and the median (IQR) age was 77 (74-81) years. Overall, the intervention reduced postoperative delirium incidence (odds ratio, 0.87; 95% CI, 0.77-0.98; P = .02) and percentage of days with delirium (intervention, 5.3%; control, 6.9%; P = .03). The effect was significant in patients undergoing orthopedic or abdominal surgery (odds ratio, 0.59; 95% CI, 0.35-0.99; P = .047) but not cardiac surgery (odds ratio, 1.18; 95% CI, 0.70-1.99; P = .54). Conclusions and Relevance: This multifaceted multidisciplinary prevention intervention reduced postoperative delirium occurrence and days with delirium in older patients undergoing different elective surgical procedures but not cardiac procedures. These results suggest implementing this delirium prevention program will improve care and outcomes in older patients undergoing elective general and orthopedic procedures.

A complex intervention to promote prevention of delirium in older adults by targeting caregiver's participation during and after hospital discharge - study protocol of the TRAnsport and DElirium in older people (TRADE) project.

BACKGROUND: Among potentially modifiable risk factors for delirium, transfers between wards, hospitals and other facilities have been mentioned with low evidence. TRADE (TRAnsport and DElirium in older people) was set up to investigate i) the impact of transfer and/or discharge on the onset of delirium in older adults and ii) feasibility and acceptance of a developed complex intervention targeting caregiver's participation during and after hospital discharge or transfer on cognition and the onset of delirium in older adults. METHODS: The study is designed according to the guidelines of the UK Medical Research Council (MRC) for development and evaluation of complex interventions and comprises two steps: development and feasibility/piloting. The development phase includes i) a multicenter observational prospective cohort study to assess delirium incidence and cognitive decline associated with transfer and discharge, ii) a systematic review of the literature, iii) stakeholder focus group interviews and iv) an expert workshop followed by a Delphi survey. Based on this information, a complex intervention to better and systematically involve family caregivers in discharge and transport was developed. The intervention will be tested in a pilot study using a stepped wedge design with a detailed process and health economic evaluation. The study is conducted at four acute care hospitals in southwest Germany. Primary endpoints are the delirium incidence and cognitive function. Secondary endpoints include prevalence of caregiver companionship, functional decline, cost and cost effectiveness, quality of discharge management and quality of admission management in admitting hospitals or nursing homes. Data will be collected prior to discharge as well as after 3, 7 and 90 days. DISCUSSION: TRADE will help to evaluate transfer and discharge as a possible risk factor for delirium. In addition, TRADE evaluates the impact and modifiability of caregiver's participation during patient's transfer or discharge on delirium incidence and cognitive decline providing the foundation for a confirmatory implementation study. TRIAL REGISTRATION: DRKS (Deutsches Register für klinische Studien) DRKS00017828 . Registered on 17th September 2019. Retrospectively registered.

Evidence gap on antihyperglycemic pharmacotherapy in frail older adults : A systematic review.

BACKGROUND: Although antihyperglycemic pharmacotherapy in frail older adults with type 2 diabetes mellitus (T2DM) is challenging, recommendations from international guidelines are mainly based on indirect evidence from trials not including frail participants. OBJECTIVE: This systematic review investigated the effectiveness and safety of pharmacotherapy in frail older adults with T2DM. MATERIAL AND METHODS: Randomized (RCT) and non-randomized prospective clinical trials (non-RCT) were searched in three electronic databases (Medline, Embase, Central) up to October 2018. Trials in older adults with T2DM who were assessed as significantly or severely impaired by defined cut-off scores of assessment instruments on frailty, activities of daily living or physical functional impairment were included. RESULTS: Two reviewers independently screened 17,391 references for inclusion and assessed risk of bias with ROBINS­I. Five non-RCTs and no RCT were identified. Treatment of T2DM without insulin compared to insulin could be associated with increased improvement in cardiac functions in patients with cardiac resynchronization therapy and with decreased falls in frail older women. While better glycemic control with low variability and low HbA1c (hemoglobin A1c) values (<7%) was associated with better maintenance of physical function in community-dwelling older persons, higher HbA1c values (8-8.9%) were associated with a reduction in the composite outcome of death or functional decline in community-dwelling diabetic older adults with need for skilled assistance. Due to serious risk of bias in all studies, results should be considered with caution. CONCLUSION: Well-designed, large-scale RCTs including this important group of patients are required to assess the effectiveness and safety of pharmacotherapy and HbA1c targets.

The Pharmacological Treatment of Arterial Hypertension in Frail, Older Patients­a Systematic Review

BACKGROUND: It is debated whether the treatment goals and decision-making algorithms for elderly patients with hypertension should be the same as those for younger patients. The American and European guidelines leave decisions about antihypertensive treatment in frail, institutionalized patients up to the treating physician. We therefore systematically searched the literature for publications on the phamacotherapy of arterial hypertension in frail patients. METHODS: The MEDLINE, Embase, and Central databases were systematically searched for randomized, controlled trials (RCTs) and non-randomized studies, including observational studies, on the pharmacotherapy of arterial hypertension in elderly patients since the introduction of the concept of frailty, published over the period 1992-2017. RESULTS: Out of 19 282 citations for randomized, controlled trials and 5659 for non-randomized trials and observational studies, four RCTs and three observational studies were included in the further analysis. The included RCTs showed a trend to- wards a benefit from pharmacotherapy of hypertension in frail patients with respect to mortality, cardiovascular disease, functional status, and quality of life. On the other hand, some of the observational studies indicated a lower rate of falls and lower mortality among patients who received no antihypertensive treatment. CONCLUSION: In view of the conflicting findings of RCTs and non-randomized studies, the lower representation of frail subjects in RCTs, and the high risk of bias in non- randomized studies, the findings of the studies included in this review do not enable the formulation of any strictly evidence-based treatment recommendations. As a rule of thumb, the authors propose that a target systolic blood pressure of <150 mmHg should be aimed at in patients whose gait speed is less than 0.8 m/s, while a target range of 130-139 mmHg can be set for patients over age 80 who are no more than mildly frail.

A Proposal for the Retrospective Identification and Categorization of Older People With Functional Impairments in Scientific Studies-Recommendations of the Medication and Quality of Life in Frail Older Persons (MedQoL) Research Group.

When treating older adults, a main factor to consider is physical frailty. Because specific assessments in clinical trials are frequently lacking, critical appraisal of treatment evidence with respect to functional status is challenging. Our aim was to identify and categorize assessments for functional status given in clinical trials in older adults to allow for a retrospective characterization and indirect comparison of treatment evidence from these cohorts. We conducted 4 separate systematic reviews of randomized and nonrandomized controlled clinical trials in older people with hypertension, diabetes, depression, and dementia. All assessments identified that reflected functional status were analyzed. Assessments were categorized across 4 different functional status levels. These levels span from functionally not impaired, slightly impaired, significantly impaired, to severely impaired/disabled. If available from the literature, cut-offs for these 4 functioning levels were extracted. If not, or if the existing cut-offs did not match the predefined functional levels, cut-off points were defined by an expert group composed of geriatricians, pharmacists, pharmacologists, neurologists, psychiatrists, and epidemiologists using a patient-centered approach. We identified 51 instruments that included measures of functional status. Although some of the assessments had clearly defined cut-offs across our predefined categories, many others did not. In most cases, no cut-offs existed for slightly impaired or severely impaired older adults. Missing cut-offs or values to adjust were determined by the expert group and are presented as described. The functional status assessments that were identified and operationalized across 4 functional levels could now be used for a retrospective characterization of functional status in randomized controlled trials and observational studies. Allocated categories only serve as approximations and should be validated head-to-head in future studies. Moreover, as general standard, upcoming studies involving older adults should include and explicitly report functional impairment as a baseline characteristic of all participants enrolled.

Biomarkers associated with sedentary behaviour in older adults: A systematic review.

OBJECTIVE: Pathomechanisms of sedentary behaviour (SB) are unclear. We conducted a systematic review to investigate the associations between SB and various biomarkers in older adults. METHODS: Electronic databases were searched (MEDLINE, EMBASE, CINAHL, AMED) up to July 2015 to identify studies with objective or subjective measures of SB, sample size ≥50, mean age ≥60years and accelerometer wear time ≥3days. Methodological quality was appraised with the CASP tool. The protocol was pre-specified (PROSPERO CRD42015023731). RESULTS: 12701 abstracts were retrieved, 275 full text articles further explored, from which 249 were excluded. In the final sample (26 articles) a total of 63 biomarkers were detected. Most investigated markers were: body mass index (BMI, n=15), waist circumference (WC, n=15), blood pressure (n=11), triglycerides (n=12) and high density lipoprotein (HDL, n=15). Some inflammation markers were identified such as interleukin-6, C-reactive protein or tumor necrosis factor alpha. There was a lack of renal, muscle or bone biomarkers. Randomized controlled trials found a positive correlation for SB with BMI, neck circumference, fat mass, HbA1C, cholesterol and insulin levels, cohort studies additionally for WC, leptin, C-peptide, ApoA1 and Low density lipoprotein and a negative correlation for HDL. CONCLUSION: Most studied biomarkers associated with SB were of cardiovascular or metabolic origin. There is a suggestion of a negative impact of SB on biomarkers but still a paucity of high quality investigations exist. Longitudinal studies with objectively measured SB are needed to further elucidate the pathophysiological pathways and possible associations of unexplored biomarkers.

Depression and Reduced Bone Mineral Density at the Hip and Lumbar Spine: A Comparative Meta-Analysis of Studies in Adults 60 Years and Older.

PURPOSE: Older adults with depression are more likely to experience fractures, but it is unclear if this group has reduced bone mineral density (BMD). We conducted a systematic review and meta-analysis to compare BMD in older adults (60 years or older) with or without depression. METHODS: Two independent authors conducted searches of major electronic databases from inception till April 2015. Articles that measured BMD (in g/cm) by dual-energy x-ray absorptiometry at the hip or lumbar spine in a sample with depression (including those with major depressive disorder and depressive symptoms, henceforth called "depression") and a control group were included. A random-effects meta-analysis and meta-regression were conducted. RESULTS: Eleven publications across 10 unique studies representing 2511 participants with depression (mean [standard deviation] = 67.4 [6.5] years, 41.8% female) and 32,574 matched controls (mean [standard deviation] = 67.5 [5.9] years, 38.9% female) were included. Only one study confirmed a diagnosis of major depressive disorder, seven studies used a screening measure to define depressive symptoms, and two studies categorized depression by antidepressant medication use. Meta-analysis established that BMD is reduced at the hip in older adults with depression (g = -0.141, 95% confidence interval = -0.220 to -0.062, p < .0001, I = 61%). Meta-analysis from seven studies suggests that lumbar spine BMD may be reduced (g = -0.122, 95% confidence interval = -0.250 to 0.005, p = .06, I = 71%). CONCLUSIONS: Hip BMD is reduced in older adults with depression, although the effect size is small. Nevertheless, considering the deleterious impact of hip fractures in this population, the results are important. Future research should seek to disentangle the independent effects of depression and antidepressant medication on bone loss in older age.

What works to prevent falls in older adults dwelling in long term care facilities and hospitals? An umbrella review of meta-analyses of randomised controlled trials.

Preventing falls in long term care facilities (LTCF) and hospitals is an international priority. Many interventions have been investigated and summarised in meta-analyses (MA) and there is a need to synthesise the top of the hierarchy of evidence in one place. Therefore we conducted an umbrella review of MA of randomised controlled trials (RCTs) of falls prevention interventions LTCF and hospitals. Two independent reviewers searched major electronic databases from inception till October 2014 for MA containing ≥3 RCTs investigating any intervention to prevent falls in LTCF or hospitals in older adults aged ≥60 years. Methodological quality was assessed by the AMSTAR tool and data were narratively synthesised. The methodological quality of the MA was moderate to high across the 10 included MA. Nine MA provided data for LTCF and only two considered hospital settings. Only one MA defined a fall and two reported adverse events (although minor). Consistent evidence suggests that multifactorial interventions reduce falls (including the rate, risk and odds of falling) in LTCF and hospitals. Inconsistent evidence exists for exercise and vitamin D as single interventions in LTCF, whilst no MA has investigated this in hospitals. No evidence exists for hip protectors and medication review on falls in LTCF. In conclusion, multifactorial interventions appear to be the most effective interventions to prevent falls in LTCF and hospital settings. This is not without limitations and more high quality RCTs are needed in hospital settings in particular. Future RCTs and MA should clearly report adverse events.

What Works to Prevent Falls in Community-Dwelling Older Adults? Umbrella Review of Meta-analyses of Randomized Controlled Trials.

BACKGROUND: Preventing falls is an international priority. There is a need to synthesize the highest-quality falls prevention evidence in one place for clinicians. PURPOSE: The aim of this study was to conduct an umbrella review of meta-analyses of randomized controlled trials (RCTs) of falls prevention interventions in community-dwelling older adults. DATA SOURCES: The MEDLINE, EMBASE, CINAHL, AMED, BNI, PsycINFO, Cochrane Library, PubMed, and PEDro databases were searched. STUDY SELECTION: Meta-analyses with one pooled analysis containing ≥3 RCTs that investigated any intervention to prevent falls in community-dwelling older adults aged ≥60 years were eligible. Sixteen meta-analyses, representing 47 pooled analyses, were included. DATA EXTRACTION: Two authors independently extracted data. DATA SYNTHESIS: Data were narratively synthesized. The methodological quality of the meta-analyses was moderate. Three meta-analyses defined a fall, and 3 reported adverse events (although minor). There is consistent evidence that exercise reduces falls (including the rate, risk, and odds of falling), with 13/14 pooled analyses (93%) from 7 meta-analyses demonstrating a significant reduction. The methodological quality of meta-analyses investigating exercise were medium/high, and effect sizes ranged from 0.87 (relative risk 95% confidence interval=0.81, 0.94; number of studies=18; number of participants=3,568) to 0.39 (rate ratio 95% confidence interval=0.23, 0.66; number of meta-analyses=6). There is consistent evidence that multifactorial interventions reduce falls (5/6, 83% reported significant reduction). There is conflicting evidence regarding the influence of vitamin D supplementation (7/12, 58.3% reported significant reduction). LIMITATIONS: Meta-analyses often used different methods of analysis, and reporting of key characteristics (eg, participants, heterogeneity, publication bias) was often lacking. There may be some overlap among included meta-analyses. CONCLUSIONS: There is consistent evidence that exercise and individually tailored multifactorial interventions are effective in reducing falls in community-dwelling older adults.