Stepped Wedge Cluster Research Articles

IMplementing Predictive Analytics towards efficient COPD Treatments (IMPACT): protocol for a stepped-wedge cluster randomized impact study

IntroductionPersonalized disease management informed by quantitative risk prediction has the potential to improve patient care and outcomes. The integration of risk prediction into clinical workflow should be informed by the experiences and preferences of stakeholders, and the impact of such integration should be evaluated in prospective comparative studies.The objectives of the IMplementing Predictive Analytics towards efficient chronic obstructive pulmonary disease (COPD) treatments (IMPACT) study are to integrate an exacerbation risk prediction tool into routine care and to determine its impact on prescription appropriateness (primary outcome), medication adherence, quality of life, exacerbation rates, and sex and gender disparities in COPD care (secondary outcomes).MethodsIMPACT will be conducted in two phases. Phase 1 will include the systematic and user-centered development of two decision support tools: (1) a decision tool for pulmonologists called the ACCEPT decision intervention (ADI), which combines risk prediction from the previously developed Acute COPD Exacerbation Prediction Tool with treatment algorithms recommended by the Canadian Thoracic Society’s COPD pharmacotherapy guidelines, and (2) an information pamphlet for COPD patients (patient tool), tailored to their prescribed medication, clinical needs, and lung function. In phase 2, we will conduct a stepped-wedge cluster randomized controlled trial in two outpatient respiratory clinics to evaluate the impact of the decision support tools on quality of care and patient outcomes. Clusters will be practicing pulmonologists (n ≥ 24), who will progressively switch to the intervention over 18 months. At the end of the study, a qualitative process evaluation will be carried out to determine the barriers and enablers of uptake of the tools.DiscussionThe IMPACT study coincides with a planned harmonization of electronic health record systems across tertiary care centers in British Columbia, Canada. The harmonization of these systems combined with IMPACT’s implementation-oriented design and partnership with stakeholders will facilitate integration of the tools into routine care, if the results of the proposed study reveal positive association with improvement in the process and outcomes of clinical care. The process evaluation at the end of the trial will inform subsequent design iterations before largescale implementation.Trial registrationNCT05309356.

Advanced practice physiotherapy care in emergency departments for patients with musculoskeletal disorders: a pragmatic cluster randomized controlled trial and cost analysis

BackgroundAdvanced practice physiotherapy (APP) models of care where physiotherapists are primary contact emergency department (ED) providers are promising models of care to improve access, alleviate physicians’ burden, and offer efficient centered patient care for patients with minor musculoskeletal disorders (MSKD).ObjectivesTo compare the effectiveness of an advanced practice physiotherapist (APPT)-led model of care with usual ED physician care for persons presenting with a minor MSKD, in terms of patient-related outcomes, health care resources utilization, and health care costs.MethodsThis trial is a multicenter stepped-wedge cluster randomized controlled trial (RCT) with a cost analysis. Six Canadian EDs (clusters) will be randomized to a treatment sequence where patients will either be managed by an ED APPT or receive usual ED physician care. Seven hundred forty-four adults with a minor MSKD will be recruited. The main outcome measure will be the Brief Pain Inventory Questionnaire. Secondary measures will include validated self-reported disability questionnaires, the EQ-5D-5L, and other health care utilization outcomes such as prescription of imaging tests and medication. Adverse events and re-visits to the ED for the same complaint will also be monitored. Health care costs will be measured from the perspective of the public health care system using time-driven activity-based costing. Outcomes will be collected at inclusion, at ED discharge, and at 4, 12, and 26 weeks following the initial ED visit. Per-protocol and intention-to-treat analyses will be performed using linear mixed models with a random effect for cluster and fixed effect for time.DiscussionMSKD have a significant impact on health care systems. By providing innovative efficient pathways to access care, APP models of care could help relieve pressure in EDs while providing efficient care for adults with MSKD.Trial registrationClinicalTrials.govNCT05545917. Registered on September 19, 2022

Effectiveness of Self-guided Tailored Implementation Strategies in Integrating and Embedding Internet-Based Cognitive Behavioral Therapy in Routine Mental Health Care: Results of a Multicenter Stepped-Wedge Cluster Randomized Trial.

Internet-based cognitive behavioral therapy (iCBT) services for common mental health disorders have been found to be effective. There is a need for strategies that improve implementation in routine practice. One-size-fits-all strategies are likely to be ineffective. Tailored implementation is considered as a promising approach. The self-guided integrated theory-based Framework for intervention tailoring strategies toolkit (ItFits-toolkit) supports local implementers in developing tailored implementation strategies. Tailoring involves identifying local barriers; matching selected barriers to implementation strategies; developing an actionable work plan; and applying, monitoring, and adapting where necessary. This study aimed to compare the effectiveness of the ItFits-toolkit with implementation-as-usual (IAU) in implementing iCBT services in 12 routine mental health care organizations in 9 countries in Europe and Australia. A stepped-wedge cluster randomized trial design with repeated measures was applied. The trial period lasted 30 months. The primary outcome was the normalization of iCBT delivery by service providers (therapists, referrers, IT developers, and administrators), which was measured with the Normalization Measure Development as a proxy for implementation success. A 3-level linear mixed-effects modeling was applied to estimate the effects. iCBT service uptake (referral and treatment completion rates) and implementation effort (hours) were used as secondary outcomes. The perceived satisfaction (Client Satisfaction Questionnaire), usability (System Usability Scale), and impact of the ItFits-toolkit by implementers were used to assess the acceptability of the ItFits-toolkit. In total, 456 mental health service providers were included in this study. Compared with IAU, the ItFits-toolkit had a small positive statistically significant effect on normalization levels in service providers (mean 0.09, SD 0.04; P=.02; Cohen d=0.12). The uptake of iCBT by patients was similar to that of IAU. Implementers did not spend more time on implementation work when using the ItFits-toolkit and generally regarded the ItFits-toolkit as usable and were satisfied with it. The ItFits-toolkit performed better than the usual implementation activities in implementing iCBT services in routine practice. There is practical utility in the ItFits-toolkit for supporting implementers in developing and applying effective tailored implementation strategies. However, the effect on normalization levels among mental health service providers was small. These findings warrant modesty regarding the effectiveness of self-guided tailored implementation of iCBT services in routine practice. ClinicalTrials.gov NCT03652883; https://clinicaltrials.gov/ct2/show/NCT03652883. RR2-10.1186/s13063-020-04686-4.

Factor structure of post-operative quality of recovery questionnaire (QoR-15): An Italian adaptation and validation.

The Quality of Recovery questionnaire (QoR-15) is an English instrument for measuring quality of recovery in surgical patients, not yet translated and validated in Italian when the Enhanced Recovery After Surgery (ERAS) Piemonte studies were planned. To produce the Italian version of the QoR-15 questionnaire, to evaluate its factorial structure and to assess the invariance between two types of surgery. The Italian version (QoR-15I) was obtained translating and adapting the original version to the Italian context. The validation was performed suppling the QoR-15I to 3,784 patients enrolled in two parallel stepped wedge cluster randomised trials (ERAS Colon-rectum Piemonte; ERAS Gyneco Piemonte). The factor structure and its invariance between types of surgery was tested using confirmatory bifactor model and multi-group analysis. Comparative fit index (CFI), root mean square error of approximation (RMSEA), and standardized root mean square residual (SRMR) fit indices and their changes between nested models were used to assess the factor structure and the invariance. The bifactor model showed good fit (RMSEA = 0.049, CFI =0.957, SRMR = 0.036) and provided a general recovery factor and two specific factors for physical and mental recovery. Eighty-four percent of the common variance is attributable to the general factor, and thus the QoR-15I is sufficiently 'one-dimensional' with an adequate reliability (ωh = 0.70). The ωs values for the physical and mental recovery factors were 0.01 and 0.13, respectively. Multigroup analysis supported configural (RMSEA = 0.053, CFI = 0.950, SRMR = 0.035) and metric invariance (ΔRMSEA = -0.004; ΔCFI = -0.002; ΔSRMR = 0.014), whereas the intercept constraint was removed from item 15 to obtain partial scalar invariance (ΔRMSEA = 0.002; ΔCFI = 0.007; ΔSRMR = 0.004). Construct validity was supported by a negative association of QoR-15I scores with all variables related to worse patient condition and more complex surgery. Our results support the use of the QoR-15I as a valid, reliable, and clinically feasible tool for measuring the quality of recovery after surgery. The results of the confirmatory factor analyses suggest that a unique recovery score can be calculated and support measurement invariance of the QOR-15I across the two type of surgery, suggesting that the questionnaire has the same meaning and the same measurement parameters in colorectal and gynaecologic patients.

Abstract WMP13: Implementation Issues Arising From Less-intense Monitoring In Routine Care: Process Evaluation Of The Optimial Post Rtpa-iv Monitoring In Acute Ischemic Stroke (OPTIMISTmain) Study

Background and Aims: OPTIMISTmain is an international, multicenter, stepped-wedge cluster randomized trial to determine effectiveness and safety of less-intensive versus standard monitoring in thrombolysis-treated patients with mild-moderate acute ischemic stroke. A process evaluation was undertaken to determine feasibility, acceptability, and impact of the intervention on care processes, experience and staffing. Methods: A sample of stroke care nursing managers and unit staff from 7 US sites were invited to participate in semi-structured interviews at an early stage of the study. Implementer clinician surveys were undertaken pre- and post-intervention to define integration of the intervention. Qualitative data were independently analyzed by 2 coders; survey data reported from descriptive analysis. Results: 19 nurses were interviewed from the units with 1:2 to 1:6 nurse-to-patient ratios. Less-intensive monitoring was well accepted: less time constraints and improved workload, and perceived to be cost efficient from improved use of neuro-intensive care beds. Some nurses had initial safety concerns over missing deteriorating patients. Less-intensive monitoring led to patients being less irritable and more cooperative from having more rest. There was greater flexibility in the allocation of nursing staff from workforce shortages arising due to the COVID pandemic. Similar results were evident in the survey (13 hospitals, 34 respondents): 80% of respondents agreed that less-intensive monitoring benefited work; 74% believed it should be widely adopted at a national level. Nurses reported time being freed up to provide more patient education (56%), continence/daily living care (50%), early mobilization (26%), mood/cognition assessment (44%), and other aspects (24%, e.g. communication, family support). Conclusions: Less-intensive monitoring after thrombolysis for acute ischemic stroke patients appears feasible and acceptable among US healthcare professionals.

GEEMAEE: A SAS macro for the analysis of correlated outcomes based on GEE and finite-sample adjustments with application to cluster randomized trials

Background and objectivesGeneralized estimating equations (GEE) are used to analyze correlated outcomes in marginal regression models with population-averaged interpretations of exposure effects. Limitations of popular software for GEE include: (i) user choice is restricted to a small set of within-cluster pairwise correlation (intra-class correlation; ICC) structures; and (ii) inference on ICC parameters is usually not possible because the precision of their estimates is not quantified. This is important because ICC values inform the design of cluster randomized trials. Beyond the standard GEE implementation, use of paired estimating equations (Prentice 1988) provides: (i) flexible specification of models for pairwise correlations and (ii) standard errors for ICC estimates. However, most GEEs give biased estimates of standard errors and correlations when the number of clusters is small (roughly, ≤40). Consequently, there is a need for software to provide GEE analysis with finite-sample bias-corrections. MethodsThe SAS macro GEEMAEE implements paired estimating equations to simultaneously estimate parameters in marginal mean and ICC models. It provides bias-corrected standard errors and uses matrix-adjusted estimating equations (MAEE) for bias-corrected estimation of correlations. Several built-in correlation matrix options, rarely found in software, are offered for multi-period, cluster randomized trials and similarly structured longitudinal observational data structures. Additional options include user-specified correlation structures and deletion diagnostics, namely Cooks’ Distance and DBETA statistics that estimate the influence of observations, cluster-periods (when applicable) and clusters. ResultsGEEMAEE is illustrated for a binary and a count outcome in two stepped wedge cluster randomized trials and a binary outcome in a longitudinal study of disease surveillance. Use of MAEE resulted in larger values of correlation estimates compared to uncorrected estimating equations. Use of bias-corrected variance estimators resulted in (appropriately) larger values of standard errors compared to the usual sandwich estimators. Deletion diagnostics identified the clusters and cluster-periods having the most influence. ConclusionsThe SAS macro GEEMAEE provides regression analysis for clustered or longitudinal responses, and is particularly useful when the number of clusters is small. Flexible specification and bias-corrected estimation of pairwise correlation parameters and standard errors are key features of the software to provide valid inference in real-world settings.

Effectiveness of an intensive care telehealth programme to improve process quality (ERIC): a multicentre stepped wedge cluster randomised controlled trial

PurposeSupporting the provision of intensive care medicine through telehealth potentially improves process quality. This may improve patient recovery and long-term outcomes. We investigated the effectiveness of a multifaceted telemedical programme on the adherence to German quality indicators (QIs) in a regional network of intensive care units (ICUs) in Germany.MethodsWe conducted an investigator-initiated, large-scale, open-label, stepped-wedge cluster randomised controlled trial enrolling adult ICU patients with an expected ICU stay of ≥ 24 h. Twelve ICU clusters in Berlin and Brandenburg were randomly assigned to three sequence groups to transition from control (standard care) to the intervention condition (telemedicine). The quality improvement intervention consisted of daily telemedical rounds guided by eight German acute ICU care QIs and expert consultations. Co-primary effectiveness outcomes were patient-specific daily adherence (fulfilled yes/no) to QIs, assessed by a central end point adjudication committee. Analyses used mixed-effects logistic modelling adjusted for time. This study is completed and registered with ClinicalTrials.gov (NCT03671447).ResultsBetween September 4, 2018, and March 31, 2020, 1463 patients (414 treated on control, 1049 on intervention condition) were enrolled at ten clusters, resulting in 14,783 evaluated days. Two randomised clusters recruited no patients (one withdrew informed consent; one dropped out). The intervention, as implemented, significantly increased QI performance for “sedation, analgesia and delirium” (adjusted odds ratio (99.375% confidence interval [CI]) 5.328, 3.395–8.358), “ventilation” (OR 2.248, 1.198–4.217), “weaning from ventilation” (OR 9.049, 2.707–30.247), “infection management” (OR 4.397, 1.482–13.037), “enteral nutrition” (OR 1.579, 1.032–2.416), “patient and family communication” (OR 6.787, 3.976–11.589), and "early mobilisation" (OR 3.161, 2.160–4.624). No evidence for a difference in adherence to “daily multi-professional and interdisciplinary clinical visits” between both conditions was found (OR 1.606, 0.780–3.309). Temporal trends related and unrelated to the intervention were detected. 149 patients died during their index ICU stay (45 treated on control, 104 on intervention condition).ConclusionA telemedical quality improvement program increased adherence to seven evidence-based German performance indicators in acute ICU care. These results need further confirmation in a broader setting of regional, non-academic community hospitals and other healthcare systems.

Chronic disease IMPACT (chronic disease early detection and improved management in primary care project): An Australian stepped wedge cluster randomised trial.

Interrelated chronic vascular diseases (chronic kidney disease (CKD), type 2 diabetes (T2D) and cardiovascular disease (CVD)) are common with high morbidity and mortality. This study aimed to assess if an electronic-technology-based quality improvement intervention in primary care could improve detection and management of people with and at risk of these diseases. Stepped-wedge trial with practices randomised to commence intervention in one of five 16-week periods. Intervention included (1) electronic-technology tool extracting data from general practice electronic medical records and generating graphs and lists for audit; (2) education regarding chronic disease and the electronic-technology tool; (3) assistance with quality improvement audit plan development, benchmarking, monitoring and support. De-identified data analysis using R 3.5.1 conducted using Bayesian generalised linear mixed model with practice and time-specific random intercepts. At baseline, eight included practices had 37,946 active patients (attending practice ≥3 times within 2 years) aged ≥18 years. Intervention was associated with increased OR (95% CI) for: kidney health checks (estimated glomerular filtration rate, urine albumin:creatinine ratio (uACR) and blood pressure) in those at risk 1.34 (1.26-1.42); coded diagnosis of CKD 1.18 (1.09-1.27); T2D diagnostic testing (fasting glucose or HbA1c) in those at risk 1.15 (1.08-1.23); uACR in patients with T2D 1.78 (1.56-2.05). Documented eye checks within recommended frequency in patients with T2D decreased 0.85 (0.77-0.96). There were no significant changes in other assessed variables. This electronic-technology-based intervention in primary care has potential to help translate guidelines into practice but requires further refining to achieve widespread improvements across the interrelated chronic vascular diseases.

Automated vs. manual case investigation and contact tracing for pandemic surveillance: Evidence from a stepped wedge cluster randomized trial.

Case investigation and contact tracing (CICT) is an important tool for communicable disease control, both to proactively interrupt chains of transmission and to collect information for situational awareness. We run the first randomized trial of COVID-19 CICT to investigate the utility of manual (i.e., call-based) vs. automated (i.e., survey-based) CICT for pandemic surveillance. Between December 15, 2021 and February 5, 2022, a stepped wedge cluster randomized trial was run in which Santa Clara County ZIP Codes progressively transitioned from manual to automated CICT. Eleven individual-level data fields on demographics and disease dynamics were observed for non-response. The data contains 106,522 positive cases across 29 ZIP Codes. Automated CICT reduced overall collected information by 29 percentage points (SE=0.08, p<0.01), as well as the response rate for individual fields. However, we find no evidence of differences in information loss by race or ethnicity. Automated CICT can serve as a useful alternative to manual CICT, with no substantial evidence of skewing data along racial or ethnic lines, but manual CICT improves completeness of key data for monitoring epidemiologic patterns. This research was supported in part by the Stanford Office of Community Engagement and the Stanford Institute for Human-Centered Artificial Intelligence.

PS-BPP04-9: THE RXPATH RANDOMIZED TRIAL OF THE HYPERTENSION CANADA PROFESSIONAL CERTIFICATION PROGRAM: A NOVEL IMPLEMENTATION STRATEGY FOR HYPERTENSION GUIDELINES

The uptake of clinical practice guidelines into practice is poor for many chronic conditions, including hypertension. We designed a guidelines-based educational program for primary care clinicians, the Hypertension Canada Professional Certification Program (HC-PCP, www.hypertension.ca/professional-certification-program). It consists of four online modules, an online prospective patient registry, and expert evaluations of the blood pressure measurement technique and case management by the learner. We then evaluated its impact on patient level outcomes. Objective: The objective of RxPATH was to determine the effect of the HC-PCP for pharmacists on systolic blood pressure reduction in patients with poorly controlled hypertension. Design and Methods: Design: Stepped wedge cluster randomized trial (unit of randomization was the pharmacy). Setting: Community pharmacies in Alberta, Canada Population: Pharmacists with prescriptive authority volunteered to participate. We enrolled patients with poorly controlled hypertension (BP &gt; 140/90mmHg or &gt; 130/80mmHg in those with diabetes), identified by their pharmacist. Intervention: Pharmacists were enrolled in the HC-PCP. They then provided this care to their patients with poorly controlled hypertension. Control: Pharmacists were given a copy of the Hypertension Canada Guidelines and provided usual care to their patients prior to undertaking the HC-PCP. Outcomes: The primary outcome was difference in change in systolic blood pressure between intervention and control groups at 3 months. We also evaluated patient satisfaction using the Consultant Satisfaction Questionnaire (CSQ). Results: We enrolled 890 patients from 61 pharmacies (104 pharmacists). Mean age was 61.6 (SD 14.1) years, 46% were female, 35.5% had diabetes, and mean baseline BP was 152.4 (SD 13.8)/87.0 (SD 10.6)mmHg. Change in systolic BP was 9.9 (SD 16.5) for the intervention group, compared to 9.9 (SD 16.2) mmHg in the control group, p = 0.29. Patient satisfaction using the CSQ was high at 76 (of 90 maximum). Conclusions: Most educational programs do not get evaluated at the patient level. RxPATH demonstrated that the HC-PCP intervention did not result in a greater reduction in systolic BP compared to control. While both groups did have clinically meaningful reductions in BP, possible reasons for lack of a difference with the intervention include: COVID-19 staffing/workload issues in pharmacies, selection bias for pharmacists interested in hypertension/contamination of usual care group, and short follow-up duration. Feedback on the HC-PCP from pharmacists was positive, patient satisfaction was high, and we plan to make this program widely available to primary care providers.

Prevalence and predictors of inappropriate prescribing in outpatients with severe mental illness.

Potentially inappropriate prescribing (PIP) is frequent in geriatrics and results in an increased risk for adverse effects, morbidity, mortality and reduced quality of life. Research on PIP in psychiatry has mainly focused on elderly patients and inpatients. To determine the prevalence and the predictors of PIP of psychotropic medication in outpatients with severe mental illness. This study is part of the Muva study, a pragmatic open Stepped Wedge Cluster Randomized Trial of a physical activity intervention for patients (age ⩾ 16 years) with severe mental illness. A structured medication interview, questionnaires on social functioning, quality of life and psychiatric symptoms, and BMI and waist circumference measurements were performed followed by a structured medication review. Patients were divided into groups: PIP versus no PIP. Between-group differences were calculated and a multivariate binary logistic regression was performed to examine predictors for PIP. A receiver operating characteristics analysis was performed to determine the area under the curve (AUC). In 75 patients, an average of 5.2 medications of which 2.5 psychotropic medication was used. 35 (46.7%) patients were identified with PIP. Unindicated long-term benzodiazepine use was the most frequently occurring PIP (34.1%). Predictors of PIP were female gender [odds ratio (OR) = 4.88, confidence interval (CI) = 1.16-20.58, p = 0.03], number of medications (OR = 1.41, CI = 1.07-1.86, p = 0.02) and lower social functioning (OR = 1.42, CI = 1.01-2.00, p = 0.05). The AUC was 0.88 for the combined prediction model. The prevalence of PIP of psychotropic medication in outpatients with severe mental illness is high. It is therefore important to identify, and where possible, resolve PIP by frequently performing a medication review with specific attention to females, patients with a higher number of medications and patients with lower social functioning. This trial was registered in The Netherlands Trial Register (NTR) as NTR NL9163 on 20 December 2020 (https://trialsearch.who.int/Trial2.aspx?TrialID=NL9163).

Implementation evaluation of an evidence-based emergency nursing framework (HIRAID): study protocol for a step-wedge randomised control trial

IntroductionPoor patient assessment results in undetected clinical deterioration. Yet, there is no standardised assessment framework for >29 000 Australian emergency nurses. To reduce clinical variation and increase safety and quality...

Nationwide implementation of best practices in pancreatic cancer care: stepped-wedge cluster RCT

Background: Implementation of new treatment strategies in cancer care is often inadequate and slow. We aimed to implement best practices in pancreatic cancer care using a nationwide stepped wedge design and assess the impact on overall survival.

Nationwide Implementation of Best Practices in Pancreatic Cancer Care (PACAP-1): Stepped-wedge Cluster Randomized Trial

Nationwide Implementation of Best Practices in Pancreatic Cancer Care (PACAP-1): Stepped-wedge Cluster Randomized Trial

Power analyses for stepped wedge designs with multivariate continuous outcomes.

Multivariate outcomes are common in pragmatic cluster randomized trials. While sample size calculation procedures for multivariate outcomes exist under parallel assignment, none have been developed for a stepped wedge design. In this article, we present computationally efficient power and sample size procedures for stepped wedge cluster randomized trials (SW-CRTs) with multivariate outcomes that differentiate the within-period and between-period intracluster correlation coefficients (ICCs). Under a multivariate linear mixed model, we derive the joint distribution of the intervention test statistics which can be used for determining power under different hypotheses and provide an example using the commonly utilized intersection-union test for co-primary outcomes. Simplifications under a common treatment effect and common ICCs across endpoints and an extension to closed-cohort designs are also provided. Finally, under the common ICC across endpoints assumption, we formally prove that the multivariate linear mixed model leads to a more efficient treatment effect estimator compared to the univariate linear mixed model, providing a rigorous justification on the use of the former with multivariate outcomes. We illustrate application of the proposed methods using data from an existing SW-CRT and present extensive simulations to validate the methods.

PATIENT AND CAREGIVER PERCEPTIONS OF MOBILITY AFTER DISCHARGE FROM SKILLED NURSING FACILITIES TO HOME

Abstract Functional outcomes of older adults in post-acute care is poorly understood. The purpose of this study was to describe skilled nursing facility (SNF) patient or caregiver perceptions of patient mobility and factors associated with patient mobility in 30 days after discharge from SNF to home. We conducted a secondary analysis of data from a stepped-wedge cluster randomized trial of the Connect-Home intervention set in 6 SNFs in North-Carolina. The sample included SNF patients (N=249) and their caregivers (N=249). In 30 days after discharge, SNF patients or their caregivers (as proxies) rated patient mobility using the Life-Space Assessment (LSA). LSA total-scores (range= 0-120), with higher scores indicating greater mobility. Linear mixed models, with random effects to adjust for clustering in SNFs, were used to describe associations between LSA total-score and patient, caregiver, and health-system factors. Participants were typically female (63%), White (74%), and average age of 76.3 years. In 30 days after discharge, LSA total-scores ranged from 0-90 with a mean score of 22 (SD=16.01). Most (85%) required caregiver and/or assistive devices to transfer inside and outside of their homes. In the mixed models, lower LSA scores were associated with older age [-0.232(0.108), p&amp;lt; 0.05], lower cognition score [1.182(0.384), p&amp;lt; 0.005], diagnosis of dementia [-6.863(3.057), p&amp;lt; 0.05], lower baseline mobility in the SNF [0.296(0.142), p&amp;lt; 0.05] and longer SNF stay [-0.200(0.068), p&amp;lt; 0.005]. Low LSA scores in this sample suggest the need for caregiver support to continue rehabilitation and promote functional ability at home. Studies are needed to augment transitional care and address these care needs.

A STEPPED WEDGE CLUSTER RANDOMIZED TRIAL OF THE STRIDE SUPERVISED WALKING PROGRAM IN VA HOSPITALS

Abstract In trials, hospital walking programs improved functional ability after discharge, but little evidence exists on their effectiveness under routine practice conditions or their implementation across health systems. We conducted a Type III hybrid implementation-effectiveness, stepped-wedge cluster randomized trial (SW-CRT) in 8 Veterans Affairs hospitals examining a hospital-based walking program known as STRIDE. Based on the SW-CRT design, hospitals were randomized to a sequence (timeline) for STRIDE, and additionally randomized 1:1 to receive implementation support according to the Replicating Effective Programs (REP) framework only or REP plus additional team-based communication training known as CONNECT. The study was powered to examine impact of STRIDE on discharge destination to home vs other (primary outcome); hospital length of stay (LOS) was a secondary outcome. Patient-hospitalizations in pre-STRIDE time periods (n=8167) were similar to post-STRIDE time periods (n=9070) (e.g., mean age 73, 97% male, 28–30% Black race). In adjusted models, odds of discharge to home were higher among eligible patients hospitalized in post-STRIDE time periods (OR 1.6; 95% CI 1.3–2) compared to pre-STRIDE. Findings were robust to 3 sets of sensitivity analyses. There was no difference in LOS (IRR 1.01; 95% CI 0.94,1.09). Hospitals randomized to CONNECT had higher program reach (mean 13% vs 3%) but lower daily fidelity (mean 25.7% vs 37.5%). Despite limited direct program reach, implementation of a hospital walking program was associated with higher odds of discharge to home. Implementation strategies like CONNECT that enhance teamwork and communication may improve patient access to clinical programs being implemented in new settings.

Short- and long-term effects of an electronic medication management system on paediatric prescribing errors

Electronic medication management (eMM) systems are designed to improve safety, but there is little evidence of their effectiveness in paediatrics. This study assesses the short-term (first 70 days of eMM use) and long-term (one-year) effectiveness of an eMM system to reduce prescribing errors, and their potential and actual harm. We use a stepped-wedge cluster randomised controlled trial (SWCRCT) at a paediatric referral hospital, with eight clusters randomised for eMM implementation. We assess long-term effects from an additional random sample of medication orders one-year post-eMM. In the SWCRCT, errors that are potential adverse drug events (ADEs) are assessed for actual harm. The study comprises 35,260 medication orders for 4821 patients. Results show no significant change in overall prescribing error rates in the first 70 days of eMM use (incident rate ratio [IRR] 1.05 [95%CI 0.92–1.21], but a 62% increase (IRR 1.62 [95%CI 1.28–2.04]) in potential ADEs suggesting immediate risks to safety. One-year post-eMM, errors decline by 36% (IRR 0.64 [95%CI 0.56–0.72]) and high-risk medication errors decrease by 33% (IRR 0.67 [95%CI 0.51–0.88]) compared to pre-eMM. In all periods, dose error rates are more than double that of other error types. Few errors are associated with actual harm, but 71% [95%CI 50–86%] of patients with harm experienced a dose error. In the short-term, eMM implementation shows no improvement in error rates, and an increase in some errors. A year after eMM error rates significantly decline suggesting long-term benefits. eMM optimisation should focus on reducing dose errors due to their high frequency and capacity to cause harm.

Power swgee: GEE-based power calculations in stepped wedge cluster randomized trials.

Stepped wedge cluster randomized trials are increasingly being used to evaluate interventions in medical, public health, educational, and social science contexts. With the longitudinal and crossover nature of a SW-CRT, complex analysis techniques are often needed which makes appropriately powering SW-CRTs challenging. In this paper, we introduce a newly-developed SW-CRT power calculator, embedded within the power command in Stata. The power calculator assumes a marginal model (i.e., generalized estimating equations [GEE]) for the primary analysis of SW-CRTs, for which other currently available SW-CRT power calculators may not be suitable. The program accommodates complete cross-sectional and closed-cohort designs, and includes multilevel correlation structures appropriate for such designs. We discuss the methods and formulae underlying our SW-CRT calculator, and provide illustrative examples of the use of power swgee. We provide suggestions about the choice of parameters in power swgee, and conclude by discussing areas of future research which may improve the program.

Feasibility of a theory-based intervention to reduce sedentary behaviour among contact centre staff: the SUH stepped-wedge cluster RCT

Background Sedentary behaviour is linked to increased risk of type 2 diabetes, cardiovascular disease, musculoskeletal issues and poor mental well-being. Contact (call) centres are associated with higher levels of sedentary behaviour than other office-based workplaces. Stand Up for Health is an adaptive intervention designed to reduce sedentary behaviour in contact centres. Objectives The objectives were to test the acceptability and feasibility of implementing the intervention; to assess the feasibility of the study design and methods; to scope the feasibility of a future health economic evaluation; and to consider the impact of COVID-19 on the intervention. All sites received no intervention for between 3 and 12 months after the start of the study, as a waiting list control. Design This was a cluster-randomised stepped-wedge feasibility design. Setting The trial was set in 11 contact centres across the UK. Participants Eleven contact centres and staff. Intervention Stand Up for Health involved two workshops with staff in which staff developed activities for their context and culture. Activities ranged from using standing desks to individual goal-setting, group walks and changes to workplace policies and procedures. Main outcome measures The primary outcome was accelerometer-measured sedentary time. The secondary outcomes were subjectively measured sedentary time, overall sedentary behaviour, physical activity, productivity, mental well-being and musculoskeletal health. Results Stand Up for Health was implemented in 7 out of 11 centres and was acceptable, feasible and sustainable (objective 1). The COVID-19 pandemic affected the delivery of the intervention, involvement of contact centres, data collection and analysis. Organisational factors were deemed most important to the success of Stand Up for Health but also the most challenging to change. There were also difficulties with the stepped-wedge design, specifically maintaining contact centre interest (objective 2). Feasible methods for estimating cost-efficiency from an NHS and a Personal Social Services perspective were identified, assuming that alternative feasible effectiveness methodology can be applied. Detailed activity-based costing of direct intervention costs was achieved and, therefore, deemed feasible (objective 3). There was significantly more sedentary time spent in the workplace by the centres that received the intervention than those that did not (mean difference 84.06 minutes, 95% confidence interval 4.07 to 164.1 minutes). The other objective outcomes also tended to favour the control group. Limitations There were significant issues with the stepped-wedge design, including difficulties in maintaining centre interest and scheduling data collection. Collection of accelerometer data was not feasible during the pandemic. Conclusions Stand Up for Health is an adaptive, feasible and sustainable intervention. However, the stepped-wedge study design was not feasible. The effectiveness of Stand Up for Health was not demonstrated and clinically important reductions in sedentary behaviour may not be seen in a larger study. However, it may still be worthwhile conducting an effectiveness study of Stand Up for Health incorporating activities more relevant to hybrid workplaces. Future work Future work could include developing hybrid (office and/or home working) activities for Stand Up for Health; undertaking a larger effectiveness study and follow-up economic analysis (subject to its success); and exploring organisational features of contact centres that affect the implementation of interventions such as Stand Up for Health. Trial registration This trial is registered as ISRCTN11580369. Funding This project was funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 10, No. 13. See the NIHR Journals Library website for further project information.