Protocol for a process evaluation of a stepped wedge randomised controlled trial to reduce unnecessary hospitalisations of older people from residential aged care: the EDDIE+ study

Introduction
The Early Detection of Deterioration in Elderly residents (EDDIE+) programme is a theory-informed, multi-component intervention aimed at upskilling and empowering nursing and personal care staff to identify and manage early signs of deterioration in residents of aged care facilities. The intervention aims to reduce unnecessary hospital admissions from residential aged care (RAC) homes. Alongside a stepped wedge randomised controlled trial, an embedded process evaluation will be conducted to assess the fidelity, acceptability, mechanisms of action and contextual barriers and enablers of the EDDIE+ intervention.

Methods and analysis
Twelve RAC homes in Queensland, Australia are participating in the study. A comprehensive mixed-methods process evaluation, informed by the integrated Promoting Action on Research Implementation in Health Services (i-PARIHS) framework, will assess intervention fidelity, contextual barriers and enablers, mechanisms of action, and the acceptability of the programme from various stakeholder perspectives. Quantitative data will be collected prospectively from project documentation, including baseline context mapping of participating sites, activity tracking and regular check-in communication sheets. Qualitative data will be collected postintervention via semi-structured interviews with a range of stakeholder groups. The i-PARIHS constructs of innovation, recipients, context and facilitation will be applied to frame the analysis of quantitative and qualitative data.

Ethics and dissemination
Ethical approval for this study has been granted by the Bolton Clarke Human Research Ethics Committee (approval number: 170031) with administrative ethical approval granted by the Queensland University of Technology University Human Research Ethics Committee (2000000618). Full ethical approval includes a waiver of consent for access to residents’ demographic, clinical and health services de-identified data. A separate health services data linkage based on RAC home addresses will be sought through a Public Health Act application. Study findings will be disseminated through multiple channels, including journal publications, conference presentations and interactive webinars with a stakeholder network.

Trial registration number
Australia New Zealand Clinical Trial Registry (ACTRN12620000507987).

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Febbraio 2023

Evaluating safety and effectiveness of the early-onset sepsis calculator to reduce antibiotic exposure in Dutch at-risk newborns: a protocol for a cluster randomised controlled trial

Introduction
Newborns are at risk for early-onset sepsis (EOS). In the Netherlands, EOS affects less than 0.2% of newborns, but approximately 5% are treated with empirical antibiotics. These numbers form an example of overtreatment in countries using risk-factor based guidelines for administrating antibiotics. An alternative to these guidelines is the EOS calculator, a tool that calculates an individual EOS risk and provides management recommendation. However, validation outside the North-American setting is limited, especially for safety outcomes. We aim to investigate whether EOS calculator use can safely reduce antibiotic exposure in newborns with suspected EOS compared with the Dutch guideline.

Methods and analysis
This protocol describes a cluster randomised controlled trial assessing whether EOS calculator use is non-inferior regarding safety, and superior regarding limiting overtreatment, compared with the Dutch guideline. We will include newborns born at ≥34 weeks’ gestation, with at least one risk factor consistent with EOS within 24 hours after birth. After 1:1 randomisation, the 10 participating Dutch hospitals will use either the Dutch guideline or the EOS calculator as standard of care for all newborns at risk for EOS. In total, 1830 newborns will be recruited. The coprimary non-inferiority outcome will be the presence of at least one of four predefined safety criteria. The coprimary superiority outcome will be the proportion of participants starting antibiotic therapy for suspected and, or proven EOS within 24 hours after birth. Secondary outcomes will be the total duration of antibiotic therapy, the percentage of antibiotic therapy started between 24 and 72 hours after birth, and parent-reported quality of life. Analyses will be performed both as intention to treat and per protocol.

Ethics and dissemination
This trial has been approved by the Medical Ethics Committee of the Amsterdam UMC (NL78203.018.21). Results will be presented in peer-reviewed journals and at international conferences.

Trial registration number
NCT05274776.

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Febbraio 2023

Digitally deployed, GP remote consultation video intervention that aims to reduce opioid prescribing in primary care: protocol for a mixed-methods evaluation

Introduction
Opioid prescribing rates are disproportionately high in the North of England. In addition to patients’ complex health needs, clinician prescribing behaviour is also a key driver. Although strategies have been initiated to reduce opioid prescribing nationally, the COVID-19 pandemic has interrupted service provision and created challenges for the system and health professionals to tackle this complex issue. A pilot intervention using smartphone video messaging has been developed to remotely explain the rationale for opioid reduction and facilitate self-initiation of support. The aim of this study is to evaluate the potential benefits, risks and economic consequences of ‘at scale’ implementation.

Methods and analysis
This will be a mixed-methods study comprising a quasi-experimental non-randomised before-and-after study and qualitative interviews. The intervention arm will comprise 50 General Practitioner (GP) Practices using System 1 (a clinical computer system hosting the intervention) who will deliver the video to their patients via text message. The control arm will comprise 50 practices using EMIS (a different computer system) who will continue usual care. Monthly practice level prescribing and consultation data will be observed for 6 months postintervention. A general linear model will be used to estimate the association between the exposure and the main outcome (opioid prescribing; average daily quantity (ADQ)/1000 specific therapeutic group age-sex related prescribing unit). Semi-structured interviews will be undertaken remotely with purposively selected participants including patients who received the video, and health professionals involved in sending out the videos and providing additional support. Interviews will be audio recorded, transcribed and analysed thematically.

Ethics and dissemination
Ethics approval has been granted by the NHS Health Research Authority Research Ethics Committee (22/PR/0296). Findings will be disseminated to the participating sites, participants, and commissioners, and in peer-reviewed journals and academic conferences.

Trial registration number
NCT05276089.

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Febbraio 2023

Feasibility study of high-intensity interval training to reduce cardiometabolic disease risks in individuals with acute spinal cord injury

Introduction
Individuals ageing with spinal cord injury (SCI) experience an accelerated trajectory of diseases and disorders, such as cardiovascular disease and diabetes, that resemble those experienced with ageing alone. Currently, an evidence-based approach toward managing this problem does not exist and therefore the purpose of this study is to determine the feasibility of conducting a high-intensity exercise intervention in individuals with acute (

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Febbraio 2023

Abstract WP33: Bedside Insertion Of Implantable Loop Recorders Prior To Hospital Discharge Improves Detection Of Atrial Fibrillation After Cryptogenic Stroke And May Reduce Stroke Recurrence

Stroke, Volume 54, Issue Suppl_1, Page AWP33-AWP33, February 1, 2023. Atrial fibrillation (AF) is responsible for 15-20% of ischemic strokes. AF can be asymptomatic and remain undetected following acute stroke, initially classifying the event as cryptogenic. Implantable loop recorders (ILRs) provide long-term cardiac monitoring and are superior to traditional methods for detecting AF in patients with cryptogenic stroke. ILR placement is often performed by a cardiologist in an outpatient setting. Our institution identified that some patients were missing or cancelling appointments for device implantation. Failure to detect AF is associated with a greater risk of stroke recurrence. An interdisciplinary inpatient process was developed to place ILRs at the bedside on the stroke unit, prior to discharge. The purpose of the program was to increase patient compliance with ILRs, improve detection of asymptomatic AF, and reduce incidence of stroke recurrence through timely initiation of oral anticoagulants. To evaluate the program and provide recommendations, measures of success included rates of patient compliance with ILR implantation using inpatient vs. outpatient procedure and the percentage of patients who received a diagnosis of AF after ILR placement. Using 18 months of pre-implementation data as a benchmark, the average implant rate increased in the first 12 months following implementation. Of 97 patients who received ILR placement, nine (9%) have received a diagnosis of AF. Since three-year ILR monitoring has shown significantly higher AF detection than 30-day cardiac monitoring after cryptogenic stroke, more patients with AF may yet be identified. This presentation will demonstrate an increase in ILR implant rates and AF detection and highlight positive results using advanced practice professionals to perform the procedure. The program produced financial benefit and mitigated access to care barriers, with no poor outcomes or compromise in quality, and no negative impact on inpatient length of stay. In conclusion, bedside insertion of ILRs prior to discharge after cryptogenic stroke is a safe, efficient, cost-effective process that increases patient compliance when compared to outpatient return visits, improving detection of AF and prompt initiation of oral anticoagulants, and may reduce stroke recurrence.

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Febbraio 2023

Abstract WP80: The Heart-brain Connection: Implementing Strategies To Reduce The Rate Of Perioperative Stroke For Patients Undergoing Coronary Artery Bypass Graft Surgery

Stroke, Volume 54, Issue Suppl_1, Page AWP80-AWP80, February 1, 2023. Background:Stroke is a known complication of cardiac surgery. The objective of this study was to implement a systemwide strategy to reduce perioperative stroke after isolated coronary artery bypass graft (CABG) surgery utilizing best practices from cardiothoracic surgery and neurology expertise.Methods:A prospective, quality improvement study of all isolated CABG patients at three hospitals within a multicenter academic healthcare system, in a large metropolitan area, was completed from January 1, 2021 to June 30, 2022. Utilizing Lean methodology, a multidisciplinary team of cardiothoracic surgeons, neurologists, anesthesiologists, certified stroke nurses, and process improvement specialists conducted a gap analysis to identify interventions to decrease the observed to expected (O/E) ratio of risk-adjusted perioperative strokes. The team developed a pre-operative evaluation process for patients with a history of stroke, formalized the utilization of intra-operative epiaortic ultrasound, and deployed education on BE-FAST symptoms and the purpose of stroke alerts to providers, nurses, and ancillary staff caring for the patient population.Results:During the study period, 1175 patients underwent isolated CABG. Risk adjusted perioperative stroke rates in the first 6 months of 2021 compared to 2022 declined from an O/E ratio of 1.32 to 0.78. Among patients with new post-operative stroke symptoms, the time frame from last known well to symptom recognition decreased from 704 to 486 minutes. Following the implementation of the protocol, one site saw the utilization of inpatient stroke alerts after CABG increase from 81.3% to 100% for patients with new BE-FAST symptoms.Conclusion:Multidisciplinary implementation of best practices was associated with lower risk adjusted perioperative stroke rates, reductions in time to new symptom recognition, and increased utilization of inpatient stroke alert processes. Further study is needed to monitor the effects of the pre-operative evaluation process and the standardization of epiaortic ultrasound. Future goals are to standardize the methods and assess the benefit to other types of cardiac surgery.

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Febbraio 2023

Abstract WMP111: MicroRNAs As A Therapeutic Target To Reduce Microglial Activation After Post-stroke Social Isolation

Stroke, Volume 54, Issue Suppl_1, Page AWMP111-AWMP111, February 1, 2023. Introduction:Social isolation (SI) and loneliness are linked to all-cause mortality, as well as mortality from stroke and other vascular diseases. However, the mechanisms mediating the effects of social factors on stroke recovery are unknown. We hypothesized that differential expression of miRNAs contributes to the deleterious effects of post-stroke SI.Methods:Aged (18-20 months) C57BL/6 male mice were used to examine the detrimental effects of post-stroke SI on miRNA profiles in the brain. Mice were randomly assigned to either pair housing (PH), or single housing (SI) three days after a 60-minute transient right middle cerebral artery occlusion (MCAO). At this time point (post-stroke day 3), the infarct is complete, and was equivalent between groups, avoiding potential changes seen with differing infarct sizes. Temporal miRNA profiling of the ipsilateral hemisphere was assessed at two-time points (post-stroke SI D4 and D27). Brain cells were analyzed by flow cytometry.Results:Post-stroke SI resulted in significant alterations of distinct miRNA profiles within the brain across both acute and chronic time points (n=4/grp, FDR adjusted *p

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Febbraio 2023

Abstract WP26: Multidisciplinary Case Reviews Reduce “Door-to” Times

Stroke, Volume 54, Issue Suppl_1, Page AWP26-AWP26, February 1, 2023. Background:Rapid reperfusion is critical for positive outcomes in stroke patients. To improve patient outcomes, the organization reduced program goals for all door-to metrics. To reach the aggressive new goals, a door-to task force led by the Stroke Program Coordinator was created. The multidisciplinary task force meets monthly and consists of members from Pre-Hospital, ED, Stroke, CT, and Neurointerventional Radiology (NIR).Interventions:Door-to data is shared monthly and case reviews on all door-to fall-outs are performed. The task force reviews door-to-CT, door-to-thrombolytics, and door-to-puncture metrics. An RCA is conducted on each case that exceeds our time goals looking for areas for improvement. Each case is evaluated from initial EMS contact through initiation of treatment; with all members of the multidisciplinary team participating. A trend in prolonged door-to-puncture was seen; so further investigation into the causes for the delays was done by the task force. This led to several improvement initiatives that addressed each of the delays. Education was completed for ED, CT, and NIR staff on the significance of a rapid initial evaluation and transport to NIR. An outside hospital (OSH) transfer notification process was created for OSH transfers eligible for thrombectomy. A direct-to-angio process was also developed to allow transport from CT to the NIR suite without stopping in an ED room.Results:The combination of these initiatives had a positive impact on door-to-puncture times. When comparing 2021 data to year-to-date 2022 post-implementation data, a reduction in door-to-puncture has been seen. Median time for door-to-puncture in 2021 was 60 minutes. This time has reduced to 48 minutes for the January through June 2022 timeframe.Conclusion:A multidisciplinary door-to task force reduces door-to-puncture times by keeping constant focus on door-to metrics and by creating a shared accountability for the process. With the door-to task force, real-time case reviews can be completed to allow for rapid identification of areas of opportunities and initiation of process improvement initiatives to reduce door-to times.

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Febbraio 2023

Abstract WP237: Maternal Dietary Choline Deficiencies During Pregnancy And Lactation Reduce Cerebral Blood Flow In 3-month-old Female Mice Offspring Following Ischemic Stroke To The Sensorimotor Cortex

Stroke, Volume 54, Issue Suppl_1, Page AWP237-AWP237, February 1, 2023. A maternal diet that provides adequate nutrition during pregnancy and lactation is vital to the neurodevelopment of offspring. One-carbon metabolism plays an important role in the closure of the neural tube of the developing embryo; however, the impact of maternal one-carbon dietary deficiencies on offspring neurological function later in life remains relatively unknown. Stroke is one of the leading causes of death globally, and its prevalence is expected to increase in younger age groups as the incidence of various risk factors for stroke increases. The aim of our study was to determine the impact of maternal nutritional deficiencies on cerebral flow and peripheral hemodynamics after ischemic stroke in adult offspring. Adult female C57BL/6J mice were placed on either control (CD), choline (ChDD) or folic acid (FADD) deficient diets for four weeks to deplete stores prior to mating and were maintained on the assigned diet during pregnancy and lactation. Female offspring were weaned on to a CD for the duration of the study. Ischemic stroke was induced in the sensorimotor cortex of 2- and 10-month-old female offspring using the photothrombosis model. Six weeks after induction of stroke, cerebral and peripheral blood flow was measured using the Vevo2100 Pulse Wave Doppler tracing modality. Three and half-month-old female offspring from a ChDD mothers had reduced blood flow in the posterior cerebral artery compared to CD mice, this effect disappeared in 11.5-month-old offspring. In 11.5-month-old females we observed changes in peripheral hemodynamics, but not in young animals. The findings of our study suggest that a maternal dietary deficiency in choline results in reduced blood flow in adult female offspring after ischemic stroke, but the long-term effects are not present. This result points to the key role of the maternal diet in early life neuro-programming, while emphasizing its effects on both fetal development and long-term cerebrovascular health.

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Febbraio 2023

Abstract WP9: Number Needed To Treat With Intravenous Tenecteplase To Reduce The Need For Mechanical Thrombectomy In Large Vessel Occlusion Acute Ischemic Stroke Patients: Real-world Experience Data.

Stroke, Volume 54, Issue Suppl_1, Page AWP9-AWP9, February 1, 2023. Objective:We sought to describe short term outcomes in patients with large vessel occlusion acute ischemic stroke (LVOAIS) who were treated with intravenous tenecteplase (TNK) as compared to alteplase, focusing on reduction in the need for mechanical thrombectomy (MT).Background:In LVOAIS, TNK has shown improved reperfusion and outcomes with a similar safety profile to alteplase. Ultra-early reperfusion has been described with TNK which would prevent the need for MT. We analyze the magnitude of this effect in a “real-world” setting.Design/Methods:In this retrospective study, demographic, clinical, and imaging information from patients with LVOAIS treated with intravenous thrombolysis was collected. Data was compared between the group treated with TNK and alteplase.Results:One hundred eighty-six patients met the criteria for the study (LVOAIS and candidates for IV thrombolysis and MT). Of these, 144 patients received tPA and 42 received TNK. Nine had clinical improvement prior to groin puncture and did not require angiography. This phenomenon occurred in 2.1% who received IV tPA and 14.3% who received TNK (p=0.005). For 8.2 patients treated with TNK rather than tPA, one catheter angiography would be prevented. When combining the number of patients who had recanalization on angiography before MT, and those who had clinical improvement prior to angiography, there were a total of 23 patients. This was noted in 9.7% of patients who received tPA, and 21.4% of those who received TNK (p=0.043). For 8.5 patients treated with TNK rather than tPA, one patient will have spontaneous recanalization either angiographically or with clinical improvement, preventing the need for MT.Conclusions:Intravenous TNK in patients with LVOAIS reduces the need for catheter angiography and mechanical thrombectomy.

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Febbraio 2023