Developing and evaluating a complex intervention in stroke: using very early mobilisation as an example

Background: Complex interventions, those that incorporate multiple interacting components, are difficult to define, measure and implement. The aim of this research was to develop and evaluate the complex intervention, very early mobilisation (VEM) in acute stroke care. The clinical effectiveness and cost-effectiveness of VEM were evaluated whilst simultaneously considering the implications for future implementation. Methods: A mixed methods approach was used: systematic review, predictive modelling, observational study design, individual patient data meta-analysis, qualitative methods and economic evaluation. Statistical models to accurately predict mobility post-stroke were developed. A multicentre observational study was conducted to establish pre-implementation activity levels of acute stroke patients. Data from two completed and comparable feasibility trials were used to estimate the clinical and economic impact of VEM. A qualitative process evaluation was conducted to identify the barriers and facilitators to implementing VEM, if shown to be effective. Results: Two predictive models were developed with age and stroke type common factors to both. Pre-implementation activity levels were low. Patients who underwent VEM were 3-times more likely to be independent at 3 months than were standard care (SC) patients. The incremental cost-effectiveness ratio associated with VEM in comparison to SC indicated VEM to be potentially cost-effective from a societal perspective. Barriers and facilitators identified for each stage of the stroke pathway and a set of HCPs’ beliefs towards VEM were formulated. Conclusions: This research has adhered to current guidance provided by the Medical Research Council to develop and evaluate VEM. The clinical effectiveness and cost-effectiveness of VEM were estimated. The ongoing A Very Early Rehabilitation Trial phase III will provide definitive evidence for the effectiveness of VEM and the wider consequences for stroke care. This research has provided the support and the foundations for the development of a clear implementation strategy for VEM

Guideline Adherence As An Indicator of the Extent of Antithrombotic Overuse and Underuse: A Systematic Review

Thromboembolic events are a common risk in adults with atrial fibrillation, those with previous cerebrovascular accidents and undergoing emergency or elective surgeries. The widespread availability of antithrombotic agents and differing guidelines contribute to practice variations and increased risk of complications and deaths. The objective of this review was to investigate the extent of overuse and underuse of antithrombotics for primary or secondary prevention as measured by deviation from prescribing guideline recommendations. We conducted a systematic review of Medline and EMBASE for quantitative articles published between 2000 and 2021 and used a modified version of the Hoy's risk of bias assessment tool. Here we report evidence from the past decade about wide practice variations in hospitals and primary care, and discuss clinician and patient-driven determinants of non-adherence to guidelines. Finally, we summarise implications for practice, identify enhanced ways of measuring overuse and underuse, and propose potential solutions to the measurement challenges

Nurse-initiated acute stroke care in emergency departments

Background and Purpose: We aimed to evaluate the effectiveness of an intervention to improve triage, treatment, and transfer for patients with acute stroke admitted to the emergency department (ED). Methods: A pragmatic, blinded, multicenter, parallel group, cluster randomized controlled trial was conducted between July 2013 and September 2016 in 26 Australian EDs with stroke units and tPA (tissue-type plasminogen activator) protocols. Hospitals, stratified by state and tPA volume, were randomized 1:1 to intervention or usual care by an independent statistician. Eligible ED patients had acute stroke \u3c48 hours from symptom onset and were admitted to the stroke unit via ED. Our nurse-initiated T3 intervention targeted (1) Triage to Australasian Triage Scale category 1 or 2; (2) Treatment: tPA eligibility screening and appropriate administration; clinical protocols for managing fever, hyperglycemia, and swallowing; (3) prompt (\u3c4 hours) stroke unit Transfer. It was implemented using (1) workshops to identify barriers and solutions; (2) face-to-face, online, and written education; (3) national and local clinical opinion leaders; and (4) email, telephone, and site visit follow-up. Outcomes were assessed at the patient level. Primary outcome: 90-day death or dependency (modified Rankin Scale score of ≥2); secondary outcomes: functional dependency (Barthel Index ≥95), health status (Short Form [36] Health Survey), and ED quality of care (Australasian Triage Scale; monitoring and management of tPA, fever, hyperglycemia, swallowing; prompt transfer). Intention-to-treat analysis adjusted for preintervention outcomes and ED clustering. Patients, outcome assessors, and statisticians were masked to group allocation. Results: Twenty-six EDs (13 intervention and 13 control) recruited 2242 patients (645 preintervention and 1597 postintervention). There were no statistically significant differences at follow-up for 90-day modified Rankin Scale (intervention: n=400 [53.5%]; control n=266 [48.7%]; P=0.24) or secondary outcomes. Conclusions: This evidence-based, theory-informed implementation trial, previously effective in stroke units, did not change patient outcomes or clinician behavior in the complex ED environment. Implementation trials are warranted to evaluate alternative approaches for improving ED stroke care. Clinical Trial Registration: URL: http://www.anzctr.org.au. Unique identifier: ACTRN1261400093969

Nurse-initiated acute stroke care in emergency departments: The triage, treatment, and transfer implementation cluster randomized controlled trial

Background and Purpose-: We aimed to evaluate the effectiveness of an intervention to improve triage, treatment, and transfer for patients with acute stroke admitted to the emergency department (ED). Methods-: A pragmatic, blinded, multicenter, parallel group, cluster randomized controlled trial was conducted between July 2013 and September 2016 in 26 Australian EDs with stroke units and tPA (tissue-type plasminogen activator) protocols. Hospitals, stratified by state and tPA volume, were randomized 1:1 to intervention or usual care by an independent statistician. Eligible ED patients had acute stroke =2); secondary outcomes: functional dependency (Barthel Index >=95), health status (Short Form [36] Health Survey), and ED quality of care (Australasian Triage Scale; monitoring and management of tPA, fever, hyperglycemia, swallowing; prompt transfer). Intention-to-treat analysis adjusted for preintervention outcomes and ED clustering. Patients, outcome assessors, and statisticians were masked to group allocation. Results-: Twenty-six EDs (13 intervention and 13 control) recruited 2242 patients (645 preintervention and 1597 postintervention). There were no statistically significant differences at follow-up for 90-day modified Rankin Scale (intervention: n=400 [53.5%]; control n=266 [48.7%]; P=0.24) or secondary outcomes. Conclusions-: This evidence-based, theory-informed implementation trial, previously effective in stroke units, did not change patient outcomes or clinician behavior in the complex ED environment. Implementation trials are warranted to evaluate alternative approaches for improving ED stroke care