Benefit of linking hospital resource information and patient-level stroke registry data

Variation in the delivery of evidence-based care affects outcomes for patients with stroke. A range of hospital (organizational), patient, and clinical factors can affect care delivery. Clinical registries are widely used to monitor stroke care and guide quality improvement efforts within hospitals. However, hospital features are rarely collected. We aimed to explore the influence of hospital resources for stroke, in metropolitan and regional/rural hospitals, on the provision of evidence-based patient care and outcomes. The 2017 National Audit organizational survey (Australia) was linked to patient-level data from the Australian Stroke Clinical Registry (2016–2017 admissions). Regression models were used to assess the associations between hospital resources (based on the 2015 Australian National Acute Stroke Services Framework) and patient care (reflective of national guideline recommendations), as well as 90–180-day readmissions and health-related quality of life. Models were adjusted for patient factors, including the severity of stroke. Fifty-two out of 127 hospitals with organizational survey data were merged with 22 832 Australian Stroke Clinical Registry patients with an admission for a first-ever stroke or transient ischaemic attack (median age 75 years, 55% male, and 66% ischaemic). In metropolitan hospitals (n = 42, 20 977 patients, 1701 thrombolyzed, and 2395 readmitted between 90 and 180 days post stroke), a faster median door-to-needle time for thrombolysis was associated with ≥500 annual stroke admissions [−15.9 minutes, 95% confidence interval (CI) −27.2, −4.7], annual thrombolysis >20 patients (−20.2 minutes, 95% CI −32.0, −8.3), and having specialist stroke staff (dedicated medical lead and stroke coordinator; −12.7 minutes, 95% CI −25.0, −0.4). A reduced likelihood of all-cause readmissions between 90 and 180 days was evident in metropolitan hospitals using care pathways for stroke management (odds ratio 0.82, 95% CI 0.67–0.99). In regional/rural hospitals (n = 10, 1855 patients), being discharged with a care plan was also associated with the use of stroke clinical pathways (odds ratio 3.58, 95% CI 1.45–8.82). No specific hospital resources influenced 90–180-day health-related quality of life. Relevant to all international registries, integrating information about hospital resources with clinical registry data provides greater insights into factors that influence evidence-based care

An updated systematic review of stroke clinical practice guidelines to inform aphasia management

Background: Aphasia is a common consequence of stroke, and people who live with this condition experience poor outcomes. Adherence to clinical practice guidelines can promote high-quality service delivery and optimize patient outcomes. However, there are currently no high-quality guidelines specific to post-stroke aphasia management. Aims: To identify and evaluate recommendations from high-quality stroke guidelines that can inform aphasia management. Summary of review: We conducted an updated systematic review in accordance with PRISMA guidelines to identify high-quality clinical guidelines published between January 2015 and October 2022. Primary searches were performed using electronic databases: PubMed, EMBASE, CINAHL, and Web of Science. Gray literature searches were conducted using Google Scholar, guideline databases, and stroke websites. Clinical practice guidelines were evaluated using the Appraisal of Guidelines and Research and Evaluation (AGREE II) tool. Recommendations were extracted from high-quality guidelines (scored \u3e 66.7% on Domain 3: “Rigor of Development”), classified as aphasia-specific or aphasia-related, and categorized into clinical practice areas. Evidence ratings and source citations were assessed, and similar recommendations were grouped. Twenty-three stroke clinical practice guidelines were identified and 9 (39%) met our criteria for rigor of development. From these guidelines, 82 recommendations for aphasia management were extracted: 31 were aphasia-specific, 51 aphasia-related, 67 evidence-based, and 15 consensus-based. Conclusion: More than half of stroke clinical practice guidelines identified did not meet our criteria for rigorous development. We identified 9 high-quality guidelines and 82 recommendations to inform aphasia management. Most recommendations were aphasia-related; aphasia-specific recommendation gaps were identified in three clinical practice areas: “accessing community supports,” “return to work, leisure, driving,” and “interprofessional practice.

Development of an electronic health message system to support recovery after stroke: Inspiring Virtual Enabled Resources following Vascular Events (iVERVE)

Purpose: Worldwide, stroke is a leading cause of disease burden. Many survivors have unmet needs after discharge from hospital. Electronic communication technology to support post-discharge care has not been used for patients with stroke. In this paper, we describe the development of a novel electronic messaging system designed for survivors of stroke to support their goals of recovery and secondary prevention after hospital discharge. Participants and methods: This was a formative evaluation study. The design was informed by a literature search, existing data from survivors of stroke, and behavior change theories. We established two working groups; one for developing the electronic infrastructure and the other (comprising researchers, clinical experts and consumer representatives) for establishing the patient-centered program. Following agreement on the categories for the goal-setting menu, we drafted relevant messages to support and educate patients. These messages were then independently reviewed by multiple topic experts. Concurrently, we established an online database to capture participant characteristics and then integrated this database with a purpose-built messaging system. We conducted alpha testing of the approach using the first 60 messages. Results: The initial goal-setting menu comprised 26 subcategories. Following expert review, another 8 goal subcategories were added to the secondary prevention category: managing cholesterol; smoking; physical activity; alcohol consumption; weight management; medication management; access to health professionals, and self-care. Initially, 455 health messages were created by members of working group 2. Following refinement and mapping to different goals by the project team, 980 health messages across the health goals and 69 general motivational messages were formulated. Seventeen independent reviewers assessed the messages and suggested adding 73 messages and removing 16 (2%). Overall, 1,233 messages (18 administrative, 69 general motivation and 1,146 health-related) were created. Conclusion: This novel electronic self-management support system is ready to be pilot tested in a randomized controlled trial in patients with stroke

A mixed-methods feasibility study of a new digital health support package for people after stroke : The Recovery-focused Community support to Avoid readmissions and improve Participation after Stroke (ReCAPS) intervention

Background Evidence for digital health programmes to support people living with stroke is growing. We assessed the feasibility of a protocol and procedures for the Recovery-focused Community support to Avoid readmissions and improve Participation after Stroke (ReCAPS) trial. Methods We conducted a mixed-method feasibility study. Participants with acute stroke were recruited from three hospitals (Melbourne, Australia). Eligibility: Adults with stroke discharged from hospital to home within 10 days, modified Rankin Score 0–4 and prior use of Short Message System (SMS)/email. While in hospital, recruited participants contributed to structured person-centred goal setting and completed baseline surveys including self-management skills and health-related quality of life. Participants were randomised 7–14 days after discharge via REDCap® (1:1 allocation). Following randomisation, the intervention group received a 12-week programme of personalised electronic support messages (average 66 messages sent by SMS or email) aligned with their goals. The control group received six electronic administrative messages. Feasibility outcomes included the following: number of patients screened and recruited, study retainment, completion of outcome measures and acceptability of the ReCAPS intervention and trial procedures (e.g. participant satisfaction survey, clinician interviews). Protocol fidelity outcomes included number of goals developed (and quality), electronic messages delivered, stop messages received and engagement with messages. We undertook inductive thematic analysis of interview/open-text survey data and descriptive analysis of closed survey questions. Results Between November 2018 and October 2019, 312 patients were screened; 37/105 (35%) eligible patients provided consent (mean age 61 years; 32% female); 33 were randomised (17 to intervention). Overall, 29 (88%) participants completed the12-week outcome assessments with 12 (41%) completed assessments in the allocated timeframe and 16 also completing the satisfaction survey (intervention=10). Overall, trial participants felt that the study was worthwhile and most would recommend it to others. Six clinicians participated in one of three focus group interviews; while they reported that the trial and the process of goal setting were acceptable, they raised concerns regarding the additional time required to personalise goals. Conclusion The study protocol and procedures were feasible with acceptable retention of participants. Consent and goal personalisation procedures should be centralised for the phase III trial to reduce the burden on hospital clinicians. Trial registration Australian New Zealand Clinical Trials Registry, ACTRN12618001468213 (date 31/08/2018); Universal Trial Number: U1111-1206-723

Chronic disease management improves survival but not hospital presentations: a target trial approach using linked data from the Australian Stroke Clinical Registry.

Objectives Data linkage can provide sufficient breadth and size of data, to draw reliable estimates of effectiveness, at a population level using real-world data. We compared differences in survival and hospital presentations following stroke or transient ischaemic attack (TIA), based on whether a Medicare funded chronic disease management plan was claimed. Approach A population-based, comparative effectiveness study of Victorian and Queensland Australian Stroke Clinical Registrants (January 2012-June 2015), using the emulated target trial approach, was performed. Chronic disease management items were identified from Medicare claims in the 6-18 months post-stroke (exposure period). Data on covariates for model adjustment were obtained from hospital, pharmacy and aged care datasets. Outcomes at 19-30 months post-stroke were determined using the national death registry and state hospital data. Cox regression, adjusted using propensity score methods with inverse probability treatment weights was used to determine the effect of receipt of chronic disease management claims on outcomes. Results Of 28,775 AuSCR registrants, 27,435 (95.3%) were linked across the Medicare, pharmacy and hospital datasets. Following exclusions, 11,574 registrants from 42 hospitals (42% female, median age 70 years, 27% TIA) were eligible for the study. Overall, 45% of participants received chronic disease management during the exposure period. After propensity score weighting, there was excellent balance between groups across 35 baseline variables (standardised differences <0.1). Receipt of chronic disease management (vs non-receipt) was associated with a 30% reduced hazard of death (adjusted Hazard Ratio [aHR]: 0.70, 95%CI: 0.57, 0.87) but a 17% increase in hospital presentations (aHR: 1.17, 95%CI: 1.12, 1.23). Variation was observed between planned (aHR: 1.21, 95%CI: 1.10, 1.33) and unplanned (aHR: 1.15, 95%CI: 1.07, 1.23) presentations. Conclusion We provide an evaluation of the effectiveness of Medicare funded chronic disease management within “real world” healthcare provision, thereby demonstrating the value of linked population data in health services research. Further work is underway to examine causal mechanisms

Describing hospital utilisation and associated factors following stroke using linked clinical registry and hospital administrative data.

Introduction Survivors of stroke have complex needs from ongoing disabilities and have increased risk of cardiovascular diseases. The societal costs are therefore substantial. Person-level longitudinal data on the longer-term hospital utilizations of patients with stroke in Australia, and the factors that may influence usage in this setting, are rarely reported. Objectives and Approach We used person-level linkages between the Australian Stroke Clinical Registry (AuSCR: 2009-2013) and hospital admission and Emergency Department (ED) data from four states to examine determinants of hospital utilisation following stroke. The index event was the first event recorded in AuSCR. The rate of hospital contacts/person/year was calculated from contacts 30-365 days post-discharge. Disability was determined from responses to EQ-5D-3L data collected at 90-180 days post-stroke. Comorbidities were identified using ICD-10 discharge diagnosis codes (5 year look back including the index event). Negative binomial regression was used adjusting for patient clustering by hospital and pre-stroke contacts and stratified by disability. Results Among 10,082 adults with acute stroke (55% male, median age 74 years, 81% ischaemic, 14% hemorrhagic, 5% undetermined, 44% with disability) from 39 hospitals, 57% had a hospital admission or ED contact in the first 30-365 days post-hospital discharge, with median contacts/person/year post-stroke of 1.09 (Q1, Q3: 0, 3.27) compared to a pre-contact rate of 0 (Q1, Q3: 0, 2.18). The strongest associations with subsequent hospital contacts were prior contacts (IRR:1.10, 95%CI:1.07, 1.13), not able to walk on admission (stroke severity) (IRR:1.19, 95%CI 1.07, 1.31) and having a higher comorbidity index score (IRR:1.18, 95%CI:1.14, 1.22). Within stratified cohorts younger age was associated with increased contacts in those with disability ( Conclusion/Implications In a large linked cohort of patients we have demonstrated the substantial ongoing burden that stroke imposes on hospital systems, particularly regarding survivors with other comorbidities and younger survivors with disability. Knowledge of disability and comorbidity burden may assist with targeting community and hospital interventions to reduce post-stroke hospital usage

High quality linked data for stroke obtained using non-government clinical registry and routinely collected hospital and death data

Introduction Recent advances in data linkage infrastructure in Australia mean that data can be linked based on various identifiers across datasets. In a first for Australia, we tested the feasibility of linking data between a clinical quality disease registry with Australian and state government health data across multiple jurisdictions. Objectives and Approach To determine whether high quality linked data for stroke can be obtained using a non-government managed registry (Australian Stroke Clinical Registry, AuSCR), national death registry data (Australian government), and hospital admission and emergency presentation data (state governments) to assess the accuracy of consistent variables across the different datasets. We used a cohort design with probabilistic data linkage to merge patient-level records. Descriptive statistics presented for matching concordance and Cohen’s kappa for concordance across demographic variables. The sensitivity and specificity of in-hospital deaths collected in the AuSCR was assessed against national death registrations. Results There were 16,214 registrants in the study cohort. Their identifiers in the AuSCR from 2009-2013 were linked with death, emergency department and hospital discharge data from April 2004 to December 2016. In total, 99% of the AuSCR registrants were linked to one or more datasets; 98\% were linked with emergency presentation (80%) and/or admission (95%) data. Linkage to national death registrations identified 4,183 death; 1440 of these were identified as in-hospital deaths in both data sets demonstrating that in-hospital death classification in AuSCR had a 98.7% sensitivity and 99.6% specificity. Concordance between common demographic variables was excellent (kappa 0.84 for aboriginal status and kappa 0.99 for sex). Conclusion/Implications The majority of AuSCR registrants were accurately linked to the Australian and state government datasets. Linkage quality was excellent and there was high concordance between common variables. The ability to reliably merge the datasets assures future comprehensive analyses of stroke care, ongoing health care resource utilisation and patient outcomes

Mixed methods evaluation to explore participant experiences of a pilot randomized trial to facilitate self‐management of people living with stroke: Inspiring virtual enabled resources following vascular events (iVERVE)

Introduction: Despite digital health tools being popular for supporting self‐ management of chronic diseases, little research has been undertaken on stroke. We developed and pilot tested, using a randomized controlled design, a multicomponent digital health programme, known as Inspiring Virtual Enabled Resources following Vascular Events (iVERVE), to improve self‐management after stroke. The 4‐week trial incorporated facilitated person‐centred goal setting, with those in the intervention group receiving electronic messages aligned to their goals, versus limited administrative messages for the control group. In this paper, we describe the participant experience of the various components involved with the iVERVE trial. Methods: Mixed method design: satisfaction surveys (control and intervention) and a focus group interview (purposively selected intervention participants). Experiences relating to goal setting and overall trial satisfaction were obtained from intervention and control participants, with feedback on the electronic message component from intervention participants. Inductive thematic analysis was used for interview data and open‐text responses, and closed questions were summarized descriptively. Triangulation of data allowed participants' perceptions to be explored in depth. Results: Overall, 27/54 trial participants completed the survey (13 intervention: 52%; 14 control: 48%); and 5/8 invited participants in the intervention group attended the focus group. Goal setting: The approach was considered comprehensive, with the involvement of health professionals in the process helpful in developing realistic, meaningful and person‐centred goals. Electronic messages (intervention): Messages were perceived as easy to understand (92%), and the frequency of receipt was considered appropriate (11/13 survey; 4/5 focus group). The content of messages was considered motivational (62%) and assisted participants to achieve their goals (77%). Some participants described the benefits of receiving messages as a ‘reminder’ to act. Overall trial satisfaction: Messages were acceptable for educating about stroke (77%). Having options for short message services or email to receive messages was considered important. Feedback on the length of the intervention related to specific goals, and benefits of receiving the programme earlier after stroke was expressed. Conclusion: The participant experience has indicated acceptance and utility of iVERVE. Feedback from this evaluation is invaluable to inform refinements to future Phase II and III trials, and wider research in the field. Patient or Public Contribution: Two consumer representatives sourced from the Stroke Foundation (Australia) actively contributed to the design of the iVERVE programme. In this study, participant experiences directly contributed to the further development of the iVERVE intervention and future trial design

Protocol of a randomized controlled trial investigating the effectiveness of Recovery-focused Community support to Avoid readmissions and improve Participation after Stroke (ReCAPS)

Rationale: To address unmet needs, electronic messages to support person-centred goal attainment and secondary prevention may avoid hospital presentations/readmissions after stroke, but evidence is limited. Hypothesis: Compared to control participants, there will be a 10% lower proportion of intervention participants who represent to hospital (emergency/admission) within 90 days of randomisation. Methods and design: Multicentre, double-blind, randomised controlled trial with intention-to-treat analysis. The intervention group receives 12 weeks of personalised, goal-centred and administrative electronic messages, while the control group only receives administrative messages. The trial includes a process evaluation, assessment of treatment fidelity and an economic evaluation. Participants: Confirmed stroke (modified Rankin Score: 0-4), aged �18 years with internet/mobile phone access, discharged directly home from hospital. Randomisation: 1:1 computer-generated, stratified by age and baseline disability. Outcomes Assessments: Collected at 90 days and 12 months following randomisation. Outcomes: Primary: Hospital emergency presentations/admissions within 90 days of randomisation. Secondary outcomes include goal attainment, self-efficacy, mood, unmet needs, disability, quality-of-life, recurrent stroke/cardiovascular events/deaths at 90 days and 12 months, and death and cost-effectiveness at 12 months. Sample size: To test our primary hypothesis, we estimated a sample size of 890 participants (445 per group) with 80% power and two-tailed significance threshold of α=0.05. Given uncertainty for the effect size of this novel intervention, the sample size will be adaptively re-estimated when outcomes for n=668 are obtained, with maximum sample capped at 1100. Discussion: We will provide new evidence on the potential effectiveness, implementation and cost-effectiveness of a tailored eHealth intervention for survivors of stroke

Statistical analysis plan for the Recovery-focused Community support to Avoid readmissions and improve Participation after Stroke randomised controlled clinical trial

Background: Unplanned hospital presentations may occur post-stroke due to inadequate preparation for transitioning from hospital to home. The Recovery-focused Community support to Avoid readmissions and improve Participation after Stroke (ReCAPS) trial was designed to test the effectiveness of receiving a 12-week, self-management intervention, comprising personalised goal setting with a clinician and aligned educational/motivational electronic messages. Primary outcome is as follows: self-reported unplanned hospital presentations (emergency department/admission) within 90-day post-randomisation. We present the statistical analysis plan for this trial. Methods/design: Participants are randomised 1:1 in variable block sizes, with stratification balancing by age and level of baseline disability. The sample size was 890 participants, calculated to detect a 10% absolute reduction in the proportion of participants reporting unplanned hospital presentations/admissions, with 80% power and 5% significance level (two sided). Recruitment will end in December 2023 when funding is expended, and the sample size achieved will be used. Logistic regression, adjusted for the stratification variables, will be used to determine the effectiveness of the intervention on the primary outcome. Secondary outcomes will be evaluated using appropriate regression models. The primary outcome analysis will be based on intention to treat. A p-value ≤ 0.05 will indicate statistical significance. An independent Data Safety and Monitoring Committee has routinely reviewed the progress and safety of the trial. Conclusions: This statistical analysis plan ensures transparency in reporting the trial outcomes. ReCAPS trial will provide novel evidence on the effectiveness of a digital health support package post-stroke. Trial registration: ClinicalTrials.gov ACTRN12618001468213. Registered on August 31, 2018. SAP version 1.13 (October 12 2023) Protocol version 1.12 (October 12, 2022) SAP revisions Ni