Development of an automated system for clinical study recruitment

Introduction The AFTER AKI study was developed to evaluate implementation of a clinical decision support initiative for acute kidney injury patients. Recruitment relies on staff observing changes in serum creatinine, discussing the study with patients, and then alerting study personnel for consenting patients – a process that misses many eligible patients. Objectives and Approach To improve the efficiency of patient recruitment, we sought to develop an automated system to alert nurses on participating wards when patients on their wards met the study criteria with minimal risk of a data breech. To accomplish this, data from several databases were linked: • Calgary Laboratory Services (CLS; a subsidiary of Alberta Health Services (AHS)) • Data refreshed daily to capture serum creatinine labs • AHS Analytics Data Warehouse • Admission/Discharge/Transfer (ADT) data to determine patient location in hospital on previous day • Discharge Abstract Database (DAD) to exclude patients with prior renal transplant Results The data were linked using the following process: • Daily procedure scheduled to flag patients who met the lab criteria on the previous day using CLS laboratory data. • The identified patients were located by hospital and ward using ADT data, and to exclude patients with a prior renal transplant. Only non-transplant patients located one of the study wards were retained. • Cumulative patient list updated with new patients and dates. • Tableau report created and securely released to ward clerk to enable clerk to view new patients each day for their assigned wards and discuss study with them as an impartial third party. • Consenting patients can then be approached by study personnel to discuss in more detail. Conclusion/Implications A system was successfully created to enable an automated process for patient identification in a clinical trial. Patient privacy was protected by applying user-level security when disseminating reports to ensure that only health care providers within a patient’s ‘circle of care’ had access to necessary information

Health Data Governance for Research Use in Alberta

Alberta has rich clinical and health services data held under the custodianship of Alberta Health and Alberta Health Services (AHS), which is not only used for clinical and administrative purposes but also disease surveillance and epidemiological research. Alberta is the largest province in Canada with a single payer centralised health system, AHS, and a consolidated data and analytics team supporting researchers across the province. This paper describes Alberta's data custodians, data governance mechanisms, and streamlined processes followed for research data access. AHS has created a centralised data repository from multiple sources, including practitioner claims data, hospital discharge data, and medications dispensed, available for research use through the provincial Data and Research Services (DRS) team. The DRS team is integrated within AHS to support researchers across the province with their data extraction and linkage requests. Furthermore, streamlined processes have been established, including: 1) ethics approval from a research ethics board, 2) any necessary operational approvals from AHS, and 3) a tripartite legal agreement dictating terms and conditions for data use, disclosure, and retention. This allows researchers to gain timely access to data. To meet the evolving and ever-expanding big-data needs, the University of Calgary, in partnership with AHS, has built high-performance computing (HPC) infrastructure to facilitate storage and processing of large datasets. When releasing data to researchers, the analytics team ensures that Alberta's Health Information Act's guiding principles are followed. The principal investigator also ensures data retention and disposition are according to the plan specified in ethics and per the terms set out by funding agencies. Even though there are disparities and variations in the data protection laws across the different provinces in Canada, the streamlined processes for research data access in Alberta are highly efficient

The COVID-19 pandemic did not negatively impact frequency or continuity of outpatient care in Alberta, Canada

Abstract Outpatient care patterns have changed markedly during the COVID-19 pandemic. In this population-based retrospective cohort study, we compared the frequency of outpatient care (whether in-person or virtual) and continuity of care for all community-dwelling adults in Alberta between March 1, 2019 and February 29, 2020 (pre-pandemic) versus March 1, 2020 to February 28, 2021 (pandemic). We calculated provider continuity using Breslau’s Usual Provider Continuity (UPC) for patients with at least 2 outpatient encounters. In 2019–20, 594,350 (98.4%) of 603,877 community-dwelling adults with ambulatory care sensitive conditions (ACSC) had $$\ge$$ ≥ 1 outpatient visit (median 8 visits, mean UPC score 0.61, SD 0.23), compared to 566,569 (98.6%) of 574,613 (median 8 visits, mean UPC score 0.67, SD 0.23) during the first year of the pandemic. Similar patterns were seen for adults without ACSC: 2,207,710 (93.9%) of 2,350,147 had $$\ge$$ ≥ 1 outpatient visit (median 3 visits, mean UPC score 0.61, SD 0.24) pre-pandemic compared to 2,113,239 (93.5%, median 4 visits, mean UPC 0.67, SD 0.24) in the first year of the pandemic. Thus, the COVID-19 pandemic did not impact frequency of follow-up while continuity of care improved both for patients with or without ACSC in Alberta, Canada

Resident loneliness, social isolation and unplanned emergency department visits from supportive living facilities: a population-based study in Alberta, Canada

Abstract Background Supportive living (SL) facilities are intended to provide a residential care setting in a less restrictive and more cost-effective way than nursing homes (NH). SL residents with poor social relationships may be at risk for increased health service use. We describe the demographic and health service use patterns of lonely and socially isolated SL residents and to quantify associations between loneliness and social isolation on unplanned emergency department (ED) visits. Methods We conducted a retrospective cohort study using population-based linked health administrative data from Alberta, Canada. All SL residents aged 18 to 105 years who had at least one Resident Assessment Instrument-Home Care (RAI-HC) assessment between April 1, 2013 and March 31, 2018 were observed. Loneliness and social isolation were measured as a resident indicating that he/she feels lonely and if the resident had neither a primary nor secondary caregiver, respectively. Health service use in the 1 year following assessment included unplanned ED visits, hospital admissions, admission to higher levels of SL, admission to NH and death. Multivariable Cox proportional hazard models examined the association between loneliness and social isolation on the time to first unplanned ED visit. Results We identified 18,191 individuals living in Alberta SL facilities. The prevalence of loneliness was 18% (n = 3238), social isolation was 4% (n = 713). Lonely residents had the greatest overall health service use. Risk of unplanned ED visit increased with loneliness (aHR = 1.10, 95% CI: 1.04–1.15) but did not increase with social isolation (aHR = 0.95, 95% CI: 0.84–1.06). Conclusions Lonely residents had a different demographic profile (older, female, cognitively impaired) from socially isolated residents and were more likely to experience an unplanned ED visit. Our findings suggest the need to develop interventions to assist SL care providers with how to identify and address social factors to reduce risk of unplanned ED visits

Beyond the revised cardiac risk index: Validation of the hospital frailty risk score in non-cardiac surgery.

Frailty is an established risk factor for adverse outcomes following non-cardiac surgery. The Hospital Frailty Risk Score (HFRS) is a recently described frailty assessment tool that harnesses administrative data and is composed of 109 International Classification of Disease variables. We aimed to examine the incremental prognostic utility of the HFRS in a generalizable surgical population. Using linked administrative databases, a retrospective cohort of patients admitted for non-cardiac surgery between October 1st, 2008 and September 30th, 2019 in Alberta, Canada was created. Our primary outcome was a composite of death, myocardial infarction or cardiac arrest at 30-days. Multivariable logistic regression was undertaken to assess the impact of HFRS on outcomes after adjusting for age, sex, components of the Charlson Comorbidity Index (CCI), Revised Cardiac Risk Index (RCRI) and peri-operative biomarkers. The final cohort consisted of 712,808 non-cardiac surgeries, of which 55·1% were female and the average age was 53·4 +/- 22·4 years. Using the HFRS, 86.3% were considered low risk, 10·7% were considered intermediate risk and 3·1% were considered high risk for frailty. Intermediate and high HFRS scores were associated with increased risk of the primary outcome with an adjusted odds ratio of 1·61 (95% CI 1·50-1.74) and 1·55 (95% CI 1·38-1·73). Intermediate and high HFRS were also associated with increased adjusted odds of prolonged hospital stay, in-hospital mortality, and 1-year mortality. The HFRS is a minimally onerous frailty assessment tool that can complement perioperative risk stratification in identifying patients at high risk of short- and long-term adverse events

Impact of Rural Residence on Warfarin Use and Clinical Events in Patients with Non-Valvular Atrial Fibrillation: A Canadian Population Based Study.

We studied whether anticoagulant use and outcomes differed between rural versus urban Canadian non-valvular atrial fibrillation (NVAF) patients prior to the introduction of direct oral anticoagulant drugs.Retrospective cohort study of 25,284 adult Albertans with NVAF between April 1, 1999 and December 31, 2008.Compared to urban patients, rural patients were older (p = 0.0009) and had more comorbidities but lower bleeding risk at baseline. In the first year after NVAF diagnosis, urban patients were less likely to be hospitalized (aOR 0.82, 95%CI 0.77-0.89) or have an emergency department visit for any reason (aOR 0.61, 95%CI 0.56-0.66) but warfarin dispensation rates (72.2% vs 71.8% at 365 days, p = 0.98) and clinical outcomes were similar: 7.8% died in both groups, 3.2% rural vs. 2.8% urban had a stroke or systemic embolism (SSE) (aOR 0.92, 95%CI 0.77-1.11), and 6.6% vs. 5.7% (aOR 0.93, 95%CI 0.81-1.06) had a bleed. Baseline SSE risk did not impact warfarin dispensation (73.0% in those with high vs. 72.8% in those with low CHADS2 score, p = 0.85) but patients at higher baseline bleeding risk were less likely to be using warfarin (69.2% high vs. 73.6% low HASBLED score, p<0.0001) in the first 365 days after diagnosis. In warfarin users, bleeding was more frequent (7.5% vs 6.2%, aHR 1.51 [95%CI 1.33-1.72]) but death or SSE was less frequent (7.0% vs 18.1%, aHR 0.60 [0.54-0.66]).Warfarin use and clinical event rates did not differ between rural and urban NVAF patients in a universal access publically-funded healthcare system

Bedtime versus morning use of antihypertensives in frail continuing care residents (BedMed-Frail): protocol for a prospective, randomised, open-label, blinded end-point pragmatic trial

Introduction BedMed-Frail explores risks and benefits of switching antihypertensives from morning to bedtime in a frail population at greater risk of hypotensive adverse effects.Methods and analysis Design: Prospective parallel randomised, open-label, blinded end-point trial.Participants: Hypertensive continuing care residents, in either long-term care or supportive living, who are free from glaucoma, and using ≥1 once daily antihypertensive.Setting: 16 volunteer continuing care facilities in Alberta, Canada, with eligible residents identified using electronic health claims data.Intervention: All non-opted out eligible residents are randomised centrally by the provincial health data steward to bedtime versus usual care (typically morning) administration of once daily antihypertensives. Timing changes are made (maximum one change per week) by usual care facility pharmacists.Follow-up: Via linked governmental healthcare databases tracking hospital, continuing care and community medical services.Primary outcome: Composite of all-cause death, or hospitalisation for myocardial infarction/acute-coronary syndrome, stroke, or congestive heart failure.Secondary outcomes: Each primary outcome element on its own, all-cause unplanned hospitalisation or emergency department visit, non-vertebral fracture and, as assessed roughly 135 days postrandomisation, fall in the last 30 days, deteriorated cognition, urinary incontinence, decubitus skin ulceration, inappropriate or disruptive behaviour a minimum of 4 days per week, and receipt of antipsychotic medication or physical restraints in the last 7 days.Process outcome: Proportion of blood pressure medication doses taken at bedtime (broken down monthly).Primary outcome analysis: Cox-Proportional Hazards Survival Analysis.Sample size: The trial will continue until a projected 368 primary outcome events have occurred.Current status: Enrolment is ongoing with 642 randomisations to date (75% female, mean age 88 years).Ethics and dissemination BedMed-Frail has ethical approval from the University of Alberta Health Ethics Review Board (Pro00086129) and will publish results in a peer-reviewed journal.Trial registration number NCT04054648

Baseline Characteristics of N = 25,284 Rural and Urban Residents with incident non-valvular atrial fibrillation (NVAF).

<p>Table 1 legend</p><p>^a ED represents emergency department; TIA represents transient ischemic attack; GP represents general practitioner.</p><p>Numbers are n (%) unless otherwise specified. P-values are calculated using Chi-Square test (proportion), t-test (mean), or Wilcoxin rank sum test (median)</p><p>Baseline Characteristics of N = 25,284 Rural and Urban Residents with incident non-valvular atrial fibrillation (NVAF).</p