Browsing by Author "Klarenbach, Scott"
Now showing 1 - 9 of 9
Results Per Page
Sort Options
Item Open Access A cluster randomized controlled trial for the Evaluation of routinely Measured PATient reported outcomes in HemodialYsis care (EMPATHY): a study protocol(2020-08-10) Johnson, Jeffrey A; Al Sayah, Fatima; Buzinski, Robert; Corradetti, Bonnie; Davison, Sara N; Elliott, Meghan J; Klarenbach, Scott; Manns, Braden; Schick-Makaroff, Kara; Short, Hilary; Thomas, Chandra; Walsh, MichaelAbstract Background Kidney failure requiring dialysis is associated with poor health outcomes and health-related quality of life (HRQL). Patient-reported outcome measures (PROMs) capture symptom burden, level of functioning and other outcomes from a patient perspective, and can support clinicians to monitor disease progression, address symptoms, and facilitate patient-centered care. While evidence suggests the use of PROMs in clinical practice can lead to improved patient experience in some settings, the impact on patients’ health outcomes and experiences is not fully understood, and their cost-effectiveness in clinical settings is unknown. This study aims to fill these gaps by evaluating the effectiveness and cost-effectiveness of routinely measuring PROMs on patient-reported experience, clinical outcomes, HRQL, and healthcare utilization. Methods The EMPATHY trial is a pragmatic multi-centre cluster randomized controlled trial that will implement and evaluate the use of disease-specific and generic PROMs in three kidney care programs in Canada. In-centre hemodialysis units will be randomized into four groups, whereby patients: 1) complete a disease-specific PROM; 2) complete a generic PROM; 3) complete both types of PROMs; 4) receive usual care and do not complete any PROMs. While clinical care pathways are available to all hemodialysis units in the study, for the three active intervention groups, the results of the PROMs will be linked to treatment aids for clinicians and patients. The primary outcome of this study is patient-provider communication, assessed by the Communication Assessment Tool (CAT). Secondary outcomes include patient management and symptoms, use of healthcare services, and the costs of implementing this intervention will also be estimated. The present protocol fulfilled the Standard Protocol Items: Recommendations for Intervention Trials (SPIRIT) checklist. Discussion While using PROMs in clinical practice is supported by theory and rationale, and may engage patients and enhance their role in decisions regarding their care and outcomes, the best approach of their use is still uncertain. It is important to rigorously evaluate such interventions and investments to ensure they provide value for patients and health systems. Trial registration Protocol version (1.0) and trial registration data are available on www.clinicaltrials.gov , identifier: NCT03535922 , registered May 24, 2018.Item Open Access Catheter-related blood stream infections in hemodialysis patients: a prospective cohort study(2017-12-08) Thompson, Stephanie; Wiebe, Natasha; Klarenbach, Scott; Pelletier, Rick; Hemmelgarn, Brenda R; Gill, John S; Manns, Braden J; Tonelli, MarcelloAbstract Background For people requiring hemodialysis, infectious mortality is independently associated with geographic distance from a nephrologist. We aimed to determine if differential management of catheter-related blood stream infections (CRBSIs) could explain poorer outcomes. Methods We prospectively collected data from adults initiating hemodialysis with a central venous catheter between 2005 and 2015 in Alberta, Canada. We collected indicators of CRBSI management (timely catheter removal, relapsing bacteremia); frequency of CRBSIs; hospitalizations; predictors of CRBSIs, and bacteremia. We evaluated indicators and infectious episodes as a function of the shortest distance by road to the closest nephrologist’s practice: <50 (referent); 50–99; and ≥100 km. Results One thousand one hundred thirty-one participants were followed for a median of 755 days (interquartile range (IQR) 219, 1465) and used dialysis catheters for a median of 565 days (IQR 176, 1288). Compared to the referent group, there was no significant difference in the rate ratio (RR) of CRBSI in the 50–100 and >100 km distance categories: RR 1.63; 95% confidence interval (CI) (0.91, 2.91); RR 0.84 (95% CI 0.44, 1.58); p = 0.87, respectively or in bacteremia: RR 1.42; (95% CI 0.83, 2.45); RR 0.79 (95% CI 0.45,1.39) p = 0.74, respectively. There were no differences in indicators of appropriate CRBSI management or hospitalizations according to distance. The overall incidence of CRBSIs was low (0.19 per 1000 catheter days) as was the frequency of relapse. Only liver disease was independently associated with CRBSI (RR 2.11; 95% CI 1.15, 3.86). Conclusions The frequency and management of CRBSIs did not differ by location; however, event rates were low.Item Open Access Correction to: Patient-reported outcome measures in the care of in-centre hemodialysis patients(2021-11-03) Davison, Sara N.; Klarenbach, Scott; Manns, Braden; Schick-Makaroff, Kara; Buzinski, Robert; Corradetti, Bonnie; Short, Hilary; Johnson, Jefrey A.Item Open Access Health care costs associated with hospital acquired complications in patients with chronic kidney disease(2017-12-28) Bohlouli, Babak; Jackson, Terri; Tonelli, Marcello; Hemmelgarn, Brenda; Klarenbach, ScottAbstract Background Patients with CKD are at increased risk of potentially preventable hospital acquired complications (HACs). Understanding the economic consequences of preventable HACs, may define the scope and investment of initiatives aimed at prevention. Methods Adult patients hospitalized from April, 2003 to March, 2008 in Alberta, Canada comprised the study cohort. Healthcare costs were determined and categorized into ‘index hospitalization’ including hospital cost and in-hospital physician claims, and ‘post discharge’ including ambulatory care cost, physician claims, and readmission costs from discharge to 90 days. Multivariable regression was used to estimate the incremental healthcare costs associated with potentially preventable HACs. Results In fully adjusted models, the median incremental index hospitalization cost was CAN-$6169 (95% CI; 6003–6336) in CKD patients with ≥1 potentially preventable HACs, compared with those without. Post-discharge incremental costs were 1471(95% CI; 844–2099) in those patients with CKD who developed potentially preventable HACs within 90 days after discharge compared with patients without potentially preventable HACs. Additionally, the incremental costs associated with ≥1 potentially preventable HACs within 90 days from admission in patients with CKD were $7522 (95% CI; 7219–7824). A graded relation of the incremental costs was noted with the increasing number of complications. In patients without CKD but with ≥1 preventable HACs incremental costs within 90 days from hospital admission was $6688 (95% CI: 6612–6723). Conclusions Potentially preventable HACs are associated with substantial increases in healthcare costs in people with CKD. Investment in implementing targeted strategies to reduce HACs may have a significant benefit for patient and health system outcomes.Item Open Access Overview of the Alberta Kidney Disease Network(BioMed Central, 2009-10-19) Hemmelgarn, Brenda; Clement, Fiona; Manns, Braden J.; Klarenbach, Scott; James, Matthew T.; Ravani, Pietro; Pannu, Neesh; Ahmed, Sofia B; MacRae, Jennifer; Scott-Douglas, Nairne; Jindal, Kailash; Quinn, Robert; Culleton, Bruce F.; Wiebe, Natasha; Krause, Richard; Thorlacius, Laurel; Tonelli, MarcelloItem Open Access Patient-reported outcome measures in the care of in-centre hemodialysis patients(2021-10-12) Davison, Sara N.; Klarenbach, Scott; Manns, Braden; Schnick-Makaroff, Kara; Buzinski, Robert; Corradetti, Bonnie; Short, Hilary; Johnson, Jeffrey A.Abstract Kidney failure requiring dialysis is associated with high symptom burden and low health-related quality of life (HRQL). Patient-reported outcome measures (PROMs) are standardized instruments that capture patients’ symptom burden, level of functioning, and HRQL. The routine use of PROMs can be used to monitor aspects of patients’ health that may otherwise be overlooked, inform care planning, and facilitate the introduction of treatments. Incorporating PROMs into clinical practice is an appropriate strategy to engage patients and enhance their role in decisions regarding their care and outcomes. However, the implementation of PROMs measurement and associated interventions can be challenging given the nature of clinical practice in busy hemodialysis units, the variations in organization and clinical workflow across units, as well as regional programs. Implementing PROMs and linking these with actionable treatment aids to alleviate bothersome symptoms and improve patients’ wellbeing is key to improving patients’ health. Other considerations in implementing PROMs within a hemodialysis setting include integration into electronic medical records, purchase and configuration of electronic tools (i.e., tablets), storage and disinfection of such tools, and ongoing IT resources. It is important to train clinicians on the practical elements of using PROMs, however there is also a need to engage clinicians to use PROMs on an ongoing basis. This article describes how PROMs have been implemented at in-centre hemodialysis units in Alberta, Canada, addressing each of these elements.Item Open Access Prevalence of polypharmacy and associated adverse health outcomes in adult patients with chronic kidney disease: protocol for a systematic review and meta-analysis(2021-07-04) Okpechi, Ikechi G.; Tinwala, Mohammed M.; Muneer, Shezel; Zaidi, Deenaz; Ye, Feng; Hamonic, Laura N.; Khan, Maryam; Sultana, Naima; Brimble, Scott; Grill, Allan; Klarenbach, Scott; Lindeman, Cliff; Molnar, Amber; Nitsch, Dorothea; Ronksley, Paul; Shojai, Soroush; Soos, Boglarka; Tangri, Navdeep; Thompson, Stephanie; Tuot, Delphine; Drummond, Neil; Mangin, Dee; Bello, Aminu K.Abstract Background Polypharmacy, often defined as the concomitant use of ≥ 5 medications, has been identified as a significant global public health threat. Aging and multimorbidity are key drivers of polypharmacy and have been linked to a broad range of adverse health outcomes and mortality. Patients with chronic kidney disease (CKD) are particularly at high risk of polypharmacy and use of potentially inappropriate medications given the numerous risk factors and complications associated with CKD. The aim of this systematic review will be to assess the prevalence of polypharmacy among adult patients with CKD, and the potential association between polypharmacy and adverse health outcomes within this population. Methods/design We will search empirical databases such as MEDLINE, Embase, Cochrane Library, CINAHL, Web of Science, and PsycINFO and grey literature from inception onwards (with no language restrictions) for observational studies (e.g., cross-sectional or cohort studies) reporting the prevalence of polypharmacy in adult patients with CKD (all stages including dialysis). Two reviewers will independently screen all citations, full-text articles, and extract data. Potential conflicts will be resolved through discussion. The study methodological quality will be appraised using an appropriate tool. The primary outcome will be the prevalence of polypharmacy. Secondary outcomes will include any adverse health outcomes (e.g., worsening kidney function) in association with polypharmacy. If appropriate, we will conduct random effects meta-analysis of observational data to summarize the pooled prevalence of polypharmacy and the associations between polypharmacy and adverse outcomes. Statistical heterogeneity will be estimated using Cochran’s Q and I2 index. Additional analyses will be conducted to explore the potential sources of heterogeneity (e.g., sex, kidney replacement therapy, multimorbidity). Discussion Given that polypharmacy is a major and a growing public health issue, our findings will highlight the prevalence of polypharmacy, hazards associated with it, and medication thresholds associated with adverse outcomes in patients with CKD. Our study will also draw attention to the prognostic importance of improving medication practices as a key priority area to help minimize the use of inappropriate medications in patients with CKD. Systematic review registration PROSPERO registration number: [ CRD42020206514 ].Item Open Access Screening to prevent fragility fractures among adults 40 years and older in primary care: protocol for a systematic review(2019-08-23) Gates, Michelle; Pillay, Jennifer; Thériault, Guylène; Limburg, Heather; Grad, Roland; Klarenbach, Scott; Korownyk, Christina; Reynolds, Donna; Riva, John J; Thombs, Brett D; Kline, Gregory A; Leslie, William D; Courage, Susan; Vandermeer, Ben; Featherstone, Robin; Hartling, LisaAbstract Purpose To inform recommendations by the Canadian Task Force on Preventive Health Care by systematically reviewing direct evidence on the effectiveness and acceptability of screening adults 40 years and older in primary care to reduce fragility fractures and related mortality and morbidity, and indirect evidence on the accuracy of fracture risk prediction tools. Evidence on the benefits and harms of pharmacological treatment will be reviewed, if needed to meaningfully influence the Task Force’s decision-making. Methods A modified update of an existing systematic review will evaluate screening effectiveness, the accuracy of screening tools, and treatment benefits. For treatment harms, we will integrate studies from existing systematic reviews. A de novo review on acceptability will be conducted. Peer-reviewed searches (Medline, Embase, Cochrane Library, PsycINFO [acceptability only]), grey literature, and hand searches of reviews and included studies will update the literature. Based on pre-specified criteria, we will screen studies for inclusion following a liberal-accelerated approach. Final inclusion will be based on consensus. Data extraction for study results will be performed independently by two reviewers while other data will be verified by a second reviewer; there may be some reliance on extracted data from the existing reviews. The risk of bias assessments reported in the existing reviews will be verified and for new studies will be performed independently. When appropriate, results will be pooled using either pairwise random effects meta-analysis (screening and treatment) or restricted maximum likelihood estimation with Hartun-Knapp-Sidnick-Jonkman correction (risk prediction model calibration). Subgroups of interest to explain heterogeneity are age, sex, and menopausal status. Two independent reviewers will rate the certainty of evidence using the GRADE approach, with consensus reached for each outcome rated as critical or important by the Task Force. Discussion Since the publication of other guidance in Canada, new trials have been published that are likely to improve understanding of screening in primary care settings to prevent fragility fractures. A systematic review is required to inform updated recommendations that align with the current evidence base.Item Open Access The evaluating self-management and educational support in severely obese patients awaiting multidisciplinary bariatric care (EVOLUTION) trial: principal results(2017-03-02) Padwal, Raj S; Klarenbach, Scott; Sharma, Arya M; Fradette, Miriam; Jelinski, Susan E; Edwards, Alun; Majumdar, Sumit RAbstract Background In Canada, demand for multidisciplinary bariatric (obesity) care far outstrips capacity. Consequently, prolonged wait times exist that contribute to substantial health impairments. A supportive, educational, self-management intervention (with in-person and web-based versions) for patients wait-listed for bariatric care has already been implemented in Northern and Central Alberta, Canada, but its effectiveness is unknown. The objective of this trial is to evaluate the clinical and economic outcomes of two self-management programs of varying intensity that are currently in use. Methods We conducted a pragmatic, prospective, parallel-arm, randomized controlled trial of 651 wait-listed patients from two regional bariatric programs. Patients were randomized to (1) an in-person, group-based intervention (13 sessions; n = 215) or (2) a web-based intervention (13 modules; n = 225) or (3) control group (printed educational materials; n = 211). After randomization, subjects had 3 months to review the content assigned to them (the intervention period) prior to bariatric clinic entry. The primary outcome was the proportion of patients achieving 5% weight loss at 9 months. Intention-to-treat two-way comparisons were performed and adjusted for baseline age, sex, site and body mass index. Results At baseline, mean age was 40.4 ± 9.8 years, mean weight was 134.7 ± 25.2 kg, mean body mass index was 47.7 ± 7.0 kg/m2 and 83% of participants were female. A total of 463 patients (71%) completed 9 months follow-up. At least 5% weight loss was achieved by 24.2% of those in the in-person strategy, 24.9% for the web-based strategy and 21.3% for controls (adjusted p value = 0.26 for in-person vs. controls, 0.28 for web-based vs. controls, 0.96 for in-person vs. web-based). Absolute and relative (% of baseline) mean weight reductions were 3.7 ± 7.1 kg (2.7 ± 5.4%) for in-person strategy, 2.8 ± 6.7 kg (2.0 ± 4.8%) for web-based and 2.9 ± 8.8 kg (1.9 ± 5.9%) for controls (p > 0.05 for all comparisons). No between-group differences were apparent for any clinical or humanistic secondary outcomes. Total annual costs in Canadian dollars were estimated at $477,000.00 for the in-person strategy, $9456.78 for the web-based strategy and $2270.31 for provision of printed materials. Discussion Two different self-management interventions were no more effective and were more costly than providing printed education materials to severely obese patients. Our findings underscore the need to develop more potent interventions and the importance of comprehensively evaluating self-management strategies before widespread implementation. Trial registration ClinicalTrials.gov, NCT01860131 . Registered 17 May 2013.