Re-Purposing the Ordering of Routine Laboratory Tests in Hospitalized Medical Patients (RePORT): protocol for a multicenter stepped-wedge cluster randomised trial to evaluate the impact of a multicomponent intervention bundle to reduce laboratory test over-utilization.

BACKGROUND: Laboratory test overuse in hospitals is a form of healthcare waste that also harms patients. Developing and evaluating interventions to reduce this form of healthcare waste is critical. We detail the protocol for our study which aims to implement and evaluate the impact of an evidence-based, multicomponent intervention bundle on repetitive use of routine laboratory testing in hospitalized medical patients across adult hospitals in the province of British Columbia, Canada. METHODS: We have designed a stepped-wedge cluster randomized trial to assess the impact of a multicomponent intervention bundle across 16 hospitals in the province of British Columbia in Canada. We will use the Knowledge to Action cycle to guide implementation and the RE-AIM framework to guide evaluation of the intervention bundle. The primary outcome will be the number of routine laboratory tests ordered per patient-day in the intervention versus control periods. Secondary outcome measures will assess implementation fidelity, number of all common laboratory tests used, impact on healthcare costs, and safety outcomes. The study will include patients admitted to adult medical wards (internal medicine or family medicine) and healthcare providers working in these wards within the participating hospitals. After a baseline period of 24 weeks, we will conduct a 16-week pilot at one hospital site. A new cluster (containing approximately 2-3 hospitals) will receive the intervention every 12 weeks. We will evaluate the sustainability of implementation at 24 weeks post implementation of the final cluster. Using intention to treat, we will use generalized linear mixed models for analysis to evaluate the impact of the intervention on outcomes. DISCUSSION: The study builds upon a multicomponent intervention bundle that has previously demonstrated effectiveness. The elements of the intervention bundle are easily adaptable to other settings, facilitating future adoption in wider contexts. The study outputs are expected to have a positive impact as they will reduce usage of repetitive laboratory tests and provide empirically supported measures and tools for accomplishing this work. TRIAL REGISTRATION: This study was prospectively registered on April 8, 2024, via ClinicalTrials.gov Protocols Registration and Results System (NCT06359587). https://classic. CLINICALTRIALS: gov/ct2/show/NCT06359587?term=NCT06359587&recrs=ab&draw=2&rank=1.

Emergency Department Use Among Adults Receiving Dialysis.

Importance: People with kidney failure receiving maintenance dialysis visit the emergency department (ED) 3 times per year on average, which is 3- to 8-fold more often than the general population. Little is known about the factors that contribute to potentially preventable ED use in this population. Objective: To identify the clinical and sociodemographic factors associated with potentially preventable ED use among patients receiving maintenance dialysis. Design, Setting, and Participants: This cohort study used linked administrative health data within the Alberta Kidney Disease Network to identify adults aged 18 years or older receiving maintenance dialysis (ie, hemodialysis or peritoneal dialysis) between April 1, 2010, and March 31, 2019. Patients who had been receiving dialysis for more than 90 days were followed up from cohort entry (defined as dialysis start date plus 90 days) until death, outmigration from the province, receipt of a kidney transplant, or end of study follow-up. The Andersen behavioral model of health services was used as a conceptual framework to identify variables related to health care need, predisposing factors, and enabling factors. Data were analyzed in March 2024. Main Outcomes and Measures: Rates of all-cause ED encounters and potentially preventable ED use associated with 4 kidney disease-specific ambulatory care-sensitive conditions (hyperkalemia, heart failure, volume overload, and malignant hypertension) were calculated. Multivariable negative binomial regression models were used to examine the association between clinical and sociodemographic factors and rates of potentially preventable ED use. Results: The cohort included 4925 adults (mean [SD] age, 60.8 [15.5] years; 3071 males [62.4%]) with kidney failure receiving maintenance hemodialysis (3183 patients) or peritoneal dialysis (1742 patients) who were followed up for a mean (SD) of 2.5 (2.0) years. In all, 3877 patients had 34 029 all-cause ED encounters (3100 [95% CI, 2996-3206] encounters per 1000 person-years). Of these, 755 patients (19.5%) had 1351 potentially preventable ED encounters (114 [95% CI, 105-124] encounters per 1000 person-years). Compared with patients with a nonpreventable ED encounter, patients with a potentially preventable ED encounter were more likely to be in the lowest income quintile (38.8% vs 30.9%; P < .001); to experience heart failure (46.8% vs 39.9%; P = .001), depression (36.6% vs 32.5%; P = .03), and chronic pain (60.1% vs 54.9%; P = .01); and to have a longer duration of dialysis (3.6 vs 2.6 years; P < .001). In multivariable regression analyses, potentially preventable ED use was higher for younger adults (incidence rate ratio [IRR], 1.69 [95% CI, 1.33-2.15] for those aged 18 to 44 years) and patients with chronic pain (IRR, 1.35 [95% CI, 1.14-1.61]), greater material deprivation (IRR, 1.57 [95% CI, 1.16-2.12]), a history of hyperkalemia (IRR, 1.31 [95% CI, 1.09-1.58]), and historically high ED use (ie, ≥3 ED encounters in the prior year; IRR, 1.46 [95% CI, 1.23-1.73). Conclusions and Relevance: In this study of adults receiving maintenance dialysis in Alberta, Canada, among those with ED use, 1 in 5 had a potentially preventable ED encounter; reasons for such encounters were associated with both psychosocial and medical factors. The findings underscore the need for strategies that address social determinants of health to avert potentially preventable ED use in this population.

Health system structure and its influence on outcomes: The Canadian experience.

Healthcare delivery systems in Canada are structured using three models: individual institutions, health regions, and single provincial systems, usually with smaller geographic zones. The comparative ability of these models to improve care, outcomes, and the Quadruple Aim is largely unstudied. We reviewed Canadian studies examining outcomes of provincial healthcare delivery system restructuring. Across models, results were inconsistent, and quality of evidence was low. For all provinces, primary care sits outside healthcare delivery systems, with limited governance and integration. The single provincial model can reduce costs of non-clinical support functions like finance, human resources, and analytics. This model may also be best at reducing variations in care, improving electronic information integration that enables clinical decision support and reporting, and supporting the provincial spread and scale of innovations, but further refinements are required and existing studies have major limitations, limiting definitive conclusions.

The Association Between Intradialytic Symptom Clusters and Recovery Time in Patients Undergoing Maintenance Hemodialysis: An Exploratory Analysis.

Background: Individuals receiving hemodialysis often experience concurrent symptoms during treatment and frequently report feeling unwell after dialysis. The degree to which intradialytic symptoms are related, and which specific symptoms may impair health-related quality of life (HRQoL) is uncertain. Objectives: To explore intradialytic symptoms clusters, and the relationship between intradialytic symptom clusters with dialysis treatment recovery time and HRQoL. Design/setting: We conducted a post hoc analysis of a prospective cohort study of 118 prevalent patients receiving hemodialysis in two centers in Calgary, Alberta and Hamilton, Ontario, Canada. Participants: Adults receiving hemodialysis treatment for at least 3 months, not scheduled for a modality change within 6 weeks of study commencement, who could provide informed consent and were able to complete English questionnaires independently or with assistance. Methods: Participants self-reported the presence (1 = none to 5 = very much) of 10 symptoms during each dialysis treatment, the time it took to recover from each treatment, and weekly Kidney Disease Quality of Life 36-Item-Short Form (KDQoL-36) assessments. Principal component analysis identified clusters of intradialytic symptoms. Mixed-effects, ordinal and linear regression examined the association between symptom clusters and recovery time (categorized as 0, >0 to 2, >2 to 6, or >6 hours), and the physical component and mental component scores (PCS and MCS) of the KDQoL-36. Results: One hundred sixteen participants completed 901 intradialytic symptom questionnaires. The most common symptom was lack of energy (56% of treatments). Two intradialytic symptom clusters explained 39% of the total variance of available symptom data. The first cluster included bone or joint pain, muscle cramps, muscle soreness, feeling nervous, and lack of energy. The second cluster included nausea/vomiting, diarrhea and chest pain, and headache. The first cluster (median score: -0.56, 25th to 75th percentile: -1.18 to 0.55) was independently associated with longer recovery time (odds ratio [OR] 1.62 per unit difference in score, 95% confidence interval [CI]: 1.23-2.12) and decreased PCS (-0.72 per unit difference in score, 95% CI: -1.29 to -0.15) and MCS scores (-0.82 per unit difference in score, 95% CI: -1.48 to -0.16), whereas the second cluster was not (OR 1.24, 95% CI: 0.97-1.58; PCS 0.19, 95% CI -0.46 to 0.83; MCS -0.72, 95% CI: -1.50 to 0.06). Limitations: This was an exploratory analysis of a small data set from 2 centers. Further work is needed to externally validate these findings to confirm intradialytic symptom clusters and the generalizability of our findings. Conclusions: Intradialytic symptoms are correlated. The presence of select intradialytic symptoms may prolong the time it takes for a patient to recover from a dialysis treatment and impair HRQoL.

Contexte: Il arrive fréquemment que les personnes qui reçoivent des traitements d'hémodialyse éprouvent des symptômes concomitants pendant la dialyze et signalent un malaise après le traitement. On en sait toutefois peu sur le degré de corrélation de ce malaise avec les symptômes intradialytiques et sur les symptômes précis qui peuvent altérer la qualité de vie liée à la santé (QVLS). Objectifs: Explorer différents groupes de symptômes intradialytiques et la relation de ceux-ci avec le temps de récupération post-dialyze et la QVLS. Cadre et conception de l'étude: Nous avons procédé à une analyze post-hoc d'une étude de cohorte prospective portant sur 118 patients prévalents recevant une hémodialyse dans deux centers, soit à Calgary (Alberta) et à Hamilton (Ontario) au Canada. Sujets: Des adultes qui recevaient des traitements d'hémodialyse depuis au moins trois mois ­ sans changement de modalité prévu dans les six semaines suivant le début de l'étude ­ qui pouvaient donner leur consentement éclairé et qui étaient en mesure de remplir des questionnaires en anglais de façon autonome ou avec de l'aide. Méthodologie: Pour chaque traitement de dialyze, les participants devaient autoévaluer le degré de présence (de 1 [non présent] à 5 [très présent]) de dix symptômes et le temps nécessaire pour récupérer de chaque traitement, puis remplir des évaluations hebdomadaires à l'aide du questionnaire KDQoL-36. Une analyze des composantes principales a permis de définir des groupes de symptômes intradialytiques. Une régression à effets mixtes, ordinale et linéaire, a servi à examiner l'association entre les groupes de symptômes et le temps de récupération (0 heure; de 0 à 2 heures; de 2 à 6 hures; plus de 6 heures), et les scores des composantes physiques et psychologiques du KDQoL-36. Résultats: Cent seize patients ont rempli un total de 901 questionnaires sur les symptômes intradialytiques. Le symptôme le plus fréquemment déclaré était le manque d'énergie (56 % des traitements). Deux groupes de symptômes intradialytiques ont expliqué 39 % de la variance totale des données disponibles sur les symptômes. Le premier groupe comprenait des douleurs osseuses ou articulaires, des crampes musculaires, des douleurs musculaires, une sensation de nervosité et un manque d'énergie. Le deuxième groupe comprenait des nausées/vomissements, de la diarrhée, des douleurs thoraciques et des maux de tête. Le premier groupe (score médian : ­0,56; du 25e au 75e percentile : ­1, 18 à 0,55) a été indépendamment associé à un temps de récupération plus long (rapport de cotes : 1,62 par unité de différence de score; IC 95 % : 1,23 à 2,12) et à une diminution des scores des composantes physiques (RC : ­0,72; IC 95 % : ­1, 29 à ­0,15) et des scores des composantes psychologiques (RC : ­0,82; IC 95 % : ­1, 48 à ­0,16). Le deuxième groupe n'a pas été associé avec le temps de récupération (RC : 1,24; IC 95 % : 0,97 à 1,58) ni avec le score des composantes physiques (RC : 0,19; IC 95 % : ­0,46 à 0,83) et les scores des composantes psychologiques (RC : ­0,72; IC 95 % : ­1, 50 à 0,06). Limites: Il s'agissait d'une analyze exploratoire d'un petit ensemble de données provenant de deux centers. D'autres études externes sont nécessaires pour valider ces résultats et, ainsi, confirmer nos groupes de symptômes intradialytiques et la généralisabilité de nos résultats. Conclusion: Les symptômes intradialytiques sont corrélés. La présence de certains symptômes intradialytiques peut prolonger le temps de récupération post-dialyze et altérer la qualité de vie des patients.

The impact of the Starting dialysis on Time, At home on the Right Therapy (START) project on the use of peritoneal dialysis.

BACKGROUND: Peritoneal dialysis (PD) is actively promoted, but increasing PD utilisation is difficult. The objective of this study was to determine if the Starting dialysis on Time, At Home, on the Right Therapy (START) project was associated with an increase in the proportion of dialysis patients receiving PD within 6 months of starting therapy. METHODS: Consecutive patients over age 18, with end-stage kidney failure, who started dialysis between 1 April 2015 and 31 March 2018 in the province of Alberta, Canada. Programmes were provided with high-quality data about the individual steps in the process of care that drive PD utilisation that were used to identify problem areas, design and implement interventions to address them, and then evaluate whether those interventions had impact. The primary outcome was the proportion of patients receiving PD within 6 months of starting dialysis. Secondary outcomes included hospitalisation, death or probability of transfer to haemodialysis (HD). Interrupted time series methodology was used to evaluate the impact of the quality improvement initiative on the primary and secondary outcomes. RESULTS: A total of 1962 patients started dialysis during the study period. Twenty-seven per cent of incident patients received PD at baseline, and there was a 5.4% (95% confidence interval: 1.5-9.2) increase in the use of PD in the province immediately after implementation. There were no changes in the rates of hospitalisation, death or probability of transfer to HD after the introduction of START. CONCLUSIONS: The approach used in the START project was associated with an increase in the use of PD in a setting with high baseline utilisation.

Implementing a Formalized Risk-Based Approach to Determine Candidacy for Multidisciplinary CKD Care: A Descriptive Cohort Study.

Background: The kidney failure risk equation (KFRE) can be used to predict progression to end-stage kidney disease in a clinical setting. Objective: Evaluate implementation of a formalized risk-based approach in nephrologists' outpatient clinics and multidisciplinary chronic kidney disease (CKD) clinics to determine candidacy for multidisciplinary care, and the impact of CKD care selection on clinical outcomes. Design: Population-based descriptive cohort study. Setting: Alberta Kidney Care South. Patients: Adults attending or considered for a multidisciplinary CKD clinic between April 1, 2017, and March 31, 2019. Measurements: Exposure-The course of CKD care assigned by the nephrologist: management at multidisciplinary CKD clinic; management by a nephrologist or primary care physician. Primary Outcome-CKD progression, defined as commencement of kidney replacement therapy (KRT). Secondary Outcomes-Death, emergency department visits, and hospitalizations. Methods: We linked operational data from the clinics (available until March 31, 2019) with administrative health and laboratory data (available until March 31, 2020). Comparisons among patient groups, courses of care, and clinical settings with negative binomial regression count models and calculated unadjusted and fully adjusted incidence rate ratios. For the all-cause death outcome, we used Cox survival models to calculate unadjusted and fully adjusted hazard ratios. Results: Of the 1748 patients for whom a KFRE was completed, 1347 (77%) remained in or were admitted to a multidisciplinary CKD clinic, 310 (18%) were managed by a nephrologist only, and 91 (5%) were referred back for management by their primary care physician. There was a much higher kidney failure risk among patients who remained at or were admitted to a multidisciplinary CKD clinic (median 2-year risk of 34.7% compared with 3.6% and 0.8% who remained with a nephrologist or primary care physician, respectively). None of the people managed by their primary care physician alone commenced KRT, while only 2 (0.6%) managed by a nephrologist without multidisciplinary CKD care commenced KRT. The rates of emergency department visits, hospitalizations, and death were lower in those assigned to management outside the multidisciplinary CKD clinics when compared with those managed in the multidisciplinary care setting. Limitations: The follow-up period may not have been long enough to determine outcomes, and potentially limited generalizability given variability of care in multidisciplinary clinics. Conclusions: Our findings indicate that a portion of patients can be directed to less resource-intensive care without a higher risk of adverse events. Trial registration: Not applicable.

Contexte: L'équation KFRE (Kidney Failure Risk Equation) peut être utilisée en environnement clinique pour prédire le risque d'évolution vers l'insuffisance rénale terminale (IRT). Objectif: Évaluer la mise en œuvre d'une approche structurée fondée sur le risque dans les cliniques multidisciplinaires d'insuffisance rénale chronique (IRC) et les cliniques ambulatoires des néphrologues afin de déterminer l'aptitude des patients à recevoir des soins multidisciplinaires et de mesurer l'incidence des soins d'IRC reçus sur les résultats cliniques. Conception: Étude de cohorte populationnelle descriptive. Cadre: Alberta Kidney Care South. Sujets: Adultes fréquentant ou envisageant de fréquenter une clinique multidisciplinaire d'IRC entre le 1er avril 2017 et le 31 mars 2019. Mesures: Exposition­le parcours de soins d'IRC attribué par le néphrologue ­ prise en charge en clinique multidisciplinaire d'IRC; prise en charge par un néphrologue ou un médecin de premier recours. Principaux résultats­progression de l'IRC, définie comme l'amorce d'une thérapie de remplacement rénal (TRR). Résultats secondaires­décès, visites aux urgences et hospitalisations. Méthodologie: Nous avons couplé les données opérationnelles des cliniques (disponibles jusqu'au 31 mars 2019) aux données administratives de santé et aux données de laboratoire (disponibles jusqu'au 31 mars 2020). Des modèles de régression binomiale négative et des rapports des taux d'incidence non corrigés et entièrement corrigés ont servi aux comparaisons entre les groupes de patients, les parcours de soins et les environnements cliniques. Les risques relatifs non corrigés et entièrement corrigés de décès toutes causes confondues ont été calculés à l'aide de modèles de survie de Cox. Résultats: Des 1 748 patients avec une KFRE calculée, 1 347 (77 %) sont restés ou ont été admis dans une clinique multidisciplinaire d'IRC, 310 (18 %) ont été pris en charge par un néphrologue seulement et 91 (5 %) ont été orientés pour une prise en charge par leur médecin de premier recours. Le risque d'insuffisance rénale terminale était beaucoup plus élevé chez les patients restés ou admis dans une clinique multidisciplinaire d'IRC (risque médian à 2 ans : 34,7 %) que chez ceux pris en charge par un néphrologue (3,6 %) et par un médecin de premier recours (0,8 %). Aucun patient pris en charge par un médecin de premier recours n'avait amorcé une TRR; 2 personnes (0,6 %) prises en charge par un néphrologue sans soins multidisciplinaires d'IRC avaient amorcé une TRR. Les taux de visites aux urgences, d'hospitalisations et de décès étaient plus faibles chez les patients pris en charge à l'extérieur des cliniques multidisciplinaires d'IRC comparativement à ceux pris en charge dans ces cliniques. Limites: La période de suivi n'était peut-être pas été assez longue pour déterminer les résultats. La variabilité des soins dans les cliniques multidisciplinaires pourrait également limiter la généralisation des résultats. Conclusion: Nos résultats suggèrent qu'une partie des patients pourrait être dirigée vers des soins nécessitant moins de ressources sans hausser le risque d'événements indésirables.

Physician Variation and the Impact of Payment Model in Cardiac Imaging.

BACKGROUND: The influence of fee-for-service reimbursement on cardiac imaging has not been compared with other payment models. Furthermore, variation in ordering practices is not well understood. METHODS AND RESULTS: This retrospective, population-based cohort study using linked administrative data from Alberta, Canada included adults with chronic heart disease (atrial fibrillation, coronary artery disease, and heart failure) seen by cardiac specialists for a new outpatient consultation April 2012 to December 2018. Generalized linear mixed-effects models estimated the association of payment model (including the ability to bill to interpret imaging tests) and the use of cardiac imaging and quantified variation in cardiac imaging. Among 31 685 adults seen by 308 physicians at 136 sites, patients received an observed mean of 0.67 (95% CI, 0.67-0.68) imaging tests per consultation. After adjustment, patients seeing fee-for-service physicians had 2.07 (95% CI, 1.68-2.54) and fee-for-service physicians with ability to interpret had 2.87 (95% CI, 2.16-3.81) times the rate of receiving a test than those seeing salaried physicians. Measured patient, physician, and site effects accounted for 31% of imaging variation and, following adjustment, reduced unexplained site-level variation 40% and physician-level variation 29%. CONCLUSIONS: We identified substantial variation in the use of outpatient cardiac imaging related to physician and site factors. Physician payment models have a significant association with imaging use. Our results raise concern that payment models may influence cardiac imaging practice. Similar methods could be applied to identify the source and magnitude of variation in other health care processes and outcomes.

Nurse Practitioner Care Compared with Primary Care or Nephrologist Care in Early CKD.

BACKGROUND: Early interventions in CKD have been shown to improve health outcomes; however, gaps in access to nephrology care remain common. Nurse practitioners can improve access to care; however, the quality and outcomes of nurse practitioner care for CKD are uncertain. METHODS: In this propensity score-matched cohort study, patients with CKD meeting criteria for nurse practitioner care were matched 1:1 on their propensity scores for ( 1 ) nurse practitioner care versus primary care alone and ( 2 ) nurse practitioner versus nephrologist care. Processes of care were measured within 1 year after cohort entry, and clinical outcomes were measured over 5 years of follow-up and compared between propensity score-matched groups. RESULTS: A total of 961 (99%) patients from the nurse practitioner clinic were matched on their propensity score to 961 (1%) patients receiving primary care only while 969 (100%) patients from the nurse practitioner clinic were matched to 969 (7%) patients receiving nephrologist care. After matching to patients receiving primary care alone, those receiving nurse practitioner care had greater use of angiotensin-converting enzyme inhibitors/angiotensin receptor blocker (82% versus 79%; absolute differences [ADs] 3.4% [95% confidence interval, 0.0% to 6.9%]) and statins (75% versus 66%; AD 9.7% [5.8% to 13.6%]), fewer prescriptions of nonsteroidal anti-inflammatory drugs (10% versus 17%; AD -7.2% [-10.4% to -4.2%]), greater eGFR and albuminuria monitoring, and lower rates of all-cause hospitalization (34.1 versus 43.3; rate difference -9.2 [-14.7 to -3.8] per 100 person-years) and all-cause mortality (3.3 versus 6.0; rate difference -2.7 [-3.6 to -1.7] per 100 person-years). When matched to patients receiving nephrologist care, those receiving nurse practitioner care were also more likely to be prescribed angiotensin-converting enzyme inhibitors/angiotensin receptor blockers and statins, with no difference in the risks of experiencing adverse clinical outcomes. CONCLUSIONS: Nurse practitioner care for patients with CKD was associated with better guideline-concordant care than primary care alone or nephrologist care, with clinical outcomes that were better than or equivalent to primary care alone and similar to those with care by nephrologists. PODCAST: This article contains a podcast at https://dts.podtrac.com/redirect.mp3/www.asn-online.org/media/podcast/CJASN/2023_12_08_CJN0000000000000305.mp3.

Patient Perspectives on a Tailored Self-Management Education and Support Intervention for Low-Income Seniors With Chronic Health Conditions.

Background: The Assessing Outcomes of Enhanced Chronic Disease Care Through Patient Education and a Value-based Formulary Study (ACCESS) was a 2 x 2 factorial randomized trial that tested the impact of a tailored self-management education support (SMES) program, which demonstrated a 22% reduction in adverse clinical events. We sought to qualitatively explore participants' perspectives on the SMES intervention, and the ways in which it may have improved self-management skills. Methods: We used a qualitative descriptive approach and conducted individual semistructured interviews. We conducted inductive and deductive thematic analysis using NVivo 12 (QSR International, Burlington, MA). Results: We interviewed 20 participants who had recently completed the 3-year SMES intervention. The following 3 main themes emerged from the data: (i) empowerment; (ii) intervention acceptability; and (iii) suggestions for improvement. Regarding empowerment, we identified subthemes of health literacy, self-efficacy, self-management, and active role in health. Several participants reported that empowerment promoted health behaviour change or improved confidence in self-management. Regarding acceptability, we identified subthemes of ease of use and presentation style. Most participants expressed positive feelings toward the intervention and felt that it was easy to understand. Finally, we identified subthemes of learning style, content, and engagement strategies, within the theme of suggestions for improvement. Some participants said that the messages were too general and did not fully address the complex health concerns they had. Conclusions: Our results highlighted key strategies to promote patient engagement and self-management behaviours and demonstrated how they may have been used to improve clinical endpoints. Additionally, we demonstrated the novel use of marketing principles in SMES interventions.

Contexte: L'étude ACCESS (pour Assessing Outcomes of Enhanced Chronic Disease Care Through Patient Education and a Value-based Formulary Study) était un essai à répartition aléatoire avec un plan factoriel 2 x 2 qui a mesuré l'effet d'un programme personnalisé de soutien à la formation sur l'autogestion dans laquelle une réduction de 22 % des événements cliniques défavorables a été observée. Notre objectif était de réaliser une exploration qualitative du point de vue des patients au sujet de l'intervention et des façons dont elle a permis d'améliorer leurs habiletés d'autogestion. Méthodologie: Nous avons utilisé une approche descriptive et qualitative et nous avons mené des entretiens individuels semi-structurés auprès des participants. Des analyses thématiques inductive et déductive ont été réalisées avec NVivo 12 (QSR International, Burlington MA). Résultats: Des entretiens ont été menés auprès de 20 personnes ayant récemment terminé l'intervention de 3 ans. Les données recueillies ont permis de cerner 3 thèmes principaux : (i) l'autonomisation; (ii) l'acceptabilité de l'intervention; et (iii) les suggestions pour l'amélioration du programme. En ce qui concerne l'autonomisation des patients, nous avons relevé les sous-thèmes de la littératie dans le domaine de la santé, de l'auto-efficacité, de l'autogestion et de la participation active dans le domaine de la santé. Plusieurs participants ont mentionné que l'autonomisation avait favorisé des changements de comportements liés à la santé ou avait amélioré leur niveau de confiance quant à leur autogestion. Pour ce qui est de l'acceptabilité, nous avons noté les sous-thèmes de la facilité d'utilisation et du style des présentations. La plupart des participants ont exprimé une opinion favorable au sujet de l'intervention et la trouvaient facile à comprendre. En dernier lieu, nous avons relevé les thèmes des styles d'apprentissage, du contenu et des stratégies de mobilisation, que nous avons regroupés sous le thème des suggestions d'amélioration. Certains participants ont mentionné que les messages étaient trop généraux et n'abordaient pas leurs préoccupations complexes liées à la santé. Conclusions: Les résultats que nous avons obtenus ont mis en évidence des stratégies clés pour favoriser la participation des patients et leurs comportements d'autogestion et la façon dont elles ont pu améliorer les résultats cliniques de patients. De plus, nous avons démontré une nouvelle utilisation de principes tirés du domaine du marketing dans des interventions de soutien à la formation sur l'autogestion.

Alignment Among Patient, Caregiver, and Health Care Provider Perspectives on Hemodialysis Vascular Access Decision-Making: A Qualitative Study.

Background: Updates to the Kidney Disease Outcomes Quality Initiative Clinical Practice Guideline for Vascular Access emphasize the "right access, in the right patient, at the right time, for the right reasons." Although this implies a collaborative approach, little is known about how patients, their caregivers, and health care providers engage in vascular access (VA) decision-making. Objective: To explore how the perspectives of patients receiving hemodialysis, their caregivers, and hemodialysis care team align and diverge in relation to VA selection. Design: Qualitative descriptive study. Setting: Five outpatient hemodialysis centers in Calgary, Alberta. Participants: Our purposive sample included 19 patients receiving maintenance hemodialysis, 2 caregivers, and 21 health care providers (7 hemodialysis nurses, 6 VA nurses, and 8 nephrologists). Methods: We conducted semi-structured interviews with consenting participants. Using an inductive thematic analysis approach, we coded transcripts in duplicate and characterized themes addressing our research objective. Results: While participants across roles shared some perspectives related to VA decision-making, we identified areas where views diverged. Areas of alignment included (1) optimizing patient preparedness-acknowledging decisional readiness and timing, and (2) value placed on trusting relationships with the kidney care team-respecting decisional autonomy with guidance. Perspectives diverged in the following aspects: (1) differing VA priorities and preferences-patients' emphasis on minimizing disruptions to normalcy contrasted with providers' preferences for fistulas and optimizing biomedical parameters of dialysis; (2) influence of personal and peer experience-patients preferred pragmatic, experiential knowledge, whereas providers emphasized informational credibility; and (3) endpoints for VA review-reassessment of VA decisions was prompted by access dissatisfaction for patients and a medical imperative to achieve a functioning access for health care providers. Limitations: Participation was limited to individuals comfortable communicating in English and from urban, in-center hemodialysis units. Few informal caregivers of people receiving hemodialysis and younger patients participated in this study. Conclusions: Although patients, caregivers, and healthcare providers share perspectives on important aspects of VA decisions, conflicting priorities and preferences may impact the decisional outcome. Findings highlight opportunities to bridge knowledge and readiness gaps and integrate shared decision-making in the VA selection process.

Contexte: Les mises à jour des lignes directrices de pratiques cliniques en matière d'accès vasculaire de la KDOQI (Kidney Disease Outcomes Quality Initiative) insistent sur la création « du bon accès, à la bonne personne, au bon moment et pour les bonnes raisons ¼. Ces recommandations sous-entendent une approche collaborative, mais la façon dont les patients, leurs soignants et les prestataires de soins de santé participent à la prise de décision sur l'accès vasculaire (AV) demeure mal connue. Objectif: Explorer les accords et les divergences dans les points de vue des patients sous hémodialyse, leurs soignants et leur équipe de soins relativement à la sélection de l'AV. Conception: Étude qualitative et descriptive. Cadre: Cinq centres d'hémodialyse ambulatoire à Calgary (Alberta). Sujets: Notre échantillon choisi à dessein était composé de 19 patients sous hémodialyse d'entretien, 2 soignants et 21 prestataires de soins de santé (7 infirmières en hémodialyse, 6 infirmières en AV et 8 néphrologues). Méthodologie: Nous avons mené des entrevues semi-structurées auprès des participants consentants. Une approche d'analyse thématique inductive a été employée pour coder les transcriptions en double et caractériser les thèmes répondant à l'objectif de recherche. Résultats: Certains points de vue sur la prise de décision en matière d'AV étaient partagés par tous les participants, mais nous avons identifié quelques domaines de divergence. Les participants s'entendaient sur : 1) l'optimisation de la préparation des patients ­ reconnaître l'état de préparation et le moment de prendre la décision; et 2) la valeur accordée aux relations de confiance avec l'équipe de soins rénaux ­ respecter l'autonomie décisionnelle après conseils. Les points de vue divergeaient sur : 1) les priorités et préférences à l'égard de l'AV ­ l'accent mis par les patients sur la minimisation des perturbations de la vie courante contrastait avec les préférences des prestataires de soins pour les fistules et l'optimisation des paramètres biomédicaux de la dialyse; 2) l'influence de l'expérience personnelle et des pairs ­ les patients préféraient des connaissances pragmatiques et expérientielles, tandis que les prestataires de soins mettaient l'accent sur la crédibilité de l'information; et 3) les critères d'évaluation de l'AV ­ la réévaluation du choix de l'AV est motivée par l'insatisfaction des patients à l'égard de l'accès et, du côté des prestataires de soins, par l'impératif médical de parvenir à un accès fonctionnel. Limites: Seules les personnes fréquentant une unité d'hémodialyse en centre urbain et à l'aise de communiquer en anglais ont pu participer. Les participants comptaient peu de patients plus jeunes et de soignants informels de personnes sous hémodialyse. Conclusion: Bien que les patients, les soignants et les prestataires de soins de santé s'entendent sur certains aspects importants de la décision concernant l'AV, celle-ci pourrait être influencée par des priorités et préférences contradictoires. Nos résultats mettent en évidence des occasions d'intégrer la prise de décision partagée dans le processus de sélection d'un AV et de combler les lacunes dans les connaissances et la préparation des patients.

A Systems-Level Evaluation Framework for Virtual Care.

The virtual care landscape is significantly changing, largely due to an increased demand initiated by the COVID-19 pandemic and the evolution of technology. Complex questions about how to best leverage virtual care and its impact remain unanswered. Our team developed a systems-level evaluation framework to inform virtual care service design and evaluation to take a more comprehensive approach to planning and implementing virtual care. We designed the framework for application in Alberta Health Services (AHS) by engaging virtual care users (patients, families and healthcare providers), implementation staff and decision makers across the organization. Here we report our design process and key lessons learned. The framework received endorsement by AHS senior leadership for application across the system. Our next step is to test the framework. By sharing our design process and experiences, we aim to help inform other national and international jurisdictions plan virtual care evaluations within their context.

Associations between hearing loss and clinical outcomes: population-based cohort study.

Background: Hearing loss (HL) is a leading cause of disability worldwide, but its clinical consequences and population burden have been incompletely studied. Methods: We did a retrospective population-based cohort study of 4,724,646 adults residing in Alberta between April 1, 2004 and March 31, 2019, of whom 152,766 (3.2%) had HL identified using administrative health data. We used administrative data to identify comorbidity and clinical outcomes, including death, myocardial infarction, stroke/transient ischemic attack, depression, dementia, placement in long-term care (LTC), hospitalization, emergency visits, pressure ulcers, adverse drug events and falls. We used Weibull survival models (binary outcomes) and negative binomial models (rate outcomes) to compare the likelihood of outcomes in those with vs without HL. We calculated population-attributable fractions to estimate the number of binary outcomes associated with HL. Findings: The age-sex-standardized prevalence of all 31 comorbidities at baseline was higher among participants with HL than those without. Over median follow-up of 14.4 y and after adjustment for potential confounders at baseline, participants with HL had higher rates of days in hospital (rate ratio 1.65, 95% CI 1.39, 1.97), falls (RR 1.72, 95% CI 1.59, 1.86), adverse drug events (RR 1.40, 95% CI 1.35, 1.45), and emergency visits (RR 1.21, 95% CI 1.14, 1.28) compared to those without, and higher adjusted hazards of death, myocardial infarction, stroke/transient ischemic attack, depression, heart failure, dementia, pressure ulcers and LTC placement. The estimated number of people with HL who required new LTC placement annually in Canada was 15,631, of which 1023 were attributable to HL. Corresponding estimates for new dementia among people with HL were 14,959 and 4350, and for stroke/TIA the estimates were 11,582 and 2242. Interpretation: HL is common, is often accompanied by substantial comorbidity, and is associated with significant increases in risk for a broad range of adverse clinical outcomes, some of which are potentially preventable. This high population health burden suggests that increased and coordinated investment is needed to improve the care of people with HL. Funding: Canadian Institutes of Health Research; David Freeze chair in health services research.

Effect of Free Medicine Distribution on Health Care Costs in Canada Over 3 Years: A Secondary Analysis of the CLEAN Meds Randomized Clinical Trial.

Importance: Few interventions are proven to reduce total health care costs, and addressing cost-related nonadherence has the potential to do so. Objective: To determine the effect of eliminating out-of-pocket medication fees on total health care costs. Design, Setting, and Participants: This secondary analysis of a multicenter randomized clinical trial using a prespecified outcome took place across 9 primary care sites in Ontario, Canada (6 in Toronto and 3 in rural areas), where health care services are generally publicly funded. Adult patients (≥18 years old) reporting cost-related nonadherence to medicines in the past 12 months were recruited between June 1, 2016, and April 28, 2017, and followed up until April 28, 2020. Data analysis was completed in 2021. Interventions: Access to a comprehensive list of 128 medicines commonly prescribed in ambulatory care with no out-of-pocket costs for 3 years vs usual medicine access. Main Outcome and Measures: Total publicly funded health care costs over 3 years, including costs of hospitalizations. Health care costs were determined using administrative data from Ontario's single-payer health care system, and all costs are reported in Canadian dollars with adjustments for inflation. Results: A total of 747 participants from 9 primary care sites were included in the analysis (mean [SD] age, 51 [14] years; 421 [56.4%] female). Free medicine distribution was associated with a lower median total health care spending over 3 years of $1641 (95% CI, $454-$2792; P = .006). Mean total spending was $4465 (95% CI, -$944 to $9874) lower over the 3-year period. Conclusions and Relevance: In this secondary analysis of a randomized clinical trial, eliminating out-of-pocket medication expenses for patients with cost-related nonadherence in primary care was associated with lower health care spending over 3 years. These findings suggest that eliminating out-of-pocket medication costs for patients could reduce overall costs of health care. Trial Registration: ClinicalTrials.gov Identifier: NCT02744963.

Low-value preoperative cardiac testing before low-risk surgical procedures: a population-based cohort study.

BACKGROUND: Choosing Wisely Canada (CWC) recommends avoiding noninvasive advanced cardiac testing (e.g., exercise stress testing [EST], echocardiography and myocardial perfusion imaging [MPI]) for preoperative assessment in patients scheduled to undergo low-risk noncardiac surgery. In this study, we assessed the temporal trends in testing, overlapping with the introduction of the CWC recommendations in 2014, and patient and provider factors associated with low-value testing. METHODS: In this population-based retrospective cohort study, we used linked health administrative data in Alberta, Canada, to identify adult patients who underwent elective noncardiac surgery between Apr. 1, 2011, and Mar. 31, 2019, who had preoperative noninvasive advanced cardiac tests (EST, echocardiography or MPI) within 6 months before surgery. We included electrocardiography as an exploratory outcome. We excluded patients at high risk using the Revised Cardiac Risk Index (score ≥ 1 considered to indicate high risk), and modelled patient and temporal factors associated with the number of tests. RESULTS: We identified 1 045 896 elective noncardiac operations performed in 798 599 patients and 25 599 advanced preoperative cardiac tests; 2.1% of operations were preceded by advanced cardiac testing. The incidence of testing increased over the study period, and, by 2018/19, patients were 1.3 times (95% confidence interval 1.2-1.4) more likely to receive a preoperative advanced test compared to 2011/12. Urban patients were more likely to receive a preoperative advanced cardiac test than their rural counterparts. Electrocardiography was the most common preoperative cardiac test, preceding 182 128 procedures (17.4%). INTERPRETATION: Preoperative advanced cardiac testing was infrequent in adult Albertans who underwent low-risk elective noncardiac operations. Despite CWC recommendations, the use of some tests appears to be increasing, and there was substantial variation across geographic areas.

Quality improvement strategies for diabetes care: Effects on outcomes for adults living with diabetes.

BACKGROUND: There is a large body of evidence evaluating quality improvement (QI) programmes to improve care for adults living with diabetes. These programmes are often comprised of multiple QI strategies, which may be implemented in various combinations. Decision-makers planning to implement or evaluate a new QI programme, or both, need reliable evidence on the relative effectiveness of different QI strategies (individually and in combination) for different patient populations. OBJECTIVES: To update existing systematic reviews of diabetes QI programmes and apply novel meta-analytical techniques to estimate the effectiveness of QI strategies (individually and in combination) on diabetes quality of care. SEARCH METHODS: We searched databases (CENTRAL, MEDLINE, Embase and CINAHL) and trials registers (ClinicalTrials.gov and WHO ICTRP) to 4 June 2019. We conducted a top-up search to 23 September 2021; we screened these search results and 42 studies meeting our eligibility criteria are available in the awaiting classification section. SELECTION CRITERIA: We included randomised trials that assessed a QI programme to improve care in outpatient settings for people living with diabetes. QI programmes needed to evaluate at least one system- or provider-targeted QI strategy alone or in combination with a patient-targeted strategy. - System-targeted: case management (CM); team changes (TC); electronic patient registry (EPR); facilitated relay of clinical information (FR); continuous quality improvement (CQI). - Provider-targeted: audit and feedback (AF); clinician education (CE); clinician reminders (CR); financial incentives (FI). - Patient-targeted: patient education (PE); promotion of self-management (PSM); patient reminders (PR). Patient-targeted QI strategies needed to occur with a minimum of one provider or system-targeted strategy. DATA COLLECTION AND ANALYSIS: We dual-screened search results and abstracted data on study design, study population and QI strategies. We assessed the impact of the programmes on 13 measures of diabetes care, including: glycaemic control (e.g. mean glycated haemoglobin (HbA1c)); cardiovascular risk factor management (e.g. mean systolic blood pressure (SBP), low-density lipoprotein cholesterol (LDL-C), proportion of people living with diabetes that quit smoking or receiving cardiovascular medications); and screening/prevention of microvascular complications (e.g. proportion of patients receiving retinopathy or foot screening); and harms (e.g. proportion of patients experiencing adverse hypoglycaemia or hyperglycaemia). We modelled the association of each QI strategy with outcomes using a series of hierarchical multivariable meta-regression models in a Bayesian framework. The previous version of this review identified that different strategies were more or less effective depending on baseline levels of outcomes. To explore this further, we extended the main additive model for continuous outcomes (HbA1c, SBP and LDL-C) to include an interaction term between each strategy and average baseline risk for each study (baseline thresholds were based on a data-driven approach; we used the median of all baseline values reported in the trials). Based on model diagnostics, the baseline interaction models for HbA1c, SBP and LDL-C performed better than the main model and are therefore presented as the primary analyses for these outcomes. Based on the model results, we qualitatively ordered each QI strategy within three tiers (Top, Middle, Bottom) based on its magnitude of effect relative to the other QI strategies, where 'Top' indicates that the QI strategy was likely one of the most effective strategies for that specific outcome. Secondary analyses explored the sensitivity of results to choices in model specification and priors.  Additional information about the methods and results of the review are available as Appendices in an online repository. This review will be maintained as a living systematic review; we will update our syntheses as more data become available. MAIN RESULTS: We identified 553 trials (428 patient-randomised and 125 cluster-randomised trials), including a total of 412,161 participants. Of the included studies, 66% involved people living with type 2 diabetes only. Participants were 50% female and the median age of participants was 58.4 years. The mean duration of follow-up was 12.5 months. HbA1c was the commonest reported outcome; screening outcomes and outcomes related to cardiovascular medications, smoking and harms were reported infrequently. The most frequently evaluated QI strategies across all study arms were PE, PSM and CM, while the least frequently evaluated QI strategies included AF, FI and CQI. Our confidence in the evidence is limited due to a lack of information on how studies were conducted.  Four QI strategies (CM, TC, PE, PSM) were consistently identified as 'Top' across the majority of outcomes. All QI strategies were ranked as 'Top' for at least one key outcome. The majority of effects of individual QI strategies were modest, but when used in combination could result in meaningful population-level improvements across the majority of outcomes. The median number of QI strategies in multicomponent QI programmes was three.  Combinations of the three most effective QI strategies were estimated to lead to the below effects:  - PR + PSM + CE: decrease in HbA1c by 0.41% (credibility interval (CrI) -0.61 to -0.22) when baseline HbA1c < 8.3%; - CM + PE + EPR: decrease in HbA1c by 0.62% (CrI -0.84 to -0.39) when baseline HbA1c > 8.3%;  - PE + TC + PSM: reduction in SBP by 2.14 mmHg (CrI -3.80 to -0.52) when baseline SBP < 136 mmHg; - CM + TC + PSM: reduction in SBP by 4.39 mmHg (CrI -6.20 to -2.56) when baseline SBP > 136 mmHg;  - TC + PE + CM: LDL-C lowering of 5.73 mg/dL (CrI -7.93 to -3.61) when baseline LDL < 107 mg/dL; - TC + CM + CR: LDL-C lowering by 5.52 mg/dL (CrI -9.24 to -1.89) when baseline LDL > 107 mg/dL. Assuming a baseline screening rate of 50%, the three most effective QI strategies were estimated to lead to an absolute improvement of 33% in retinopathy screening (PE + PR + TC) and 38% absolute increase in foot screening (PE + TC + Other). AUTHORS' CONCLUSIONS: There is a significant body of evidence about QI programmes to improve the management of diabetes. Multicomponent QI programmes for diabetes care (comprised of effective QI strategies) may achieve meaningful population-level improvements across the majority of outcomes. For health system decision-makers, the evidence summarised in this review can be used to identify strategies to include in QI programmes. For researchers, this synthesis identifies higher-priority QI strategies to examine in further research regarding how to optimise their evaluation and effects. We will maintain this as a living systematic review.

Prediction of major postoperative events after non-cardiac surgery for people with kidney failure: derivation and internal validation of risk models.

BACKGROUND: People with kidney failure often require surgery and experience worse postoperative outcomes compared to the general population, but existing risk prediction tools have excluded those with kidney failure during development or exhibit poor performance. Our objective was to derive, internally validate, and estimate the clinical utility of risk prediction models for people with kidney failure undergoing non-cardiac surgery. DESIGN, SETTING, PARTICIPANTS, AND MEASURES: This study involved derivation and internal validation of prognostic risk prediction models using a retrospective, population-based cohort. We identified adults from Alberta, Canada with pre-existing kidney failure (estimated glomerular filtration rate [eGFR] < 15 mL/min/1.73m2 or receipt of maintenance dialysis) undergoing non-cardiac surgery between 2005-2019. Three nested prognostic risk prediction models were assembled using clinical and logistical rationale. Model 1 included age, sex, dialysis modality, surgery type and setting. Model 2 added comorbidities, and Model 3 added preoperative hemoglobin and albumin. Death or major cardiac events (acute myocardial infarction or nonfatal ventricular arrhythmia) within 30 days after surgery were modelled using logistic regression models. RESULTS: The development cohort included 38,541 surgeries, with 1,204 outcomes (after 3.1% of surgeries); 61% were performed in males, the median age was 64 years (interquartile range [IQR]: 53, 73), and 61% were receiving hemodialysis at the time of surgery. All three internally validated models performed well, with c-statistics ranging from 0.783 (95% Confidence Interval [CI]: 0.770, 0.797) for Model 1 to 0.818 (95%CI: 0.803, 0.826) for Model 3. Calibration slopes and intercepts were excellent for all models, though Models 2 and 3 demonstrated improvement in net reclassification. Decision curve analysis estimated that use of any model to guide perioperative interventions such as cardiac monitoring would result in potential net benefit over default strategies. CONCLUSIONS: We developed and internally validated three novel models to predict major clinical events for people with kidney failure having surgery. Models including comorbidities and laboratory variables showed improved accuracy of risk stratification and provided the greatest potential net benefit for guiding perioperative decisions. Once externally validated, these models may inform perioperative shared decision making and risk-guided strategies for this population.

Self-Management Support Using Advertising Principles for Older Adults With Low Income at High Cardiovascular Risk: A Randomized Controlled Trial.

BACKGROUND: Self-management education and support (SMES) interventions have modest effects on intermediate outcomes for those at risk of cardiovascular disease, but few studies have measured or demonstrated an effect on clinical end points. Advertising for commercial products is known to influence behavior, but advertising principles are not typically incorporated into SMES design. METHODS: This randomized trial studied the effect of a novel tailored SMES program designed by an advertising firm among a population of older adults with low income at high cardiovascular risk in Alberta, Canada. The intervention included health promotion messaging from a fictitious "peer" and facilitated relay of clinical information to patients' primary care provider and pharmacist. The primary outcome was the composite of death, myocardial infarction, stroke, coronary revascularization, and hospitalizations for cardiovascular-related ambulatory care-sensitive conditions. Rates of the primary outcome and its components were compared using negative binomial regression. Secondary outcomes included quality of life (EQ-5D [EuroQoL 5-dimension] index score), medication adherence, and overall health care costs. RESULTS: We randomized 4761 individuals, with a mean age of 74.4 years, of whom 46.8% were female. There was no evidence of statistical interaction (P=0.99) or of a synergistic effect between the 2 interventions in the factorial trial with respect to the primary outcome, which allowed us to evaluate the effect of each intervention separately. Over a median follow-up time of 36 months, the rate of the primary outcome was lower in the group that received SMES compared with the control group (incidence rate ratio, 0.78 [95% CI, 0.61 to 1.00]; P=0.047). No significant between-group changes in quality of life over time were observed (mean difference, 0.0001 [95% CI, -0.018 to 0.018]; P=0.99). The proportion of participants who were adherent to medications was not different between the 2 groups (P=0.199 for statins and P=0.754 for angiotensin-converting enzyme inhibitors/angiotensin receptor blockers). Overall adjusted health care costs did not differ between those receiving SMES and the control group ($2015 [95% CI, -$1953 to $5985]; P=0.320). CONCLUSIONS: For older adults with low income, a tailored SMES program using advertising principles reduced the rate of clinical outcomes compared with usual care. The mechanisms of improvement are unclear and further studies are required. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT02579655.

Eliminating Medication Copayments for Low-Income Older Adults at High Cardiovascular Risk: A Randomized Controlled Trial.

BACKGROUND: One in eight people with heart disease has poor medication adherence that, in part, is related to copayment costs. This study tested whether eliminating copayments for high-value medications among low-income older adults at high cardiovascular risk would improve clinical outcomes. METHODS: This randomized 2×2 factorial trial studied 2 distinct interventions in Alberta, Canada: eliminating copayments for high-value preventive medications and a self-management education and support program (reported separately). The findings for the first intervention, which waived the usual 30% copayment on 15 medication classes commonly used to reduce cardiovascular events, compared with usual copayment, is reported here. The primary outcome was the composite of death, myocardial infarction, stroke, coronary revascularization, and cardiovascular-related hospitalizations over a 3-year follow-up. Rates of the primary outcome and its components were compared using negative binomial regression. Secondary outcomes included quality of life (Euroqol 5-dimension index score), medication adherence, and overall health care costs. RESULTS: A total of 4761 individuals were randomized and followed for a median of 36 months. There was no evidence of statistical interaction (P=0.99) or of a synergistic effect between the 2 interventions in the factorial trial with respect to the primary outcome, which allowed us to evaluate the effect of each intervention separately. The rate of the primary outcome was not reduced by copayment elimination, (521 versus 533 events, incidence rate ratio 0.84 [95% CI, 0.66-1.07], P=0.162). The incidence rate ratio for nonfatal myocardial infarction, nonfatal stroke, and cardiovascular death (0.97 [95% CI, 0.67-1.39]), death (0.94 [95% CI, 0.80 to 1.11]), and cardiovascular-related hospitalizations (0.78 [95% CI, 0.57 to 1.06]) did not differ between groups. No significant between-group changes in quality of life over time were observed (mean difference, 0.012 [95% CI, -0.006 to 0.030], P=0.19). The proportion of participants who were adherent to statins was 0.72 versus 0.69 for the copayment elimination versus usual copayment groups, respectively (mean difference, 0.03 [95% CI, 0.006-0.06], P=0.016). Overall adjusted health care costs did not differ ($3575 [95% CI, -605 to 7168], P=0.098). CONCLUSIONS: In low-income adults at high cardiovascular risk, eliminating copayments (average, $35/mo) did not improve clinical outcomes or reduce health care costs, despite a modest improvement in adherence to medications. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT02579655.