Multimorbidity, Management of COPD and Health Outcomes among Medicaid Beneficiaries

Chronic Obstructive Pulmonary Disease (COPD) is characterized by persistent and progressive airflow limitation caused due to chronic inflammation in the lungs. Approximately 15 million adults in the United States (U.S.) are estimated to be diagnosed with COPD and an equal number may have undiagnosed COPD. Challenges to COPD management include high prevalence of inflammation-related multimorbidity among individuals with COPD. The association between multimorbidity, existing COPD management and role of novel therapies with anti-inflammatory properties (e.g. statins) in improving COPD-specific outcomes is not well researched. Therefore, the purpose of this study was to use real-world observational data to provide a comprehensive understanding of the relationship between multimorbidity and COPD management as well as assess the effectiveness and safety of statins in terms of COPD management. The specific aims of three studies were to: (1) examine the association between inflammation-related multimorbidity and COPD management in terms of COPD medication receipt, long-acting bronchodilators persistence and COPD-specific outcomes; (2) assess the effectiveness of novel statin therapy in improving COPD-specific outcomes; (3) evaluate the safety of statins and other commonly used medications (antidepressants and inhaled corticosteroids) in terms of new-onset diabetes. This study used a retrospective longitudinal dynamic cohort design using data extracted from multiple years (2005-2008) of Medicaid Analytic eXtract (MAX) files to identify Medicaid beneficiaries with newly diagnosed COPD (n = 19,060). Findings from the first study documented very high prevalence of inflammation-related multimorbidity and indicated that it was significantly associated with reduced COPD-medication utilization and decreased persistence on long-bronchodilators. Our study findings suggest that COPD medication management may be poor due to competing demands arising from the presence of inflammation-related multimorbidity. The results from the study on effectiveness of statins revealed that any statin use improved COPD-specific outcomes compared to no statin use. A closer examination of the data revealed that only those with long-term statin use had better outcomes as compared to those with no statin use. We also found that beneficiaries with inflammation-related multimorbidity and statin use had better COPD-specific outcomes compared to those with multimorbidity and no statin use. From the third study, we found that association between statin use and risk of new-onset diabetes was no longer significant in analyses that controlled for selection bias in unobserved characteristics. Collectively, these findings indicate poor COPD management among those with multimorbidity and emphasize the need for novel therapies to effectively manage COPD. In this context, the current study underscores the advantage of statins in improving COPD-specific clinical and economic outcomes. This study indicate the need of randomized clinical trials and long-term observational studies to establish the efficacy, effectiveness, and safety of novel therapeutic agents in management of COPD

Expanding Paramedicine in the Community (EPIC): study protocol for a randomized controlled trial.

BackgroundThe incidence of chronic diseases, including diabetes mellitus (DM), heart failure (HF) and chronic obstructive pulmonary disease (COPD) is on the rise. The existing health care system must evolve to meet the growing needs of patients with these chronic diseases and reduce the strain on both acute care and hospital-based health care resources. Paramedics are an allied health care resource consisting of highly-trained practitioners who are comfortable working independently and in collaboration with other resources in the out-of-hospital setting. Expanding the paramedic's scope of practice to include community-based care may decrease the utilization of acute care and hospital-based health care resources by patients with chronic disease.Methods/designThis will be a pragmatic, randomized controlled trial comparing a community paramedic intervention to standard of care for patients with one of three chronic diseases. The objective of the trial is to determine whether community paramedics conducting regular home visits, including health assessments and evidence-based treatments, in partnership with primary care physicians and other community based resources, will decrease the rate of hospitalization and emergency department use for patients with DM, HF and COPD. The primary outcome measure will be the rate of hospitalization at one year. Secondary outcomes will include measures of health system utilization, overall health status, and cost-effectiveness of the intervention over the same time period. Outcome measures will be assessed using both Poisson regression and negative binomial regression analyses to assess the primary outcome.DiscussionThe results of this study will be used to inform decisions around the implementation of community paramedic programs. If successful in preventing hospitalizations, it has the ability to be scaled up to other regions, both nationally and internationally. The methods described in this paper will serve as a basis for future work related to this study.Trial registrationClinicalTrials.gov: NCT02034045. Date: 9 January 2014

L'usage secondaire des données médico-administratives afin d’optimiser l’usage des médicaments chez les patients atteints de maladies respiratoires chroniques : adhésion aux médicaments, identification de cas et intensification du traitement

Medication adherence in patients with asthma and chronic obstructive pulmonary disease (COPD) is notoriously low and is associated with suboptimal therapeutic outcomes. To intervene effectively, family physicians need to assess medication adherence efficiently and accurately. Otherwise, failure to detect nonadherence may further reduce patient disease control and result in unnecessary treatment escalation that can increase the risk of adverse events and lead to more complex and costly drug regimens. The overarching goal of this thesis was to investigate how the use of secondary healthcare data can be leveraged to optimize medication adherence in clinical practice. Methodological considerations to facilitate our understanding of treatment escalation in asthma using secondary healthcare data were also examined. In the first part of my doctoral research program, I led a project which aimed at developing e-MEDRESP, a novel web-based tool built from pharmacy claims data that provides to family physicians with objective and easily interpretable information on patient adherence to asthma/COPD medications. This tool was developed in collaboration with family physicians and patients using a framework inspired by user-centered design principles. As part of a feasibility study, e-MEDRESP was subsequently implemented in electronic medical records across several family medicine clinics in Quebec (346 patients, 19 physicians). Findings showed that its integration within physician workflow was feasible. Physicians reported that the tool helped to: 1) better evaluate their patients’ medication adherence; and 2) adjust prescribed therapies, with mean ± sd ratings (5-point Likert scale) of 4.8±0.7 and 4.3±0.9, respectively. A pre-post analysis did not reveal improvement in adherence among patients whose physician consulted e-MEDRESP during a medical visit. However, significant improvements in adherence for inhaled corticosteroids (Proportion of days covered (PDC): 26.4% (95% CI: 14.3-39.3%)) and long-acting muscarinic agents (PDC: 26.4% (95% CI: 12.4-40.2%)) were observed among patients whose adherence level was less than 80% in the 6-month period prior to the medical visit. The second part of this research program consisted of two studies which laid the groundwork to estimate the association between medication adherence and treatment escalation in asthma using Canadian healthcare administrative data, a phenomenon that is currently under-explored in the literature. Prior to embarking in this study, it is important to ensure that healthcare administrative databases can be used to identify asthma patients and treatment escalations in an adequate manner. First, a systematic review was conducted to obtain an overview of the available evidence supporting the validity of algorithms to identify asthma patients in healthcare administrative databases. The algorithm developed by Gershon et al. (Canadian Respiratory Journal, 2009;16(6):183-188) comprising ≥2 ambulatory medical visits or ≥1 hospitalization for asthma over two years had the best trade-off between sensitivity (84 %) and specificity (77%). Second, an operational definition of treatment escalation was developed through a Delphi study that incorporated an expert consensus process. This definition includes 7 steps and was inspired by the 2020 Global for Initiative for Asthma treatment guidelines. I plan to integrate the definitions obtained from these two studies in a future cohort study which aims to examine the association between medication adherence and treatment escalation in asthma. My research provides compelling evidence on the importance of developing and evaluating the feasibility of implementing tools which can aid physicians in assessing medication adherence in clinical practice and extends the literature on treatment escalation in asthma.L’adhésion aux médicaments chez les patients présentant un asthme ou une maladie pulmonaire obstructive chronique (MPOC) est reconnue pour être faible. Pour intervenir efficacement, les médecins de famille doivent évaluer de manière précise l’adhésion aux médicaments. Ne pas détecter la non-adhésion peut réduire davantage la maîtrise de la maladie, entraîner une intensification non-nécessaire du traitement, mener à des schémas pharmacologiques plus complexes et coûteux et par conséquent, augmenter le risque d’événements indésirables. La présente thèse vise à approfondir les connaissances sur l'usage secondaire des données médico-administratives afin d’optimiser l’adhésion et l’usage des médicaments chez les patients atteints de maladies respiratoires chronique, au moyen d’une approche méthodologique mixte de recherche. Plusieurs questions méthodologiques cruciales concernant l’étude de l’intensification du traitement en asthme ont également été abordées. Le premier axe porte sur le développement de l’outil e-MEDRESP, qui s’appuie sur les renouvellements d’ordonnances et qui est conçu pour donner rapidement accès aux médecins de famille à une mesure objective et facilement interprétable de l’adhésion aux médicaments utilisés dans le traitement de l’asthme et de la MPOC. L’outil a été développé en collaboration avec des médecins de famille et des patients à l’aide de groupes de discussion et d’entrevues individuelles. Dans le cadre d’une étude de faisabilité, l’outil e-MEDRESP a été par la suite implanté dans les dossiers médicaux électroniques de plusieurs cliniques de médecine familiale au Québec (346 patients, 19 médecins). Les résultats ont montré que l’intégration de d’e-MEDRESP dans le flux de travail des médecins était faisable. Les médecins ont indiqué que l’outil leur a permis de : 1) mieux évaluer l’adhésion aux médicaments de leurs patients (cote moyenne et écart-type sur une échelle de Likert à 5 points [perception d’accord] de 4,8±0,7); et 2) ajuster les traitements prescrits (4,8±0,7 et 4.3±0,9). Une analyse pré-post n’a pas révélé d’amélioration au niveau de l’adhésion aux médicaments chez les patients dont le médecin a consulté e-MEDRESP lors d’une visite médicale. Toutefois, une amélioration statistiquement significative a été observée chez les patients dont le niveau d’adhésion était inférieur à 80 % au cours de la période de six mois précédant la visite et qui étaient traités par des corticostéroïdes inhalés (Proportion of days covered (PDC) = 26,4 % (IC à 95 % : 14,3-39,3 %) ou des antagonistes muscariniques à action prolongée (PDC = 26,9 % (IC à 95 % : 12,4-40,2 %)). Le deuxième axe présente des travaux préparatoires à la conduite d’une cohorte qui sera réalisée à partir de bases de données médico-administratives et qui aura comme objectif d’estimer l’association entre l’adhésion aux médicaments et l’intensification du traitement de l’asthme, une question peu explorée à ce jour. Avant de débuter une telle étude, il est important de s’assurer que les bases de données médico-administratives peuvent être utilisées pour identifier de manière adéquate les patients asthmatiques et l’intensification du traitement. Dans un premier temps, une revue systématique a été effectuée pour identifier les données probantes disponibles concernant la validité des algorithmes permettant d’identifier les patients asthmatiques dans les bases de données médico-administratives. L’algorithme qui a été développé par Gershon et coll. (Revue canadienne de pneumologie, 2009; vol. 16, no 6, p. 183-188), qui comprenait deux visites médicales ambulatoires ou une hospitalisation pour asthme sur deux ans, présentait le meilleur compromis entre la sensibilité (84 %) et la spécificité (77 %). Dans un second temps, une définition opérationnelle de l’intensification du traitement a été élaborée dans le cadre d’une étude Delphi qui incorporait un processus consensuel d’experts. Cette définition comprend sept étapes et s’inspire des lignes directrices 2020 de l'initiative mondiale de lutte contre l'asthme. Les définitions obtenues à partir de ces deux études seront intégrées dans l’étude de cohorte. Les études constituant cette thèse démontrent l’importance de développer des outils qui permettent aux médecins d’évaluer l’adhésion aux médicaments dans leur pratique clinique, en plus d’enrichir la littérature scientifique médicale sur l’intensification du traitement chez les patients asthmatiques

Enhancing the Identification of Rheumatoid Arthritis-Associated Lung Disease

Rheumatoid arthritis (RA) is a systemic autoimmune disease that predisposes afflicted individuals to reduced quality of life, physical disability, and premature mortality. While joint involvement is the primary manifestation of RA, extra-articular features including lung disease are responsible for a significant portion of the excess mortality. In this dissertation I demonstrate the contribution of chronic lung diseases to premature mortality in RA, contrasting with the more widely recognized comorbidity in RA of cardiovascular disease. Then, I establish that a novel serum biomarker, anti-malondialdehyde-acetaldehyde adduct (MAA) antibody, is associated with the presence of interstitial lung disease (ILD) in RA subjects. Further implicating its role in the pathogenesis of RA-ILD, I will demonstrate the presence of MAA as well as the co-localization of MAA with RA autoantigens and immune effectors cells in the lungs of RA-ILD subjects. Finally, I describe how biomedical informatics algorithms that incorporate multiple ILD diagnosis codes, provider specialty, and diagnostic testing can accurately classify ILD status in RA subjects. Together, these studies advance our ability to identify RA-associated lung diseases across the spectrum of clinical and translational research. These results will pave the way for future clinical and translational research studies to compose biomarker panels that aid in the screening of RA subjects for lung disease, identify pathways that could be targeted for novel therapeutics in RA-ILD, and facilitate the completion of comparative effectiveness and outcomes research studies using real-world data

Effect of a telephonic alert system (Healthy Outlook) for patients with chronic obstructive pulmonary disease: cohort study with matched controls

Background: Healthy Outlook was a telephonic alert system for patients with Chronic Obstructive Pulmonary Disease (COPD) in the United Kingdom. It used routine meteorological and communicable disease reports to identify times of increased risk to health. We tested its effect on hospital use and mortality. Methods: Enrolees with a history of hospital admissions were linked to hospital administrative data. They were compared with control patients from local general practices, matched for demographic characteristics, health conditions, previous hospital use and predictive risk scores. We compared unplanned hospital admissions, admissions for COPD, outpatient attendances, planned admissions and mortality, over 12 months following enrolment. Results: Intervention and matched control groups appeared similar at baseline (n=1,413 in each group). Over the 12 months following enrolment, Healthy Outlook enrolees experienced more COPD admissions than matched controls (adjusted rate ratio 1.26, 95% CI, 1.05 to 1.52) and more outpatient attendances (adjusted rate ratio 1.08, 95% CI 1.03 to 1.12). Enrolees also had lower mortality rates over 12 months (adjusted odds ratio 0.61, 95% CI, 0.45 to 0.84). Conclusion: Healthy Outlook did not reduce admission rates, though mortality rates were lower. Findings for hospital utilisation were unlikely to have been affected by confounding

Geographic accessibility and risk of hospitalization and mortality among patients with chronic respiratory diseases

Spatial differences exist in hospitalization and mortality among patients with Chronic Obstructive Pulmonary Disease (COPD) and asthma. Objective: Examine the association between geographic accessibility, hospitalization, and mortality among COPD and asthma patients in Newfoundland and Labrador (NL). Methods: A retrospective cohort of adults diagnosed with COPD and asthma were followed from diagnosis until hospitalization, death or end of the study. Geographic accessibility was defined using accessibility-remoteness index. Multivariate and geospatial analyses were performed. Result: We identified 44876 (43.8% inaccessible) COPD patients and 28316 asthma patients (37.4% inaccessible). Living in inaccessible areas increased hospitalization incidence for COPD (OR=2.57, 95% CI 1.54-4.25, P<0.00136) and asthma (OR=12.38, 95% CI:6.28-24.46, P<0.001). Mortality was associated with geographic accessibility only for COPD (OR=10.73, 95% CI; 2.27-44.77, P=0.002). COPD hospitalization (MI=0.034, p<0.03), mortality (MI=0.047, p<0.011) and asthma hospitalization (MI=0.065, p<0.001) were spatially autocorrelated. Conclusion: Living with chronic respiratory diseases in NL remote areas increases risk of hospitalization

A Chronic Obstructive Pulmonary Disease Pilot Using Risk Stratification to Improve Resource Allocation and Reduce Readmissions

Background: Chronic Obstructive Pulmonary Disease (COPD) impacts 250 million people, is associated with high hospital readmission rates, and costs over $50 billion annually. Purpose: Apply risk stratification identifying higher risk patients to prioritize complex, time-consuming interventions and resources. Methods: Patients hospitalized with COPD were risk stratified using PEARL. Moderate-high risk patients were referred to specialty nurse practitioners, who used real-time interventions and motivational interviewing during intense weekly visits over 30 days targeting self-management, patient-specific risks, and resources. Results: No patients were readmitted or died during the pilot using risk stratification with patient-specific tertiary preventive care to communicate resource allocation. Impact: This process provided recommendations for expansion throughout the healthcare facility, other chronic health conditions, budgets and policy for value-based care, and further research

ASSOCIATION BETWEEN DISPENSING CHANNEL AND CHRONIC OBSTRUCTIVE PULMONARY DISORDER EXACERBATIONS AMONG MEDICARE BENEFICIARIES

Elderly patients with chronic obstructive pulmonary disease may be at increased risk of exacerbation due to physical and cognitive deficits that make proper inhaled medication adherence more difficult despite consistent medication access. This retrospective study utilized administrative medical and pharmacy claims data to examine the likelihood of having a COPD exacerbation requiring acute medical care by means of an emergency room visit or hospitalization in elderly patients receiving maintenance COPD medications from mail order and retail pharmacies. It was hypothesized that mail order patients would be more likely to experience exacerbations despite differences in medication access when compared to retail patients. The primary outcome of interest was exacerbation frequency expressed as the incidence density rate, and the secondary outcome was the proportion of days covered (PDC). The incidence rate ratio for acute exacerbations was not significantly different for mail order and retail groups, indicating patients using mail-order pharmacies were not significantly more likely to experience an exacerbation requiring acute medical care. Despite insignificant differences in incidence rates, mail order patients had significantly higher adherence rates

Predicting risk of COPD in primary care:development and validation of a clinical risk score

OBJECTIVES: To develop and validate a clinical risk score to identify patients at risk of chronic obstructive pulmonary disease (COPD) using clinical factors routinely recorded in primary care. DESIGN: Case–control study of patients containing one incident COPD case to two controls matched on age, sex and general practice. Candidate risk factors were included in a conditional logistic regression model to produce a clinical score. Accuracy of the score was estimated on a separate external validation sample derived from 20 purposively selected practices. SETTING: UK general practices enrolled in the Clinical Practice Research Datalink (1 January 2000 to 31 March 2006). PARTICIPANTS: Development sample included 340 practices containing 15 159 newly diagnosed COPD cases and 28 296 controls (mean age 70 years, 52% male). Validation sample included 2259 cases and 4196 controls (mean age 70 years, 50% male). MAIN OUTCOME MEASURES: Area under the receiver operator characteristic curve (c statistic), sensitivity and specificity in the validation practices. RESULTS: The model included four variables including smoking status, history of asthma, and lower respiratory tract infections and prescription of salbutamol in the previous 3 years. It had a high average c statistic of 0.85 (95% CI 0.83 to 0.86) and yielded a sensitivity of 63.2% (95% CI 63.1 to 63.3) and specificity 87.4% (95% CI 87.3 to 87.5). CONCLUSIONS: Risk factors associated with COPD and routinely recorded in primary care have been used to develop and externally validate a new COPD risk score. This could be used to target patients for case finding