Reduce Health Care Resource Use Research Articles

Patient Experience of Digitalized Follow-up of Antidepressant Treatment in Psychiatric Outpatient Care: Qualitative Analysis.

Nonadherence to pharmaceutical antidepressant treatment is common among patients with depression. Digitalized follow-up (ie, self-monitoring systems through mobile apps) has been suggested as an effective adjunct to conventional antidepressant treatment to increase medical adherence, improve symptoms of depression, and reduce health care resource use. The aim of this study was to determine patients' experience of digitalized follow-up using a mobile app as an adjunct to treatment concurrent with a new prescription, a change of antidepressant, or a dose increase. This was a qualitative, descriptive study. Patients at 2 psychiatric outpatient clinics were recruited at the time of changing antidepressant medication. After using a mobile app (either a commercial app or a public app) for 4-6 weeks with daily registrations of active data, such as medical intake and questions concerning general mental health status, individual semistructured interviews were conducted. Recorded data were transcribed and then analyzed using content analysis. In total, 13 patients completed the study. The mean age was 35 (range 20-67) years, 8 (61.5%) were female, and all reported high digital literacy. Overall, the emerging themes indicated that the patients found the digital app to be a valuable adjunct to antidepressant treatment but with potential for improvement. Both user adherence and medical adherence were positively affected by a daily reminder and the app's ease of use. User adherence was negatively affected by the severity of depression. The positive experience of visually presented data as graphs was a key finding, which was beneficial for self-awareness, the patient-physician relationship, and user adherence. Finally, the patients had mixed reactions to the app's content and requested tailored content. The patients identified several factors addressing both medical adherence and user adherence to a digital app when using it for digitalized follow-up concurrent with the critical time related to changes in antidepressant medication. The findings highlight the need for rigorous evidence-based empirical studies to generate sustainable research results.

The impact of a point-of-care visual clinical decision support tool on admissions for cellulitis in the University of Maryland medical system.

Cellulitis is commonly diagnosed in emergency departments (EDs), yet roughly one third of ED patients admitted for presumed cellulitis have another, usually benign, condition instead (eg, stasis dermatitis). This suggests there is an opportunity to reduce health care resource use through improved diagnosis at the point of care. This study seeks to test whether a clinical decision support (CDS) tool interoperable with the electronic medical record (EMR) can reduce inappropriate hospital admissions and drive more appropriate and accurate care. This study was a trial of an EMR-interoperable, image-based CDS tool for evaluation of ED patients with suspected cellulitis. At the point of assigning a provisional diagnosis of cellulitis in the EMR, the clinician was randomly prompted to use the CDS. Based on the patient features entered into the CDS by the clinician, the CDS provided the clinician a list of likely diagnoses. The following were recorded: patient demographics, disposition and final diagnosis of patients, and whether antibiotics were prescribed. Logistic regression methods were used to determine the impact of CDS engagement on our primary outcome of admission for cellulitis, adjusted for patient factors. Antibiotic use was a secondary end point. From September 2019 to February 2020 (or 7 months), the CDS tool was deployed in the EMR at 4 major hospitals in the University of Maryland Medical System. There were 1269 encounters for cellulitis during the study period. The engagement with the CDS was low (24.1%, 95/394), but engagement was associated with an absolute reduction in admissions (7.1%, p=0.03). After adjusting for age greater than 65 years, female sex, non-White race, and private insurance, CDS engagement was associated with a significant reduction of admissions (adjusted OR=0.62, 95% confidence interval (CI): 0.40-0.97, p=0.04) and antibiotic use (Adjusted OR=0.63, 95% CI: 0.40-0.99, p=0.04). CDS engagement was associated with decreased admissions for cellulitis and decreased antibiotic use in this study, despite low levels of CDS engagement. Further research should examine the impact of CDS engagement in other practice environments and measure longer-term outcomes in patients discharged from the ED.

EE364 Reduced Healthcare Resource Use in Patients With Chronic Insomnia After Treatment With a Digital Therapeutic With 2-Year Follow-Up

EE364 Reduced Healthcare Resource Use in Patients With Chronic Insomnia After Treatment With a Digital Therapeutic With 2-Year Follow-Up

Clinical Characteristics, Treatment Persistence, and Outcomes Among Patients With COPD Treated With Single- or Multiple-Inhaler Triple Therapy: A Retrospective Analysis in Spain

COPD is a leading cause of death and disability. COPD therapy goals include reducing exacerbations and improving symptom control. Single-inhaler triple therapy (SITT) or multiple-inhaler triple therapy (MITT) is indicated for patients with frequent exacerbations despite bronchodilator therapy. No available evidence compares SITT vsMITT in Spain in terms of treatment persistence, exacerbations, and other outcomes. Do COPD patients in Spain initiating SITT vsMITT have improved persistence, exacerbations, and health care resource utilization? This real-world, observational, retrospective cohort study analyzed electronic health records in the Spanish National Healthcare System BIG-PAC database to identify COPD patients aged≥ 40 years initiating SITT or MITT (using two or three inhalers) between June 1, 2018 and December 31, 2019. Comparative data on persistence (allowing up to 60days without prescription refill), exacerbation rates, and health care resource utilization and costs during 12-month follow-up were analyzed. Multivariate adjusted analyses were performed. Eligible patients (N= 4,625) initiating SITT (n= 1,011) or MITT (n= 3,614) had a mean age of 70.9 years; most were male (73.9%) with mainly moderate (62.0%) or severe (26.5%) airflow limitation. Between-cohort baseline characteristics were similar. At 12-month follow-up, SITT patients had higher persistence (hazard ratio [HR]= 1.37; 95%CI= 1.22-1.53; P< .001), reduced risk of exacerbations (HR= 0.68; 95%CI= 0.61-0.77; P= .001), and lower all-cause mortality risk (HR= 0.67; 95%CI= 0.63-0.71, P= .027), compared with MITT patients. SITT was associated with significantly reduced health care resource use (mean annual cost savings: €403 vsMITT). For both SITT and MITT, persistence was associated with improved exacerbation rates vsnonpersistence, and substantial adjusted mean annual cost savings (€2,115 and €2,700, respectively). Patients initiating SITT had a clinically relevant improvement in persistence leading to reductions in mortality, incidence of exacerbations, and health care resource use with consequent mean cost savings.

Kidney Transplantation 2: Care of the Kidney Transplant Recipient

Renal transplantation is the preferred therapy for patients with end-stage kidney disease, leading to increased life expectancy, improved quality of life, and reduced health care resource use. Owing to their preexisting burden of disease, caring for renal transplant recipients is complex. Patient management following successful renal transplantation involves a multifactorial approach to cardiovascular risk factor management, along with titration of immunosuppression, management of complications related to immunosuppression, and active monitoring of allograft function. Recent advances in immunosuppressive management hold promise for improved long-term allograft survival. Finally, immune monitoring of transplant recipients is an area of considerable research, with the ultimate aim of individualized management of immunosuppression and the ability to induce transplant-specific tolerance. This review contains 7 figures, 11 tables, and 119 references. Key words: cardiovascular disease, drug interactions, immunosuppression, infection, interstitial fibrosis and tubular atrophy, malignancy, rejection, tolerance

Kidney Transplantation 2: Care of the Kidney Transplant Recipient

Renal transplantation is the preferred therapy for patients with end-stage kidney disease, leading to increased life expectancy, improved quality of life, and reduced health care resource use. Owing to their preexisting burden of disease, caring for renal transplant recipients is complex. Patient management following successful renal transplantation involves a multifactorial approach to cardiovascular risk factor management, along with titration of immunosuppression, management of complications related to immunosuppression, and active monitoring of allograft function. Recent advances in immunosuppressive management hold promise for improved long-term allograft survival. Finally, immune monitoring of transplant recipients is an area of considerable research, with the ultimate aim of individualized management of immunosuppression and the ability to induce transplant-specific tolerance. This review contains 7 figures, 11 tables, and 119 references. Key words: cardiovascular disease, drug interactions, immunosuppression, infection, interstitial fibrosis and tubular atrophy, malignancy, rejection, tolerance

Kidney Transplantation 2: Care of the Kidney Transplant Recipient

Renal transplantation is the preferred therapy for patients with end-stage kidney disease, leading to increased life expectancy, improved quality of life, and reduced health care resource use. Owing to their preexisting burden of disease, caring for renal transplant recipients is complex. Patient management following successful renal transplantation involves a multifactorial approach to cardiovascular risk factor management, along with titration of immunosuppression, management of complications related to immunosuppression, and active monitoring of allograft function. Recent advances in immunosuppressive management hold promise for improved long-term allograft survival. Finally, immune monitoring of transplant recipients is an area of considerable research, with the ultimate aim of individualized management of immunosuppression and the ability to induce transplant-specific tolerance. This review contains 7 figures, 11 tables, and 119 references. Key words: cardiovascular disease, drug interactions, immunosuppression, infection, interstitial fibrosis and tubular atrophy, malignancy, rejection, tolerance

Phase 3 trial Design of the Hepatocyte Growth Factor Mimetic ANG-3777 in Renal Transplant Recipients With Delayed Graft Function

IntroductionOne-third of kidney transplantation patients experience acute kidney injury (AKI) resulting in delayed graft function (DGF), associated with increased risk of graft failure and mortality. Preclinical and phase 2 data indicate that treatment with ANG-3777 (formerly BB3), a hepatocyte growth factor (HGF) mimetic, may improve long-term kidney function and reduce health care resource use and cost, but these data require validation in a phase 3 randomized controlled trial.MethodsThe Graft Improvement Following Transplant (GIFT) trial is a multicenter, double-blind randomized controlled trial, designed to determine the efficacy and safety of ANG-3777 in renal transplantation patients showing signs of DGF. Subjects are randomized 1:1 to ANG-3777 (2 mg/kg) administered intravenously once daily for 3 consecutive days starting within 30 hours after transplantation, or to placebo.ResultsThe primary endpoint is estimated glomerular filtration rate (eGFR) at 12 months. Secondary endpoints include proportion of subjects with eGFR >30 at days 30, 90, 180, and 360; proportion of subjects whose graft function is slow, delayed, or primary nonfunction; length of hospitalization; and duration of dialysis through day 30. Adverse events are assessed throughout the study.ConclusionGIFT will generate data that are important to advancing treatment of DGF in this medically complex population.

SIS.NET: a randomized controlled trial evaluating a web-based system for symptom management after treatment of breast cancer.

As cancer survivorship increases, health care systems will be challenged to meet patient needs. With the limited availability of clinician time and resources, novel methods of using patient-reported outcomes may improve the quality and efficiency of follow-up care in patients with breast cancer. The authors conducted a randomized trial in patients with TNM stage I to III breast cancer comparing standard care with SIS.NET (System for Individualized Survivorship Care, based on patient self-reported data, with review by Nurse practitioners, targeted Education, and Triage), a follow-up protocol including integration of online health questionnaires at 3-month intervals and the evaluation of self-reported symptoms monitored and addressed remotely by a nurse practitioner (NP). The primary endpoint was to quantify the time between symptom reporting and remote evaluation of symptoms. The secondary endpoint was to compare use of health care resources (breast cancer-related visits, total medical appointments, and laboratory and imaging studies) over an 18-month period. A total of 102 participants were enrolled; 2 patients were excluded due to cancer recurrence. In the SIS.NET arm, 74% of new or changed self-reported symptoms were reviewed by a NP in <3 days. SIS.NET patients reported more new or changed symptoms compared with standard care patients (7.36 vs 3.2; P = .0045). During the 18-month trial, there were no statistically significant differences noted between the SIS.NET and standard care arms with regard to oncology-related appointments (mean, 4.2 vs 4.1 appointments), number of physician visits (mean, 10.8 vs 9.6 visits), or medical tests (mean, 5.5 vs 5 tests). Integration of online health questionnaires with remote review by a NP facilitated symptom reporting and may provide a means of convenient symptom assessment, but it did not appear to reduce health care resource use.

Amlodipine/valsartan 5/160 mg versus valsartan 160 mg in Chinese hypertensives

BackgroundA majority of hypertensives require treatment with ≥2 antihypertensive therapies to achieve blood pressure (BP) goals. Single-pill combinations (SPC) may improve convenience and adherence to therapy and reduce health care resource use and costs. The antihypertensive effects of amlodipine and valsartan are well established. This study evaluated the efficacy and safety of amlodipine/valsartan 5/160mg SPC for the treatment of hypertension in predominantly Chinese patients not adequately controlled on valsartan 160mg alone. MethodsIn this multicentre study (24 centres), adults with stage 1 or 2 hypertension not adequately controlled with valsartan monotherapy were randomised to receive double-blind amlodipine/valsartan 5/160mg SPC or valsartan 160mg once daily for 8weeks. ResultsThe least-square mean change (standard error) from baseline to endpoint in mean sitting diastolic blood pressure (MSDBP) at trough, the primary efficacy variable, was –10.3 (0.39) mm Hg with amlodipine/valsartan and –6.6 (0.40) mm Hg with valsartan (difference: –3.7 [0.54] mm Hg, p<0.0001). The corresponding results for mean sitting systolic blood pressure (MSSBP) were –14.9 (0.61) mm Hg and –7.0 (0.61) mm Hg, respectively (difference: –7.9 [0.84] mm Hg, p<0.0001). A significantly greater proportion of patients achieved overall BP control (MSSBP/MSDBP<140/90mm Hg) with combination therapy (61.3%) versus monotherapy (39.3%; p<0.0001). Both treatments were well tolerated. ConclusionAmlodipine/valsartan 5/160mg SPC is a safe and effective therapy for lowering BP in predominantly Chinese adults with stage 1 or 2 hypertension not adequately controlled with valsartan 160mg monotherapy.

Best practice for peripheral blood progenitor cell mobilization and collection in adults and children: results of a Società Italiana Di Emaferesi e Manipolazione Cellulare (SIDEM) and Gruppo Italiano Trapianto Midollo Osseo (GITMO) consensus process

A large heterogeneity in current mobilization and collection practices is perceived. Moreover, recent evidence introduced novel issues into some specific topics. Optimization of the clinical practice, through the adoption of clinical practice guidelines, previously proved to reduce health care resource use. Two Italian scientific societies, Società Italiana Di Emaferesi e Manipolazione Cellulare (SIDEM) and Gruppo Italiano Trapianto Midollo Osseo (GITMO), perceived the need of hematologists and transfusionists to share a common paradigm in the setting of hematopoietic stem cell transplantation (SCT). The aim of the current position paper is to provide common definitions and criteria for mobilization and collection of peripheral blood stem cells both in autologous and in the allogeneic setting. Current international and national standards (i.e., International Society of Hematotherapy and Graft Engineering) and recommendations (i.e., European Group for Blood and Marrow Transplantation) were harmonized with the Panel recommendations. The Expert Panel consisted of nine members (five transfusionists and four hematologists with both clinical and scientific experience of SCT in both pediatric and adult setting) and one methodologist and first convened on April 19, 2010: they in turn agreed on the questions to be answered by the project. Available literature was reviewed by one expert and the methodologist and presented to the other members. Statements were then formulated. SIDEM and GITMO planned an informal meeting of the Panel every 2 years to discuss relevant updates and possible changes to the recommendations. The efforts of the expert panel members allowed to set up and share a common approach to the mobilization, enumeration, and collection issues in the field of both autologous and allogeneic peripheral blood SCT.

Treatment outcomes with methylphenidate formulations among patients with ADHD: retrospective claims analysis of a managed care population

Objective:Describe treatment patterns, resource use, and predictors of methylphenidate (MPH) switch among children (6–12 years), adolescents (13–17 years), and adults (≥18 years) with attention-deficit/hyperactivity disorder (ADHD).Methods:This retrospective U.S. managed care database study used medical, pharmacy, and enrollment data to examine treatment patterns among patients with ≥1 ADHD diagnosis code (ICD-9 314.00-314.9), MPH pharmacy claims during 01/01/2004–09/30/2006, and no ADHD pharmacy claims in prior 6 months. Patients were followed for 1 year for dosage change, switch (change to non-MPH treatment), augmentation, persistence (number days on index medication) and adherence (days supplied/days persistent). End points were assessed by age group and MPH formulation. Cox proportional hazards modeling was conducted to determine predictors of MPH switch.Results:Among 23,860 MPH users, 51.4% had a dosing change, 14% switched to a non-MPH agent, and 4% augmented MPH therapy. Among those prescribed long-acting (LA) MPH (N = 14,681), switching rates were 14% for children, 13% for adolescents, and 16% for adults. Augmentation rates for LA MPH were <5%. Overall, 53% of patients were adherent with mean persistence of 219 days. For the subgroup of patients prescribed LA MPH (n = 14,681), adherence ranged from 49% (adolescents) to 59% (children); persistence varied between 183 days (adults) to 256 days (children). During the 1-year follow-up, office/clinic visits were the major driver of health care resource use in MPH patients (mean 9.7 visits/patient). Patients with psychiatric comorbidity utilized significantly greater services. Predictors of MPH switch included psychiatric comorbidity (hazards ratio [HR] 1.37; 95% confidence interval [CI] = 1.26–1.48; p < 0.0001) and specialty prescribers (HR 1.19, 95% CI = 1.04–1.35; p = 0.011). Potential limitations of this study include use of claims data for definition of drug usage; inclusion of medications approved for use in ADHD; assessment of switching that may not have captured short-term augmentation; absence of economic, clinical and other variables from the claims dataset that may have influenced treatment selection, and outcomes. The 6-month baseline period to determine newly treated patients may not guarantee exclusion of all previously treated patients who restart therapy after an extended period.Conclusions:Children exhibited the highest persistence of MPH users. ADHD patients on MPH therapy with a psychiatric comorbidity may require additional follow-up to help improve adherence and reduce health care resource use.

The impact of enrollment in a specialized interdisciplinary neuropathic pain clinic.

Chronic pain clinics have been created because of the increasing recognition of chronic pain as a very common, debilitating condition that requires specialized care. Neuropathic pain (NeP) is a multifaceted, specialized form of chronic pain that often requires input from multiple disciplines for assessment and management. To determine the impact of an interdisciplinary clinic for evaluation and treatment of patients with NeP. Patients with heterogeneous etiologies for NeP were prospectively evaluated using an interdisciplinary approach every six months. Diagnostic evaluation, comorbidity evaluation, education, and pharmacological and⁄or nonpharmacological management were completed. Severity (visual analogue scale) and features of pain (Modified Brief Pain Inventory), sleep difficulties (Medical Outcomes Study - Sleep Scale), mood⁄anxiety disruption (Hospital Anxiety and Depression Scale), quality of life (European Quality-of-Life Five-Domain index), health care resources use, patient satisfaction (Pain Treatment Satisfaction Scale and Neuropathic Pain Symptom Inventory) and self-perceived change in well-being (Patient Global Impression of Change scale) were examined at each visit. Pain severity only decreased after one year of follow-up, while anxiety and quality- of-life indexes improved after six months. Moderate improvements of sleep disturbance, less frequent medication use and reduced health care resource use were observed during enrollment at the NeP clinic. Despite the limitations of performing a real-world, uncontrolled study, patients with NeP benefit from enrollment in a small interdisciplinary clinic. Education and a complete diagnostic evaluation are hypothesized to lead to improvements in anxiety and, subsequently, pain severity. Questions remain regarding the long-term maintenance of these improvements and the optimal structure of specialized pain clinics.

Demographic and clinical characteristics of children and adolescents with severe or difficult-to-treat asthma

Young patients with severe or difficult-to-treat asthma are an understudied population. To assess age-associated and gender-associated differences in children and adolescents in the observational study, The Epidemiology and Natural History of Asthma: Outcomes and Treatment Regimens. Cross-sectional baseline data for patients greater than or equal to 6 years and less than or equal to 17 years (n = 1261) were stratified by age group (6-8, 9-11, 12-14, and 15-17 years). The chi(2) test for categorical variables and analysis of variance for continuous variables were used to identify differences among age groups, stratified by gender. Most patients had moderate (55%) or severe (41%) asthma by physician assessment. Of those using greater than or equal to 3 long-term controllers (62%), 53% of children (6-11 years) and 44% of adolescents (12-17 years) reported an oral corticosteroid burst and 25% and 19%, respectively, had an emergency department visit in the previous 3 months; 10% and 15%, respectively, reported past intubation. In females, weight for age ranged between the 67th and 70th percentiles; height for age was between the 42nd and 54th percentiles (P < .01 among age groups). Lung function was lower in adolescents than children: prebronchodilator percent predicted forced expiratory volume in 1 second (FEV(1))/forced vital capacity was 0.92 (6-8 years) and 0.83 (15-17 years), P less than .05, in males; and 0.94 (6-8 years) and 0.87 (15-17 years), P less than .05, in females. Children and adolescents demonstrated high rates of health care use and loss of lung function, despite using multiple long-term controllers. Asthma treatments that prevent loss of lung function and reduce health care resource use are needed in young patients with severe or difficult-to-treat asthma.

Cost‐effectiveness of asthma control: an economic appraisal of the GOAL study

The Gaining Optimal Asthma ControL (GOAL) study has shown the superiority of a combination of salmeterol/fluticasone propionate (SFC) compared with fluticasone propionate alone (FP) in terms of improving guideline defined asthma control. Clinical and economic data were taken from the GOAL study, supplemented with data on health related quality of life, in order to estimate the cost per quality adjusted life year (QALY) results for each of three strata (previously corticosteroid-free, low- and moderate-dose corticosteroid users). A series of statistical models of trial outcomes was used to construct cost effectiveness estimates across the strata of the multinational GOAL study including adjustment to the UK experience. Uncertainty was handled using the non-parametric bootstrap. Cost-effectiveness was compared with other treatments for chronic conditions. Salmeterol/fluticasone propionate improved the proportion of patients achieving totally and well-controlled weeks resulting in a similar QALY gain across the three strata of GOAL. Additional costs of treatment were greatest in stratum 1 and least in stratum 3, with some of the costs offset by reduced health care resource use. Cost-effectiveness by stratum was 7600 pound (95% CI: 4800-10,700 pound) per QALY gained for stratum 3; 11,000 pound (8600-14,600 pound) per QALY gained for stratum 2; and 13,700 pound (11,000-18,300 pound) per QALY gained for stratum 1. The GOAL study previously demonstrated the improvement in total control associated with the use of SFC compared with FP alone. This study suggests that this improvement in control is associated with cost-per-QALY figures that compare favourably with other uses of scarce health care resources.

A Respiratory Therapist-Directed Protocol for Managing Inpatients with Asthma and COPD Incorporating a Long-Acting Bronchodilator

This prospective study was designed to determine whether incorporating formoterol into a standardized respiratory therapist-directed protocol for administering bronchodilators to hospitalized patients with obstructive airway disease would reduce health care resource use and provide a safety advantage. All patients admitted to Washington Hospital Center with asthma and chronic obstructive pulmonary disease (CODP) are administered bronchodilators under a standardized respiratory therapist-directed protocol. Formoterol was the primary bronchodilator for the intervention period from January through March 2002, with levalbuterol, albuterol, and ipratropium available as needed. Results for the intervention period were compared against two historical control periods. From January through March 2000, the bronchodilators in the protocol were albuterol and ipratropium, and from January through March 2001 levalbuterol, albuterol, and ipratropium were available. Health care resource use was determined by the number of bronchodilator treatments administered per admission. Costs (adjusted to 2002 dollars) for supplies, therapist time, and drugs were calculated for the three time periods. Adverse events related to bronchodilator administration were recorded in a standardized manner for all three time periods. Bronchodilator treatments per admission, respiratory therapist visits per admission, and time spent per admission, and cost per bronchodilator treatment significantly decreased in 2002. Significantly fewer adverse events related to bronchodilator treatments were reported in 2002 than 2000. The addition of formoterol to a respiratory therapist-directed protocol for administering bronchodilators reduced health care resource use and adverse events for patients with asthma and COPD.

The Canadian Optimal Therapy of COPD Trial: Design, Organization and Patient Recruitment

There are no published studies that have assessed whether adding long-acting beta 2-agonist bronchodilators and/or inhaled steroids to chronic therapy with tiotropium would provide additional clinical benefit to patients with moderate to severe chronic obstructive pulmonary disease (COPD). The Canadian Optimal Therapy of COPD Trial is a randomized, prospective, double-blind, placebo-controlled, multicentre trial funded by the Canadian Institutes of Health Research that has been designed to determine which combination of inhaled medications will most effectively prevent exacerbations and optimize disease-specific quality of life in patients with COPD. The trial is the first to evolve from the Canadian Thoracic Society Clinical Trials Group. The study will randomize 432 patients with moderate to severe COPD to one of three parallel treatment arms for 52 weeks: tiotropium and fluticasone/salmeterol; tiotropium and salmeterol; or tiotropium and placebo inhaler. The participants will be allowed to use salbutamol as required throughout the trial period. The primary outcome measure is the proportion of patients in the three treatment groups who experienced a respiratory exacerbation within 52 weeks of randomization. Other outcomes that will be assessed over the 52-week trial period will include: changes in disease-specific quality of life and changes in dyspnea, health care use and changes in lung function. A pharmacoeconomic analysis will also be performed to evaluate the cost of these therapies. The study commenced recruitment in October 2003. It is currently operating at 22 centres across Canada and has randomized 137 patients during the first four months of recruitment. Recruitment is scheduled to continue until April 2005 or until 432 patients have been randomized. The present randomized, placebo-controlled trial offers a unique opportunity to answer the question, what is the best combination of inhaled medications to use for COPD patients? It is hoped that optimal use of inhaled medications will improve patient health and quality of life, reduce patient respiratory exacerbations, and ultimately, reduce health care resource use.