Cluster-Randomized Trial of a Behavioral Intervention to Incorporate a Treat-to-Target Approach to Care of US Patients With Rheumatoid Arthritis.

OBJECTIVE: To assess the feasibility and efficacy of implementing a treat-to-target approach versus usual care in a US-based cohort of rheumatoid arthritis patients. METHODS: In this behavioral intervention trial, rheumatology practices were cluster-randomized to provide treat-to-target care or usual care. Eligible patients with moderate/high disease activity (Clinical Disease Activity Index [CDAI] score >10) were followed for 12 months. Both treat-to-target and usual care patients were seen every 3 months. Treat-to-target providers were to have monthly visits with treatment acceleration at a minimum of every 3 months in patients with CDAI score >10; additional visits and treatment acceleration were at the discretion of usual care providers and patients. Coprimary end points were feasibility, assessed by rate of treatment acceleration conditional on CDAI score >10, and achievement of low disease activity (LDA; CDAI score ≤10) by an intent-to-treat analysis. RESULTS: A total of 14 practice sites per study arm were included (246 patients receiving treat-to-target and 286 receiving usual care). The groups had similar baseline demographic and clinical characteristics. Rates of treatment acceleration (treat-to-target 47% versus usual care 50%; odds ratio [OR] 0.92 [95% confidence interval (95% CI) 0.64, 1.34]) and achievement of LDA (treat-to-target 57% versus usual care 55%; OR 1.05 [95% CI 0.60, 1.84]) were similar between groups. Treat-to-target providers reported patient reluctance and medication lag time as common barriers to treatment acceleration. CONCLUSION: This study is the first to examine the feasibility and efficacy of a treat-to-target approach in typical US rheumatology practice. Treat-to-target care was not associated with increased likelihood of treatment acceleration or achievement of LDA, and barriers to treatment acceleration were identified.

Implementing Population Medicine in a Pain Management Practice.

PURPOSE: To document and improve the quality of our chronic pain management using population management methods. METHODS: An analytic registry was developed, and all new patients were enrolled for 12 months. Patient demographics, standardized pain and function measures, and treatments were recorded. Usual care was provided. The registry was used to organize care and analyze management and outcomes. RESULTS: Of 454 total patients, only 154 (34%) completed a 6-month cycle of care. High no-show rates were documented for follow-up appointments for several reasons. The majority of 6-month completers showed improved pain levels. DISCUSSION: This quality improvement project identified assessment and care gaps and led to improvements. An ongoing need to improve measures of pain and function was documented.

The rheumatoid arthritis treat-to-target trial: a cluster randomized trial within the Corrona rheumatology network.

BACKGROUND: The treat-to-target (T2T) approach to the care of patients with rheumatoid arthritis involves using validated metrics to measure disease activity, frequent follow-up visits for patients with moderate to high disease activity, and escalation of therapy when patients have inadequate therapeutic response as assessed by standard disease activity scores. The study described is a newly launched cluster-randomized behavioral intervention to assess the feasibility and effectiveness of the T2T approach in US rheumatology practices. It is designed to identify patient and provider barriers to implementing T2T management. This initial paper focuses on the novel study design and methods created to provide these insights. METHODS/DESIGN: This trial cluster-randomizes rheumatology practices from the existing Corrona network of private and academic sites rather than patients within sites or individual investigators to provide either T2T or usual care (UC) for qualified patients who meet the 2010 revised American College of Rheumatology criteria for the diagnosis of rheumatoid arthritis and have moderate to high disease activity. Specific medication choices are left to the investigator and patient, rather than being specified in the protocol. Enrollment is expected to be completed by the end of 2013, with 30 practices randomized and enrolling a minimum of 530 patients. During the 12-month follow-up, visits are mandated as frequently as monthly in patients with active disease in the T2T group and every 3 months for the UC group. Safety data are collected at each visit. The coprimary endpoints include a comparison of the proportion of patients achieving low disease activity in the T2T and UC groups and assessment of the feasibility of implementing T2T in rheumatology practices, specifically assessment of the rates of treatment acceleration, frequency of visits, time to next visit conditional on disease activity, and probability of acceleration conditional on disease activity in the 2 groups. DISCUSSION: This cluster-randomized behavioral intervention study will provide valuable insights on the outcomes and feasibility of employing a T2T treatment approach in clinical practice in the United States. TRIAL REGISTRATION: NCT01407419.

Making the first fracture the last fracture: ASBMR task force report on secondary fracture prevention.

Fragility fractures are common, affecting almost one in two older women and one in three older men. Every fragility fracture signals increased risk of future fractures as well as risk of premature mortality. Despite the major health care impact worldwide, currently there are few systems in place to identify and "capture" individuals after a fragility fracture to ensure appropriate assessment and treatment (according to national guidelines) to reduce future fracture risk and adverse health outcomes. The Task Force reviewed the current evidence about different systematic interventional approaches, their logical background, as well as the medical and ethical rationale. This included reviewing the evidence supporting cost-effective interventions and developing a toolkit for reducing secondary fracture incidence. This report presents this evidence for cost-effective interventions versus the human and health care costs associated with the failure to address further fractures. In particular, it summarizes the evidence for various forms of Fracture Liaison Service as the most effective intervention for secondary fracture prevention. It also summarizes the evidence that certain interventions, particularly those based on patient and/or community-focused educational approaches, are consistently, if unexpectedly, ineffective. As an international group, representing 36 countries throughout Asia-Pacific, South America, Europe, and North America, the Task Force reviewed and summarized the international data on barriers encountered in implementing risk-reduction strategies. It presents the ethical imperatives for providing quality of care in osteoporosis management. As part of an implementation strategy, it describes both the quality improvement methods best suited to transforming care and the research questions that remain outstanding. The overarching outcome of the Task Force's work has been the provision of a rational background and the scientific evidence underpinning secondary fracture prevention and stresses the utility of one form or another of a Fracture Liaison Service in achieving those quality outcomes worldwide. © 2012 American Society for Bone and Mineral Research.

Prescribing practices in a US cohort of rheumatoid arthritis patients before and after publication of the American College of Rheumatology treatment recommendations.

OBJECTIVE: To examine prescribing practices in the use of biologic and nonbiologic disease-modifying antirheumatic drugs (DMARDs) to treat patients with rheumatoid arthritis (RA), before and after publication of the American College of Rheumatology (ACR) treatment recommendations. METHODS: Biologics-naive RA patients under the care of a rheumatologist in the US were identified from the Consortium of Rheumatology Researchers of North America registry. Patients were included if their visits occurred prior to and/or at least 6 months after publication of the ACR treatment recommendations (time periods of February 2002-June 2008 versus December 2008-December 2009). The population was divided into 2 mutually exclusive cohorts: 1) methotrexate (MTX) monotherapy users, and 2) multiple nonbiologic DMARD users. Initiation or dose escalation of biologic and nonbiologic DMARDs in response to active disease was assessed cross-sectionally and longitudinally in comparison to the ACR recommendations. The impact of the publication of the ACR recommendations on treatment practices was assessed using logistic regression, stratified by disease activity and adjusted for clustering of physicians and geographic region. RESULTS: After 1 visit, 24-37% of patients receiving MTX monotherapy who had moderate disease activity and a poor prognosis or high disease activity received care consistent with the ACR recommendations; after 2 visits, 34-56% of the MTX monotherapy group received care consistent with the recommendations. In the patients receiving multiple nonbiologic DMARDs, 31-47% of those with moderate or high disease activity received care consistent with the recommendations after 1 visit, and 43-51% received such care after 2 visits. Publication of the recommendations did not significantly change treatment patterns for those with active disease. CONCLUSION: Substantial numbers of RA patients with active disease did not receive care consistent with the current ACR treatment recommendations. Innovative approaches to improve care are necessary.

The uses of disease activity scoring and the physician global assessment of disease activity for managing rheumatoid arthritis in rheumatology practice.

OBJECTIVE: To evaluate the uses of quantitative disease activity scoring and a physician global assessment of disease activity for managing rheumatoid arthritis (RA) in rheumatology practice. METHODS: The Global Arthritis Score (GAS) and a physician global assessment (Physician Global) were determined during each office visit for a community practice RA population. The GAS was calculated from patients' self-reported pain, functional assessment, and tender joint count. The Physician Global was recorded on a 10-point visual analog scale. The correlation of these 2 disease activity measures was determined for the most recent office visit of 185 patients with RA, and the reasons for discordant results were identified by chart review. RESULTS: The GAS and Physician Global were concordant for active or inactive disease in 126 of 185 patients (68%) and were discordant in 59 (32%). Forty-five of these discordant patients had a high GAS while their Physician Global indicated inactive disease. Their GAS values were high because of osteoarthritis, back pain, soft tissue rheumatism, and/or prior joint damage rather than active RA. The other 14 patients had a low GAS with an uncontrolled Physician Global for a variety of reasons. CONCLUSION: (1) An RA disease activity score and a quantitative Physician Global can be measured during rheumatology office visits to document patients' disease status. (2) Disease activity scoring contributes valuable information, but should not replace the Physician Global in guiding RA patient management or reimbursement decisions.

Quality of care in rheumatic diseases: performance measures and improvement.

PURPOSE OF REVIEW: To acquaint rheumatologists with pay-for-performance and the American College of Rheumatology quality initiative, and to suggest how practice process redesigns and effective measurement of performance and disease outcomes will help rheumatologists document and improve the quality of rheumatic disease care. RECENT FINDINGS: The options for treating rheumatic diseases have improved, but many patients are not achieving optimal outcomes. Pay for performance programs being introduced by Medicare and other insurers will link provider revenues to quality indicators, requiring rheumatologists to measure, document, and improve their patients' outcomes. Expected rheumatology manpower losses will also require greater practice efficiency and increased reliance on inter-disciplinary care teams. Some publications advocate improving healthcare by expanding research to improve knowledge transfer from clinical studies to clinical practice; others suggest continuous process improvement methods to improve delivery of care processes. Practical disease activity measurements and rheumatology practice improvements are being reported that suggest a positive future. SUMMARY: Rheumatologists need to recognize the need to improve delivery of care and patient outcomes, measure and document clinical performance, and learn the methods for managing clinical process improvement.

Osteoporosis disease management for fragility fracture patients: new understandings based on three years' experience with an osteoporosis care service.

OBJECTIVE: To review the 3-year performance of an established osteoporosis care service and consider further improvements in an effort to reduce fragility fractures. METHODS: Osteoporosis care has been coordinated for all willing and able patients with orthopedic fragility fractures in our health system by a nurse and medical director since 2003, using a guideline-based care algorithm and task management software. Patients were followed by telephone for 2 years to monitor their status and optimize adherence to treatment. Demographics, management recommendations, clinical data, and adherence to treatment were reviewed for the 2003-2005 patient population. RESULTS: Of 1,019 patients with fragility fractures, 61% underwent osteoporosis evaluation and treatment. The remainder included 15% who refused to participate and 24% who were unable to participate for various logistical and health reasons. More patients age >80 years were unwilling or unable to participate. Bone densities (dual x-ray absorptiometry [DXA]) were normal, low, or osteoporotic in 24%, 55%, and 21% of patients, respectively, and 60% of the osteoporotic group had > or = 1 abnormal metabolic bone laboratory result. Only 17% of the total reported a previous fracture, and 47% had ever undergone DXA. Few experienced bone loss, a new fracture, or bisphosphonate intolerance during treatment. CONCLUSION: An osteoporosis care service has coordinated care for every willing and able fragility fracture patient with positive outcomes. In addition, the results suggest a high priority for earlier proactive diagnosis and intervention of the at-risk population if fractures are to be reduced.

A 3-month, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of a highly optimized, capacitively coupled, pulsed electrical stimulator in patients with osteoarthritis of the knee.

OBJECTIVE: To investigate the efficacy and safety of a capacitively coupled, pulsed electrical stimulation device in treating knee osteoarthritis (OA). DESIGN: Fifty-eight outpatients with moderate to severe OA of the knee entered a 3-month, double-blind, placebo-controlled trial, using either an active or placebo device at home for 6 to 14 h/day. Outcome measures included a patient global evaluation, a patient report of knee pain severity, and the Western Ontario and McMaster Universities (WOMAC) questionnaire. RESULTS: Active treatment provided superior outcomes between baseline and 3-month follow-up measurements: 50.6% greater improvement than placebo in patient global (P=0.03), 31.2% in patient pain (P=0.04), 25.1% in WOMAC stiffness (P=0.03), 29.5% in WOMAC function (P=0.01), 19.9% in WOMAC pain (P=0.11), and 27% in total WOMAC (P=0.01). The percent of patients who improved by more than 50% was 38.5 active vs 5.3 placebo in patient global (P=0.01), 43.6 vs 15.8 in patient pain (P=0.04), 38.5 vs 10.5 in WOMAC pain (P=0.03), 28.2 vs 5.3 in WOMAC stiffness (P=0.08), 23.1 vs 5.3 in WOMAC function (P=0.14), and 23.1 vs 5.3 in total WOMAC (P=0.14). Twenty-one percent of placebo and 18% of actively treated patients developed a transient rash at the electrode sites. No other adverse device effects were reported. CONCLUSION: A highly optimized, capacitively coupled, pulsed electrical stimulus device significantly improved symptoms and function in knee OA without causing any serious side effects.

Successes and failures in improving osteoporosis care after fragility fracture: results of a multiple-site clinical improvement project.

OBJECTIVE: To improve osteoporosis diagnosis and treatment of fragility fracture patient populations because osteoporosis care is provided infrequently to those patients, leaving them vulnerable to further fractures and increasing debility. METHODS: Osteoporosis experts from 11 US health systems participated in a clinical improvement project based on previously described successful osteoporosis care process redesigns. Participants were taught rapid cycle process improvement methods that are widely used in clinical improvement projects, and were supported in their efforts by the program coordinator. Measures of successful process development included establishing reliable referral from orthopedic fracture care to osteoporosis diagnosis and treatment, nurse coordination and monitoring of osteoporosis care, and use of process management software for registering patients and organizing work. RESULTS: Four sites were able to establish these critical referral and osteoporosis management processes. Two sites were partially successful in increasing orthopedic referrals to consultative care, but otherwise continued traditional care processes. Five were unsuccessful due to inability to implement 1 or more of these key process improvements. CONCLUSION: Reliable osteoporosis care for fracture patients is possible if traditional practice processes are replaced with more effective, well-recognized approaches to chronic disease management.

Redesigning the care of fragility fracture patients to improve osteoporosis management: a health care improvement project.

OBJECTIVE: To develop new processes that assure more reliable, population-based care of fragility fracture patients. METHODS: A 4-year clinical improvement project was performed in a multispecialty, community practice health system using evidence-based guidelines and rapid cycle process improvement methods (plan-do-study-act cycles). RESULTS: Prior to this project, appropriate osteoporosis care was provided to only 5% of our 1999 hip fracture patients. In 2001, primary physicians were provided prompts about appropriate care (cycle 1), which resulted in improved care for only 20% of patients. A process improvement pilot in 2002 (cycle 2) and full program implementation in 2003 (cycle 3) have assured osteoporosis care for all willing and able patients with any fragility fracture. Altogether, 58% of 2003 fragility fracture patients, including 46% of those with hip fracture, have had a bone measurement, have been assigned to osteoporosis care with their primary physician or a consultant, and are being monitored regularly. Only 19% refused osteoporosis care. Key process improvements have included using orthopedic billings to identify patients, referring patients directly from orthopedics to an osteoporosis care program, organizing care with a nurse manager and process management computer software, assigning patients to primary or consultative physician care based on disease severity, and monitoring adherence to therapy by telephone. CONCLUSION: Reliable osteoporosis care is achievable by redesigning clinical processes. Performance data motivate physicians to reconsider traditional approaches. Improving the care of osteoporosis and other chronic diseases requires coordinated care across specialty boundaries and health system support.

Hip fracture patients are not treated for osteoporosis: a call to action.

OBJECTIVE: To determine whether hip fracture patients, a group at very high risk for additional fragility fractures, are being evaluated and treated effectively for osteoporosis. METHODS: Clinical and bone densitometry (dual x-ray absorptiometry [DXA]) records were reviewed in hip fracture patients at 4 Midwestern US health systems to determine the frequency of DXA use, calcium and vitamin D supplementation, and antiresorptive drug treatment. RESULTS: DXA was performed at the 4 study sites in only 12%, 12%, 13%, and 24% of patients, respectively. Calcium and vitamin D supplements were prescribed in 27%, 1%, 3%, and 25% of the patients at the 4 study sites. Antiresorptive drugs were prescribed in 26%, 12%, 7%, and 37% of the patients with only 2-10% receiving a bisphosphonate. CONCLUSION: Reducing osteoporotic fractures will require more effective approaches to managing hip fracture patients and other high-risk populations.