Osteoarthritis (OA) is the most prevalent joint

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1 CURATA: A Patient Health Management Program for the Treatment of Osteoarthritis in Québec: An Integrated Approach to Improving the Appropriate Utilization of Anti-Inflammatory/Analgesic Medications Michèle Beaulieu, MEd; Denis Choquette, MD; Elham Rahme, PhD; Louis Bessette, MD; and Robert Carrier, BSc Objectives: To identify gaps in current osteoarthritis (OA) care in Québec, Canada, and to implement and evaluate interventions to promote appropriate use of evidence-based medicine. Study Design: Pretest and posttest; analysis of the Québec health insurance database. Methods: CURATA is a patient health management program utilizing an evidence-based approach for OA treatment. Evaluation of the current level of care revealed major gaps in physicians knowledge of (1) risk factors for gastrointestinal (GI) toxicity associated with nonsteroidal anti-inflammatory drugs (NSAIDs); (2) NSAID-induced toxicity associated with long-term administration and contraindications for NSAID use in patients with hypertension, cardiovascular disease, or renal insufficiency; (3) choice of cytoprotection; and (4) use of nonpharmacologic treatments for OA. The CURATA intervention consisted of educational workshops, with and without presentation of a decision tree regarding appropriate use of pharmacologic and nonpharmacologic OA treatments. Participating physicians were asked to complete an 8-item questionnaire before and after the workshop, as well as 3 and 6 months later, to test their immediate and remote knowledge of treatment choices. The prescribing patterns of GPs also were evaluated through analysis of the Québec health insurance database. Results: The participating physicians were better immediate and remote risk assessors of GI bleeding and made more appropriate treatment choices (15.2% improvement relative to mean preworkshop score). Conclusion: These evidence-based interventions were successful not only in improving the physicians knowledge regarding the diagnosis and management of OA, but also more importantly in changing their behavior to make more appropriate therapy choices for their patients. (Am J Manag Care. 2004;10: ) Osteoarthritis (OA) is the most prevalent joint disorder; its primary signs and symptoms of joint pain, swelling, and stiffness reflect the loss of joint cartilage integrity. 1,2 There is currently no cure for OA. Available treatments include a range of pharmacologic and nonpharmacologic interventions designed to reduce pain and inflammation, maintain or improve mobility, and limit functional disability. 2 Osteoarthritis has been shown in a variety of USbased studies to be a leading contributor to the cost of medical appointments, over-the-counter drug use, and restricted activity. 3-5 Drug therapy represents a large proportion of the direct costs, with analgesics accounting for approximately 20% of the total. The treatment of gastrointestinal (GI) adverse reactions related to nonselective nonsteroidal anti-inflammatory drug (NSAID) use adds significantly to both direct and indirect costs. 6,7 Nonpharmacologic modalities such as physical and occupational therapy also contribute to these costs. Indirect costs (eg, absenteeism) are responsible for the majority of the economic burden of OA. As a result of our aging population, the increased demand for healthcare for this disease adds to these concerns. There is a critical need to develop strategies to manage the disease more cost effectively through better diagnosis, safer and more effective treatment, and enhanced patient education. This paper describes an innovative approach using patient health management to address this need. CURRENT TRENDS IN THE PHARMACOLOGIC TREATMENT OF OSTEOARTHRITIS Despite their side effects, conventional NSAIDs have been widely used and are the agents of choice in the treatment of OA 8 for patients who do not respond to acetaminophen. In Canada, the most commonly prescribed NSAIDs include diclofenac sodium, a combination of diclofenac and misoprostol, ibuprofen, and From Merck Frosst Canada Ltd, Kirkland, Québec, Canada (MB, RC); Institut de Rhumatologie de Montréal, Montréal, Canada (DC); Division of Clinical Epidemiology, McGill University Health Center, Montréal General Hospital, Montréal, Canada (ER); and Hopital Régional de Rimouski, Rimouski, Québec, Canada (LB). This work has been done as a project of the program CURATA with the financial support of Merck Frosst Canada Ltd. Address correspondence to: Michele Beaulieu, MEd, Merck Frosst Canada Ltd, Patient Health Management, Trans Canada Highway, Kirkland, Québec H9H 3L1. michele_beaulieu@merck.com. VOL. 10, NO. 8 THE AMERICAN JOURNAL OF MANAGED CARE 569

2 naproxen. 6 However, current concerns about the greater risk of GI toxicity associated with prolonged use of NSAIDs, 9-16 including potentially fatal perforation, ulcer, and bleed (PUB), 11 have led to a reexamination of their role in the treatment of the disease. Risk factors for GI toxicity include age more than 65 years, a history of peptic ulcer or upper-gi bleeding, concomitant use of oral corticosteroids and anticoagulants, comorbidities such as cardiac conditions, and renal dysfunction For patients with GI risk factors, coprescription of a gastroprotective (GPA) agent has been advised. More recently, with the introduction of the cyclooxygenase-2 (COX-2) inhibitors, it has been recommended that patients who require chronic analgesia and who are at risk for GI adverse events with NSAIDs receive first-line alternative therapy with acetaminophen; if they do not respond, they should receive a COX-2 inhibitor. 17 The COX-2 inhibitors have recently emerged as an alternative class of anti-inflammatory drugs with efficacy in reducing pain and inflammation equivalent to that of NSAIDs and a clearly reduced potential for upper- GI injury relative to NSAIDs. 18,22-24,26-28 Traditional NSAIDs inhibit both the COX-1 and COX-2 forms of the cyclooxygenase enzyme. Prostaglandins involved in the protection of the GI mucosa are produced by COX-1, whereas those that mediate inflammation and pain are induced by COX The COX-2 inhibitors rofecoxib and celecoxib (coxibs) selectively inhibit COX-2, with little effect on COX However, they are not free of side effects: dyspepsia has been reported with coxib use, but at a lower frequency than with NSAIDs. 30,31 A retrospective cohort study conducted in Québec between April and November 2000 reported that coxibs were more frequently prescribed than acetaminophen or NSAIDs to elderly ( 65 years) patients with musculoskeletal diseases. The study also found that elderly patients with a history of GI events were more frequently given a coxib or acetaminophen as opposed to NSAIDs. The study also reported that coxibs were 47% less likely to be prescribed with a GPA than were NSAIDs. 32 BACKGROUND The Healthcare System in Québec The Régie de l assurance maladie du Québec (RAMQ) applies and administers the provincial health insurance plan established by the Health Insurance Act. The public prescription drug insurance plan, instituted in 1997, guarantees basic coverage for all Québec residents for drugs purchased in Québec and listed on the provincial formulary (liste de médicaments). Adults with access to a private insurance plan through their workplace (4.2 million individuals; 57% of the population) must pay to receive coverage for themselves and their dependents. All others are covered by the provincial plan, including those receiving employment assistance and persons age 65 years and over Celecoxib became eligible for reimbursement by RAMQ in October 1999, followed in April 2000 by rofecoxib. In the first half of 2000, no published guidelines or consensus existed for the utilization of these new anti-inflammatory drugs. Clinical experience was still developing. Profile of NSAID Use in Québec In the planning stage of this study, we conducted a literature review to profile and identify the care gaps in NSAID and coxib utilization in Québec. A study conducted in 1997 by the Québec College of Physicians using administrative data obtained from RAMQ revealed inappropriate utilization of NSAIDs. The study found that general practitioners (GPs) often ignored drug interactions, dosages, and adverse events in prescribing NSAIDs and did not prescribe GPAs as advised by the guidelines. 37,38 In a second study, Choquette et al surveyed the NSAID prescription patterns of all GPs in the province of Québec (D. Choquette, MD unpublished data, 1999). The results of this self-reported questionnaire, based on 2328 participants (30% response rate), corroborated the finding of the Québec College of Physicians and demonstrated a lack of understanding of the indications, contraindications, dosage, and duration of NSAID treatment. A recent study by Rahme et al concluded that the use of NSAIDs significantly increased the risk of GI adverse events by 2.48-fold, requiring an additional cost of 0.66 Canadian dollars per patient-day of treatment with NSAIDs. 39 Tamblyn et al 40 conducted a blinded, office-based study using simulated patients, in which 2 clinical cases (chronic hip pain due to early OA and NSAID-induced gastropathy) were used to assess the management decisions of 112 physicians for elderly patients with arthritis. In 41.7% of office visits, unnecessary prescriptions for NSAIDs or other drugs were given. Gastropathy related to NSAID use was properly diagnosed in 93.4% of cases, but acceptably managed in only 77.4% of cases. The risk for suboptimal management of NSAID-related adverse events was increased 16.6-fold with an incorrect diagnosis versus a correct diagnosis. These studies revealed significant gaps between optimal and actual practice. The results raise questions about the appropriateness of NSAID use in the elderly 570 THE AMERICAN JOURNAL OF MANAGED CARE AUGUST 2004

3 Improving NSAID Use population at large and concerns that current prescribing patterns are contributing to GI morbidity in the elderly, with the associated avoidable health costs. Selective utilization of coxibs in the elderly is perhaps a better medical practice. Their acquisition cost is much higher than that of NSAIDs. However, the cost of treatment with an NSAID plus a proton pump inhibitor in Canada is greater than the cost of a COX-2 inhibitor alone. 41 In a public healthcare system such as that of Québec, the widespread utilization of coxibs and NSAIDs plus proton pump inhibitors, combined with their high acquisition costs, makes them affordable only at the expense of other healthcare services. Therefore, programs that promote appropriate utilization of the coxibs and NSAIDs are needed. The CURATA Program CURATA (Concertation pour une Utilisation Raisonnée des Anti-inflammatoires dans le Traitement de l Arthrose [An Integrated Approach to Improving the Appropriate Utilization of Anti-Inflammatory/Analgesic Medications in the Treatment of Osteoarthritis in Québec]) is a patient health management program developed by the Association of Rheumatologists and Merck Frosst Canada in It was developed to address the gaps in OA care and implement effective interventions to promote evidence-based medication prescription for OA patients, with the goal of optimizing the management of OA. Its objectives are to improve the quality of life of OA patients and to encourage the appropriate utilization of NSAIDs and coxibs in the treatment of the disease. The patient health management approach seeks to optimally manage disease through improvement of practice patterns and patient outcomes. It is a patient-centered approach in which best practices are compared with current practices, and modifications are introduced to improve therapeutic results in the most cost-effective manner. Its goal is to bring the greatest health benefit to the largest number of people at the best cost. To be optimally effective, patient health management mobilizes a wide range of healthcare stakeholders: governments, thirdparty payers, university researchers, health charities, community specialists, family physicians, nurses, pharmacists, specialinterest groups, pharmaceutical companies, and above all, patients. These partnerships will ensure the broadest application of the program and its interventions. The key to success of this process is continuous measurement and feedback of outcomes obtained from the broadest application of evidence-based therapies. 42,43 A community-based approach to research provides the greatest opportunity for highly committed stakeholders to identify the gaps in care and to work as partners to define best practices to achieve optimal outcomes at the lowest possible cost. Another view might be that partnership-directed, evidence-based disease management represents healthcare improvement from the ground up, as opposed to the top down. The functional processes are illustrated in Figure 1. The Continuing Medical Education Department of the University of Montréal, in collaboration with delegates of the Association of Rheumatologists, developed the CURATA educational tools. The partners in the program include representatives from government, academia, charitable organizations, and the pharmaceutical industry (Appendix). METHODS The program activities were coordinated by using a modified structure similar to that utilized by the National Institutes of Health to conduct a large-scale study. 44 The primary objectives of the CURATA program were to (1) improve the GP s ability to identify OA patients Figure 1. Outline of the Suggested Strategic Management for a Patient Health Management Program Continuous Quality Improvement Loop Reproduced with permission from reference 42. Baseline measurement of process of care, outcomes, health service use Analysis of baseline data Contextual feedback Development of responsive interventions Application of interventions Measurement of new baseline Analysis of new baseline data Comparison with previous baseline VOL. 10, NO. 8 THE AMERICAN JOURNAL OF MANAGED CARE 571

4 through appropriate questioning and musculoskeletal examination and (2) to enhance the GP s ability to select appropriate pharmacologic and nonpharmacologic therapy according to a defined decision tree. The underlying hypothesis was that an integrated program involving professionals and patients whose goals were to enhance the appropriate use of NSAIDs and GPAs would facilitate bridging the gap that exists between the current state of care and optimal practice. Phases of the CURATA Program In the first phase of the program, the current level of care was evaluated in an effort to identify potential discrepancies with optimal evidence-based treatment. Studies identified in this stage of the program are described in the section titled Profile of NSAID Use in Québec. In summary, there were major gaps in physicians knowledge of (1) risk factors for GI toxicity associated with NSAIDs; (2) NSAID-induced toxicity associated with long-term administration and contraindications for NSAID use in patients with hypertension, cardiovascular disease, or renal insufficiency; (3) choice of cytoprotection; and (4) use of nonpharmacologic treatments for OA Figure 2. Decision Tree: An Algorithm for the Optimal Treatment of Osteoarthritis Yes Nonpharmacologic treatment 1 Use acetaminophen to maximum dosage (1g QID) Intra-articlular injection if possible If response is inadequate Risk factors for PUB 2 No 1. Nonpharmacologic Treatment Education Education and reassurance about the disease: define osteoarthritis, its causes, its consequences, and prognosis for the patient Establish treatment goals: relieve pain, maintain function, improve quality of life Education about diet (weight loss) and exercise No Use a Coxib 3 History of PUB or anticoagulant use? Yes No GPA 4 Add a GPA 4 If response is inadequate 5 or intolerance Use conventional NSAID with GPA Rx Regularly reassess indication for NSAID therapy, BP, cardiac and renal function If response is inadequate, consider referral to a specialist Regularly reassess therapy Recommend use of a conventional NSAID 3 If response is inadequate 5 or intolerance Use another conventional NSAID or a Coxib Education about medication (simple analgesics vs NSAIDSs) Rehabilitation Physiotherapy Range of motion exercises for osteoarthritis of the hip and knee Muscle strengthening exercises for osteoarthritis of the hip and knee Occupational therapy Joint protection and energy conservation Assistive devices for activities of daily living Aerobic exercise program Orthotics, adapted shoes, and assistive devices for ambulation (cane) 2. Risk Factors for PUB Age > 75 years History of ulcer or upper GI bleeding Corticosteroid therapy Serious systemic disease: CAD, diabetes, COPD, etc Anticoagulant therapy Treatment with other NSAIDs including low-dose of ASA Between ages 65 and 75, in the absence of risk factors, take the patient's general condition into account 3. Avoid use of NSAIDs (conventional NSAID and Coxib) if there is uncontrolled blood pressure, cardiac insufficiency, or renal insufficience 4. GPA: misoptrostol, minimum daily dosage 600 µg, or proton pump inhibitor 5. Therapeutic response to a maximum dose of a nonsteroidal anti-inflammatory may be considered inadequate if there is no improvement 7 to 10 days after initiating therapy ASA indicates aspirin; BP, blood pressure; CAD, coronary artery disease; COPD, chronic obstructive pulmonary disease; Coxib, rofecoxib or celecoxib; GI, gastrointestinal; GPA, gastroprotective agent; NSAID, nonsteroidal anti-inflammatory drug; PUD, perforation, ulcer, and bleed; QID, four times daily. Reproduced with permission from reference THE AMERICAN JOURNAL OF MANAGED CARE AUGUST 2004

5 Improving NSAID Use In the second phase, interventions were introduced. To provide guidelines for the appropriate utilization of NSAIDs and coxibs as well as GPAs, the CURATA development committee created a decision tree with an algorithm for optimizing OA treatment approaches (Figure 2). 45 To maximize adoption of this decision tree, the committee developed a workshop including 3 clinical cases on the diagnosis and treatment of OA. It has been demonstrated that small-group, interactive, case-based workshops ideally facilitate the dissemination of such material and provide a forum for peer discussion and emulation of the desire to excel. 46 For each clinical case, a participant worked individually to answer questions, then shared his or her answers with all others in a small group. The group produced a summary of individual responses on transparency for discussion in a plenary session. In this session, experts shared their experience with all participants. This format allowed participants to reflect on their own processes of data interpretation in making clinical decisions and to examine those of experts. The workshop was accredited by the College of Family Physicians of Canada and provided 1.5 hours of MAINPRO-C credit to its participants. A large group session was held for pharmacists and other health professionals. A patient follow-up sheet was created for pharmacists, which included questions regarding patients use of homeopathic and other alternative medicine products. A series of 5 brochures detailing the various joints affected by OA was developed for patients. In addition, there was a brief presentation by a physiotherapist and an occupational therapist to describe their role in patient management of OA. A multidisciplinary panel including a physician, pharmacist, physiotherapist, and occupational therapist then discussed a case study. Evaluation of the Educational Intervention To assess the impact of CURATA, 2 measurements were undertaken: one to evaluate the impact on medication prescription and the other to determine the immediate and remote impact on retention of knowledge regarding treatment selection for OA. Although CURATA was implemented throughout the province of Québec, the evaluation was undertaken in 8 cities. Impact on Medication Prescription. The intervention was comprised of the workshop and a decision tree in the form of a laminated sheet. There were 4 intervention types: workshop and tree, workshop only, decision tree only, and control group; each type was assigned to 2 cities. Records of all patients age 65 years or older who had filled a prescription for a coxib, NSAID, or acetaminophen between May 2000 and June 2001 (the date when the data were requested) from an eligible GP (GP with 2 NSAID prescriptions) were retrieved from the RAMQ database. Only new prescriptions preceded by a diagnosis of OA in the previous 3 years were considered. In general, prescriptions for a chronic condition are written with the possibility of 3 refills. New prescriptions were either a new treatment or a continued treatment filled for the first time (nonrenewal). Because a prescription could have been written before the workshop took place and refilled later, refills were not assessed. A 0/1 score was given to every filled prescription according to the instruction on the decision tree. All acetaminophen prescriptions were given a score of 1, and all patients were presumed to have used acetaminophen before NSAIDs or coxibs prescriptions. Mean scores were calculated for each GP in the preintervention and postintervention periods. The analyses were done both by intent-to-treat (including all GPs who practice in 1 of the 8 cities) and per protocol (including only GPs who attended the workshops in the intervention groups) and were compared with the scores of all GPs in the control group. Details of the methodology adopted in this study and the results have been published. 45 RESULTS In the intent-to-treat analysis, the study demonstrated an adjusted significant improvement on mean scores of 8% (P =.003) between the control group and the workshop and workshop and tree groups combined. No significant improvement was reported in the tree group versus the control group. A per protocol analysis revealed a 12% (P =.008) improvement in mean scores. In summary, the intervention had a positive impact on these physicians prescription patterns for OA. In view of the widespread use of coxibs, nonselective NSAIDs, and acetaminophen, and given that more than 50% of these prescriptions were for the treatment of OA, the positive impact should reflect considerable cost savings. Immediate and Remote Impact on Retention of Knowledge. The GPs were asked to fill a questionnaire consisting of 8 multiple-choice questions before (pretest) and after (posttest) the workshop, as well as 3 and 6 months later. (For a copy of this questionnaire, please contact the author.) Each question was scored 1 or 0 according to whether or not the checked answer agreed with the workshop content. Overall pretest and posttest scores for each GP were calculated and compared by using a paired t test. Questions were divided into 2 types, those concerning patients with no GI risk factors and those concerning patients with GI risk factors. Of 52 GPs invited to the workshop, 26 completed the questionnaire. VOL. 10, NO. 8 THE AMERICAN JOURNAL OF MANAGED CARE 573

6 Nonparametric tests were used to compare the median pretest and posttest scores for the 2 types of questions. Overall median scores (pretest, posttest, and P value) were 2.0, 3.5, and <.0001, respectively, for questions describing patients with no GI risk factors (4 questions) and 3.0, 3.5, and <.01, respectively, for questions describing patients with GI risk factors (4 questions). At the 6- month evaluation, the knowledge improvement was sustained; scores were similar to those seen on the immediate posttest. Thus, physicians who attended the workshop were, in fact, better assessors of GI bleeding, both immediately afterwards and 6 months later; and they selected a more appropriate therapeutic regimen. On completion of this workshop, the GPs were able to adopt a structured approach to the assessment of joint pain, identify the principal signs of OA on clinical examination, use a decision tree to manage patients with OA, and select an anti-inflammatory medication appropriate to the patient s clinical condition. In light of these encouraging results, 50 small-group sessions and 2 large-group sessions were held, with a total of 1000 physicians attending. The decision tree was disseminated to 7500 physicians in June We anticipate that the positive effect of CURATA will be even greater once the intervention for pharmacists and other health professionals is implemented. CONCLUSION The results of the initial evaluations have demonstrated that these evidence-based interventions were successful not only in improving physicians knowledge regarding the diagnosis and management of OA, but also more importantly in changing their behavior to make more appropriate therapy choices for their patients. The observed modification of their prescription patterns reflects an improvement in their medical practice, which may lead to better patient outcomes and generate greater cost efficiencies for the health care system. The immediate impact of this patient health management approach was demonstrated in late 2001, when the reimbursement policy for coxibs was being reevaluated by the Québec Ministry of Health and transition to exception-medication status was under consideration. This reevaluation was motivated by concerns about increased consumption and the associated costs, as well as questions regarding the appropriateness of coxib use. Results of the CURATA evaluation provided sufficient evidence for the government to decide to maintain an open reimbursement policy for this new class of drugs. The widespread implementation of the interventions of the CURATA program will further encourage the appropriate use of coxibs, and through these efforts evidence-based guidelines will be developed. The capacity for programs such as CURATA to shape the healthcare environment is further validated by the current requirement of the Ministry of Health to establish patient health management programs as a measure to ensure appropriate utilization of various classes of drugs. In addition, a concurrent drug utilization review must be carried out. The Ministry also has required the collaborative involvement of multiple pharmaceutical industry partners in these programs. This collaboration represents the next challenge. The establishment of effective patient health management programs relies heavily on the commitment and cooperation of a broad range of partners representing academia, government, industry, and most importantly, patients. 42,43 The general public has become increasingly aware of health concerns in recent times and is eager to be involved in such innovative approaches to optimizing the quality of health and healthcare delivery. Similarly, there is an evolving role for the pharmaceutical industry. Beyond an interest in profits, the pharmaceutical industry shares the commitment of its partners as well as its expertise in the development of programs that will enhance patient adherence to optimal therapies, while controlling costs and improving health outcomes. The promising results of programs such as CURATA demonstrate their potential to achieve the ultimate goal of patient health management: to provide the best health for the greatest number of people at the best possible cost. 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CURATA Committee Members Advisory Québec College of Physicians Rheumatologists Association Geriatricians Association Arthritis Society Association Québecoise des Pharmaciens Propriétaires (Québec Pharmacy Owners Association) Québec Order of Pharmacists Québec Health and Social Services Ministry Association professionnelle des physiothérapeutes du Québec (Professional Association of Physiotherapists of Québec) Ordre des ergothérapeutes du Québec (Québec Order of Occupational Therapists) Canadian College of Family Physicians Executive Rheumatologists Association University of Montréal, Research Center Merck Frosst Canada Ltd, Patient Health Management Division Development University of Montréal, Faculty of Medicine, Continuing Medical Education Department Rheumatologists Association VOL. 10, NO. 8 THE AMERICAN JOURNAL OF MANAGED CARE 575