Glucocorticoid-Induced Osteoporosis Program (GIOP): a novel ...

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Methods. An organized program of care—GIOP (Glucocorticoid-Induced Osteoporosis Program)—was designed and implemented. The program goals were to ...

Osteoporos Int (2006) 17:1428–1434 DOI 10.1007/s00198-006-0149-3

ORIGINAL ARTICLE

Glucocorticoid-Induced Osteoporosis Program (GIOP): a novel, comprehensive, and highly successful care program with improved outcomes at 1 year E. D. Newman & C. K. Matzko & T. P. Olenginski & J. L. Perruquet & T. M. Harrington & G. Maloney-Saxon & T. Culp & G. C. Wood

Received: 20 February 2006 / Accepted: 10 April 2006 / Published online: 1 June 2006 # International Osteoporosis Foundation and National Osteoporosis Foundation 2006

Abstract Introduction Patients who take chronic glucocorticoids (GC) are at increased risk of osteoporosis and fracture. Only a minority of patients who take chronic GC receive optimal osteoporosis prevention, diagnosis, and/or treatment. Methods An organized program of care—GIOP (Glucocorticoid-Induced Osteoporosis Program)—was designed and implemented. The program goals were to identify patients at risk of fracture, provide education, redesign and implement new pathways of care, and monitor outcomes. Two hundred chronic GC users were seen at baseline, and follow-up visits scheduled at 6 months and 1 year. Results Patient retention of knowledge, frequent exercise, and 25-OH Vitamin D levels all significantly improved at 1 year. A significant decrease in GC dose was seen. In terms of adherence, 91% of patients considered at high risk were taking a bisphosphonate or teriparatide at 1 year, and 96% of patients overall were adherent to their prescribed regimen of calcium, vitamin D, and prescription treatment (if indicated). Bone density at the spine and total hip increased significantly. Conclusions GIOP is the first organized program of care for patients who take chronic GC that has demonstrated a clinically significant improvement in outcome. The program’s design can be adapted and used by other health systems and organizations.

Keywords Glucocorticoid . Osteoporosis . Outcomes . Program

G. C. Wood Center for Health Research and Rural Advocacy, Geisinger Health System, 100 N. Academy Avenue, Danville, PA 17822-3003, USA

Materials and methods

E. D. Newman (*) : C. K. Matzko : T. P. Olenginski : J. L. Perruquet : T. M. Harrington : G. Maloney-Saxon : T. Culp Department of Rheumatology, Geisinger Medical Center, 100 N. Academy Avenue, Danville, PA 17822-1341, USA e-mail: [email protected]

Introduction Glucocorticoids (GC) are used in 0.2–0.5% of the general population [1]. The most important side effects in patients who take GC chronically are osteoporosis and fracture. GCinduced osteoporosis is the second most common form of osteoporosis after menopause-related bone loss. Fractures related to osteoporosis occur in up to 50% of chronic GC users [1, 2]. Published guidelines for the management of patients on chronic GC suggest calcium and vitamin D supplementation, bone density testing [dual X-ray absorptiometry (DXA)], and bisphosphonate therapy in at-risk patients [3–5]. Unfortunately, only a small minority of GC users receive effective preventive, diagnostic, and therapeutic interventions [2, 6]. Endeavors to improve this by empowering patients [7] or educating health care providers [8, 9] have not been associated with substantial improvements in the quality of care for this population. Our system-wide osteoporosis disease management program demonstrated success in improving outcomes in patients with postmenopausal osteoporosis [10]. In an effort to provide similar benefits specifically to a high-fracture-risk group (patients taking chronic glucocorticoids), we developed an organized program of care termed GIOP (Glucocorticoid-Induced Osteoporosis Program).

GIOP’s roots began in 1998 with an assessment of the magnitude of bone health problems in chronic GC users in

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Fig. 1 Glucocorticoid-Induced Osteoporosis Program (GIOP) process flow

our health care system. Despite educational and process changes in the care of patients taking GC over the next several years, there remained a significant at-risk population. A formal organized program (GIOP), developed in 2003, was deemed the only viable solution to improving the bone health status of patients taking chronic GC. The following sections outline in greater detail baseline assessment, program development, enrollment strategies, and statistical analysis. GIOP baseline assessment In 1997, osteoporosis guidelines containing specific recommendations for GC users were disseminated to physicians in our health care system, and continuing medical education (CME)-based lectures and discussion were given [10]. Using data extracted from our electronic medical record (EMR) (EPIC-Madison, WI, USA), all GC users across our health care system from 1998–1999 were assessed for whether osteoporosis prevention and treatment had been performed. Only 15% of GC users had received a DXA, and only 6% of GC users were taking bisphosphonates. To improve the appropriate use of bisphosphonates in GC users, our healthcare system DXA team developed a standardized consultative DXA reporting strategy [11]. Follow-up evaluation showed a

modest (24%) improvement in bisphosphonate prescription in high-risk GC users (defined as T score below −1.0), but the use of DXA only rose 4%. Based on the continued low attention to osteoporosis and fracture prevention, diagnosis, and treatment, despite physician education, formal guidelines, and standardized consultative DXA reporting, a decision was made to develop a formal program as the best solution to improving osteoporosis care of GC users. GIOP program development GIOP was designed and implemented by members of the Department of Rheumatology. The GIOP team consisted of a nurse specialist program leader (CM), physician co-leader (EN), nurse specialist care provider (GM), physician consultants (TH, TO, JP), and data manager (TC). GIOP goals were developed and included: – – – – –

Identifying at-risk patients in our healthcare system Educating patients Developing/implementing pathways to improve GCinduced osteoporosis diagnosis and treatment Monitoring GC-induced osteoporosis outcomes Utilizing technology/process flows to “make it easy to do the right thing”

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A GC-induced osteoporosis care pathway, as previously developed by the Geisinger Osteoporosis Disease Management Team [10], was adapted for GIOP use. This pathway was based in part on the American College of Rheumatology recommendations for prevention and treatment of GC-induced osteoporosis (1996, updated 2001) [3]. Salient pathway points included: calcium 1,500 mg and vitamin D 800 IU daily, 25-OH vitamin D levels, DXA scan, and vertebral fracture assessment. For patients with 25-OH vitamin D levels below 30 ng/ml, vitamin D 50,000 IU twice weekly was prescribed. Levels were rechecked approximately every 3 months and the dose adjusted accordingly to aim for a level above 30 ng/ml. Prescription osteoporosis treatment was recommended if the T score at the spine or hip was below −1.0 or if a prevalent nontraumatic vertebral fracture was discovered (defining patient as “high risk”). In this high-risk group, treatment with a bisphosphonate (alendronate or risedronate) was recommended. If there was a contraindication to or intolerance of a bisphosphonate, then teriparatide (recombinant human PTH (1–34)) was recommended. The patient education program was then designed. This consisted of a slide presentation on GC and osteoporosis, as well as the development of a patient “Frac-Pac” (GIOP educational material, a GIOP calendar, a GIOP magnet, and a night light). GIOP process flow was developed (Fig. 1). Patients could enter the program through self referral, physician referral, or by a physician–program pact (described below under “Enrollment strategies”). Patients could enter as a consult only (where recommendations would be given to their physician) or consult and treat (where the patient received education, prevention, diagnosis, treatment, and follow-up). Standardized consult and follow-up communication templates were developed for the EMR. A database was developed for programmatic monitoring and included baseline demographics, GC dose, osteoporosis risk factors, osteoporosis medication use, 25-OH vitamin D levels, DXA results, vertebral fracture assessment (using either DXA-VFA or plain radiography of the thoracic and lumbar spine), medication prescription and adherence, exercise, and preeducation testing. Follow-up visits were scheduled for 6 months and 1 year. At these visits, posteducation testing, exercise, GC dose, 25-OH vitamin D levels, medication costs, and medication adherence were evaluated and recorded. Follow-up DXAs were performed at an interval per the GIOP pathway as indicated. GIOP enrollment strategies Enrollment strategies were developed for patients and physicians, focusing on easy mechanisms for entering GIOP. Patient-initiated enrollment strategy focused on advertising in physician waiting areas. A poster with

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handouts was created. The poster summarized in lay terms the problem of GC-induced fractures and offered a toll-free phone number to call for more information. Patients would then be connected to our health system’s interactive voice recognition (IVR) system—the patient could say the word GIOP (“gee-op”) and they would be connected to a person trained in GIOP to answer their questions and get them enrolled. Physician-initiated strategies also provided easy mechanisms for patient enrollment. For physicians that share our EMR, typing “GIOP” under the orders section in the EMR would open a prefilled GIOP consult. Once signed electronically, the consult was automatically forwarded to a trained GIOP scheduler. Physicians not using our EMR were offered a toll-free phone number to connect to our IVR. Similar to the patient-initiated strategy above, after saying the word GIOP (“gee-op”), physicians would be connected to a nurse trained in GIOP to answer questions and facilitate scheduling of their patient. The final enrollment strategy involved proactively searching for GC users and obtaining authorization from their physicians to contact and enroll their patients for them (physician–program pact). A site was chosen and the physicians at that site agreed to have their patients be considered for entry into GIOP. The process of study entry proceeded as follows. A computerized list of GC users was given to the treating physician. The treating physician was allowed to remove any patients that they felt would not be candidates, such as patients at the end of life, patients with active severe diseases undergoing treatment (e.g. chemotherapy for cancer), or other problems, at their discretion. The remaining patients were contacted on behalf of their physician to seek enrollment into GIOP. GIOP statistical analysis Descriptive statistics, such as the calculation of means and percentages, were used to describe the study population at baseline, 6 months of follow-up and 1 year of follow-up. When comparing baseline to follow-up, analyses were limited to those with follow-up complete at 6 months and 1 year, respectively. Changes in mean from baseline to follow-up were analyzed using paired t tests. The McNemar test was used to test the equality of binary response in a paired population (i.e., baseline versus follow-up). Similarly, the marginal homogeneity test, which is a generalization of the McNemar test, was used to test the equality of an ordered multinomial response in a paired population. Exact statistical tests were used when appropriate. SAS version 8.01 (Statistical Analysis Systems; Cary, NC, USA) and StatXact version 5 (Cytel software; Cambridge, MA, USA) were used for statistical analysis. All test were two sided, and p