Interventions to improve inpatient osteoporosis management following Wrst osteoporotic fracture: the PREVENT project

Transcription

1 Arch Orthop Trauma Surg (2009) 129: DOI /s OSTEOPOROTIC FRACTURE MANAGEMENT Interventions to improve inpatient osteoporosis management following Wrst osteoporotic fracture: the PREVENT project Pedro Carpintero Enrique Gil-Garay Daniel Hernández-Vaquero Humbert Ferrer Luis Munuera Received: 2 January 2008 / Published online: 6 January 2009 Springer-Verlag 2009 Abstract Objectives To establish a protocol for the treatment of fragility fractures in the hospital setting based on treatment of osteoporosis. Materials and methods An intervention protocol was implemented in patients with fragility fractures based on (1) indicating the diagnosis of osteoporotic fracture in the summary of discharge; (2) lifestyle recommendations ; and (3) therapy for osteoporosis. Thirty-one hospitals were involved and they were informed of the importance of protocol compliance. In the Wrst phase, a retrospective study was conducted to establish the number of low-energy fractures treated and the percentage of them that had complied with the protocol (n = 887). Then, prospectively, the same data were collected for the patients managed for 1 year (n = 6,826) in three sections of 4-month intervals. Results The percentage of compliance increased from 8.2 to 57.2% in the Wrst point, from 12.6 to 42.4% in the second, and from 10.3 to 43.2% in the third. A part of this study has been presented in the 73rd Annual Meeting of the American Academy of Orthopedic Surgeons, March 2006, Chicago, IL. P. Carpintero (&) University Hospital Reina SoWa, Mejorana 45, Cordoba, Spain pcarpinterob@medynet.com E. Gil-Garay L. Munuera University Hospital La Paz, Madrid, Spain D. Hernández-Vaquero University Hospital San Agustin, Aviles, Spain H. Ferrer Hospital Mutua De Tarrasa, Tarrasa, Spain Conclusion The implementation of programs to improve osteoporosis treatment is very useful for ensuring adherence in the management of osteoporosis following admission due to fragility fracture. Keywords Osteoporotic fractures Osteoporosis treatment Secondary prevention Introduction Fragility fractures, particularly of the hip, are the worst consequence of osteoporosis, in that they are associated with increased morbidity and mortality and with a marked decline in the patient s quality of life, as well as high economic costs for health systems [14]. Patients who have sustained a previous osteoporotic fracture have a two- to ninefold greater risk of sustaining additional fractures [2, 3, 23], regardless of bone mineral density values [5]. It would therefore seem reasonable to initiate osteoporosis treatment in patients following osteoporotic fracture; the evectiveness of such treatment in reducing the number of new fractures has been demonstrated [12] and the treatment is now recommended in the various guidelines available [18, 19, 25]. Despite the increased risk of subsequent fracture and despite the high morbidity and mortality associated with fractures secondary to osteoporosis, only a small percentage of patients who have sustained a fracture of this sort currently receive speciwc treatment for osteoporosis [22]. Indeed, a number of studies suggest that the appropriate treatment of low-energy fractures is generally the exception, not the rule [26]; underdiagnosis and undertreatment of osteoporosis in patients with fragility fractures are common [17]. The lack of secondary prevention of osteoporotic fractures can be attributed to a range of major factors:

2 246 Arch Orthop Trauma Surg (2009) 129: insuycient awareness of current osteoporosis guidelines; the belief that the eycacy of osteoporosis treatment has not yet been demonstrated; the health status of elderly patients, who may have several comorbidities and be apprehensive about trying new treatments; and the perception among orthopedic surgeons that osteoporosis treatment is not their responsibility, perhaps compounded by a shortage of time [2, 10, 13, 21]. Elliot-Gibson et al. [10], in a systematic review, found that patients with fragility fractures failed to receive appropriate investigation for osteoporosis; in most studies, investigation of osteoporosis by bone mineral density scans was reported in less than 32% of patients. The same was true of post-fracture osteoporosis treatment: bisphosphonates were used in only % of observational studies. Of the four intervention studies describing attempts to increase osteoporosis treatments in patients with prior fragility fracture, the percentage was considerably higher in two, the percentage of patients appropriately treated rising to 78.8% [4] and 90.7% [5], while in the other two, outcomes continued to be dewcient with only 17.3% [11] and 35.1% [8] patients, respectively, receiving treatment. More recently, Bogoch et al. [2], implementing an Osteoporotic Exemplary Care Program, reported that over 95% of fragility-fracture patients were diagnosed and treated appropriately. With the aim of improving treatment for osteoporosis in fragility-fracture patients seen in Spanish hospitals, the Osteoporosis Study Group run by the Spanish Society for Orthopedic Surgery and Traumatology designed a study with the following goals: 1. To evaluate the percentage of patients admitted with a fragility fracture who received treatment for osteoporosis at discharge. 2. After an educational intervention to improve osteoporosis treatment, to evaluate the results of that approach in discharge recommendations for treatment of osteoporosis. The study was run at centers all over Spain, retrospectively for the Wrst goal and prospectively thereafter. This paper presents the results related to changes in treatment for osteoporosis. Materials and methods The PREVENT program comprises a mixed design of observation, intervention and evaluation, with chronological determination of a series of phases for establishing the minimum hospital measures required for managing osteoporotic fracture patients, with further evaluation of the program. The program steering committee Wrst drew up a set of recommendations regarding minimum hospital measures at discharge in order to improve the secondary prevention of osteoporotic fracture. The recommendations were that the discharge report should specify the anti-reabsorption treatment prescribed for secondary prevention of osteoporotic fracture; a bisphosphonate is to be preferred, plus calcium and vitamin D, except when contraindicated [27]. Minimum recommendations are shown in Table 1. For the secondary prevention purposes, the steering committee dewned the osteoporotic fracture patient as any patient meeting the following criteria: age 50 or over, presenting fracture at any site other than skull or face, presenting low-trauma fracture or fracture not proportional to consequences, and patients with pathological fractures due to skeletal disorders other than osteoporosis were excluded. It was established that all patients meeting osteoporotic fracture criteria and hospitalized in the Department of Orthopedic Surgery and Traumatology should receive the speciwc care measures set down in the minimum recommendations with regard to the diagnosis and treatment of osteoporosis, treatment being tailored to individual patient needs. Patients would also receive verbal or written information about osteoporosis, highlighting the following points: Table 1 Minimum recommendations established by the PREVENT project Osteoporosis treatment The diagnosis osteoporotic fracture must be stated in the Emergency Department case history The discharge report should rexect the diagnosis of osteoporotic fracture The discharge report should specify the anti-reabsorption treatment prescribed for secondary prevention of osteoporotic fracture. A bisphosphonate is to be preferred, except when contraindicated (Spanish Society for Orthopedic Surgery and Traumatology, SECOT) The main contraindications for bisphosphonate treatment are esophageal disease complicating emptying, the impossibility to remain standing or seated for 30 min, hypocalcemia, and hypersensitivity to bisphosphonates. In the case of contraindication, a selective estrogen receptor modulator (SERM) raloxifene once a day or calcitonin 200 U intranasal once a day can be prescribed

3 Arch Orthop Trauma Surg (2009) 129: the importance of complying with antiresorptive treatment to strengthen the skeleton and prevent fractures, the need to consume calcium-rich foods or take calcium supplements (minimum 1,000 mg/day plus 800 U/day of vitamin D), measures to prevent falls: (a) review of psychotropic medication (by GP); (b) removal of obstacles around the home; (c) moderate exercise, suited to patient characteristics, in order to improve muscle tone and coordination. Having drawn up this set of secondary prevention measures, a retrospective study of the baseline situation was carried out in all participating centers prior to implementation of the program (baseline survey). Educational material about the agreed minimum recommendations was then prepared for distribution at all centers. The study included all eligible patients discharged between March 2004 and March The survey was repeated at three 4-month intervals (surveys 1, 2 and 3) in order to monitor compliance with minimum recommendations and determine patient awareness. Data were supplied to the project steering committee by the stav appointed for this purpose at each hospital by means of a computer program (PREVENT ), which was used to collect patient s epidemiological data: prior fractures, inpatient treatment received, and treatment recommended in the discharge report. At each participating hospital, two members of stav from the orthopedic surgery unit were appointed (unpaid) to collect and send data. Every 3 months, stav from all participating hospitals met members of the program steering committee to address any data-collection problems arising at any hospital. Once a year, coinciding with the National Congress of the Spanish Orthopaedic Surgery and Injuries Society, a speciwc session was held to present the results of any hospital who wished to present them. A bulletin was sent regularly to those responsible for data collection. Table 2 Description of the centers according to number of beds and patients No. of beds No. of centers No. of patients Baseline time point point 1 had not received any OP treatment prior to admission for osteoporotic fracture (Table 3). In most cases, the OP treatment recommended in the discharge report was bisphosphonate therapy (from 85% in the baseline survey to 96.2% by the end of the program). A similar proportion of patients received vitamin D and calcium supplements (78.9% at baseline, rising to 89.8% of eligible patients; Table 3). The diagnosis of osteoporotic fracture was included in the discharge report for only 8% of patients in the baseline survey (Table 4). Compliance with minimum recommendations point 2 point 3 < , , ,157 >1, Total ,368 2,111 2,347 The proportion of patients whose discharge report contained an indication of osteoporotic fracture diagnosis and treatment or an indication of why the treatment was not provided rose at each survey (from 8.2 to 54.6%, from 10.4 to 43.8% and from barely 0.3 to 9.5%, respectively; Table 4). Percentage of hospital compliance with minimum recommendations for the prevention of osteoporotic fractures rose progressively, reaching 28.6% by the end of the program (Table 4). The smallest increase was recorded in hospitals with 500 1,000 beds (around 17% compliance; Fig. 1). Results Patient details, fracture type and OP treatment A total of 31 centers took part in this study (including 14 hospitals with 500 1,000 beds); by the end of the program, data had been collected on 7,713 admissions for osteoporotic fracture (Table 2). In all surveys (baseline to survey 3), patients were mostly female (78.8, 79.7, 79.4 and 80.9%, respectively) and mean patient age ranged from 78 to 80 (Table 3). Patients admitted for hip fractures constituted %; over 80% of these had not experienced fractures prior to the current admission. Around 92% of all patients Discussion The results of the baseline survey were similar to those reported in other Spanish and European studies, which have highlighted a consistent underdiagnosis and undertreatment of osteoporosis despite new advances in monitoring techniques and despite the fact that osteoporosis is a major public health problem [16]. Here, 92% of patients were not prescribed treatment at discharge and very few of them (barely 0.3%) were told why no treatment had been prescribed. Similar Wndings have been recorded in other European countries [9]; only 19% of osteoporotic fracture patients in Europe are given drug treatment. Implementation of the program led to a progressive increase in the proportion of patients whose discharge

4 248 Arch Orthop Trauma Surg (2009) 129: Table 3 Description of the patient characteristics in the diverent study time point evaluations Baseline time point point 1 point 2 point 3 Sex (% females) Age (mean SD) Type of osteoporotic fracture (%) upon admission Vertebral Hip Other non-vertebral Other OP fracture prior to admission (% no) Surgery (%) Treatment prior to admission (% no) Type of treatment for OP prior to admission (%) Bisphosphonates Calcitonin Others Type of supplements prior to admission Calcium Calcium + vitamin D Type of treatment for OP in discharge report (%) Bisphosphonates Calcitonin Others Type of supplements after discharge (%) Calcium Calcium + vitamin D Table 4 Degree of compliance with the main recommendations for the treatment for osteoporosis Recommendations Baseline time point point 1 point 2 point 3 Diagnosis of OP fracture in discharge report (% yes) Treatment for OP in discharge report (% yes) Information on reasons for the absence of treatment in discharge report (% yes) % < 500 beds beds > 1000 beds Fig. 1 Compliance with all the minimum recommendations for osteoporosis treatment report included the diagnosis of, and treatment for, osteoporotic fracture or an indication of the reasons why the treatment had not been prescribed (increase of 54.6, Baseline time point point 1 point 2 point and 9.5%, respectively, in the three interim surveys). By the last survey, minimum treatment recommendations for the prevention of osteoporotic fracture were received by 28.6% of patients. Figures for compliance with preventive treatment were similar to those reported following the implementation of comparable protocols in Israel and New Zealand. In both the cases, researchers highlighted the need to identify the barriers to increase extending treatment to over 50% of patients [15, 24] and drew attention to the diyculty involved in ensuring patient compliance at primary healthcare level [7, 20]. However, this signiwcant increase in the protocolization of preventive treatment for osteoporotic fracture is likely to lead to a lower rate of subsequent fracture, and thus to an improvement in quality of life for osteoporosis patients as well as a saving in healthcare, drug and rehabilitation resources [20]. Clinical trials and metaanalysis of the evectiveness of bisphosphonates have

5 Arch Orthop Trauma Surg (2009) 129: demonstrated a signiwcant reduction in the risk of repeat fracture [1, 6]. For that reason, one of the primary postdischarge recommendations in the PREVENT study is bisphosphonate therapy where this is not contraindicated together with assessment of the need for calcium and vitamin D supplements. Similar treatment protocols have been developed by the National Institute for Clinical Excellence (NICE) for application in England and Wales [25], and by hospital Orthopedic Surgery and Traumatology departments in Germany, Italy and Spain [9]. In general terms, the PREVENT program prompted a considerable and consistent increase in the rate of compliance with minimum recommendations for the secondary prevention of osteoporotic fractures. The best compliance rates for all recommendations were recorded for hospitals with fewer than 500 beds. The PREVENT program, in short, proved suitable as a means of improving osteoporosis treatment in patients hospitalized for fragility fractures and led to a reduction in variations in clinical practice between hospitals. However, greater evort should be made to promote the secondary prevention of osteoporotic fractures and further research is required to identify the most evective means for monitoring patient compliance with therapeutic recommendations [24]. One weakness of the present study was that it addressed only inpatients and not the large number of outpatients with fragility fractures. A new protocol is currently being designed to improve the treatment of these patients. Acknowledgment Financial support for this study was obtained from Merck Sharp and Dohme, Spain. References 1. 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