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Keywords:

  • Osteoporosis;
  • Clinical process redesign

Abstract

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. MATERIALS AND METHODS
  5. RESULTS
  6. DISCUSSION
  7. Acknowledgements
  8. REFERENCES

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.


INTRODUCTION

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. MATERIALS AND METHODS
  5. RESULTS
  6. DISCUSSION
  7. Acknowledgements
  8. REFERENCES

More than 1.5 million osteoporotic fractures occur annually in the United States, resulting in $13.8 billion dollars in direct health care costs (1995 data), pain, disability, and sometimes death for those affected (1, 2). The possibilities for reducing this important health problem have improved dramatically in recent years. The populations at high risk for osteoporosis have been defined, dual x-ray absorptiometry (DXA) precisely measures bone density, and effective therapies to reduce fractures have been developed (3).

Yet few osteoporosis patients are receiving these benefits, most strikingly those who have experienced a fragility fracture and are therefore at very high risk of fracturing again and again (4–7). At least 16 publications have documented that fracture patients have seldom had a DXA or preventive treatment before fracturing, nor are they offered diagnosis and treatment afterwards (among the most recent, references 8–12). In contrast, only a few examples of more dependable care have been reported, all from outside of the United States (13–15).

In our own health system (University of Wisconsin Medical Foundation [UW]), only 5% of patients who sustained a hip fracture in 1999 were provided DXA and bisphosphonate treatment, either before or after their fracture, and few patients were being referred for DXA because of other fragility fractures (8). In 2000, we began an improvement project to address this deficiency. Our goal was to provide diagnosis and treatment for osteoporosis to every fracture patient able and willing to participate. This publication describes our successful improvement project, the rapid-cycle process improvement methods used, the fundamental changes required to improve care, and our current program for managing all fragility fracture patients.

MATERIALS AND METHODS

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. MATERIALS AND METHODS
  5. RESULTS
  6. DISCUSSION
  7. Acknowledgements
  8. REFERENCES

Clinical process improvement.

Rapid cycle process improvement methods are used widely in other industries (16), and the Institute of Healthcare Improvement and others are advocating their use in the health industry as well (17). These methods involve executing sequential plan-do-study-act (PDSA) cycles. “Planning” identifies a problem, uses appropriate measures to define a performance baseline, shares this data with concerned providers and administrators, and identifies possible solutions. Next, the “do” tests a process change, often in small pilot projects. Its impact on performance is then “studied.” The cycle is completed by “acting” to implement and expand the new process, discard it, or initiate a new cycle to test further alternatives. This is a fundamentally different approach from clinical research, is better suited to real-time process redesign, and is generally exempted by institutional review boards and from Health Insurance Portability and Accountability Act regulations (18, 19). The present project has been reviewed and exempted by the University of Wisconsin Medical School Institutional Review Board.

Health system.

The UW has employed more than 800 physicians since a merger of the UW clinical faculty in 1998 with Physicians Plus Medical Group, a community-based multispecialty partnership. Physicians Plus Division providers generally are affiliated with Meriter Hospital in Madison, Wisconsin. Resources for osteoporosis care include primary physicians, orthopedists, osteoporosis specialists in rheumatology, a rheumatology nurse manager, physical and occupational therapists, and DXA scanners. Rheumatologists interpret DXAs, provide consultation, and have regularly offered continuing education regarding osteoporosis since 1986. A 7-member Physicians Plus Division orthopedic practice has been involved in our project.

Fracture patient populations.

Hip fracture patients involved in cycle 1 of this project were identified at the time of hospitalization for acute fracture care at Meriter Hospital. Fragility fracture patients, including those with hip fracture, for cycles 2 and 3 were identified from monthly orthopedic section billing data and included all patients older than age 50 years with a fracture of the spine, ribs, pelvis, or long bones. Fracture patients were generally assigned for care to the on call orthopedist. Table 1 indicates the International Classification of Diseases, Ninth Revision (ICD-9) codes used to identify these patients (20). Patient demographic and clinical data were obtained from DXA reports, a questionnaire routinely administered with DXA, and system electronic medical records.

Table 1. Cycles 2 and 3 fracture sites and fracture ICD-9 codes*
Fracture sitePatientsICD-9 code
Cycle 2 nCycle 3 n
  • *

    ICD-9 = International Classification of Diseases Ninth Revision, Clinical Modification.

Vertebra88805, 806
Rib01807
Pelvis042808
Clavicle06810
Humerus324812
Radius or ulna370813
Carpal bones00814
Femur1226820, 821
Patella38822
Tibia or fibula819823
Ankle023824.8
Total all sites37227 

Fracture care algorithm.

Algorithms for postfracture osteoporosis diagnosis, treatment, and monitoring of adherence to therapy were developed initially for hospitalized hip fracture patients. The current algorithm being used for all fragility fracture patients in our direct referral program from orthopedics to the osteoporosis care service is outlined in Figure 1 and is also described in the Results section. It embodies several published, evidence-based osteoporosis guidelines (21–24), and has evolved during our process improvement cycles. An osteoporosis improvement taskforce has participated in this activity. At various stages this group has included primary physicians, orthopedists, hospital administrators, physical and occupational therapists, nurse managers, a rheumatologist project manager, and an industrial process software consultant. Meriter Hospital physical and occupational therapists have also developed osteoporosis rehabilitation and falls assessment/prevention programs to complement medical therapy. This algorithm has been conveyed to system providers in continuing education conferences and written communications.

thumbnail image

Figure 1. Current postfracture osteoporosis care algorithm. DXA = dual x-ray absorptiometry; P.T. = physical therapy.

Download figure to PowerPoint

Osteoporosis care service.

As this program has evolved, a specialty service has been developed to coordinate osteoporosis care for fracture patients. Personnel include a rheumatologist director, nurse managers, DXA technicians, and faculty rheumatologists who interpret DXA tests and provide patient consultations. Service functions include coordinating referrals from orthopedics, registering and educating fracture patients, obtaining records and prior DXA results or arranging for a new DXA, arranging physical therapy falls prevention if needed, assigning patients to primary or consultative physician care, and informing primary physicians. The nurse manager facilitates these tasks and monitors patient status every 3 months for at least 2 years when a repeat DXA is obtained, if indicated.

Osteoporosis care process management software.

Organizing the diagnosis, treatment, and followup care of these patients proved to be impossible from the outset in the absence of process management computer support. Such computer programs are widely used for process control and documentation in other industries, but are seldom used in health care (25, 26). We have developed and tested a software program to meet these needs based on the fracture care algorithm (Figure 1) with the assistance of an experienced industrial process management consultant. Its purposes and functions are distinct from those of electronic clinical data repositories. It is copyrighted as Stop Osteoporosis software by the Wisconsin Alumni Research Foundation, Madison, WI. The Alliance for Better Bone Health, which provided grant support for its development, has not influenced the process improvement work described in this publication or the care provided to our patients.

RESULTS

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. MATERIALS AND METHODS
  5. RESULTS
  6. DISCUSSION
  7. Acknowledgements
  8. REFERENCES

The portion of our patients who received DXA and osteoporosis treatment after experiencing a fragility fracture increased from 5% of hip fracture patients in 1999 to 58% of patients with any fragility fracture in 2003, including 46% of those with hip fracture. The 3 sequential PDSA cycles required to achieve this improvement are summarized below.

Cycle 1: Hip fracture patient osteoporosis care by primary physicians (2000–2001).

Plan.

Osteoporosis-related continuing education, DXA, and osteoporosis consultation have been available to our physicians since 1986, yet it appeared that few patients at high risk for fragility fractures were being referred for DXA, including those with previous fractures, women older than 65 years, and those receiving long-term glucocorticoid treatment. We began our improvement project by studying osteoporosis care in hip fracture patients because they have a high risk of additional fractures and were believed to be a small accessible subpopulation. A retrospective baseline study indicated that only 5% of 1999 hip fracture patients were referred for DXA or treated with an antiresorptive drug either before or after their fracture (8).

Project planning began with presenting this data to our orthopedic and primary care physicians. Most physicians were interested in improving care, although some felt that hip fracture patients were beyond help or that treatment was unproven. Orthopedists did not wish to participate in ordering DXA or initiating antiresorptive treatments and felt that primary physicians should provide these services. Primary physicians agreed, but indicated that they required more timely notification of the fracture event. Neither group felt that involvement of osteoporosis specialists was necessary when this alternative was proposed.

Do.

In December 2000, primary physicians were educated regarding osteoporosis care after hip fracture at conferences and through mailings. From January to October 2001, a Meriter Hospital nurse practitioner notified each hip fracture patient's primary physician by phone on the day of admission, and a letter was sent to confirm the notification. Patients and their families were also educated about osteoporosis and the risk of further fractures.

Study.

Primary physicians indicated in 80% of 98 cases that they were too busy to see the patient in the hospital and would provide treatment later. Six months after discharge, only 20% of patients had received a DXA and any osteoporosis care. Fifty consecutive patients or a family member were then surveyed to determine why they had not received treatment. Of 46 contacted, 31 (67%) indicated that they were waiting for their physician to act, 5 were receiving appropriate care, and 10 were too ill or unwilling to participate.

Our experiences also suggested that providing osteoporosis consultation during hospitalization was impractical due to patients' condition and short hospital stays, that this process could not be extended to fracture outpatients, and that computer support would be required to manage the care of these patients over time.

Act.

After reviewing these findings, primary physicians endorsed direct referral from orthopedics to an osteoporosis fracture service for diagnosis, initiation of treatment, and monitoring of adherence. A direct referral program was then discussed with our orthopedists, but several members considered this care to be unnecessary, and the proposal was rejected.

Cycle 2: Direct referral pilot study (2002).

Plan.

Three members of the orthopedic section agreed to participate in a direct referral pilot project, which was conducted from January through May 2002. We also determined that their monthly billing data could be used to identify all fragility fracture patients, and that in most cases they preferred using this list to request DXA and consultations rather than initiating referrals during fracture care office visits.

Do.

A nurse managed the direct referral process and contacted the patients to arrange DXA and osteoporosis consultation.

Study.

Forty-two fragility fracture patients treated by the participating orthopedists were identified and registered. Five were unavailable for care, 2 being deceased and 3 residing elsewhere. Thirty-seven were referred to the osteoporosis care service, 32 women and 5 men. Twenty-three accepted referral, whereas 9 preferred to obtain care from their primary physician and 5 were either unwilling or unable to participate. Their fracture sites are shown in Table 1 with the ICD-9 codes used to search billing data. Of the 37 patients, 14 reported at least 1 previous fragility fracture (38%), only 10 had had a previous DXA (27%), and 4 were taking a bisphosphonate at the time of fracture (11%).

The pilot study patients' management is summarized in Table 2, and is contrasted to that of 55 other fracture patients treated traditionally by nonparticipating orthopedists during the same period. All 23 of the osteoporosis service and 4 of 9 primary care patients had a DXA test (84%). Their T-scores were distributed as follows: above −1 = 4, between −1 and −2.5 = 11, and below −2.5 = 12. Two osteoporosis service patients were found to have previously undiagnosed hyperparathyroidism. Nineteen osteoporosis service and 3 primary care patients were treated with calcium and a bisphosphonate (66%). In contrast, a chart review showed that none of the 55 patients treated by the nonparticipating orthopedists during the same time span were provided with DXA. Bisphosphonate treatment was continued in 1 and initiated in 2 after fracture. In 16 cases, primary physicians had acknowledged the need for osteoporosis care subsequent to fracture, but only 8 patients received any treatment. Of the 12 hip fracture patients in the pilot group, 6 were measured and treated (50%), whereas the rest either preferred management by primary care (4) or refused altogether (2).

Table 2. Cycle 2 pilot patients' osteoporosis care*
 Redesigned care (3 orthopedists) nTraditional care (4 orthopedists) n
  • *

    DXA = dual x-ray absorptiometry.

  • By provider: osteoporosis care service = 1; primary physician = 6; none = 5.

Total patients3755
Osteoporosis care provider  
 Osteoporosis care service23
 Primary physician916
 None539
DXA obtained270
 Osteoporosis care service23
 Primary physician40
 None00
Treatment  
 Bisphosphonate, calcium, vitamin D223
 Calcium alone05
 Estrogen20
 Calcitonin10
 None1247

The 23 osteoporosis service and 9 primary care patients were contacted every 3 months to determine their clinical status, to check on adherence to treatment, to identify any new clinical fractures, and to answer their questions. After 12 months, all but 1 were adherent to treatment. No new fractures were reported, and they responded positively to our interest in their status. As of July 2004, 20 osteoporosis service and 6 primary care patients had completed 24 months of nurse followup, 5 were deceased, and 1 had moved. All were continuing treatment, and no new fractures were reported.

This pilot was used to test the osteoporosis process management software. Each patient was registered. Their demographic data were used to contact them and their primary physicians. Weekly task lists were generated to prompt performance of DXA, consultation, osteoporosis rehabilitation, and quarterly telephone followups. The software has also facilitated regular progress reports and the preparation of this publication.

Act.

In late 2002, orthopedic surgery and our primary care leadership endorsed full implementation of this direct referral process and the osteoporosis care service.

Cycle 3: full implementation (2003–July 2004).

Plan.

A business plan was presented to system leadership outlining the expected revenues and resource requirements for fully implementing the fracture patient direct referral program and beginning a primary prevention program for female patients ≥65 years cared for by our affiliated primary physicians.

Do.

Since January 2003, all of the 7 orthopedists' fracture patients >50 years old, totaling 287 for the year, have been identified from orthopedic billings, registered in the osteoporosis care service, and scheduled for a DXA test. An additional nurse manager was hired in September 2003 to accommodate this caseload. These fracture patients from 2003 and each month's new fracture patients in 2004 are assigned for osteoporosis care to either their primary physician or an osteoporosis consultant, based on their DXA results and clinical information. Those with normal and low bone density (osteopenia) are generally scheduled with their primary physician, whereas those with osteoporosis or clinical concerns about secondary bone loss are scheduled for consultation and more extensive evaluation for metabolic bone disorders. Patients with a recent DXA are managed similarly, using their previous information. The DXA report and other communications include recommendations for further evaluation and treatment to assist primary physicians, as has been true previously in our program. Calcium, a vitamin D supplement, and bisphosphonate treatment are recommended for fracture patients with osteopenia and osteoporosis. The nurse manager is following each registered patient at 3-month intervals to determine their status and ensure adherence to treatment. Patients will be followed for 2 years, when a new DXA will be scheduled if indicated.

Study.

Initial management of 287 orthopedic referrals eliminated 60 patients who had clearly sustained a traumatic fracture and did not otherwise meet National Osteoporosis Foundation criteria for DXA testing (21% of total). The remaining 227 fragility fracture patients were contacted to explain the program by letter and followup phone calls. Their fracture sites are shown in Table 1. A prior DXA from the previous 3 years was available for 52 (23%). The remaining 175 (77%) were invited to schedule a DXA. As of July 2004, 79 additional patients have had a DXA (35%) and 96 have not (42%). Of the 131 with a DXA (58%), 24 with a normal bone density were discharged to primary care, 37 were scheduled for osteoporosis consultation, 66 were referred to primary care for bisphosphonate treatment, and 4 were unwilling or unable to participate (1 refused further care, 2 preferred treatment elsewhere, and 1 died). The 96 without a DXA included 33 who refused care (19% of the total), 28 who were unreachable, 19 in very poor health, 14 treated elsewhere, and 2 deceased. Of 26 hip fracture patients, 12 (46%) had a DXA and treatment and 14 were unable or unwilling to participate. The delay in contacting many of these 2003 patients until the new nurse manager was hired in September appears to explain the high numbers of unwilling or unreachable patients, as suggested by our more favorable recent experience with month-to-month management. Studies of these patients' clinical parameters, their management by primary physicians and consultants, and their adherence to therapies are ongoing.

Act.

These data have been reviewed with orthopedic surgeons and primary physicians, and a reliable osteoporosis care process for fragility fracture patients is now in place. A primary prevention program for women older than age 65 years is being started.

DISCUSSION

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. MATERIALS AND METHODS
  5. RESULTS
  6. DISCUSSION
  7. Acknowledgements
  8. REFERENCES

The Institute of Medicine report “Crossing the Quality Chasm” emphasizes that chronic diseases, such as diabetes, hypertension, asthma, depression, and others, account for 70% of US health care costs, but that one-third of these monies, amounting to $500 billion per year, are being wasted on unnecessary and ineffective care. At the same time, necessary care—mandated by new knowledge and technology and recommended in published guidelines—is often omitted. The report concludes that redesign of delivery processes will be required if cost, efficiency, and outcomes are to improve (27). These concerns are reinforced by other indications of generalized underperformance in chronic disease management (28).

Our findings are in agreement with the Institute of Medicine's position, in that our patients' lack of necessary osteoporosis care can often be attributed to ineffective, uncoordinated delivery processes. Fundamental process redesigns and physician consensus across specialty boundaries have been required to provide osteoporosis care for every willing and able patient in our 2002 pilot population, to maintain reliable treatment for up to 24 months, and to implement this program for all of our fragility fracture patients since January 2003. Our performance continues to improve in 2004 as these new processes become part of routine postfracture care. Weaker interventions that simply overlaid traditional care, such as educating and prompting busy primary physicians, did not work in our system, nor have they worked elsewhere for osteoporosis or other chronic diseases (10, 11, 15, 29, 30). In fact, our more successful approach is very similar to those reported in other countries (13–15), and is fundamentally different from traditional delivery processes in the United States and elsewhere.

We have chosen to focus this communication as much on the process of change as on the new processes developed and the results obtained because system redesign methods are a requirement for achieving meaningful improvement. Successful care improvement projects share several common features, including activities directed at changing clinician behavior, changes to the organization of practice, information systems enhancements, and education or support programs aimed at patients (31, 32). Our project contains each of these elements. A nurse-centered management program is shown to be effective in coordinating interdisciplinary care, as others have demonstrated for other diseases (31–37). Direct referral from orthopedics to an osteoporosis care service is also critical to providing reliable care, as previously reported from Switzerland, Canada, and Scotland (13–15). Clinical process management software, such as that we are using, is essential to organizing the program's work. Telephone monitoring at predetermined intervals promotes adherence to therapy in our patients, as others have reported (38–41). Our other key strategies include using algorithms to define care and provider roles (42), identifying fracture patients from billing data, piloting to test and refine process changes (16, 17), and regular data reporting to providers and system administrators. We also believe that medical subspecialists have a unique value as both chronic disease program managers and providers of care for complex patients in such interdisciplinary programs (31, 34–37). The limited scope of our cycle 2 pilot may concern some, but we view this as an example of effective process testing and proof of principle. We also acknowledge that other strategies must be developed to capture vertebral and other fracture patients who may not receive orthopedic management.

We encountered several barriers to improving care that are likely to also discourage similar efforts in other health systems. The first was our colleagues' initial adherence to their traditional approaches and roles. Most viewed care from an individual physician–individual patient perspective rather than acknowledging the need for population- and system-based management. In addition, when the baseline data were presented, our primary physicians and orthopedists were reluctant to involve our osteoporosis experts, even though the severity of bone loss and the prevalence of secondary osteoporosis that are well-recognized in fracture patients suggested the need for consultative care (43). To their credit, our physicians were willing to reconsider their beliefs and practice methods in response to our documenting the problem and their patients' desire for care. Use of obtainable performance data is critical to encouraging physician involvement in clinical process improvement.

A second barrier has been the paucity of support and resources for innovation in our health system. Much of our time and effort, our slow rate of progress, and the limited scale of our project relate to this inertia. Traditional health care assumptions, priorities, politics, decision making, reimbursement mechanisms, and compensation plans do not support change (44). We were able to provide the additional patient care for our pilot project with existing resources by decreasing other unnecessary work through a rheumatology preappointment management program (45). Sustaining care for all fracture patients has required additional provider manpower, staffing, space, and equipment that have taken time to acquire, even after we presented a business plan showing that this care would be profitable. Assigning patients to primary physicians and consultants based on disease severity has permitted us to provide this expanded care without adding providers. In a broader sense, strong leadership support and redesign of health system management and finances are required for sustaining and disseminating health care improvement (32, 44, 46). In fact, the relatively few health systems that have developed an improvement mindset and skills appear to be outperforming more traditional delivery environments (47, 48).

The absence of prior osteoporosis diagnosis and treatment in our fracture patients begs for improved primary prevention in women older than 65 years, as published guidelines recommend (30), and probably in men older than 70 years (49). In our own system, only 30% of women >65 years old and few older men have had a DXA (unpublished data), as reflected in our fracture population. Pharmaceutical data additionally suggest that adherence to osteoporosis treatment is poor in those few patients who are treated. Developing effective population-based prevention programs for these other high-risk patients is likely to be an even more demanding task, but has the potential for further reducing fracture incidence and cost (50, 51). We hope this publication will encourage similar health care redesign efforts in other health systems for osteoporosis and other chronic diseases.

Acknowledgements

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. MATERIALS AND METHODS
  5. RESULTS
  6. DISCUSSION
  7. Acknowledgements
  8. REFERENCES

We appreciate the contributions to patient care and this improvement project by nursing and physical therapy providers of the University of Wisconsin Medical Foundation and Meriter hospital. We also thank Abigail F. Cantor, PE, MCSD, Process Research Solutions LLC, Madison, WI, for her invaluable contribution in developing the Stop Osteoporosis software.

REFERENCES

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. MATERIALS AND METHODS
  5. RESULTS
  6. DISCUSSION
  7. Acknowledgements
  8. REFERENCES
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