Download Osteoporosis Disease Management

OUTCOMES IN PRACTICE
Osteoporosis Disease Management: Best Practices
from the Penn State Geisinger Health System
Eric D. Newman, MD, Ralph H. Starkey, MD, William T. Ayoub, MD, FACP, FACR, Charles M. Davis III, MD, PhD,
Jessica M. Diehl, BSN, Philip M. Hanus, PharmD, G. Craig Wood, MS, and Carolin M. Frey, PhD
O
steoporosis is a common and costly systemic disease that affects an estimated 26 million women in
the United States [1]. A 50-year-old white woman
has a 40% chance of suffering an osteoporotic hip, wrist, or
spine fracture during her lifetime [1]. The consequences of
an osteoporotic hip fracture may include extended disability
or death. The economic costs of osteoporosis are significant:
nearly $14 billion was spent in 1995 to treat complications of
the disease [2].
Strategies to diagnose and treat osteoporosis are available
[3–8]. Bone mineral density (BMD) measurement can be
used to reliably identify patients at risk for fracture [9,10].
Lifestyle modification (eg, exercise, smoking cessation), hormone replacement therapy, and several classes of medications have been shown to improve BMD and reduce fracture
risk [3]. Given the prevalence of osteoporosis and its potentially serious consequences, the appropriate diagnosis and
management of this disease should be high on the list of priorities for health care providers.
In 1996, the Penn State Geisinger Health System (PSGHS)
convened a multidisciplinary team consisting of representatives from rheumatology, endocrinology, general internal
medicine, gynecology, orthopedics, radiology, nursing, pharmacy, biostatistics, and administration to develop a disease
management program for osteoporosis. PSGHS is an integrated delivery system with 90 primary care sites serving 40 counties in central Pennsylvania. The Penn State
Geisinger Health Plan (PSGHP) is one of the largest rural
managed care plans in the country, with over 300,000 members and approximately 1000 employed or empanelled primary care physicians. A cost-benefit analysis based on
prevalence data was undertaken that suggested that a comprehensive testing and treatment program for PSGHP
enrollees could potentially result in a cost savings of $8 million over 5 years. This article will present the components of
the program, the derived paradigms and projects, and program results to date.
Program Elements
Treatment Algorithms and Provider Education
Comprehensive treatment algorithms were developed
Vol. 7, No. 5
between April 1996 and April 1997. Information and recommendations contained in the American Association of Clinical Endocrinologists (AACE) guidelines for the prevention
and treatment of postmenopausal osteoporosis [4] and in the
American College of Rheumatology (ACR) guidelines for
prevention and treatment of steroid-induced osteoporosis [5]
provided the foundation for the algorithms. While these
society guidelines contained valuable review information,
they did not define a clear pathway that a practitioner could
refer to when an individual patient presented to the clinic.
Thus, the team combined information from the guidelines
with practical advice for the clinician and developed 4 algorithms: one for premenopausal women, one for postmenopausal women < 75 years, one for elderly women and
men ≥ 75 years, and one for steroid-treated patients. The
algorithm for premenopausal women is shown in Figure 1.
Several points about the algorithms are worth mentioning.
In the algorithm for premenopausal women, patients at highrisk for osteoporosis are identified. These include patients
with certain chronic diseases (eg, rheumatoid arthritis, chronic liver disease), who may be underrecognized by physicians
as being at risk. In the postmenopausal algorithm, all women
with no contraindications are offered hormone replacement
therapy (HRT). Measurement of BMD is offered only if a
woman refuses or cannot take long-term HRT; it is assumed
that a woman compliant with HRT will receive bone protection, and testing early on would be unlikely to result in a
change in therapy. In addition, the cost for testing in this
Eric D. Newman, MD, Director, Department of Rheumatology,
Geisinger Medical Center, Danville, PA; Ralph H. Starkey, MD, Head,
Endocrinology Section, Geisinger Medicial Center; William T. Ayoub,
MD, FACP, FACR, Associate, Rheumatology, Geisinger Medical Group,
State College, PA; Charles M. Davis III, MD, PhD, Assistant Professor,
Department of Orthopedics and Rehabilitation, Penn State College of
Medicine, Hershey Medical Center, Hershey, PA; Jessica M. Diehl, BSN,
Coordinator of Women’s Health and Community Outreach, Geisinger
Medical Center; Philip M. Hanus, PharmD, Director, Pharmaceutical
Care, Penn State Geisinger Health System, Danville, PA; G. Craig
Wood, MS, Biostatistician, Department of Clinical Research, Penn State
Geisinger Health System; and Carolin M. Frey, PhD, Staff Biostatistician, Penn State Geisinger Health System.
JCOM May 2000 23
OSTEOPOROSIS DISEASE MANAGEMENT
REVIEW PREVENTIVE MEASURES
• Weight bearing exercise
• Dietary changes1
(calcium & vitamin D)
• Smoking cessation
• Adjust thyroid medication
(to avoid overreplacement)
Is patient taking or will patient be
taking chronic steroids (≥ 7.5 mg/d
prednisone for > 3 months)?
YES
See Steroid Algorithm
NO
IDENTIFY OTHER POTENTIALLY OSTEOPOROTIC PATIENTS2
•
•
•
•
•
•
•
•
•
Premature menopause (natural or surgical) – see Postmenopausal Algorithm
Amenorrhea or sex hormone deficiency (eg, athletes, eating disorders)
Asymptomatic primary hyperparathyroidism
Chronic diseases (eg, rheumatoid arthritis, liver, renal, malabsorption)
Medication (especially thyroid, anticonvulsant, anticoagulant)
Excessive alcohol consumption
Demineralization on previous radiographs
Spontaneous fractures
Documented loss of height > 11/2 ”
Consider specialty
referral if appropriate
Routine
follow-up
NO
Potentially osteoporotic?
YES
YES
T-score at or below –1.5 ?
NO
Consider BMD
recheck in 1–2 years
Consider BMD test3
Consider secondary causes 2
See dietary sheet
See secondary causes
of osteoporosis
3
See bone mineral
density sheet
1
2
Reemphasize preventive measures
T-score at or below –1?
NO
YES
Figure 1. Osteoporosis disease management algorithm for premenopausal women and for men younger than 75 years. BMD =
bone mineral density.
24 JCOM May 2000
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OUTCOMES IN PRACTICE
population would be significant and results would not likely
influence treatment. If a patient who will not or cannot take
HRT has a BMD T-score of –1.5 or below, she is offered alendronate. In the algorithm for elderly patients, the threshold
for offering a test of BMD is low. This group would in general
have the highest prevalence of osteoporosis, making routine
testing even more likely to yield a positive diagnosis. These
3 algorithms refer the user to the steroid algorithm if the
patient is currently on or plans to be on long-term corticosteroids (prednisone ≥ 7.5 mg per day for > 3 months). The
steroid algorithm focuses on appropriate calcium and vitamin D supplementation, education, exercise, and early BMD
testing. Alendronate is considered the nonhormonal treatment of choice.
Dissemination of the algorithms and provider education
began in April 1997. Booklets were assembled that contained
the osteoporosis algorithms; information about diet, secondary
causes of osteoporosis, BMD measurement, and medications;
and excerpts from the AACE and ACR guidelines. These were
distributed to all employed and empanelled primary care
physicians plus selected specialists in PSGHS and PSGHP. A
uniform slide set that discusses the epidemiology of osteoporosis and the algorithms and presents example patient scenarios was developed for health care provider education. A
dedicated osteoporosis education faculty was formed and
used this slide set to deliver more than 30 educational sessions
to more than 500 providers over 2 years; sessions were preapproved for CME credit. The guideline booklet was placed in
electronic form on the system’s intranet. Almost 2000 laminated algorithm sets were distributed to primary care physicians
for their examination rooms.
Community Education
Community pharmacists with ties to PSGHS were engaged
to provide education to interested women in their respective
communities. Approximately 80 pharmacists were trained in
a day-long session with emphasis on prevention, diagnosis,
and treatment of osteoporosis as outlined in the PSGHS
guidelines. A lay-person education program (flip-chart and
slides) was developed to be used by the pharmacists as a
visual aid. The pharmacy classes were advertised in the local
media by the individual pharmacist and held at the pharmacy or in a community hall. In addition to local advertising, all
PSGHP women aged 50 and older (n = approximately 50,000)
were mailed a letter inviting them to receive an osteoporosis
informational packet and/or sign up for a community-based
informational class to learn more about osteoporosis.
Classes were approximately 2 hours long and included a
didactic session on osteoporosis and menopause followed
by a question-and-answer session. Participants were asked
to complete surveys that captured demographic and risk factor information. Participants were also asked to rate the class
Vol. 7, No. 5
content using a satisfaction questionnaire. Following the
program, participants received a postcard “reminder for
action” thanking them for participating and urging them to
consider making healthy lifestyle changes and to seek the
counsel of their primary health care provider. Participants
judged to be at high risk for osteoporosis (those with a score
of 6 or greater on the Simple Calculated Osteoporosis Risk
Estimation [SCORE] questionnaire) [11] were contacted by
phone by a nurse who discussed with them their risk status
and need for further evaluation; the primary care physicians
of high-risk patients were sent a fax informing them of their
patient’s status. A 4- to 6-month follow-up call was made to
all pharmacy class participants to ask about actions taken
since the program to improve bone health, such as use of
exercise or medications, or whether they had contacted their
primary care physician.
Peripheral Bone Mineral Density Measurement
To facilitate BMD testing among the enrolled population,
3 Sahara portable heel ultrasound bone mineral densitometers (Hologic, Bedford, MA) were purchased and rotated
among 25 primary care sites on a monthly schedule, such
that each site had a machine at least once per month. Use of
the peripheral technology increased availability of BMD testing within the system, which was previously limited to
4 central DEXA sites (one in each of our 4 geographic regions). In addition to the primary care sites, heel ultrasounds
were performed in several other locations, including work
sites, community health fairs, and senior centers. Testing was
offered only when the outcome of the test would influence
clinical intervention; premenopausal women and postmenopausal women taking hormone therapy were not routinely offered BMD testing.
Results from ultrasound BMD measurement were used
to risk-stratify and counsel patients. “Low-risk” patients
had an ultrasound BMD T-score of > 0.0, “indeterminaterisk” patients had a T-score of 0.0 to –1.5, and “high-risk”
patients had a score below –1.5. Results were reported on a
form for the physician that provided uniform criteria for
interpretation and recommendations. Patients received an
easy-to-understand report of their results with suggestions
for follow-up. High-risk patients received the recommendation to have a DEXA of the hip and spine, or to consider
therapy (if score was below –2.0). For indeterminate-risk
patients, follow-up was up to the discretion of the physician
and patient based on additional osteoporosis risk factors and
patient preferences. When testing occurred outside the primary care physician’s office (eg, a health fair), the same
forms and reports were utilized and the physician results
sheet was mailed to the patient’s primary care physician,
along with a letter describing the program and thanking
them for following through with any recommendations.
JCOM May 2000 25
OSTEOPOROSIS DISEASE MANAGEMENT
HRT Use
Percentage
Percentage
8
30
20
0
6
4
2
10
0
6
n9
u
J
n–
Ja
7
n9
u
J
–
Jul
8
n9
u
J
–
Jul
9
n9
u
J
–
Jul
6
n9
u
J
n–
Ja
50–54
55–59
60–64
Calcitonin Use
3.5
3.0
Percentage
Alendronate Use
10
40
7
n9
u
J
–
Jul
8
n9
u
J
–
Jul
9
n9
u
J
–
Jul
65–69
70–74
75+
2.5
2.0
1.5
1.0
0.5
0
6
n9
u
J
n–
Ja
97
un
J
–
Jul
98
Jun
–
l
Ju
99
un
J
–
Jul
Program Results to Date
The percentage of female PSGHP enrollees 55 years of age
or older who have been diagnosed with osteoporosis by
their physician rose from 1.8% in fiscal year (FY) 1996 to
6.5% in FY1999. The total number of DEXA scans performed rose from 1916 in FY1996 to 5107 in FY1999. Consistent use of osteoporosis medication since program inception is shown in Figure 2. Consistent users were considered
to be women who filled their prescriptions more than 50%
of the time. HRT use rose early on and appears to have
reached a plateau in most of the age groups. Approximately 28% of all women 50 years or older are now taking
HRT. Alendronate use has risen steadily in all age-groups,
such that 4% of all women 50 years or older, and 7% of
women 65 years and older are now taking this medication.
The use of calcitonin has also risen steadily in most agegroups, so that approximately 1.5% of women 50 or older
are now using this medication.
Hip fracture rate estimation began 3 years ago, and rates
26 JCOM May 2000
Figure 2. Use of osteoporosis medications among female PSGHP
enrollees with a health plan drug rider, by age-group. Figure
shows percentage of women who filled their prescriptions more
than 50% of the time. HRT = hormone replacement therapy.
appear to be remaining steady in the 55- to 64-year agegroup (1.3 hip fractures per 1000 patient years) and the 65- to
74-year age-group (4.3 hip fractures per 1000 patient years).
In the 75- to 84-year age-group, there was a decrease in hip
fracture rate from 19 to 15 hip fractures per 1000 patient-years
over the 3-year period.
As of September 1999, 336 women have attended the pharmacy classes. Survey data collected at the classes revealed that
the mean (±SEM) age of participants was 54.2 ±0.8 years. Fiftytwo percent of the women had more than a high school education. Six percent had taken steroids for more than 3 months,
and 15% had experienced a fracture during adulthood. Thirtyeight percent exercised more than twice per week, and 51%
were taking calcium. Thirty-two percent were taking prescription hormone therapy, and 4% were taking alendronate.
Eleven percent had previously received a test of bone density.
Course content was rated excellent by 77% and very good by
23% of respondents. To date, 153 patients have passed their
6-month follow-up timepoint and were interviewed by phone.
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OUTCOMES IN PRACTICE
Of these 153, 34% said they were exercising more; 5% exercising less. Fifty-five percent had seen their physician, and 28%
had received a test of bone density. In women who had not previously taken preventive medication, 55% were taking calcium, 22% hormone therapy, and 9% alendronate therapy.
To date, over 1700 heel ultrasounds have been performed,
the majority (64%) at primary care sites. The mean (± SEM)
age of the women tested was 62.2 ± 0.4 years. T-score distribution analysis showed that 43% of women tested were at
high risk, 33% were at indeterminate risk, and 24% were at
low risk for osteoporotic fracture.
Discussion
Our program has been in place now for over 3 years, providing ample time to track outcome and process measures.
Primary care physicians are now diagnosing osteoporosis
more frequently. Diagnostic testing has risen markedly (as
evidenced by the increased number of DEXA scans performed), as has the use of prescription osteoporosis medications. The community pharmacy program demonstrated
improvement in self-reported osteoporosis-favorable behavior, including healthier lifestyles and rates of seeking appropriate consultation, testing, and medications. Hip fracture
rates have declined in the older age-strata, but 1 to 2 more
years of fracture rate monitoring will be necessary to have
more confidence in this improvement.
There are a number of strengths to our program. It is
multifaceted, addressing issues of professional education
and community service and providing access to technology
in a rural environment. Our program is novel in that we
employ the use of pharmacists as members of the allied
health care professional team. It is community-based, addressing issues of bone health in thousands of women in
central Pennsylvania. Our guidelines are facilitatory, making
it easier for clinicians to apply best practices. The program is
transportable: other plans and systems can adopt pieces of
this program for their use. Finally, it is plastic; we recognize
the importance of upkeep and have just published an updated version of our guidelines booklet.
Our program also has several limitations. Since this is not
a controlled research study, it could be argued that our
results simply represent trends echoed elsewhere in the
United States. There is no universal database: we do not follow an individual patient from diagnosis through therapy,
and accordingly the outcome measures may reflect slightly
different population groups. Finally, our ability to measure a
decrease in hip fracture rate is constantly diluted. Patients
who have received treatment may leave the plan before we
can measure the benefit achieved, and others may enter the
plan and form part of the measurement before we have had
a chance to intervene.
In summary, the PSGHS osteoporosis disease manageVol. 7, No. 5
ment program employs a comprehensive approach to the
prevention, diagnosis, and management of osteoporosis.
Each individual piece of the program offers a distinctive feature that enhances the strength of the program as a whole.
The health care provider piece employs the use of practical
algorithms that provide a “user-friendly” framework for
osteoporosis diagnosis and treatment. The patient piece
employs the use of pharmacists to assist in education, testing, and encouraging women in the community to adopt
healthier lifestyles. The testing piece employs the use of
ultrasound technology, providing rural women access to
bone density testing while simultaneously engaging the primary care provider/office in osteoporosis awareness. Future
plans include an updated guideline, a focus on high-risk
groups, and a study of the electronic record as a means of
improving the diagnosis and treatment of osteoporosis.
The authors thank Drs. David Gutknecht, Sheryl Russ, David
Brill, Dom Conca, David Bush, Ronald Monsaert, and Al
Peters for their expertise and time; and Dr. Dennis Torretti for
his original vision, which led us to where we are today.
Author addresses: Drs. Newman, Starkey, and Frey, Ms.
Diehl, and Mr. Wood: Geisinger Medical Center, Danville, PA
17822, e-mail [email protected], [email protected].
Dr. Hanus: CHA-Health, 300 Vine St., Lexington, KY 40507.
For a copy of the updated osteoporosis guidelines booklet, contact Dr. Newman.
References
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JCOM May 2000 27
OSTEOPOROSIS DISEASE MANAGEMENT
management of osteoporosis in postmenopausal women:
clinical guidelines. Clin Therapeut 1999;21:1025–44.
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Ensrud K, et al. Bone density at various sites for prediction if
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BL. Long-term fracture prediction by bone mineral assessed
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This program is supported by educational grants from Merck
& Co., Wyeth-Ayerst Laboratories, Hoechst Marion Roussel,
and Novartis Pharmaceuticals.
Copyright 2000 by Turner White Communications Inc., Wayne, PA. All rights reserved.
28 JCOM May 2000
Vol. 7, No. 5