Osteoporosis International

, 19:1733

A multifaceted intervention to improve treatment of osteoporosis in postmenopausal women with wrist fractures: a cluster randomized trial

Authors

    • Clinical Epidemiology Program, Ottawa Health Research Institute, and Department of MedicineUniversity of Ottawa
    • Clinical Epidemiology ProgramOttawa Health Research Institute
  • M. Lam
    • Departments of Medicine, Community Health and EpidemiologyQueen’s University
  • L. Ruhland
    • Department of MedicineQueen’s University
  • R. Brison
    • Departments of Medicine, Community Health and EpidemiologyQueen’s University
    • Departments of Emergency Medicine and Family MedicineQueen’s University
  • M. Godwin
    • Primary Healthcare Research UnitMemorial University
  • M. M. Harrison
    • Human Mobility Research Centre and Department of Orthopedic SurgeryQueen’s University
  • M. B. Harrison
    • School of NursingQueen’s University
  • T. Anastassiades
    • Department of MedicineQueen’s University
    • Human Mobility Research Centre and Division of RheumatologyQueen’s University
  • J. M. Grimshaw
    • Clinical Epidemiology Program, Ottawa Health Research Institute, and Department of MedicineUniversity of Ottawa
  • I. D. Graham
    • Clinical Epidemiology Program, Ottawa Health Research Institute, and Department of MedicineUniversity of Ottawa
    • Faculty of Health SciencesUniversity of Ottawa
Original Artic le

DOI: 10.1007/s00198-008-0669-0

Cite this article as:
Cranney, A., Lam, M., Ruhland, L. et al. Osteoporos Int (2008) 19: 1733. doi:10.1007/s00198-008-0669-0

Abstract

Summary

In a cluster randomized trial, we evaluated the effect of a multifaceted intervention (directed at both patient and primary care physician) on the rates of testing and treatment of osteoporosis in postmenopausal women within six months of their wrist fracture. Compared to usual care, women in the intervention practices were three times more likely to receive bone mineral density testing and prescribed osteoporosis treatments.

Introduction

Postmenopausal women with wrist fractures are at increased risk of future fragility fractures, yet they frequently do not receive evaluation and treatment for osteoporosis. We set out to evaluate a multifaceted intervention designed to improve management of osteoporosis in older women with recent wrist fractures.

Methods

Cluster randomized trial of 270 women cared for in 119 primary care practices. We recruited postmenopausal women with an acute wrist fracture from the emergency departments of hospitals in southeastern Ontario, Canada. Family practices were randomly assigned to either the intervention or usual care. The intervention consisted of a mailed reminder with a summary of treatment guidelines and letter sent to the primary care physician, in addition to an educational package and letter to the women. The primary outcome was the proportion of women prescribed osteoporosis therapy within 6 months of their fracture.

Results

The mean age of women was 69(10.9) years. The intervention increased the proportion of women started on osteoporosis medications (28% vs. 10%) of controls, adjusted OR 3.45, 95% CI, 1.58–7.56, p = 0.002) and the proportion who had a bone mineral density (BMD) test (53.3% vs. 26%) of controls, OR 3.38, 95% CI, 1.83–6.26, p < 0.001). In addition to the intervention, having a female physician was a predictor of increased testing and treatment rates.

Conclusion

A multifaceted intervention significantly improved rates of osteoporosis treatment and BMD testing in postmenopausal women with wrist fractures.

Keywords

Cluster randomized trialMultifaceted interventionOsteoporosisWrist fractures

Introduction

Osteoporosis is a common skeletal disorder associated with an increased risk of fractures [1]. Forty percent of postmenopausal women will experience an osteoporotic fracture during their lifetime [2]. Wrist fractures are associated with a two-fold increase in the risk of subsequent fractures and are regarded as a sentinel event, since they usually precede vertebral and hip fractures by 10–15 years [35].

Clinical practice guidelines recommend that women with fragility fractures should be targeted for secondary prevention with osteoporosis therapies (e.g., anti-resorptive medications), since these medications reduce the risk of recurrent fractures by 40–50% [6, 7]. However, despite the dissemination of evidence-based recommendations, the majority of older adults with fragility fractures do not receive prescribed osteoporosis medications or advice on fall prevention strategies [810].

For the treatment of women with wrist fractures, a number of barriers limit the translation of research evidence into clinical practice. These can be categorized into the following: (1) health care system-related (e.g., inadequate access to BMD testing, and lack of communication between orthopedic surgeons and primary health care providers), (2) patient-related (unaware of the relationship between fracture and osteoporosis, and concerns relating to costs and side-effects of medications) and, (3) physician-related (failure to make the connection between fracture and osteoporosis, or lack of knowledge of effective treatment options, lack of time to discuss treatments with their patient) [1115].

Quality improvement interventions, such as reminders, audit and feedback and multifaceted interventions have been used to improve physician adherence with clinical practice guidelines. For example, reminder messages have resulted in improvements in practice with modest effect sizes of 10–20% [16, 17]. However, not all trials of reminders have resulted in improvements in provider care, which may related to a number of factors, including a true lack of an effect, or insufficient power to detect a change [18].

Given the acute nature of the wrist fracture and existing barriers to the evaluation of osteoporosis, we hypothesized that a multifaceted intervention (clinician and patient reminder and clinician and patient educational material) would improve the continuity of care between providers and patient and provider awareness of the importance of consideration of osteoporosis treatment in this population.

The objective of the study was to evaluate if a multifaceted intervention would improve the use of osteoporosis treatments in women with acute wrist fractures.

Methods

Study design

We conducted a cluster randomized trial in which the family practice was the level of randomization and the woman with the fracture the unit of inference [19]. A cluster design was chosen to minimize the effect of contamination, since in a patient randomized trial the management of women in the usual care arm by their physician could be affected by awareness of care recommended for women in the intervention arm [20, 21]. Ethics approval for the trial was obtained from the Research Ethics Board of Queen’s University, Kingston, Ontario, Canada.

Setting and participants

Family practices in Kingston, Ontario and the surrounding southeastern Ontario region were included in the sample. The practices were drawn from the Canadian Medical Association directory and verified from a network of family practices established for research studies in primary care in southeastern Ontario. Randomization of practices to either intervention or control was performed at the onset of the trial, using a computer-generated list of random numbers in a blinded fashion. Practices were stratified by variables that could influence the impact of the intervention, such as the size of practice and urban versus rural location.

Eligibility criteria

Participants included postmenopausal women who had sustained a wrist fracture (confirmed by x-ray). Women currently taking osteoporosis therapies (e.g., risedronate, raloxifene, alendronate, teriparatide) were excluded, but we did not exclude women on hormone therapy (HT), since they may have been taking HT for menopausal symptoms. Women who had a traumatic wrist fracture (based on description of fracture), or were unable to communicate in English or give consent were also excluded. Women who had a previous BMD test were not excluded, since a previous test could be a predictor of receiving osteoporosis therapy.

Participants were recruited in person from emergency departments or fracture clinics of five hospitals (two of which were teaching hospitals) from October 2003 to January 2006. Participants were approached about the trial by the staff in the emergency department or fracture clinic. If they agreed to be contacted, then their phone number was provided to the study coordinator. Telephone contact was made and consent obtained within two weeks of the fracture.

Intervention

The intervention was directed at both the patient and physician.

Physician component

The research coordinator mailed a letter to the primary care physicians in the intervention group at 2 weeks and 2 months post fracture. The personalized letter notified the physician that their patient had a recent wrist fracture and highlighted that wrist fractures can be associated with osteoporosis, and that assessment for osteoporosis treatment is recommended for women with wrist fractures. A two-page educational tool that included a summary of recommended osteoporosis therapies for patients with fractures, including benefits and risks of these medications based on the results of systematic reviews. A treatment algorithm for patients with fragility fractures from Osteoporosis Canada’s clinical practice guidelines was included [6].

Patient component

In the intervention arm, a reminder letter was mailed to the women at 2 weeks and 2 months after their fracture. The letter recommended they schedule a follow-up visit with their primary care physician to discuss osteoporosis. A one-page checklist of risks for fractures was included, so the woman could calculate her five-year absolute fracture risk to discuss with her physician, during their visit. An educational booklet which included information about osteoporosis, an evidence-based summary of treatment options for osteoporosis, and recommended lifestyle changes was provided.

Usual care group

Patients and family physicians in the control practices were not sent any communication until the trial was completed, at which point they were sent the educational material.

Outcomes and measurements

The primary outcome was the proportion of women who reported they were started on osteoporosis therapy (i.e., bisphosphonates, raloxifene, hormone therapy or teriparatide) within six months of fracture in the intervention versus usual care practices. The main secondary outcome was bone mineral density testing by six months. Outcomes were ascertained without knowledge of allocation to the intervention or usual care arm and outcome assessment was measured through patient self-report. Telephone interviews with the patients were conducted after the fracture and at 6 months post fracture, using a pre-developed data collection questionnaire. Other outcomes included the proportion of women who reported that their primary care physician discussed osteoporosis with them (6 months post fracture by self-report) and changes in the participant’s knowledge of osteoporosis using the Osteoporosis Knowledge Questionnaire (OPQ). The OPQ was administered by telephone interview at baseline and 6 months [22]. A five-year fracture risk score was calculated for each woman using a validated clinical fracture risk index [23].

Statistical analyses

The sample size was based on the assumption that at least 90 practices (with 2–3 women per practice) were required to detect an effect size of 20% (increase from baseline of 30%) in osteoporosis treatment, with 80% power, 5% level of significance, and allowing for 20% loss to follow-up. The minimal clinically important difference for the primary outcome of prescribed osteoporosis medications was derived from a pilot study on rates of treatment in women in wrist fractures [24]. An intra-cluster correlation of 0.10 was used, since this was supported by the literature evaluating process variables [20, 25].

We examined demographic and clinical characteristics in the intervention and control groups using descriptive statistics that accounted for clustering to assess the quality of randomization. Differences between outcomes in the intervention and control groups were tested using multi-level hierarchical modeling with random effects regression for continuous outcomes, and random effects logistic regression for dichotomous outcomes, in which patients were clustered within physician practices [26].

To adjust for practice and patient-level characteristics that differed between groups, the multi-level models were extended to include covariates (both patient-level and practice-level), which were either potential confounders or found to be significant predictors of initiating prescribed osteoporosis treatments or BMD testing in the univariate analysis at p < 0.15. Patient-level covariates included the following: age, osteoporosis knowledge at baseline, prior history of fracture or falls, previous BMD, and baseline number of alcoholic drinks per week; and practice-level variables were: size of practice, urban versus rural location and physician gender. The models were simplified by excluding those covariates which demonstrated little evidence of confounding and that were no longer related to the outcome (p > 0.15), which may have been due to collinearity with other covariates. A final multi-level model was developed for each of the two outcomes: use of osteoporosis treatment and BMD testing. Adjusted odds ratios for intervention and the covariates (included in the final model) were obtained from these final multilevel models. All analyses were conducted using SAS software for Windows version 9.1 (SAS Institute, Cary, North California).

Results

Study flow

During the study period, 380 women with wrist fractures were screened for eligibility. Of these, 110 women were excluded: 49 were already taking osteoporosis medications, 18 declined to participate, nine were unavailable, 17 were unable to participate due to cognitive or visual impairments, five did not speak English, three did not have a primary care physician and nine were excluded for other reasons (e.g., traumatic fracture ascertained by type of injury). Nine women were lost to follow-up by six months.

The sample consisted of 270 women (145 in control practices, 125 in intervention) and 119 primary care practices (174 physicians), (Fig. 1). Most clusters consisted of either 1 or 2 physicians (range of 1–7 physicians). Fifty-five physicians were female (31.6%), and 54 physicians practiced in rural settings.
https://static-content.springer.com/image/art%3A10.1007%2Fs00198-008-0669-0/MediaObjects/198_2008_669_Fig1_HTML.gif
Fig. 1

Flow of patients through the trial

The mean age of women with wrist fractures was 69 years, 65.6% were retired, and 22.6% currently employed. Twenty-three percent had a history of a previous fracture, and 32% reported a fall in the past year. Forty-seven percent of women reported having had a prior BMD test. Demographic and clinical characteristics were not significantly different in patients in the intervention and control groups. At recruitment, the mean (SD).

Osteoporosis Knowledge Score was 11.02 (4.47), out of 25, which did not differ between the intervention and control groups. (Table 1).
Table 1

Demographic and clinical risk factors measured at baseline

Demographic characteristics of participants

Intervention, (n = 125) Mean (SD) or (N) %

Control, (n = 145) mean (SD) or %

p-value

Age (range), years

68.1 (10.6) [50–91]

69.8 (11.2) [47–94]

0.24

Weight (kg)

66.4 (12.8)

67 (12.1)

0.73

College/University education

(45) 36%

(54) 37.3%

0.76

Retired

(85) 68%

(92) 63.5%

0.45

Prior BMD

(58) 46.4%

(70) 48.3%

0.84

Calcium supplements

(76) 60.8%

(90) 62.1%

0.83

Vitamin D supplements

(49) 39.2%

(66) 45.5%

0.38

Recruited from teaching hospital

64.14%

52.8%

0.06

 

Clinical risk factors

Prior history of OP fracture

(25) 20%

(37) 25.5%

0.29

Current smoker

(15) 12.0%

(19) 13.1%

0.75

Maternal history of hip fracture

(12) 9.6%

(18) 12.4%

0.46

History of hyperthyroidism

(3) 2.4%

(10) 6.9%

0.10

Rheumatoid arthritis

(2) 1.6%

(3) 2.1%

0.76

Prednisone use

(5) 4%

(8) 5.5%

0.67

History of falls in past 12 months

(39) 31.2%

(47) 32.4%

0.88

Mean # alcoholic drinks per week

3.16 (4.97)

2.60 (5.45)

0.42

Mean Osteoporosis Knowledge (out of 25)

11.36 (4.52)

10.73 (4.41)

0.26

Five-year fracture risk (out of 11)

4.05 (2.21)

4.4 (2.29)

0.25

The intervention increased the proportion of women started on prescribed osteoporosis medications; with 28% (n = 35) of intervention participants versus 10% (n = 15) of controls, cluster adjusted OR 3.45, 95% CI 1.58–7.56, p = 0.002. In all cases except one woman who was started on raloxifene, the medication started was a bisphosphonate. As shown in Table 2, the proportion of women who had a BMD increased significantly in the intervention; 53.5% of intervention participants versus 25.5% of controls, cluster adjusted OR 3.38, 95% CI 1.83–6.26, p < 0.0001. Compared to controls, more women were started on calcium and vitamin D in the intervention group; however, the difference was not significant. Eighty-two percent of women reported they had followed up with their primary care physician within six months of their fracture. Moreover, a significantly higher proportion of women in the intervention arm reported that they received osteoporosis counseling from their physician, (71% vs. 43%), p < 0.001 (Table 2). However, only 8.3% of women reported being told that their fracture was related to osteoporosis (9.5% in intervention and 7.3% of controls, p = 0.53). The intervention did not have a significant effect on the percentage of women who received counseling on falls from their primary care physician.
Table 2

Primary and secondary outcomes six months post fracture

Outcome (n)%, or mean (SD)

Control (145)

Intervention (125)

Adj OR or mean difference (95% CI)

p-value

Osteoporosis treatment (n = 270)

(15) 10.3%

(35) 28.0%

3.45 (1.58, 7.56)

0.002

BMD scan done (n = 261)

(36) 25.5%

(64) 53.3%

3.38 (1.83, 6.26)

<0.0001

Calcium or vit D started post fracture (n = 261)

(38) 27.0%

(43) 35.8%

1.51 (0.89, 2.58)

0.13

Mean change in OPQ (n = 239)

1.14(2.79)

1.59 (3.22)

0.45 (-0.38, 1.29)

0.28

MD discussed OP (n = 212)

(48) 42.9%

(71) 71.0%

3.27 (1.83, 5.84)

<0.001

*In the control group 38 (27%) had either calcium or vitamin D recommended post fracture, and of these 13 were not on Ca or vitamin D at baseline. In the intervention group, 43 (35.8%) had either Ca or vitamin D recommended post fracture and of these, 18 were not on Ca or vitamin D at baseline

Osteoporosis knowledge scores (OPQ) were higher in the intervention group as compared to controls (13.1 versus 11.7, p = 0.015); however, the mean change in OPQ scores was not significant different (Table 2).

Predictors of osteoporosis treatment and BMD testing

The final multi-level model included six variables (p < 0.15), as potential predictors of starting osteoporosis therapy. As shown in Table 3 of the six variables, those that significantly predicted the initiation of OP treatment (p < 0.05) included: the intervention (adjusted OR 4.02, 95% CI 1.66, 9.72, p = 0.002), having a female physician (3.28, 95% CI 1.45, 7.41, p < 0.005), and baseline osteoporosis knowledge (p = 0.015).
Table 3

Predictors of BMD testing or osteoporosis treatment

Variable

BMD testing

Starting osteoporosis treatment

 

Adjusted OR (95% CI)

p-value

Adjusted OR (95% CI)

p-value

Intervention

3.54 (1.92, 6.53)

<0.0001

4.02 (1.66, 9.72)

0.002

Age (10 years)

0.93 (0.72, 1.21)

0.109

1.38 (0.93, 2.05)

0.109

Female physician

1.96 (1.06, 3.62)

0.032

3.28 (1.45, 7.41)

0.005

Fall in the last year

  

1.86 (0.87, 4.00)

0.110

Baseline OPQ score

  

1.14 (1.03, 1.27)

0.015

# alcoholic drinks/wk

  

0.87 (0.77, 0.98)

0.024

History of fracture

    

Previously taken OP medications

    

Had prior BMD test

    

Recruited at teaching hospital

    

For predictors of BMD testing, three variables were included in the final multi-level model (intervention, age, and having a female physician) and two variables, the intervention (adjusted OR 3.54, 1.92, 6.53, p < 0.001) and having a female physician (OR 1.96, 1.06, 3.62, p = 0.032) were significant predictors of a BMD test (Table 3). There was no evidence of a statistically significant interaction between physician gender and the intervention.

Discussion

The gap between what is recommended by research evidence and clinical management of postmenopausal women with fragility fractures has been well documented in the literature [8]. To address barriers to osteoporosis testing and treatment, we designed a multifaceted intervention directed at both patients and physicians, and found a significant increase in absolute treatment rates (18%) and BMD testing (27%) by six months. We selected process of care measures, as opposed to recurrent fractures, since process measures have been shown to be sensitive to improvements in the quality of practice in quality improvement trials [27].

Strengths of our trial include that it was randomized and used a cluster design, to minimize the potential effect of contamination. A potential limitation of our trial is that the outcomes are based on self-report data, which may have resulted in an underestimation of treatment effect. However, Cadarette et al. demonstrated excellent agreement between self-reporting of whether a BMD test was done, as compared to a reference standard [28], and Majumdar reported 100% agreement between the self-reported outcome of starting a bisphosphonate and what was recorded in the pharmacy dispensing records [29].

The magnitude of improvement in our study is similar to that reported in two other randomized trials of similar types of interventions in fracture patients [29, 30]. Majumdar et al. in a trial of both older men and women with wrist fractures in a Canadian health care setting, demonstrated that a multifaceted intervention increased absolute rates of bisphosphonate use by 15% and BMD testing by 34%, which confirmed findings of a earlier quasi-experimental trial [29, 31]. Feldstein et al. in a randomized trial of 311 women with fractures in a U.S. Healthcare Maintenance Organization, found that an electronic medical record-generated reminder improved osteoporosis management, with 51.5% of women receiving osteoporosis management (composite outcome of BMD test or OP treatment), versus 5.9% receiving usual care [30].

However, not all implementation trials have documented improvements in osteoporosis management. For example, a randomized trial of a multifaceted intervention directed at both physicians and patients in the setting of a large drug benefit plan in the U.S. did not show improvements in osteoporosis treatment in the subgroup of older adults with fractures [32]. Similarly, Bliuc et al. in Australia randomly allocated fracture patients to either a patient-reminder letter or an intervention (reminder letter and a free bone density test) and did not find any improvement in OP treatment rates [12]. The lack of improvement in some randomized trials could be related to the intervention itself and who the intervention was directed at (patient vs. physician and patient). Moreover, primary care physicians may respond differently depending on the health care settings and interventions may need to be tailored accordingly.

In our trial, osteoporosis knowledge did not improve significantly by six months, despite the patient educational component in our trial. This finding was also noted by Majumdar and colleagues who used a different measure to assess change in knowledge [29]. This lack of change suggests that patient-directed education may not play a major role in initiation of osteoporosis therapies, or that the tool used to assess osteoporosis knowledge was not sensitive enough to detect change.

In addition to the intervention, having a female physician was associated with a greater likelihood of BMD testing and OP treatment. Female physicians may have more female patients in their practice or they may be more recent graduates of medical school when compared to their male colleagues.

We found a significant increase in the use of osteoporosis therapies; however, approximately 40% of eligible women did not receive treatment, which is consistent with results of other trials of multifaceted interventions [29, 33]. Potential reasons for not finding larger improvements include: inadequate access to BMD testing in some settings [34], or failure of physicians to discuss osteoporosis treatments with their patient. Primary care physicians may have discussed osteoporosis with their patient, but have been reluctant to start therapy, if the BMD results were not consistent with osteoporosis, despite knowledge that most osteoporotic fractures occur in older women with osteopenia [35]. In addition, patients may have been reluctant to start medications due to concerns about side-effects.

A variety of strategies could be used to improve management of osteoporosis. Some of these include increased patient activation, through use of decision support material, and improved BMD reporting for physicians with inclusion of absolute fracture risk linked to treatment recommendations [36].

An advantage of our intervention is that it should be relatively easily and inexpensive to implement in a variety of health care settings. Potential long-term benefits include a reduction in the burden of osteoporotic fractures through increased adherence with guideline recommendations.

Conclusions

In summary, in a publicly funded health care system, we found a multifaceted intervention improved osteoporosis management in postmenopausal women with wrist fractures. Future research should focus on methods to implement automatic reminders into clinical practice and knowledge translation strategies that will improve post fracture care.

Acknowledgements

We would like to thank the staff in the emergency departments and fracture clinics of the Kingston, Brockville, Belleville, Perth/Smith Falls and Prince Edward County hospitals for their enthusiastic assistance with this research. A. Cranney and M. B. Harrison received salary support from the Canadian Institutes of Health Research. J. Grimshaw holds a Canada Research Chair.

Conflicts of interest

A. Cranney has received speaker fees from MerckFrosst and Procter and Gamble.

Copyright information

© International Osteoporosis Foundation and National Osteoporosis Foundation 2008