Impact of a centralized osteoporosis coordinator on post-fracture osteoporosis management: a cluster randomized trial

This cluster randomized trial in 36 small community hospitals with 267 study participants who suffered a low trauma fracture found that the multi-faceted intervention resulted in a significant increase in the proportion of patients appropriately managed within 6 months of fracture among the intervention compared to patients in the control group, about a 20% absolute difference. The intervention also resulted in more patients having a BMD scheduled or performed and most having a discussion about osteoporosis with their primary care physician compared to patients in the control group.

To our knowledge, this is the first and only randomized trial that has been restricted to patients from small or rural communities. To date, there have been nine published post-fracture care randomized controlled trials [24] that have evaluated various interventions to improve management of osteoporosis in this high-risk population. Two of these were cluster randomized trials [19, 20], one in a health maintenance organization with a large number of primary care practices [16], three in one or two hospitals [17, 21, 23] and four in-patient interventions for those with hip fracture [15, 17, 18, 22]. The pooled absolute improvements across these nine trials in BMD testing was 36% and for osteoporosis treatment 20% (95% CI, 10–30) which is virtually identical to what we observed in terms of our pre-defined outcome of appropriate osteoporosis management.

The interventions vary in many of the nine prior randomized trials, ranging from point-of-care reminders to physicians to patient-specific education. This is reflected in the heterogeneity seen when trying to pool results (e.g. an I2 of 88% for improvements in osteoporosis treatment) [24]. In the study by Feldstein et al. [16], the intervention was an electronic medical record reminder which resulted in 52% of intervention patients getting a BMD test or osteoporosis medication at 6 months compared with 6% of the usual care. Whereas, in the study by Majumdar et al. [21], the intervention was multi-faceted with telephone-based nurse led education, a patient-specific reminder sent to the physician and guidelines endorsed by local opinion leaders. These findings with 22% of intervention and 7% of control patients on treatment with a bisphosphonate 6 months after a wrist fracture are similar to those reported by Cranney et al. [20] who only used mailed reminders to patients and primary care physicians and a patient education package. Rozenthal et al. [23] randomized 50 distal radius fracture patients to either the orthopaedic surgeon ordering a BMD test and forwarding the results to the primary care physician or just sending a letter to the primary care physician outlining guidelines for osteoporosis screening. Initiation of osteoporosis therapy was much higher (74%) than in other studies but this trial did not only consider treatment with bisphosphonates but also counted initiation with calcium and vitamin D as a treatment outcome.

We believe the key factor to the success of our intervention was that the coordinator empowered the patient to ask for a BMD test and made the patient the ‘reminder’ for the physician. This particular combination of a multi-faceted intervention, where you have a triad of a coordinator, patient and primary care physician, should be evaluated as a model for improving guideline adherence for other chronic diseases, particularly among physicians in smaller communities with limited access to specialist care.

One of the advantages of the current trial is the ability to examine sex differences in post-fracture osteoporosis management. Previous research has shown that the care gap is significant in both men and women but more so in men [38, 39]. Our study has shown that care improved for both; however, there are still substantially greater care gaps in men versus women, as others have shown despite interventions; possible reasons are men and their physicians view osteoporosis as a disease of elderly women [40, 41] and more importantly, guidelines are unclear about treatment options. In the new 2010 Canadian guidelines, there is grade A evidence for investigating men with a fracture but grade D evidence for prescribing bisphosphonate therapy in men [42].

This study had a number of strengths. This was a randomized trial with a cluster design which minimized contamination because hospital sites rather than individual patients were randomized. The cluster design also increases the generalizability of the findings since the study was carried out in a large number of hospitals. This is the only randomized trial published to date of a post-fracture care intervention in rural communities without access to osteoporosis specialists and in many cases orthopaedic surgeons. One of the limitations of this study is the potential for selection bias as were unable to reach a large proportion of eligible patients. These patients were called a maximum of seven times at different times of the day and messages were left where possible. These could be individuals who were not interested in additional follow-up for their fracture, thus, limiting the generalizability of the findings. In the future, one way to improve this may be to send patients a letter informing them about the program before the coordinator calls. In addition, the loss to follow-up was greater in among intervention patients. As a result the ‘complete case’ analysis would potentially overestimate the impact of the intervention since those lost to follow-up in the intervention probably did not want to be contacted again if they did not comply with the coordinator’s suggestions made at baseline. Another potential limitation is the lack of quality control procedures to assess treatment fidelity. The coordinator was not taped or observed when delivering the intervention. It was assumed that treatment fidelity was high given that the centralized coordinator was a physical therapist with expertise in osteoporosis management.

Our findings are also limited by the fact that we relied on self-report data, which may have biased our estimate of appropriate management since we did not have access to the actual BMD reports or patient charts. A validation study of DXA results identifies that patients underestimate bone loss, and although 84% of patients with normal BMD by DXA correctly identify their bones as normal, 49% with ‘osteopenia’ and 15% with osteoporosis also state that their bones are normal [30]. This would overestimate our findings for appropriate management. Similar to all of the other post-fracture care randomized trials, we measured ‘process’ outcomes, BMD testing and appropriate management, and not a clinical endpoint, such as recurrent fracture. However, receipt of a BMD test and/or use of a medication for osteoporosis is considered an important quality of care indicator, used by the majority of health plans in the USA to measure performance of the health care system [www.​ncqa.​org].

In conclusion, we found that a multi-faceted intervention with a centralized osteoporosis coordinator is effective in improving osteoporosis care in smaller communities that do not have access to osteoporosis specialists, but there is still a care gap. There are number of ways in which this intervention could be improved. There could be better advertising of the program. For example, there could be pamphlets/posters in the waiting room and more importantly staff in the ED could mention to fracture patients the link between osteoporosis and fracture and that the hospital has a special program for fracture patients. Rates of BMD testing are higher than appropriate management suggesting that interventions in the future need to address issues with reporting and interpretation of bone density measurements and fracture risk in treatment decision making. Treatment rates might be higher if patients understood their BMD results better for example this could be achieved with a standardized report for the family physicians outlining fracture risk and treatment recommendations and a patient-specific BMD report. We also need to improve our efforts to disseminate information about the importance of osteoporosis in men to health care providers and clarify treatment recommendations. Finally, in terms of knowledge translation this intervention is best suited for a universal or managed care setting.