Improving Bone Protection Provision for Patients with Fragility Fractures ^†

Abstract

Osteoporosis therapy is a crucial component of fragility fracture patients’ care. A Quality Improvement Project (QIP) was undertaken to review and improve such bone protection practice within a busy UK hospital orthopaedic department. Full-loop audit cycles, totalling 216 patients, were conducted before and after the implementation of a single-page checklist. This intervention significantly increased consultant-led osteoporosis plans by 37%, enhanced bone-sparing treatment administration by 20%, and eliminated unsafe prescriptions. Provision timeliness was not affected, but the communication of correct discharge information was significantly improved by 27%, and staff surveys showed the checklist was well-received, easy-to-use, and educational. Hopefully this will encourage other orthogeriatric teams to utilise a similarly effective and simple QI strategy.

1. Introduction

Fractures sustained from low-energy trauma, known as fragility fractures, indicate underlying osteoporosis, pose a significant risk for subsequent fractures, and are associated with vast socioeconomic burden [1]. Accordingly, UK national guidelines emphasise that older fragility fracture patients receive osteoporosis therapy, such as bisphosphonates and denosumab, alongside appropriate vitamin D and calcium supplementation, for fracture secondary prevention [2,3]. Quality Improvement Projects (QIPs) are a cornerstone for improving health services, involving the systematic audit of clinical practice and implementing a change to benefit patient care [4]. Therefore, a QIP was performed at a busy British district general hospital, caring for over 400 neck of femur (NOF) fracture patients alone annually [5], to review and improve bone protection practice.

2. Materials and Methods

A cogent plan–do–study–act (PDSA) audit structure, essential for iterative healthcare improvement [6], was adhered to throughout and guided every step of this QIP.

2.1. Stakeholder Engagement

Enacting clinical change requires strong involvement from the entire multidisciplinary team. Consulting stakeholders facilitates broader perspectives, ensures all legitimate interests partake, and ultimately improves QI effort buy-in [7]. Therefore, during the initial planning phase, a stakeholders’ meeting was held between nursing staff, ward matrons, pharmacists, junior doctors, and consultants in rheumatology, trauma and orthopaedics, and orthogeriatrics. This highlighted aspects of bone protection practice to address, revealing four main concerns. Firstly, insufficiently clear documentation in patients’ paper notes hindered following osteoporosis treatment plans. Secondly, prescribing issues, such as bisphosphonate prescriptions without recent renal function blood tests, were apparent. Thirdly, practice impacted smooth patient discharge by ward staff rushing to administer medication on the final day of admission, difficulty providing bone protection to patients discharged to community hospitals, and incorrect follow-up advice given within discharge summaries or inappropriate referrals to outpatient follow-up services. Fourthly, the team’s experiences strikingly agreed that fragility fracture patients missed out on necessary bone protection medication.

2.2. Audit Benchmarks

The National Osteoporosis Guideline Group (NOGG) emphasises providing treatment without assessment for fragility fracture patients over 70 years of age [3], thus a major benchmark here was whether patients received bone protection medication. Imperatively, such treatment must be safe, as stressed by the General Medical Council; prescriptions must only be conducted safely with sufficient and reliable information [8]. The safety of osteoporosis therapy, including vitamin D replacement, was thus a key criterion too. Treatment provision’s timeliness, with inherent implications for ward efficiency and patient flow, was another assessment metric. Moreover, an older patient population requires continuity of care that carefully considers the challenges of polypharmacy and repeat healthcare attendance, as laid out by the Care Quality Commission [9]. Therefore, the final audit barometer was whether correct bone protection information was communicated to community physicians and carers on discharge.

2.3. Data Collection and Analysis

The first PDSA cycle data were collected over a two-month period from December 2023 to January 2024. All fragility fracture patients were identified based on their mechanism of injury from acute trauma admissions lists. Key quantitative information was gathered from inpatient notes, drug charts, and discharge summaries. Patients were excluded if during admission they died, began an end-of-life care pathway prior to bone protection provision, had pre-existing treatment escalation plans to avoid active hospital interventions, or refused, with capacity, offered osteoporosis therapy. Following the QI intervention, the second two-month PDSA cycle’s data were collected from March to May 2024 via weekly reviews of inpatient notes. Additionally, preceding and proceeding the checklist’s implementation, qualitative data were gathered about the clinical team’s experiences via anonymised nursing staff and junior doctor online surveys.

During audit cycle study phases, statistical analysis was performed comparing data before versus after checklist implementation. Two-tailed z-testing was undertaken as, given the large sample sizes, datasets had approximately normal distributions, patient sampling was random, observations were independent, and the alternative hypothesis could predict changed bone protection care in either a positive or negative direction.

2.4. Checklist Design and Implementation

A simple single-page checklist (see Appendix A Figure A1) was created to guide ward clinicians safely through osteoporosis treatment. This used local and national guidelines [2,3,10] to present osteoporosis treatment for fragility fracture patients in a readily appreciable format. Tick-boxes facilitate correct vitamin D and calcium replacement and easily followable bone protection plans. Crucially, the importance of checking and acknowledging patients’ renal function, calcium levels, and vitamin D repletion is highlighted within the checklist. Furthermore, guidance on appropriate discharge information and follow-up is provided. The checklist was printed on green paper for greater visibility within records and introduced into two orthopaedic wards in March 2024. Posters were also displayed to promote the checklist and raise awareness of the QIP.

3. Results

3.1. Patient Demographics and Fracture Types

Following nine patients’ exclusion for reasons stated above, 133 patients were in the first audit cycle with a mean age of 81.5 years. In total, 85 (64%) were women and 48 (36%) were men. A majority (59%) of patients suffered NOF fractures, with the remaining sustaining distal femoral, tibial, vertebral, humeral, forearm, rib, or other pelvic fractures, such as pubic rami and sacral. In the second audit cycle, 8 patients were excluded for reasons listed above, leaving 83 patients; 54 (65%) were women and 29 (35%) were men, with a mean 80.0 years of age. Again, most patients (77%) were admitted with fractured NOFs. The remainder had other pelvic, distal femoral, tibial, vertebral, humeral, or forearm fractures. There was reasonable checklist uptake within the second cycle cohort; it was used for 34 (41%) patients and not for 49 (59%).

3.2. Bone Protection Plans and Provision

Figure 1a shows bone protection plans for patients in the first cycle. Three patients with advanced chronic kidney disease (CKD) were excluded from this analysis as no osteoporosis medication is appropriate for very low renal function, and instead, they were correctly only prescribed alfacalcidol. Concerningly, no bone protection plan was in place for 37.5% of patients. However, when the checklist was used in the second cycle (seven advanced CKD patients were excluded) no patients were without consultant-led bone protection plans, as portrayed in Figure 1a. This equates to a significant 37% increase (z = 3.98, p = 0.00006) in osteoporosis care planning. After removing patients planned for Dual-energy X-ray Absorptiometry (DEXA) scans, the checklist generated significant improvements by 40% (z = 4.16, p = 0.00003) and 17% (z = 2.03, p = 0.042) in planned osteoporosis medication for all fragility fractures and NOF fractures, respectively, as shown in Figure 1b.

Additionally, in the second cycle, there was a significant 25% increase (z = 2.74, p = 0.006) in emplaced osteoporosis treatment plans for all fragility fractures when the checklist was used versus when it was not. In this regard, there was also no significant difference (z = 0.98, p = 0.33) between first-cycle NOF fracture cases and those without checklist use in the second cycle. Moreover, the first cycle revealed that 24% of inpatients did not receive their planned bone protection, but this was greatly improved in the second cycle; checklist utilisation significantly increased treatment provision by 20% (z = 2.35, p = 0.018).

3.3. Prescription Safety

Vitamin D replacement must be prescribed according to patients’ levels (deficient, insufficient or replete) and the planned bone-sparing medication. This was performed significantly better when the checklist was used, with 30% improvement (z = 3.54, p = 0.0004) in correct vitamin D replacement compared to pre-intervention. A total of 5 prescriptions were unsafe out of 51 osteoporosis medications administered in the first cycle. These constituted bisphosphonates given twice to patients with creatine clearance < 30 mL/min, denosumab given to a patient with creatine clearance < 20 mL/min, one patient never having renal function checks prior to starting alendronate, and calcium levels not being checked before bisphosphonate administration to two patients. In all instances, clinical incident reports were filed, and the patients involved were informed as per duty of candour. Conversely, all prescriptions were safe when the checklist was used, with a significant 14% improvement in safety (z = 2.04, p = 0.04) compared to prescriptions made without using the checklist in the second audit cycle, as depicted in Figure 2.

3.4. Timeliness and Discharge Information

Vitamin D levels should be checked, and replacement should be initiated on the first day of admission; hence, completing a seven-day cholecalciferol loading course (40,000 units once daily) and starting bone protection within 10 days is a reasonable target. This was not achieved for 55% of patients in the first cycle. However, the checklist did not significantly affect provision within this timeframe (z = 0.06, p = 0.96). Patients often had long admissions exceeding 10 days due to complex clinical courses and discharge planning. Administering bone-sparing therapy in a rush on the final day of admission causes discharge delays, and this occurred for 28% of patients admitted for >10 days in the first audit cycle. Again, the checklist had no significant effect on this (z = 0.44, p = 0.66).

Table 1. Incorrect bone protection information provided in first audit cycle discharge summaries.

Incorrect Discharge Information	Number of Patients
No information despite bone protection plan in place	14
No mention of bone protection in discharge summary or follow-up clinic letters	46
No formal denosumab letter for continuation by community GP	6
Inadequate details regarding continuing zoledronate	5

GP, general practitioner.

summarises how 53% of first-cycle patients had incorrect discharge summary information regarding bone protection. By contrast, the checklist significantly increased correct discharge information by 27% (z = 2.77, p = 0.006) compared to pre-intervention.

3.5. Staff Surveys

Pre-intervention surveys highlighted ward staffs’ concerns about delays providing bone protection and lack of confidence when prescribing, and of 14 junior doctors surveyed, 93% felt patients missed osteoporosis therapy. Post-intervention surveys encouragingly demonstrated that the checklist was well-received. All responders reported that the checklist was easy-to-use, enhanced confidence prescribing bone protection, and had meant fewer patients missed out on fragility fracture secondary prevention.

4. Discussion

There were clearly inpatient bone protection practice shortcomings highlighted by the first PDSA cycle. This is akin to other studies’ findings of missed opportunities for fragility fracture secondary prevention in primary care [11,12], outpatient orthopaedic clinics [13], and rehabilitation settings [14]. However, this study shows that a simple checklist intervention can have a very positive impact on osteoporosis care. NOGG asserts fragility fracture patients over 70 years old should receive treatment without assessment [3]. Therefore, ideally, no patients in this audit should have been planned for community DEXA scans, and the checklist beneficially reduced such practice. This is particularly important for secondary prevention after NOF fractures, which have huge burden on patient morbidity, mortality, and health economics [15]. Therefore, the checklist’s osteoporosis treatment planning improvements for fractured NOF cases are very promising.

Prescription safety is unequivocally important. This includes vitamin D replacement, as excess cholecalciferol given to hypercalcaemic patients further potentiates raised serum calcium via increased renal reabsorption and intestinal uptake [16]. On the other hand, insufficient vitamin D supplementation before bisphosphonate administration can exacerbate drug-induced dangerous hypocalcaemia. Bisphosphonates reduce osteoclast-mediated bone resorption, thus decreasing calcium efflux from bone, which is aggravated by vitamin D deficiency [17]. Furthermore, patients must have adequate kidney function to receive osteoporosis medication, as reduced bisphosphonate renal clearance augments side effects and toxicity, and denosumab’s hypocalcaemia risk grows in renal impairment [18]. The checklist’s total elimination of unsafe prescriptions, which inadequately checked or ignored calcium levels and kidney function, is thus of major benefit to patient care.

Orthogeriatric patients are often comorbid, present acutely, and are unstable peri-operatively. Therefore, combined with staff shortages and pressures, bone protection is understandably pushed down the clinical priority list. Hence, the checklist alone was inevitably unlikely to impact osteoporosis care’s timeliness in this multifactorial context. However, it is auspicious to see it could still help patient flow by ameliorating discharge information. The Royal Osteoporosis Society (ROS) accentuates the need for coordinated follow-up and clear information sharing between secondary and primary care [19]. In this vein, the checklist advises how long bone protection should be continued for in the community before re-assessing fracture risk. The checklist additionally explains how to refer patients for annual intravenous zoledronate doses, thus enhancing osteoporosis care’s coordination and continuity.

There are some limitations to this QIP. The second cycle’s smaller patient cohort may reflect potential seasonality of fragility fractures, with slippery winter conditions possibly increasing rates [20]. However, it could also represent a study shortcoming; weekly inpatient note reviews in the second cycle may have missed patients admitted and discharged within the intervening period. Another limitation is delineating whether changes directly resulted from the checklist’s implementation or were a QIP byproduct. Some improvement certainly stemmed from the QIP and associated posters generating raised bone protection awareness on the wards. However, the checklist itself was paramount. This is conveyed by significantly increased osteoporosis treatment plans for all fragility fracture patients when the checklist was used compared to when it was not used within the second cycle. There was also a lack of significant difference in therapeutic osteoporosis planning for fractured NOFs in the first cycle compared to those in the second cycle without checklist use, further attributing this QIP’s positive impact directly to the checklist. Although there are many examples of checklists’ potent benefits for patient safety, such as the WHO Surgical Safety Checklist [21] and VTE Risk Stratification Proforma [22], they can be perceived as unwanted additions to busy clinicians’ workloads [23]. This could restrict the bone protection checklist’s future uptake. However, the staff surveys indicate very positive reception by the multidisciplinary team and the checklist has now become a key component of Buckinghamshire Healthcare NHS Trust’s femoral fracture clerking booklet.

5. Conclusions

It is rewarding to see how a simple single-page checklist has demonstrably improved safe bone-sparing therapy for fragility fracture patients in several key clinical domains. There is scope to further assess this QIP’s impact going forwards, such as changes to ROS leaflet provision for better educating patients about their bone health and whether there has been a long-term effect on medication continuity for patients needing 6-monthly denosumab injections or annual zoledronate infusions. Ultimately, this work will hopefully encourage other clinical teams caring for orthogeriatric patients to evaluate their osteoporosis practice and deploy a similar QI strategy.