Reducing Patient’s Refusal of Anticoagulant Medication to Decrease Venous Thromboembolism Risk

Venous thromboembolism (VTE) events include deep vein thromboembolisms (DVT) and pulmonary embolisms (PE). These events can have negative impacts on patient outcomes and can lead to an increased length of stay and a rise in medical costs. VTEs affect approximately 900 000 Americans each year, leading to 100 000 deaths.1 The prevalence of VTEs in the United States is estimated to be 422 per 100 000 individuals and may reach 567 per 100 000 individuals in 2050.2 Hospital-acquired venous thromboembolisms (HA-VTE) are costly, exceeding approximately $5 billion dollars per year.1 While both mechanical and chemical prophylaxis have been shown to decrease the risk of VTE events, anticoagulant medication is considered the first line of defense for prevention.3 However, compliance with VTE reduction measures remains a challenge within the hospital setting. Administration of VTE prophylaxis is a crucial step, and prescription does not guarantee administration.4 Literature shows that patients refuse chemical prophylaxis such as heparin and enoxaparin (Lovenox®) at higher rates than other prescribed medications.5 Within the setting of this quality improvement (QI) project, an increase in HA-VTE occurrences was noted in 2021 and 2022. The hospital VTE rate per 1000 patient days in 2020 was 4.63 and rose to 6.23 in 2022. According to the Agency for Healthcare Research and Quality, the benchmark VTE rate for 2022 was 3.23.6 These data initiated conversations with hospital leaders to analyze the data and explore why VTE events were occurring. Bi-monthly meetings occurred at the facility level to review all VTE events. Anticoagulant administration was one element that was assessed and determined to be a factor in those patients who developed a VTE. This prompted the creation of a report built from the medical record that captured all missed doses of anticoagulants, including refusals. This investigation revealed that a high number of patients were refusing their anticoagulant medications. Recognition of this opportunity by nursing leaders promoted collaboration at the microsystem level surrounding VTE reduction work. In alignment with hospital goals, a pilot QI project was implemented. This pilot sought to prevent VTE occurrences by reducing the number of anticoagulant medication refusals through real-time follow-up and proper nurse and patient education. METHODS This QI project took place on a 36-bed medical-surgical unit within a large Magnet designated academic trauma center located in the southeastern region of the United States. The key stake olders included Clinical Nurse Leaders (CNLs), a Clinical Nurse Specialist, Performance Improvement Quality Team members, nurse manager, unit educator, and other operational and nursing facility leaders. An initial assessment revealed that the unit had 8 HA-VTE events from October 2021 to September 2022 (a VTE rate of 0.54 per 1000 patient days) and had the highest number of anticoagulant medication refusals. Interventions To allow for data sharing and efficient compliance tracking, a data report was created that tracked daily patient refusals of anticoagulant medications, including heparin and Lovenox®. This report identified patients who had missed doses from the previous calendar day, which included patient refusals, provider orders, contraindicated, or documented as "other." Those documented as "other" were found to be specific situations such as the patient being off of the unit for procedures or testing. The report also included demographic data (ie, name, age, account number, and ethnicity) and information about the medication, including the name, time of the missed dose, medication route, nurse who held the dose, the reason the dose was not administered, and whether the provider was notified. After reviewing the daily report, the CNL followed up with both the patient and nurse to reveal the specific reason for medication refusal and to provide real-time education on the importance of VTE prophylaxis. Follow-up with nurses and patients was not necessary if a medication was missed due to being contraindicated or held by the provider. These findings were manually exported into an Excel file to identify barriers and trending areas of opportunity. A prior study from the literature demonstrated that there is a misconception that ambulation is an adequate substitute for pharmacological VTE prophylaxis, even though there is no clear evidence that ambulation solely prevents VTE events in the hospitalized patient.4 The same study implemented nurse education modules focusing on crucial aspects of VTE prophylaxis and reviewed leading VTE prevention practices, which resulted in a 13% reduction in missed doses of anticoagulant medications.4 Literature also shows that patients and families play a crucial role in VTE prevention, making it essential to ensure they are thoroughly educated and involved in the plan of care.7 Inadequate understanding can impact patients' adherence to VTE prevention measures.7 If the right educational approach is provided to patients by front-line nurses, patient anticoagulant dose refusals can be reduced.7 Although staff nurses are not the prescribing body of VTE prevention strategies, they play a key role in influencing and maintaining patient adherence to VTE prevention.7 Based on the literature review, the team created several countermeasures that included the implementation of a new process flow to aid nurses with a standard approach when patients refused anticoagulant medication doses (Figure 1). One countermeasure included the creation of a nursing education module by the project team that validated the importance of mobility, mechanical and chemical prophylaxis, and the new process flow for addressing patient refusals. Another countermeasure included the development of health-literate patient education. The need for this patient education was identified and created in response to best practices, as well as barriers identified by the CNL during follow-up of patient refusals. This printed VTE prevention educational flyer included the importance of mobility, chemical, and mechanical prophylaxis. Secondarily, it served as a guide for nurses to deliver VTE education in response to patient refusals of medication. Figure 1.: Standard process flow for chemical prophylaxis refusals. Abbreviations: CNL, Clinical Nurse Leader; EMR, Electronic Medical Record; NM, nurse manager. RESULTS The 13-week pilot occurred from October 23, 2022, to January 15, 2023. For the 12 months prior to this pilot (October 2021-September 2022), the unit had 8 VTE events equating to a 0.54 rate per 1000 patient days. In the 12 months following implementation (October 2022-September 2023), the unit had 2 VTE events equating to a 0.23 rate per 1000 patient days, a 57% reduction (Figure 2). During the pilot period, the total number of anticoagulant medication doses refused was 144 doses. Average weekly medication refusals at the beginning of the pilot were 20 refusals a week. By the end of the pilot, average weekly refusals had decreased to 11 per week, resulting in a 45% reduction in anticoagulant medication refusals. Figure 3 displays the total number of anticoagulant refusals during the 13-week pilot phase. Some patients continued to refuse anticoagulant medication doses despite education from both nursing and providers, which skewed the data. The team defined patients who refused more than 3 anticoagulant medication doses during their hospital stay as "chronic refusers." With "chronic refuser" doses removed, the number of doses refused was 44 doses. Figure 2.: Unit VTE rates per 1000 patient days. Abbreviation: VTE, venous thromboembolism.Figure 3.: Total number of patient medication refusals during project pilot. Common reasons for patients refusing their anticoagulants included not wanting to receive a needle stick, refusing all medications due to lack of mental capacity, not believing they needed the medication due to being ambulatory, or not wanting to be woken for medication administration. Many patients also refused anticoagulant doses on the day of discharge. Some patients had misconceptions of anticoagulant uses and side effects, such as fear of major bleeding complications. As anticoagulants are high-risk medications, provider notification and response to patient refusals is an area of opportunity for improvement. INTERVENTION SUSTANABILITY AND LIMITATIONS Tracking and improving quality measures, such as the prevalence of VTEs within the hospital setting, is crucial to ensuring the improvement of patient outcomes. Through interdisciplinary collaboration, barriers to VTE prevention protocols can be identified. Continued focus and conversation are necessary to ensure the sustainability of new initiatives and identify limitations. The VTE prophylaxis education developed from this project must also be provided to all staff members upon hire and annually to increase awareness surrounding the importance of VTE reduction work. While this QI project saw success, these findings may be limited due to the inclusion of 1 medical-surgical unit. Future projects should include various units with a broad variety of patient populations. Other identified limitations include high staff turnover, which led to an influx of temporary registered nurses (float, resource, and travelers) on the unit, thus creating challenges with accountability and follow-up. Although the report utilized in this project allowed for sufficient data collection, the team identified that a report populated in real time could lead to further success in reducing medication refusals. Lastly, inaccurate documentation such as documenting that the medication was refused when it was in fact on hold by the provider created challenges with accurate data collection. However, interventions put in place with this pilot project with real-time follow-up and nursing education helped reduce these documentation errors, thus reducing the overall refusal rate. CONCLUSIONS After implementing real-time follow-up, as well as providing patient and nurse education about the importance of VTE prophylaxis, this QI project found reductions in VTE events and patient refusal of anticoagulant medication. Collaboration and follow-up with providers are critical components to achieving a successful reduction of medication refusals and effective VTE management. This QI project could be easily replicated in other clinical settings and has already shown promising results of sustainment. The next steps include evaluating other components of VTE management, such as sequential compression device compliance and patient mobility.