Abstract
Background: Adult patients with bleeding disorders (PWBD), such as hemophilia or von Willebrand Disease (VWD), frequently require surgeries and procedures. In order to achieve and maintain hemostasis throughout the peri-operative period, clotting factor concentrates (CFCs) are prescribed. Patients then adhere to a detailed CFC treatment plan (TP), which outlines exact doses to take, when to take them, and for how long. However, despite following the TP, non-adherence sometimes occurs. Importantly, if inadequate amounts of CFC are prescribed or taken, and under-treatment leads to bleeding complications, even simple procedures could result in death. As a result, the ability to evaluate clinical effectiveness in real-time is urgently needed. However, most post-procedure-related recovery happens outside of the hospital or clinic setting. Therefore, little is known about clinical outcomes post-procedurally. A baseline study at our institution showed only 51% of PWBD answered their phone when clinic staff called to assess the effectiveness of and adherence to the TP. A better understanding of CFC adherence and bleeding rates may improve cost-effectiveness of and patient satisfaction with CFC use peri-procedurally. Our aims were to assess feasibility of 2-way SMS text messaging (TM) between our clinic and PWBD, establish peri-operative CFC adherence rates, evaluate for post-operative bleeding, and to determine patient-preferred methods of communication during peri-operative management.
Design/Methods: The Utah Center for Bleeding & Clotting Disorders at the University of Utah follows approximately 500 PWBD, all of whom were eligible for participation. Patients were consented using Adobe Sign software. Webtext.com served as the TM platform. Mobile devices were provided to patients free-of-charge using grant funding. HIPAA-compliant, templated TMs were sent by clinic staff to participants each day CFCs were prescribed to assess adherence to the TP, and incidence and severity of post-procedural bleeding. A patient satisfaction survey was emailed on the final day of CFC therapy. Study data, captured using REDCap, included baseline demographics, bleeding disorder type and severity, procedure type, factor therapy prescribed, and TM responses. Descriptive analyses were used for all study endpoints. The primary endpoint was to compare the ability to reach patients using TMs vs. phone call (feasibility). Secondary endpoints included: doses taken vs. prescribed, incidence of post-operative bleeding, overall patient satisfaction with TM, and average total cost of CFC therapy.
Results: To date, 50 PWBD consented. Average age: 37 years (range: 18 - 81); 28 PWBD had hemophilia (19 HA, 9 HB), 20 had VWD, and 2 had unconfirmed bleeding disorders; 50% were women. Eleven PWBD lived ≥ 50 miles from the HTC. Ten were taking CFC prophylaxis. Of the 50 PWBD, 10 have undergone surgery (Table 1). The remaining PWBD have yet to undergo their planned procedure. The average cost of CFC procured per PWBD per procedure exceeded $100,000. In total, PWBDs responded to 121/142 (85%) of TMs sent. All PWBD (n=10; 100%) responded to at least one text message sent. Daily communication (time from first text sent to time when last response received) lasted roughly 8 minutes. Protocol adherence: In total, 87% (55/63) of CFC doses prescribed were taken (Table 1). Post-op bleeding occurred in 3 PWBD (30%). Patient satisfaction survey results showed 70% (7/10) of PWBD preferred TM to communication via chart messaging, 90% (9/10) chose to use TM again for their care, and no PWBD was dissatisfied with TM communication.
Conclusion: This is the first study to assess the impact and feasibility of using TM to determine protocol adherence and clinical outcomes in adult PWBD undergoing surgery or procedures in a real-world setting. Compared to phone calls, the response rate to TM was 34% higher. This study identified both PWBD that were non-adherent to the TP, and those who experienced post-operative bleeding at home. Most PWBD (90%) elected to continue using TM to communicate with clinic staff. These data may help improve the cost-effective management of future procedures for PWBD.
Disclosures
Gilreath:American Regent: Consultancy. Rodgers:Pharmacosmos: Consultancy. Lim:Hema Biologics: Consultancy; Dova: Consultancy; Forma Therapeutics: Consultancy; Takeda: Consultancy.
