Development of a pharmacist counseling tool for subcutaneous anticoagulant use in Covid-19 patients

Abstract

Early anticoagulant therapy decreases thrombosis risk and mortality in COVID-19 patients. However, anticoagulant use comes with risks of bleeding and hence appropriate patient education, counseling and monitoring is required. The existing anticoagulant counseling tools are inapplicable for use in COVID-19 disease as patients are often confused with its use for infection. Thus, the aim of the study was to develop parenteral anticoagulant counseling tools for use in COVID-19 patients. The objective of the first study was to determine VTE prevalence, factors affecting VTE among COVID-19 patients, associated with pattern use and clinical effectiveness of subcutaneous anticoagulants. A total of 450 hospitalized COVID-19 patients in tertiary hospitals were included. Fondaparinux was the most common anticoagulant used (n=114, 38.1%). A total of 80 patients (93.0%) experienced DVT and PE (n=6, 7.0%) during thromboprophylaxis. 423 patients (94.0%) were discharged well while 27 patients (6.0%) were admitted to ICU. The length of hospital stay was 9.9 ± 4.7 days. VTE had higher risk among patients not receiving subcutaneous (SC) anticoagulants (adjusted odds ratio [aOR] 54.3, 95% confidence interval [CI]: 7.1, 416.5), and those that received fondaparinux (aOR 2.5, 95% CI: 1.2, 5.3). The objective of the second study was to develop and validate written and infographic anticoagulant counseling tools for COVID-19 use with a panel of experts (n=6). Initially a written tool was developed and content validation was performed among hospital pharmacists (n=26) and patients (n=28). The written tool indicated high content validity among hospital pharmacists, as all items in the tool (n=18, 100%) indicated Content Validity Index (ICVIs) ranging from 0.96-1.00, I-CVI average (Sum of I-CVI/no. of items: 17.88/18) was 0.99, and Scale-level-CVI (S-CVI) / Universal Acceptance (UA)) (Sum of UA/no. of items: 15/18) was 0.83. Among patients there was a high acceptance and good comprehension of all items (n=18, 100%) reported among patients with an Item Acceptance Index (IAI) ranging from 0.93-1.00, and IAI average (Sum of IAI/no. of items: 17.82/18) of 0.99. An infographic tool was then generated, with an excellent content validity among hospital pharmacists as all items (n=18, 100%) presenting ICVIs ranging from 0.96-1.00, I-CVI average (Sum of I-CVI/no. of items: 17.92/18) was approximately 1.00, and Scale-level-CVI (S-CVI) / Universal Acceptance (UA)) (Sum of UA/no. of items: 16/18) was 0.89. Through face validation among patients, the tool content indicated great acceptance and well comprehension with an IAI value of 1.00, and IAI average (Sum of IAI/no. of items: 18/18) was 1.00. The final study aimed to test the efficacy of both written and infographic tools and involved 161 subjects in the written group, and 162 subjects in the infographic group. Better knowledge of anticoagulant use in COVID-19 disease were reported among younger respondents and higher educational holders in both written and infographic groups (p<0.001). Knowledge scorings were significantly higher in post-counseling than pre-counseling for written and infographic tools (p<0.001). Overall, pharmacists are recommended to implement standard counseling tools to educate patients on anticoagulant use among COVID-19 patients for better clinical outcomes and to minimize undesirable adverse effects.