Study of assessment of knowledge and understanding for coping with sick days among patients with diabetes in community pharmacy: a cluster randomized controlled trial (SAKURA trial)

Kado et al. Journal of Pharmaceutical Policy and Practice https://doi.org/10.1186/s40545-023-00614-4 (2023) 16:104 Journal of Pharmaceutical Policy and Practice Open Access RESEARCH Study of assessment of knowledge and understanding for coping with sick days among patients with diabetes in community pharmacy: a cluster randomized controlled trial (SAKURA trial) Keisuke Kado1, Hiroshi Okada2* , Shota Suzuki2,3, Masako Satake1, Toru Yamazaki1, Mayumi Kurosawa1, Mie Yamamoto1, Miho Takahashi1 and Takeo Nakayama2 Abstract Background Awareness regarding coping with sick days among patients with diabetes is limited. Thus, we evaluated the effectiveness of sick-day education by community pharmacists among patients with type 2 diabetes (T2D) using sick-day educational materials (sick-day cards). Methods A cluster randomized controlled trial was conducted. Pharmacists in the intervention group educated patients with T2D on coping with sick days (adjusting medication dosage and seeking medical advice) using sickday cards compared with the usual counseling. Differences in questionnaire scores (“Anxiety”, “Intention”, “Attitude”, and “Knowledge” about sick days) before and after the intervention were compared between the groups. Results Overall, 318 patients with T2D (intervention, 119; control, 199) participated in this study, and 270 (intervention, 92; control, 178) patients were examined. There were no significant differences in “Anxiety”, “Intention”, or “Attitude” scores between the two groups, but “Knowledge” scores improved in the intervention group. For all intervention groups (92/92), a physician reviewed and approved medication and adjustment doses for sick days on the cards. Conclusions According to patients’ responses, sick-day education using teaching materials improved patient knowledge. This may help patients and their caregivers cope with sick days appropriately through medication dose adjustment and fluid intake. Research registration number: UMIN000043161 (February 1, 2021), https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr.cgifu nction=brows&action=brows&recptno=R000048124&type=summar y&language=J Keywords Community pharmacy, Diabetes, Education intervention, Implementation research, Randomized controlled trial, Sick day *Correspondence: Hiroshi Okada Full list of author information is available at the end of the article © The Author(s) 2023. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. 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Journal of Pharmaceutical Policy and Practice (2023) 16:104 Page 2 of 10 Background On sick days, during treatment, patients with diabetes experience significant symptoms such as fever, diarrhea, vomiting, or loss of appetite, which may result in lifethreatening hyperglycemia and ketoacidosis [1, 2]. Primary care physicians and community pharmacists should provide sick-day education to all patients with diabetes [3]. Most patients with diabetes presenting to the emergency room for severe hypoglycemia or diabetic ketoacidosis (DKA) are older patients with type 2 diabetes (T2D) with an infectious disease characterized by high fever or diarrhea [4]. Therefore, diabetes-related organizations have published various guidelines for patients and medical professionals on coping with sick days [5–9]. In recent years, the use of sodium–glucose cotransporter 2 (SGLT2) inhibitors has expanded for diabetes treatment, and cases of DKA have been reported even among patients without hyperglycemia [10]. One-third of DKA cases are those with coexisting T2D [11]. The World Health Organization and International Pharmaceutical Federation published a guideline, “Developing Pharmacy Practice: A focus on patient care” in 2000, encouraging pharmacists in the community to shift their focus from traditional dispensing to holistic patient care [12]. A systematic review reported a 0.76% improvement in hemoglobin A1c (HbA1c) levels when pharmacists educated patients with diabetes [13], and various other health promotion interventions have been reported to improve patient outcomes such as blood pressure, asthma, and cholesterol [14, 15]. However, the educational impact of sick days in community pharmacies remains unclear. Moreover, traditional sick-day education is provided by diabetes specialists to adolescents with type 1 diabetes [7, 8]. However, few reports have examined its effectiveness for patients with T2D through a collaboration between pharmacies and primary care physicians. According to a survey of patients with diabetes and healthcare providers in Japan, 56% of the patients treated with oral medication reported that they were unaware of the sick-day rule, and 66% of the patients reported that they did not receive any guidance regarding sick days [16]. Based on a 2020 survey, the proportion of individuals aged ≥ 65 years has reached 28.4%, which is the highest worldwide [17, 18]. In 2016, the “family pharmacies and pharmacist system” was launched to support the health of residents in this super-aging society. In this system, pharmacies provide various patient care services, such as a 24-h consultation in case of an emergency [19, 20]. We investigated whether education provided to patients by pharmacists, in collaboration with primary care physicians, using sick-day cards about how to deal with sick days, including how to adjust medication dosages and how to see a physician (sick day rules), would change patients’ awareness and knowledge of sick days. We also examined the feasibility of pharmacists and physicians working together to educate patients about sick days. Furthermore, we examined the implementation of medical education by physicians and pharmacists and collaboration between them using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework. This framework has been widely used to evaluate the effectiveness of interventions to implement research findings in actual clinical practice [21, 22]. Methods Study design A randomized controlled tr (...truncated)