Department of Emergency Medicine, Duke University, Durham, NC.
Division of Pediatric Hematology and Oncology, Washington University School of Medicine, St. Louis, MO.
Blood Adv. 2024 Oct 22;8(20):5330-5338. doi: 10.1182/bloodadvances.2023012439.
To address acute vaso-occlusive episodes (VOEs), the leading cause of emergency department (ED) visits among individuals with sickle cell disease (SCD), we conducted the clinical study, ALIGN (An Individualized Pain Plan with Patient and Provider Access for Emergency Department care of SCD), across 8 sites. We hypothesized an improvement of 0.5 standard deviations in perceived quality of ED pain treatment of a VOE after implementing individualized pain plans (IPPs) accessible to both patients and providers. Patients with SCD were aged 18 to 45 years, owned a cell phone, and had an ED VOE visit within 90 days prior. Patients completed the perceived quality of care surveys at baseline and within 96 hours after an ED VOE visit. Providers completed surveys regarding comfort managing VOEs at baseline and after managing an enrolled patient. Most of the 153 patients were African American (95.4%), female (64.7%), and had Hb SS/Sβ0 genotype (71.9%). The perceived quality of ED pain treatment was high at both baseline and after implementation of IPPs; our primary outcome hypothesis was not met, because no statistically significant change in the patient-perceived quality of ED treatment occurred. A total of 135 providers completed baseline and follow-up surveys. On a scale of 1 to 7, with 7 being extremely comfortable managing VOEs, 60.5% reported a score ≥6 after IPP implementation vs 57.8% at baseline. Almost all (97.6%) ordered the recommended medication, and 94.7% intended to use IPPs. In this implementation protocol, all sites successfully implemented IPPs. Patients and ED providers both endorsed the use of IPPs. This trial was registered at www.ClinicalTrials.gov as # NCT04584528.
为了治疗镰状细胞病（SCD）患者急诊就诊的主要原因——急性血管阻塞发作（VOE），我们在 8 个地点开展了 ALIGN 临床研究（用于 SCD 患者急诊治疗的个体化疼痛计划，可使患者和医护人员都能获得）。我们假设在实施患者和医护人员都可获得的个体化疼痛计划（IPP）后，VOE 急诊治疗的患者感知质量提高 0.5 个标准差。18 至 45 岁、拥有手机且在 90 天内有过急诊 VOE 就诊的 SCD 患者符合入组条件。患者在基线和 VOE 急诊就诊后 96 小时内完成感知质量调查问卷。医护人员在基线和管理完纳入患者后完成关于 VOE 管理舒适度的调查。153 名患者中，大多数为非裔美国人（95.4%）、女性（64.7%）和 Hb SS/Sβ0 基因型（71.9%）。在基线和实施 IPP 后，患者对 ED 疼痛治疗的感知质量均较高；我们的主要研究假设未得到满足，因为患者对 ED 治疗的感知质量并未发生统计学显著变化。共有 135 名医护人员完成了基线和随访调查。在 1 到 7 的评分中，7 表示非常舒适地管理 VOE，实施 IPP 后 60.5%的医护人员报告评分≥6，而基线时为 57.8%。几乎所有医护人员（97.6%）都开具了推荐药物，94.7%的医护人员打算使用 IPP。在本实施协议中，所有地点均成功实施了 IPP。患者和 ED 医护人员均支持使用 IPP。该试验在 www.ClinicalTrials.gov 上注册，编号为 #NCT04584528。
