Del Cura-González Isabel, López-Rodríguez Juan A, Leiva-Fernández Francisca, Gimeno-Miguel Antonio, Poblador-Plou Beatriz, López-Verde Fernando, Lozano-Hernández Cristina, Pico-Soler Victoria, Bujalance-Zafra Mª Josefa, Gimeno-Feliu Luis A, Aza-Pascual-Salcedo Mercedes, Rogero-Blanco Marisa, González-Rubio Francisca, García-de-Blas Francisca, Polentinos-Castro Elena, Sanz-Cuesta Teresa, Castillo-Jimena Marcos, Alonso-García Marcos, Calderón-Larrañaga Amaia, Valderas José M, Marengoni Alessandra, Muth Christiane, Prados-Torres Juan Daniel, Prados-Torres Alexandra
Research Unit, Primary Care Assistance Management, Madrid Health Service (Servicio Madrileño de Salud), 28035 Madrid, Spain.
Department of Medical Specialties and Public Health, School of Health Sciences, Rey Juan Carlos University (Universidad Rey Juan Carlos), 28922 Madrid, Spain.
J Pers Med. 2022 May 6;12(5):752. doi: 10.3390/jpm12050752.
(1) Purpose: To investigate a complex MULTIPAP intervention that implements the Ariadne principles in a primary care population of young-elderly patients with multimorbidity and polypharmacy and to evaluate its effectiveness for improving the appropriateness of prescriptions. (2) Methods: A pragmatic cluster-randomized clinical trial was conducted involving 38 family practices in Spain. Patients aged 65-74 years with multimorbidity and polypharmacy were recruited. Family physicians (FPs) were randomly allocated to continue usual care or to provide the MULTIPAP intervention based on the Ariadne principles with two components: FP training (eMULTIPAP) and FP patient interviews. The primary outcome was the appropriateness of prescribing, measured as the between-group difference in the mean Medication Appropriateness Index (MAI) score change from the baseline to the 6-month follow-up. The secondary outcomes were quality of life (EQ-5D-5 L), patient perceptions of shared decision making (collaboRATE), use of health services, treatment adherence, and incidence of drug adverse events (all at 1 year), using multi-level regression models, with FP as a random effect. (3) Results: We recruited 117 FPs and 593 of their patients. In the intention-to-treat analysis, the between-group difference for the mean MAI score change after a 6-month follow-up was -2.42 (95% CI from -4.27 to -0.59) and, between baseline and a 12-month follow-up was -3.40 (95% CI from -5.45 to -1.34). There were no significant differences in any other secondary outcomes. (4) Conclusions: The MULTIPAP intervention improved medication appropriateness sustainably over the follow-up time. The small magnitude of the effect, however, advises caution in the interpretation of the results given the paucity of evidence for the clinical benefit of the observed change in the MAI. Trial registration: Clinicaltrials.gov NCT02866799.
(1) 目的：研究一种复杂的多模式干预措施，该措施在患有多种疾病和使用多种药物的年轻老年初级保健人群中实施阿丽亚德妮原则，并评估其对提高处方合理性的有效性。(2) 方法：在西班牙进行了一项实用的整群随机临床试验，涉及38个家庭医疗诊所。招募了年龄在65 - 74岁、患有多种疾病且使用多种药物的患者。家庭医生被随机分配继续常规护理或基于阿丽亚德妮原则提供多模式干预措施，该措施有两个组成部分：家庭医生培训（电子多模式干预）和家庭医生与患者访谈。主要结局是处方的合理性，以从基线到6个月随访期间平均药物合理性指数（MAI）评分变化的组间差异来衡量。次要结局包括生活质量（EQ - 5D - 5L）、患者对共同决策的认知（协作率）、医疗服务使用情况、治疗依从性以及药物不良事件的发生率（均在1年时），使用多水平回归模型，将家庭医生作为随机效应。(3) 结果：我们招募了117名家庭医生及其593名患者。在意向性分析中，6个月随访后平均MAI评分变化的组间差异为 - 2.42（95%置信区间为 - 4.27至 - 0.59），基线至12个月随访时为 - 3.40（95%置信区间为 - 5.45至 - 1.34）。在任何其他次要结局方面均无显著差异。(4) 结论：多模式干预措施在随访期间可持续改善药物合理性。然而，鉴于MAI观察到的变化对临床益处的证据不足，效应量较小，因此在解释结果时需谨慎。试验注册：Clinicaltrials.gov NCT02866799
