Health Technology Assessment in Primary Care and Mental Health (PRISMA) Research Group, Institut de Recerca Sant Joan de Déu, Santa Rosa 39-57, 08950, Esplugues de Llobregat, Spain.
Centro de Investigación Biomédica en Red de Epidemiología y Salud Pública (CIBERESP), Madrid, Spain.
BMC Prim Care. 2022 Jul 5;23(1):170. doi: 10.1186/s12875-022-01727-6.
Between 2 and 43% of patients who receive a new prescription in PC do not initiate their treatments. Non-initiation is associated with poorer clinical outcomes, more sick leave and higher costs to the healthcare system. Existing evidence suggests that shared decision-making positively impacts medication initiation. The IMA-cRCT assesses the effectiveness of the IMA intervention in improving adherence and clinical parameters compared to usual care in patients with a new treatment for cardiovascular disease and diabetes prescribed in PC, and its cost-effectiveness, through a cRCT and economic modelling.
The IMA intervention is a shared decision-making intervention based on the Theoretical Model of Non-initiation. A cRCT will be conducted in 24 PC teams in Catalonia (Spain), randomly assigned to the intervention group (1:1), and community pharmacies in the catchment areas of the intervention PC teams. Healthcare professionals in the intervention group will apply the intervention to all patients who receive a new prescription for cardiovascular disease or diabetes treatment (no other prescription from the same pharmacological group in the previous 6 months). All the study variables will be collected from real-world databases for the 12 months before and after receiving a new prescription. Effectiveness analyses will assess impact on initiation, secondary adherence, cardiovascular risk, clinical parameters and cardiovascular events. Cost-effectiveness analyses will be conducted as part of the cRCT from a healthcare and societal perspective in terms of extra cost per cardiovascular risk reduction and improved adherence; all analyses will be clustered. Economic models will be built to assess the long-term cost-effectiveness of the IMA intervention, in terms of extra cost for gains in QALY and life expectancy, using clinical trial data and data from previous studies.
The IMA-cRCT represents an innovative approach to the design and evaluation of behavioural interventions that use the principles of complex interventions, pragmatic trials and implementation research. This study will provide evidence on the IMA intervention and on a new methodology for developing and evaluating complex interventions. The results of the study will be disseminated among stakeholders to facilitate its transferability to clinical practice.
ClinicalTrials.gov, NCT05026775 . Registered 30 August 2021.
在接受新处方的患者中，有 2%至 43%的患者未开始治疗。未开始治疗与临床结局较差、请病假更多和医疗保健系统成本更高有关。现有证据表明，共同决策对药物治疗的开始有积极影响。IMA-cRCT 通过一项 cRCT 和经济建模，评估 IMA 干预措施在改善接受心血管疾病和糖尿病新治疗的患者的依从性和临床参数方面与常规护理相比的有效性，以及其成本效益。
IMA 干预措施是一种基于非起始理论模型的共同决策干预措施。将在西班牙加泰罗尼亚的 24 个初级保健团队（PC）中进行一项 cRCT，随机分为干预组（1:1）和干预 PC 团队集水区的社区药房。干预组的医疗保健专业人员将对所有接受心血管疾病或糖尿病治疗新处方的患者（过去 6 个月内没有同一药物组的其他处方）应用该干预措施。在收到新处方之前和之后的 12 个月内，将从真实世界的数据库中收集所有研究变量。有效性分析将评估对起始、次要依从性、心血管风险、临床参数和心血管事件的影响。从医疗保健和社会角度，将作为 cRCT 的一部分进行成本效益分析，以每降低心血管风险和提高依从性的额外成本来评估；所有分析将聚类。将构建经济模型，以根据临床试验数据和先前研究的数据，评估 IMA 干预措施在获得 QALY 和预期寿命方面的额外成本的长期成本效益。
IMA-cRCT 代表了一种创新的方法，用于设计和评估使用复杂干预措施、实用试验和实施研究原则的行为干预措施。这项研究将提供关于 IMA 干预措施和开发和评估复杂干预措施的新方法的证据。研究结果将在利益相关者中传播，以促进其向临床实践的转移。
ClinicalTrials.gov，NCT05026775。2021 年 8 月 30 日注册。
