基于King's达标理论的药师患者沟通的理论模型与机制研究

Insufficient pharmacist-patient communication has the significant impact on health and economics. Practices related to policies of pharmacist-patient communication are increasingly prevalent, and TGA is regarded as the best model guiding for it. However, fundamental research is limited. The core and urgent problem, this study intends to address, is to develop a reliable theoretical model and tool to measure pharmacist-patient communication based on TGA. TGA theoretical models, including the consensus models and the disputed models, will be developed based on dimensions and their relationships by grounded theory, modified nominal group technique, in-depth interview, etc. Furthermore, the consensus models will be tested by structural equation modelling (SEM）from empirical data. Disputed models will be tested if only consensus models cannot provide an optimal model. The Anderson & Gerbing nested model selection method/ Cross validity analysis, or Akaike’s information criterion will be applied to select the optimal model and tool if many of the consensus models or disputed models fit well. Secondly, the chosen model will be evaluated for its validity and its’ applicability in other fields. Finally, the effects of the intervention on poor performance of the mechanism will be evaluated by multicenter matched-pair cluster randomised controlled trial. The core techniques include the strict use of SEM, grounded theory, and modified nominal group technique. The mechanism and tool of measuring pharmacist-patient communication will contribute to enriching TGA, building provider’s mechanism and service package of pharmaceutical services, promoting pharmaceutical quality in community pharmacy, primary health care institutions and hospitals, eventually, realising the objectives of the 13th Five-Year Plan for health and medicine safety.

药师患者(药患)沟通缺乏对健康与经济影响重大，相关政策实践不佳，目标达成理论(TGA)适合指导药患沟通但基础研究薄弱；如何构建高效的药患沟通机制是亟待解决的科学问题。本研究将基于TGA，通过扎根理论、名义群体法等方法，确定药患沟通机制理论模型的交互、目标设置、目标实现方式、目标达成等维度及其关系，形成若干理论模型（共识模型和非共识模型）及测量工具；利用结构方程模型对理论模型进行实证分析，优先拟合共识模型，最终形成理论与实证一致的数学模型；如拟合的模型不唯一，则通过嵌套模型选择等方法确定最优药患沟通机制模型。采用多中心整群随机对照实验验证药患沟通机制、并评价机制薄弱环节的干预效果；采用横断面研究评价机制在其他领域的适用性。建立的理论模型、机制及工具，将创新TGA理论、供方机制和药学沟通服务包建设，对医院药房社会化、分级诊疗中基层服务质量提升等十三五卫生与健康规划和药品安全规目标实现意义重大。

随着医药科学的进步和全球老龄化进程的加快，全球的处方数量和健康药品支出将呈指数性增长。不合理的用药每年导致了不必要的药物不良反应、快速增加的药物耐药性和数十亿巨额药物花费，因此亟待优化患者的药物使用。由于缺乏适当的理论框架模型和沟通需要的复杂性，药师如何与患者进行沟通、药患沟通如何影响患者结局的研究十分缺乏。因此本探究提出以下研究目标：1、基于已有沟通模型构建适合于药师-患者沟通背景的沟通模型；2、构建药师-患者沟通模型的测量工具并验证模型有效性并鉴别其薄弱环节；3、采用随机对照实验评估药患沟通干预措施的有效性。.本研究系统综述药学服务沟通模型，并采用专家评分法根据Fawcett理论模型评估框架对纳入沟通模型进行评估。采用探索性和验证性因子分析对药学服务沟通问卷的信度和效度进行检验。采用结构方程模型验证药师-患者沟通模型的有效性和稳健性，并鉴别其薄弱环节作为干预点；最终基于构建沟通干预措施，采用随机对照实验评估药患沟通干预措施的有效性。.根据系统文献综述及模型评估结果显示达标理论模型为最适用于药学服务沟通模型。问卷调查阶段总计现场调查600名患者。验证性因子分析的结果显示模型具有良好的模型适配指数。沟通模型所有的假设路径都具有统计显着性（p <0.001）。随机对照实验设计结果显示干预组药患沟通显著减少药物相关问题发生率(p<0.05)。.系统文献综述和模型评估结果显示达标理论模型为当前最适用于药学服务沟通模型，实证研究结果显示共同设置目标和探索实现目标的方式并达成共识两个要素的关系最紧密，尤其以共同目标设置为核心设计药师-患者沟通干预策略。以此作为药患沟通的干预措施，采取随机对照实验结果验证药患沟通干预措施的有效性，显著降低可以有效降低药物相关问题的发生率，药患之间沟通对患者用药安全具有重要意义。