【目的】 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、开发评价药师-患者沟通模型的测量工具并验证模型有效性; 3、提出针对于现阶段药患沟通薄弱环节的靶向干预策略。 【方法】 采用系统综述的方法搜集并筛选药学服务沟通模型的相关文章,根据Baxter和Braithwaite等人提出的人际沟通沟通理论(模型)的分类方式对纳入的药学服务沟通模型进行分类:以个体为中心(individually centered)、以交互为中心(interactioncentered)和以关系为中心(relationship-centered)视角对综述沟通模型进行分类。采用专家评分法根据Fawcett提出的理论模型评估框架(概念清晰度(conceptual clarity)、内容全面性(comprehensiveness of content)、逻辑一致性(logical congruence)、模型抽象性(model abstract)和临床效用(clinical utility))对纳入沟通模型进行评估。 采用名义小组法开发药学服务沟通过程的关键核心维度——共同目标设置(mutual goal setting,MGS)。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:探索性因子分析采用平行性分析和MAP检验确定保留的因子数量,根据因子载荷对问卷条目进行筛选;验证性因子分析对测量模型的测量效度和区别效度进行评价并筛选条目,并评价测量模型的整体拟合度;采用Cronbach’s alpha系数对问卷的内部一致性进行检验。同时采用多组CFA模型来检验TGA沟通模型量表是否在不同组别对潜变量的测量具有不变性。 采用结构方程模型验证药师-患者沟通模型和患者结果指标之间的关系,考虑到个体的社会学特征可能对沟通过程产生影响,采用多因多果模型(Multiple Indictors,Multiple Causes,MIMIC)纳入个体层面的控制变;多组SEM模型探索控制变量和沟通模型各要素之间的关系①不同分组测量模型是否具有不变性;②不同分组结构模型是否具有不变性;③不同分组特定路径系数或者协方差系数是否具有不变性;④不同分组潜在变量的平均数是否具有不变性。最后,基于模型实证研究结果和Bartholomew的干预映射(Intervention Mapping,IM)方法指导药学服务沟通干预的设计。 【结果】 药学服务沟通模型综述和评估:根据系统文献综述,总计纳入13个药师患者沟通模型。通过专家评分法的模型评估结果显示TGA模型在概念清晰度、内容全面性、逻辑一致性、模型抽象性和临床效用5个维度的标化得分均为最优,认为当前TGA模型为最适用于药学服务沟通模型。 基于TGA模型构建药学服务沟通测量工具:通过名义小组技术完成MGS条目开发过程后最终确定纳入4个条目,纳入原始药学服务沟通条目池。问卷调查589名患者。验证性因子分析的结果显示预期的沟通过程沟通过程的4因子模型(TLI=0.99, CFI=0.99,RMSEA=0.08)和患者满意度的单因子模型(TLI=0.99,CFI=0.99, RMSEA=0.07)具有良好的模型适配指数。多组CFA模型验证结果显示药学服务沟通工具在在不同年龄、性别、文化程度、慢性病分组、调研地点分组组别对潜变量的测量具有不变性。 基于TGA药学服务沟通模型构建:启动和反应对识别问题有直接影响(β=0.21, p<0.001)。识别问题对共同目标设置有直接影响(β=0.47,p<0.001)。然后,共同目标设定直接影响探索实现目标的方式并达成共识(β=0.76,p<0.001)。探索实现目标的方式并达成共识直接影响患者满意度(β=0.42,p<0.001)。SEM模型显示良好的模型适配指数(TLI=0.99,CFI=0.99,RMSEA=0.06)。多因多果模型结果显示调查地点(β=0.479,p<0.001)和慢性病(β=0.199,p=0.020)是“识别问题”和“患者满意度”的显著预测因子。高等教育水平(β=-0.083,p=0.026;β=-0.119,p<0.001)与“共同目标设置”和“患者满意度”显着相关。年龄(β=-0.01,p=0.004)和性别(β=-0.173, p=0.031)与“启动因素和反应因素”有显着相关性。多组SEM结果显示不同调研地点、性别、慢性病分组人群TGA沟通模型四条路径均系数也均有显著意义,但是分组路径系数均不完全相同。 药学服务沟通干预策略构建:基于模型实证结果和干预映射构建靶向药学服务沟通策略:①影响药学服务沟通的关键因素包括:知识、态度、技能和自我效能。②在提高药师与患者共同设置目标的沟通行为总体目标下,具体的绩效目标(Performance objectives,PO)包括:PO1药师与患者共同识别问题;OP2与患者进行情感交流;PO3与患者讨论治疗方案信息;PO4在沟通过程中询问患者偏好(例如,用药途径是方便、是否能够报销);PO5与患者总结与反馈。结合沟通行为影响因素和绩效目标,相交叉形成行为改变目标矩阵;③并针对上一阶段的具体行为改变目标选择恰当的基本方法和实际策略;④基于选择的实践策略进行干预设计。 【结论】 系统文献综述和模型评估结果显示TGA模型为当前最适用于药学服务沟通模型,为下一步基于TGA模型构建和开发沟通模型工具,并验证基于TGA的药学服务沟通模型提供了研究基础。首先,基于TGA开发和修订的测量工具首次对药学服务沟通过程进行测量并验证,验证结果显示该修订后的沟通过程工具具有良好的信度和效度。该工具也能为医学领域其他沟通过程的测量提供启示。其次,TGA模型验证结果显示该模型框架为指导药学服务沟通提供了有效的框架,模型结果定量化研究了基于TGA的药学服务沟通模型各要素之间的直接关系和间接关系,结果显示:①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②沟通过程与满意度直接相关。该研究发现与之前护理领域内TGA模型应用的结果一致。另一方面,TGA框架为卫生决策者提供了新的思路,例如,在医务人员和患者沟通过程要素中设计新的干预计划,改善患者沟通结局。本研究基于TGA理论模型,尤其以共同目标设置为核心,发展药师-患者沟通干预策略。IM虽然是一个耗时的过程,但却让我们能够捕捉到这种复杂性,并使我们能够开发出基于行为改变目标的干预途径,涵盖了通用和有针对性的方法,这些方法可以整合到当前的药学服务沟通实践中。需要进一步研究以评估这些干预措施的可接受性和可持续性。 【创新与不足】 本研究采用系统综述、专家法等综述并评估药学服务沟通模型,TGA仍被认为是当前适用于药学服务沟通模型,采用人群调查数据进行实证验证并基于结构方程模型构建TGA沟通模型,其产出不仅是对TGA理论的丰富、也将是药患沟通机制建设的创新;研究验证结果可以用于指导药学服务沟通提供了有效的框架和沟通工具的构建,开发关键元素的测量条目并通过人群调查检验沟通测量工具,弥补测量工具之不足,同时为医患、护患和其他医院人员与患者沟通模型和测量工具提供思路;另一方面, TGA框架为卫生决策者提供了新的思路,在本研究中根据实证结果基于共同目标设置构建干预策略,也为医务人员和患者沟通过程要素中设计新的干预计划提供新的视角。 研究局限方面,考虑到药学服务沟通模型研究的缺乏,文献综述结果未对纳入的文献进行质量评估和筛选,迫切需要高质量的药学服务沟通研究和综述对沟通模型进行补充,但在现阶段高质量研究缺乏的基础上难以实现。专家评分法和名义小组讨论法是主观评价方法,本研究专家选择主要考虑本研究药学服务沟通背景和TGA原始工具应用的护理学背景,专家的权威性和经验等可能会影响研究结局,但不作为本研究关注的重点内容,因此需要下一步研究评估专家质量对结果的影响。尽管基于结构方程模型结果构建药学服务沟通干预措施,然而,需要进一步研究设计以评估这些干预措施的可接受性和可持续性。药学服务沟通模型的实证研究主要在三级医疗机构进行,药学服务沟通模型工具构建和模型验证的结果在基层医疗机构需要更多的实证研究进行验证。分组CFA模型和分组SEM模型构建存在样本量不足的问题;SEM模型构建对样本量要求比较高,加大样本量有助于估计系数、标准误等参数的计算稳定性。此外,可以纳入更多的影响因素分析其对沟通模型的影响,可以使SEM模型结果更加完善。提高患者依从性也是药学服务沟通的重要指标之一,也是达标理论的重要结局指标,由于患者依从性在药学服务沟通调研不可及,因此仅用患者满意度作为患者结局指标。 关键词:达标理论(Theory of Goal Attainment,TGA);药学服务沟通;模型;测量;因子分析;概念模型;结构方程模型;干预映射
[Purpose] With the advancement of medical science and the acceleration of the global aging process, the number of prescriptions and health care products worldwide will increase exponentially. Unreasonable medications lead to unnecessary adverse drug reactions, rapidly increasing drug resistance, and billions of dollars in drug costs each year, so there is an urgent need to optimize drug use in patients. Due to the lack of appropriate theoretical framework models and the complexity of communication needs, there is a lack of research on how pharmacists communicate with patients and how patient communication affects patient outcomes. Based on the research status quo at home and abroad, the communication model of pharmaceutical care needs to be studied. The research objectives of this study are as follows: 1.Literature review of the pharmacist-patient communication model; 2.Develop and validate communication model tools of pharmaceutical care and validte the communication model of pharmcetuical care; 3.Develop intervention strategies for communication of pharmaceutical care based on Intervenrtion mapping and empirical results. [Methods] The systematic review method was used to collect and screen related articles on the pharmacist-patient communication model, and the included communication models was classified according to the interpersonal communication theory model proposed by Baxter and Braithwaite et al: individually centered, interaction-centered and relationship-centered model. The model was evaluated based on Fawcett's model theory evaluation framework with five dimensions: conceptual clarity, comprehensiveness of content, logical congruence, model abstraction, and clinical utility. Based on the results of the model evaluation, the TGA model is still considered to be the most appropriate communication model of pharmaceutical care at the time. The nominal group technique was applied to develop the core dimension of TGA model—Mutual goal setting . Exploratory and confirmatory factor analysis was used to test the reliability and validity of the questionnaire. Parallel analysis and MAP test were applied to determine the number of factors retained, and filter the questionnaire entries according to the factor loadings. The confirmatory factor analysis evaluateed the measurement validity and discriminant validity of the measurement model and screens the items. The internal consistency of the questionnaire was tested using Cronbach’s alpha coefficient. At the same time, multi- group CFA models were used to verify whether the TGA communication model scale used in the study was invariant in different groups. Structural equation model was applied to verify the relationship between the pharmacist-patient communication model and patient outcome measures. Considering that the influences of sociological characteristics of individuals on the communication process, Multiple Indictors Multiple Causes Model (MIMIC) was constructed to include individuallevel confounding variables in the process of establishing mathematical models. Multi-group SEM models explore the relationship between control variables and the various elements of the communication model: ①Whether the different group measurement models are invariant; ②Whether the different grouping structure models are invariant; ③Whether the different path-specific path coefficients or covariance coefficients are invariant; ④Whether the average number of latent variables in different groups is invariant. Finally, Bartholomew's Intervention Mapping (IM) method was used to guide the construction of communication interventions with the empirical result of model vaildiation of pharmaceutical care. [Results] According to the literature review, a total of 13 communication models were included. The model evaluation results of the experts grading method show that the TGA model is optimal in the five dimensions of conceptual clarity, comprehensiveness of content, logical congruence, model abstract and clinical utility. It is considered that currently TGA model is the most appropriate communication model of pharmaceutical care. Construction of communication measurement tool of pharmaceutical care based on TGA model: After completing the MGS development process by nominal group technology, the final inclusion of 4 items was included in the original ATS scale with a total of 20 items. Patient outcome measures were measured using patient satisfaction. A total of 600 patients were investigated on-site during the questionnaire survey, and the final qualified number of questionnaire was 589. Two ATS items and one PES satisfaction questionnaire item were deleted following exploratory factor analysis principles. The results of the confirmatory factor analysis showed that the expected communication process ATS's 4-factor model (14 items) and PES's single-factor (6-items) model were validated with good model adaptation indices, measuring the initiation and response of pharmacist-patient communication, problem identification, mutual goal setting, exploring means and agreeing on means to achieve goals and patient satisfaction in five dimensions. The results of multi-group CFA showed that the communication model of pharmaceutical care were invariant to the measurement of latent variables at different ages, genders, educational levels, chronic disease groups, and survey locations. Construction of communication model of pharmaceutical care based on TGA model: As originally proposed, initating and response had a direct impact on identifying problems. Identifying problems had a direct impact on mutual goal settign. The mutual goal setting directly affected exploring and agreeing on means to achieve goals. As for the link between the communication process and patient satisfaction, exploring and agreeing on means to achieve goals and reaching consensus directly affected patient satisfaction. The final SEM model showed a good model fit index (TLI = 0.99, CFI = 0.99, RMSEA = 0.06). The MIMIC model results showed survey locations and chronic conditions were significant predictors of “identification of problems” and “patient satisfaction”. The level of higher education is significantly related to “mutual goal setting” and “patient satisfaction”. Age and gender were significantly associated with “initiating and responding”. Multi-group SEM results showed that the four path coefficients of the TGA communication model of different survey locations, gender, and chronic disease groups were also significant, but the grouping path coefficients were not identical. Construction of pharmacy service communication intervention strategy based on intervention mapping: The results of the needs assessment showed that the key factors affecting the communication of pharmaceutical care included: knowledge, attitudes, skills and self-efficacy. Under the overall goal of improving the communication behavior of mutual goal setting between the pharmacist and the patient, the specific objectives of the focus group discussion results under the overall goal (Performance objectives, PO) settings included: PO1 pharmacists and patients identify problems together; OP2with patients Emotional communication; P03Discuss treatment plan information with patients; P04Ask patient preferences during communication (for example, whether the medication expense is reimbursable); P05 Summary the conversation and provide the feedback. Obtaining the data from need assessment and focus interview groups, the behavior change matrix was formed by crossing the influencing factors and performance objectives, and the appropriate basic methods and practical strategies were selected for the specific behavior change objectives of the previous stage. According to the behavior change matrix, basic method and practical strategy design, the three-stage pharmaceutical care communication training was designed aiming to achieve behavior change goals through basic methods and specific practical strategies. [Conclusions] Based on the results of literature review and model evaluation, the TGA model is considered to be the most appropriate model for pharmaceutical care communication. The model evaluation results provided the research basis for constructing and developing communication measurement tools based on TGA model and verifying the communication model of pharmaceutical care based on TGA. First, the revised ATS tool measures and verified the communication process for the first time in the field of pharmaceutical services. The verification results showed that the revised communication process tool has good reliability and validity (content validity and discriminant validity). The tool also provided insights into the measurement of other communication processes in the medical field. First, the revised ATS tool measures and verified the communication process for the first time in the field of pharmaceutical services. The verification results showed that the revised communication process tool has good reliability and validity (content validity and discriminant validity). The tool also provided insights into the measurement of other communication processes in the medical field. Multi-group CFA showed that the CFA model maintains measurement invariance at different ages, genders, educational levels, and survey locations, which meaned the TGA communication measurement tool has the same factor number, factor load, and item intercept in different groupings. At the same time, Multi-CFA models were tested by structural model invariance: the relationship between the five factors of the TGA communication model are invariant among patients with different genders, ages, educational levels, chronic disease patients and survey locations. Second, the results of the TGA model validation showed that the model framework provides an valid framework for guiding pharmaceutical care communication. This study validated the TGA communication model through empirical investigation. The model results quantitatively explored the direct and indirect relationship between the various elements of the pharmaceutical care communication model based on TGA. The results showed that: The elements of mutual goal setting and exploring and agreeing on ways to achieve goals are the two most closely related. The communication process was directly related to satisfaction. The study found consistent with the results of the TGA model application in the previous studies. Multi-group SEM results showed that the communication model had good model indexes in different genders, chronic diseases status and different survey locations. However, the communication model was variant at different ages and educational levels. On the other hand, the TGA framework provided new insight for health policy makers, such as designing new interventions in the medical staff and patient communication process elements to improve patient communication outcomes. The SEM model verification results show that the relationship between the common goal setting and the exploration target achievement mode and the consensus dimension in the TGA communication process was the strongest. Information exchange involves mutual goal setting, exploring ways to achieve goals and reaching consensus. With the close connection between the elements of information exchange, the role of common goal setting was emphasized and seen as a key element in interfering with the pharmacist-patient communication process and improving patient outcomes. Therefore, this study was based on the TGA theoretical model, especially with the mutual goal setting as the core to develop a pharmacist-patient communication intervention strategy. IM is a time-consuming process, it allowed us to capture this complexity and enable us to develop training and written materials based on behavioral change goals, covering both versatile and targeted approaches. These methods can be integrated into current pharmaceutical service practices. Further research is needed to assess the acceptability and sustainability of these interventions. [Strengths and Limitations] Systematic review and expert interview was applied to review and evaluate the pharmaceutical care communication model. TGA is considered to be currently applicable to the pharmaceutical service communication model. The communication model of pharmaceutical care was validated using empirical survey data based on structural equation model. The results enrich TGA theory, but also provided new insights in the construction of communication model of pharmaceutical care. The validation of the model of pharmaceutical care can be used to guide the communication of pharmaceutical care by providing an effective framework and develop key elements of measurement items and testing communication measurement tools to make up for the deficiencies of measurement tools by empirical study, while at the same time provide ideas for doctor-patient, nurse-patient and other health care provider-patient communication. On the other hand, the TGA framework provided a new way for health decision makers to construct intervention strategies based on common results based on empirical results in this study, and to provide a new perspective for designing new intervention programs among medical staff and patient communication process elements. There were some limitations in this study. Considering the lack of research on the communication model of pharmaceutical services, the literature review results did not evaluate quality of the included literature. At this stage, the process is hard to achieve due to lack of quality research. The expert scoring method and the nominal group technique method are subjective evaluation methods. The background of the pharmacy service communication and the nursing background of the TGA original tool application were considered for election of experts. The authority and experience of the experts may affect the research outcome, as the focus of this study, the next step is to evaluate the impact of expert quality on the results. Although communication interventions of pharmaceutical care were constructed based on structural equation model results, further research is needed to assess the acceptability and sustainability of these interventions. In addition, the empirical research on the pharmacy service communication model was mainly carried out in tertiary medical institutions. The results of the pharmaceutical service communication model need to be verified in the primary medical institutions. The problem of insufficient sample size exists in the construction of Multi-group CFA model and Multi-group SEM model. In addition, more influencing factors can be included to analyze its impacts on the communication model, which can make the SEM model results more comprehensive. Patient adherence is one important indicator of pharmaceutical care and theory of goal attainment. As this indicator was not available in cross-sectional survey, further researches are needed to include the indicator. Keywords: Theory of goal attainment; Pharmaceutical care communication; Model; Factor analysis; Theoretical model; Structural equation model; Intervention mapping.