Characteristics of participating PHCPs by arm.

Background

Cluster randomized trials (cRTs) on the effectiveness of training programs face complex challenges when conducted in real-world settings. Process evaluations embedded within cRTs can help explain their results by exploring possible causal mechanisms impacting training effectiveness.

Objective

To conduct a process evaluation embedded within a cRT by comparing the impact of team-based vs. individual clinician-focused SICP training on primary healthcare professionals’ (PHCPs) intention to have serious illness conversations with patients.

Methods

The cRT involved 45 primary care practices randomized into a team-based (intervention) or individual clinician-focused (comparator) training program and measured primary outcomes at the patient level: days at home and goals of care. To perform this theory-informed mixed-methods process evaluation embedded within the cRT, a different outcome was measured at the level of the PHCPs, namely, PHCPs’ intention to have serious illness conversations with patients as measured with CPD-Reaction. Barriers and facilitators to implementing the conversations were identified through open-ended questions and analyzed using the Theoretical Domains Framework. The COM-B framework was used to triangulate data. Results were reported using the CONSORT and GRAMMS reporting guidelines.

Results

Of 535 PHCPs from 45 practices, 373 (69.7%) fully completed CPD-Reaction (30.8% between 25-34 years old; 78.0% women; 54.2% had a doctoral degree; 50.1% were primary care physicians). Mean intention scores for the team-based (n = 223) and individual clinician-focused arms (n = 150) were 5.97 (standard error (SE): 0.11) and 6.42 (SE: 0.13), respectively. Mean difference between arms was 0.0 (95% CI -0.29; 0.30; p = 0.99) after adjusting for age, education and profession. The team-based arm reported barriers with communication, workflow, and more discomfort in having serious illness conversations with patients.

Conclusions

Team-based training did not outperform individual clinician-focused in influencing PHCPs’ intention to have serious illness conversations. This process evaluation suggests that team-based training could improve intervention effectiveness by focusing on interprofessional communication, better organized workflows, and better support and training for non-clinician team members.
Registration: ClinicalTrials.gov (ID: NCT03577002).

背景
针对培训项目有效性开展的整群随机试验（cluster randomized trials, cRTs）在真实世界场景中实施时，往往面临诸多复杂挑战。嵌入于整群随机试验的过程评估，可通过探究影响培训有效性的潜在因果机制，助力阐释试验结果。

研究目标
本研究拟于一项整群随机试验中嵌入过程评估，对比基于团队与针对个体临床医生的重症沟通（Serious Illness Conversation, SICP）培训，对基层医疗专业人员（primary healthcare professionals, PHCPs）与患者开展重症沟通的意愿所产生的影响。

研究方法
该整群随机试验共纳入45家基层医疗诊所，将其随机分配至基于团队的干预组，或针对个体临床医生的对照组，接受对应培训项目；试验以患者为层级测量主要结局指标：居家天数与医疗照护目标。为开展本次依托理论框架的混合方法嵌入型过程评估，本研究以基层医疗专业人员为层级测量另一项结局指标，即采用CPD-Reaction量表评估其与患者开展重症沟通的意愿。研究通过开放式问卷识别沟通实施过程中的阻碍因素与促进因素，并采用理论领域框架（Theoretical Domains Framework）开展分析；同时运用COM-B框架对数据进行三角验证。本研究结果依照CONSORT与GRAMMS报告规范进行撰写。

研究结果
来自45家诊所的535名基层医疗专业人员中，共373名（69.7%）完整完成CPD-Reaction量表测评，其中25-34岁年龄段占比30.8%，女性占比78.0%，拥有博士学位者占比54.2%，基层医生占比50.1%。基于团队组（n=223）与针对个体临床医生组（n=150）的重症沟通意愿平均得分分别为5.97（标准误(standard error, SE): 0.11）与6.42（SE: 0.13）。在校正年龄、学历与职业因素后，两组间的平均得分差为0.0（95%置信区间(CI): -0.29~0.30；p=0.99）。基于团队组反馈的阻碍因素包括沟通问题、工作流程问题，以及与患者开展重症沟通时更强烈的不适感。

研究结论
在影响基层医疗专业人员与患者开展重症沟通的意愿方面，基于团队的培训并未优于针对个体临床医生的培训。本次过程评估提示，若聚焦跨专业沟通、优化工作流程，并为非临床团队成员提供更优质的支持与培训，基于团队的培训可提升干预效果。

注册信息
本试验注册于ClinicalTrials.gov（注册号：NCT03577002）。