Department of General Practice and Health Services Research, University Hospital Heidelberg, Im Neuenheimer Feld 130.3, 69120, Heidelberg, Germany.
Institute of Medical Biometry, University of Heidelberg, Im Neuenheimer Feld 130.3, 69120, Heidelberg, Germany.
BMC Med Res Methodol. 2022 Sep 19;22(1):243. doi: 10.1186/s12874-022-01725-3.
The ARena study (Sustainable Reduction of Antimicrobial Resistance in German Ambulatory Care) is a three-arm, cluster randomized trial to evaluate a multifaceted implementation program in a German primary care setting. In the context of a prospective process evaluation conducted alongside ARena, this study aimed to document and explore fidelity of the implementation program.
This observational study is based on data generated in a three-wave survey of 312 participating physicians in the ARena program and attendance documentation. Measures concerned persistence of participation in the ARena program and adherence to intervention components (thematic quality circles, e-learning, basic expenditure reimbursements, additional bonus payments and a computerized decision support system). Participants' views on five domains of the implementation were also measured. Binary logistic and multiple linear regression analyses were used to explore which views on the implementation were associated with participants' adherence to quality circles and use of additional bonus compensation.
The analysis of fidelity showed overall high persistence of participation in the intervention components across the three intervention arms (90,1%; 97,9%; 92,9%). 96.4% of planned quality circles were delivered to study participants and, across waves, 30.4% to 93% of practices participated; 56.1% of physicians attended the maximum of four quality circles. 84% of the practices (n = 158) with a minimum of one index patient received a performance-based additional bonus payment at least once. In total, bonus compensation was triggered for 51.8% of affected patients. Participation rate for e-learning (a prerequisite for reimbursement of project-related expenditure) covered 90.8% of practices across all intervention arms, with the highest rate in arm II (96.5%). Uptake of expenditure reimbursement was heterogeneous across study arms, with a mean rate of 86.5% (89.1% in arm I, 96.4% in arm II and 74.1% in arm III). Participants' views regarding participant responsiveness (OR = 2.298) 95% CI [1.598, 3.305] and Context (OR = 2.146) 95% CI [1.135, 4.055] affected additional bonus payment. Participants' views on participant responsiveness (Beta = 0.718) 95% CI [0.479, 0.957], Context (Beta = 0.323) 95% CI [0.055, 0.590] and Culture of shared decision-making (Beta = -0.334) 95% CI [-0.614, -0.053] affected quality circle attendance.
This study showed an overall high fidelity to the implementation program. Participants' views on the implementation were associated with degree of intervention fidelity.
ISRCTN, ISRCTN58150046.
Arena 研究(德国门诊护理中抗菌药物耐药性的可持续减少)是一项三臂、集群随机试验,旨在评估德国初级保健环境中综合实施计划的效果。在与 Arena 同期进行的前瞻性过程评估中,本研究旨在记录和探讨实施计划的忠实程度。
本观察性研究基于 Arena 计划中 312 名参与医生的三波调查和出勤记录的数据。测量指标包括持续参与 Arena 计划和对干预措施(主题质量圈、电子学习、基本支出报销、额外奖金支付和计算机化决策支持系统)的依从性。还测量了参与者对实施的五个领域的看法。采用二项逻辑回归和多元线性回归分析来探讨参与者对实施的看法与他们对质量圈的依从性和额外奖金补偿的使用之间的关系。
忠实度分析显示,三个干预组的干预措施在整个研究过程中均保持较高的参与度(90.1%;97.9%;92.9%)。计划中的 96.4%的质量圈已交付给研究参与者,在三个波次中,有 30.4%至 93%的实践参与;56.1%的医生参加了最多的四个质量圈。84%(n=158)的至少有一个索引患者的实践收到了基于绩效的额外奖金支付至少一次。总共,51.8%的受影响患者触发了奖金补偿。电子学习的参与率(报销与项目相关支出的前提条件)在所有干预组中均达到 90.8%,在组 II 中最高(96.5%)。研究组之间的支出报销参与率存在异质性,平均参与率为 86.5%(组 I 为 89.1%,组 II 为 96.4%,组 III 为 74.1%)。参与者对参与者响应性的看法(OR=2.298)95%CI[1.598, 3.305]和背景(OR=2.146)95%CI[1.135, 4.055]影响了额外奖金的支付。参与者对参与者响应性(Beta=0.718)95%CI[0.479, 0.957]、背景(Beta=0.323)95%CI[0.055, 0.590]和共享决策文化(Beta=-0.334)95%CI[-0.614, -0.053]的看法影响了质量圈的出勤率。
本研究显示对实施计划具有总体的高度忠实性。参与者对实施的看法与干预措施的忠实程度有关。
ISRCTN,ISRCTN58150046。