Effect of a multifaceted intervention to improve clinical quality of care through stepwise certification (SafeCare) in health-care facilities in Tanzania: a cluster-randomised controlled trial.
Effect of a multifaceted intervention to improve clinical quality of care through stepwise certification (SafeCare) in health-care facilities in Tanzania: a cluster-randomised controlled trial.
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坦桑尼亚医疗机构通过逐步认证（SafeCare）进行多方面干预以提高临床护理质量的效果：一项集群随机对照试验。
DOI：
10.1016/s2214-109x(21)00228-x
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发表时间：
2021-09
期刊：
影响因子：
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通讯作者：
Goodman C
中科院分区：
文献类型：
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作者：
King JJC;Powell-Jackson T;Makungu C;Spieker N;Risha P;Mkopi A;Goodman C
在许多低收入和中等收入国家的卫生保健机构中，包括在私人设施中，保健质量一直显示不足，这些设施的数量正在迅速增加，但往往没有有效的质量管理机制。安全护理规划旨在解决这一护理质量差距，采用适合资源匮乏环境的基于标准的方法，包括评估、指导、培训和获得贷款，以提高临床质量和设施业务绩效。我们评估了安全护理项目对坦桑尼亚宗教机构和私营营利性机构患者护理质量的影响。在这项聚类随机对照试验中，坦桑尼亚的诊所、保健中心或宗教部门或私营营利部门的医院均符合资格。我们使用计算机生成的分层随机化方法随机分配设施（1:1），以接受完整的SafeCare包（干预）或仅进行评估（对照）。实施人员和参与者对结果测量不知情，主要结果由不知道研究组分配的现场工作人员测量。主要结果是卫生工作者对感染预防和控制（IPC）做法的依从性，通过观察提供者与患者的相互作用来衡量，以及在终点（至少18个月后）对秘密标准化患者的正确病例管理。采用改良意向治疗法进行分析。试验注册号为ISRCTN， ISRCTN93644888。在2016年3月7日至11月30日期间，我们招募并随机分配了237家卫生机构进行干预（n=118）或对照（n=119）。9个设施（7个干预设施和2个控制设施）在试验期间关闭，未纳入分析。2018年2月7日至4月5日期间，我们在5425例医患互动中观察到29608例IPC适应症。2018年5月3日至6月12日期间，卫生机构接待了909名标准化患者。干预设施的终末安全护理标准评估得分比对照设施高4.4个百分点（95% CI 0.9 - 7.7; p=0.015）。然而，没有证据表明干预组和对照组在临床质量上有差异。干预设施的14366个指征中有8181个（56.9%）符合IPC规范，对照设施的15242个指征中有8336个（54.7%）符合IPC规范（绝对差异2.2个百分点，95% CI - 0.2至- 4.7;p= 0.071）。干预组444例标准化患者中有120例（27.0%）得到了正确的治疗，对照组465例患者中有136例（29.2%）得到了正确的治疗（绝对差异为- 2.8个百分点，95% CI为- 8.6 ~ - 3.1;p= 0.36）。通过遵守IPC规范和正确的病例管理来评估，SafeCare并没有提高临床质量。缺乏对临床质量的影响可能反映了干预强度不足，结构质量与护理过程之间的联系不足，质量改进的资源稀缺，以及改进的财政和监管激励不足。英国卫生系统研究计划（医学研究委员会、经济和社会研究委员会、英国国际发展部、全球挑战研究基金和威康信托基金）。
Quality of care is consistently shown to be inadequate in health-care settings in many low-income and middle-income countries, including in private facilities, which are rapidly growing in number but often do not have effective quality stewardship mechanisms. The SafeCare programme aims to address this gap in quality of care, using a standards-based approach adapted to low-resource settings, involving assessments, mentoring, training, and access to loans, to improve clinical quality and facility business performance. We assessed the effect of the SafeCare programme on quality of patient care in faith-based and private for-profit facilities in Tanzania. In this cluster-randomised controlled trial, health facilities were eligible if they were dispensaries, health centres, or hospitals in the faith-based or private for-profit sectors in Tanzania. We randomly assigned facilities (1:1) using computer-generated stratified randomisation to receive the full SafeCare package (intervention) or an assessment only (control). Implementing staff and participants were masked to outcome measurement and the primary outcomes were measured by fieldworkers who had no knowledge of the study group allocation. The primary outcomes were health worker compliance with infection prevention and control (IPC) practices as measured by observation of provider–patient interactions, and correct case management of undercover standardised patients at endline (after a minimum of 18 months). Analyses were by modified intention to treat. The trial is registered with ISRCTN, ISRCTN93644888. Between March 7 and Nov 30, 2016, we enrolled and randomly assigned 237 health facilities to the intervention (n=118) or control (n=119). Nine facilities (seven intervention facilities and two control facilities) closed during the trial and were not included in the analysis. We observed 29 608 IPC indications in 5425 provider–patient interactions between Feb 7 and April 5, 2018. Health facilities received visits from 909 standardised patients between May 3 and June 12, 2018. Intervention facilities had a 4·4 percentage point (95% CI 0·9–7·7; p=0.015) higher mean SafeCare standards assessment score at endline than control facilities. However, there was no evidence of a difference in clinical quality between intervention and control groups at endline. Compliance with IPC practices was observed in 8181 (56·9%) of 14 366 indications in intervention facilities and 8336 (54·7%) of 15 242 indications in control facilities (absolute difference 2·2 percentage points, 95% CI −0·2 to −4·7; p=0·071). Correct management occurred in 120 (27·0%) of 444 standardised patients in the intervention group and in 136 (29·2%) of 465 in the control group (absolute difference −2·8 percentage points, 95% CI −8·6 to −3·1; p=0·36). SafeCare did not improve clinical quality as assessed by compliance with IPC practices and correct case management. The absence of effect on clinical quality could reflect a combination of insufficient intervention intensity, insufficient links between structural quality and care processes, scarcity of resources for quality improvement, and inadequate financial and regulatory incentives for improvement. UK Health Systems Research Initiative (Medical Research Council, Economic and Social Research Council, UK Department for International Development, Global Challenges Research Fund, and Wellcome Trust).