Background

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.

Methods

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.

Findings

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).

Interpretation

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.

Funding

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).

中文翻译：

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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

背景

在许多低收入和中等收入国家的卫生保健机构中，包括私人机构在内的医疗保健质量一直被证明是不足的，这些机构的数量正在迅速增长，但往往没有有效的质量管理机制。SafeCare 计划旨在解决护理质量方面的这一差距，使用适用于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 SafeCare 计划对坦桑尼亚基于信仰和私人营利性设施的患者护理质量的影响。

方法

在这项集群随机对照试验中，如果卫生设施是坦桑尼亚信仰或私营营利部门的药房、卫生中心或医院，则符合条件。我们使用计算机生成的分层随机化随机分配设施 (1:1)，以接收完整的 SafeCare 包（干预）或仅评估（控制）。实施人员和参与者对结果测量不知情，主要结果由不了解研究组分配的实地工作人员测量。主要结果是卫生工作者对感染预防和控制 (IPC) 实践的依从性（通过观察提供者与患者的互动来衡量），以及在终点线（至少 18 个月后）对卧底标准化患者的正确病例管理。通过改良的治疗意向进行分析。该试验已在 ISRCTN 注册，ISRCTN93644888。

发现

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 家医疗机构进行干预（n=118）或对照组（n=119）。九个设施（七个干预设施和两个控制设施）在试验期间关闭，未包括在分析中。在 2018 年 2 月 7 日至 4 月 5 日期间，我们在 5425 名医患互动中观察到了 29608 项 IPC 适应症。在 2018 年 5 月 3 日至 6 月 12 日期间，医疗机构接受了 909 名标准化患者的就诊。干预机构有 4·4 个百分点（95% CI 0·9–7·7；p=0.015) 终点线的平均 SafeCare 标准评估分数高于对照设施。然而，没有证据表明干预组和对照组在终线时的临床质量存在差异。干预设施中的 14 366 个适应症中的 8181 个 (56·9%) 和控制设施中的 15 242 个适应症中的 8336 个 (54·7%) 遵守 IPC 实践（绝对差异 2·2 个百分点，95% CI -0 ·2至-4·7；p=0·071)。干预组 444 名标准化患者中有 120 名 (27·0%) 和对照组 465 名标准化患者中的 136 名 (29·2%) 发生了正确管理（绝对差异 -2·8 个百分点，95% CI -8· 6至-3·1；p=0·36)。

解释

根据 IPC 实践的合规性和正确的病例管理评估，SafeCare 并未提高临床质量。对临床质量没有影响可能反映了干预强度不足、结构质量和护理过程之间联系不足、质量改进资源稀缺以及改进的财务和监管激励不足的组合。

资金

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）。