米戈里县关爱服务提供者改善患者体验研究第二阶段 (CPIPE2)
2025年5月5日 更新者:University of California, San Francisco
解决医疗服务提供者的压力和无意识偏见,以提高孕产妇保健质量
本提案中描述的活动旨在解决医疗保健提供者的压力和无意识偏见,以提高孕产妇医疗保健的质量,特别是与以人为本的护理方面相关的问题,即
尊重并响应女性的需求、偏好和价值观的护理。
研究人员重点关注卫生服务提供者的压力和无意识偏见,因为它们是护理质量差的关键驱动因素,而旨在提高孕产妇保健质量的干预措施往往没有解决这些问题。
研究人员计划 (1) 设计一种干预措施,使提供者能够识别和管理他们的压力和无意识偏见; (2) 试点干预措施,评估其可行性和可接受性; (3) 评估干预对以下方面的初步效果: (a) 提供者与压力和无意识偏见相关的知识、态度和行为; (b) 提供者的压力水平。
研究概览
地位
完全的
干预/治疗
详细说明
以穷人为中心的孕产妇保健 (PCMHC) 导致撒哈拉以南非洲 (SSA) 孕产妇和新生儿死亡率较高,而 PCMHC 的差异正在加剧孕产妇保健服务使用方面的差异。
然而,关于如何改善 PCMHC 和减少差距的研究很少。
研究人员试图通过这个项目来填补这一空白。
他们建议将医疗服务提供者的压力和无意识偏见作为导致 PCMHC 不良和 PCMHC 差异的基本因素。
医疗保健提供者的压力和无意识偏见是需要考虑的重要因素,因为:(1) 资源匮乏环境中的提供者通常在压力很大的条件下工作; (2) 无意识的偏见在包括SSA在内的每个社会中都普遍存在; (3) 这些因素相互促进,导致护理质量差和以人为本的护理存在差异。
在该项目的第一阶段 (CPIPE1),他们进行了研究以检查 (1) 与 PCMHC 相关的因素,并确定提供者压力和无意识偏见是关键影响因素。
他们还研究了肯尼亚米戈里县的提供者压力和无意识偏见的水平以及压力源和偏见的类型。
该研究的结果将用于为这一阶段(CPIPE2)提供信息,其目标是:(1)设计一种多成分理论和基于证据的干预措施,使提供者能够识别和管理他们的压力和无意识偏见; (2) 试点干预措施,评估其可行性和可接受性; (3) 评估干预对以下方面的初步效果: (a) 提供者与压力和无意识偏见相关的知识、态度和行为; (b) 使用测试前-测试后对照组设计的提供者压力水平。
他们将利用试点结果来完善干预措施,并制定 R01 提案,以进行多地点评估,以更大的样本和更长的随访时间来评估对 PCMHC 的影响。
这项研究将产生有价值的信息,为 PCMHC 的质量改进工作提供信息。
研究类型
介入性
注册 (实际的)
83
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
-
Migori、肯尼亚
- Migori County hospital and sub-county hospitals
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
描述
纳入标准:
- 在干预设施产科单位工作的提供者都有资格。
排除标准:
- 无法参加预定的培训。
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:卫生服务研究
- 分配:非随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:干预臂
|
减少有意识的偏见和压力的培训
促进同行和指导机会
县和设施层面的领导参与
帮助当地冠军促进干预
|
|
无干预:控制臂
干预期间不会接受任何培训
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
感知压力量表 (PSS) 评分从基线到 6 个月的变化
大体时间:基线和 6 个月
|
感知压力量表 (PSS) 分数范围为 0 到 40,分数越高表明感知压力越高。
|
基线和 6 个月
|
|
Shirom-Melamed 倦怠测量 (SMBM) 评分从基线到 6 个月的变化
大体时间:基线和 6 个月
|
Shirom-Melamed 倦怠测量范围从 1 到 7,分数越高表明倦怠程度越高
|
基线和 6 个月
|
|
压力知识和态度评分从基线到 6 个月的变化
大体时间:基线和 6 个月
|
压力知识和态度得分由 14 个调查问题来衡量,得分范围为 0 到 14。分数越高,表明对压力和压力管理的了解和积极态度越高。
我们使用了 14 项调查量表中的 13 项。
使用的分数范围是 0 到 13,如限制部分中所述。
|
基线和 6 个月
|
|
无意识偏见知识和态度评分从基线到 6 个月的变化
大体时间:基线和 6 个月
|
无意识偏见知识和态度得分由 17 个调查问题来衡量,得分范围为 0 到 17。得分越高,表明对无意识偏见和无意识偏见缓解的了解和积极态度越高
|
基线和 6 个月
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
头发皮质醇水平从基线到 6 个月的变化
大体时间:基线和 6 个月
|
皮质醇水平没有具体的界限,但平均而言,皮质醇水平越高表明压力越大。
|
基线和 6 个月
|
|
心率变异性 (HRV) 水平从基线到 6 个月的变化
大体时间:基线和 6 个月
|
HRV 没有指定的截止值,但平均而言,较低的 HRV 分数表明较高的压力
|
基线和 6 个月
|
|
社会经济地位的变化——以人为本的孕产妇护理内隐关联测试(IAT)分数
大体时间:基线和 6 个月
|
IAT 分数在 -2 和 +2 之间变化。
在本研究中,较高的正分表明良好患者的高状态与困难患者的低状态之间存在更强的隐含关联
|
基线和 6 个月
|
|
显性偏差分数从基线到 6 个月的变化
大体时间:基线和 6 个月
|
显性偏差分数来自对小插图的响应,范围从 4 到 28。
分数越高表明偏见越明显
|
基线和 6 个月
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 首席研究员:Patience Afulani, PhD, MD, MPH、University of California, San Francisco
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研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2021年8月16日
初级完成 (实际的)
2022年6月24日
研究完成 (实际的)
2023年8月31日
研究注册日期
首次提交
2021年8月18日
首先提交符合 QC 标准的
2021年8月18日
首次发布 (实际的)
2021年8月24日
研究记录更新
最后更新发布 (实际的)
2025年5月7日
上次提交的符合 QC 标准的更新
2025年5月5日
最后验证
2025年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.