DE-RESTRICT: Deimplementing Activity Restriction for Preterm Birth Prevention
2026年8月5日 更新者：Beth Pineles、University of Pennsylvania
Deimplementation of Activity Restriction for Preterm Birth Prevention in High-Risk Pregnancy (DE-RESTRICT): A Pilot Single-Arm Hybrid Effectiveness-Deimplementation Trial
DE-RESTRICT is a pilot study testing whether a strategy to reduce the use of activity restriction and bedrest in pregnancy is acceptable, appropriate, and feasible for prenatal care providers, and whether it changes how often activity restriction is recommended.
Activity restriction and bedrest are commonly advised to try to prevent preterm birth, but they do not prevent it and may cause harm, and national guidelines recommend against them.
The study takes place at two prenatal care settings within one health system and unfolds across four periods.
In the pre-deimplementation period the study team develops a local clinical guideline and measures baseline outcomes.
In the run-in period most provider education is delivered through interactive sessions with feedback, and audit and feedback begins.
In the maintenance period audit and feedback continues.
In the post-deimplementation period audit and feedback continues and outcomes are measured again.
The study measures provider acceptability, appropriateness, and feasibility, the rate of activity restriction recommendations, patient-reported wellbeing and care experience, and the preterm birth rate.
研究概览
详细说明
This pilot single-arm hybrid effectiveness-deimplementation trial evaluates a multicomponent strategy to deimplement activity restriction and bedrest prescribed for preterm birth prevention among prenatal care providers and patients at high risk for preterm birth. All participating practices receive the strategy; there is no control arm. The strategy comprises a locally developed clinical guideline aligning with national recommendations, interactive provider education with feedback, and audit and feedback on the rate of activity restriction recommendations.
The four periods are sequential. The guideline is developed during the pre-deimplementation period, when baseline outcomes are also measured. Most provider education is delivered during the run-in period through interactive educational sessions with feedback, and audit and feedback begins. Audit and feedback continues through the maintenance and post-deimplementation periods. Outcomes are measured in the pre-deimplementation and post-deimplementation periods, and the rate of activity restriction recommendations is tracked continuously through an existing clinical text-messaging platform to support audit and feedback.
Primary outcomes are provider-reported acceptability, appropriateness, and feasibility. Secondary outcomes are the penetration of activity restriction recommendations and patient-reported outcomes. The preterm birth rate is an exploratory outcome. Analyses compare the pre-deimplementation and post-deimplementation periods, with nonresponse weighting and adjustment for patient age, race, parity, and qualifying diagnosis, and a hospital by period interaction for hospital-level estimates.
研究类型
介入性
注册 (估计的)
237
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。
学习联系方式
- 姓名：Beth Pineles, MD, PhD
- 电话号码：267-283-8210
- 邮箱：Beth.Pineles@Pennmedicine.upenn.edu
研究联系人备份
- 姓名：Kelli Jackson
- 邮箱：Kelli.Jackson@PennMedicine.upenn.edu
学习地点
-
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19107
- 招聘中
- Pennsylvania Hospital
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接触：
- Beth L Pineles, MD, PhD
- 邮箱：Beth.Pineles@Pennmedicine.upenn.edu
-
Philadelphia、Pennsylvania、美国、19104
- 招聘中
- Hospital of the University of Pennsylvania
-
接触：
- Beth L Pineles, MD, PhD
- 邮箱：Beth.Pineles@Pennmedicine.upenn.edu
-
-
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
- 成人
- 年长者
接受健康志愿者
是的
描述
Inclusion Criteria:
- For Providers: Physicians, midwives, physician assistants, nurse practitioners, nurses, nursing assistants, medical assistants, and other healthcare staff who provide or participate in prenatal or high-risk pregnancy care or consultation at a participating site.
- For Patients: Secondary patient-reported outcomes draw on pregnant individuals at high risk for preterm birth (qualifying diagnoses include short cervix, cervical insufficiency, multiple gestation, preterm labor, preterm contractions, vaginal bleeding, placental conditions, or a history of prior preterm birth), between 0 and 12 weeks postpartum for the survey measures. The activity restriction recommendation measure is collected through the Take Home Electronic Assessment (THEA) and therefore reaches only patients enrolled in THEA, at 33 weeks of gestation, across all periods; in the pre-deimplementation and post-deimplementation periods the additional survey battery is sent only to patients with a qualifying high-risk diagnosis.
Exclusion Criteria:
- For Providers: Staff who self-exclude by choosing not to interact with deimplementation meetings and communications
- For Patients: Patients are excluded if they are unable to walk or are hospitalized without discharge home before delivery after the qualifying diagnosis is made.
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：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Deimplementation strategy
All participating practices and providers receive the multicomponent deimplementation strategy.
There is a single group and no control arm.
The strategy comprises a locally developed clinical guideline aligning with national recommendations (developed in the pre-deimplementation period), interactive educational sessions with feedback delivered to providers (most delivered in the run-in period), and audit and feedback on the rate of activity restriction recommendations (delivered continuously from the run-in period through the post-deimplementation period).
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A multicomponent strategy to reduce provider-recommended activity restriction and bedrest for preterm birth prevention, comprising development of a local clinical guideline aligned with national recommendations and identification of site champions; interactive educational sessions for providers with feedback; periodic audit and feedback to practices on the rate of activity restriction recommendations; and patient educational materials on safe physical activity in pregnancy that are made available to clinicians, who may choose to share them with patients.
Delivered across the run-in, maintenance, and post-deimplementation periods and linked to the single study arm.
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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 |
|---|---|---|
|
Acceptability of Intervention Measure (AIM)
大体时间：Post-deimplementation period (approximately months 13 to 14)
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Mean provider score on the 4-item AIM, 5-point scale; higher scores indicate greater acceptability of the deimplementation strategy.
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Post-deimplementation period (approximately months 13 to 14)
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Intervention Appropriateness Measure (IAM)
大体时间：Post-deimplementation period (approximately months 13 to 14)
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Mean provider score on the 4-item IAM, 5-point scale; higher scores indicate greater perceived appropriateness.
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Post-deimplementation period (approximately months 13 to 14)
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Feasibility of Intervention Measure (FIM)
大体时间：Post-deimplementation period (approximately months 13 to 14)
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Mean provider score on the 4-item FIM, 5-point scale; higher scores indicate greater perceived feasibility.
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Post-deimplementation period (approximately months 13 to 14)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Penetration of activity restriction recommendations
大体时间：Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)
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Proportion of patients enrolled in THEA who, at 33 weeks, report a provider recommendation for activity restriction or bedrest, measured through the clinical text-messaging platform.
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Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)
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Generalized anxiety (GAD-7)
大体时间：Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)
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Patient score on the GAD-7.
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Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)
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Depressive symptoms (EPDS)
大体时间：Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)
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Patient score on the Edinburgh Postnatal Depression Scale.
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Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)
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Perceived stress (PSS-10)
大体时间：Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)
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Patient score on the Perceived Stress Scale.
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Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)
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Patient and clinician relationship (PDRQ-9)
大体时间：Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)
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Patient score on the Patient Doctor Relationship Questionnaire.
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Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)
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Quality of prenatal care (QPCQ)
大体时间：Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)
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Patient score on the Quality of Prenatal Care Questionnaire across its six subscales.
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Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Preterm birth rate
大体时间：Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)
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Deliveries before 37 weeks divided by total deliveries at the included hospitals; no participant identifiers collected.
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Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)
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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。
调查人员
- 首席研究员：Beth L Pineles, MD, PhD、University of Pennsylvania
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)
2026年7月16日
初级完成 (估计的)
2027年8月31日
研究完成 (估计的)
2027年8月31日
研究注册日期
首次提交
2026年6月30日
首先提交符合 QC 标准的
2026年7月7日
首次发布 (实际的)
2026年7月13日
研究记录更新
最后更新发布 (实际的)
2026年8月10日
上次提交的符合 QC 标准的更新
2026年8月5日
最后验证
2026年7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.