Deimplementation of Activity Restriction for Preterm Birth Prevention in High-Risk Pregnancy (DE-RESTRICT): A Pilot Single-Arm Hybrid Effectiveness-Deimplementation Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 237
- 试验地点
- 2
- 主要终点
- Acceptability of Intervention Measure (AIM)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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).
干预措施: Multicomponent deimplementation strategy (Behavioral)
结局指标
主要结局
Acceptability of Intervention Measure (AIM)
时间窗: Post-deimplementation period (approximately months 13 to 14)
Mean provider score on the 4-item AIM, 5-point scale; higher scores indicate greater acceptability of the deimplementation strategy.
Intervention Appropriateness Measure (IAM)
时间窗: Post-deimplementation period (approximately months 13 to 14)
Mean provider score on the 4-item IAM, 5-point scale; higher scores indicate greater perceived appropriateness.
Feasibility of Intervention Measure (FIM)
时间窗: Post-deimplementation period (approximately months 13 to 14)
Mean provider score on the 4-item FIM, 5-point scale; higher scores indicate greater perceived feasibility.
次要结局
- Penetration of activity restriction recommendations(Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14))
- Generalized anxiety (GAD-7)(Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14))
- Depressive symptoms (EPDS)(Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14))
- Perceived stress (PSS-10)(Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14))
- Patient and clinician relationship (PDRQ-9)(Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14))
- Quality of prenatal care (QPCQ)(Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14))
研究者
Beth Pineles
Assistant Professor of Obstetrics & Gynecology and Epidemiology
University of Pennsylvania