DE-RESTRICT: Deimplementing Activity Restriction for Preterm Birth Prevention

Официальное название

Deimplementation of Activity Restriction for Preterm Birth Prevention in High-Risk Pregnancy (DE-RESTRICT): A Pilot Single-Arm Hybrid Effectiveness-Deimplementation Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Multicomponent deimplementation strategy
  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 availabl

Первичные конечные точки

• Acceptability of Intervention Measure (AIM) [Срок оценки: Post-deimplementation period (approximately months 13 to 14)]
• Intervention Appropriateness Measure (IAM) [Срок оценки: Post-deimplementation period (approximately months 13 to 14)]
• Feasibility of Intervention Measure (FIM) [Срок оценки: Post-deimplementation period (approximately months 13 to 14)]

Вторичные конечные точки (6)

• Penetration of activity restriction recommendations [Срок оценки: Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)]
• Generalized anxiety (GAD-7) [Срок оценки: Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)]
• Depressive symptoms (EPDS) [Срок оценки: Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)]
• Perceived stress (PSS-10) [Срок оценки: Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)]
• Patient and clinician relationship (PDRQ-9) [Срок оценки: Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)]
• Quality of prenatal care (QPCQ) [Срок оценки: Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

США · 2 центра

• Hospital of the University of Pennsylvania — Philadelphia
• Pennsylvania Hospital — Philadelphia

Идентификаторы

NCT: NCT07698483 · 26-6387

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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