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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (推定)
237
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Beth Pineles, MD, PhD
- 電話番号：267-283-8210
- メール：Beth.Pineles@Pennmedicine.upenn.edu
研究連絡先のバックアップ
- 名前：Kelli Jackson
- メール：Kelli.Jackson@PennMedicine.upenn.edu
研究場所
-
-
Pennsylvania
-
Philadelphia、Pennsylvania、アメリカ、19107
- 募集
- Pennsylvania Hospital
-
コンタクト：
- Beth L Pineles, MD, PhD
- メール：Beth.Pineles@Pennmedicine.upenn.edu
-
Philadelphia、Pennsylvania、アメリカ、19104
- 募集
- Hospital of the University of Pennsylvania
-
コンタクト：
- Beth L Pineles, MD, PhD
- メール：Beth.Pineles@Pennmedicine.upenn.edu
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
はい
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：ヘルスサービス研究
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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).
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Acceptability of Intervention Measure (AIM)
時間枠：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.
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Post-deimplementation period (approximately months 13 to 14)
|
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Intervention Appropriateness Measure (IAM)
時間枠：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.
|
Post-deimplementation period (approximately months 13 to 14)
|
|
Feasibility of Intervention Measure (FIM)
時間枠：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.
|
Post-deimplementation period (approximately months 13 to 14)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Penetration of activity restriction recommendations
時間枠：Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)
|
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)
時間枠：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)
時間枠：Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)
|
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)
|
|
Perceived stress (PSS-10)
時間枠：Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)
|
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)
時間枠：Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)
|
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)
時間枠：Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)
|
Patient score on the Quality of Prenatal Care Questionnaire across its six subscales.
|
Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Preterm birth rate
時間枠：Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)
|
Deliveries before 37 weeks divided by total deliveries at the included hospitals; no participant identifiers collected.
|
Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Beth L Pineles, MD, PhD、University of Pennsylvania
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年7月16日
一次修了 (推定)
2027年8月31日
研究の完了 (推定)
2027年8月31日
試験登録日
最初に提出
2026年6月30日
QC基準を満たした最初の提出物
2026年7月7日
最初の投稿 (実際)
2026年7月13日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月10日
QC基準を満たした最後の更新が送信されました
2026年8月5日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- 26-6387
個々の参加者データ (IPD) の計画
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いいえ
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