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DE-RESTRICT: Deimplementing Activity Restriction for Preterm Birth Prevention

5. August 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

237

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Versorgungsforschung
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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).
Verhalten: 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 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Acceptability of Intervention Measure (AIM)
Zeitfenster: 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.
Post-deimplementation period (approximately months 13 to 14)
Intervention Appropriateness Measure (IAM)
Zeitfenster: 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)
Zeitfenster: 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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Penetration of activity restriction recommendations
Zeitfenster: 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.
Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)
Generalized anxiety (GAD-7)
Zeitfenster: Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)
Patient score on the GAD-7.
Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)
Depressive symptoms (EPDS)
Zeitfenster: Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)
Patient score on the Edinburgh Postnatal Depression Scale.
Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)
Perceived stress (PSS-10)
Zeitfenster: Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)
Patient score on the Perceived Stress Scale.
Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)
Patient and clinician relationship (PDRQ-9)
Zeitfenster: Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)
Patient score on the Patient Doctor Relationship Questionnaire.
Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)
Quality of prenatal care (QPCQ)
Zeitfenster: 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)

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Preterm birth rate
Zeitfenster: 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)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Pennsylvania

Mitarbeiter

American Association of Obstetricians and Gynecologists Foundation (AAOGF)
Foundation for SMFM

Ermittler

  • Hauptermittler: Beth L Pineles, MD, PhD, University of Pennsylvania

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

16. Juli 2026

Primärer Abschluss (Geschätzt)

31. August 2027

Studienabschluss (Geschätzt)

31. August 2027

Studienanmeldedaten

Zuerst eingereicht

30. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

7. Juli 2026

Zuerst gepostet (Tatsächlich)

13. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

10. August 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

5. August 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 26-6387

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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

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