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DE-RESTRICT: Deimplementing Activity Restriction for Preterm Birth Prevention

7 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

237

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

Sì

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Ricerca sui servizi sanitari
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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).
Comportamentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Acceptability of Intervention Measure (AIM)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Penetration of activity restriction recommendations
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Preterm birth rate
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Pennsylvania

Collaboratori

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

Investigatori

  • Investigatore principale: Beth L Pineles, MD, PhD, University of Pennsylvania

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 luglio 2026

Completamento primario (Stimato)

31 agosto 2027

Completamento dello studio (Stimato)

31 agosto 2027

Date di iscrizione allo studio

Primo inviato

30 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

7 luglio 2026

Primo Inserito (Effettivo)

13 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

13 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

7 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 26-6387

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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Malattie rare

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