DE-RESTRICT: Deimplementing Activity Restriction for Preterm Birth Prevention

Conditions

• Activity Restriction
• Bed Rest
• Low-Value Care
• Preterm Birth

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Multicomponent deimplementation strategy — BEHAVIORAL
  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.

Study Details

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.

Key Dates

First listed

Jul 13, 2026

Start date

Jul 1, 2026

Status verified

Jul 2026

Primary completion

Aug 31, 2027

Completion

Aug 31, 2027

Study Design

Enrollment

237 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

HEALTH_SERVICES_RESEARCH

Arms

• 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).

Primary Outcome Measure

Acceptability of Intervention Measure (AIM) [ Time Frame: Post-deimplementation period (approximately months 13 to 14) ]

Central Contacts

• Beth Pineles, MD, PhD
  267-283-8210
  [email protected]
• Kelli Jackson
  [email protected]

Locations (2)

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