DE-RESTRICT: Deimplementing Activity Restriction for Preterm Birth Prevention

ConditionsPreterm Birth Activity Restriction Bed Rest Low-Value Care

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity of Pennsylvania

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

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.

Treatment groups

237 Participants

are divided into 1 treatment group

Group A: Deimplementation strategyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Acceptability of Intervention Measure (AIM)

Mean provider score on the 4-item AIM, 5-point scale; higher scores indicate greater acceptability of the deimplementation strategy.

Time frame

Post-deimplementation period (approximately months 13 to 14)

Intervention Appropriateness Measure (IAM)

Mean provider score on the 4-item IAM, 5-point scale; higher scores indicate greater perceived appropriateness.

Time frame

Post-deimplementation period (approximately months 13 to 14)

Feasibility of Intervention Measure (FIM)

Mean provider score on the 4-item FIM, 5-point scale; higher scores indicate greater perceived feasibility.

Time frame

Post-deimplementation period (approximately months 13 to 14)

Secondary outcomes

Penetration of activity restriction recommendations

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.

Time frame