Activity Restriction, Bed Rest, Low-Value Care, Preterm Birth
Conditions
Keywords
deimplementation, low-value care, activity restriction, bedrest, preterm birth, audit and feedback, implementation science, hybrid trial
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALMulticomponent 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.
Sponsors
University of Pennsylvania
Foundation for SMFM
American Association of Obstetricians and Gynecologists Foundation (AAOGF)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of Intervention Measure (AIM) | 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. |
| Intervention Appropriateness Measure (IAM) | 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. |
| Feasibility of Intervention Measure (FIM) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Penetration of activity restriction recommendations | 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. |
| Generalized anxiety (GAD-7) | Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14) | Patient score on the GAD-7. |
| Depressive symptoms (EPDS) | Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14) | Patient score on the Edinburgh Postnatal Depression Scale. |
| Perceived stress (PSS-10) | Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14) | Patient score on the Perceived Stress Scale. |
| Patient and clinician relationship (PDRQ-9) | Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14) | Patient score on the Patient Doctor Relationship Questionnaire. |
| Quality of prenatal care (QPCQ) | 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. |
Countries
United States
Contacts
CONTACTBeth Pineles, MD, PhD
CONTACTKelli Jackson
PRINCIPAL_INVESTIGATORBeth L Pineles, MD, PhD
University of Pennsylvania
Outcome results
None listed