DE-RESTRICT: Deimplementing Activity Restriction for Preterm Birth Prevention
2026년 8월 5일 업데이트: 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.
연구 개요
상태
상태
모병
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
중재적
등록 (추정된)
등록
237
단계
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
연구 연락처
- 이름: Beth Pineles, MD, PhD
- 전화번호: 267-283-8210
- 이메일: Beth.Pineles@Pennmedicine.upenn.edu
연구 연락처 백업
- 이름: Kelli Jackson
- 이메일: Kelli.Jackson@PennMedicine.upenn.edu
연구 장소
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, 미국, 19107
- 모병
- Pennsylvania Hospital
-
연락하다:
- Beth L Pineles, MD, PhD
- 이메일: Beth.Pineles@Pennmedicine.upenn.edu
-
Philadelphia, Pennsylvania, 미국, 19104
- 모병
- Hospital of the University of Pennsylvania
-
연락하다:
- Beth L Pineles, MD, PhD
- 이메일: Beth.Pineles@Pennmedicine.upenn.edu
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
예
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
1
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: 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).
|
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Acceptability of Intervention Measure (AIM)
기간: 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)
기간: 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)
기간: 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)
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Penetration of activity restriction recommendations
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
|
기타 결과 측정
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Preterm birth rate
기간: 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)
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
협력자
수사관
수사관
- 수석 연구원: Beth L Pineles, MD, PhD, University of Pennsylvania
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
연구 시작
2026년 7월 16일
기본 완료 (추정된)
기본 완료
2027년 8월 31일
연구 완료 (추정된)
연구 완료
2027년 8월 31일
연구 등록 날짜
최초 제출
최초 제출
2026년 6월 30일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2026년 7월 7일
처음 게시됨 (실제)
처음 게시됨
2026년 7월 13일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2026년 8월 10일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 5일
마지막으로 확인됨
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- 26-6387
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .