Feasibility of Immediate Postpartum Long-acting Reversible Contraception Implementation
2021년 2월 11일 업데이트: Michelle H. Moniz, University of Michigan
Immediate Postpartum LARC Implementation: Pilot Study at Michigan Medicine
The objective of this study is to test and disseminate tools that drive successful immediate postpartum Long-Acting Reversible Contraception (LARC) implementation.
The long-term goal is to reduce unintended pregnancy soon after childbirth by increasing access to immediate postpartum LARC for women who desire it.
연구 개요
상세 설명
Based on previous work, the investigators have generated a toolkit to guide the integration of immediate postpartum LARC services into widespread clinical practice.
In the proposed work, this toolkit will be used to initiate immediate postpartum LARC services in a single site with low baseline immediate postpartum LARC uptake (Michigan Medicine).
The investigators will conduct a feasibility study using mixed methods to assess acceptability and appropriateness of toolkit items; patient experience of care; immediate postpartum LARC utilization rate; and prenatal contraceptive counseling rate.
연구 유형
관찰
등록 (실제)
592
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Michigan
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Ann Arbor, Michigan, 미국, 48109
- Michigan Medicine
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
샘플링 방법
비확률 샘플
연구 인구
Study population includes women receiving prenatal care and maternity providers working at the study site.
The patient populations includes approximately 5000 women annually.
The provider population includes approximately 400 maternity providers.
설명
Inclusion Criteria:
- Female (patients)
- Pregnant (patients)
- Receiving obstetrical care at Michigan Medicine (patients)
- L&D provider at Michigan Medicine (providers)
Exclusion Criteria:
- non-English speaking
- unable to provide informed consent
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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Pre-Implementation Patients
Enrolled patients will take online surveys following a prenatal or a postpartum visit.
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Post-Implementation Patients
All enrolled patients will take online surveys following a prenatal or a postpartum visit.
A subset will be interviewed after the postpartum survey.
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Post-implementation patients and providers will be assessed after the implementation toolkit has been used to improve service delivery at the study site.
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Post-Implementation Providers
All enrolled providers will take online surveys at 6-12 months after program implementation, and a subset will be interviewed.
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Post-implementation patients and providers will be assessed after the implementation toolkit has been used to improve service delivery at the study site.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Patient experience of care
기간: Surveys will be collected from pregnant or postpartum women, during the 6-12 months after implementation of a new protocol for peripartum contraceptive care
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Patient online surveys about their experience of care during prenatal visits, hospital stay, or postpartum office visit
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Surveys will be collected from pregnant or postpartum women, during the 6-12 months after implementation of a new protocol for peripartum contraceptive care
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Acceptability of care process - patients
기간: Surveys will be collected from pregnant or postpartum women, during the 6-12 months after implementation of a new protocol for peripartum contraceptive care
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Online survey assessing experience of care, acceptability and appropriateness of implementation tools
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Surveys will be collected from pregnant or postpartum women, during the 6-12 months after implementation of a new protocol for peripartum contraceptive care
|
|
Appropriateness of care process - patients
기간: Surveys will be collected from pregnant or postpartum women, during the 6-12 months after implementation of a new protocol for peripartum contraceptive care
|
Online survey assessing experience of care, acceptability and appropriateness of implementation tools
|
Surveys will be collected from pregnant or postpartum women, during the 6-12 months after implementation of a new protocol for peripartum contraceptive care
|
|
Acceptability of implementation process - study site maternity care providers
기간: Surveys will be collected during the 6-12 months after implementation of a new protocol for peripartum contraceptive care
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Online survey assessing overall experience of care delivery, acceptability and appropriateness of implementation tools
|
Surveys will be collected during the 6-12 months after implementation of a new protocol for peripartum contraceptive care
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|
Appropriateness of implementation process - study site maternity care providers
기간: Surveys will be collected during the 6-12 months after implementation of a new protocol for peripartum contraceptive care
|
Online survey assessing overall experience of care delivery, acceptability and appropriateness of implementation tools
|
Surveys will be collected during the 6-12 months after implementation of a new protocol for peripartum contraceptive care
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Acceptability of implementation toolkit items - patients
기간: Interviews will take place after the survey is completed, during the 6-18 months after implementation of a new protocol for peripartum contraceptive care
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30-minute follow-up in-person interview of subgroup of patients who completed surveys
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Interviews will take place after the survey is completed, during the 6-18 months after implementation of a new protocol for peripartum contraceptive care
|
|
Appropriateness of implementation toolkit items - patients
기간: Interviews will take place after the survey is completed, during the 6-18 months after implementation of a new protocol for peripartum contraceptive care
|
30-minute follow-up in-person interview of subgroup of patients who completed surveys
|
Interviews will take place after the survey is completed, during the 6-18 months after implementation of a new protocol for peripartum contraceptive care
|
|
Acceptability of implementation toolkit items - providers
기간: Interviews will take place after the survey is completed, during the 6-18 months after implementation of a new protocol for peripartum contraceptive care
|
30-minute follow-up in-person interview of subgroup of providers who completed survey
|
Interviews will take place after the survey is completed, during the 6-18 months after implementation of a new protocol for peripartum contraceptive care
|
|
Appropriateness of implementation toolkit items - providers
기간: Interviews will take place after the survey is completed, during the 6-18 months after implementation of a new protocol for peripartum contraceptive care
|
30-minute follow-up in-person interview of subgroup of providers who completed survey
|
Interviews will take place after the survey is completed, during the 6-18 months after implementation of a new protocol for peripartum contraceptive care
|
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Perinatal contraceptive counseling rate
기간: Measured monthly, up to 24 months after toolkit implementation
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Proportion of delivered patients with documentation of prenatal counseling about postpartum contraception
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Measured monthly, up to 24 months after toolkit implementation
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Immediate postpartum LARC provision rate
기간: Measured monthly, up to 24 months after toolkit implementation
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Proportion of delivered patients with documentation of preference for immediate postpartum LARC who receive a LARC device
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Measured monthly, up to 24 months after toolkit implementation
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Michelle H. Moniz, MD, MSc, University of Michigan
- 수석 연구원: Vanessa K. Dalton, MD, MPH, University of Michigan
- 수석 연구원: Michelle Heisler, MD, MPH, University of Michigan
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)
2018년 9월 1일
기본 완료 (실제)
2020년 8월 16일
연구 완료 (실제)
2020년 8월 16일
연구 등록 날짜
최초 제출
2018년 11월 20일
QC 기준을 충족하는 최초 제출
2018년 12월 11일
처음 게시됨 (실제)
2018년 12월 13일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 2월 12일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 2월 11일
마지막으로 확인됨
2021년 2월 1일
추가 정보
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. .