Feasibility of Immediate Postpartum Long-acting Reversible Contraception Implementation
2021年2月11日 更新者：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.
研究概览
详细说明
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.
研究类型
观察性的
注册 (实际的)
592
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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Michigan
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Ann Arbor、Michigan、美国、48109
- Michigan Medicine
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
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.
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
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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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Patient experience of care
大体时间：Surveys will be collected from pregnant or postpartum women, during the 6-12 months after implementation of a new protocol for peripartum contraceptive care
|
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
|
|
Acceptability of care process - patients
大体时间：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
|
|
Appropriateness of care process - patients
大体时间：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
大体时间：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
|
|
Appropriateness of implementation process - study site maternity care providers
大体时间：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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Acceptability of implementation toolkit items - patients
大体时间：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
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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
大体时间：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
大体时间：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
大体时间：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
|
|
Perinatal contraceptive counseling rate
大体时间：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
大体时间：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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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Michelle H. Moniz, MD, MSc、University of Michigan
- 首席研究员：Vanessa K. Dalton, MD, MPH、University of Michigan
- 首席研究员：Michelle Heisler, MD, MPH、University of Michigan
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2018年9月1日
初级完成 (实际的)
2020年8月16日
研究完成 (实际的)
2020年8月16日
研究注册日期
首次提交
2018年11月20日
首先提交符合 QC 标准的
2018年12月11日
首次发布 (实际的)
2018年12月13日
研究记录更新
最后更新发布 (实际的)
2021年2月12日
上次提交的符合 QC 标准的更新
2021年2月11日
最后验证
2021年2月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.