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.
調査の概要
詳細な説明
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.
研究の種類
観察的
入学 (実際)
592
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Michigan
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Ann Arbor、Michigan、アメリカ、48109
- Michigan Medicine
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
サンプリング方法
非確率サンプル
調査対象母集団
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.
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Patient experience of care
時間枠：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
時間枠：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
|
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Appropriateness of care process - patients
時間枠：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
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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 implementation process - study site maternity care providers
時間枠：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
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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
時間枠：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
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Surveys will be collected during the 6-12 months after implementation of a new protocol for peripartum contraceptive care
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Acceptability of implementation toolkit items - patients
時間枠：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
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Appropriateness of implementation toolkit items - patients
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Michelle H. Moniz, MD, MSc、University of Michigan
- 主任研究者：Vanessa K. Dalton, MD, MPH、University of Michigan
- 主任研究者：Michelle Heisler, MD, MPH、University of Michigan
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2018年9月1日
一次修了 (実際)
2020年8月16日
研究の完了 (実際)
2020年8月16日
試験登録日
最初に提出
2018年11月20日
QC基準を満たした最初の提出物
2018年12月11日
最初の投稿 (実際)
2018年12月13日
学習記録の更新
投稿された最後の更新 (実際)
2021年2月12日
QC基準を満たした最後の更新が送信されました
2021年2月11日
最終確認日
2021年2月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Implementation Toolkitの臨床試験
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University of BaselNational Cancer Center, Korea; University Hospital, Geneva; Swiss National Science Foundation; University... と他の協力者募集
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University of MichiganThe Craig H. Neilsen Foundation積極的、募集していない
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Training and Implementation Associates募集従来の対面トレーニング | 家族療法のトレーニングと実装プラットフォーム (FTTIP)アメリカ