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Feasibility of Immediate Postpartum Long-acting Reversible Contraception Implementation

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ClinicalTrials.gov Identifier: NCT03774797
Recruitment Status : Enrolling by invitation
First Posted : December 13, 2018
Last Update Posted : September 4, 2019
Sponsor:
Collaborator:
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
Michelle H. Moniz, University of Michigan

Brief Summary:
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.

Condition or disease Intervention/treatment
Pregnancy Related Other: Implementation Toolkit

Detailed Description:
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.

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Study Type : Observational
Estimated Enrollment : 1200 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Immediate Postpartum LARC Implementation: Pilot Study at Michigan Medicine
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Pre-Implementation Patients
Enrolled patients will take online surveys following a prenatal or a postpartum visit.
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.
Other: Implementation Toolkit
Post-implementation patients and providers will be assessed after the implementation toolkit has been used to improve service delivery at the study site.

Post-Implementation Providers
All enrolled providers will take online surveys at 6-12 months after program implementation, and a subset will be interviewed.
Other: Implementation Toolkit
Post-implementation patients and providers will be assessed after the implementation toolkit has been used to improve service delivery at the study site.




Primary Outcome Measures :
  1. Patient experience of care [ Time Frame: 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

  2. Acceptability of care process - patients [ Time Frame: 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

  3. Appropriateness of care process - patients [ Time Frame: 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

  4. Acceptability of implementation process - study site maternity care providers [ Time Frame: 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

  5. Appropriateness of implementation process - study site maternity care providers [ Time Frame: 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


Secondary Outcome Measures :
  1. Acceptability of implementation toolkit items - patients [ Time Frame: 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

  2. Appropriateness of implementation toolkit items - patients [ Time Frame: 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

  3. Acceptability of implementation toolkit items - providers [ Time Frame: 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

  4. Appropriateness of implementation toolkit items - providers [ Time Frame: 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

  5. Perinatal contraceptive counseling rate [ Time Frame: Measured monthly, up to 24 months after toolkit implementation ]
    Proportion of delivered patients with documentation of prenatal counseling about postpartum contraception

  6. Immediate postpartum LARC provision rate [ Time Frame: Measured monthly, up to 24 months after toolkit implementation ]
    Proportion of delivered patients with documentation of preference for immediate postpartum LARC who receive a LARC device



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03774797


Locations
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United States, Michigan
Michigan Medicine
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Agency for Healthcare Research and Quality (AHRQ)
Investigators
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Principal Investigator: Michelle H. Moniz, MD, MSc University of Michigan
Principal Investigator: Vanessa K. Dalton, MD, MPH University of Michigan
Principal Investigator: Michelle Heisler, MD, MPH University of Michigan

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Responsible Party: Michelle H. Moniz, Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT03774797     History of Changes
Other Study ID Numbers: HUM00126810
First Posted: December 13, 2018    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Michelle H. Moniz, University of Michigan:
contraception
long-acting reversible contraception
postpartum
toolkit
implementation
feasibility