Clinical trial NCT03774797: Feasibility of Immediate Postpartum Long-acting Reversible Contraception Implementation
Official title: Immediate Postpartum LARC Implementation: Pilot Study at Michigan Medicine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy Related
Keywords: contraception
long-acting reversible contraception
postpartum
toolkit
implementation
feasibility
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2018-12-13
Enrollment: 592
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Patient experience of care
timeFrame: Surveys will be collected from pregnant or postpartum women, during the 6-12 months after implementation of a new protocol for peripartum contraceptive care
measure: Acceptability of care process - patients
timeFrame: Surveys will be collected from pregnant or postpartum women, during the 6-12 months after implementation of a new protocol for peripartum contraceptive care
measure: Appropriateness of care process - patients
timeFrame: Surveys will be collected from pregnant or postpartum women, during the 6-12 months after implementation of a new protocol for peripartum contraceptive care
measure: Acceptability of implementation process - study site maternity care providers
timeFrame: Surveys will be collected during the 6-12 months after implementation of a new protocol for peripartum contraceptive care
measure: Appropriateness of implementation process - study site maternity care providers
timeFrame: Surveys will be collected during the 6-12 months after implementation of a new protocol for peripartum contraceptive care
Secondary outcomes:
measure: Acceptability of implementation toolkit items - patients
timeFrame: Interviews will take place after the survey is completed, during the 6-18 months after implementation of a new protocol for peripartum contraceptive care
measure: Appropriateness of implementation toolkit items - patients
timeFrame: Interviews will take place after the survey is completed, during the 6-18 months after implementation of a new protocol for peripartum contraceptive care
measure: Acceptability of implementation toolkit items - providers
timeFrame: Interviews will take place after the survey is completed, during the 6-18 months after implementation of a new protocol for peripartum contraceptive care
measure: Appropriateness of implementation toolkit items - providers
timeFrame: Interviews will take place after the survey is completed, during the 6-18 months after implementation of a new protocol for peripartum contraceptive care
measure: Perinatal contraceptive counseling rate
timeFrame: Measured monthly, up to 24 months after toolkit implementation
measure: Immediate postpartum LARC provision rate
timeFrame: Measured monthly, up to 24 months after toolkit implementation
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Michigan Medicine
state: Michigan
Study officials:
affiliation: University of Michigan
name: Michelle H. Moniz, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Vanessa K. Dalton, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Michelle Heisler, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: