Feasibility of Immediate Postpartum Long-acting Reversible Contraception Implementation

Sponsor
University of Michigan (Other)
Overall Status
Completed
CT.gov ID
NCT03774797
Collaborator
Agency for Healthcare Research and Quality (AHRQ) (U.S. Fed)
592
1
23.5
25.2

Study Details

Study Description

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 Phase
  • 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.

Study Design

Study Type:
Observational
Actual Enrollment :
592 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
Immediate Postpartum LARC Implementation: Pilot Study at Michigan Medicine
Actual Study Start Date :
Sep 1, 2018
Actual Primary Completion Date :
Aug 16, 2020
Actual Study Completion Date :
Aug 16, 2020

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Patient experience of care [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Michigan Medicine Ann Arbor Michigan United States 48109

Sponsors and Collaborators

  • University of Michigan
  • Agency for Healthcare Research and Quality (AHRQ)

Investigators

  • 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Michelle H. Moniz, Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier:
NCT03774797
Other Study ID Numbers:
  • HUM00126810
First Posted:
Dec 13, 2018
Last Update Posted:
Feb 12, 2021
Last Verified:
Feb 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Michelle H. Moniz, Assistant Professor, University of Michigan

Study Results

No Results Posted as of Feb 12, 2021