Feasibility of Immediate Postpartum Long-acting Reversible Contraception Implementation

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy Related
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 592

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Michigan Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient experience of care	Patient online surveys about their experience of care during prenatal visits, hospital stay, or postpartum office visit	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	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	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	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	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of implementation toolkit items - patients	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
Appropriateness of implementation toolkit items - patients	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	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	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	Proportion of delivered patients with documentation of prenatal counseling about postpartum contraception	Measured monthly, up to 24 months after toolkit implementation
Immediate postpartum LARC provision rate	Proportion of delivered patients with documentation of preference for immediate postpartum LARC who receive a LARC device	Measured monthly, up to 24 months after toolkit implementation

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: 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 record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Actual): August 16, 2020
• Study Completion (Actual): August 16, 2020

Study Registration Dates

• First Submitted: November 20, 2018
• First Submitted That Met QC Criteria: December 11, 2018
• First Posted (Actual): December 13, 2018

Study Record Updates

• Last Update Posted (Actual): February 12, 2021
• Last Update Submitted That Met QC Criteria: February 11, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: contraception; postpartum; feasibility; implementation; long-acting reversible contraception; toolkit
• Other Study ID Numbers: HUM00126810

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No