Feasibility of Immediate Postpartum Long-acting Reversible Contraception Implementation

Completed

• Conditions: Pregnancy Related
• Interventions: Other: Implementation Toolkit

• Registration Number: NCT03774797
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2018-09-01
• Study First Submitted: 2018-11-20
• Study First Submitted QC: 2018-12-11
• Study First Posted: 2018-12-13
• Primary Completion: 2020-08-16
• Study Completion: 2020-08-16
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-11
• Last Update Posted: 2021-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 592

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Post-Implementation Providers	Implementation Toolkit	All enrolled providers will take online surveys at 6-12 months after program implementation, and a subset will be interviewed.
Post-Implementation Patients	Implementation Toolkit	All enrolled patients will take online surveys following a prenatal or a postpartum visit. A subset will be interviewed after the postpartum survey.

Primary Outcome Measures

Name	Time	Method
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
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
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
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
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

Secondary Outcome Measures

Name	Time	Method
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
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
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
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
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
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

Trial Locations

Locations (1)

Michigan Medicine; 🇺🇸 Ann Arbor, Michigan, United States