Feasibility of Immediate Postpartum Long-acting Reversible Contraception Implementation

Pregnancy Related Clinical Trial

Official title:

Immediate Postpartum LARC Implementation: Pilot Study at Michigan Medicine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03774797
• Other study ID #: HUM00126810
• Status: Completed
• Start date: September 1, 2018
• Est. completion date: August 16, 2020

Study information

• Verified date: February 2021
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 592
• Est. completion date: August 16, 2020
• Est. primary completion date: August 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy Related

Intervention

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.

Locations

Country	Name	City	State
United States	Michigan Medicine	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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