Feasibility of Immediate Postpartum Long-acting Reversible Contraception Implementation

NCT03774797 | Completed

• 1 other identifier: HUM00126810
• Study Type: observational
• Target: 592
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Related

Keywords

contraception; long-acting reversible contraception; postpartum; toolkit; implementation; feasibility

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (6)

• 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

• 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

• 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

• 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

• Perinatal contraceptive counseling rate

  Measured monthly, up to 24 months after toolkit implementation

Study Arms (3)

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 Providers

All enrolled providers will take online surveys at 6-12 months after program implementation, and a subset will be interviewed.

Other: Implementation Toolkit

Interventions

Implementation Toolkit OTHER

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 Patients; Post-Implementation Providers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Female (patients)
• Pregnant (patients)
• Receiving obstetrical care at Michigan Medicine (patients)
• L\&D provider at Michigan Medicine (providers)

You may not qualify if:

• non-English speaking
• unable to provide informed consent

Sponsors & Collaborators

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

Study Sites (1)

Michigan Medicine

Ann Arbor, Michigan, 48109, United States

Location

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 20, 2018
• First Posted: December 13, 2018
• Study Start: September 1, 2018
• Primary Completion: August 16, 2020
• Study Completion: August 16, 2020
• Last Updated: February 12, 2021

Record last verified: 2021-02

Locations

US (1)