Pregnancy RelatedNCT03774797
Feasibility of Immediate Postpartum Long-acting Reversible Contraception Implementation
An observational study of Pregnancy Related, run by University of Michigan at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- Implementation Toolkit
- How many people
- 592 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2018to 16 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Female (patients)
- Pregnant (patients)
- Receiving obstetrical care at Michigan Medicine (patients)
- L\&D provider at Michigan Medicine (providers)
Who cannot join
- non-English speaking
- unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pregnancy Related
- Being tested
- Implementation Toolkit
- Keywords
- contraception, long-acting reversible contraception, postpartum, toolkit, implementation, feasibility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation ToolkitOther
Post-implementation patients and providers will be assessed after the implementation toolkit has been used to improve service delivery at the study site.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Implementation Toolkit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient experience of care
Patient online surveys about their experience of care during prenatal visits, hospital stay, or postpartum office visit
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
30-minute follow-up in-person interview of subgroup of patients who completed surveys
Measured: 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
Measured: 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
Measured: 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
Measured: 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: 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: Measured monthly, up to 24 months after toolkit implementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2018
- Study start1 Sep 2018
- Primary completion16 Aug 2020
- Study completion16 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 592 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Michelle H. Moniz, University of Michigan
- Investigators
- Michelle H. Moniz, MD, MSc, Principal investigator, University of MichiganVanessa K. Dalton, MD, MPH, Principal investigator, University of MichiganMichelle Heisler, MD, MPH, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03774797
- Sponsor's protocol ID
- HUM00126810
- Status last verified
- Feb 2021
- First submitted
- 20 Nov 2018
- Last updated
- 12 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Postpartum LARC Implementation: Pilot Study at Michigan Medicine
- ClinicalTrials.gov ID
- NCT03774797
- Acronym / sponsor ID
- HUM00126810
- Conditions
- Pregnancy Related
- Keywords
- contraception, long-acting reversible contraception, postpartum, toolkit, implementation, feasibility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 592 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 16 Aug 2020 (actual)
- Study completion
- 16 Aug 2020 (actual)
- First posted
- 13 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pre-Implementation Patients | – | –Enrolled patients will take online surveys following a prenatal or a postpartum visit. |
| Post-Implementation Patients | – | Other: Implementation ToolkitAll enrolled patients will take online surveys following a prenatal or a postpartum visit. A subset will be interviewed after the postpartum survey. |
| Post-Implementation Providers | – | Other: Implementation ToolkitAll enrolled providers will take online surveys at 6-12 months after program implementation, and a subset will be interviewed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Female (patients)
- Pregnant (patients)
- Receiving obstetrical care at Michigan Medicine (patients)
- L\&D provider at Michigan Medicine (providers)
Key exclusion criteria (2 listed)
- non-English speaking
- unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implementation ToolkitPost-implementation patients and providers will be assessed after the implementation toolkit has been used to improve service delivery at the study site. | Other | Post-Implementation Patients, Post-Implementation Providers |
Primary outcome
Patient experience of care
Time frame: 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 care process - patients
Time frame: 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
Appropriateness of care process - patients
Time frame: 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 implementation process - study site maternity care providers
Time frame: 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
Time frame: 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
6 secondary outcomes
Acceptability of implementation toolkit items - patients
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Measured monthly, up to 24 months after toolkit implementation
Immediate postpartum LARC provision rate
Time frame: Measured monthly, up to 24 months after toolkit implementation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle H. Moniz, MD, MSc principal investigator
University of Michigan
Vanessa K. Dalton, MD, MPH principal investigator
University of Michigan
Michelle Heisler, MD, MPH principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Related, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient experience of care (time frame: Surveys will be collected from pregnant or postpartum women, during the 6-12 months after implementation of a new protocol for peripartum contraceptive care). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2021.