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Feasibility of Immediate Postpartum Long-acting Reversible Contraception Implementation

11 februari 2021 uppdaterad av: Michelle H. Moniz, University of Michigan

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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Faktisk)

592

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Michigan
      • Ann Arbor, Michigan, Förenta staterna, 48109
        • Michigan Medicine

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
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.
Övrig: 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.
Övrig: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Patient experience of care
Tidsram: 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
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
Tidsram: 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
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
Tidsram: 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
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
Tidsram: 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
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
Tidsram: 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
Surveys will be collected during the 6-12 months after implementation of a new protocol for peripartum contraceptive care

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Acceptability of implementation toolkit items - patients
Tidsram: 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
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
Tidsram: 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
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
Tidsram: 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
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
Tidsram: 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
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
Tidsram: Measured monthly, up to 24 months after toolkit implementation
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
Tidsram: 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
Measured monthly, up to 24 months after toolkit implementation

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of Michigan

Samarbetspartners

Agency for Healthcare Research and Quality (AHRQ)

Utredare

  • Huvudutredare: Michelle H. Moniz, MD, MSc, University of Michigan
  • Huvudutredare: Vanessa K. Dalton, MD, MPH, University of Michigan
  • Huvudutredare: Michelle Heisler, MD, MPH, University of Michigan

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 september 2018

Primärt slutförande (Faktisk)

16 augusti 2020

Avslutad studie (Faktisk)

16 augusti 2020

Studieregistreringsdatum

Först inskickad

20 november 2018

Först inskickad som uppfyllde QC-kriterierna

11 december 2018

Första postat (Faktisk)

13 december 2018

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

12 februari 2021

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

11 februari 2021

Senast verifierad

1 februari 2021

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

  • HUM00126810

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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