- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03774797
Feasibility of Immediate Postpartum Long-acting Reversible Contraception Implementation
11. februar 2021 oppdatert 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.
Studieoversikt
Detaljert beskrivelse
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.
Studietype
Observasjonsmessig
Registrering (Faktiske)
592
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Michigan
-
Ann Arbor, Michigan, Forente stater, 48109
- Michigan Medicine
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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.
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / 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.
|
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.
|
Post-implementation patients and providers will be assessed after the implementation toolkit has been used to improve service delivery at the study site.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Patient experience of care
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Acceptability of implementation toolkit items - patients
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Michelle H. Moniz, MD, MSc, University of Michigan
- Hovedetterforsker: Vanessa K. Dalton, MD, MPH, University of Michigan
- Hovedetterforsker: Michelle Heisler, MD, MPH, University of Michigan
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. september 2018
Primær fullføring (Faktiske)
16. august 2020
Studiet fullført (Faktiske)
16. august 2020
Datoer for studieregistrering
Først innsendt
20. november 2018
Først innsendt som oppfylte QC-kriteriene
11. desember 2018
Først lagt ut (Faktiske)
13. desember 2018
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
12. februar 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
11. februar 2021
Sist bekreftet
1. februar 2021
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- HUM00126810
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Graviditetsrelatert
-
King's College Hospital NHS TrustEuropean Association for the Study of the LiverRekrutteringSkrumplever, lever | HELLP syndrom | Intrahepatisk kolestase ved graviditet | Graviditetssykdom | AFLP - Acute Fatty Liver of PregnancyStorbritannia
Kliniske studier på Implementation Toolkit
-
Harvard School of Public Health (HSPH)Beacon Communities; The Community BuildersPåmelding etter invitasjonTobakksbruk | Tobakksrøyking | Tobakksbruksforstyrrelse | Opphør av tobakksbruk | Brukt tobakksrøykForente stater
-
University of MichiganFullførtKvinner med BRCA 1 eller BRCA 2 mutasjon | Ikke-testede kvinnelige familiemedlemmerForente stater
-
University of WashingtonFullført
-
Boise State UniversityU.S. Department of JusticeFullførtProblematferdForente stater
-
University of TorontoUniversity Health Network, Toronto; Sunnybrook Health Sciences Centre; McMaster... og andre samarbeidspartnereFullført
-
Yale UniversityNational Institutes of Health (NIH); National Institute on Aging (NIA); Trinity...Fullført
-
University of MichiganThe Craig H. Neilsen FoundationRekrutteringRyggmargsskaderForente stater
-
Nemours Children's ClinicNational Institute of General Medical Sciences (NIGMS)Aktiv, ikke rekrutterendeMedfødt hjertesykdomForente stater
-
Portland State UniversityOregon Health and Science University; Kaiser PermanenteFullførtAutismespektrumforstyrrelseForente stater
-
Julia BlanchetteThe Leona M. and Harry B. Helmsley Charitable TrustHar ikke rekruttert ennåType 1 diabetesForente stater