- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04448015
Perinatal Care and Medication Assisted Treatment: Carbon/Emery Counties
9. november 2020 opdateret af: Jerry Cochran, University of Utah
The purpose of this study is to enhance perinatal opioid use disorder (OUD) treatment in a rural setting by developing an evaluated curriculum of perinatal OUD provider education.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The research team will establish and evaluate a perinatal model of care for OUD serving two counties, Carbon and Emery, which have high rates of OUD and overdose.
This model of care will entail University of Utah medical clinicians providing education and webinars to healthcare providers in Carbon/Emery counties who care for pregnant women with OUD and their babies.
This model of care will also help other social and behavioral health care providers in the area to understand how to treat and better coordinate care.
No clinical services are being provided by University of Utah investigators or staff.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
4
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Utah
-
Price, Utah, Forenede Stater, 84501
- Eastern Utah Women's Health LLC
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Provider Inclusion Criteria:
- Must be employed as staff at one of our sub-contracted agencies or community partners
- Must directly provide care to pregnant women with OUD in Carbon and/or Emery Counties, UT
Provider Exclusion Criteria:
- Unwilling or unable to adopt treatment approaches presented from University of Utah clinicians to patient care
- Not directly working with pregnant patients with OUD
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Enhanced Perinatal Care
Pregnant women enrolled in the study will receive enhanced perinatal care from community healthcare providers that have participated in the perinatal OUD education curriculum.
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University of Utah clinicians will provide face-to-face, online, and written training materials for health, mental health, and substance use service providers in Carbon and Emery Counties, UT.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Self-report of linkage and adherence to treatment as assessed by the Treatment Service Review- 6 (TSR-6)
Tidsramme: This data will be collected from each participant during a baseline assessment, a pre-delivery assessment occurring between 34 and 40 weeks of gestation, and a final assessment conducted within 30-days following delivery.
|
Patients will complete the Treatment Services Review-6 (TSR-6) in order to measure changes in service across time.
The TSR-6 is a clinically validated 56-item measure with excellent reliability for assessing drug and alcohol treatment engagement, medication use (including drug, alcohol, psychiatric, and physical health medications), psychiatric care, family services, financial/employment/housing, and legal services.
This measure captures linkage/retention in care, that is to say: initiation and daily engagement in services.
Specifically, the research team will capture frequency of meetings/sessions/days in OUD and other substance counseling and psychiatric care and social services.
The research team will also use the TSR-6 medication use section to capture adherence to buprenorphine or methadone.
Data collected will be used to measure change across time in linkage and retention in health and behavioral health services.
|
This data will be collected from each participant during a baseline assessment, a pre-delivery assessment occurring between 34 and 40 weeks of gestation, and a final assessment conducted within 30-days following delivery.
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. februar 2019
Primær færdiggørelse (Faktiske)
1. august 2020
Studieafslutning (Faktiske)
29. september 2020
Datoer for studieregistrering
Først indsendt
18. juni 2020
Først indsendt, der opfyldte QC-kriterier
22. juni 2020
Først opslået (Faktiske)
25. juni 2020
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
10. november 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
9. november 2020
Sidst verificeret
1. november 2020
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Psykiske lidelser
- Kemisk inducerede lidelser
- Stof-relaterede lidelser
- Narkotika-relaterede lidelser
- Opioid-relaterede lidelser
- Lægemidlers fysiologiske virkninger
- Depressive midler til centralnervesystemet
- Agenter fra det perifere nervesystem
- Analgetika
- Sensoriske systemagenter
- Narkotika
- Analgetika, Opioid
Andre undersøgelses-id-numre
- A02769
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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