- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04188977
Facilitating the Implementation of Interim Methadone to Increase Treatment Access
27. juli 2022 oppdatert av: Friends Research Institute, Inc.
Facilitating the Implementation of Interim Methadone to Increase Treatment Access: A Multi-Site Implementation Trial
The primary aim of this study is to evaluate the effectiveness of Implementation Facilitation (IF) in promoting increased accessibility to methadone treatment.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
This is a Type 3 implementation-effectiveness type study using a modified stepped wedge design.
The study's purpose is to examine the effectiveness of Implementation Facilitation (IF) to prompt participating Opioid Treatment Programs (OTPs) to utilize interim methadone treatment and other approaches to reduce OTP admission delays.
Interim methadone treamtent is an evidence-based practice permitted under federal OTP regulations to provide methadone treatment without routine counseling for individuals requesting methadone treatment who otherwise would not be able to be admitted to such treatment within 14 days of request.
The study will be conducted at six OTPs in the US that are unable to admit individuals within 14 days of their request for methadone treatment.
The OTPs will participate in a baseline Pre-Implementation Phase, an Implementation Phase, followed by a Sustainability Phase.
OTPs will be randomly assigned in groups of two to the order in which they will initiate the Implementation Phase.
IF will be delivered at the level of the OTP staff and their state health department official responsible for OTP oversight.
OTP staff and state health department officials will be interviewed regarding facilitators and barriers to implementing interim methadone and other approaches to reduce admission delays.
De-identified data will be gathered from the OTPs on the effectiveness of IF in prompting the implementation of interim methadone and reducing admission delays.
Studietype
Intervensjonell
Registrering (Faktiske)
18
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Maryland
-
Baltimore, Maryland, Forente stater, 21201
- Robert Philip Schwartz, M.D.
-
-
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
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria (Staff):
- OTP staff
- State health department staff responsible for OTP oversight
Exclusion Criteria:
- Unwilling to be interviewed
Inclusion Criteria (OTP applicants):
- requesting admission to OTP
Exclusion Criteria:
- None
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Sekvensiell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Annen: Usual Practice
OTPs are able to request from state and federal health department officials to utilize interim methadone treatment to address admission delays in their OTP.
|
OTP Directors are able to ask their state health officials permission to use interim methadone treatment.
The state officials are in turn able to ask officials from the Center of Substance Abuse Treatment for permission to provide interim methadone treatment.
|
|
Eksperimentell: Implementation Facilitation
Implementation Facilitation (IF) will consist of educational outreach to OTP staff, identification of local champions, training, performance feedback, and learning collaborative for OTP staff and state health department officials.
|
Implementation Facilitation (IF) will consist of educational outreach to OTP staff, identification of local champions, training, performance feedback, and learning collaborative for OTP staff and state health department officials.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Accessibility
Tidsramme: Nine months
|
Accessibility will be assessed from de-identified OTP records as the proportion of individuals requesting methadone treatment who receive at least one dose of methadone through either interim methadone (IM) or standard methadone within 14 days, divided by the number of individuals requesting methadone treatment.
|
Nine months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Uptake
Tidsramme: Nine months
|
Uptake will be assessed from de-identified OTP records as the proportion of individuals unable to gain admission within 14 days who receive at least one interim methadone dose divided by the number of individuals who were unable to be admitted within 14 days.
|
Nine months
|
|
Efficiency
Tidsramme: Nine months
|
Efficiency will be assessed from de-identified OTP records as the number of days from the request for OTP admission prior to receiving a first methadone dose.
|
Nine months
|
|
Fidelity
Tidsramme: Six months
|
Fidelity will be assessed from de-identified OTP records as the proportion of interim methadone patients transferred to standard methadone treatment within the permitted time limit from starting interim methadone treatment.
|
Six months
|
|
Uptake during the Sustainability Phase
Tidsramme: Six months
|
Sustainability will be assessed from de-identified OTP records as the proportion of interim methadone patients admitted within 14 days of request during the Sustainability Phase
|
Six months
|
|
Effectiveness: percentage of opioid positive tests
Tidsramme: Six months
|
Effectiveness will be assessed from de-identified OTP records as the percentage of opioid-positive urine tests of interim methadone patients at the time of transfer to standard methadone treatment
|
Six months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Robert P Schwartz, M.D., Friends Research Institute, Inc.
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. november 2019
Primær fullføring (Faktiske)
30. april 2022
Studiet fullført (Faktiske)
30. april 2022
Datoer for studieregistrering
Først innsendt
12. november 2019
Først innsendt som oppfylte QC-kriteriene
3. desember 2019
Først lagt ut (Faktiske)
6. desember 2019
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
29. juli 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
27. juli 2022
Sist bekreftet
1. juli 2022
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- U01DA046910 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
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Nei
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