- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT03544112
Emergency Department Connection to Care With Buprenorphine for Opioid Use Disorder (ED-CONNECT)
NIDA CTN-0079: Emergency Department Connection to Care With Buprenorphine for Opioid Use Disorder
The purpose of this study is to learn what resources are needed to improve outcomes for patients with opioid use disorder. The study will look at how patients engage in treatment and the decisions that patients and providers make regarding treatment, specifically buprenorphine treatment, for opioid use disorder.
The aims of this study are:
- To evaluate using mixed methods the feasibility and acceptability of OUD screening, ED-initiated BUP, and referral.
Over the course of the study and as XR-BUP is added to hospital formularies, to estimate the percentage and confidence intervals of patients assessed, treated, and engaged in treatment at Day 30. This will be a three-site study employing a multi-faceted approach to facilitate clinical protocol implementation and to assess feasibility, acceptability, and impact. Investigators will develop, introduce and update site-specific ED clinical protocols and implementation plans for OUD screening, ED-initiated BUP, and referral for treatment. A participatory action research approach will be utilized along with mixed methods incorporating data derived from:
- Medical record and administrative data abstraction,
- Research assessments involving patients who are eligible for and willing to receive ED-initiated BUP (including both those who do, and do not, receive BUP); these assessments will document the index ED visit and the 30th day after the index ED visit,
- Qualitative interviews, focus groups, and quantitative assessments involving providers and staff, patients, and other stakeholders.
Tutkimuksen yleiskatsaus
Tila
Ehdot
Opintotyyppi
Ilmoittautuminen (Todellinen)
Yhteystiedot ja paikat
Opiskelupaikat
-
-
New Hampshire
-
Claremont, New Hampshire, Yhdysvallat, 03743
- Valley Regional Healthcare
-
Manchester, New Hampshire, Yhdysvallat, 03102
- Catholic Medical Center
-
-
New York
-
New York, New York, Yhdysvallat, 10016
- New York University School of Medicine
-
New York, New York, Yhdysvallat, 10016
- Bellevue Hospital Center
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Näytteenottomenetelmä
Tutkimusväestö
Kuvaus
Inclusion Criteria:
- ED STAFF: ED/Hospital leadership and staff: Leadership and staff across multiple disciplines (e.g., nurses, social workers, physicians, NPs, PAs, pharmacist, physician and nursing directors) at each ED site will be recruited to participate in the formative evaluation and the IF.
- PROVIDERS: Community treatment providers/OTP leadership and program staff: Providers, leadership and staff involved in the provision of office-based BUP, community treatment, and/or at opioid treatment programs (OTPs) will be recruited to participate in the formative evaluation and the Implementation Facilitation.
- COMMUNITY: Other Stakeholders: Other community leaders and members (e.g., EMS, fire department, police, local government leadership, community advocacy groups, etc.) may be recruited to participate in qualitative interviews or focus groups.
- PATIENTS: ED patients will be recruited to participate in interviews or focus groups.
- PATIENT-PARTICIPANTS: ED patients who are eligible for and willing to receive ED-initiated BUP will be recruited to participate in two research visits.
- ALL ED PATIENTS: Administrative and health record data will be examined to assess rates of screening, assessment, eligibility determination, etc.
Stakeholder-Participant Inclusion Criteria
- A member of one of the stakeholder groups (1-4 above)
Patient-Participant Inclusion Criteria
Eligible for and willing to receive ED-initiated BUP
- Eligibility for ED-initiated BUP is operationally defined as meeting site clinical protocol criteria determined and documented by site clinical staff. See Section 9.2 Clinical Protocol.
- Willing to receive ED-initiated BUP is operationally defined as providing an affirmative answer to the following question, which will be embedded in each site's clinical protocol: Would you like to receive buprenorphine today?
- NOTE: Patients meeting these criteria, and not meeting exclusion criteria below, may be included as study participants regardless of whether they receive or do not receive ED-initiated BUP
Exclusion Criteria:
Stakeholder-Participant Exclusion Criteria
- Unwilling or unable to provide consent
- Currently in jail, prison or any inpatient overnight facility as required by court of law or have pending legal action or that could prevent participation in the study
Patient-Participant Exclusion Criteria
- Not able to speak English sufficiently to understand study procedures and provide written informed consent
- Unable or unwilling to provide written informed consent or to participate in study procedures
- Currently receiving any medication treatment for OUD at the time of index ED visit
- Current research participant in a substance use intervention study or previous participation in the current study
- Are currently in jail, prison or any inpatient overnight facility as required by court of law or have pending legal action or that could prevent participation in the study
- Inadequate locator information (unable to provide 2 unique means of contact)
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
Kohortit ja interventiot
Ryhmä/Kohortti |
Interventio / Hoito |
---|---|
ED and OUD treatment providers and staff
|
Implementation will include developing clinical protocols containing core components of the intervention to which fidelity is expected, along with aspects that may be adapted by local sites to aid implementation.
In partnership with multidisciplinary teams at each site, we will adapt clinical practices from other contexts and available information about SL-BUP and XR-BUP to site-specific clinical protocols and implementation strategies.
The study implementation facilitators will assist local champions to identify potential treatment providers and draw on existing resources for training and ongoing support.
|
Community Stakeholders
|
Implementation will include developing clinical protocols containing core components of the intervention to which fidelity is expected, along with aspects that may be adapted by local sites to aid implementation.
In partnership with multidisciplinary teams at each site, we will adapt clinical practices from other contexts and available information about SL-BUP and XR-BUP to site-specific clinical protocols and implementation strategies.
The study implementation facilitators will assist local champions to identify potential treatment providers and draw on existing resources for training and ongoing support.
|
Patients
ED patients will be recruited to participate in interviews or focus groups.
|
Implementation will include developing clinical protocols containing core components of the intervention to which fidelity is expected, along with aspects that may be adapted by local sites to aid implementation.
In partnership with multidisciplinary teams at each site, we will adapt clinical practices from other contexts and available information about SL-BUP and XR-BUP to site-specific clinical protocols and implementation strategies.
The study implementation facilitators will assist local champions to identify potential treatment providers and draw on existing resources for training and ongoing support.
The study implementation facilitators will assist local champions to identify potential treatment providers and draw on existing resources for training and ongoing support.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
Receipt of ED-initiated BUP (binary) and will be abstracted from the health record.
Aikaikkuna: 12 Months
|
Proportion receiving emergency department BUP amongst patients who have been determined to be eligible for and willing to receive ED-initiated BUP
|
12 Months
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Aikaikkuna |
---|---|
Proportion of patients who received ED-initiated BUP who are engaged in formal addiction treatment 30 days after the index ED visit.
Aikaikkuna: 12 Months
|
12 Months
|
Yhteistyökumppanit ja tutkijat
Sponsori
Yhteistyökumppanit
Tutkijat
- Päätutkija: Ryan McCormack, MD, NYU Langone Health
Julkaisuja ja hyödyllisiä linkkejä
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 17-01513
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