Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:20 PM
Ignite Modification Date:
2025-12-26 @ 10:20 PM
NCT ID:
NCT03544112
Eligibility Criteria:
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
1. 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.
2. 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?
3. 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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03544112
Study Brief:
Protocol Section:
NCT03544112