Emergency Department Outcomes for Patients With Opioid Use Disorder
Study Details
Study Description
Brief Summary
Using mixed methods and triangulating multiples sources of data collected over the course of the parent (CTN-0079) and the ancillary studies to evaluate the feasibility, acceptability, sustainability and impact of the ED-initiated BUP clinical program and implementation facilitation strategy and identify factors influencing diffusion and effectiveness.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
The ancillary study will use mixed-methods combining quantitative and qualitative inquiry (interview/focus group and field notes) with administrative and health record data with some analyses including data collected from the parent CTN-0079 study. Further, qualitative data will be analyzed in the context of themes derived from CTN-0069 and CTN-0079. CTN-0079-A1 is planned to be conducted at two of the three sites of the parent study: (1) Catholic Medical Center, Manchester, NH; (2) Bellevue/NYU Health and Hospitals, New York, NY. Many of the methods, operating procedures, measures and forms will be retained or adapted from the parent study. However, CTN-0079-A1 is a new study in which lessons learned through the parent study have informed important design modifications necessary to improve study rigor and utility.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| ED patients Administrative and health record data will be examined to assess rates of screening, assessment, eligibility determination, etc. |
Behavioral: Clinical program implementation
Using mixed methods and triangulating multiple sources of data collected over the course of parent and ancillary studies to evaluate the feasibility, acceptability, sustainability, and impact of the ED-initiated BUP clinical program and implementation facilitation strategy and identify factors influencing diffusion and effectiveness. Converging provider and patient perspectives and field notes with process measures and intervention outcomes, including proportions screened, treated, and engaged in treatment, will provide explanation to contextualize and better understand feasibility, acceptability, and factors associated with the rate with which the ED-initiated BUP innovation is adopted and how well it is sustained.
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| Stakeholders and community leaders Stakeholders within and outside the hospital, including ED providers, hospital leadership, ED patients, ED staff, and community opinion leaders will be recruited to participate in the IF booster and qualitative focus groups and interviews. |
Behavioral: Clinical program implementation
Using mixed methods and triangulating multiple sources of data collected over the course of parent and ancillary studies to evaluate the feasibility, acceptability, sustainability, and impact of the ED-initiated BUP clinical program and implementation facilitation strategy and identify factors influencing diffusion and effectiveness. Converging provider and patient perspectives and field notes with process measures and intervention outcomes, including proportions screened, treated, and engaged in treatment, will provide explanation to contextualize and better understand feasibility, acceptability, and factors associated with the rate with which the ED-initiated BUP innovation is adopted and how well it is sustained.
|
| ED-initiated BUP patients ED patients who are eligible for and willing to receive ED-initiated BUP will be recruited to participate in two research visits and data matching. |
Behavioral: Clinical program implementation
Using mixed methods and triangulating multiple sources of data collected over the course of parent and ancillary studies to evaluate the feasibility, acceptability, sustainability, and impact of the ED-initiated BUP clinical program and implementation facilitation strategy and identify factors influencing diffusion and effectiveness. Converging provider and patient perspectives and field notes with process measures and intervention outcomes, including proportions screened, treated, and engaged in treatment, will provide explanation to contextualize and better understand feasibility, acceptability, and factors associated with the rate with which the ED-initiated BUP innovation is adopted and how well it is sustained.
|
| ED-initiated BUP patients - 2 ED patients who are eligible to receive ED-initiated BUP but unable or unwilling to participate will provide authorization for health services review and data matching with available registry, claims or administrative data. |
Behavioral: Clinical program implementation
Using mixed methods and triangulating multiple sources of data collected over the course of parent and ancillary studies to evaluate the feasibility, acceptability, sustainability, and impact of the ED-initiated BUP clinical program and implementation facilitation strategy and identify factors influencing diffusion and effectiveness. Converging provider and patient perspectives and field notes with process measures and intervention outcomes, including proportions screened, treated, and engaged in treatment, will provide explanation to contextualize and better understand feasibility, acceptability, and factors associated with the rate with which the ED-initiated BUP innovation is adopted and how well it is sustained.
|
| Data-matching ED patients All ED patients screening positive for non-medical opioid use |
Behavioral: Clinical program implementation
Using mixed methods and triangulating multiple sources of data collected over the course of parent and ancillary studies to evaluate the feasibility, acceptability, sustainability, and impact of the ED-initiated BUP clinical program and implementation facilitation strategy and identify factors influencing diffusion and effectiveness. Converging provider and patient perspectives and field notes with process measures and intervention outcomes, including proportions screened, treated, and engaged in treatment, will provide explanation to contextualize and better understand feasibility, acceptability, and factors associated with the rate with which the ED-initiated BUP innovation is adopted and how well it is sustained.
|
Outcome Measures
Primary Outcome Measures
- Number of participants who received Emergency Department (ED)-initiated/expedited Buprenorphine (BUP) out of total number of candidates for ED-initiated BUP. [12 months]
[(Candidates who receive ED-initiated BUP with any disposition) + (Candidates who receive ED-expedited BUP and who are discharged)] / [(Candidates who are discharged) + (Candidates who receive ED-initiated BUP that are not discharged)] This will be reported as a proportion (participants who receives ED-initiated/expedited BUP / total candidates for ED-initiated BUP. Receipt of ED-initiated BUP is defined to include: (1) administration of BUP in the ED, (2) prescription for BUP as part of the ED visit, (3) provision of a specific "warm" referral or transfer of care to a provider, clinic, or treatment setting with the capacity to administer or prescribe BUP within no more than 24 hours. This data will be obtained from EMRs and/or determined through research staff assessments.
- Number of participants who are confirmed to be engaged in formal addiction treatment for Opioid Use Disorder (OUD) on the 30th day following discharge out of total number of participants who received ED-initiated/expedited BUP. [12 months]
This will be reported as a proportion (participants who are confirmed to be engaged in formal addiction treatment for Opioid Use Disorder (OUD) on the 30th day following discharge / total number of participants who receives ED-initiated/expedited BUP).
Secondary Outcome Measures
- Number of participants in receipt of ED-initiated BUP. [12 months]
This will be reported as a proportion of ED participants receiving ED-initiated BUP amongst ED participants who are candidates for ED-initiated BUP. ED-initiated BUP / all candidates.
- Number of participants with confirmed linkage to formal addiction treatment for OUD within 7-10 days following ED discharge out of total number of participants who received ED-initiated/expedited BUP. [12 months]
This will be reported as a proportion (participants with confirmed linkage to formal addiction treatment for OUD within 7-10 days following ED discharge / total number of participants who received ED-initiated BUP).
- Number of participants using drugs as reported by Saliva Drug Screen Testing [30 days]
Saliva testing will be performed on full study participants for the presence of buprenorphine, fentanyl and other substances that may include alcohol, amphetamine, benzodiazepines, barbiturates, cocaine, methamphetamine, methadone, opioids, oxycodone, and tetrahydrocannabinol.
- Number of days of opioid and other drug use as assessed by Timeline Followback (TLFB) Assessment [Baseline]
The TLFB assessment will elicit participant's self-reported use of illicit substances. At the baseline visit the assessment period will be the 7 days preceding the index ED visit.
- Number of days of opioid and other drug use as assessed by Timeline Followback (TLFB) Assessment [30 days]
The TLFB assessment will elicit the participant's self-reported use of illicit substances. At the Day 30 follow-up visit the assessment period will be the 7 days preceding the Day 30 post index ED visit.
- Number of self-reported opioid-related overdose events [Baseline]
Participants will be asked to report number of opioid-related overdose events experienced in the past 12 months and past 30 days through a self-report form.
- Number of self-reported opioid-related overdose events [30 days]
Participants will be asked to report number of opioid-related overdose events experienced in the past 30 days through a self-report form.
- Number of Quality-adjusted Life Years (QALYs) [30 days]
Number of QALYs is calculated using the formula which assumes a utility value (quality of life) between 1 = perfect health and 0 = dead: years of life x utility value = number of QALYs.
Eligibility Criteria
Criteria
Inclusion Criteria:
Qualitative Population:
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Key stakeholder or opinion leader for ED-initiated BUP
-
18 years of age or older
Full Study Population & Limited Study Population:
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Be able to speak English sufficiently to understand study procedures
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Be a potential candidate for ED-initiated BUP by meeting either of the 2 criteria:
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Clinical determination: patient is a willing and eligible candidate for ED-initiated BUP or for whom this can be reasonably inferred, including any patient who is administered and/or prescribed BUP as part of the index ED visit.
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Research determination: Both a and b below must be true at the time of study enrollment:
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Assessment conducted by an RA indicates that the patient- (all must be true): i. has had nonmedical opioid use within the last 7 days, ii. meets DSM-5 criteria for moderate or severe OUD, iii. denies methadone use within 72 hours of ED visit registration, iv. is not engaged in formal MOUD treatment, v. is not prescribed opioids for chronic pain management, vi. reports being interested or "not sure" if interested in receiving BUP as elicited on the ED Health Survey during the index ED visit.
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Absence of clinical documentation associated with the ED visit indicating that the patient is not a candidate for ED-initiated BUP.
Exclusion Criteria:
Qualitative Population:
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Unwilling or unable to provide consent
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currently in jail, prison, or any inpatient overnight facility
Full Study Population:
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Unwilling or unable to provide written/electronic informed consent
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Currently engaged in formal MOUD treatment at the time of index ED visit
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Currently in jail, prison or any inpatient overnight facility as required by court of law
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Previous participation as a patient- participant in CTN-0079 or previous participation as a Full Study participant in the current study
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Presents from a medical-based extended care facility
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Current research participant in a substance use intervention study
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Inadequate locator information (unable or unwilling to provide 2 unique means of contact)
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Unable or unwilling to complete research visits at baseline and Day 30.
Limited Study Population:
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Unwilling or unable to provide written/electronic informed consent
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Currently engaged in formal MOUD treatment at the time of index ED visit
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Currently in jail, prison or any inpatient overnight facility as required by court of law
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Previous participation in the current study as a Limited study or Full study participant
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Presents from a medical-based extended care facility
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Catholic Medical Center | Manchester | New Hampshire | United States | 03102 |
| 2 | Bellevue Hospital Center | New York | New York | United States | 10016 |
Sponsors and Collaborators
- NYU Langone Health
- National Institute on Drug Abuse (NIDA)
Investigators
- Principal Investigator: Ryan McCormack, MD, MS, NYU Langone Health
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 19-01444
- 3UG1DA013035-18S3