Opioid-use Disorder
Conditions
Brief summary
Using mixed methods and triangulating multiples sources of data collected over the course of the parent (CTN-0079 - NCT03544112) and the ancillary studies to evaluate the feasibility, acceptability, sustainability and impact of the emergency department (ED)-initiated Buprenorphine (BUP) clinical program and implementation facilitation strategy and identify factors influencing diffusion and effectiveness.
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 (NCT03544112) study. Further, qualitative data will be analyzed in the context of themes derived from CTN-0069 (NCT03023930) 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, New Hampshire; (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. As in the parent study, CTN-0079, all clinical care (BUP and referral) will be delivered as part of each facility's clinical protocol, rather than as a research procedure. Implementation Facilitation (IF) activities will continue during ancillary trial preparation with a more intensive booster of IF activities occurring in the last month prior to trial commencement. Thereafter, all study IF support will cease and ancillary study data collection will begin. Data collection will occur over a course of approximately 12 months, divided into two 6-month study periods - the Post-IF and Maintenance Periods. A period of at least 6 months should separate the beginning of the Maintenance Period from the time of last study intervention.
Interventions
BEHAVIORALClinical 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.
Sponsors
National Institute on Drug Abuse (NIDA)
NYU Langone Health
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Qualitative Population: * Key stakeholder or opinion leader for ED-initiated BUP * 18 years of age or older Full Study Population & Limited Study Population: * Be able to speak English sufficiently to understand study procedures * Be a potential candidate for ED-initiated BUP by meeting either of the 2 criteria: 1. 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. 2. Research determination: Both a and b below must be true at the time of study enrollment: a) 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 opioid use disorder (OUD), iii. denies methadone use within 72 hours of ED visit registration, iv. is not engaged in formal medications for opioid use disorder (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. b) 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: * Unwilling or unable to provide consent * currently in jail, prison, or any inpatient overnight facility Full Study Population: * Unwilling or unable to provide written/electronic informed consent * Currently engaged in formal MOUD treatment at the time of index ED visit * Currently in jail, prison or any inpatient overnight facility as required by court of law * Previous participation as a patient- participant in CTN-0079 or previous participation as a Full Study participant in the current study * Presents from a medical-based extended care facility * Current research participant in a substance use intervention study * Inadequate locator information (unable or unwilling to provide 2 unique means of contact) * Unable or unwilling to complete research visits at baseline and Day 30. Limited Study Population: * Unwilling or unable to provide written/electronic informed consent * Currently engaged in formal MOUD treatment at the time of index ED visit * Currently in jail, prison or any inpatient overnight facility as required by court of law * Previous participation in the current study as a Limited study or Full study participant * Presents from a medical-based extended care facility
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Participants Who Received Emergency Department (ED)-Initiated/Expedited Buprenorphine (BUP) | Up to Month 12 | The outcome will be calculated using the following formula: \[(Candidates who receive ED-initiated BUP with any disposition) + (Candidates who receive ED-expedited BUP and who are discharged)\] / \[(Candidates who are discharged) + (Candidates who receive ED-initiated BUP that are not discharged)\]. |
| Percent of Participants Who Received ED-Initiated/Expedited BUP Who Were Confirmed to be Engaged in Formal Addiction Treatment for Opioid Use Disorder (OUD) on the 30th Day Following Discharge | Day 30 Post-Discharge (Up to Month 12) | The outcome will be calculated using the following formula: (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 received ED-initiated/expedited BUP). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Participants Who Received ED-Initiated BUP | Up to Month 12 | The outcome will be calculated using the following formula: (ED-initiated, all) / \[All discharged candidates + (ED-initiated, not discharged)\] |
| Percent of Participants Who Received ED-Initiated/Expedited BUP | Up to Month 12 | The outcome will be calculated using the following formula: (ED-initiated/expedited, all) / \[All discharged candidates + (ED-initiated/expedited, not discharged)\] |
| Percent of Discharged Participants Who Received ED-Initiated BUP | Up to Month 12 | The outcome will be calculated using the following formula: \[(ED-initiated, discharged) + (ED-expedited, discharged)\] / All candidates who were discharged |
| Change in Number of Self-Reported Opioid-Related Overdose Events | Baseline, Day 30 | Participants will be asked to report the number of opioid-related overdose events experienced in the past 30 days through a self-report form. |
| Change in Number of Days of Opioid and/or Other Drug Use as Assessed by Timeline Followback (TLFB) Assessment | Baseline, Day 30 | The TLFB assessment will elicit the participant's self-reported use of illicit substances over the previous 7 days. At the Day 30 follow-up visit the assessment period will be the 7 days preceding the Day 30 post index ED visit. |
| Percent of Not-Admitted Participants Who Received ED-Initiated BUP | Up to Month 12 | The outcome will be calculated using the following formula: (ED-initiated, not admitted) /All candidates who were not admitted |
Countries
United States
Participant flow
Pre-assignment details
Certain Outcome Measures of the current study were pre-specified to utilize participants not enrolled in the study. These participants are represented in the Patients Identified via Chart Review arm. As these participants were not enrolled in the study, they are not counted in the Protocol Enrollment. Enrolled participants are represented in the ED Patients arm.
Participants by arm
| Arm | Count |
|---|---|
| ED Patients Administrative and health record data will be examined to assess rates of screening, assessment, eligibility determination, etc.
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. | 39 |
| Patients Identified Via Chart Review Patients who were identified via chart review. | 1,489 |
| Total | 1,528 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 14 | 0 |
Baseline characteristics
| Characteristic | Patients Identified Via Chart Review | Total | ED Patients |
|---|---|---|---|
| Age, Continuous | 41.3 years STANDARD_DEVIATION 11.91 | 42.25 years STANDARD_DEVIATION 11.315 | 43.2 years STANDARD_DEVIATION 10.72 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 198 Participants | 205 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1044 Participants | 1076 Participants | 32 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 47 Participants | 47 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 10 Participants | 10 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 4 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 317 Participants | 325 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 35 Participants | 35 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 50 Participants | 54 Participants | 4 Participants |
| Race (NIH/OMB) White | 658 Participants | 685 Participants | 27 Participants |
| Region of Enrollment United States | 1489 participants | 1528 participants | 39 participants |
| Sex: Female, Male Female | 277 Participants | 287 Participants | 10 Participants |
| Sex: Female, Male Male | 1211 Participants | 1240 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 39 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Percent of Participants Who Received ED-Initiated/Expedited BUP Who Were Confirmed to be Engaged in Formal Addiction Treatment for Opioid Use Disorder (OUD) on the 30th Day Following Discharge
The outcome will be calculated using the following formula: (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 received ED-initiated/expedited BUP).
Time frame: Day 30 Post-Discharge (Up to Month 12)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients Identified Via Chart Review | Percent of Participants Who Received ED-Initiated/Expedited BUP Who Were Confirmed to be Engaged in Formal Addiction Treatment for Opioid Use Disorder (OUD) on the 30th Day Following Discharge | 48.3 Percentage of participants |
Primary
Percent of Participants Who Received Emergency Department (ED)-Initiated/Expedited Buprenorphine (BUP)
The outcome will be calculated using the following formula: \[(Candidates who receive ED-initiated BUP with any disposition) + (Candidates who receive ED-expedited BUP and who are discharged)\] / \[(Candidates who are discharged) + (Candidates who receive ED-initiated BUP that are not discharged)\].
Time frame: Up to Month 12
Population: The overall number of participants analyzed for this outcome measure (n=1489) represents individuals identified via retrospective chart review and data matching for all adult emergency department (ED) patients identified to have nonmedical opioid use presenting to the ED during the IF, Post-IF or Maintenance periods. This outcome was not assessed among participants in the ED patients arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients Identified Via Chart Review | Percent of Participants Who Received Emergency Department (ED)-Initiated/Expedited Buprenorphine (BUP) | 39.40 Percentage of participants |
Secondary
Change in Number of Days of Opioid and/or Other Drug Use as Assessed by Timeline Followback (TLFB) Assessment
The TLFB assessment will elicit the participant's self-reported use of illicit substances over the previous 7 days. At the Day 30 follow-up visit the assessment period will be the 7 days preceding the Day 30 post index ED visit.
Time frame: Baseline, Day 30
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Patients Identified Via Chart Review | Change in Number of Days of Opioid and/or Other Drug Use as Assessed by Timeline Followback (TLFB) Assessment | -2.3 Days |
Secondary
Change in Number of Self-Reported Opioid-Related Overdose Events
Participants will be asked to report the number of opioid-related overdose events experienced in the past 30 days through a self-report form.
Time frame: Baseline, Day 30
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Patients Identified Via Chart Review | Change in Number of Self-Reported Opioid-Related Overdose Events | 1.78 Overdose events |
Secondary
Percent of Discharged Participants Who Received ED-Initiated BUP
The outcome will be calculated using the following formula: \[(ED-initiated, discharged) + (ED-expedited, discharged)\] / All candidates who were discharged
Time frame: Up to Month 12
Population: The overall number of participants analyzed for this outcome measure (n=1281) represents individuals identified via retrospective chart review and data matching for all adult emergency department (ED) patients identified to have nonmedical opioid use presenting to the ED during the IF, Post-IF or Maintenance periods. This outcome was not assessed among participants in the ED patients arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients Identified Via Chart Review | Percent of Discharged Participants Who Received ED-Initiated BUP | 32.10 Percentage of participants |
Secondary
Percent of Not-Admitted Participants Who Received ED-Initiated BUP
The outcome will be calculated using the following formula: (ED-initiated, not admitted) /All candidates who were not admitted
Time frame: Up to Month 12
Population: The overall number of participants analyzed for this outcome measure (n=1317) represents individuals identified via retrospective chart review and data matching for all adult emergency department (ED) patients identified to have nonmedical opioid use presenting to the ED during the IF, Post-IF or Maintenance periods. This outcome was not assessed among participants in the ED patients arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients Identified Via Chart Review | Percent of Not-Admitted Participants Who Received ED-Initiated BUP | 28.10 Percentage of participants |
Secondary
Percent of Participants Who Received ED-Initiated BUP
The outcome will be calculated using the following formula: (ED-initiated, all) / \[All discharged candidates + (ED-initiated, not discharged)\]
Time frame: Up to Month 12
Population: The overall number of participants analyzed for this outcome measure (n=1310) represents individuals identified via retrospective chart review and data matching for all adult emergency department (ED) patients identified to have nonmedical opioid use presenting to the ED during the IF, Post-IF or Maintenance periods. This outcome was not assessed among participants in the ED patients arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients Identified Via Chart Review | Percent of Participants Who Received ED-Initiated BUP | 30.7 Percentage of participants |
Secondary
Percent of Participants Who Received ED-Initiated/Expedited BUP
The outcome will be calculated using the following formula: (ED-initiated/expedited, all) / \[All discharged candidates + (ED-initiated/expedited, not discharged)\]
Time frame: Up to Month 12
Population: The overall number of participants analyzed for this outcome measure (n=1489) represents individuals identified via retrospective chart review and data matching for all adult emergency department (ED) patients identified to have nonmedical opioid use presenting to the ED during the IF, Post-IF or Maintenance periods. This outcome was not assessed among participants in the ED patients arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients Identified Via Chart Review | Percent of Participants Who Received ED-Initiated/Expedited BUP | 25.4 Percentage of participants |