Opioid Use Disorder
Conditions
Keywords
Opioid Use Disorder
Brief summary
The purpose of this study is to evaluate the impact of (1) Implementation Facilitation (IF) on rates of provision of Emergency Department (ED)-initiated buprenorphine/naloxone (BUP) treatment with referral for ongoing medication-assisted treatment (MAT) and the (2) effectiveness of IF on patient engagement in formal addiction treatment at 30 days.
Detailed description
The study was originally proposed to use a Hybrid Type 3 Effectiveness-Implementation framework and a modified stepped wedge design. Original protocol registration language: The study will be conducted at four EDs with a high prevalence of patients with untreated opioid use disorder (OUD). The four sites will receive the same sequence of evaluations and interventions: the baseline evaluation period after the standard dissemination practice, the IF phase, and continuation of facilitation into the IF evaluation period. The timing of initiation of the study activities at each site will be randomly offset by \ 3 month increments to accommodate logistical constraints of simultaneous implementation at all sites. The study populations will include (1) ED providers and staff involved in the treatment of patients with OUD; (2) Community opioid treatment provider and program staff involved in providing care for patients with OUD referred from the ED; and (3) ED patients with moderate to severe OUD. Exploratory analyses have been added to assess the impact of COVID-19 and social distancing guidance on drug use and drug supply; access to medications for opioid use disorder; and COVID19 disease from the perspectives of patient participants and ED leadership. Upon results entry, changes were made to reflect that the study design originally was described as a modified step wedge but ultimately was not designed or implemented as such, as there was no substantial overlap of the baseline evaluation and IF evaluation periods. Thus, the statistical plan was adjusted accordingly.
Interventions
OTHERStandard Dissemination Practice
Emergency department provider education using a grand rounds format. The content of the lecture will cover the scope of the opioid problem, ED specific facts related to the epidemic, potential models of intervention including the results of publications outlining the efficacy of ED-initiated BUP.
OTHERImplementation Facilitation (IF)
IF involves a formative evaluation to identify the specific and dynamic needs of stakeholders and the context for implementation of evidence-based practices. This evaluation informs the initial tailoring and refinement of the IF, which includes a bundle of services tailored to meet site-specific needs, such as identifying and engaging local stakeholders, providing extensive ongoing education, tailoring program to the site and monitoring performance and offering feedback.
Sponsors
National Institute on Drug Abuse (NIDA)
The Emmes Company, LLC
Yale University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Masking description
Note: Care Providers and Research Associates are masked during Baseline Evaluation Period
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patient Inclusion Criteria: * Patients who are treated in the ED during study screening hours with Diagnostic and Statistical Manual (DSM)-5 criteria for moderate to severe OUD and provide an opioid positive urine sample will be eligible to participate. Patient
Exclusion criteria
* Patients who test positive for fentanyl only are not eligible due to lack of uniformly available rapid urine tests. * Patients will be excluded if they have a medical or psychiatric condition requiring hospitalization at the index ED visit, are acutely suicidal or severely cognitively impaired precluding informed consent, present from an extended care facility, require continued prescription opioids for a pain condition, are a prisoner or in police custody at time of index ED visit, are currently (past 30 days) enrolled in formal addiction treatment including by court order, are unable to provide 2 contact numbers, are unwilling to follow study procedures, have been previously enrolled in the current study or do not speak English. ED and Community Participants Inclusion Criteria: * ED and community providers and administrators (i.e. physicians, residents, fellows, nursing, nurse practitioners, physician assistants, pharmacists, social workers, counselors, administrative directors, office-based physicians and opioid treatment program representatives) as well as ED patients with OUD.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness | 30 Days Post Enrollment | The primary effectiveness outcome is defined as the rates of patient engagement in formal addiction treatment on the 30th day post enrollment. |
| Implementation (Considered the Primary Outcome) | 12 months | The primary implementation outcome will be evaluated assessing the rate of ED-initiated BUP therapy with referral for ongoing MAT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Implementation: ED Organizational Readiness to Change Assessment (ORCA) Score | Pre IF (Baseline) | ED ORCA score relating to ED-initiated BUP with referral for ongoing MAT. Scores are dichotomized as less ready (scores 0-6) or most ready (scores 7-10). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness: Overdose Event | 30 days post enrollment | Overdose event (past 30 days) captured by participant self-report, state medical examiner records, National Death Index and review of medical records |
| Effectiveness: Opioid Use | 30 days post enrollment | Self-reported days of illicit opioid use (past 7 days) as measured by Time-Line Follow-Back methods at 30 days |
| Effectiveness: HIV Risk | 30 days post enrollment | HIV risk taking behaviors (past 30 days) as measured by HIV Risk Taking Behavior Scale |
| Implementation: ED Provider Readiness and Preparedness Ruler Score | Pre IF (Baseline) | ED provider readiness and preparedness ruler score to initiate BUP and provide referral for ongoing MAT. |
| Implementation: Community Readiness and Preparedness Ruler Score | Pre IF (Baseline) | Community opioid treatment provider/program readiness and preparedness ruler score to continue MAT for patients with OUD who have received ED-initiated BUP |
| Implementation: ED Organizational Readiness to Change Assessment (ORCA) Score | Post IF (6 months) | ED ORCA score relating to ED-initiated BUP with referral for ongoing MAT |
| Implementation: Fidelity | Baseline Period (Baseline) | Fidelity will be measured using a critical action checklist relating to the provision of ED-initiated BUP with referral for ongoing MAT in eligible patients. |
| Implementation: Community ORCA Score | Pre IF (Baseline) | Community opioid treatment provider/program ORCA score relating to receiving patients with OUD who have received ED-initiated BUP |
| Effectiveness: Illicit Opioid Urine Toxicology | 30 days post enrollment | Rates of illicit opioid negative urines |
| Effectiveness: Healthcare Service Utilization | 30 days post enrollment | All Healthcare Service Utilization Inpatient and Outpatient |
Countries
United States
Participant flow
Recruitment details
A total of 27,748 patients were screened during the baseline evaluation period and 394 were enrolled and analyzed. During the IF evaluation period, 26,456 were screened and 362 enrolled and analyzed. The study was originally conceived as a modified step wedge but not designed or implemented as such, as there was no substantial overlap of the baseline evaluation and IF evaluation periods. A total of 975 unique providers were assessed across the study periods via survey.
Participants by arm
| Arm | Count |
|---|---|
| Baseline Evaluation Period Cohort Evaluating standard dissemination practice compared with implementation facilitation
Standard Dissemination Practice: Emergency department provider education using a grand rounds format. The content of the lecture will cover the scope of the opioid problem, ED specific facts related to the epidemic, potential models of intervention including the results of publications outlining the efficacy of ED-initiated BUP.
Implementation Facilitation (IF): IF involves a formative evaluation to identify the specific and dynamic needs of stakeholders and the context for implementation of evidence-based practices. This evaluation informs the initial tailoring and refinement of the IF, which includes a bundle of services tailored to meet site-specific needs, such as identifying and engaging local stakeholders, providing extensive ongoing education, tailoring program to the site and monitoring performance and offering feedback. | 394 |
| IF Evaluation Period Cohort Evaluating standard dissemination practice compared with implementation facilitation
Standard Dissemination Practice: Emergency department provider education using a grand rounds format. The content of the lecture will cover the scope of the opioid problem, ED specific facts related to the epidemic, potential models of intervention including the results of publications outlining the efficacy of ED-initiated BUP.
Implementation Facilitation (IF): IF involves a formative evaluation to identify the specific and dynamic needs of stakeholders and the context for implementation of evidence-based practices. This evaluation informs the initial tailoring and refinement of the IF, which includes a bundle of services tailored to meet site-specific needs, such as identifying and engaging local stakeholders, providing extensive ongoing education, tailoring program to the site and monitoring performance and offering feedback. | 362 |
| Total | 756 |
Baseline characteristics
| Characteristic | Baseline Evaluation Period Cohort | IF Evaluation Period Cohort | Total |
|---|---|---|---|
| Age, Continuous | 38.9 years STANDARD_DEVIATION 11.7 | 39.7 years STANDARD_DEVIATION 11.7 | 39.3 years STANDARD_DEVIATION 11.7 |
| Currently living in any of the following places Emergency, temporary, transitional or halfway house | 4 Participants | 9 Participants | 13 Participants |
| Currently living in any of the following places On the street or public place not intended for sleeping | 94 Participants | 98 Participants | 192 Participants |
| Currently living in any of the following places Shelter for homeless persons | 41 Participants | 41 Participants | 82 Participants |
| Currently living in any of the following places Welfare hotel or SRO | 3 Participants | 6 Participants | 9 Participants |
| Education ≥ College degree | 50 Participants | 28 Participants | 78 Participants |
| Education High school graduate or equivalent (GED) | 130 Participants | 146 Participants | 276 Participants |
| Education Less than high school diploma | 140 Participants | 126 Participants | 266 Participants |
| Education Some college, no degree | 74 Participants | 62 Participants | 136 Participants |
| Employment Disabled permanently or temporarily | 80 Participants | 62 Participants | 142 Participants |
| Employment Unemployed | 228 Participants | 192 Participants | 420 Participants |
| Employment Working | 63 Participants | 66 Participants | 129 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 49 Participants | 39 Participants | 88 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 345 Participants | 323 Participants | 668 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Health insurance Medicaid | 287 Participants | 254 Participants | 541 Participants |
| Health insurance Medicare | 31 Participants | 37 Participants | 68 Participants |
| Health insurance Private/commercial | 45 Participants | 24 Participants | 69 Participants |
| Health insurance Unknown | 50 Participants | 66 Participants | 116 Participants |
| Mental Health History Any psychiatric treatment, past 30 day | 60 Participants | 42 Participants | 102 Participants |
| Mental Health History Lifetime psychiatric treatment: Inpatient | 161 Participants | 116 Participants | 277 Participants |
| Mental Health History Lifetime psychiatric treatment: Outpatient | 185 Participants | 150 Participants | 335 Participants |
| Mental Health History Psych eval during the ED visit? | 11 Participants | 15 Participants | 26 Participants |
| Number of Positive UDS results by substance Amphetamine | 114 Participants | 102 Participants | 216 Participants |
| Number of Positive UDS results by substance Barbiturates | 7 Participants | 1 Participants | 8 Participants |
| Number of Positive UDS results by substance Benzodiazepines | 101 Participants | 126 Participants | 227 Participants |
| Number of Positive UDS results by substance Buprenorphine | 144 Participants | 169 Participants | 313 Participants |
| Number of Positive UDS results by substance Cocaine | 177 Participants | 165 Participants | 342 Participants |
| Number of Positive UDS results by substance Ecstasy | 21 Participants | 26 Participants | 47 Participants |
| Number of Positive UDS results by substance Fentanyl | 200 Participants | 216 Participants | 416 Participants |
| Number of Positive UDS results by substance Marijuana | 153 Participants | 128 Participants | 281 Participants |
| Number of Positive UDS results by substance Methadone | 43 Participants | 56 Participants | 99 Participants |
| Number of Positive UDS results by substance Methamphetamine | 146 Participants | 141 Participants | 287 Participants |
| Number of Positive UDS results by substance Opiates (300 ng) | 328 Participants | 283 Participants | 611 Participants |
| Number of Positive UDS results by substance Oxycodone | 159 Participants | 139 Participants | 298 Participants |
| Overdose History Injection drug use past month | 232 Participants | 185 Participants | 417 Participants |
| Overdose History Overdosed at least once in the past 30 days | 108 Participants | 106 Participants | 214 Participants |
| Overdose History Report a medical intervention overdose | 84 Participants | 79 Participants | 163 Participants |
| Primary Medical Provider Clinic | 116 Participants | 96 Participants | 212 Participants |
| Primary Medical Provider Emergency Department or none | 217 Participants | 204 Participants | 421 Participants |
| Primary Medical Provider Not reported | 3 Participants | 2 Participants | 5 Participants |
| Primary Medical Provider Private physician office | 57 Participants | 59 Participants | 116 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 12 Participants | 15 Participants | 27 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 4 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 110 Participants | 113 Participants | 223 Participants |
| Race (NIH/OMB) More than one race | 14 Participants | 16 Participants | 30 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 47 Participants | 24 Participants | 71 Participants |
| Race (NIH/OMB) White | 206 Participants | 188 Participants | 394 Participants |
| Region of Enrollment United States | 394 participants | 362 participants | 756 participants |
| Sex: Female, Male Female | 121 Participants | 95 Participants | 216 Participants |
| Sex: Female, Male Male | 273 Participants | 267 Participants | 540 Participants |
| Unstable Housing Doubled up in someone else's house apartment | 190 Participants | 135 Participants | 325 Participants |
| Unstable Housing On the street/public place not intended for sleeping | 191 Participants | 192 Participants | 383 Participants |
| Unstable Housing Shelter for homeless persons | 102 Participants | 108 Participants | 210 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 394 | 2 / 362 |
| other Total, other adverse events | 0 / 394 | 0 / 362 |
| serious Total, serious adverse events | 0 / 394 | 0 / 362 |
Outcome results
Primary
Effectiveness
The primary effectiveness outcome is defined as the rates of patient engagement in formal addiction treatment on the 30th day post enrollment.
Time frame: 30 Days Post Enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Baseline Evaluation Period Cohort | Effectiveness | 40 Participants |
| IF Evaluation Period Cohort | Effectiveness | 59 Participants |
p-value: 0.011Regression, Logistic
Primary
Implementation (Considered the Primary Outcome)
The primary implementation outcome will be evaluated assessing the rate of ED-initiated BUP therapy with referral for ongoing MAT
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Baseline Evaluation Period Cohort | Implementation (Considered the Primary Outcome) | 2 Participants |
| IF Evaluation Period Cohort | Implementation (Considered the Primary Outcome) | 53 Participants |
p-value: <0.001Regression, Logistic
Secondary
Implementation: ED Organizational Readiness to Change Assessment (ORCA) Score
ED ORCA score relating to ED-initiated BUP with referral for ongoing MAT. Scores are dichotomized as less ready (scores 0-6) or most ready (scores 7-10).
Time frame: Pre IF (Baseline)
Population: Clinicians assessed at baseline.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Baseline Evaluation Period Cohort | Implementation: ED Organizational Readiness to Change Assessment (ORCA) Score | Most Ready | 56 Participants |
| Baseline Evaluation Period Cohort | Implementation: ED Organizational Readiness to Change Assessment (ORCA) Score | Less Ready | 212 Participants |
Other Pre-specified
Effectiveness: Healthcare Service Utilization
All Healthcare Service Utilization Inpatient and Outpatient
Time frame: 30 days post enrollment
Other Pre-specified
Effectiveness: HIV Risk
HIV risk taking behaviors (past 30 days) as measured by HIV Risk Taking Behavior Scale
Time frame: 30 days post enrollment
Other Pre-specified
Effectiveness: Illicit Opioid Urine Toxicology
Rates of illicit opioid negative urines
Time frame: 30 days post enrollment
Other Pre-specified
Effectiveness: Opioid Use
Self-reported days of illicit opioid use (past 7 days) as measured by Time-Line Follow-Back methods at 30 days
Time frame: 30 days post enrollment
Other Pre-specified
Effectiveness: Overdose Event
Overdose event (past 30 days) captured by participant self-report, state medical examiner records, National Death Index and review of medical records
Time frame: 30 days post enrollment
Other Pre-specified
Implementation: Community ORCA Score
Community opioid treatment provider/program ORCA score relating to receiving patients with OUD who have received ED-initiated BUP
Time frame: Post IF (6 months)
Other Pre-specified
Implementation: Community ORCA Score
Community opioid treatment provider/program ORCA score relating to receiving patients with OUD who have received ED-initiated BUP
Time frame: post IF Evaluation Period (12 months)
Other Pre-specified
Implementation: Community ORCA Score
Community opioid treatment provider/program ORCA score relating to receiving patients with OUD who have received ED-initiated BUP
Time frame: Pre IF (Baseline)
Other Pre-specified
Implementation: Community Readiness and Preparedness Ruler Score
Community opioid treatment provider/program readiness and preparedness ruler score to continue MAT for patients with OUD who have received ED-initiated BUP
Time frame: post IF Evaluation Period (12 months)
Other Pre-specified
Implementation: Community Readiness and Preparedness Ruler Score
Community opioid treatment provider/program readiness and preparedness ruler score to continue MAT for patients with OUD who have received ED-initiated BUP
Time frame: Pre IF (Baseline)
Other Pre-specified
Implementation: Community Readiness and Preparedness Ruler Score
Community opioid treatment provider/program readiness and preparedness ruler score to continue MAT for patients with OUD who have received ED-initiated BUP
Time frame: Post IF (6 months)
Other Pre-specified
Implementation: ED Organizational Readiness to Change Assessment (ORCA) Score
ED ORCA score relating to ED-initiated BUP with referral for ongoing MAT
Time frame: Post IF (6 months)
Other Pre-specified
Implementation: ED Organizational Readiness to Change Assessment (ORCA) Score
ED ORCA score relating to ED-initiated BUP with referral for ongoing MAT
Time frame: Post IF Evaluation Period (12 months)
Other Pre-specified
Implementation: ED Provider Readiness and Preparedness Ruler Score
ED provider readiness and preparedness ruler score to initiate BUP and provide referral for ongoing MAT
Time frame: Post IF (6 months)
Other Pre-specified
Implementation: ED Provider Readiness and Preparedness Ruler Score
ED provider readiness and preparedness ruler score to initiate BUP and provide referral for ongoing MAT
Time frame: post IF Evaluation Period (12 months)
Other Pre-specified
Implementation: ED Provider Readiness and Preparedness Ruler Score
ED provider readiness and preparedness ruler score to initiate BUP and provide referral for ongoing MAT.
Time frame: Pre IF (Baseline)
Other Pre-specified
Implementation: Fidelity
Fidelity will be measured using a critical action checklist relating to the provision of ED-initiated BUP with referral for ongoing MAT in eligible patients.
Time frame: Baseline Period (Baseline)
Other Pre-specified
Implementation: Fidelity
Fidelity will be measured using a critical action checklist relating to the provision of ED-initiated BUP with referral for ongoing MAT in eligible patients.
Time frame: IF Evaluation Period (18 months)