Opioid-use Disorder, Recidivism
Conditions
Keywords
MOUD, OUD, Justice Populations, Jails, ECHO, NIATx, Inter-agency
Brief summary
The grant will test two timely and successful evidence-based implementation practices, NIATx Coaching and ECHO, with jail/community-based healthcare providers to increase medication assisted treatment (MAT) use with justice populations.
Detailed description
In this trial, the investigators will test two implementation interventions being applied to medications for opioid use disorder (MOUD) dissemination and implementation in justice settings for justice-involved populations: NIATx Coaching and the Extension for Community Healthcare Outcomes (ECHO) model. NIATx Coaches provide expertise in MOUD implementation and organizational change to help treatment organizations and staff make, sustain, and spread MOUD. The ECHO platform focuses only on the provider side by connecting the primary care provider with expert MOUD prescribers to promote high-quality MOUD practices. This will be the first trial that assesses the comparative effectiveness of these approaches overall, and in justice settings. The trial will be conducted with a combination of 48 jails and community-based organizations that treat individuals with opioid use disorders (OUDs) post-incarceration. Sites will be randomly assigned to one of four study arms, with 12 sites in each arm: High-Dose Coaching/ECHO, Low-Dose Coaching/ECHO, High-Dose Coaching/No ECHO, and Low-Dose Coaching/No ECHO. The intervention period will be over a 12-month span with an additional 12-months for sustainability.
Interventions
BEHAVIORALNIATx Coaching
NIATx framework provides each participating site with a NIATx Coach who is an expert in MOUD implementation and organizational change and will help the organization adopt, implement, and increase the use of MOUD. Coaches help the sites think through key issues, offer process improvement training, and suggest changes.
BEHAVIORALECHO
The ECHO model connects MOUD prescribers and experts with primary care providers and medical teams to promote high-quality MOUD practices. ECHO is provided monthly through videoconferences. Experienced MOUD prescribers address topics such as counseling strategies, urine test interpretation, and transitioning from buprenorphine, naltrexone and methadone.
Sponsors
George Mason University
National Institute on Drug Abuse (NIDA)
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
The proposed study will implement a cluster randomized block design where staff are nested within sites. The community-based provider sites and jails will be grouped into homogeneous blocks and then randomly assigned into 2x2 factorial design for each block. The forty-eights sites will be assigned to one of four study arms using a matching strategy within the blocks that groups four jail-clinic combination together prior to randomization. Each jail and cognitive behavioral (CB) treatment provider (or clinic) in these combinations will be treated as a site.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Site Inclusion Criteria: * Have an interest in embedding or increasing the use of MOUD within their site. * Have the funds to pay for medications for the duration of the study (24 months); whether it be from grants, insurance or private pay. * Sites agree to implement or continue to use at least one medication, although they will be encouraged to offer more than one medication. * Have leadership support at all levels. * Agree to provide data described in the MOU or Information Sheet.
Exclusion criteria
* N/A
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Number of New Eligible Justice Involved Persons Initiated With MOUD Per Month: Sustainability Phase | 13 months, 24 months | The intervention reach will be measured using data gathered through organization monthly tracking sheets to track MOUD use. 'Involved persons' include those who are initiated onto any MOUD (buprenorphine, extended-release injectable naltrexone, or methadone) and engaged with MOUD use. |
| Mean Total Number of Eligible Justice Involved Persons on MOUD Per Month: Sustainability Phase | 13 months to 24 months | The intervention reach will be measured using data gathered through organization monthly tracking sheets to track MOUD use. 'Involved persons' include those who are initiated onto any MOUD (buprenorphine, extended-release injectable naltrexone, or methadone) and engaged with MOUD use. |
| Change in Number of Prescribers Using MOUD | baseline, 12 months, 24 months | The adoption of each intervention will be in part measured by tracking the number of prescribers using MOUD at each time point. |
| Mean Number of New Eligible Justice Involved Persons Initiated With MOUD Per Month: Intervention Phase | baseline to 12 months | The intervention reach will be measured using data gathered through organization monthly tracking sheets to track MOUD use. 'Involved persons' include those who are initiated onto any MOUD (buprenorphine, extended-release injectable naltrexone, or methadone) and engaged with MOUD use. |
| Mean Total Number of Eligible Justice Involved Persons on MOUD Per Month: Intervention Phase | baseline to 12 months | The intervention reach will be measured using data gathered through organization monthly tracking sheets to track MOUD use. 'Involved persons' include those who are initiated onto any MOUD (buprenorphine, extended-release injectable naltrexone, or methadone) and engaged with MOUD use. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MOUD Sustainability Measured Using the Program Sustainability Assessment Tool | baseline, 12 months, 24 months | The maintenance of the intervention (MOUD Sustainability) will be measured using the Program Sustainability Assessment Tool included in the Staff Survey at three points during the study (baseline, 12-months & 24-months) to determine if likelihood of sustainability increases as study progresses. This tool has a total possible range of scores from 0-63 with higher scores indicating increased sustainability of the intervention. |
Other
| Measure | Time frame | Description |
|---|---|---|
| NIATx Fidelity | 12 months, 24 months | Assess fidelity to the NIATx implementation strategies at two points during the study using a 10-item measure with scores ranging from 0-40 with higher scores indicating stronger fidelity of the intervention. |
Countries
United States
Participant flow
Recruitment details
48 sites were recruited, 38 (25 jails & 13 Community based treatment provider (CBTP) sites completed the study (sites per intervention listed in the participant flow). Consenting Participants are staff at the sites who provided data, including counts of people prescribed medications for opioid use disorder (MOUD) at their sites (see outcome measures for this data).
Participants by arm
| Arm | Count |
|---|---|
| High-Dose NIATx Coaching & ECHO * Four-hour, Virtual Kick-Off Meeting split into two days with Study Team & Coaches
* 12 monthly (one-hour) coaching calls with Change Leader/Team
* Prescribers participate in 12 monthly (one-hour) scheduled video conference calls | 78 |
| High-Dose NIATx Coaching & ECHO * Four-hour, Virtual Kick-Off Meeting split into two days with Study Team & Coaches
* 12 monthly (one-hour) coaching calls with Change Leader/Team
* Prescribers participate in 12 monthly (one-hour) scheduled video conference calls | 14 |
| Low-Dose NIATx Coaching & ECHO * Four-hour, Virtual Kick-Off Meeting split into two days with Study Team & Coaches
* Four (one-hour) coaching calls at months 1, 4, 8, and 12 with Change Leader/Team
* Prescribers participate in 12 monthly (one-hour) scheduled video conference calls | 65 |
| Low-Dose NIATx Coaching & ECHO * Four-hour, Virtual Kick-Off Meeting split into two days with Study Team & Coaches
* Four (one-hour) coaching calls at months 1, 4, 8, and 12 with Change Leader/Team
* Prescribers participate in 12 monthly (one-hour) scheduled video conference calls | 11 |
| High-Dose NIATx Coaching & No ECHO * Four-hour, Virtual Kick-Off Meeting split into two days with Study Team & Coaches
* 12 monthly (one-hour) coaching calls with Change Leader/Team | 60 |
| High-Dose NIATx Coaching & No ECHO * Four-hour, Virtual Kick-Off Meeting split into two days with Study Team & Coaches
* 12 monthly (one-hour) coaching calls with Change Leader/Team | 10 |
| Low-Dose NIATx Coaching & No ECHO * Four-hour, Virtual Kick-Off Meeting split into two days with Study Team & Coaches
* Four (one-hour) coaching calls at months 1, 4, 8, and 12 with Change Leader/Team | 53 |
| Low-Dose NIATx Coaching & No ECHO * Four-hour, Virtual Kick-Off Meeting split into two days with Study Team & Coaches
* Four (one-hour) coaching calls at months 1, 4, 8, and 12 with Change Leader/Team | 13 |
| Total | 304 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 0 | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 43 | 42 | 24 | 29 |
Baseline characteristics
| Characteristic | Total | High-Dose NIATx Coaching & ECHO | Low-Dose NIATx Coaching & ECHO | High-Dose NIATx Coaching & No ECHO | Low-Dose NIATx Coaching & No ECHO |
|---|---|---|---|---|---|
| Age, Continuous | 46 years | 46 years | 42 years | 46 years | 46 years |
| Average Daily Population (Jails only) 101-250 | 10 Sites Starting Study | 1 Sites Starting Study | 3 Sites Starting Study | 1 Sites Starting Study | 5 Sites Starting Study |
| Average Daily Population (Jails only) 251-500 | 6 Sites Starting Study | 2 Sites Starting Study | 0 Sites Starting Study | 3 Sites Starting Study | 1 Sites Starting Study |
| Average Daily Population (Jails only) greater than 500 | 7 Sites Starting Study | 4 Sites Starting Study | 1 Sites Starting Study | 1 Sites Starting Study | 1 Sites Starting Study |
| Average Daily Population (Jails only) less than 100 | 6 Sites Starting Study | 1 Sites Starting Study | 3 Sites Starting Study | 2 Sites Starting Study | 0 Sites Starting Study |
| Average Monthly OUD Intakes (CBTP) 201-500 | 1 Sites Starting Study | 0 Sites Starting Study | 0 Sites Starting Study | 1 Sites Starting Study | 0 Sites Starting Study |
| Average Monthly OUD Intakes (CBTP) 51-200 | 3 Sites Starting Study | 0 Sites Starting Study | 2 Sites Starting Study | 1 Sites Starting Study | 0 Sites Starting Study |
| Average Monthly OUD Intakes (CBTP) greater than 500 | 1 Sites Starting Study | 0 Sites Starting Study | 0 Sites Starting Study | 0 Sites Starting Study | 1 Sites Starting Study |
| Average Monthly OUD Intakes (CBTP) less than 50 | 7 Sites Starting Study | 3 Sites Starting Study | 0 Sites Starting Study | 1 Sites Starting Study | 3 Sites Starting Study |
| Average Monthly OUD Intakes (CBTP) unknown | 7 Sites Starting Study | 3 Sites Starting Study | 2 Sites Starting Study | 0 Sites Starting Study | 2 Sites Starting Study |
| CBTP Arrangements with Jails Electronic Health Record Access | 4 Sites Starting Study | 2 Sites Starting Study | 0 Sites Starting Study | 2 Sites Starting Study | 0 Sites Starting Study |
| CBTP Arrangements with Jails Joint Staffings | 7 Sites Starting Study | 3 Sites Starting Study | 1 Sites Starting Study | 1 Sites Starting Study | 2 Sites Starting Study |
| CBTP Arrangements with Jails Referral Processes | 13 Sites Starting Study | 3 Sites Starting Study | 3 Sites Starting Study | 3 Sites Starting Study | 4 Sites Starting Study |
| CBTP Arrangements with Jails Shared Written Agreements | 11 Sites Starting Study | 3 Sites Starting Study | 2 Sites Starting Study | 3 Sites Starting Study | 3 Sites Starting Study |
| Ethnicity (NIH/OMB) Hispanic or Latino | 15 Participants | 5 Participants | 9 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 224 Participants | 64 Participants | 52 Participants | 59 Participants | 49 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 17 Participants | 9 Participants | 4 Participants | 1 Participants | 3 Participants |
| Gender Served Both | 47 Sites Starting Study | 14 Sites Starting Study | 10 Sites Starting Study | 10 Sites Starting Study | 13 Sites Starting Study |
| Gender Served Female only | 0 Sites Starting Study | 0 Sites Starting Study | 0 Sites Starting Study | 0 Sites Starting Study | 0 Sites Starting Study |
| Gender Served Male only | 1 Sites Starting Study | 0 Sites Starting Study | 1 Sites Starting Study | 0 Sites Starting Study | 0 Sites Starting Study |
| Geographic Location of Sites Rural | 15 Sites Starting Study | 3 Sites Starting Study | 5 Sites Starting Study | 4 Sites Starting Study | 3 Sites Starting Study |
| Geographic Location of Sites Suburban | 13 Sites Starting Study | 1 Sites Starting Study | 3 Sites Starting Study | 3 Sites Starting Study | 6 Sites Starting Study |
| Geographic Location of Sites Urban | 20 Sites Starting Study | 10 Sites Starting Study | 3 Sites Starting Study | 3 Sites Starting Study | 4 Sites Starting Study |
| MOUD Offered at Baseline Buprenorphine/Naloxone | 36 Sites Starting Study | 10 Sites Starting Study | 8 Sites Starting Study | 7 Sites Starting Study | 11 Sites Starting Study |
| MOUD Offered at Baseline Methadone | 18 Sites Starting Study | 7 Sites Starting Study | 3 Sites Starting Study | 6 Sites Starting Study | 2 Sites Starting Study |
| MOUD Offered at Baseline Naltrexone (injectable) | 30 Sites Starting Study | 8 Sites Starting Study | 10 Sites Starting Study | 5 Sites Starting Study | 7 Sites Starting Study |
| MOUD Offered at Baseline Naltrexone (oral) | 22 Sites Starting Study | 6 Sites Starting Study | 4 Sites Starting Study | 6 Sites Starting Study | 6 Sites Starting Study |
| MOUD Offered at Baseline No MOUD | 1 Sites Starting Study | 0 Sites Starting Study | 0 Sites Starting Study | 1 Sites Starting Study | 0 Sites Starting Study |
| MOUD Offered at Baseline Unknown | 2 Sites Starting Study | 1 Sites Starting Study | 0 Sites Starting Study | 0 Sites Starting Study | 1 Sites Starting Study |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 10 Participants | 7 Participants | 0 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 36 Participants | 17 Participants | 2 Participants | 10 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 11 Participants | 4 Participants | 5 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 4 Participants | 2 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 26 Participants | 11 Participants | 7 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) White | 169 Participants | 37 Participants | 50 Participants | 44 Participants | 38 Participants |
| Region of Enrollment United States | 256 participants | 78 participants | 65 participants | 60 participants | 53 participants |
| Sex/Gender, Customized Female | 146 Participants | 45 Participants | 39 Participants | 32 Participants | 30 Participants |
| Sex/Gender, Customized Male | 92 Participants | 23 Participants | 22 Participants | 27 Participants | 20 Participants |
| Sex/Gender, Customized Unknown | 18 Participants | 10 Participants | 4 Participants | 1 Participants | 3 Participants |
| Type of Healthcare Model at Jails Contracted | 13 Sites Starting Study | 4 Sites Starting Study | 4 Sites Starting Study | 1 Sites Starting Study | 4 Sites Starting Study |
| Type of Healthcare Model at Jails Direct | 7 Sites Starting Study | 3 Sites Starting Study | 2 Sites Starting Study | 1 Sites Starting Study | 1 Sites Starting Study |
| Type of Healthcare Model at Jails Hybrid | 9 Sites Starting Study | 1 Sites Starting Study | 1 Sites Starting Study | 5 Sites Starting Study | 2 Sites Starting Study |
| Type of Study Site Community Based Treatment Providers | 19 Sites Starting Study | 6 Sites Starting Study | 4 Sites Starting Study | 3 Sites Starting Study | 6 Sites Starting Study |
| Type of Study Site Jails | 29 Sites Starting Study | 8 Sites Starting Study | 7 Sites Starting Study | 7 Sites Starting Study | 7 Sites Starting Study |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 78 | 0 / 65 | 1 / 60 | 0 / 53 |
| other Total, other adverse events | 0 / 78 | 0 / 65 | 0 / 60 | 0 / 53 |
| serious Total, serious adverse events | 0 / 78 | 0 / 65 | 0 / 60 | 0 / 53 |
Outcome results
Primary
Change in Number of Prescribers Using MOUD
The adoption of each intervention will be in part measured by tracking the number of prescribers using MOUD at each time point.
Time frame: baseline, 12 months, 24 months
Population: Data was not collected for this outcome. This outcome was determined to not be a key variable at study start and should have been removed from the protocol. It was apparent from listening to sites that increasing the number of prescribers was not a goal as they were already encountering high turnover rates and staffing.
| Arm | Measure | Group | Value |
|---|---|---|---|
| Unknown | Change in Number of Prescribers Using MOUD | baseline | — |
| Unknown | Change in Number of Prescribers Using MOUD | 12 months | — |
| Unknown | Change in Number of Prescribers Using MOUD | 24 months | — |
Primary
Mean Number of New Eligible Justice Involved Persons Initiated With MOUD Per Month: Intervention Phase
The intervention reach will be measured using data gathered through organization monthly tracking sheets to track MOUD use. 'Involved persons' include those who are initiated onto any MOUD (buprenorphine, extended-release injectable naltrexone, or methadone) and engaged with MOUD use.
Time frame: baseline to 12 months
Population: The Overall Number of Participants Analyzed reported are justice involved individuals staff (who were not consented and enrolled). Staff (consented participants) collected counts of justice involved individuals with various MOUD from their sites. Not all sites provided all three forms of medication at all times. Due to lack of tracking systems in the jail, some sites were only able to provide one of the two monthly counts.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High-Dose NIATx Coaching & ECHO | Mean Number of New Eligible Justice Involved Persons Initiated With MOUD Per Month: Intervention Phase | Naltrexone | 0.19 New Justice Involved Persons per month | Standard Deviation 0.28 |
| High-Dose NIATx Coaching & ECHO | Mean Number of New Eligible Justice Involved Persons Initiated With MOUD Per Month: Intervention Phase | Buprenorphine | 21.79 New Justice Involved Persons per month | Standard Deviation 28.5 |
| High-Dose NIATx Coaching & ECHO | Mean Number of New Eligible Justice Involved Persons Initiated With MOUD Per Month: Intervention Phase | Methadone | 20.36 New Justice Involved Persons per month | Standard Deviation 51.31 |
| Low-Dose NIATx Coaching & ECHO | Mean Number of New Eligible Justice Involved Persons Initiated With MOUD Per Month: Intervention Phase | Buprenorphine | 3.00 New Justice Involved Persons per month | Standard Deviation 4.05 |
| Low-Dose NIATx Coaching & ECHO | Mean Number of New Eligible Justice Involved Persons Initiated With MOUD Per Month: Intervention Phase | Methadone | 0.55 New Justice Involved Persons per month | Standard Deviation 1.57 |
| Low-Dose NIATx Coaching & ECHO | Mean Number of New Eligible Justice Involved Persons Initiated With MOUD Per Month: Intervention Phase | Naltrexone | 0.33 New Justice Involved Persons per month | Standard Deviation 0.42 |
| High-Dose NIATx Coaching & No ECHO | Mean Number of New Eligible Justice Involved Persons Initiated With MOUD Per Month: Intervention Phase | Methadone | 4.47 New Justice Involved Persons per month | Standard Deviation 9.63 |
| High-Dose NIATx Coaching & No ECHO | Mean Number of New Eligible Justice Involved Persons Initiated With MOUD Per Month: Intervention Phase | Buprenorphine | 5.01 New Justice Involved Persons per month | Standard Deviation 2.98 |
| High-Dose NIATx Coaching & No ECHO | Mean Number of New Eligible Justice Involved Persons Initiated With MOUD Per Month: Intervention Phase | Naltrexone | 0.44 New Justice Involved Persons per month | Standard Deviation 0.86 |
| Low-Dose NIATx Coaching & No ECHO | Mean Number of New Eligible Justice Involved Persons Initiated With MOUD Per Month: Intervention Phase | Buprenorphine | 17.43 New Justice Involved Persons per month | Standard Deviation 25.56 |
| Low-Dose NIATx Coaching & No ECHO | Mean Number of New Eligible Justice Involved Persons Initiated With MOUD Per Month: Intervention Phase | Naltrexone | 1.37 New Justice Involved Persons per month | Standard Deviation 2.05 |
| Low-Dose NIATx Coaching & No ECHO | Mean Number of New Eligible Justice Involved Persons Initiated With MOUD Per Month: Intervention Phase | Methadone | 2.03 New Justice Involved Persons per month | Standard Deviation 5.57 |
Comparison: Change in new patient counts (Combined MOUD) for Intervention Phase (from baseline to 12 months)p-value: 0.002Mixed Models Analysis
Comparison: Change in new patient counts (Buprenorphine) for Intervention Phase (from baseline to 12 months)p-value: 0.0008Mixed Models Analysis
Comparison: Change in new patient counts (Methadone) for Intervention Phase (from baseline to 12 months)p-value: 0.111Mixed Models Analysis
Comparison: Change in new patient counts (Naltrexone) for Intervention Phase (from baseline to 12 months)p-value: 0.235Mixed Models Analysis
Primary
Mean Number of New Eligible Justice Involved Persons Initiated With MOUD Per Month: Sustainability Phase
The intervention reach will be measured using data gathered through organization monthly tracking sheets to track MOUD use. 'Involved persons' include those who are initiated onto any MOUD (buprenorphine, extended-release injectable naltrexone, or methadone) and engaged with MOUD use.
Time frame: 13 months, 24 months
Population: The Overall Number of Participants Analyzed reported are justice involved individuals staff (who were not consented and enrolled). Staff (consented participants) collected counts of justice involved individuals with various MOUD from their sites. Not all sites provided all three forms of medication at all times. Due to lack of tracking systems in the jail, some sites were only able to provide one of the two monthly counts.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High-Dose NIATx Coaching & ECHO | Mean Number of New Eligible Justice Involved Persons Initiated With MOUD Per Month: Sustainability Phase | Methadone | 28.29 New Justice Involved Persons per month | Standard Deviation 75.24 |
| High-Dose NIATx Coaching & ECHO | Mean Number of New Eligible Justice Involved Persons Initiated With MOUD Per Month: Sustainability Phase | Naltrexone | 0.09 New Justice Involved Persons per month | Standard Deviation 0.13 |
| High-Dose NIATx Coaching & ECHO | Mean Number of New Eligible Justice Involved Persons Initiated With MOUD Per Month: Sustainability Phase | Buprenorphine | 30.37 New Justice Involved Persons per month | Standard Deviation 35.77 |
| Low-Dose NIATx Coaching & ECHO | Mean Number of New Eligible Justice Involved Persons Initiated With MOUD Per Month: Sustainability Phase | Methadone | 0.01 New Justice Involved Persons per month | Standard Deviation 0.03 |
| Low-Dose NIATx Coaching & ECHO | Mean Number of New Eligible Justice Involved Persons Initiated With MOUD Per Month: Sustainability Phase | Naltrexone | 1.32 New Justice Involved Persons per month | Standard Deviation 1.59 |
| Low-Dose NIATx Coaching & ECHO | Mean Number of New Eligible Justice Involved Persons Initiated With MOUD Per Month: Sustainability Phase | Buprenorphine | 3.3 New Justice Involved Persons per month | Standard Deviation 4.4 |
| High-Dose NIATx Coaching & No ECHO | Mean Number of New Eligible Justice Involved Persons Initiated With MOUD Per Month: Sustainability Phase | Buprenorphine | 7.89 New Justice Involved Persons per month | Standard Deviation 3.18 |
| High-Dose NIATx Coaching & No ECHO | Mean Number of New Eligible Justice Involved Persons Initiated With MOUD Per Month: Sustainability Phase | Methadone | 4.67 New Justice Involved Persons per month | Standard Deviation 6.6 |
| High-Dose NIATx Coaching & No ECHO | Mean Number of New Eligible Justice Involved Persons Initiated With MOUD Per Month: Sustainability Phase | Naltrexone | 0.71 New Justice Involved Persons per month | Standard Deviation 0.79 |
| Low-Dose NIATx Coaching & No ECHO | Mean Number of New Eligible Justice Involved Persons Initiated With MOUD Per Month: Sustainability Phase | Methadone | 2.41 New Justice Involved Persons per month | Standard Deviation 6.31 |
| Low-Dose NIATx Coaching & No ECHO | Mean Number of New Eligible Justice Involved Persons Initiated With MOUD Per Month: Sustainability Phase | Naltrexone | 0.79 New Justice Involved Persons per month | Standard Deviation 1.01 |
| Low-Dose NIATx Coaching & No ECHO | Mean Number of New Eligible Justice Involved Persons Initiated With MOUD Per Month: Sustainability Phase | Buprenorphine | 32.32 New Justice Involved Persons per month | Standard Deviation 60.72 |
Comparison: Change in new patient counts (Combined MOUD) for Sustainability Phase (from 13 to 24 months)p-value: 0.485Mixed Models Analysis
Comparison: Change in new Justice Involved Person counts (Buprenorphine) for Sustainability Phase (from 13 to 24 months)p-value: 0.0008Mixed Models Analysis
Comparison: Change in new patient counts (Methadone) for Sustainability Phase (from 13 to 24 months)p-value: 0.015Mixed Models Analysis
Comparison: Change in new patient counts (Naltrexone) for Sustainability Phase (from 13 to 24 months)p-value: 0.241Mixed Models Analysis
Primary
Mean Total Number of Eligible Justice Involved Persons on MOUD Per Month: Intervention Phase
The intervention reach will be measured using data gathered through organization monthly tracking sheets to track MOUD use. 'Involved persons' include those who are initiated onto any MOUD (buprenorphine, extended-release injectable naltrexone, or methadone) and engaged with MOUD use.
Time frame: baseline to 12 months
Population: The Overall Number of Participants Analyzed reported are justice involved individuals staff (who were not consented and enrolled). Staff (consented participants) collected counts of justice involved individuals with various MOUD from their sites. Not all sites provided all three forms of medication at all times. Due to lack of tracking systems in the jail, some sites were only able to provide one of the two monthly counts.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High-Dose NIATx Coaching & ECHO | Mean Total Number of Eligible Justice Involved Persons on MOUD Per Month: Intervention Phase | Naltrexone | 0.24 Justice Involved Persons per month | Standard Deviation 0.34 |
| High-Dose NIATx Coaching & ECHO | Mean Total Number of Eligible Justice Involved Persons on MOUD Per Month: Intervention Phase | Methadone | 98.73 Justice Involved Persons per month | Standard Deviation 216.36 |
| High-Dose NIATx Coaching & ECHO | Mean Total Number of Eligible Justice Involved Persons on MOUD Per Month: Intervention Phase | Buprenorphine | 104.07 Justice Involved Persons per month | Standard Deviation 145.32 |
| Low-Dose NIATx Coaching & ECHO | Mean Total Number of Eligible Justice Involved Persons on MOUD Per Month: Intervention Phase | Buprenorphine | 117.62 Justice Involved Persons per month | Standard Deviation 190.42 |
| Low-Dose NIATx Coaching & ECHO | Mean Total Number of Eligible Justice Involved Persons on MOUD Per Month: Intervention Phase | Methadone | 0.08 Justice Involved Persons per month | Standard Deviation 0.35 |
| Low-Dose NIATx Coaching & ECHO | Mean Total Number of Eligible Justice Involved Persons on MOUD Per Month: Intervention Phase | Naltrexone | 2.60 Justice Involved Persons per month | Standard Deviation 5.29 |
| High-Dose NIATx Coaching & No ECHO | Mean Total Number of Eligible Justice Involved Persons on MOUD Per Month: Intervention Phase | Naltrexone | 5.81 Justice Involved Persons per month | Standard Deviation 15.04 |
| High-Dose NIATx Coaching & No ECHO | Mean Total Number of Eligible Justice Involved Persons on MOUD Per Month: Intervention Phase | Methadone | 56.58 Justice Involved Persons per month | Standard Deviation 158.4 |
| High-Dose NIATx Coaching & No ECHO | Mean Total Number of Eligible Justice Involved Persons on MOUD Per Month: Intervention Phase | Buprenorphine | 36.50 Justice Involved Persons per month | Standard Deviation 45.29 |
| Low-Dose NIATx Coaching & No ECHO | Mean Total Number of Eligible Justice Involved Persons on MOUD Per Month: Intervention Phase | Buprenorphine | 60.57 Justice Involved Persons per month | Standard Deviation 105.31 |
| Low-Dose NIATx Coaching & No ECHO | Mean Total Number of Eligible Justice Involved Persons on MOUD Per Month: Intervention Phase | Methadone | 0.94 Justice Involved Persons per month | Standard Deviation 1.8 |
| Low-Dose NIATx Coaching & No ECHO | Mean Total Number of Eligible Justice Involved Persons on MOUD Per Month: Intervention Phase | Naltrexone | 3.21 Justice Involved Persons per month | Standard Deviation 6.16 |
Comparison: Change in census patient counts (Combined MOUD) for Intervention Phase (from baseline to 12 months)p-value: 0.00002Mixed Models Analysis
Comparison: Change in census patient counts (Buprenorphine) for Intervention Phase (from baseline to 12 months)p-value: 0.00004Mixed Models Analysis
Comparison: Change in census patient counts (Methadone) for Intervention Phase (from baseline to 12 months)p-value: 0.118Mixed Models Analysis
Comparison: Change in census patient counts (Naltrexone) for Intervention Phase (from baseline to 12 months)p-value: 0.02Mixed Models Analysis
Primary
Mean Total Number of Eligible Justice Involved Persons on MOUD Per Month: Sustainability Phase
The intervention reach will be measured using data gathered through organization monthly tracking sheets to track MOUD use. 'Involved persons' include those who are initiated onto any MOUD (buprenorphine, extended-release injectable naltrexone, or methadone) and engaged with MOUD use.
Time frame: 13 months to 24 months
Population: The Overall Number of Participants Analyzed reported are justice involved individuals staff (who were not consented and enrolled). Staff (consented participants) collected counts of justice involved individuals with various MOUD from their sites. Not all sites provided all three forms of medication at all times. Due to lack of tracking systems in the jail, some sites were only able to provide one of the two monthly counts.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High-Dose NIATx Coaching & ECHO | Mean Total Number of Eligible Justice Involved Persons on MOUD Per Month: Sustainability Phase | Buprenorphine | 127.32 Justice Involved Persons per month | Standard Deviation 177.17 |
| High-Dose NIATx Coaching & ECHO | Mean Total Number of Eligible Justice Involved Persons on MOUD Per Month: Sustainability Phase | Naltrexone | 0.22 Justice Involved Persons per month | Standard Deviation 0.31 |
| High-Dose NIATx Coaching & ECHO | Mean Total Number of Eligible Justice Involved Persons on MOUD Per Month: Sustainability Phase | Methadone | 110.19 Justice Involved Persons per month | Standard Deviation 219.28 |
| Low-Dose NIATx Coaching & ECHO | Mean Total Number of Eligible Justice Involved Persons on MOUD Per Month: Sustainability Phase | Methadone | 0.01 Justice Involved Persons per month | Standard Deviation 0.03 |
| Low-Dose NIATx Coaching & ECHO | Mean Total Number of Eligible Justice Involved Persons on MOUD Per Month: Sustainability Phase | Naltrexone | 1.67 Justice Involved Persons per month | Standard Deviation 1.56 |
| Low-Dose NIATx Coaching & ECHO | Mean Total Number of Eligible Justice Involved Persons on MOUD Per Month: Sustainability Phase | Buprenorphine | 154.78 Justice Involved Persons per month | Standard Deviation 227.42 |
| High-Dose NIATx Coaching & No ECHO | Mean Total Number of Eligible Justice Involved Persons on MOUD Per Month: Sustainability Phase | Buprenorphine | 43.71 Justice Involved Persons per month | Standard Deviation 43.31 |
| High-Dose NIATx Coaching & No ECHO | Mean Total Number of Eligible Justice Involved Persons on MOUD Per Month: Sustainability Phase | Methadone | 77.22 Justice Involved Persons per month | Standard Deviation 183.37 |
| High-Dose NIATx Coaching & No ECHO | Mean Total Number of Eligible Justice Involved Persons on MOUD Per Month: Sustainability Phase | Naltrexone | 10.86 Justice Involved Persons per month | Standard Deviation 18.72 |
| Low-Dose NIATx Coaching & No ECHO | Mean Total Number of Eligible Justice Involved Persons on MOUD Per Month: Sustainability Phase | Methadone | 1.96 Justice Involved Persons per month | Standard Deviation 3.71 |
| Low-Dose NIATx Coaching & No ECHO | Mean Total Number of Eligible Justice Involved Persons on MOUD Per Month: Sustainability Phase | Naltrexone | 3.7 Justice Involved Persons per month | Standard Deviation 6.44 |
| Low-Dose NIATx Coaching & No ECHO | Mean Total Number of Eligible Justice Involved Persons on MOUD Per Month: Sustainability Phase | Buprenorphine | 78.24 Justice Involved Persons per month | Standard Deviation 136.17 |
Comparison: Change in census patient counts (Combined MOUD) for Sustainability Phase (from 13 to 24 months)p-value: 0.045Mixed Models Analysis
Comparison: Change in census patient counts (Buprenorphine) for Sustainability Phase (from 13 to 24 months)p-value: 0.000002Mixed Models Analysis
Comparison: Change in census patient counts (Methadone) for Sustainability Phase (13 to 24 months)p-value: 0.076Mixed Models Analysis
Comparison: Change in census patient counts (Naltrexone) for Sustainability Phase (from 13 to 24 months)p-value: 0.019Mixed Models Analysis
Secondary
MOUD Sustainability Measured Using the Program Sustainability Assessment Tool
The maintenance of the intervention (MOUD Sustainability) will be measured using the Program Sustainability Assessment Tool included in the Staff Survey at three points during the study (baseline, 12-months & 24-months) to determine if likelihood of sustainability increases as study progresses. This tool has a total possible range of scores from 0-63 with higher scores indicating increased sustainability of the intervention.
Time frame: baseline, 12 months, 24 months
Population: Number of participants and sites included in data analysis changed through study conduct.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High-Dose NIATx Coaching & ECHO | MOUD Sustainability Measured Using the Program Sustainability Assessment Tool | 12 months | 50.71429 score on a scale | Standard Deviation 8.827025 |
| High-Dose NIATx Coaching & ECHO | MOUD Sustainability Measured Using the Program Sustainability Assessment Tool | 24 months | 51.51429 score on a scale | Standard Deviation 13.18504 |
| High-Dose NIATx Coaching & ECHO | MOUD Sustainability Measured Using the Program Sustainability Assessment Tool | baseline | 44.79487 score on a scale | Standard Deviation 17.88808 |
| Low-Dose NIATx Coaching & ECHO | MOUD Sustainability Measured Using the Program Sustainability Assessment Tool | 12 months | 50.78571 score on a scale | Standard Deviation 8.252304 |
| Low-Dose NIATx Coaching & ECHO | MOUD Sustainability Measured Using the Program Sustainability Assessment Tool | 24 months | 49.30435 score on a scale | Standard Deviation 8.704413 |
| Low-Dose NIATx Coaching & ECHO | MOUD Sustainability Measured Using the Program Sustainability Assessment Tool | baseline | 43.75385 score on a scale | Standard Deviation 15.68342 |
| High-Dose NIATx Coaching & No ECHO | MOUD Sustainability Measured Using the Program Sustainability Assessment Tool | baseline | 43.16667 score on a scale | Standard Deviation 14.61386 |
| High-Dose NIATx Coaching & No ECHO | MOUD Sustainability Measured Using the Program Sustainability Assessment Tool | 12 months | 45.95556 score on a scale | Standard Deviation 10.73642 |
| High-Dose NIATx Coaching & No ECHO | MOUD Sustainability Measured Using the Program Sustainability Assessment Tool | 24 months | 48.37143 score on a scale | Standard Deviation 11.95847 |
| Low-Dose NIATx Coaching & No ECHO | MOUD Sustainability Measured Using the Program Sustainability Assessment Tool | 12 months | 51.61905 score on a scale | Standard Deviation 10.70736 |
| Low-Dose NIATx Coaching & No ECHO | MOUD Sustainability Measured Using the Program Sustainability Assessment Tool | 24 months | 53.70833 score on a scale | Standard Deviation 14.0077 |
| Low-Dose NIATx Coaching & No ECHO | MOUD Sustainability Measured Using the Program Sustainability Assessment Tool | baseline | 43.96226 score on a scale | Standard Deviation 12.7701 |
Other Pre-specified
NIATx Fidelity
Assess fidelity to the NIATx implementation strategies at two points during the study using a 10-item measure with scores ranging from 0-40 with higher scores indicating stronger fidelity of the intervention.
Time frame: 12 months, 24 months
Population: Number of participants included in data analysis changed through study conduct.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High-Dose NIATx Coaching & ECHO | NIATx Fidelity | 12 months | 24.2381 score on a scale | Standard Deviation 6.449842 |
| High-Dose NIATx Coaching & ECHO | NIATx Fidelity | 24 months | 24.57143 score on a scale | Standard Deviation 5.494841 |
| Low-Dose NIATx Coaching & ECHO | NIATx Fidelity | 12 months | 25.39286 score on a scale | Standard Deviation 4.474945 |
| Low-Dose NIATx Coaching & ECHO | NIATx Fidelity | 24 months | 23.13043 score on a scale | Standard Deviation 4.07101 |
| High-Dose NIATx Coaching & No ECHO | NIATx Fidelity | 24 months | 24.62857 score on a scale | Standard Deviation 7.272372 |
| High-Dose NIATx Coaching & No ECHO | NIATx Fidelity | 12 months | 24.11111 score on a scale | Standard Deviation 6.544332 |
| Low-Dose NIATx Coaching & No ECHO | NIATx Fidelity | 24 months | 27.16667 score on a scale | Standard Deviation 6.112472 |
| Low-Dose NIATx Coaching & No ECHO | NIATx Fidelity | 12 months | 24.71429 score on a scale | Standard Deviation 5.917287 |