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| ID | Type | Description | Link |
|---|---|---|---|
| 3U2CDA050097-01S1 | U.S. NIH Grant/Contract | View source | |
| 20200548 | Other Identifier | WIRB protocol number | |
| A195010 | Other Identifier | UW Madison | |
| ENGR/CHESS PROGRAM | Other Identifier | UW Madison |
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| Name | Class |
|---|---|
| George Mason University | OTHER |
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-Dose NIATx Coaching & ECHO | Experimental |
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| Low-Dose NIATx Coaching & ECHO | Experimental |
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| High-Dose NIATx Coaching & No ECHO | Experimental |
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| Low-Dose NIATx Coaching & No ECHO | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NIATx Coaching | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline to 12 months |
| 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. | 13 months, 24 months |
| 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. | baseline to 12 months |
| 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. | 13 months to 24 months |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months, 24 months |
Site Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Todd Molfenter, PhD | University of Wisconsin, Madison | Principal Investigator |
| Faye Taxman, PhD | George Mason University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin-Madison | Madison | Wisconsin | 53706 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39901259 | Result | Molfenter T, Vechinski J, Kim JS, Zhang J, Meng L, Tveit J, Madden L, Taxman FS. Assessing the comparative effectiveness of ECHO and coaching implementation strategies in a jail/provider MOUD implementation trial. Implement Sci. 2025 Feb 3;20(1):7. doi: 10.1186/s13012-025-01419-6. |
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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).
| ID | Title | Description |
|---|---|---|
| FG000 | High-Dose NIATx Coaching & ECHO |
NIATx 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. ECHO: 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. |
| FG001 | Low-Dose NIATx Coaching & ECHO |
NIATx 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. ECHO: 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. |
| FG002 | High-Dose NIATx Coaching & No ECHO |
NIATx 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. |
| FG003 | Low-Dose NIATx Coaching & No ECHO |
NIATx 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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The overall number analyzed includes the count of staff participants consented. The overall number of units analyzed is the number of sites that started the study.
| ID | Title | Description |
|---|---|---|
| BG000 | High-Dose NIATx Coaching & ECHO |
|
| BG001 | Low-Dose NIATx Coaching & ECHO |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | New Justice Involved Persons per month | baseline to 12 months | sites | sites |
|
up to 24 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | High-Dose NIATx Coaching & ECHO |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Todd Molfenter, PhD | University of Wisconsin - Madison | 608-262-1685 | tdmolfenter@wisc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 2, 2020 | Dec 4, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 6, 2020 | Dec 4, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D000075665 | Recidivism |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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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.
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|
| ECHO | Behavioral | 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. |
|
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| baseline, 12 months, 24 months |
| baseline, 12 months, 24 months |
| Death |
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| BG002 | High-Dose NIATx Coaching & No ECHO |
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| BG003 | Low-Dose NIATx Coaching & No ECHO |
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| BG004 | Total | Total of all reporting groups |
| Sites Starting Study |
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| years |
| Participants |
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| Sex/Gender, Customized | Count of Participants | Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants | Participants |
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| Region of Enrollment | Number | participants | Participants |
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| Geographic Location of Sites | Data applies to site characteristics. | Count of Units | Sites Starting Study | Sites Starting Study |
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| Gender Served | Data applies to site characteristics. | Count of Units | Sites Starting Study | Sites Starting Study |
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| Average Daily Population (Jails only) | Data applies to site characteristics for Jails only. | Count of Units | Sites Starting Study | Sites Starting Study |
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| Average Monthly OUD Intakes (CBTP) | Data applies to site characteristics for CBTP only. | Count of Units | Sites Starting Study | Sites Starting Study |
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| Type of Healthcare Model at Jails | Data applies to site characteristics at Jails only. | Count of Units | Sites Starting Study | Sites Starting Study |
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| CBTP Arrangements with Jails | Data applies to site characteristics CBTP only. | Count of Units | Sites Starting Study | Sites Starting Study |
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| MOUD Offered at Baseline | Data applies to site characteristics. | Count of Units | Sites Starting Study | Sites Starting Study |
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| Type of Study Site | Count of Units | Sites Starting Study | Sites Starting Study |
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| OG001 | Low-Dose NIATx Coaching & ECHO |
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| OG002 | High-Dose NIATx Coaching & No ECHO |
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| OG003 | Low-Dose NIATx Coaching & No ECHO |
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|
| 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. | 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. | Posted | Mean | Standard Deviation | New Justice Involved Persons per month | 13 months, 24 months | sites | sites |
|
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|
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| 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. | 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. | Posted | Mean | Standard Deviation | Justice Involved Persons per month | baseline to 12 months | sites | sites |
|
|
|
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| 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. | 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. | Posted | Mean | Standard Deviation | Justice Involved Persons per month | 13 months to 24 months | sites | sites |
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| 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. | 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. | Posted | baseline, 12 months, 24 months |
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| 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. | Number of participants and sites included in data analysis changed through study conduct. | Posted | Mean | Standard Deviation | score on a scale | baseline, 12 months, 24 months | sites | sites |
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| 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. | Number of participants included in data analysis changed through study conduct. | Posted | Mean | Standard Deviation | score on a scale | 12 months, 24 months |
|
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|
| 0 |
| 78 |
| 0 |
| 78 |
| 0 |
| 78 |
| EG001 | Low-Dose NIATx Coaching & ECHO |
| 0 | 65 | 0 | 65 | 0 | 65 |
| EG002 | High-Dose NIATx Coaching & No ECHO |
| 1 | 60 | 0 | 60 | 0 | 60 |
| EG003 | Low-Dose NIATx Coaching & No ECHO |
| 0 | 53 | 0 | 53 | 0 | 53 |
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| D000066479 | Criminal Behavior |
| D001519 | Behavior |
| Male |
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| Unknown |
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| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Suburban |
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| Urban |
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| Female only |
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| Both |
|
| 101-250 |
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| 251-500 |
|
| greater than 500 |
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| 51-200 |
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| 201-500 |
|
| greater than 500 |
|
| unknown |
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| Contracted |
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| Hybrid |
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| Shared Written Agreements |
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| Electronic Health Record Access |
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| Referral Processes |
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| Naltrexone (injectable) |
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| Naltrexone (oral) |
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| Methadone |
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| No MOUD |
|
| Unknown |
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| Community Based Treatment Providers |
|
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|
| sites |
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| Buprenorphine |
|
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| Naltrexone |
|
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Change in new Justice Involved Person counts (Buprenorphine) for Sustainability Phase (from 13 to 24 months) |
| Mixed Models Analysis |
| 0.0008 |
a priori threshold: 0.05 |
| Slope |
| 0.642 |
| Standard Deviation |
| 0.19 |
| 2-Sided |
Slope is per month. |
| Superiority |
| Change in new patient counts (Methadone) for Sustainability Phase (from 13 to 24 months) | Mixed Models Analysis | 0.015 | a priori threshold: 0.05 | Slope | -0.377 | Standard Deviation | 0.154 | 2-Sided | Slope is per month. | Superiority |
| Change in new patient counts (Naltrexone) for Sustainability Phase (from 13 to 24 months) | Mixed Models Analysis | 0.241 | a priori threshold: 0.05 | Slope | -0.02 | Standard Deviation | 0.017 | 2-Sided | Slope is per month. | Superiority |
| sites |
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|
| Buprenorphine |
|
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| Naltrexone |
|
|
Change in census patient counts (Buprenorphine) for Intervention Phase (from baseline to 12 months) |
| Mixed Models Analysis |
| 0.00004 |
a priori threshold: 0.05 |
| Slope |
| 0.855 |
| Standard Deviation |
| 0.206 |
| 2-Sided |
Slope is per month. |
| Superiority |
| Change in census patient counts (Methadone) for Intervention Phase (from baseline to 12 months) | Mixed Models Analysis | 0.118 | a priori threshold: 0.05 | Slope | 0.322 | Standard Deviation | 0.206 | 2-Sided | Slope is per month. | Superiority |
| Change in census patient counts (Naltrexone) for Intervention Phase (from baseline to 12 months) | Mixed Models Analysis | 0.020 | a priori threshold: 0.05 | Slope | 0.073 | Standard Deviation | 0.031 | 2-Sided | Slope is per month. | Superiority |
| sites |
|
|
| Buprenorphine |
|
|
| Naltrexone |
|
|
Change in census patient counts (Buprenorphine) for Sustainability Phase (from 13 to 24 months) |
| Mixed Models Analysis |
| 0.000002 |
a priori threshold: 0.05 |
| Slope |
| 1.103 |
| Standard Deviation |
| 0.229 |
| 2-Sided |
Slope is per month. |
| Superiority |
| Change in census patient counts (Methadone) for Sustainability Phase (13 to 24 months) | Mixed Models Analysis | 0.076 | a priori threshold: 0.05 | Slope | -0.387 | Standard Deviation | 0.218 | 2-Sided | Slope is per month | Superiority |
| Change in census patient counts (Naltrexone) for Sustainability Phase (from 13 to 24 months) | Mixed Models Analysis | 0.019 | a priori threshold: 0.05 | Slope | 0.086 | Standard Deviation | 0.036 | 2-Sided | Slope is per month. | Superiority |
| sites |
|
|
| 12 months |
|
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| 24 months |
|
|
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| 24 months |
|
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