Trial Outcomes & Findings for Fostering MAT Use in Justice Populations (NCT NCT04363320)

NCT ID: NCT04363320

Last Updated: 2025-05-28

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

256 participants

Primary outcome timeframe

baseline to 12 months

Results posted on

2025-05-28

Participant Flow

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).

Unit of analysis: Sites

Participant milestones

Participant milestones
Measure
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 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.
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 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.
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 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.
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 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.
Overall Study
STARTED
78 14
65 11
60 10
53 13
Overall Study
COMPLETED
35 9
23 10
35 9
24 10
Overall Study
NOT COMPLETED
43 5
42 1
25 1
29 3

Reasons for withdrawal

Reasons for withdrawal
Measure
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 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.
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 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.
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 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.
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 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.
Overall Study
Lost to Follow-up
43
42
24
29
Overall Study
Death
0
0
1
0

Baseline Characteristics

Data applies to site characteristics.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
High-Dose NIATx Coaching & ECHO
n=14 Sites Starting Study
* 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
Low-Dose NIATx Coaching & ECHO
n=11 Sites Starting Study
* 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
High-Dose NIATx Coaching & No ECHO
n=10 Sites Starting Study
* Four-hour, Virtual Kick-Off Meeting split into two days with Study Team \& Coaches * 12 monthly (one-hour) coaching calls with Change Leader/Team
Low-Dose NIATx Coaching & No ECHO
n=13 Sites Starting Study
* 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
Total
n=48 Sites Starting Study
Total of all reporting groups
Age, Continuous
46 years
n=78 Participants
42 years
n=65 Participants
46 years
n=60 Participants
46 years
n=53 Participants
46 years
n=256 Participants
Sex/Gender, Customized
Female
45 Participants
n=78 Participants
39 Participants
n=65 Participants
32 Participants
n=60 Participants
30 Participants
n=53 Participants
146 Participants
n=256 Participants
Sex/Gender, Customized
Male
23 Participants
n=78 Participants
22 Participants
n=65 Participants
27 Participants
n=60 Participants
20 Participants
n=53 Participants
92 Participants
n=256 Participants
Sex/Gender, Customized
Unknown
10 Participants
n=78 Participants
4 Participants
n=65 Participants
1 Participants
n=60 Participants
3 Participants
n=53 Participants
18 Participants
n=256 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
5 Participants
n=78 Participants
9 Participants
n=65 Participants
0 Participants
n=60 Participants
1 Participants
n=53 Participants
15 Participants
n=256 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
64 Participants
n=78 Participants
52 Participants
n=65 Participants
59 Participants
n=60 Participants
49 Participants
n=53 Participants
224 Participants
n=256 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
9 Participants
n=78 Participants
4 Participants
n=65 Participants
1 Participants
n=60 Participants
3 Participants
n=53 Participants
17 Participants
n=256 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=78 Participants
0 Participants
n=65 Participants
0 Participants
n=60 Participants
0 Participants
n=53 Participants
0 Participants
n=256 Participants
Race (NIH/OMB)
Asian
7 Participants
n=78 Participants
0 Participants
n=65 Participants
0 Participants
n=60 Participants
3 Participants
n=53 Participants
10 Participants
n=256 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
2 Participants
n=78 Participants
1 Participants
n=65 Participants
0 Participants
n=60 Participants
1 Participants
n=53 Participants
4 Participants
n=256 Participants
Race (NIH/OMB)
Black or African American
17 Participants
n=78 Participants
2 Participants
n=65 Participants
10 Participants
n=60 Participants
7 Participants
n=53 Participants
36 Participants
n=256 Participants
Race (NIH/OMB)
White
37 Participants
n=78 Participants
50 Participants
n=65 Participants
44 Participants
n=60 Participants
38 Participants
n=53 Participants
169 Participants
n=256 Participants
Race (NIH/OMB)
More than one race
4 Participants
n=78 Participants
5 Participants
n=65 Participants
2 Participants
n=60 Participants
0 Participants
n=53 Participants
11 Participants
n=256 Participants
Race (NIH/OMB)
Unknown or Not Reported
11 Participants
n=78 Participants
7 Participants
n=65 Participants
4 Participants
n=60 Participants
4 Participants
n=53 Participants
26 Participants
n=256 Participants
Region of Enrollment
United States
78 participants
n=78 Participants
65 participants
n=65 Participants
60 participants
n=60 Participants
53 participants
n=53 Participants
256 participants
n=256 Participants
Geographic Location of Sites
Rural
3 Sites Starting Study
n=14 Sites Starting Study • Data applies to site characteristics.
5 Sites Starting Study
n=11 Sites Starting Study • Data applies to site characteristics.
4 Sites Starting Study
n=10 Sites Starting Study • Data applies to site characteristics.
3 Sites Starting Study
n=13 Sites Starting Study • Data applies to site characteristics.
15 Sites Starting Study
n=48 Sites Starting Study • Data applies to site characteristics.
Geographic Location of Sites
Suburban
1 Sites Starting Study
n=14 Sites Starting Study • Data applies to site characteristics.
3 Sites Starting Study
n=11 Sites Starting Study • Data applies to site characteristics.
3 Sites Starting Study
n=10 Sites Starting Study • Data applies to site characteristics.
6 Sites Starting Study
n=13 Sites Starting Study • Data applies to site characteristics.
13 Sites Starting Study
n=48 Sites Starting Study • Data applies to site characteristics.
Geographic Location of Sites
Urban
10 Sites Starting Study
n=14 Sites Starting Study • Data applies to site characteristics.
3 Sites Starting Study
n=11 Sites Starting Study • Data applies to site characteristics.
3 Sites Starting Study
n=10 Sites Starting Study • Data applies to site characteristics.
4 Sites Starting Study
n=13 Sites Starting Study • Data applies to site characteristics.
20 Sites Starting Study
n=48 Sites Starting Study • Data applies to site characteristics.
Gender Served
Male only
0 Sites Starting Study
n=14 Sites Starting Study • Data applies to site characteristics.
1 Sites Starting Study
n=11 Sites Starting Study • Data applies to site characteristics.
0 Sites Starting Study
n=10 Sites Starting Study • Data applies to site characteristics.
0 Sites Starting Study
n=13 Sites Starting Study • Data applies to site characteristics.
1 Sites Starting Study
n=48 Sites Starting Study • Data applies to site characteristics.
Gender Served
Female only
0 Sites Starting Study
n=14 Sites Starting Study • Data applies to site characteristics.
0 Sites Starting Study
n=11 Sites Starting Study • Data applies to site characteristics.
0 Sites Starting Study
n=10 Sites Starting Study • Data applies to site characteristics.
0 Sites Starting Study
n=13 Sites Starting Study • Data applies to site characteristics.
0 Sites Starting Study
n=48 Sites Starting Study • Data applies to site characteristics.
Gender Served
Both
14 Sites Starting Study
n=14 Sites Starting Study • Data applies to site characteristics.
10 Sites Starting Study
n=11 Sites Starting Study • Data applies to site characteristics.
10 Sites Starting Study
n=10 Sites Starting Study • Data applies to site characteristics.
13 Sites Starting Study
n=13 Sites Starting Study • Data applies to site characteristics.
47 Sites Starting Study
n=48 Sites Starting Study • Data applies to site characteristics.
Average Daily Population (Jails only)
less than 100
1 Sites Starting Study
n=8 Sites Starting Study • Data applies to site characteristics for Jails only.
3 Sites Starting Study
n=7 Sites Starting Study • Data applies to site characteristics for Jails only.
2 Sites Starting Study
n=7 Sites Starting Study • Data applies to site characteristics for Jails only.
0 Sites Starting Study
n=7 Sites Starting Study • Data applies to site characteristics for Jails only.
6 Sites Starting Study
n=29 Sites Starting Study • Data applies to site characteristics for Jails only.
Average Daily Population (Jails only)
101-250
1 Sites Starting Study
n=8 Sites Starting Study • Data applies to site characteristics for Jails only.
3 Sites Starting Study
n=7 Sites Starting Study • Data applies to site characteristics for Jails only.
1 Sites Starting Study
n=7 Sites Starting Study • Data applies to site characteristics for Jails only.
5 Sites Starting Study
n=7 Sites Starting Study • Data applies to site characteristics for Jails only.
10 Sites Starting Study
n=29 Sites Starting Study • Data applies to site characteristics for Jails only.
Average Daily Population (Jails only)
251-500
2 Sites Starting Study
n=8 Sites Starting Study • Data applies to site characteristics for Jails only.
0 Sites Starting Study
n=7 Sites Starting Study • Data applies to site characteristics for Jails only.
3 Sites Starting Study
n=7 Sites Starting Study • Data applies to site characteristics for Jails only.
1 Sites Starting Study
n=7 Sites Starting Study • Data applies to site characteristics for Jails only.
6 Sites Starting Study
n=29 Sites Starting Study • Data applies to site characteristics for Jails only.
Average Daily Population (Jails only)
greater than 500
4 Sites Starting Study
n=8 Sites Starting Study • Data applies to site characteristics for Jails only.
1 Sites Starting Study
n=7 Sites Starting Study • Data applies to site characteristics for Jails only.
1 Sites Starting Study
n=7 Sites Starting Study • Data applies to site characteristics for Jails only.
1 Sites Starting Study
n=7 Sites Starting Study • Data applies to site characteristics for Jails only.
7 Sites Starting Study
n=29 Sites Starting Study • Data applies to site characteristics for Jails only.
Average Monthly OUD Intakes (CBTP)
less than 50
3 Sites Starting Study
n=6 Sites Starting Study • Data applies to site characteristics for CBTP only.
0 Sites Starting Study
n=4 Sites Starting Study • Data applies to site characteristics for CBTP only.
1 Sites Starting Study
n=3 Sites Starting Study • Data applies to site characteristics for CBTP only.
3 Sites Starting Study
n=6 Sites Starting Study • Data applies to site characteristics for CBTP only.
7 Sites Starting Study
n=19 Sites Starting Study • Data applies to site characteristics for CBTP only.
Average Monthly OUD Intakes (CBTP)
51-200
0 Sites Starting Study
n=6 Sites Starting Study • Data applies to site characteristics for CBTP only.
2 Sites Starting Study
n=4 Sites Starting Study • Data applies to site characteristics for CBTP only.
1 Sites Starting Study
n=3 Sites Starting Study • Data applies to site characteristics for CBTP only.
0 Sites Starting Study
n=6 Sites Starting Study • Data applies to site characteristics for CBTP only.
3 Sites Starting Study
n=19 Sites Starting Study • Data applies to site characteristics for CBTP only.
Average Monthly OUD Intakes (CBTP)
201-500
0 Sites Starting Study
n=6 Sites Starting Study • Data applies to site characteristics for CBTP only.
0 Sites Starting Study
n=4 Sites Starting Study • Data applies to site characteristics for CBTP only.
1 Sites Starting Study
n=3 Sites Starting Study • Data applies to site characteristics for CBTP only.
0 Sites Starting Study
n=6 Sites Starting Study • Data applies to site characteristics for CBTP only.
1 Sites Starting Study
n=19 Sites Starting Study • Data applies to site characteristics for CBTP only.
Average Monthly OUD Intakes (CBTP)
greater than 500
0 Sites Starting Study
n=6 Sites Starting Study • Data applies to site characteristics for CBTP only.
0 Sites Starting Study
n=4 Sites Starting Study • Data applies to site characteristics for CBTP only.
0 Sites Starting Study
n=3 Sites Starting Study • Data applies to site characteristics for CBTP only.
1 Sites Starting Study
n=6 Sites Starting Study • Data applies to site characteristics for CBTP only.
1 Sites Starting Study
n=19 Sites Starting Study • Data applies to site characteristics for CBTP only.
Average Monthly OUD Intakes (CBTP)
unknown
3 Sites Starting Study
n=6 Sites Starting Study • Data applies to site characteristics for CBTP only.
2 Sites Starting Study
n=4 Sites Starting Study • Data applies to site characteristics for CBTP only.
0 Sites Starting Study
n=3 Sites Starting Study • Data applies to site characteristics for CBTP only.
2 Sites Starting Study
n=6 Sites Starting Study • Data applies to site characteristics for CBTP only.
7 Sites Starting Study
n=19 Sites Starting Study • Data applies to site characteristics for CBTP only.
Type of Healthcare Model at Jails
Direct
3 Sites Starting Study
n=8 Sites Starting Study • Data applies to site characteristics at Jails only.
2 Sites Starting Study
n=7 Sites Starting Study • Data applies to site characteristics at Jails only.
1 Sites Starting Study
n=7 Sites Starting Study • Data applies to site characteristics at Jails only.
1 Sites Starting Study
n=7 Sites Starting Study • Data applies to site characteristics at Jails only.
7 Sites Starting Study
n=29 Sites Starting Study • Data applies to site characteristics at Jails only.
Type of Healthcare Model at Jails
Contracted
4 Sites Starting Study
n=8 Sites Starting Study • Data applies to site characteristics at Jails only.
4 Sites Starting Study
n=7 Sites Starting Study • Data applies to site characteristics at Jails only.
1 Sites Starting Study
n=7 Sites Starting Study • Data applies to site characteristics at Jails only.
4 Sites Starting Study
n=7 Sites Starting Study • Data applies to site characteristics at Jails only.
13 Sites Starting Study
n=29 Sites Starting Study • Data applies to site characteristics at Jails only.
Type of Healthcare Model at Jails
Hybrid
1 Sites Starting Study
n=8 Sites Starting Study • Data applies to site characteristics at Jails only.
1 Sites Starting Study
n=7 Sites Starting Study • Data applies to site characteristics at Jails only.
5 Sites Starting Study
n=7 Sites Starting Study • Data applies to site characteristics at Jails only.
2 Sites Starting Study
n=7 Sites Starting Study • Data applies to site characteristics at Jails only.
9 Sites Starting Study
n=29 Sites Starting Study • Data applies to site characteristics at Jails only.
CBTP Arrangements with Jails
Joint Staffings
3 Sites Starting Study
n=6 Sites Starting Study • Data applies to site characteristics CBTP only.
1 Sites Starting Study
n=4 Sites Starting Study • Data applies to site characteristics CBTP only.
1 Sites Starting Study
n=3 Sites Starting Study • Data applies to site characteristics CBTP only.
2 Sites Starting Study
n=6 Sites Starting Study • Data applies to site characteristics CBTP only.
7 Sites Starting Study
n=19 Sites Starting Study • Data applies to site characteristics CBTP only.
CBTP Arrangements with Jails
Shared Written Agreements
3 Sites Starting Study
n=6 Sites Starting Study • Data applies to site characteristics CBTP only.
2 Sites Starting Study
n=4 Sites Starting Study • Data applies to site characteristics CBTP only.
3 Sites Starting Study
n=3 Sites Starting Study • Data applies to site characteristics CBTP only.
3 Sites Starting Study
n=6 Sites Starting Study • Data applies to site characteristics CBTP only.
11 Sites Starting Study
n=19 Sites Starting Study • Data applies to site characteristics CBTP only.
CBTP Arrangements with Jails
Electronic Health Record Access
2 Sites Starting Study
n=6 Sites Starting Study • Data applies to site characteristics CBTP only.
0 Sites Starting Study
n=4 Sites Starting Study • Data applies to site characteristics CBTP only.
2 Sites Starting Study
n=3 Sites Starting Study • Data applies to site characteristics CBTP only.
0 Sites Starting Study
n=6 Sites Starting Study • Data applies to site characteristics CBTP only.
4 Sites Starting Study
n=19 Sites Starting Study • Data applies to site characteristics CBTP only.
CBTP Arrangements with Jails
Referral Processes
3 Sites Starting Study
n=6 Sites Starting Study • Data applies to site characteristics CBTP only.
3 Sites Starting Study
n=4 Sites Starting Study • Data applies to site characteristics CBTP only.
3 Sites Starting Study
n=3 Sites Starting Study • Data applies to site characteristics CBTP only.
4 Sites Starting Study
n=6 Sites Starting Study • Data applies to site characteristics CBTP only.
13 Sites Starting Study
n=19 Sites Starting Study • Data applies to site characteristics CBTP only.
MOUD Offered at Baseline
Buprenorphine/Naloxone
10 Sites Starting Study
n=14 Sites Starting Study • Data applies to site characteristics.
8 Sites Starting Study
n=11 Sites Starting Study • Data applies to site characteristics.
7 Sites Starting Study
n=10 Sites Starting Study • Data applies to site characteristics.
11 Sites Starting Study
n=13 Sites Starting Study • Data applies to site characteristics.
36 Sites Starting Study
n=48 Sites Starting Study • Data applies to site characteristics.
MOUD Offered at Baseline
Naltrexone (injectable)
8 Sites Starting Study
n=14 Sites Starting Study • Data applies to site characteristics.
10 Sites Starting Study
n=11 Sites Starting Study • Data applies to site characteristics.
5 Sites Starting Study
n=10 Sites Starting Study • Data applies to site characteristics.
7 Sites Starting Study
n=13 Sites Starting Study • Data applies to site characteristics.
30 Sites Starting Study
n=48 Sites Starting Study • Data applies to site characteristics.
MOUD Offered at Baseline
Naltrexone (oral)
6 Sites Starting Study
n=14 Sites Starting Study • Data applies to site characteristics.
4 Sites Starting Study
n=11 Sites Starting Study • Data applies to site characteristics.
6 Sites Starting Study
n=10 Sites Starting Study • Data applies to site characteristics.
6 Sites Starting Study
n=13 Sites Starting Study • Data applies to site characteristics.
22 Sites Starting Study
n=48 Sites Starting Study • Data applies to site characteristics.
MOUD Offered at Baseline
Methadone
7 Sites Starting Study
n=14 Sites Starting Study • Data applies to site characteristics.
3 Sites Starting Study
n=11 Sites Starting Study • Data applies to site characteristics.
6 Sites Starting Study
n=10 Sites Starting Study • Data applies to site characteristics.
2 Sites Starting Study
n=13 Sites Starting Study • Data applies to site characteristics.
18 Sites Starting Study
n=48 Sites Starting Study • Data applies to site characteristics.
MOUD Offered at Baseline
No MOUD
0 Sites Starting Study
n=14 Sites Starting Study • Data applies to site characteristics.
0 Sites Starting Study
n=11 Sites Starting Study • Data applies to site characteristics.
1 Sites Starting Study
n=10 Sites Starting Study • Data applies to site characteristics.
0 Sites Starting Study
n=13 Sites Starting Study • Data applies to site characteristics.
1 Sites Starting Study
n=48 Sites Starting Study • Data applies to site characteristics.
MOUD Offered at Baseline
Unknown
1 Sites Starting Study
n=14 Sites Starting Study • Data applies to site characteristics.
0 Sites Starting Study
n=11 Sites Starting Study • Data applies to site characteristics.
0 Sites Starting Study
n=10 Sites Starting Study • Data applies to site characteristics.
1 Sites Starting Study
n=13 Sites Starting Study • Data applies to site characteristics.
2 Sites Starting Study
n=48 Sites Starting Study • Data applies to site characteristics.
Type of Study Site
Jails
8 Sites Starting Study
n=14 Sites Starting Study
7 Sites Starting Study
n=11 Sites Starting Study
7 Sites Starting Study
n=10 Sites Starting Study
7 Sites Starting Study
n=13 Sites Starting Study
29 Sites Starting Study
n=48 Sites Starting Study
Type of Study Site
Community Based Treatment Providers
6 Sites Starting Study
n=14 Sites Starting Study
4 Sites Starting Study
n=11 Sites Starting Study
3 Sites Starting Study
n=10 Sites Starting Study
6 Sites Starting Study
n=13 Sites Starting Study
19 Sites Starting Study
n=48 Sites Starting Study

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Low-Dose NIATx Coaching & No ECHO
n=13 sites
* 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
High-Dose NIATx Coaching & ECHO
n=14 sites
* 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
Low-Dose NIATx Coaching & ECHO
n=11 sites
* 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
High-Dose NIATx Coaching & No ECHO
n=10 sites
* Four-hour, Virtual Kick-Off Meeting split into two days with Study Team \& Coaches * 12 monthly (one-hour) coaching calls with Change Leader/Team
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
20.36 New Justice Involved Persons per month
Standard Deviation 51.31
0.55 New Justice Involved Persons per month
Standard Deviation 1.57
4.47 New Justice Involved Persons per month
Standard Deviation 9.63
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
21.79 New Justice Involved Persons per month
Standard Deviation 28.5
3.00 New Justice Involved Persons per month
Standard Deviation 4.05
5.01 New Justice Involved Persons per month
Standard Deviation 2.98
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
0.19 New Justice Involved Persons per month
Standard Deviation 0.28
0.33 New Justice Involved Persons per month
Standard Deviation 0.42
0.44 New Justice Involved Persons per month
Standard Deviation 0.86

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Low-Dose NIATx Coaching & No ECHO
n=13 sites
* 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
High-Dose NIATx Coaching & ECHO
n=14 sites
* 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
Low-Dose NIATx Coaching & ECHO
n=11 sites
* 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
High-Dose NIATx Coaching & No ECHO
n=10 sites
* Four-hour, Virtual Kick-Off Meeting split into two days with Study Team \& Coaches * 12 monthly (one-hour) coaching calls with Change Leader/Team
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
28.29 New Justice Involved Persons per month
Standard Deviation 75.24
0.01 New Justice Involved Persons per month
Standard Deviation 0.03
4.67 New Justice Involved Persons per month
Standard Deviation 6.6
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
30.37 New Justice Involved Persons per month
Standard Deviation 35.77
3.3 New Justice Involved Persons per month
Standard Deviation 4.4
7.89 New Justice Involved Persons per month
Standard Deviation 3.18
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
0.09 New Justice Involved Persons per month
Standard Deviation 0.13
1.32 New Justice Involved Persons per month
Standard Deviation 1.59
0.71 New Justice Involved Persons per month
Standard Deviation 0.79

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Low-Dose NIATx Coaching & No ECHO
n=13 sites
* 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
High-Dose NIATx Coaching & ECHO
n=14 sites
* 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
Low-Dose NIATx Coaching & ECHO
n=11 sites
* 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
High-Dose NIATx Coaching & No ECHO
n=10 sites
* Four-hour, Virtual Kick-Off Meeting split into two days with Study Team \& Coaches * 12 monthly (one-hour) coaching calls with Change Leader/Team
Mean Total Number of Eligible Justice Involved Persons on MOUD Per Month: Intervention Phase
Methadone
0.94 Justice Involved Persons per month
Standard Deviation 1.80
98.73 Justice Involved Persons per month
Standard Deviation 216.36
0.08 Justice Involved Persons per month
Standard Deviation 0.35
56.58 Justice Involved Persons per month
Standard Deviation 158.40
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
104.07 Justice Involved Persons per month
Standard Deviation 145.32
117.62 Justice Involved Persons per month
Standard Deviation 190.42
36.50 Justice Involved Persons per month
Standard Deviation 45.29
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
0.24 Justice Involved Persons per month
Standard Deviation 0.34
2.60 Justice Involved Persons per month
Standard Deviation 5.29
5.81 Justice Involved Persons per month
Standard Deviation 15.04

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Low-Dose NIATx Coaching & No ECHO
n=13 sites
* 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
High-Dose NIATx Coaching & ECHO
n=14 sites
* 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
Low-Dose NIATx Coaching & ECHO
n=11 sites
* 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
High-Dose NIATx Coaching & No ECHO
n=10 sites
* Four-hour, Virtual Kick-Off Meeting split into two days with Study Team \& Coaches * 12 monthly (one-hour) coaching calls with Change Leader/Team
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
110.19 Justice Involved Persons per month
Standard Deviation 219.28
0.01 Justice Involved Persons per month
Standard Deviation 0.03
77.22 Justice Involved Persons per month
Standard Deviation 183.37
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
127.32 Justice Involved Persons per month
Standard Deviation 177.17
154.78 Justice Involved Persons per month
Standard Deviation 227.42
43.71 Justice Involved Persons per month
Standard Deviation 43.31
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
0.22 Justice Involved Persons per month
Standard Deviation 0.31
1.67 Justice Involved Persons per month
Standard Deviation 1.56
10.86 Justice Involved Persons per month
Standard Deviation 18.72

PRIMARY outcome

Timeframe: 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.

The adoption of each intervention will be in part measured by tracking the number of prescribers using MOUD at each time point.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline, 12 months, 24 months

Population: Number of participants and sites included in data analysis changed through study conduct.

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.

Outcome measures

Outcome measures
Measure
Low-Dose NIATx Coaching & No ECHO
n=13 sites
* 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
High-Dose NIATx Coaching & ECHO
n=14 sites
* 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
Low-Dose NIATx Coaching & ECHO
n=11 sites
* 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
High-Dose NIATx Coaching & No ECHO
n=10 sites
* Four-hour, Virtual Kick-Off Meeting split into two days with Study Team \& Coaches * 12 monthly (one-hour) coaching calls with Change Leader/Team
MOUD Sustainability Measured Using the Program Sustainability Assessment Tool
baseline
43.96226 score on a scale
Standard Deviation 12.7701
44.79487 score on a scale
Standard Deviation 17.88808
43.75385 score on a scale
Standard Deviation 15.68342
43.16667 score on a scale
Standard Deviation 14.61386
MOUD Sustainability Measured Using the Program Sustainability Assessment Tool
12 months
51.61905 score on a scale
Standard Deviation 10.70736
50.71429 score on a scale
Standard Deviation 8.827025
50.78571 score on a scale
Standard Deviation 8.252304
45.95556 score on a scale
Standard Deviation 10.73642
MOUD Sustainability Measured Using the Program Sustainability Assessment Tool
24 months
53.70833 score on a scale
Standard Deviation 14.0077
51.51429 score on a scale
Standard Deviation 13.18504
49.30435 score on a scale
Standard Deviation 8.704413
48.37143 score on a scale
Standard Deviation 11.95847

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months, 24 months

Population: Number of participants included in data analysis changed through study conduct.

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.

Outcome measures

Outcome measures
Measure
Low-Dose NIATx Coaching & No ECHO
n=53 Participants
* 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
High-Dose NIATx Coaching & ECHO
n=78 Participants
* 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
Low-Dose NIATx Coaching & ECHO
n=65 Participants
* 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
High-Dose NIATx Coaching & No ECHO
n=60 Participants
* Four-hour, Virtual Kick-Off Meeting split into two days with Study Team \& Coaches * 12 monthly (one-hour) coaching calls with Change Leader/Team
NIATx Fidelity
12 months
24.71429 score on a scale
Standard Deviation 5.917287
24.2381 score on a scale
Standard Deviation 6.449842
25.39286 score on a scale
Standard Deviation 4.474945
24.11111 score on a scale
Standard Deviation 6.544332
NIATx Fidelity
24 months
27.16667 score on a scale
Standard Deviation 6.112472
24.57143 score on a scale
Standard Deviation 5.494841
23.13043 score on a scale
Standard Deviation 4.07101
24.62857 score on a scale
Standard Deviation 7.272372

Adverse Events

High-Dose NIATx Coaching & ECHO

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Low-Dose NIATx Coaching & ECHO

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

High-Dose NIATx Coaching & No ECHO

Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths

Low-Dose NIATx Coaching & No ECHO

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Todd Molfenter, PhD

University of Wisconsin - Madison

Phone: 608-262-1685

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place