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.
COMPLETED
NA
256 participants
baseline to 12 months
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
| 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
| 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
| 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 monthsPopulation: 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
| 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 monthsPopulation: 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
| 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 monthsPopulation: 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
| 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 monthsPopulation: 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
| 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 monthsPopulation: 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 monthsPopulation: 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
| 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 monthsPopulation: 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
| 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
Low-Dose NIATx Coaching & ECHO
High-Dose NIATx Coaching & No ECHO
Low-Dose NIATx Coaching & No ECHO
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place