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Project MIMIC (Maximizing Implementation of Motivational Incentives in Clinics)

Implementing Contingency Management in Opioid Treatment Centers Across New England: A Type 3 Hybrid Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03931174
Acronym
MIMIC
Enrollment
780
Registered
2019-04-30
Start date
2019-04-09
Completion date
2024-07-31
Last updated
2025-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid-use Disorder

Keywords

implementation, opioid use

Brief summary

There is an urgent need for effective treatments for patients with opioid use disorder (OUD). This study will train opioid treatment programs in an evidence-based behavioral treatment called contingency management (CM). Contingency management (i.e., motivational incentives for achieving pre-defined treatment goals) is one of the only behavioral interventions shown to improve patient treatment outcomes when combined with FDA-approved pharmacotherapy. Unfortunately, however, uptake of CM in opioid treatment programs remains low. In response to the urgent need for evidence-based behavioral OUD treatments, the investigators propose a large-scale type 3 hybrid trial comparing two comprehensive strategies to promote CM implementation as an adjunct to pharmacotherapy within opioid treatment programs. The control condition is the staff training strategy used by the New England Addiction Technology Transfer Center, which consists of didactic workshop, performance feedback, and staff coaching. The experimental condition is the ATTC strategy enhanced by external leadership coaching (using a model called Implementation Sustainment Facilitation; ISF) and provider incentives (using a model called Pay for Performance; P4P). A cluster randomized design trial will be conducted with 30 opioid treatment programs across New England. Centers will be randomized to one of the two implementation conditions (ATTC vs. enhanced-ATTC) over the 5 year project. At each opioid treatment program, data will be collected at multiple intervals from CM treatment providers, organizational leaders, and newly admitted patients. Additionally, patient charts will be randomly selected for review to examine sustainment. Data collection will include electronic medical record review, ratings of audio recordings by staff blind to condition, well-validated measures, and provider weekly report of patient encounter data. Specific Aims of the study are to experimentally compare the effect of the two conditions on implementation outcomes (Primary Aim) and on patient outcomes (Secondary Aim). An Exploratory Aim is to test whether two organization-level variables (i.e., implementation climate, leadership engagement) partially mediate the relationship between implementation condition and the key study outcomes.

Detailed description

Overdoses and deaths due to opioid use disorders (OUDs) have been declared a public health emergency in the United States, bringing to light an urgent need for highly effective OUD treatments. There are currently five FDA-approved medication formulations, which relative to placebo have demonstrated effectiveness in helping patients attain abstinence from opioids. Nonetheless, patients' opioid abstinence rates are sub-optimal: even when treated with the newest extended-release formulations only about 40% of patients maintain abstinence during the first 6-months of treatment. Contingency management (CM; i.e., motivational incentives for achieving pre-defined treatment goals) is one of the only behavioral interventions shown to improve patient abstinence from opioids when combined with FDA-approved pharmacotherapy. Unfortunately, however, uptake of CM in opioid treatment programs remains low. The primary purpose of this study is to experimentally evaluate two different comprehensive training models to train opioid treatment programs in CM. A Type 3 Hybrid Trial will be conducted collecting data on both implementation and patient outcomes. Using a cluster randomized design, 30 opioid treatment programs across New England will be randomized to one of two comprehensive training conditions over a 5 year period. The control condition is the staff training strategy used by the Substance Abuse and Mental Health Services Administration (SAMHSA)-funded network of Addiction Technology Transfer Centers (ATTC; i.e., didactic workshop + performance feedback + staff coaching). The experimental condition is the ATTC strategy enhanced by external leadership coaching (using a model called Implementation Sustainment Facilitation \[ISF\], i.e., leadership coaching focused on sustainment planning) and provider incentives (using a model called Pay for Performance \[P4P\]; i.e., monetary bonuses for achieving pre-defined implementation goals), hereafter referred to as E-ATTC. Elements of the E-ATTC condition were informed by our team's prior NIH-funded work evaluating organization-level implementation strategies. At each OUD treatment center, data will be collected at multiple intervals from up to 2-5 CM treatment providers (n=60-150 providers), 1-2 organizational leaders (n=30-60 leaders), and 25 newly admitted patients (n=750 patients). Additionally, 25 patient charts per center (n=750 charts) will be randomly selected for review to examine sustainment. Data collection will include electronic medical record review, ratings of audio recordings by staff blind to condition, well-validated measures, and biological verification of abstinence. The Primary Aim of the study is to experimentally compare the effect of the two training strategies on implementation outcomes. Focal implementation outcomes include: CM Exposure (provider-level measure of the proportion of providers delivering the target number of CM sessions to at least one patient during 9-month Implementation phase), CM Competence (provider-level measure of CM quality during month Implementation phase), and CM Sustainment (organization-level measure of the proportion of programs continuing to deliver CM sessions during 6-month Sustainment phase). The Secondary Aim of the study is to experimentally compare the effect of the two training strategies on patient outcomes. Focal patient outcomes include abstinence from opioids and opioid-related problems. An Exploratory Aim is to test whether two provider-level variables (i.e., implementation climate, leadership engagement) partially mediate the relationship between implementation condition and the key study outcomes. Pursuit of these aims is significant given the potential to improve the treatment of OUDs in community settings, which is one of the greatest public health challenges currently facing our nation. Major strengths of the approach include the study's experimental design (cluster randomized trial), novel implementation strategy based on mixed-methods pilot data by the investigative team, large sample of organizations (N = 30), partnership with a SAMHSA-funded national training center, and rigorously measured implementation and patient outcomes.

Interventions

BEHAVIORALAddiction Technology Transfer Center (ATTC) Training Strategy

Participating organizations will receive training consisting of 3 components: 1) didactic workshop - full-day workshop led by a contingency management (CM) expert for both CM staff and leaders, 2) performance feedback - submission of CM session recordings for review and performance feedback at least monthly for 9 months for CM staff, and 3) staff coaching - monthly provider coaching calls led by a CM expert for 9 months for both CM staff and leaders.

BEHAVIORALEnhanced Addiction Technology Transfer Center (E-ATTC) Training Strategy

Participating organizations will receive all of the elements of the ATTC control condition. In addition, organizations will receive two additional elements: 1) Implementation Sustainment Facilitation - monthly coaching calls for CM leaders and staff focused on sustainment, 2) Pay for Performance - participating CM staff will have the opportunity to earn monthly monetary bonuses for achieving pre-defined implementation goals for 9 months.

Sponsors

RTI International
CollaboratorOTHER
University of Washington
CollaboratorOTHER
UConn Health
CollaboratorOTHER
National Institute on Drug Abuse (NIDA)
CollaboratorNIH
Northwestern University
CollaboratorOTHER
Ohio State University
CollaboratorOTHER
Brown University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Intervention model description

Cluster Randomized Trial

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

for community-based opioid treatment programs (n = 30): * prescribes FDA-approved medication to treat adult patients with OUDs * enrolls 5+ new patients per month * has at least 2 staff who provide psychosocial support to OUD patients

Exclusion criteria

• None Inclusion criteria for CM Providers (n = 60-150, range of 2-5 per center): * has been involved in providing psychosocial support to OUD patients on pharmacotherapy * has an active caseload * is willing to commit to 14 months of CM training and support

Design outcomes

Primary

MeasureTime frameDescription
Contingency Management Competence Scale for Reinforcing Attendance (Implementation Outcome)From baseline to 9 months post-baselineProvider scores on the Contingency Management Competence Scale for Reinforcing Attendance (CMCS; Petry & Ledgerwood, 2010). Coders blind to treatment condition rate audio recorded CM sessions using the CMCS, which measures provider skill in CM delivery. CMCS contains 6 CM-specific skill items and 3 general skill items that are scored on a scale from 0 to 7. For each item, a score of 0 indicates an audio recording was not submitted, a score of 1 indicates the lowest possible skill and a score of 7 indicates the highest possible skill. Possible scale scores range from a minimum of 0 to 63. An average score will be calculated for each provider, with a minimum of 0 and maximum of 7. Providers will submit one audio recording per month for the duration of the 9-month Implementation phase. Each provider's highest CMCS score will be used in analysis. Higher scores indicate higher skill, which is a better outcome.
CM Exposure (Implementation Outcome)From baseline to 9 months post-baselineProvider-level measure of whether the provider delivered the target number of CM sessions (at least 10 sessions) to at least one patient based on based on electronic medical record review and data entered into a study-specific CM tracker tool for up to 25 charts per site (25 charts\*30 sites = 750 charts). Providers will report on patient encounters in the electronic medical record and the study-specific CM tracker tool, and for each encounter will report if CM was provided. Using patient level data, providers will be classified as 1 (delivered 10 or more sessions to at least 1 patient) or 0 (did not deliver 10 or more CM sessions to any patients). \*This measure was initially defined as a patient-level outcome. We altered the level at which CM Exposure was assessed because our initial approach excluded providers who were trained but never delivered CM. To follow intent-to-treat principles, we aggregate CM Exposure data at the provider-level in a manner that uses all available data.
CM Sustainment (Implementation Outcome)6-month time interval following Implementation time periodProportion of programs delivering any CM after removal of active support. This is calculated based on review of all patient charts over a 6-month interval. Providers report on patient encounters in the medical record, and for each encounter report if CM was provided. Programs are classified as 1 (reported delivering CM to at least 1 patient) or 0 (did not deliver CM to any patients). The proportion of programs delivering CM is then calculated; a higher proportion is a better outcome. \*The level at which CM Sustainment was assessed was altered from provider-level to program-level because of the frequency of programs failing to report applying CM among any patients, across any of its providers. In addition, there was such high staff turnover we could not assess at the provider-level using original provider IDs. To be able to use all available data from all programs' medical records, we report on the proportion of any programs delivering CM after removal of active support.

Secondary

MeasureTime frameDescription
Global Appraisal of Individual Needs Opioid-Related Problem Scale: Past Month (Patient Outcome)Assessed at 3 and 6-months from patient baseline assessmentCount of problems as reported using an adapted version of the Global Appraisal of Needs Substance Problems Scale (Dennis et al., 2002), which has been adapted to focus specifically on problems related to opioids. The scale contains 16 items that correspond to problems related to opioid use. Patients are asked the last time they had each problem with responses including past month, past year, lifetime, or never. A count of problems experienced over the past month will be calculated for each patient. The minimum possible score is 0 and the maximum possible score is 16. Higher scores indicate higher problems, which is a worse outcome. This will be calculated for all patients who complete follow-up.
Opioid Abstinence: Past Month (Patient Outcome)Assessed at 3 and 6-months from patient baseline assessmentDays of abstinence as reported using calendar-based recall based on the Timeline Followback Interview method (Sobell & Sobell, 1992). Days of opioid abstinence will be calculated from 0 to 30 for each patient, with higher numbers indicating more days of abstinence (which is a better outcome). This will be calculated for all patients who complete follow-up.

Other

MeasureTime frameDescription
Implementation Climate ScaleFrom baseline to 9 months post baselineImplementation climate scale (Jacobs et al., 2014). This scale contains 6 items scored on a 1 to 5 scale. An average score across the 6 items will be calculated per provider. Possible scores on this outcome range from a minimum of 1 to a maximum of 6. Higher scores indicate a more positive implementation climate, which is a better outcome.
Leadership Engagement ScaleFrom baseline to 9 months post baselineMeasure of leadership engagement (Garner, unpublished data). The scale contains 4 items scored on a 1 to 5 scale. An average perceived leadership engagement scale will be calculated for each provider. Possible scores on this outcome range from a minimum score of 1 to a maximum score of 5. Higher scores indicate higher perceived leadership engagement, which is a better outcome.

Countries

United States

Participant flow

Participants by arm

ArmCount
Addiction Technology Transfer Center (ATTC) Training
Half of the opioid treatment centers will receive the ATTC training strategy. Addiction Technology Transfer Center (ATTC) Training Strategy: Participating organizations will receive training consisting of 3 components: 1) didactic workshop - full-day workshop led by a contingency management (CM) expert for both CM staff and leaders, 2) performance feedback - submission of CM session recordings for review and performance feedback at least monthly for 9 months for CM staff, and 3) staff coaching - monthly provider coaching calls led by a CM expert for 9 months for both CM staff and leaders.
381
Enhanced ATTC (E-ATTC) Training Strategy
Half of the opioid treatment centers will receive the E-ATTC training strategy. Enhanced Addiction Technology Transfer Center (E-ATTC) Training Strategy: Participating organizations will receive all of the elements of the ATTC control condition. In addition, organizations will receive two additional elements: 1) Implementation Sustainment Facilitation - monthly coaching calls for CM leaders and staff focused on sustainment, 2) Pay for Performance - participating CM staff will have the opportunity to earn monthly monetary bonuses for achieving pre-defined implementation goals for 9 months.
399
Total780

Withdrawals & dropouts

PeriodReasonFG000FG001
PatientsDeath11
PatientsLost to Follow-up6089
PatientsPost-consent screening failure11
ProvidersLost to Follow-up44
ProvidersStaff left organization2625
ProvidersStaff on leave/no longer engaged in implementation initiative114

Baseline characteristics

CharacteristicAddiction Technology Transfer Center (ATTC) TrainingTotalEnhanced ATTC (E-ATTC) Training Strategy
Age, Customized
Patients
38.15 Years
STANDARD_DEVIATION 10.11
37.83 Years
STANDARD_DEVIATION 10.19
37.48 Years
STANDARD_DEVIATION 10.28
Age, Customized
Providers
40.92 Years
STANDARD_DEVIATION 12.56
39.83 Years
STANDARD_DEVIATION 12.4
38.68 Years
STANDARD_DEVIATION 12.21
CM Exposure0 Participants0 Participants0 Participants
Race/Ethnicity, Customized
Patients
American Indian or Alaska Native
3 Participants8 Participants5 Participants
Race/Ethnicity, Customized
Patients
Asian
0 Participants4 Participants4 Participants
Race/Ethnicity, Customized
Patients
Black or African American
20 Participants42 Participants22 Participants
Race/Ethnicity, Customized
Patients
More than one race
20 Participants35 Participants15 Participants
Race/Ethnicity, Customized
Patients
Native Hawaiian or Pacific Islander
2 Participants3 Participants1 Participants
Race/Ethnicity, Customized
Patients
Unknown or Not Reported
29 Participants57 Participants28 Participants
Race/Ethnicity, Customized
Patients
White
212 Participants445 Participants233 Participants
Race/Ethnicity, Customized
Providers
American Indian or Alaska Native
1 Participants1 Participants0 Participants
Race/Ethnicity, Customized
Providers
Asian
1 Participants1 Participants0 Participants
Race/Ethnicity, Customized
Providers
Black or African American
6 Participants13 Participants7 Participants
Race/Ethnicity, Customized
Providers
More than one race
9 Participants17 Participants8 Participants
Race/Ethnicity, Customized
Providers
Native Hawaiian or Pacific Islander
0 Participants0 Participants0 Participants
Race/Ethnicity, Customized
Providers
Unknown or Not Reported
4 Participants7 Participants3 Participants
Race/Ethnicity, Customized
Providers
White
74 Participants147 Participants73 Participants
Region of Enrollment
United States
Patients
286 Participants594 Participants308 Participants
Region of Enrollment
United States
Providers
95 Participants186 Participants91 Participants
Sex/Gender, Customized
Patients
Female
129 Participants266 Participants137 Participants
Sex/Gender, Customized
Patients
Male
157 Participants328 Participants171 Participants
Sex/Gender, Customized
Providers
Female
77 Participants152 Participants75 Participants
Sex/Gender, Customized
Providers
Male
18 Participants34 Participants16 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
1 / 3811 / 399
other
Total, other adverse events
0 / 3810 / 399
serious
Total, serious adverse events
1 / 3811 / 399

Outcome results

Primary

CM Exposure (Implementation Outcome)

Provider-level measure of whether the provider delivered the target number of CM sessions (at least 10 sessions) to at least one patient based on based on electronic medical record review and data entered into a study-specific CM tracker tool for up to 25 charts per site (25 charts\*30 sites = 750 charts). Providers will report on patient encounters in the electronic medical record and the study-specific CM tracker tool, and for each encounter will report if CM was provided. Using patient level data, providers will be classified as 1 (delivered 10 or more sessions to at least 1 patient) or 0 (did not deliver 10 or more CM sessions to any patients). \*This measure was initially defined as a patient-level outcome. We altered the level at which CM Exposure was assessed because our initial approach excluded providers who were trained but never delivered CM. To follow intent-to-treat principles, we aggregate CM Exposure data at the provider-level in a manner that uses all available data.

Time frame: From baseline to 9 months post-baseline

Population: Table reports proportions with listwise deletion. The pre-specified plan uses mixed models with full maximum likelihood estimation (intent-to-treat) and data from all 95 ATTC providers and 91 E-ATTC.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Addiction Technology Transfer Center (ATTC) TrainingCM Exposure (Implementation Outcome)18 Participants
Enhanced ATTC (E-ATTC) Training StrategyCM Exposure (Implementation Outcome)31 Participants
Comparison: These analyses are unadjusted. The primary outcomes paper will report both unadjusted and adjusted analyses.p-value: 0.09795% CI: [0.85, 6.81]Mixed Models Analysis
Primary

CM Sustainment (Implementation Outcome)

Proportion of programs delivering any CM after removal of active support. This is calculated based on review of all patient charts over a 6-month interval. Providers report on patient encounters in the medical record, and for each encounter report if CM was provided. Programs are classified as 1 (reported delivering CM to at least 1 patient) or 0 (did not deliver CM to any patients). The proportion of programs delivering CM is then calculated; a higher proportion is a better outcome. \*The level at which CM Sustainment was assessed was altered from provider-level to program-level because of the frequency of programs failing to report applying CM among any patients, across any of its providers. In addition, there was such high staff turnover we could not assess at the provider-level using original provider IDs. To be able to use all available data from all programs' medical records, we report on the proportion of any programs delivering CM after removal of active support.

Time frame: 6-month time interval following Implementation time period

Population: Sustainment was measured at the organizational level (N=14 ATTC, N=14 E-ATTC) as a dichotomous variable indicating whether or not they continued delivering the intervention. The number of participants seen in each condition is unknown and therefore overall number of participants is entered as NA (not applicable).

ArmMeasureValue (COUNT_OF_UNITS)
Addiction Technology Transfer Center (ATTC) TrainingCM Sustainment (Implementation Outcome)6 Organization Sites
Enhanced ATTC (E-ATTC) Training StrategyCM Sustainment (Implementation Outcome)6 Organization Sites
Comparison: These analyses are unadjusted.p-value: 0.43Chi-squared
Primary

Contingency Management Competence Scale for Reinforcing Attendance (Implementation Outcome)

Provider scores on the Contingency Management Competence Scale for Reinforcing Attendance (CMCS; Petry & Ledgerwood, 2010). Coders blind to treatment condition rate audio recorded CM sessions using the CMCS, which measures provider skill in CM delivery. CMCS contains 6 CM-specific skill items and 3 general skill items that are scored on a scale from 0 to 7. For each item, a score of 0 indicates an audio recording was not submitted, a score of 1 indicates the lowest possible skill and a score of 7 indicates the highest possible skill. Possible scale scores range from a minimum of 0 to 63. An average score will be calculated for each provider, with a minimum of 0 and maximum of 7. Providers will submit one audio recording per month for the duration of the 9-month Implementation phase. Each provider's highest CMCS score will be used in analysis. Higher scores indicate higher skill, which is a better outcome.

Time frame: From baseline to 9 months post-baseline

Population: Table reports means and standard deviations. The pre-specified plan uses mixed models with full maximum likelihood estimation (intent-to-treat) and data from all 95 ATTC providers and 91 E-ATTC providers.

ArmMeasureValue (MEAN)Dispersion
Addiction Technology Transfer Center (ATTC) TrainingContingency Management Competence Scale for Reinforcing Attendance (Implementation Outcome)0.53 Units on the CM Competence ScaleStandard Deviation 1.66
Enhanced ATTC (E-ATTC) Training StrategyContingency Management Competence Scale for Reinforcing Attendance (Implementation Outcome)1.25 Units on the CM Competence ScaleStandard Deviation 2.14
Comparison: These analyses are unadjusted. The primary outcomes paper will report both unadjusted and adjusted analyses.p-value: 0.0295% CI: [0.11, 1.32]t-test, 2 sided
Secondary

Global Appraisal of Individual Needs Opioid-Related Problem Scale: Past Month (Patient Outcome)

Count of problems as reported using an adapted version of the Global Appraisal of Needs Substance Problems Scale (Dennis et al., 2002), which has been adapted to focus specifically on problems related to opioids. The scale contains 16 items that correspond to problems related to opioid use. Patients are asked the last time they had each problem with responses including past month, past year, lifetime, or never. A count of problems experienced over the past month will be calculated for each patient. The minimum possible score is 0 and the maximum possible score is 16. Higher scores indicate higher problems, which is a worse outcome. This will be calculated for all patients who complete follow-up.

Time frame: Assessed at 3 and 6-months from patient baseline assessment

Population: Table reports means and standard deviations with listwise deletion. The pre-specified plan uses mixed models with full maximum likelihood estimation (intent-to-treat) and data from all patients who reported any follow-up data (N = 592).

ArmMeasureGroupValue (MEAN)Dispersion
Addiction Technology Transfer Center (ATTC) TrainingGlobal Appraisal of Individual Needs Opioid-Related Problem Scale: Past Month (Patient Outcome)3-months post baseline2.43 Units on a scaleStandard Deviation 3.51
Addiction Technology Transfer Center (ATTC) TrainingGlobal Appraisal of Individual Needs Opioid-Related Problem Scale: Past Month (Patient Outcome)6-months post baseline2.24 Units on a scaleStandard Deviation 3.47
Enhanced ATTC (E-ATTC) Training StrategyGlobal Appraisal of Individual Needs Opioid-Related Problem Scale: Past Month (Patient Outcome)3-months post baseline2.55 Units on a scaleStandard Deviation 3.67
Enhanced ATTC (E-ATTC) Training StrategyGlobal Appraisal of Individual Needs Opioid-Related Problem Scale: Past Month (Patient Outcome)6-months post baseline2.17 Units on a scaleStandard Deviation 3.69
Comparison: These analyses are unadjusted. The primary outcomes paper will report both unadjusted and adjusted analyses.p-value: 0.2795% CI: [-0.82, 0.41]Mixed Models Analysis
Secondary

Opioid Abstinence: Past Month (Patient Outcome)

Days of abstinence as reported using calendar-based recall based on the Timeline Followback Interview method (Sobell & Sobell, 1992). Days of opioid abstinence will be calculated from 0 to 30 for each patient, with higher numbers indicating more days of abstinence (which is a better outcome). This will be calculated for all patients who complete follow-up.

Time frame: Assessed at 3 and 6-months from patient baseline assessment

Population: Table reports means and standard deviations with listwise deletion. The pre-specified plan uses mixed models with full maximum likelihood estimation (intent-to-treat) and data from all patients who reported any follow-up data (N = 592).

ArmMeasureGroupValue (MEAN)Dispersion
Addiction Technology Transfer Center (ATTC) TrainingOpioid Abstinence: Past Month (Patient Outcome)3-months post baseline8.89 Days of opioid abstinenceStandard Deviation 13.12
Addiction Technology Transfer Center (ATTC) TrainingOpioid Abstinence: Past Month (Patient Outcome)6-months post baseline10.15 Days of opioid abstinenceStandard Deviation 16.33
Enhanced ATTC (E-ATTC) Training StrategyOpioid Abstinence: Past Month (Patient Outcome)3-months post baseline9.39 Days of opioid abstinenceStandard Deviation 14
Enhanced ATTC (E-ATTC) Training StrategyOpioid Abstinence: Past Month (Patient Outcome)6-months post baseline8.33 Days of opioid abstinenceStandard Deviation 14.7
Comparison: These analyses are unadjusted. The primary outcomes paper will report both unadjusted and adjusted analyses.p-value: 0.03495% CI: [-1.3, -0.08]Mixed Models Analysis
Other Pre-specified

Implementation Climate Scale

Implementation climate scale (Jacobs et al., 2014). This scale contains 6 items scored on a 1 to 5 scale. An average score across the 6 items will be calculated per provider. Possible scores on this outcome range from a minimum of 1 to a maximum of 6. Higher scores indicate a more positive implementation climate, which is a better outcome.

Time frame: From baseline to 9 months post baseline

Population: Table reports means and standard deviations with listwise deletion. The pre-specified plan uses mixed models with full maximum likelihood estimation (intent-to-treat) and data from N=54 ATTC providers and N=58 E-ATTC providers.

ArmMeasureValue (MEAN)Dispersion
Addiction Technology Transfer Center (ATTC) TrainingImplementation Climate Scale3.77 Units on Implementation Climate ScaleStandard Deviation 1.17
Enhanced ATTC (E-ATTC) Training StrategyImplementation Climate Scale4.27 Units on Implementation Climate ScaleStandard Deviation 0.81
Comparison: These analyses are unadjusted. The primary outcomes paper will report both unadjusted and adjusted analyses.p-value: 0.01195% CI: [-0.88, 0.12]t-test, 2 sided
Other Pre-specified

Leadership Engagement Scale

Measure of leadership engagement (Garner, unpublished data). The scale contains 4 items scored on a 1 to 5 scale. An average perceived leadership engagement scale will be calculated for each provider. Possible scores on this outcome range from a minimum score of 1 to a maximum score of 5. Higher scores indicate higher perceived leadership engagement, which is a better outcome.

Time frame: From baseline to 9 months post baseline

Population: Table reports means and standard deviations with listwise deletion. The pre-specified plan uses mixed models with full maximum likelihood estimation (intent-to-treat) and data from N=53 ATTC providers and N=58 E-ATTC providers.

ArmMeasureValue (MEAN)Dispersion
Addiction Technology Transfer Center (ATTC) TrainingLeadership Engagement Scale3.47 Units on Leadership Engagement ScaleStandard Deviation 1.27
Enhanced ATTC (E-ATTC) Training StrategyLeadership Engagement Scale3.75 Units on Leadership Engagement ScaleStandard Deviation 1.17
Comparison: These analyses are unadjusted. The primary outcomes paper will report both unadjusted and adjusted analyses.p-value: 0.21895% CI: [-0.75, 0.17]t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Aug 27, 2026