Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT03931174 |
| Other study ID # |
#1811002260 |
| Secondary ID |
R01DA046941 |
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 9, 2019 |
| Est. completion date |
June 2024 |
Study information
| Verified date |
February 2023 |
| Source |
Brown University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
There is an urgent need for effective treatments for patients with opioid use disorder (OUD).
This study will train opioid treatment centers 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 OUD treatment centers 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 OUD centers. 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 OUD treatment centers 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 OUD treatment center, 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.
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 OUD treatment centers remains low.
The primary purpose of this study is to experimentally evaluate two different comprehensive
training models to train opioid treatment centers in CM. A Type 3 Hybrid Trial will be
conducted collecting data on both implementation and patient outcomes. Using a cluster
randomized design, 30 OUD treatment centers 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 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
(patient-level measure of number of CM sessions received during 9-month Implementation phase)
CM Competence (provider-level measure of CM quality during month Implementation phase), and
CM Sustainment (patient-level measure of number of CM sessions received during 12-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 organization-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.
