Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05182606 |
| Other study ID # |
STUDY20030189 |
| Secondary ID |
R34DA050004 |
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2022 |
| Est. completion date |
September 2024 |
Study information
| Verified date |
October 2023 |
| Source |
University of Pittsburgh |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The NIH Helping to End Addiction Long-term (HEAL) initiative has identified a critical next
step to addressing the opioid crisis: improving treatments for opioid misuse behaviors (e.g.,
using more opioids than prescribed, illicit substance use) in patients prescribed long-term
opioid therapy for chronic pain. In previous work, the investigators have developed
innovative consensus-based algorithms to manage these behaviors. By developing implementation
strategies for these algorithms, this project is directly responsive to the HEAL initiative
and promises to reduce opioid misuse-related harms.
Description:
Despite a growing understanding of the risks of long-term opioid therapy (LTOT), it continues
to be frequently prescribed and remains a mainstay of treatment for chronic pain. The Centers
for Disease and Control (CDC) Guideline for Prescribing Opioids for Chronic Pain is geared
toward primary care providers and has been adopted as the standard of care by many healthcare
organizations and insurers. Importantly, it encourages monitoring of patients on LTOT for
opioid-related harms. By implementing monitoring, primary care providers may uncover various
concerning behaviors, sometimes called aberrant drug-related behaviors or opioid misuse
behaviors, that arise among individuals prescribed LTOT for chronic pain. These behaviors
(e.g., missed appointments, using more opioid medication than prescribed, asking for an
increase in opioid dose, aggressive behavior, and alcohol and other substance use) are
common, concerning, and may represent unsafe use of LTOT or a developing opioid use disorder
(OUD). However, the CDC Guideline and other existing evidence do not provide specific,
detailed guidance about how to address concerning behaviors when they occur. Therefore, there
is a critical need to understand how to best respond to these behaviors. The long-term goal
of our program of research is to reduce LTOT-related harms, particularly from opioid misuse,
and diminish their impact on the U.S. opioid epidemic. As a first step toward accomplishing
this goal, the investigators conducted a Delphi study to rigorously establish consensus-based
approaches to managing common and challenging concerning behaviors, from which algorithms
were created. Identifying and operationalizing implementation strategies using an
evidence-based framework are the critical next steps that must occur before any testing of
the algorithms.
The investigators successfully uncovered optimal implementation strategies through primary
care provider experiences with Standardized Patients (SPs) followed by CFIR- and ERIC-guided
individual interviews. Using our prior expertise developing clinic-wide opioid risk reduction
strategies and a Patient-Provider advisory board, the investigators developed a comprehensive
"implementation package" that can be delivered to primary care practices.
The investigators now aim to conduct a pilot trial to test the algorithm implementation
package. Guided by the CFIR-based implementation plan and using the implementation package
that the investigators developed, pilot trial will be conducted to investigate feasibility,
acceptability, and preliminary effectiveness of the algorithm implementation package.
