Toward Safer Opioid Prescribing in HIV care (TOWER): a mixed-methods, cluster-randomized trial

Area of Science:

• Implementation Science
• Public Health
• Pain Management
• Infectious Disease (HIV)

Background:

• The 2016 U.S. Centers for Disease Control and Prevention (CDC) Opioid Prescribing Guideline is under revision due to concerns about potential harm to patients on long-term opioid therapy for chronic pain.
• A lack of methodology exists to implement the CDC Guideline, measure prescriber adherence, and assess its impact on patient and public health outcomes.
• This study focused on developing and testing an implementation strategy (TOWER) in an outpatient HIV-focused primary care setting.

Purpose of the Study:

• To develop and test a strategy (TOWER) to implement and measure adherence to the CDC Opioid Prescribing Guideline in an HIV-primary care setting.
• To evaluate the impact of the TOWER strategy on prescriber adherence to the CDC Guideline and patient-reported outcomes.
• To address the need for a systematic approach to CDC Guideline implementation and outcome assessment.

Main Methods:

• The TOWER strategy was developed using a stakeholder-engaged, iterative process within an Information, Motivation, and Behavioral Skills (IMB) framework.
• TOWER includes a patient-facing opioid management app (OM-App), an office visit progress note template (OM-Note), and primary care provider (PCP) training.
• A 9-month randomized controlled trial evaluated TOWER in 11 HIV-PCPs and 40 patients with HIV and chronic pain on long-term opioid therapy, measuring adherence via the Safer Opioid Prescribing Evaluation Tool (SOPET) and collecting qualitative data and patient-reported outcomes.

Main Results:

• Primary care providers randomized to TOWER demonstrated a 48% increase in adherence to the CDC Guideline (p < 0.0001).
• Significant improvements were observed in the use of non-pharmacologic treatments, functional treatment goals, opioid agreements, PDMPs, opioid benefit/harm assessment, and naloxone prescribing.
• Qualitative data indicated high provider confidence, mixed experiences with the OM-App, and no intervention-associated safety concerns (worsening of patient-reported outcomes).

Conclusions:

• Adherence to the CDC Opioid Prescribing Guideline can be effectively promoted and measured in patients with HIV receiving long-term opioid therapy for chronic pain.
• Implementing the CDC Guideline using the TOWER strategy was not associated with worsening patient outcomes.
• Future research is needed to assess the scalability of these findings and the overall public health impact of improved CDC Guideline adherence.