Study protocol for the targeting effective analgesia in clinics for HIV (TEACH) study - a cluster randomized controlled trial and parallel cohort to increase guideline concordant care for long-term opioid therapy among people living with HIV

Abstract

Background: People living with HIV (PLWH) frequently experience chronic pain and receive long-term opioid therapy (LTOT). Adherence to opioid prescribing guidelines among their providers is suboptimal. Objective: This paper describes the protocol of a cluster randomized trial, targeting effective analgesia in clinics for HIV (TEACH), which tested a collaborative care intervention to increase guideline-concordant care for LTOT among PLWH. Methods: HIV physicians and advanced practice providers (n = 41) were recruited from September 2015 to December 2016 from two HIV clinics in Boston and Atlanta. Patients receiving LTOT from participating providers were enrolled through a waiver of informed consent (n = 187). After baseline assessment, providers were randomized to the control group or the year-long TEACH intervention involving: (1) a nurse care manager and electronic registry to assist with patient management; (2) opioid education and academic detailing; and (3) facilitated access to addiction specialists. Randomization was stratified by site and LTOT patient volume. Primary outcomes (≥2 urine drug tests, early refills, provider satisfaction) were collected at 12 months. In parallel, PLWH receiving LTOT (n = 170) were recruited into a longitudinal cohort at both clinics and underwent baseline and 12-month assessments. Secondary outcomes were obtained through patient self-report among participants enrolled in both the cohort and the RCT (n = 117). Conclusions: TEACH will report the effects of an intervention on opioid prescribing for chronic pain on both provider and patient-level outcomes. The results may inform delivery of care for PLWH on LTOT for chronic pain at a time when opioid practices are being questioned in the US.

Trial registration: ClinicalTrials.gov NCT02564341 NCT02525731.

Keywords: HIV; addiction; chronic pain; long-term opioid therapy; pain management; prescription opioid misuse; substance use disorders.

Conflict of interest statement

Disclosure of Interest

The authors have no competing interests to report.

Figures

Figure 1.

Venn Diagram Describing Overlap between Targeting Effective Analgesia in Clinics for HIV (TEACH) RCT Patient Participants and Observational Cohort of Patient Participants

Figure 2.

Study Flow Diagram describing Recruitment of HIV Providers and their Patients into the Targeting Effective Analgesia in Clinics for HIV (TEACH) RCT

Figure 3.

Study Flow Diagram describing Recruitment of Patients Living with HIV into the Targeting Effective Analgesia in Clinics for HIV (TEACH) Patient Cohort