Targeting Effective Analgesia in Clinics for HIV - Intervention

The "Targeting Effective Analgesia in Clinics for HIV" (TEACH) Study will test the
effectiveness of a collaborative care intervention directed toward HIV physicians to improve
the management of chronic opioid therapy (COT) and reduce the misuse of prescription opioids
among HIV-infected persons.

The intervention is composed of the following elements: 1) collaboration with an IT enabled
nurse care manager; 2) physician education and academic detailing; and 3) facilitated access
to a specialist in addictions to help manage the most challenging HIV-infected patients on
COT. The nurse care manager will utilize an electronic registry to assist physicians in
implementing guideline-driven care including opioid treatment agreements, urine drug testing
(UDT), random pill counts and checking of online Prescription Monitoring Programs (PMPs).
Physicians in the control group will receive information summarizing guidelines for COT but
will not have access to the support of the TEACH intervention. This study is multi-site and
will be conducted at Boston Medical Center and Grady Hospital (teaching hospital of Emory
University). The 2-site study will use a cluster randomized trial design, randomized at the
level of the physician, and compare primary outcomes over one year. The Specific Aims are to
test the effectiveness of the TEACH collaborative care program to achieve the following: Aim
1 - to test whether the TEACH collaborative care program improves HIV physicians' adherence
to guidelines for prescribing COT compared to standard practice; Aim 2 - to assess whether
patient level outcomes improve as a result of the TEACH intervention; Aim 3 - to test whether
the intervention increases HIV physicians' satisfaction with prescribing COT; and Aim 4 - to
assess whether the intervention improves virologic control among HIV-infected patients who
are on COT. If effective, implementation of the intervention in HIV clinics will enable
physicians in clinical teams to deliver chronic opioid therapy according to established
guidelines with more confidence, potentially resulting in less prescription drug abuse and
improved HIV outcomes.

There are two distinct components to the study. The intervention, outlined in this Clinical
Trials Protocol Registration and Results System (PRS) summary, involves consenting physicians
as participants in a randomized controlled trial of an intervention and, via a waiver of
informed consent, extracting patient level data on the physicians' patients from the
electronic medical record. The patient cohort component, which is outlined in a separate
Clinical Trials PRS summary, will involve recruiting and consenting patients in the HIV
clinic on COT to be participants in an observational study, which will involve interviewing
them to collect self-reported data and conducting medical chart reviews.

If effective, implementation of the TEACH intervention in clinics will enable physicians who
provide primary care to HIV-infected patients in clinical teams to deliver chronic opioid
therapy according to established guidelines with more confidence, potentially resulting in
less prescription drug abuse and improved HIV outcomes.

Physician Inclusion Criteria:

- Physician (i.e. MD, DO) or Advanced Practice Provider (i.e., Nurse Practitioner or
Physicians Assistant) at enrollment sites.

- Main provider for ≥ 1 HIV-infected patient on COT (defined as having received ≥ 3
opioid prescriptions at least 21 days apart within a 6 month period).

Physician Exclusion Criteria:

- Investigator on this study.

- Planning to leave clinic < 9 months from enrollment.

Patient Inclusion Criteria:

- COT patient ages ≥ 18 who are patients of physicians enrolled in the TEACH study.

Patient Exclusion Criteria: