Clinical trial NCT02564341: Targeting Effective Analgesia in Clinics for HIV - Intervention
Official title: Collaborative Care Intervention to Improve Providers' Opioid Prescribing for HIV-infected Patients - Intervention Component
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infection
Pain
Drug Dependence
Keywords: HIV Infection
Pain
Collaborative Care
Chronic Opioid Therapy
Addiction
Analgesics, Opioid
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: Emory University
name: Grady Health System
First posted: 2015-09-30
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The TEACH randomized controlled trial will test the effectiveness of a collaborative care intervention directed towards physicians who provide care for HIV-infected persons to improve the quality of care for prescribing chronic opioid therapy (COT) for pain and reduce the misuse of prescription opioids among HIV-infected persons.

Detailed description: 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.

Eligibility criteria: 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:

* None

Primary outcomes:
measure: Patient receipt of ≥2 UDT (Electronic Medical Record (EMR) extraction)
timeFrame: 12 Months
measure: % of patients who have ≥1 early refill (i.e., any early refills) (EMR extraction)
timeFrame: 12 Months
measure: Physician satisfaction managing HIV-infected patients on COT for pain (Physician self-report)
timeFrame: 12 Months
Secondary outcomes:
measure: ≥3 primary care visits in infectious disease clinic (EMR extraction)
timeFrame: 12 Months
measure: % of patients who had a discontinuation of their narcotic prescriptions (EMR extraction)
timeFrame: 12 Months
measure: Opioid treatment agreement (EMR extraction)
timeFrame: 12 Months
measure: % of physicians who self-report consulting the state Prescription Monitoring Program (Physician self-report)
timeFrame: 12 Months
measure: Number (continuous measure) of early refills at 12 months (EMR extraction)
timeFrame: 12 Months
measure: Patient aberrant use (Patient self-report)
timeFrame: 12 Months
measure: Number of patients who have visited the emergency department to seek opioids (EMR extraction and patient self-report)
timeFrame: 12 Months
measure: Patient pain severity and interference (Patient self-report)
timeFrame: 12 Months
measure: Patient addiction severity (Patient self-report)
timeFrame: 12 Months
measure: Physician confidence in prescribing COT (Physician self-report)
timeFrame: 12 Months
measure: Patient satisfaction with COT (Patient self-report)
timeFrame: 12 Months
measure: Patient trust in physician (Patient self-report)
timeFrame: 12 Months
Other outcomes:
measure: Undetectable HIV viral load (EMR extraction)
timeFrame: 12 Months
measure: Cluster of differentiation 4 (CD4) cell count (EMR extraction)
timeFrame: 12 Months
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Jeffrey Samet, MD, MA, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Carlos del Rio, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ngo B, Liebschutz JM, Cheng DM, Colasanti JA, Merlin JS, Armstrong WS, Forman LS, Lira MC, Samet JH, Del Rio C, Tsui JI. Hazardous alcohol use is associated with greater pain interference and prescription opioid misuse among persons living with HIV and chronic pain. BMC Public Health. 2021 Mar 22;21(1):564. doi: 10.1186/s12889-021-10566-6.
citation: Lira MC, Tsui JI, Liebschutz JM, Colasanti J, Root C, Cheng DM, Walley AY, Sullivan M, Shanahan C, O'Connor K, Abrams C, Forman LS, Chaisson C, Bridden C, Podolsky MC, Outlaw K, Harris CE, Armstrong WS, Del Rio C, Samet JH. 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. HIV Res Clin Pract. 2019 Apr;20(2):48-63. doi: 10.1080/15284336.2019.1627509.