Clinical trial NCT02525731: Targeting Effective Analgesia in Clinics for HIV - Patient Cohort
Official title: Collaborative Care Intervention to Improve Providers' Opioid Prescribing for HIV-infected Patients - Patient Cohort Component
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infection
Pain
Drug Dependence
Keywords: HIV Infection
Pain
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: 2015-08-17
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV-infected COT patients from the HIV clinics at Boston Medical Center and Grady Memorial Hospital

Brief summary: The TEACH patient cohort will characterize a clinic sample of HIV-infected patients on chronic opioid therapy (COT) by describing basic demographics and health status, including characteristics of pain (severity and interference), aberrant behaviors/misuse of COT, substance use and trust/satisfaction with providers. In addition, data on a subset of participants will be used to supplement analysis of secondary outcomes for the TEACH randomized controlled trial (RCT), an intervention study directed at COT providers (outlined in a separate Clinical Trials Protocol Registration and Results (PRS) summary).

Detailed description: The TEACH patient cohort study is multi-site and will be conducted at Boston Medical Center and Grady Memorial Hospital. It will involve recruiting and consenting HIV-infected patients on chronic opioid therapy (COT) to be participants in an observational study. The patient cohort will characterize a clinic sample of HIV-infected patients on COT by describing basic demographics and health status, including characteristics of pain (severity and interference), aberrant behaviors/misuse of COT, substance use and trust/satisfaction with providers. Participation in the study will involve completing one baseline and one follow-up assessment. The follow-up assessment will take place approximately 12 months after the baseline assessment. Both the baseline and follow-up assessments will be conducted at the clinical site, and a single signed consent form will be obtained for both visits. A similar assessment instrument will be used at baseline and follow-up. Additional health information will be collected from the medical record.

There are two distinct components to the TEACH study. The patient cohort component, which is outlined in this Clinical Trials PRS summary, will involve recruiting and consenting patients in the HIV clinic on COT to be participants in an observational study. The intervention, outlined in a separate Clinical Trials PRS summary, will involve 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. Data on a subset of observational cohort participants will be used to supplement analysis of secondary outcomes for the intervention (i.e. those patients whose providers were enrolled).

The TEACH patient cohort component seeks to inform physicians and other providers about patients who use chronic opioid therapy, including valuable information on the effect of the COT prescriber-directed intervention on patients. This knowledge will guide both prescribers and patients in improving care and reducing risks associated with chronic opioid therapy.

Eligibility criteria: Inclusion Criteria:

* Patient is HIV-infected
* Patient receives care in the HIV clinic at participating sites
* Patient is on chronic opioid therapy (e.g. 3 or more opioid prescriptions written at least 21 days apart in the prior 6 months)
* Patient is at least 18 years of age
* Patient can provide contact information for at least two contacts to assist with follow-up
* Patient has a home or mobile telephone
* Patient speaks English

Exclusion Criteria:

* Patient plans to move from area within 12 months
* Patient is unable to consent or understand interview (determined by trained research staff)

Primary outcomes:
measure: Pain severity in the past week (Brief Pain Inventory)
timeFrame: Participants will be followed up to one year
measure: Opioid misuse (Current Opioid Misuse Measure)
timeFrame: Participants will be followed up to one year
Secondary outcomes:
measure: Pain interference in the past week (Brief Pain Inventory)
timeFrame: Participants will be followed up to one year
measure: Any emergency department visit to seek opioids (medical chart review and interview)
timeFrame: Participants will be followed up to one year
measure: Number of days of drug use in the past 30 days (Addiction Severity Index)
timeFrame: Participants will be followed up to one year
measure: Trust in provider (Physician Trust Scale)
timeFrame: Participants will be followed up to one year
measure: Satisfaction with COT (questions created)
timeFrame: Participants will be followed up to one year
Other outcomes:
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
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.