TEACH: Targeting Effective Analgesia in Clinics for HIV - Patient Cohort

Sponsor

Boston Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT02525731

Collaborator

National Institute on Drug Abuse (NIDA) (NIH), Emory University (Other), Grady Health System (Other)

170

Enrollment

Locations

Actual Duration (Months)

Patients Per Site

2.1

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
HIV Infection Pain Drug Dependence

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.

Study Design

Study Type:

Observational

Actual Enrollment :

170 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Collaborative Care Intervention to Improve Providers' Opioid Prescribing for HIV-infected Patients - Patient Cohort Component

Actual Study Start Date :

Jul 1, 2015

Actual Primary Completion Date :

Nov 1, 2018

Actual Study Completion Date :

Nov 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Patient Cohort The TEACH patient cohort component will establish an observational cohort of HIV-infected patients on chronic opioid therapy.

Outcome Measures

Primary Outcome Measures

Pain severity in the past week (Brief Pain Inventory) [Participants will be followed up to one year]
Opioid misuse (Current Opioid Misuse Measure) [Participants will be followed up to one year]

Secondary Outcome Measures

Pain interference in the past week (Brief Pain Inventory) [Participants will be followed up to one year]
Any emergency department visit to seek opioids (medical chart review and interview) [Participants will be followed up to one year]
Number of days of drug use in the past 30 days (Addiction Severity Index) [Participants will be followed up to one year]
Trust in provider (Physician Trust Scale) [Participants will be followed up to one year]
Satisfaction with COT (questions created) [Participants will be followed up to one year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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