Pain Clinical Trial
Official title:
Collaborative Care Intervention to Improve Providers' Opioid Prescribing for HIV-infected Patients - Patient Cohort Component
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).
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.
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