Targeting Effective Analgesia in Clinics for HIV - Patient Cohort (TEACH)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02525731|
Recruitment Status : Active, not recruiting
First Posted : August 17, 2015
Last Update Posted : July 10, 2018
|Condition or disease|
|HIV Infection Pain Drug Dependence|
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 Type :||Observational|
|Actual Enrollment :||170 participants|
|Official Title:||Collaborative Care Intervention to Improve Providers' Opioid Prescribing for HIV-infected Patients - Patient Cohort Component|
|Actual Study Start Date :||July 2015|
|Estimated Primary Completion Date :||November 2018|
|Estimated Study Completion Date :||November 2018|
The TEACH patient cohort component will establish an observational cohort of HIV-infected patients on chronic opioid therapy.
- Pain severity in the past week (Brief Pain Inventory) [ Time Frame: Participants will be followed up to one year ]
- Opioid misuse (Current Opioid Misuse Measure) [ Time Frame: Participants will be followed up to one year ]
- Pain interference in the past week (Brief Pain Inventory) [ Time Frame: Participants will be followed up to one year ]
- Any emergency department visit to seek opioids (medical chart review and interview) [ Time Frame: Participants will be followed up to one year ]
- Number of days of drug use in the past 30 days (Addiction Severity Index) [ Time Frame: Participants will be followed up to one year ]
- Trust in provider (Physician Trust Scale) [ Time Frame: Participants will be followed up to one year ]
- Satisfaction with COT (questions created) [ Time Frame: Participants will be followed up to one year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02525731
|United States, Georgia|
|Atlanta, Georgia, United States, 30322|
|United States, Massachusetts|
|Boston Medical Center|
|Boston, Massachusetts, United States, 02118|
|Principal Investigator:||Jeffrey Samet, MD, MA, MPH||Boston Medical Center|