Targeting Effective Analgesia in Clinics for HIV - Patient Cohort

Pain Clinical Trial

— TEACH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02525731
• Other study ID #: H-33343
• Secondary ID: R01DA037768
• Status: Completed
• Start date: July 2015
• Est. completion date: November 2018

Study information

• Verified date: November 2018
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: November 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Drug Dependence
• HIV Infection
• HIV Infections
• Pain
• Substance-Related Disorders

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
Boston Medical Center	Emory University, Grady Health System, National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

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