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Targeting Effective Analgesia in Clinics for HIV - Patient Cohort (TEACH)

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ClinicalTrials.gov Identifier: NCT02525731
Recruitment Status : Active, not recruiting
First Posted : August 17, 2015
Last Update Posted : July 10, 2018
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
Emory University
Grady Health System
Information provided by (Responsible Party):
Jeffrey Samet, Boston Medical Center

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
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 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 : July 2015
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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



Primary Outcome Measures :
  1. Pain severity in the past week (Brief Pain Inventory) [ Time Frame: Participants will be followed up to one year ]
  2. Opioid misuse (Current Opioid Misuse Measure) [ Time Frame: Participants will be followed up to one year ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
HIV-infected COT patients from the HIV clinics at Boston Medical Center and Grady Memorial Hospital
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)

Information from the National Library of Medicine

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


Locations
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
National Institute on Drug Abuse (NIDA)
Emory University
Grady Health System
Investigators
Principal Investigator: Jeffrey Samet, MD, MA, MPH Boston Medical Center

Responsible Party: Jeffrey Samet, Chief of General Internal Medicine, Boston Medical Center
ClinicalTrials.gov Identifier: NCT02525731     History of Changes
Other Study ID Numbers: H-33343
R01DA037768 ( U.S. NIH Grant/Contract )
First Posted: August 17, 2015    Key Record Dates
Last Update Posted: July 10, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make individual participant data available.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jeffrey Samet, Boston Medical Center:
HIV Infection
Pain
Chronic Opioid Therapy
Addiction
Analgesics, Opioid

Additional relevant MeSH terms:
HIV Infections
Substance-Related Disorders
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents