Targeting Effective Analgesia in Clinics for HIV - Intervention

NCT02564341 | Completed

• 2 other identifiers: H-33269R01DA037768
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 2

Brief Summary

The TEACH randomized controlled trial will test the effectiveness of a collaborative care intervention directed towards physicians who provide care for HIV-infected persons to improve the quality of care for prescribing chronic opioid therapy (COT) for pain and reduce the misuse of prescription opioids among HIV-infected persons.

Conditions

HIV Infection; Pain; Drug Dependence

Keywords

HIV Infection; Pain; Collaborative Care; Chronic Opioid Therapy; Addiction; Analgesics, Opioid

Outcome Measures

Primary Outcomes (3)

• Patient receipt of ≥2 UDT (Electronic Medical Record (EMR) extraction)

  12 Months

• % of patients who have ≥1 early refill (i.e., any early refills) (EMR extraction)

  12 Months

• Physician satisfaction managing HIV-infected patients on COT for pain (Physician self-report)

  12 Months

Secondary Outcomes (12)

• ≥3 primary care visits in infectious disease clinic (EMR extraction)

  12 Months

• % of patients who had a discontinuation of their narcotic prescriptions (EMR extraction)

  12 Months

• Opioid treatment agreement (EMR extraction)

  12 Months

• % of physicians who self-report consulting the state Prescription Monitoring Program (Physician self-report)

  12 Months

• Number (continuous measure) of early refills at 12 months (EMR extraction)

  12 Months

Other Outcomes (2)

• Undetectable HIV viral load (EMR extraction)

  12 Months

• Cluster of differentiation 4 (CD4) cell count (EMR extraction)

  12 Months

Study Arms (2)

TEACH Collaborative Care Intervention

EXPERIMENTAL

Physicians randomized to the intervention will receive: 1) collaboration with an IT enabled nurse care manager; 2) physician education and academic detailing; and 3) facilitated access to a specialist in addictions to help manage the most challenging HIV-infected patients on COT.

Behavioral: Collaboration with an IT enabled nurse care manager; Behavioral: Education and academic detailing; Behavioral: Facilitated access to a specialist in addictions

Standard of Care Control

NO INTERVENTION

Physicians in the control group will receive information summarizing guidelines for COT but will not have access to the support of the TEACH intervention.

Interventions

Collaboration with an IT enabled nurse care manager BEHAVIORAL

The nurse care manager at each site will collaborate with intervention physicians to implement key essential elements of guideline driven care, namely opioid treatment agreements, urine drug testing, random pill counts and periodic checking of on-line Prescription Monitoring Programs. The nurse care manager will use an electronic registry to retrieve pain medication information from the electronic medical record (EMR). Registry data will be collected on the patients of the intervention group providers. The nurse care manager will be able to use the registry to generate reports that will allow him/her to monitor those patients who are receiving opioids for chronic pain.

TEACH Collaborative Care Intervention

Education and academic detailing BEHAVIORAL

All intervention participants will receive a 60 minute group didactic session by a national expert on opioid prescribing for pain. Physicians will receive two academic detailing sessions, and will be given the option of having a third, booster academic detailing session if desired.

TEACH Collaborative Care Intervention

Facilitated access to a specialist in addictions BEHAVIORAL

The nurse care manager will encourage and arrange referral of challenging patients with potential abuse or dependence to prescription opioids to an addiction specialist.

TEACH Collaborative Care Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Physician (i.e. MD, DO) or Advanced Practice Provider (i.e., Nurse Practitioner or Physicians Assistant) at enrollment sites.
• Main provider for ≥ 1 HIV-infected patient on COT (defined as having received ≥ 3 opioid prescriptions at least 21 days apart within a 6 month period).

You may not qualify if:

• Investigator on this study.
• Planning to leave clinic \< 9 months from enrollment.
• COT patient ages ≥ 18 who are patients of physicians enrolled in the TEACH study.
• None

Sponsors & Collaborators

• Boston Medical Center: lead
• National Institute on Drug Abuse (NIDA): collaborator
• Emory University: collaborator
• Grady Health System: collaborator

Study Sites (2)

Emory University

Atlanta, Georgia, 30322, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Related Publications (2)

• Ngo B, Liebschutz JM, Cheng DM, Colasanti JA, Merlin JS, Armstrong WS, Forman LS, Lira MC, Samet JH, Del Rio C, Tsui JI. Hazardous alcohol use is associated with greater pain interference and prescription opioid misuse among persons living with HIV and chronic pain. BMC Public Health. 2021 Mar 22;21(1):564. doi: 10.1186/s12889-021-10566-6.

  PMID: 33752634 DERIVED

• Lira MC, Tsui JI, Liebschutz JM, Colasanti J, Root C, Cheng DM, Walley AY, Sullivan M, Shanahan C, O'Connor K, Abrams C, Forman LS, Chaisson C, Bridden C, Podolsky MC, Outlaw K, Harris CE, Armstrong WS, Del Rio C, Samet JH. Study protocol for the targeting effective analgesia in clinics for HIV (TEACH) study - a cluster randomized controlled trial and parallel cohort to increase guideline concordant care for long-term opioid therapy among people living with HIV. HIV Res Clin Pract. 2019 Apr;20(2):48-63. doi: 10.1080/15284336.2019.1627509.

  PMID: 31303143 DERIVED

MeSH Terms

Conditions

HIV Infections; Pain; Substance-Related Disorders; Behavior, Addictive

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Chemically-Induced Disorders; Mental Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Jeffrey Samet, MD, MA, MPH

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

• Carlos del Rio, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of General Internal Medicine

Study Record Dates

• First Submitted: September 28, 2015
• First Posted: September 30, 2015
• Study Start: September 1, 2015
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: November 20, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)