Targeting Effective Analgesia in Clinics for HIV - Intervention

Pain Clinical Trial

— TEACH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02564341
• Other study ID #: H-33269
• Secondary ID: R01DA037768
• Status: Completed
• Phase: N/A
• Start date: September 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: Interventional

Clinical Trial 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.

Description:

The "Targeting Effective Analgesia in Clinics for HIV" (TEACH) Study will test the effectiveness of a collaborative care intervention directed toward HIV physicians to improve the management of chronic opioid therapy (COT) and reduce the misuse of prescription opioids among HIV-infected persons.

The intervention is composed of the following elements: 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. The nurse care manager will utilize an electronic registry to assist physicians in implementing guideline-driven care including opioid treatment agreements, urine drug testing (UDT), random pill counts and checking of online Prescription Monitoring Programs (PMPs). Physicians in the control group will receive information summarizing guidelines for COT but will not have access to the support of the TEACH intervention. This study is multi-site and will be conducted at Boston Medical Center and Grady Hospital (teaching hospital of Emory University). The 2-site study will use a cluster randomized trial design, randomized at the level of the physician, and compare primary outcomes over one year. The Specific Aims are to test the effectiveness of the TEACH collaborative care program to achieve the following: Aim 1 - to test whether the TEACH collaborative care program improves HIV physicians' adherence to guidelines for prescribing COT compared to standard practice; Aim 2 - to assess whether patient level outcomes improve as a result of the TEACH intervention; Aim 3 - to test whether the intervention increases HIV physicians' satisfaction with prescribing COT; and Aim 4 - to assess whether the intervention improves virologic control among HIV-infected patients who are on COT. If effective, implementation of the intervention in HIV clinics will enable physicians in clinical teams to deliver chronic opioid therapy according to established guidelines with more confidence, potentially resulting in less prescription drug abuse and improved HIV outcomes.

There are two distinct components to the study. The intervention, outlined in this Clinical Trials Protocol Registration and Results System (PRS) summary, involves 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. The patient cohort component, which is outlined in a separate Clinical Trials PRS summary, will involve recruiting and consenting patients in the HIV clinic on COT to be participants in an observational study, which will involve interviewing them to collect self-reported data and conducting medical chart reviews.

If effective, implementation of the TEACH intervention in clinics will enable physicians who provide primary care to HIV-infected patients in clinical teams to deliver chronic opioid therapy according to established guidelines with more confidence, potentially resulting in less prescription drug abuse and improved HIV outcomes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: November 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Physician Inclusion Criteria:

• 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).

Physician Exclusion Criteria:

• Investigator on this study.

• Planning to leave clinic < 9 months from enrollment.

Patient Inclusion Criteria:

• COT patient ages = 18 who are patients of physicians enrolled in the TEACH study.

Patient Exclusion Criteria:

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Collaboration with an IT enabled nurse care manager
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.
• Education and academic detailing
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.
• Facilitated access to a specialist in addictions
The nurse care manager will encourage and arrange referral of challenging patients with potential abuse or dependence to prescription opioids to an addiction specialist.

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
Other	Undetectable HIV viral load (EMR extraction)		12 Months
Other	Cluster of differentiation 4 (CD4) cell count (EMR extraction)		12 Months
Primary	Patient receipt of =2 UDT (Electronic Medical Record (EMR) extraction)		12 Months
Primary	% of patients who have =1 early refill (i.e., any early refills) (EMR extraction)		12 Months
Primary	Physician satisfaction managing HIV-infected patients on COT for pain (Physician self-report)		12 Months
Secondary	=3 primary care visits in infectious disease clinic (EMR extraction)		12 Months
Secondary	% of patients who had a discontinuation of their narcotic prescriptions (EMR extraction)		12 Months
Secondary	Opioid treatment agreement (EMR extraction)		12 Months
Secondary	% of physicians who self-report consulting the state Prescription Monitoring Program (Physician self-report)		12 Months
Secondary	Number (continuous measure) of early refills at 12 months (EMR extraction)		12 Months
Secondary	Patient aberrant use (Patient self-report)		12 Months
Secondary	Number of patients who have visited the emergency department to seek opioids (EMR extraction and patient self-report)		12 Months
Secondary	Patient pain severity and interference (Patient self-report)		12 Months
Secondary	Patient addiction severity (Patient self-report)		12 Months
Secondary	Physician confidence in prescribing COT (Physician self-report)		12 Months
Secondary	Patient satisfaction with COT (Patient self-report)		12 Months
Secondary	Patient trust in physician (Patient self-report)		12 Months