Targeting Effective Analgesia in Clinics for HIV - Intervention
- Conditions
- HIV InfectionPainDrug Dependence
- Interventions
- Behavioral: Collaboration with an IT enabled nurse care managerBehavioral: Education and academic detailingBehavioral: Facilitated access to a specialist in addictions
- Registration Number
- NCT02564341
- Lead Sponsor
- Boston Medical Center
- 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.
- Detailed 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 & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 41
- 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
- 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:
- None
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TEACH Collaborative Care Intervention Education and academic detailing 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. TEACH Collaborative Care Intervention Collaboration with an IT enabled nurse care manager 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. TEACH Collaborative Care Intervention Facilitated access to a specialist in addictions 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Number (continuous measure) of early refills at 12 months (EMR extraction) 12 Months Patient pain severity and interference (Patient self-report) 12 Months % of physicians who self-report consulting the state Prescription Monitoring Program (Physician self-report) 12 Months Patient aberrant use (Patient self-report) 12 Months Patient addiction severity (Patient self-report) 12 Months Patient satisfaction with COT (Patient self-report) 12 Months ≥3 primary care visits in infectious disease clinic (EMR extraction) 12 Months Opioid treatment agreement (EMR extraction) 12 Months Physician confidence in prescribing COT (Physician self-report) 12 Months % of patients who had a discontinuation of their narcotic prescriptions (EMR extraction) 12 Months Number of patients who have visited the emergency department to seek opioids (EMR extraction and patient self-report) 12 Months Patient trust in physician (Patient self-report) 12 Months
Trial Locations
- Locations (2)
Emory University
🇺🇸Atlanta, Georgia, United States
Boston Medical Center
🇺🇸Boston, Massachusetts, United States