Collaborative Care Intervention to Improve Providers' Opioid Prescribing for HIV-infected Patients - Intervention Component
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 4
- 主要终点
- Patient receipt of ≥2 UDT (Electronic Medical Record (EMR) extraction)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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:
研究组 & 干预措施
TEACH Collaborative Care Intervention
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.
干预措施: Collaboration with an IT enabled nurse care manager (Behavioral)
TEACH Collaborative Care Intervention
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.
干预措施: Education and academic detailing (Behavioral)
TEACH Collaborative Care Intervention
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.
干预措施: Facilitated access to a specialist in addictions (Behavioral)
Standard of Care Control
Physicians in the control group will receive information summarizing guidelines for COT but will not have access to the support of the TEACH intervention.
结局指标
主要结局
Patient receipt of ≥2 UDT (Electronic Medical Record (EMR) extraction)
时间窗: 12 Months
% of patients who have ≥1 early refill (i.e., any early refills) (EMR extraction)
时间窗: 12 Months
Physician satisfaction managing HIV-infected patients on COT for pain (Physician self-report)
时间窗: 12 Months
次要结局
- 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)
研究者
Jeffrey Samet
Chief of General Internal Medicine
Boston Medical Center