Transforming Opioid Prescribing in Primary Care
- Conditions
- Chronic PainOpioid-Related Disorders
- Interventions
- Behavioral: Electronic decision support toolsBehavioral: Enhanced patient education materialsBehavioral: Nurse care managementBehavioral: Electronic Patient RegistryBehavioral: Academic detailing
- Registration Number
- NCT01909076
- Lead Sponsor
- Boston Medical Center
- Brief Summary
Prescription opioid misuse is a significant public health problem as well as a patient safety concern. Primary care providers are the leading prescribers of opioids for chronic pain, yet few providers follow standard practice guidelines regarding assessment and monitoring. The investigators propose a novel system change in delivery of primary care services to decrease misuse of and addiction to prescription opioids for patients with chronic pain.
The proposed intervention for the overall project includes a nurse-managed registry for planning individual patient care and conducting population-based care for a population of patients receiving opioids for chronic pain. Academic detailing to clinicians is another effective way to improve care. Finally, the researchers will create a knowledge management tool to facilitate guideline adherence. This tool will be accessible via an internet link, and will include validated instruments to assess patient status and also to facilitate physician adherence to suggested monitoring.
- Detailed Description
This project will implement interventions in the primary care setting to improve management of patients prescribed opioid therapy for chronic non-cancer pain.
Prescription opioid misuse is a significant current public health problem as well as a patient safety concern. Primary care providers are the leading prescribers of opioids for chronic pain, yet few providers follow standard practice guidelines regarding assessment and monitoring. The investigators propose a novel system change in delivery of primary care services to decrease misuse of and addiction to prescription opioids for patients with chronic pain.
The researchers will conduct a cluster randomized controlled trial, randomizing 50 primary care providers and their estimated 500 patients to the intervention condition (nurse care management, registry, electronic decision support tools, and academic detailing) or control condition (electronic decision support tools and educational outreach only). The primary outcomes, measured at twelve months, are PCP adherence to chronic opioid therapy guidelines and opioid misuse.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 53
- All PCPs (physicians, doctors of osteopathy, nurse practitioners, and physicians' assistants) at participating sites with 4 patients prescribed opioid treatment along with their patients greater than or equal to age 18 who have 1) 3 or more completed visits to the primary care practice; 2) long-term opioid treatment defined by 3 or more opioid prescriptions written at least 21 days apart within 6 months; and 3) an inpatient or outpatient ICD9CM diagnosis for musculoskeletal or neuropathic pain. In addition, non-PCP staff at the health centers and at the Massachusetts State PMP who agree to be included in the qualitative assessments will be included and will be considered subjects. Note that the investigators have limited inclusion in the study to PCPs with at least 4 patients on chronic opioid therapy because it was determined that for PCPs with fewer than 4 patients the time burden associated with the study (meeting with nurse care manager, receiving academic detailing etc) would not be justified.
- Patients currently receiving care for cancer, except non-melanoma skin cancer. Patients with remote (>5 years) histories being disease-free from other cancers (e.g. breast, colon, prostate) will not be excluded due to the low risk of current cancer related pain. PCPs and staff who do not consent to the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention PCPs and patients Electronic decision support tools The Intervention Condition has three main components: access to nurse care management, access to the patient registry, and academic detailing for intervention PCPs. Intervention PCPs will also receive the control intervention of electronic decision support tools, and patients of intervention PCPs will receive the same patient education materials as patients of control PCPs. Control PCPs and their patients Enhanced patient education materials PCPs randomized to the control condition will receive electronic decision support tools. Patients of control PCPs will receive education materials that will be developed and made available to both control and intervention patients. Intervention PCPs and patients Academic detailing The Intervention Condition has three main components: access to nurse care management, access to the patient registry, and academic detailing for intervention PCPs. Intervention PCPs will also receive the control intervention of electronic decision support tools, and patients of intervention PCPs will receive the same patient education materials as patients of control PCPs. Control PCPs and their patients Electronic decision support tools PCPs randomized to the control condition will receive electronic decision support tools. Patients of control PCPs will receive education materials that will be developed and made available to both control and intervention patients. Intervention PCPs and patients Enhanced patient education materials The Intervention Condition has three main components: access to nurse care management, access to the patient registry, and academic detailing for intervention PCPs. Intervention PCPs will also receive the control intervention of electronic decision support tools, and patients of intervention PCPs will receive the same patient education materials as patients of control PCPs. Intervention PCPs and patients Nurse care management The Intervention Condition has three main components: access to nurse care management, access to the patient registry, and academic detailing for intervention PCPs. Intervention PCPs will also receive the control intervention of electronic decision support tools, and patients of intervention PCPs will receive the same patient education materials as patients of control PCPs. Intervention PCPs and patients Electronic Patient Registry The Intervention Condition has three main components: access to nurse care management, access to the patient registry, and academic detailing for intervention PCPs. Intervention PCPs will also receive the control intervention of electronic decision support tools, and patients of intervention PCPs will receive the same patient education materials as patients of control PCPs.
- Primary Outcome Measures
Name Time Method PCP adherence to chronic opioid therapy guidelines up to 12 months. The primary outcomes is PCP adherence to chronic opioid therapy guidelines and is defined as whether a PCP's patient has
1. a signed opioid treatment agreement (ever) and
2. urine drug testing (at least 1 completed urine drug test for controlled substances at any point during opioid treatment).
- Secondary Outcome Measures
Name Time Method Patient opioid misuse, as measured by number of early refills Each PCP's patient list will be assessed at baseline and at 12 months. The secondary outcome measures patient opioid misuse, defined as having multiple (\>2) early refills in the past year. To identify early refills of opioid prescriptions, the researchers will calculate the duration of a prescription based on the number dispensed and the directions, conservatively assuming that the patient took the medication at the maximal prescribed rate. The investigators define an early refill as being written at least 7 days before the previous prescription for the same medication should have been finished.
Patient opioid and illicit substance misuse and/or abuse, as measured by urine toxicology results Each PCP's patient list will be assessed at baseline and at 12 months. Patient substance abuse will be measured as urine drug tests where an illicit substance is present, the prescribed opioid is absent, and/or the patient has missed the urine drug screen.
Trial Locations
- Locations (1)
Boston Medical Center
🇺🇸Boston, Massachusetts, United States