Transforming Opioid Prescribing in Primary Care (TOPCARE)

Boston Medical Center (BMC)

Status: Completed

Conditions: Opioid-Related Disorders; Chronic Pain

Treatments: Behavioral: Academic detailing; Behavioral: Enhanced patient education materials; Behavioral: Nurse care management; Behavioral: Electronic decision support tools; Behavioral: Electronic Patient Registry

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01909076

R01DA034252-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 53 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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53 participants in 2 patient groups

Control PCPs and their patients

Active Comparator group

Description:

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.

Treatment:

Behavioral: Enhanced patient education materials

Behavioral: Electronic decision support tools

Intervention PCPs and patients

Experimental group

Description:

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.

Treatment:

Behavioral: Enhanced patient education materials

Behavioral: Electronic decision support tools

Behavioral: Nurse care management

Behavioral: Electronic Patient Registry

Behavioral: Academic detailing