Transforming Opioid Prescribing in Primary Care

NCT01909076 | Completed DMC

• 1 other identifier: R01DA034252-01
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain; Opioid-Related Disorders

Outcome Measures

Primary Outcomes (1)

• PCP adherence to chronic opioid therapy guidelines

  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).

  up to 12 months.

Secondary Outcomes (2)

• Patient opioid misuse, as measured by number of early refills

  Each PCP's patient list will be assessed at baseline and at 12 months.

• 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.

Study Arms (2)

Control PCPs and their patients

ACTIVE COMPARATOR

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.

Behavioral: Electronic decision support tools; Behavioral: Enhanced patient education materials

Intervention PCPs and patients

EXPERIMENTAL

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.

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

Interventions

Electronic decision support tools BEHAVIORAL

Electronic decision support tools available to both control and intervention PCPs include patient pain assessments, (Brief Pain Inventory, Pain/Enjoyment/General Function "PEG"), substance abuse (DAST, AUDIT) depression (PHQ9), PTSD (PTSD ChecklistCivilian), and risk of prescription drug misuse (SOAPP and COMM). The tools calculate scores with recommendation for specific action for each tool, when appropriate.

Control PCPs and their patients; Intervention PCPs and patients

Enhanced patient education materials BEHAVIORAL

Patient education materials will be developed and made available to both control and intervention patients. The investigators will design the materials for patients with low literacy, using pictures and simple graphics to augment written language. The research staff will make PDFs of the materials available on the study website during and after the project.

Control PCPs and their patients; Intervention PCPs and patients

Nurse care management BEHAVIORAL

The nurse/care management intervention will be modeled on BMC's successful collaborative care office-based opioid treatment (OBOT) program. One fulltime nurse care manager will work with PCPs assigned to the intervention condition. The care manager will be based centrally, in the Section of General Internal Medicine, and will divide his/her time between the 3 health centers. The main focus of the nurse care manager is to assure that patients are receiving guideline-adherent care, which involves appropriate clinical assessments, opioid treatment agreements, refill management, administering monitoring tools according to risk level (urine toxicology screen, pill counts, PMP data extraction) and timely physician visits to assess pain (minimum every 6 months).

Intervention PCPs and patients

Electronic Patient Registry BEHAVIORAL

The registry will be a freestanding centralized disease management application and built using standard database technology. This system will communicate with the electronic medical record (EMR) at each community health center and with the Massachusetts State Prescription Monitoring Program (PMP) system. Data that will feed into the registry include clinical data recorded from the EMR (documentation from other clinicians and labs), data from clinical users entered into the registry via pain and opioid management forms, and the PMP. The nurse care manager will use a custom registry interface to monitor key practice activities across the entire practice at each site. The nurse care manager will use population management tools to provide aggregate measures for quality monitoring and workforce management. All quality metrics can be downloaded in aggregate form for further analysis.

Intervention PCPs and patients

Academic detailing BEHAVIORAL

All PCPs in the intervention group will receive one 30 minute individual visit 23 months after project implementation at the PCP's practice site. The visits will be conducted with at least one of the study experts in pain medication management. Visit content will combine elements of audit and feedback (e.g. review registry of individual PCP compared with that of peers and goals) as well as traditional educational outreach. Specifically, experts will review each aspect of guideline concordant care (assessment of risk and appropriateness for opioid medication, medication dosing, monitoring for harm/adherence, and pain outcomes) to solicit barriers to implementation or lack of knowledge on the underlying evidence for each aspect of care. The experts will work with the individual PCPs to address barriers identified using motivational interviewing as needed to facilitate behavioral change in applying guideline concordant care.

Intervention PCPs and patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Medical Center: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Related Publications (2)

• Liebschutz JM, Xuan Z, Shanahan CW, LaRochelle M, Keosaian J, Beers D, Guara G, O'Connor K, Alford DP, Parker V, Weiss RD, Samet JH, Crosson J, Cushman PA, Lasser KE. Improving Adherence to Long-term Opioid Therapy Guidelines to Reduce Opioid Misuse in Primary Care: A Cluster-Randomized Clinical Trial. JAMA Intern Med. 2017 Sep 1;177(9):1265-1272. doi: 10.1001/jamainternmed.2017.2468.

  PMID: 28715535 DERIVED

• Lasser KE, Shanahan C, Parker V, Beers D, Xuan Z, Heymann O, Lange A, Liebschutz JM. A Multicomponent Intervention to Improve Primary Care Provider Adherence to Chronic Opioid Therapy Guidelines and Reduce Opioid Misuse: A Cluster Randomized Controlled Trial Protocol. J Subst Abuse Treat. 2016 Jan;60:101-9. doi: 10.1016/j.jsat.2015.06.018. Epub 2015 Jul 15.

  PMID: 26256769 DERIVED

MeSH Terms

Conditions

Chronic Pain; Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Karen Lasser, MD, MPH

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

• Jane E Liebschutz, MD, MPH

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: BMC Attending Physician

Study Record Dates

• First Submitted: May 24, 2013
• First Posted: July 26, 2013
• Study Start: January 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: March 3, 2016

Record last verified: 2016-03

Locations

US (1)