A Multicomponent Intervention to Improve Primary Care Provider Adherence to Chronic Opioid Therapy Guidelines and Reduce Opioid Misuse: A Cluster Randomized Controlled Trial Protocol

Abstract

Background Prescription opioid misuse is a significant public health problem as well as a patient safety concern. Primary care providers (PCPs) are the leading prescribers of opioids for chronic pain, yet few PCPs follow standard practice guidelines regarding assessment and monitoring. This cluster randomized controlled trial will determine whether four implementation strategies; nurse care management, use of a patient registry, academic detailing, and electronic tools, will increase PCP adherence to chronic opioid therapy guidelines and reduce opioid misuse among patients, relative to electronic tools alone. The implementation strategies and intervention content are based on the Chronic Care Model. Methods We include 53 PCPs from three Boston-area community health centers and one urban safety-net hospital-based primary care practice who have at least four patients meeting the following inclusion criteria: 1) age ≥ 18; 2) one or more completed visits to the primary care practice in the past year; 3) long-term opioid treatment defined as three or more opioid prescriptions written at least 21 days apart within six months and 4) an inpatient or outpatient ICD-9-CM diagnosis for musculoskeletal or neuropathic pain. We consider PCPs to be study subjects, and obtained a waiver of informed consent for patients because the study is promoting an established standard of care. We enrolled participants (PCPs) from December 2012 through March 2015. PCPs were randomized to receive the intervention, which includes four components: 1) nurse care management, 2) use of a patient registry, 3) academic detailing, and 4) electronic tools, or a control condition, which includes only the use of the electronic tools. The intervention PCPs receive the services of a nurse-managed registry for planning individual patient care and conducting population-based care for patients receiving opioids for chronic pain. In academic detailing visits, trained co-investigators provide intervention PCPs with individualized education to change prescribing practice. Electronic tools, located on a website external to the EMR, www.mytopcare.org, include validated instruments to assess patient status, and management resources to facilitate PCP adherence to suggested monitoring. Electronic tools are available to PCPs in both study arms. The primary outcomes are PCP adherence to chronic opioid therapy guidelines and patient opioid misuse. Secondary outcomes include measures of substance abuse, possible opioid diversion, and level of opioid risk among patients. We will follow PCPs and their estimated 1200 chronic pain patients for one year after study enrollment. To determine whether the intervention condition achieves greater adherence to guidelines and reduced opioid misuse after one year compared to the control condition, we will compare the baseline and follow-up measures of the individual patients, stratifying by intervention status and noting differences that are statistically significant at the p=0.05 level. Analyses will be based on intent-to-treat....

Strategies to Identify and Reduce Opioid Misuse Among Patients with Gastrointestinal Disorders: A Systematic Scoping Review

“…Specifically, we examined the practices, tools and intervention components described in the included articles, and, using the table derived from Adams et al and Lasser et al [Table 3;50, 55], mapped each component to a CCM element that best described that component. We found that all strategies discussed in the included articles aligned closely with at least one CCM element, with the majority of articles addressing a strategy to identify or reduce opioid misuse by addressing the clinical information systems element.…”

“…We recorded information on authorship, article type, publication year, key study findings, clinical setting, GI patient population, and the type of health care practice, tool and intervention to identify and/or reduce opioid misuse on this form. Using a modified version of the categorization approaches previously published [50, 55], a second data charting form was adapted to examine and classify the types of health care practices, tools and interventions presented in the articles according to the key CCM components (Table 3). Information that was organized in the data charting forms was used to collate and report the existing approaches towards identifying and reducing opioid misuse, abuse, or overuse in the GI care setting.…”

“…Although originally developed to improve chronic care delivery [46–47], the model has been successfully integrated into interventions to address alcohol abuse, opioid misuse and addiction [50–53]. Deyo et al postulated that management of chronic, painful syndromes may also benefit from adoption of the CCM elements, including productive interactions between providers and patients, self-management education, improved care coordination, and harnessing community resources [54].…”

“…Deyo et al postulated that management of chronic, painful syndromes may also benefit from adoption of the CCM elements, including productive interactions between providers and patients, self-management education, improved care coordination, and harnessing community resources [54]. Adams et al and Lasser et al classified a range of health care intervention types according to CCM components, demonstrating the model’s broader applicability to strengthen interventions [50, 55]. To our knowledge, no published studies have applied the CCM to frame a review of strategies to identify and reduce opioid misuse for patients with GI symptoms and disorders.…”

Introduction to the Special Issue on the Studies on the Implementation of Integrated Models of Alcohol, Tobacco, and/or Drug Use Interventions and Medical Care

“…Lasser et al (2016) article sheds light on common challenges in implementation research. First, patient outcomes, such as reduced mortality rates, are often difficult to power for in a study of this magnitude.…”