Eleanor T. Lewis

Evaluation of the Acceptability and Usability of a Decision Support System to Encourage Safe and Effective Use of Opioid Therapy for Chronic, Noncancer Pain by Primary Care Providers

OBJECTIVE To develop and evaluate a clinical decision support system (CDSS) named Assessment and Treatment in Healthcare: Evidenced-Based Automation (ATHENA)-Opioid Therapy, which encourages safe and effective use of opioid therapy for chronic, noncancer pain. DESIGN CDSS development and iterative evaluation using the analysis, design, development, implementation, and evaluation process including simulation-based and in-clinic assessments of usability for providers followed by targeted system revisions. RESULTS Volunteers provided detailed feedback to guide improvements in the graphical user interface, and content and design changes to increase clinical usefulness, understandability, clinical workflow fit, and ease of completing guideline recommended practices. Revisions based on feedback increased CDSS usability ratings over time. Practice concerns outside the scope of the CDSS were also identified. CONCLUSIONS Usability testing optimized the CDSS to better address barriers such as lack of provider education, confusion in dosing calculations and titration schedules, access to relevant patient information, provider discontinuity, documentation, and access to validated assessment tools. It also highlighted barriers to good clinical practice that are difficult to address with CDSS technology in its current conceptualization. For example, clinicians indicated that constraints on time and competing priorities in primary care, discomfort in patient-provider communications, and lack of evidence to guide opioid prescribing decisions impeded their ability to provide effective, guideline-adherent pain management. Iterative testing was essential for designing a highly usable and acceptable CDSS; however, identified barriers may limit the impact of the ATHENA-Opioid Therapy system and other CDSS on clinical practices and outcomes unless CDSS are paired with parallel initiatives to address these issues.

What do patients do with unused opioid medications

Objectives:The volume of opioid medications being prescribed in the United States is increasing rapidly. Problems associated with the misuse of opioid medications are also increasing, in part because of medication diversion from legitimate prescriptions. However, little is known about what patients do with any unused opioid medications. This paper uses a qualitative analysis of patients’ self-report of medication storage and retention habits to begin to address this gap. Methods:We analyzed responses to the Prescription Drug Use Questionnaire in conjunction with other data on prescription opioid use in a sample of 191 Veteran patients (83% of whom had a preexisting factor associated with higher rates of opioid misuse) who received one or more opioid prescriptions in the previous 12 months. Results:Only 6.3% of participants disposed of extra medications and 24.1% reported having no extra opioids. A total of 65.4% of participants reported retaining some or all opioids even if they ceased taking the medication, and some participants accumulated large amounts of medication. A total of 34.0% of participants described engaging in sharing or diversion of opioids at least once, most often receiving them from a family member or a friend. Discussion:A majority of patients retain unused opioids, and medication sharing is common. Interventions to improve monitoring of patient experience with opioid medication, educate patients about the dangers of opioid use by nonprescribed others, and increase information about medication disposal options could decrease the supply of opioid medications available for misuse.

Reasons for Under-Use of Prescribed Opioid Medications by Patients in Pain

BACKGROUND With the growth in opioid therapy for the treatment of chronic pain, health care providers have focused their attention on avoiding over-use of opioid medications, specifically to avoid addiction, dependency, and other misuse. Qualitative and quantitative reviews of medication adherence, in contrast, focus primarily on why patients under-use or do not take their medications as prescribed and find nonadherence rates of approximately 25%. OBJECTIVE To identify the prevalence of under-use of opioid medications and the reasons and implications of under-use. DESIGN As part of a variety of structured assessments, subjects were asked detailed questions about how they used their opioid medication in their daily lives. PARTICIPANTS One hundred ninety-one veterans who received an opioid prescription for any pain problem within the 12 months before the interview. MEASURES We defined a patient who under-used his/her medication as one who took less than their prescribed dose of medication and reported that pain impaired their ability to engage in normal daily activities. RESULTS Under-use of opioids (20%) was more common than over-use (9%), consistent with research on medication adherence. Patients who under-used their opioids offered the same reasons for under-use that patients report for other medications. However, while under-users reported more pain than other opioid users they filled only slightly fewer opioid prescriptions. Communication problems between patients and providers about opioids were common. CONCLUSIONS Improved communication between patients and providers and shared decision-making regarding opioid prescriptions may improve pain management and minimize the problems associated with over-prescription of opioids (i.e., diversion).

Development and applications of the Veterans Health Administration’s Stratification Tool for Opioid Risk Mitigation (STORM) to improve opioid safety and prevent overdose and suicide.

Concerns about opioid-related adverse events, including overdose, prompted the Veterans Health Administration (VHA) to launch an Opioid Safety Initiative and Overdose Education and Naloxone Distribution program. To mitigate risks associated with opioid prescribing, a holistic approach that takes into consideration both risk factors (e.g., dose, substance use disorders) and risk mitigation interventions (e.g., urine drug screening, psychosocial treatment) is needed. This article describes the Stratification Tool for Opioid Risk Mitigation (STORM), a tool developed in VHA that reflects this holistic approach and facilitates patient identification and monitoring. STORM prioritizes patients for review and intervention according to their modeled risk for overdose/suicide-related events and displays risk factors and risk mitigation interventions obtained from VHA electronic medical record (EMR)-data extracts. Patients’ estimated risk is based on a predictive risk model developed using fiscal year 2010 (FY2010: 10/1/2009–9/30/2010) EMR-data extracts and mortality data among 1,135,601 VHA patients prescribed opioid analgesics to predict risk for an overdose/suicide-related event in FY2011 (2.1% experienced an event). Cross-validation was used to validate the model, with receiver operating characteristic curves for the training and test data sets performing well (>.80 area under the curve). The predictive risk model distinguished patients based on risk for overdose/suicide-related adverse events, allowing for identification of high-risk patients and enrichment of target populations of patients with greater safety concerns for proactive monitoring and application of risk mitigation interventions. Results suggest that clinical informatics can leverage EMR-extracted data to identify patients at-risk for overdose/suicide-related events and provide clinicians with actionable information to mitigate risk.

Sex Differences in Chronic Pain Management Practices for Patients Receiving Opioids from the Veterans Health Administration

BACKGROUND Women experience chronic pain and use pain-related health care at higher rates than men. It is not known whether the pain-related health care female veterans receive is consistent with clinical practice guideline recommendations or whether receipt of this care differs between men and women. OBJECTIVE The aim of this study was to identify whether sex differences in chronic pain management care exist for patients served by the Veterans Health Administration (VHA). DESIGN Data on patient demographics, diagnostic criteria, and health care utilization were extracted from VHA administrative databases for fiscal year 2010 (FY10). PATIENTS Patients in this study included all VHA patients (excluding metastatic cancer patients) who received more than 90 days of a short-acting opioid medication or a long-acting opioid medication prescription in FY10 study. MEASURES Multilevel logistic regressions were conducted to identify sex differences in receipt of guideline-recommended chronic pain management. RESULTS A total of 480,809 patients met inclusion criteria. Female patients were more likely to receive most measures of guideline-recommended care for chronic pain including mental health assessments, psychotherapy, rehabilitation therapy, and pharmacy reconciliation. However, women were more likely to receive concurrent sedative prescriptions, which is inconsistent with guideline recommendations. Most of the observed sex differences persisted after controlling for key demographic and diagnostic differences. CONCLUSIONS Findings suggest that female VHA patients are more likely to receive an array of pain management practices than male patients, including both contraindicated and recommended polypharmacy. Quality improvement efforts to address underutilization of mental health and rehabilitative services for pain by male patients and polypharmacy in female patients should be considered.

Measurement of adherence to clinical practice guidelines for opioid therapy for chronic pain

ABSTRACTThe safe and effective prescribing of opioid therapy for chronic pain has become a significant health care priority over the last several years. Substantial research has focused on patient-oriented interventions toward preventing problematic use, but provider and system level factors may be more amenable to quality improvement approaches. Here, we outline administrative data-based metrics that are intended to assess adherence to key practices outlined in the 2010 Department of Veterans Affairs/Department of Defense Clinical Practice Guideline for management of opioid therapy for chronic pain. In addition to the metrics, we discuss their development process, which was done in consultation with experts on chronic opioid therapy.

Somatization is Associated With Non-Adherence to Opioid Prescriptions

UNLABELLED Non-adherence to opioid prescriptions can decrease the safety and efficacy of opioid therapy. Identifying factors associated with over- and under-use of opioids in patients presenting with pain may improve prescribing and pain management. Patients presenting with pain often also present with somatization, and somatization is associated with both excessive use of and non-adherence to medications. This study examines the relationship between somatization and non-adherence (over- and under-use) to opioid prescriptions in the Veteran sample. One hundred and ninety-one Veterans who received an opioid prescription at a Veterans Affairs Palo Alto Health Care System in the prior year participated by completing a 1.5 hour semistructured interview which included assessments of depressive symptoms, somatization, medication side effects, and opioid pain medication usage. The percentage of patients non-adherent to opioid prescriptions increased as a function of somatization: Compared to no somatization, all levels of somatization were associated with higher rates of underuse, while severe somatization was associated with increased rates of overuse. Consistent with previous studies of medication non-adherence, increased depression and medication side effects were associated with decreased adherence to opioid prescriptions. However, in exploratory analyses, somatization mediated the relationship between depressive symptoms and opioid-use patterns as well as medication side effects and opioid use patterns. PERSPECTIVE This article sought to explore the relationship between somatization and adherence to prescription opioid medications. Our findings suggest that pain management treatment plans may be optimized by addressing patient distress about physical symptoms when considering the use of prescription opioid medications.

Opioid use patterns and association with pain severity and mental health functioning in chronic pain patients.

OBJECTIVE The objective of this study was to explore the relationship between patterns of opioid use, pain severity, and pain-related mental health in chronic pain patients prescribed opioids. DESIGN The study was designed as a one-time patient interview with structured pain and opioid use assessments. SETTING The study was set in a tertiary care medical center in the United States Department of Veterans Affairs. PATIENTS.  Study participants were primary care patients with a pain condition for greater than 6 months who received at least one prescription for an opioid in the prior 12 months. OUTCOME MEASURES The Prescription Drug Use Questionnaire was used to assess patterns of opioid use. The Pain Outcomes Questionnaire was used to assess pain-related functioning. RESULTS Symptomatic use of opioid medication (e.g., taking an opioid in response to increased pain) was more common than scheduled (i.e., taking an opioid at regular times) or strategic use of opioid medication (e.g., taking an opioid specifically to engage in activities). Symptomatic use of opioids was associated with poorer pain-related mental health, after controlling for pain duration and pain-related physical functioning. Use of opioids in a scheduled pattern was associated with better pain-related mental health. Patients rarely reported that they used opioids strategically to facilitate functional activities. CONCLUSIONS The patterns in which patients use their opioid medications are associated with their psychological functioning. This is consistent with theory regarding the potential impact of reinforcing effects of opioid medication on functional outcomes. Interventions to encourage strategic or scheduled opioid use warrant investigation as methods to improve pain outcomes with opioids.

Behavioral medicine perspectives on the design of health information technology to improve decision-making, guideline adherence, and care coordination in chronic pain management.

ABSTRACTDevelopment of clinical decision support systems (CDSs) has tended to focus on facilitating medication management. An understanding of behavioral medicine perspectives on the usefulness of a CDS for patient care can expand CDSs to improve management of chronic disease. The purpose of this study is to explore feedback from behavioral medicine providers regarding the potential for CDSs to improve decision-making, care coordination, and guideline adherence in pain management. Qualitative methods were used to analyze semi-structured interview responses from behavioral medicine stakeholders following demonstration of an existing CDS for opioid prescribing, ATHENA-OT. Participants suggested that a CDS could assist with decision-making by educating providers, providing recommendations about behavioral therapy, facilitating risk assessment, and improving referral decisions. They suggested that a CDS could improve care coordination by facilitating division of workload, improving patient education, and increasing consideration and knowledge of options in other disciplines. Clinical decision support systems are promising tools for improving behavioral medicine care for chronic pain.

Primary Care-Based Skin Cancer Screening in a Veterans Affairs Health Care System.

Importance Skin cancer screening may improve melanoma outcomes and keratinocyte carcinoma morbidity, but little is known about the feasibility of skin cancer training and clinical skin examination (CSE) by primary care practitioners (PCPs) in large health care systems. Objective To assess the association of skin cancer training and screening by PCPs with dermatology referral patterns and rates of skin biopsies. Design, Setting, and Participants In this pilot interventional study performed at the Veterans Affairs Palo Alto Health Care System, patients 35 years or older scheduled for an annual health habits screen in the PCP general medicine clinics were studied. Interventions Six PCPs underwent Internet Curriculum for Melanoma Early Detection (INFORMED) training in May 2015, and 5 screened patients during the following 14 months. Main Outcomes and Measures Proportion of dermatology referrals, subsequent skin biopsies, and PCP diagnostic accuracy for skin cancer or precancer compared with dermatologist diagnosis were assessed in screened patients 14 months before the intervention (February 18, 2014, through April 30, 2015) and after the intervention (June 18, 2015, through August 30, 2016). Results Among 258 patients offered screening (median age, 70 years; age range, 35-94 years; 255 [98.8%] male), 189 (73.3%) received CSE and 69 (26.7%) declined. A total of 62 of 189 patients (32.8%) were referred to a dermatologist after intervention: 33 (53.2%) for presumptive skin cancers and 15 (24.2%) for precancers. Nine of 50 patients (18.0%) evaluated in dermatology clinic underwent biopsy to exclude skin cancer. Correct diagnoses were made by PCPs in 13 of 38 patients (34.2%; 4 of 27 patients [14.8%] diagnosed with skin cancers and 5 of 11 patients [45.5%] diagnosed with actinic keratoses). Comparison of all outpatient visits for the 5 main participating PCPs before vs after intervention revealed no significant differences in dermatology referrals overall and those for presumptive skin cancer or actinic keratoses, skin biopsies, or PCP diagnostic accuracy with the exception of significantly fewer postintervention dermatology referrals that lacked specific diagnoses (25 [1.0%] vs 10 [0.4%], P = .01). Conclusions and Relevance This pilot study suggests that PCP-based skin cancer training and screening are feasible and have the potential to improve PCP diagnostic accuracy without increasing specialty referrals or skin biopsies. Additional studies comparing screening rates, specialty referrals, and patient outcomes in trained vs untrained PCPs are needed before screening is widely implemented in large health care systems in the United States.