Design of a Multicenter Randomized Controlled Trial comparing the effectiveness of shared decision making versus motivational interviewing plus cognitive behavioral therapy for voluntary opioid tapering: The INSPIRE study protocol.

BACKGROUND: This paper describes the design and protocol of a pragmatic, randomized trial to evaluate the comparative effectiveness of shared decision making versus motivational interviewing plus cognitive behavioral therapy for chronic pain for the voluntary tapering of opioid dose in adults with chronic noncancer pain. Integrated Services for Pain: Interventions to Reduce Pain Effectively (INSPIRE) is a multicenter, randomized trial conducted at three academic health centers in the southeastern United States. Participants are adults receiving long-term opioid therapy of at least 20 morphine milligram equivalents daily for chronic noncancer pain. METHODS: Participants were randomized to either the shared decision-making intervention or the motivational interviewing session and cognitive behavioral therapy for chronic pain intervention. All participants also received guideline-concordant care supporting opioid pharmacotherapy. The primary outcome was change from baseline in average daily prescribed opioid dose at 12 months, using prescribing data from electronic health records. Secondary outcomes were Patient-Reported Outcomes Measurement Information System Pain Interference and Physical Function at 12 months. CONCLUSION: This trial evaluates the comparative effectiveness of shared decision making versus motivational interviewing plus cognitive behavioral therapy for chronic pain for the voluntary tapering of opioid dose in adults with chronic noncancer pain. Results from this study can guide clinicians, researchers, and policymakers as they seek to reduce opioid prescribing and improve management of chronic pain. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov Identifier: NCT03454555 (https://clinicaltrials.gov/ct2/show/record/NCT03454555). Participant enrollment began on June 26, 2019.

Intended and unintended consequences: Changes in opioid prescribing practices for postsurgical, acute, and chronic pain indications following two policies in North Carolina, 2012-2018 - Controlled and single-series interrupted time series analyses.

BACKGROUND: The potential misapplication of current opioid prescribing policies remains understudied and may have substantial adverse implications for patient safety. METHODS: We used autoregressive integrated moving average models to assess level and trend changes in monthly 1) prescribing rates, 2) days' supply, and 3) daily morphine milligram equivalents (MME) of incident opioid prescriptions relative to 1) a state medical board initiative to reduce high-dose and -volume opioid prescribing and 2) legislation to limit initial opioid prescriptions for acute and postsurgical pain. We examined outcomes by pain indication overall and by cancer history, using prescribing patterns for benzodiazepines to control for temporal trends. We used large private health insurance claims data to include North Carolina residents, aged 18-64, insured at any point between January 2012 and August 2018. RESULTS: After the medical board initiative, prescribing patterns for chronic pain patients did not change; conversely, acute and postsurgical pain patients experienced immediate declines in daily MME. Post-legislation prescription rates did not decline for those with acute, postsurgical, and non-cancer pain, but instead declined among cancer patients with chronic pain. Chronic pain patients experienced the largest days' supply declines post-legislation, instead of acute and postsurgical pain patients. CONCLUSIONS: We found mixed evidence on the potential impact of two opioid prescribing policies, with some observed declines in a group not intended to be impacted by the policy. This study provides evidence of the need for clearer opioid prescribing policies to ensure impacts on intended populations and avoid unintended consequences.

Development and validation of an electronic health records-based opioid use disorder algorithm by expert clinical adjudication among patients with prescribed opioids.

BACKGROUND: In the US, over 200 lives are lost from opioid overdoses each day. Accurate and prompt diagnosis of opioid use disorders (OUD) may help prevent overdose deaths. However, international classification of disease (ICD) codes for OUD are known to underestimate prevalence, and their specificity and sensitivity are unknown. We developed and validated algorithms to identify OUD in electronic health records (EHR) and examined the validity of OUD ICD codes. METHODS: Through four iterations, we developed EHR-based OUD identification algorithms among patients who were prescribed opioids from 2014 to 2017. The algorithms and OUD ICD codes were validated against 169 independent "gold standard" EHR chart reviews conducted by an expert adjudication panel across four healthcare systems. After using 2014-2020 EHR for validating iteration 1, the experts were advised to use 2014-2017 EHR thereafter. RESULTS: Of the 169 EHR charts, 81 (48%) were reviewed by more than one expert and exhibited 85% expert agreement. The experts identified 54 OUD cases. The experts endorsed all 11 OUD criteria from the Diagnostic and Statistical Manual of Mental Disorders-5, including craving (72%), tolerance (65%), withdrawal (56%), and recurrent use in physically hazardous conditions (50%). The OUD ICD codes had 10% sensitivity and 99% specificity, underscoring large underestimation. In comparison our algorithm identified OUD with 23% sensitivity and 98% specificity. CONCLUSIONS AND RELEVANCE: This is the first study to estimate the validity of OUD ICD codes and develop validated EHR-based OUD identification algorithms. This work will inform future research on early intervention and prevention of OUD.

"Cookbook medicine": Exploring the impact of opioid prescribing limits legislation on clinical practice and patient experiences.

Opioid dependence and overdose are serious public health concerns. States have responded by enacting legislation regulating opioid-prescribing practices. Through in-depth interviews with clinicians, state officials, and organizational stakeholders, this paper examines opioid prescribing limits legislation (PLL) in North Carolina and how it impacts clinical practice. Since the advent of PLL, clinicians report being more mindful when prescribing opioids and as expected, writing for shorter durations for both acute and postoperative pain. But clinicians also report prescribing opioids less frequently for acute pain, refusing to write second opioid prescriptions, foisting responsibility for patient pain care onto other clinicians, and no longer writing opioid prescriptions for chronic pain patients. They directly credit PLL for these changes, including institutional policies enacted in response to PLL, and, to a lesser degree, notions of "do no harm." However, we argue that misapplication of and ambiguities in PLL along with defensive medicine practices whereby clinicians and their institutions center their legal interests over patient care, amplify these restrictive changes in clinical practice. Clinicians' narratives reveal downstream consequences for patients including undertreated pain, being viewed as drug-seeking when questioning opioid-prescribing decisions, and having to overuse the medical system to achieve pain relief.

Association of Opioid Dose Reduction With Opioid Overdose and Opioid Use Disorder Among Patients Receiving High-Dose, Long-term Opioid Therapy in North Carolina.

Importance: Rapid reduction or discontinuation of long-term opioid therapy may increase risk of opioid overdose or opioid use disorder (OUD). Current guidelines for chronic pain management caution against rapid dose reduction but are based on limited evidence. Objective: To characterize the association between rapid reduction or abrupt discontinuation of opioid therapy (vs maintained or gradual reduction) and incidence of opioid overdose and OUD among patients prescribed high-dose, long-term opioid therapy (HDLTOT). Design, Setting, and Participants: This retrospective cohort study was conducted among patients aged 18 to 64 years who were prescribed HDLTOT (≥90 daily morphine milligram equivalents for ≥90% of 90 days) from January 2006 to September 2018, with follow-up up to 4 years after cohort entry. Claims data were drawn from a large private health insurer in North Carolina and analyzed from March 1, 2006, to September 30, 2018. Exposures: Time-varying exposure of rapid dose reduction or discontinuation (>10% dose reduction/week) vs maintenance, increase, or gradual reduction or discontinuation. Main Outcomes and Measures: The main outcome was incident opioid overdose (fatal or nonfatal) or diagnosed OUD. Inverse probability-weighted cumulative incidence of outcomes were estimated using the cumulative incidence function and hazard ratios (HRs) using marginal structural Fine-Gray models as a function of rapid dose tapering or discontinuation (vs gradual reduction or discontinuation or maintained or increased), accounting for competing risks. Results: A total of 19 443 patients (median [IQR] age, 49 [41-55] years; 10 073 [51.8%] men) who received HDLTOT were identified. Rapid reduction or discontinuation was associated with higher risk of fatal and nonfatal overdoses compared with gradual reduction after the first year (year 1: HR, 1.43; 95% CI, 0.94-2.18; years 2-4: HR, 1.95; 95% CI, 1.31-2.90). There was no association between rapid reduction or discontinuation and diagnosed OUD through 2 years of follow-up; however, the hazard of incident OUD among patients exposed to rapid tapering or discontinuation was greater 25 to 48 months after the start of follow-up (HR, 1.28; 95% CI, 1.01-1.63). Conclusions and Relevance: In this cohort study, rapid dose reduction or discontinuation was associated with increased risk of opioid overdose and OUD during long-term follow-up. These findings reinforce prior concerns about safety of rapid dose reductions for patients receiving HDLTOT and highlight the need for caution when reducing opioid doses.

Implementation of mandatory opioid prescribing limits in North Carolina: healthcare administrator and prescriber perspectives.

BACKGROUND: Recent increases in state laws to reduce opioid prescribing have demonstrated a need to understand how they are interpreted and implemented in healthcare systems. The purpose of this study was to explore the systems, strategies, and resources that hospital administrators and prescribers used to implement the 2017 North Carolina Strengthen Opioid Prevention (STOP) Act opioid prescribing limits, which limited initial prescriptions to a five (for acute) or seven (for post-surgical) days' supply. METHODS: We interviewed 14 hospital administrators and 38 prescribers with degrees in medicine, nursing, pharmacy, business administration and public health working across North Carolina. Interview guides, informed by the Consolidated Framework for Implementation Research, explored barriers and facilitators to implementation. Interview topics included communication, resources, and hospital system support. Interviews were recorded and transcribed, then analyzed using flexible coding, integrating inductive and deductive coding, to inform analytic code development and identify themes. RESULTS: We identified three main themes around implementation of STOP act mandated prescribing limits: organizational communication, prescriber education, and changes in the electronic medical record (EMR) systems. Administrators reflected on implementation in the context of raising awareness and providing reminders to facilitate changes in prescriber behavior, operationalized through email and in-person communications as well as dedicated resources to EMR changes. Prescribers noted administrative communications about prescribing limits often focused on legality, suggesting a directive of the organization's policy rather than a passive reminder. Prescribers expressed a desire for more spaces to have their questions answered and resources for patient communications. While hospital administrators viewed compliance with the law as a priority, prescribers reflected on concerns for adequately managing their patients' pain and limited time for clinical care. CONCLUSIONS: Hospital administrators and prescribers approached implementation of the STOP act prescribing limits with different mindsets. While administrators were focused on policy compliance, prescribers were focused on their patients' needs. Strategies to implement the mandate then had to balance patient needs with policy compliance. As states continue to legislate to prevent opioid overdose deaths, understanding how laws are implemented by healthcare systems and prescribers will improve their effectiveness through tailoring and maximizing available resources.

Association Between Statewide Opioid Prescribing Interventions and Opioid Prescribing Patterns in North Carolina, 2006-2018.

OBJECTIVE: To examine the impact of three sequential statewide policy and legislative interventions on opioid prescribing practices among privately insured individuals in North Carolina. METHODS: An interrupted time series approach was used to examine level and trajectory changes of new and prevalent opioid prescription rates, days' supply, and daily morphine milligram equivalents before and after implementation of a 1) prescription drug monitoring program, 2) state medical board initiative, and 3) legislative action. Analyses were conducted using individual-level claims data from a large private health insurance provider serving North Carolina residents, ages 18-64 years, from January 2006 to August 2018. RESULTS: Rates of new and prevalent prescription opioid patients were relatively unaffected by the prescription monitoring program but sharply declined in the months immediately following both medical board (-3.7 new and -19.3 prevalent patients per 10,000 person months) and legislative (-14.1 new and -26.7 prevalent patients) actions. Among all opioid prescriptions, days' supply steadily increased on average over the study period but declined after legislative action (-1.5 days' supply per year). CONCLUSIONS: The voluntary prescription drug monitoring program launched in 2010 only marginally affected opioid prescribing patterns on its own, but its redeployment as an investigative and clinical tool in multifaceted public policy approaches by the state medical board and legislature later in the decade plausibly contributed to notable declines in prescription rates and days' supply. This study lends new emphasis to the importance of enforcement mechanisms for state and national policies seeking to reverse this critical public health crisis.

Pain Agreements and Time-to-Event Analysis of Substance Misuse in a Primary Care Chronic Pain Program.

BACKGROUND: Types and correlates of pain medication agreement (PMA) violations in the primary care setting have not been analyzed. METHODS: A retrospective analysis was completed to examine patient characteristics and correlates of PMA violations, a proxy for substance misuse, over a 15-year period in an outpatient General Medicine Pain Service within the Division of General Medicine and Clinical Epidemiology, Department of Medicine, School of Medicine, University of North Carolina at Chapel Hill. Patients who signed the PMA were managed for chronic pain from 2002 through 2017 (N = 1,210). The incidence of PMA violations was measured over a 15-year span. Substance misuse was defined a priori in the study as urine toxicology screen positive for illicit or nonprescribed controlled substances, patient engagement in prescription alteration, doctor-shopping, or diversion. RESULTS: Most patients received a prescription for a controlled substance (77.4%). During enrollment, 488 (40.3%) patients had one or more violations of their PMA. One-third (33.4%) of pain service patients had a violation within 365 days of signing the agreement. Active tobacco smokers had double the incidence of agreement violation within the first 30 days of enrollment. Almost one-half (49.8%) of violations were due to inconsistent use of controlled substances. Patients with any prior DWI/DUI or drug-related offense had a significantly increased rate of substance misuse (P < 0.0001). CONCLUSIONS: PMA violations were common among a population of patients managed for chronic nonmalignant pain. Universal opioid prescribing precautions, including PMAs, require further investigation to assess their roles in mitigating the potential patient and societal harms associated with opioid prescribing.

Association between opioid analgesic therapy and initiation of buprenorphine management: An analysis of prescription drug monitoring program data.

BACKGROUND: In the US, medication assisted treatment, particularly with office-based buprenorphine, has been an important component of opioid dependence treatment among patients with iatrogenic addiction to opioid analgesics. The predictors of initiating buprenorphine for addiction among opioid analgesic patients have not been well-described. METHODS: We conducted a time-to-event analysis using data from the North Carolina (NC) Prescription Drug Monitoring Program (PDMP). Our outcome of interest was time-to-initiation of sublingual buprenorphine. Our study population was a prospective cohort of all state residents receiving a full-agonist opioid analgesic between 2011 and 2015. Predictors of initiation of sublingual buprenorphine examined included: age, gender, cumulative pharmacies and prescribers utilized, cumulative opioid intensity (defined as cumulative opioid exposure divided by duration of opioid exposure), and benzodiazepine dispensing. FINDINGS: Of 4.3 million patients receiving opioid analgesics in NC between 2011 and 2015 (accumulated 8.30 million person-years of follow-up), and a total of 28,904 patients initiated buprenorphine formulations intended for addiction treatment (overall rate 3.48 per 1,000 person-years). In adjusted multivariate models, the utilization of 3 or more pharmacies (HR: 2.93; 95% CI: 2.82, 3.05) or 6 or more controlled substance prescribers (HR: 12.09; 95% CI: 10.76, 13.57) was associated with buprenorphine initiation. A dose-response relationship was observed for cumulative opioid intensity (HR in highest decile relative to lowest decile: 5.05; 95% CI: 4.70, 5.42). Benzodiazepine dispensing was negatively associated with buprenorphine initiation (HR: 0.63; 95% CI: 0.61, 0.65). CONCLUSIONS: Opioid analgesic patients utilizing multiple prescribers or pharmacies are more likely to initiate sublingual buprenorphine. This finding suggests that patients with multiple healthcare interactions are more likely to be treated for high-risk opioid use, or may be more likely to be identified and treated for addiction. Future research should utilize prescription monitoring program data linked to electronic health records to include diagnosis information in analytic models.

Associations between implementation of Project Lazarus and opioid analgesic dispensing and buprenorphine utilization in North Carolina, 2009-2014.

BACKGROUND: Project Lazarus (PL) is a seven-strategy, community-coalition-based intervention designed to reduce opioid overdose and dependence. The seven strategies include: community education, provider education, hospital emergency department policy change, diversion control, support programs for patients with pain, naloxone policies, and addiction treatment expansion. PL was originally developed in Wilkes County, NC. It was made available to all counties in North Carolina starting in March 2013 with funding of up to $34,400 per county per year. We examined the association between PL implementation and 1) overall dispensing rate of opioid analgesics, and 2) utilization of buprenorphine. Buprenorphine is often used in connection with medication assisted treatment (MAT) for opioid dependence. METHODS: Observational interrupted time series analysis of 100 counties over 2009-2014 (n = 7200 county-months) in North Carolina. The intervention period was March 2013-December 2014. 74 of 100 counties implemented the intervention. Exposure data sources comprised process surveys, training records, Prescription Drug Monitoring Program (PDMP) data, and methadone treatment program quality data. Outcomes were PDMP-derived counts of opioid prescriptions and buprenorphine patients. Incidence Rate Ratios were estimated with adjusted GEE Poisson regression models of all seven PL strategies. RESULTS: In adjusted models, diversion control efforts were positively associated with increased dispensing of opioid analgesics (IRR: 1.06; 95% CI: 1.03, 1.09). None of the other PL strategies were associated with reduced prescribing of opioid analgesics. Support programs for patients with pain were associated with a non-significant decrease in buprenorphine utilization (IRR: 0.93; 95% CI: 0.85, 1.02), but addiction treatment expansion efforts were associated with no change in buprenorphine utilization (IRR: 0.98; 95% CI: 0.91, 1.06). CONCLUSIONS: Implementation of PL strategies did not appreciably reduce opioid dispensing and did not increase buprenorphine utilization. These results are consistent with previous findings of limited impact of PL strategies on overdose morbidity and mortality. Future studies should analyze the uptake of MAT using a more expansive view of institutional barriers, treating community coalition activity around MAT as an effect modifier.

Management of Pain in the United States-A Brief History and Implications for the Opioid Epidemic.

Pain management in the United States reflects attitudes to those in pain. Increased numbers of disabled veterans in the 1940s to 1960s led to an increased focus on pain and its treatment. The view of the person in pain has moved back and forth between a physiological construct to an individual with pain where perception may be related to social, emotional, and cultural factors. Conceptually, pain has both a medical basis and a political context, moving between, for example, objective evidence of disability due to pain and subjective concerns of malingering. In the 20th century, pain management became predominately pharmacologic. Perceptions of undertreatment led to increased use of opioids, at first for those with cancer-related pain and then later for noncancer pain without the multidimensional care that was intended. The increased use was related to exaggerated claims in the medical literature and by the pharmaceutical industry, of a lack of addiction in the setting of noncancer pain for these medications-a claim that was subsequently found to be false and deliberatively deceptive; an epidemic of opioid prescribing began in the 1990s. An alarming rise in deaths due to opioids has led to several efforts to decrease use, both in patients with noncancer conditions and in those with cancer and survivors of cancer.

Short-Acting Opioids Are Associated with Comparable Analgesia to Long-Acting Opioids in Patients with Chronic Osteoarthritis with a Reduced Opioid Equivalence Dosing.

Setting: There are no studies that exist within the primary care setting that address optimal opioid therapy in osteoarthritis patients. In light of the recently released US Centers for Disease Control and Prevention guidelines on opioid use in chronic noncancer pain, there is a pressing need to better characterize the effectiveness of long- and short-acting opioids. Objective: To examine the effectiveness of short-acting opioids (SAO) vs long-acting opioids (LAO) and combination therapies (SAO and LAO) for treating chronic osteoarthritis pain in a retrospective trial. Methods: Average and lowest pain scores approximately one to two weeks prior to patient appointments were collected and averaged for both SAO and LAO patients who were actively enrolled in a pain clinic at an academic medical center. Results: There was no statistical difference between reported average and low pain scores for the SAO vs LAO groups (P = 0.201 and P = 0.296, respectively), although the SAO group on average had a significantly lower morphine equivalence (P < 0.001). Various covariates for both groups were tested in an adjusted model to look at trends in the use of nonopioid medications (i.e., acetaminophen, nonsteroidal anti-inflammatory drugs, antidepressants, and adjunct analgesic agents). No significant differences in pain scores existed when comparing covariates for the SAO vs LAO groups. Conclusions: The study suggests that in addition to being effective, short-acting opioid medications may also provide a safer and cheaper alternative to long-acting opioid therapies in the treatment of chronic osteoarthritis. Perspective: This article investigates the effectiveness of short-acting vs long-acting opioids for the treatment of chronic noncancer pain, specifically osteoarthritis. This information could potentially aid practitioners in primary care environments to design equally efficacious and less costly opioid regimens, while simultaneously enhancing patient safety.

An Entrustable Professional Activity (EPA)-Based Framework to Prepare Fourth-Year Medical Students for Internal Medicine Careers.

The purpose of the fourth year of medical school remains controversial. Competing demands during this transitional phase cause confusion for students and educators. In 2014, the Association of American Medical Colleges (AAMC) released 13 Core Entrustable Professional Activities for Entering Residency (CEPAERs). A committee comprising members of the Clerkship Directors in Internal Medicine and the Association of Program Directors in Internal Medicine applied these principles to preparing students for internal medicine residencies. The authors propose a curricular framework based on five CEPAERs that were felt to be most relevant to residency preparation, informed by prior stakeholder surveys. The critical areas outlined include entering orders, forming and answering clinical questions, conducting patient care handovers, collaborating interprofessionally, and recognizing patients requiring urgent care and initiating that care. For each CEPAER, the authors offer suggestions about instruction and assessment of competency. The fourth year of medical school can be rewarding for students, while adequately preparing them to begin residency, by addressing important elements defined in the core entrustable activities. Thus prepared, new residents can function safely and competently in supervised postgraduate settings.

Update in internal medicine residency education: a review of the literature in 2010 and 2011.

BACKGROUND: Evidence-based practice in education requires high-quality evidence, and many in the medical education community have called for an improvement in the methodological quality of education research. OBJECTIVE: Our aim was to use a valid measure of medical education research quality to highlight the methodological quality of research publications and provide an overview of the recent internal medicine (IM) residency literature. METHODS: We searched MEDLINE and PreMEDLINE to identify English-language articles published in the United States and Canada between January 1, 2010, and December 31, 2011, focusing on IM residency education. Study quality was assessed using the Medical Education Research Study Quality Instrument (MERSQI), which has demonstrated reliability and validity. Qualitative articles were excluded. Articles were ranked by quality score, and the top 25% were examined for common themes, and 2 articles within each theme were selected for in-depth presentation. RESULTS: The search identified 731 abstracts of which 223 articles met our inclusion criteria. The mean (±SD) MERSQI score of the 223 studies included in the review was 11.07 (±2.48). Quality scores were highest for data analysis (2.70) and lowest for study design (1.41) and validity (1.29). The themes identified included resident well-being, duty hours and resident workload, career decisions and gender, simulation medicine, and patient-centered outcomes. CONCLUSIONS: Our review provides an overview of the IM medical education literature for 2010-2011, highlighting 5 themes of interest to the medical education community. Study design and validity are 2 areas where improvements in methodological quality are needed, and authors should consider these when designing research protocols.

Hypercalcemia, hypercalciuria, and elevated calcitriol concentrations with autosomal dominant transmission due to CYP24A1 mutations: effects of ketoconazole therapy.

BACKGROUND: Mutations of the CYP24A1 gene, which encodes the 1,25-dihydroxyvitamin D-24-hydroxylase cytochrome P450, Cyp24A1, are predicted to result in elevated 1,25-dihydroxyvitamin D concentrations, hypercalcemia, hypercalciuria, nephrolithiasis, and bone disease. Treatment of hypercalcemia associated with CYP24A1 gene mutations has not been described. METHODS: The genetic basis of a syndrome in a 44-yr-old Caucasian male characterized by intermittent hypercalcemia, hypercalciuria, elevated serum 1,25-dihydroxyvitamin D, undetectable serum 24,25-dihydroxyvitamin D, metabolically active nephrolithiasis, and reduced bone mineral density of the lumbar spine was examined. Sequencing of the CYP24A1 gene and biochemical and genetic analysis of seven family members in three generations was carried out. Because of hypercalcemia, hypercalciuria, and metabolically active nephrolithiasis, the patient was treated with a cytochrome 3A inhibitor, ketoconazole, 200 mg orally every 8 h, for 2 months. RESULTS: The sequence of the CYP24A1 gene showed two canonical splice junction mutations in the proband. Analysis of family members showed a phenotype associated one or both mutations, suggesting autosomal dominant transmission with partial penetrance of the trait. After therapy with ketoconazole, statistically significant reductions in previously elevated urinary calcium into the normal range were noted. Previously elevated serum 1,25-dihydroxyvitamin D and calcium concentrations decreased, and previously decreased PTH concentrations increased into the normal range, but the differences were not statistically significant. CONCLUSIONS: In a syndrome characterized by intermittent hypercalcemia, hypercalciuria, elevated 1,25-dihydroxyvitamin D, undetectable 24,25-dihydroxyvitamin D concentrations, splice junction mutations of the CYP24A1 gene, and autosomal dominant transmission of the trait, treatment with ketoconazole is useful in reducing urinary calcium.

Use of patient flow analysis to improve patient visit efficiency by decreasing wait time in a primary care-based disease management programs for anticoagulation and chronic pain: a quality improvement study.

BACKGROUND: Patients with chronic conditions require frequent care visits. Problems can arise during several parts of the patient visit that decrease efficiency, making it difficult to effectively care for high volumes of patients. The purpose of the study is to test a method to improve patient visit efficiency. METHODS: We used Patient Flow Analysis to identify inefficiencies in the patient visit, suggest areas for improvement, and test the effectiveness of clinic interventions. RESULTS: At baseline, the mean visit time for 93 anticoagulation clinic patient visits was 84 minutes (+/- 50 minutes) and the mean visit time for 25 chronic pain clinic patient visits was 65 minutes (+/- 21 minutes). Based on these data, we identified specific areas of inefficiency and developed interventions to decrease the mean time of the patient visit. After interventions, follow-up data found the mean visit time was reduced to 59 minutes (+/-25 minutes) for the anticoagulation clinic, a time decrease of 25 minutes (t-test 39%; p < 0.001). Mean visit time for the chronic pain clinic was reduced to 43 minutes (+/- 14 minutes) a time decrease of 22 minutes (t-test 34 %; p < 0.001). CONCLUSION: Patient Flow Analysis is an effective technique to identify inefficiencies in the patient visit and efficiently collect patient flow data. Once inefficiencies are identified they can be improved through brief interventions.

Predictors of opioid misuse in patients with chronic pain: a prospective cohort study.

BACKGROUND: Opioid misuse can complicate chronic pain management, and the non-medical use of opioids is a growing public health problem. The incidence and risk factors for opioid misuse in patients with chronic pain, however, have not been well characterized. We conducted a prospective cohort study to determine the one-year incidence and predictors of opioid misuse among patients enrolled in a chronic pain disease management program within an academic internal medicine practice. METHODS: One-hundred and ninety-six opioid-treated patients with chronic, non-cancer pain of at least three months duration were monitored for opioid misuse at pre-defined intervals. Opioid misuse was defined as: 1. Negative urine toxicological screen (UTS) for prescribed opioids; 2. UTS positive for opioids or controlled substances not prescribed by our practice; 3. Evidence of procurement of opioids from multiple providers; 4. Diversion of opioids; 5. Prescription forgery; or 6. Stimulants (cocaine or amphetamines) on UTS. RESULTS: The mean patient age was 52 years, 55% were male, and 75% were white. Sixty-two of 196 (32%) patients committed opioid misuse. Detection of cocaine or amphetamines on UTS was the most common form of misuse (40.3% of misusers). In bivariate analysis, misusers were more likely than non-misusers to be younger (48 years vs 54 years, p < 0.001), male (59.6% vs. 38%; p = 0.023), have past alcohol abuse (44% vs 23%; p = 0.004), past cocaine abuse (68% vs 21%; p < 0.001), or have a previous drug or DUI conviction (40% vs 11%; p < 0.001%). In multivariate analyses, age, past cocaine abuse (OR, 4.3), drug or DUI conviction (OR, 2.6), and a past alcohol abuse (OR, 2.6) persisted as predictors of misuse. Race, income, education, depression score, disability score, pain score, and literacy were not associated with misuse. No relationship between pain scores and misuse emerged. CONCLUSION: Opioid misuse occurred frequently in chronic pain patients in a pain management program within an academic primary care practice. Patients with a history of alcohol or cocaine abuse and alcohol or drug related convictions should be carefully evaluated and followed for signs of misuse if opioids are prescribed. Structured monitoring for opioid misuse can potentially ensure the appropriate use of opioids in chronic pain management and mitigate adverse public health effects of diversion.

A primary care, multi-disciplinary disease management program for opioid-treated patients with chronic non-cancer pain and a high burden of psychiatric comorbidity.

BACKGROUND: Chronic non-cancer pain is a common problem that is often accompanied by psychiatric comorbidity and disability. The effectiveness of a multi-disciplinary pain management program was tested in a 3 month before and after trial. METHODS: Providers in an academic general medicine clinic referred patients with chronic non-cancer pain for participation in a program that combined the skills of internists, clinical pharmacists, and a psychiatrist. Patients were either receiving opioids or being considered for opioid therapy. The intervention consisted of structured clinical assessments, monthly follow-up, pain contracts, medication titration, and psychiatric consultation. Pain, mood, and function were assessed at baseline and 3 months using the Brief Pain Inventory (BPI), the Center for Epidemiological Studies-Depression Scale scale (CESD) and the Pain Disability Index (PDI). Patients were monitored for substance misuse. RESULTS: Eighty-five patients were enrolled. Mean age was 51 years, 60% were male, 78% were Caucasian, and 93% were receiving opioids. Baseline average pain was 6.5 on an 11 point scale. The average CESD score was 24.0, and the mean PDI score was 47.0. Sixty-three patients (73%) completed 3 month follow-up. Fifteen withdrew from the program after identification of substance misuse. Among those completing 3 month follow-up, the average pain score improved to 5.5 (p = 0.003). The mean PDI score improved to 39.3 (p < 0.001). Mean CESD score was reduced to 18.0 (p < 0.001), and the proportion of depressed patients fell from 79% to 54% (p = 0.003). Substance misuse was identified in 27 patients (32%). CONCLUSIONS: A primary care disease management program improved pain, depression, and disability scores over three months in a cohort of opioid-treated patients with chronic non-cancer pain. Substance misuse and depression were common, and many patients who had substance misuse identified left the program when they were no longer prescribed opioids. Effective care of patients with chronic pain should include rigorous assessment and treatment of these comorbid disorders and intensive efforts to insure follow up.