Engagement in Prescription Opioid Tapering Research: the EMPOWER Study and a Coproduction Model of Success.

Patients with chronic pain experience stigma within the healthcare system. This stigma is compounded for those taking long-term prescription opioids. Often, public messaging and organizational policies have telegraphed that opioid treatment is a problem to be solved by focusing only on medication reduction efforts. Lack of data has contributed to misperceptions and poor opioid policies. In part, data collection remains poor because patients feel fractured from systems of care and are often not interested in engaging with opioid reduction mandates and research. Similarly, clinicians may fail to engage with opioid stewardship and research due to complexities that exceed their training or capacities. The EMPOWER study applies a coproduction model that engages researchers, patients, clinicians, managers, and other health system users. Key stakeholders shaped the design of the study to best ensure acceptability and engagement of the "end users"-patients who enroll in the study and the clinicians who implement the opioid tapers. Targeting the needs of any stakeholder group in isolation is suboptimal. Accordingly, we detail the EMPOWER patient-centered opioid tapering clinical research framework and specific strategies to address stakeholder concerns. We also discuss how this framework may be applied to enhance engagement in healthcare research broadly.

Comparative Effectiveness of Cognitive Behavioral Therapy for Chronic Pain and Chronic Pain Self-Management within the Context of Voluntary Patient-Centered Prescription Opioid Tapering: The EMPOWER Study Protocol.

OBJECTIVE: Evidence to date, while sparse, suggests that patients taking long-term opioids require special considerations and protections to prevent potential iatrogenic harms from opioid de-prescribing, such as increased pain or suffering. Following this study protocol, the EMPOWER study seeks to address multiple unmet needs of patients with chronic pain who desire to reduce long-term opioid therapy, and provide the clinical evidence on effective methodology. METHODS: EMPOWER applies patient-centered methods for voluntary prescription opioid reduction conducted within a comprehensive, multi-state, 3-arm randomized controlled comparative effectiveness study of three study arms (1) group cognitive behavioral therapy for chronic pain; (2) group chronic pain self-management; and (3) usual care (taper only). Specialized electronic data capture systems collect patient reported symptoms and satisfaction data weekly and monthly during the taper, with real-time clinical alerts and electronic feedback loops informing, documenting, and steering needed care actions. CONCLUSION: The EMPOWER study seeks to provide granular evidence on patient response to voluntary opioid tapering, and will provide evidence to inform clinical systems changes, clinical care, patient satisfaction, and patient outcomes for opioid reduction.

One-on-one care management and procurement of Naloxone for ambulatory use.

Background: Morbidity and mortality from prescription opioids has reached unprecedented levels. Opioids remain part of chronic pain treatment in primary care. This study was designed to determine whether one-on-one care management increases procurement of Naloxone, an opioid antagonist shown to reduce morbidity and mortality in opioid overdoses. Methods: Participants included all patients ≥18 years enrolled in a primary care-based chronic pain management program and who were prescribed a daily dose of opioids for treatment of chronic pain. In total, 153 patients chose to participate. Each had a 1 h one-on-one education meeting with a registered nurse. Results: Among the enrolled, eight patients (5.2%) had procured Naloxone prior to intervention. Overall, 31 additional patients (20.2%) procured Naloxone after intervention, a 288% relative improvement in the attainment of Naloxone (P < 0.0001) (χ2 = 29.032 with 1 degree freedom). Of the 114 participants who never procured Naloxone, 69.3% believed it was unnecessary, 20% forgot about Naloxone, 8% said it was cost prohibitive, 3.5% had access concerns and 0.9% had concerns about side effects. Conclusion: Direct one-on-one nurse care management sessions were associated with an increased procurement of Naloxone in a primary care-based pain management program. A significant number of patients believed Naloxone was unnecessary after the intervention.

A Brief Screening Tool for Opioid Use Disorder: EMPOWER Study Expert Consensus Protocol.

Growing concerns about the safety of long-term opioid therapy and its uncertain efficacy for non-cancer pain have led to relatively rapid opioid deprescribing in chronic pain patients who have been taking opioid for years. To date, empirically supported processes for safe and effective opioid tapering are lacking. Opioid tapering programs have shown high rates of dropouts and increases in patient distress and suicidal ideation. Therefore, safe strategies for opioid deprescribing that are more likely to succeed are urgently needed. In response to this demand, the EMPOWER study has been launched to examine the effectiveness of behavioral medicine strategies within the context of patient-centered opioid tapering in outpatient settings (https://empower.stanford.edu/). The EMPOWER protocol requires an efficient process for ensuring that collaborative opioid tapering would be offered to the most appropriate patients while identifying patients who should be offered alternate treatment pathways. As a first step, clinicians need a screening tool to identify patients with Opioid Use Disorder (OUD) and to assess for OUD severity. Because such a tool is not available, the study team composed of eight chronic pain and/or addiction experts has extended a validated screening instrument to develop a brief and novel consensus screening tool to identify OUD and assess for OUD severity for treatment stratification. Our screening tool has the potential to assist busy outpatient clinicians to assess OUD among patients receiving long-term opioid therapy for chronic pain.

Patient Hand-Off iNitiation and Evaluation (PHONE) study: A randomized trial of patient handoff methods.

BACKGROUND: As residency work hour restrictions have tightened, transitions of care have become more frequent. Many institutions dedicate significant time and resources to patient handoffs despite the fact that the ideal method is relatively unknown. We sought to compare the effect of a rigorous formal handoff approach to a minimized but focused handoff process on patient outcomes. METHODS: A randomized prospective trial was conducted at a large teaching hospital over ten months. Patients were assigned to services employing either formal or focused handoffs. Residents were trained on handoff techniques and then observed by trained researchers. Outcome data including mortality, negative events, adverse events, and length of stay were collected and compared between formal and focused handoff groups using t-tests and a multivariate regression analysis. RESULTS: A total of 5157 unique patient-admissions were stratified into the two study groups. Focused handoffs were significantly shorter and included fewer patients (mean 6.3 patients discussed over 6.7 min vs. 35.2 patients over 20.6 min, both p < 0.001). Adverse events occurred during 16.7% of patient admissions. While overall length of stay was slightly shorter in the formal handoff group (5.50 days vs 5.88 days, p = 0.024) in univariate analysis only, there were no significant differences in patient outcomes between the two handoff methods (all p > 0.05). CONCLUSIONS: This large randomized trial comparing two contrasting handoff techniques demonstrated no clinically significant differences in patient outcomes. A minimalistic handoff process may save time and resources without negatively affecting patient outcomes.

Patience is a virtue: an argument for delayed surgical intervention in fulminant Clostridium difficile colitis.

Recently, the incidence and severity of Clostridium difficile infection (CDI) has increased. In cases of fulminant infection, surgery is a viable therapeutic option but associated with high mortality. We sought to examine factors associated with mortality in a large sample of patients with severe CDI that underwent surgery. A retrospective study was conducted in patients with severe CDI undergoing colectomy. Demographics, risk factors, comorbidities, clinical and laboratory data, and time between admission/diagnosis of CDI and colectomy were collected. Conventional markers of severity were evaluated as predictors of mortality. Sixty-four cases were included for analysis. The overall observed mortality rate was 45.3 per cent. Few conventional markers of severity were significantly associated with mortality. Risk factors that correlated with postsurgical mortality were vasopressor use (odds ratio, 3.08; 95% confidence interval, 1.00 to 9.92) and shorter time between diagnosis and surgery (median time, 2 vs 3 days, P = 0.009). This study suggests that a delay in surgery after diagnosis of severe CDI may improve overall outcomes. The finding regarding timing of surgery is contrary to traditional teaching and may be the result of improved medical treatment and stabilization before surgery. Consideration should be given to the importance of timing of colectomy in fulminant CDI, whereas prospective studies should be conducted to elucidate causal relationships.

Inflammatory polyps: a cause of late bleeding in stapled hemorrhoidectomy.

PURPOSE: Stapled hemorrhoidectomy has become a popular treatment of hemorrhoids, mainly because of the benefits of greatly reduced postoperative pain. However, complications unique to the new procedure have been reported. This study was designed to review our series of 82 patients with a focus on complications, with particular focus on late bleeding caused by inflammatory polyps at the staple line. METHODS: A review of 82 patients who underwent stapled hemorrhoidectomy was conducted. Indications included bleeding in 29 patients, prolapse in 19, combined bleeding and prolapse in 31, and pain in 3. The procedure was performed in an outpatient setting with the Ethicon ILS 33 stapler in the standard fashion. RESULTS: Late bleeding as a result of inflammatory polyps was encountered in nine patients (11 percent). Bleeding was mild, and all cases resolved after excision of the polyps. Other complications occurred with the following frequency: urinary retention (4.9 percent), submucosal hematoma (2.4 percent), early bleeding (1.2 percent), recurrent hemorrhoids (2.4 percent), thrombosed external hemorrhoids (2.4 percent), and fecal urgency (3.7 percent). CONCLUSIONS: Bleeding from inflammatory polyps occurs in a significant number of patients undergoing stapled hemorrhoidectomy. Mild bleeding several weeks or months after the procedure should prompt a search for inflammatory polyps at the staple line. Simple excision of the polyps was adequate treatment and has not resulted in rebleeding.

Coexisting psychiatric disorders in a New Zealand outpatient alcohol and other drug clinical population.

OBJECTIVE: To describe the extent of psychiatric disorder and mental health service utilization in a representative outpatient alcohol and other drug (AOD) treatment sample in New Zealand. METHOD: A total of 105 patients were randomly recruited from two outpatient AOD treatment services in New Zealand and completed a diagnostic interview within the first 2 months of treatment. Axis I psychiatric diagnoses were made using the computerized Composite International Diagnostic Interview (CIDI-Auto), and were supplemented by the South Oaks Gambling Scale (SOGS) and the conduct disorder and antisocial personality disorder section of the Diagnostic Interview for Genetic Studies (DIGS). RESULTS: Seventy-four per cent of the sample had a current non-substance or gambling axis I disorder, with a lifetime rate of 90%. The most commonly diagnosed of these coexisting psychiatric disorders were major depressive episode (34%), social phobia (31%) and posttraumatic stress disorder (31%). Past contact with mental health services was common, while contact at the time of baseline assessment was uncommon. CONCLUSIONS: Coexisting psychiatric disorder was the rule and not the exception in this sample. AOD patients are clearly part of the larger population of mental health patients. AOD services need to be capable of comprehensive assessment and treatment planning, which includes coexisting psychiatric disorders, and should work toward better integration with other mental health services.