Piloting an opioid callback program in community pharmacies.

BACKGROUND: Although opioid prescribing has recently trended downward, opioid-related overdoses and deaths have drastically increased. Community pharmacists are accessible health care providers who are well positioned to disseminate information on opioid safety and to educate and counsel on medication use, managing adverse events, and proper medication disposal. Patient callbacks facilitate appropriate medication usage. We developed an opioid callback program that provides a framework for pharmacists to follow up with patients with an opioid prescription. OBJECTIVES: This study aimed to (1) describe the development of the opioid callback initiative and (2) report results from a pilot test in 2 community pharmacies. METHODS: The opioid callback process and data collection forms were collaboratively developed with community pharmacists at each site. Data recorded on the opioid callback forms were descriptively analyzed and chi-square test of independence explored differences by pain durations related to opioid disposal, security, and safety. Participating pharmacy staff were interviewed to identify facilitators and barriers to implementation, as well as opportunities for improvement. RESULTS: Forty-one opioid callbacks were attempted and 36 were completed (87.8%). Pharmacists were statistically significantly more likely to discuss naloxone with patients with chronic pain (89.5%) than those with acute pain (46.2%). Pharmacists reported that the program successfully raised awareness of opioid disposal opportunities and safe opioid practices, including storage and naloxone ownership. They expressed patients' willingness to answer questions and appreciation for the extra attention and care. CONCLUSION: Community pharmacists are well positioned to address the opioid crisis as access points for medication questions, opioid safety education, opioid disposal, naloxone, and medications for people with an opioid use disorder. This study presents a proof of concept for a pharmacist-led opioid callback program. Expansion could help inform patients about how to use opioids safely, how to treat an opioid overdose, and where to dispose of unused medications.

Stepped implementation-to-target: a study protocol of an adaptive trial to expand access to addiction medications.

BACKGROUND: In response to the US opioid epidemic, significant national campaigns have been launched to expand access to `opioid use disorder (MOUD). While adoption has increased in general medical care settings, specialty addiction programs have lagged in both reach and adoption. Elevating the quality of implementation strategy, research requires more precise methods in tailoring strategies rather than a one-size-fits-all-approach, documenting participant engagement and fidelity to the delivery of the strategy, and conducting an economic analysis to inform decision making and policy. Research has yet to incorporate all three of these recommendations to address the challenges of implementing and sustaining MOUD in specialty addiction programs. METHODS: This project seeks to recruit 72 specialty addiction programs in partnership with the Washington State Health Care Authority and employs a measurement-based stepped implementation-to-target approach within an adaptive trial design. Programs will be exposed to a sequence of implementation strategies of increasing intensity and cost: (1) enhanced monitoring and feedback (EMF), (2) 2-day workshop, and then, if outcome targets are not achieved, randomization to either internal facilitation or external facilitation. The study has three aims: (1) evaluate the sequential impact of implementation strategies on target outcomes, (2) examine contextual moderators and mediators of outcomes in response to the strategies, and (3) document and model costs per implementation strategy. Target outcomes are organized by the RE-AIM framework and the Addiction Care Cascade. DISCUSSION: This implementation project includes elements of a sequential multiple assignment randomized trial (SMART) design and a criterion-based design. An innovative and efficient approach, participating programs only receive the implementation strategies they need to achieve target outcomes. Findings have the potential to inform implementation research and provide key decision-makers with evidence on how to address the opioid epidemic at a systems level. TRIAL REGISTRATION: This trial was registered at ClinicalTrials.gov (NCT05343793) on April 25, 2022.

Refining a Digital Therapeutic Platform for Home Care Agencies in Dementia Care to Elicit Stakeholder Feedback: Focus Group Study With Stakeholders.

BACKGROUND: Persons living with dementia require increasing levels of care, and the care model has evolved. The Centers for Medicare and Medicaid Services is transitioning long-term care services from institutional care to home- or community-based services, including reimbursement for nonclinical services. Although home care companies are positioned to handle this transition, they need innovative solutions to address the special challenges posed by caring for persons living with dementia. To live at home longer, these persons require support from formal caregivers (FCGs; ie, paid professionals), who often lack knowledge of their personal histories and have high turnover, or informal caregivers (eg, family or friends), who may have difficulty coping with behavioral and psychological symptoms of dementia. The Generation Connect platform was developed to support these individuals and their formal and informal caregivers. In preliminary studies, the platform improved mood and influenced caregiver satisfaction. To enhance platform effectiveness, Generation Connect received a grant from the National Institutes of Health Small Business Innovation Research to improve clinical outcomes, reduce health care costs, and lower out-of-pocket costs for persons living with dementia who receive care through home care agencies. OBJECTIVE: This study aims to evaluate information elicited from a series of stakeholder focus groups to understand existing processes, needs, barriers, and goals for the use of the Generation Connect platform by home care agencies and formal and informal caregivers. METHODS: A series of focus groups were conducted with home care agency corporate leadership, home care agency franchise owners, home care agency FCGs, and informal caregivers of persons living with dementia. The qualitative approach allowed for unrestricted idea generation that best informed the platform development to enable home care providers to differentiate their dementia care services, involve informal caregivers, improve FCG well-being, and extend the ability of persons living with dementia to age in place. Using the Technology-Enabled Caregiving in the Home framework, an inductive and iterative content analysis was conducted to identify thematic categories from the transcripts. RESULTS: Overall, 39 participants participated across the 6 stakeholder focus groups. The following five overarching themes were identified: technology related; care services; data, documentation, and outcomes; cost, finance, and resources; and resources for caregivers. Within each theme, the most frequent subthemes were identified. Exemplar stakeholder group statements provided support for each of the identified themes. CONCLUSIONS: The focus group results will inform the further development of the Generation Connect platform to reduce the burden of caregiving for persons living with dementia, evaluate changes in cognition, preserve functional independence, and promote caregiver engagement between these individuals. The next step is to evaluate the effectiveness of the revised platform in the National Institutes of Health Small Business Innovation Research phase 2 clinical trial to assess the efficacy of its evidence-based interventions and market viability.

Pilot testing a tool to determine the costs and time associated with community pharmacy-based administration of injectable naltrexone.

BACKGROUND: Medications for opioid use disorder (MOUD), including injectable naltrexone (IN), are part of evidence-based OUD treatments. MOUD access often is limited, especially in rural communities. When authorized to administer non-vaccination injections, pharmacists can increase IN accessibility. However, inadequate reimbursement for pharmacist-administered IN can hinder widespread adoption. OBJECTIVES: To pilot test a process to obtain a preliminary estimate of the total costs and time associated with community-pharmacist administered IN. METHODS: A purposively-selected sample of key informants at community pharmacies administering IN were surveyed about time and cost for best practice IN activities. Respondents estimated the time to perform activities and average pharmacist/pharmacy technician hourly salary, which were used to calculate administration costs. RESULTS: The approach to estimate time and costs was feasible. Administrative costs (mean = $93, range: $48-$164) and time (mean = 123 min., range: 63-220 min.) to administer IN varied widely. Pharmacists'/pharmacy technicians' roles varied by pharmacy. CONCLUSIONS: Pharmacists allocate significant time and resources to administer IN. Insufficient reimbursement may disincentivize pharmacy-involved OUD treatment and ultimately slow needed expansion of MOUD services. Increasing IN services requires engaging pharmacies to expand their practice through educational campaigns, along with a commitment to reimburse the cost of medications and related administration activities.

Community pharmacy-based injectable naltrexone service delivery models and best practices.

BACKGROUND: Opioid use disorder (OUD) is a major public health issue in the United States. Medications for OUD (MOUD), which combines the use of approved medications with counseling and behavioral therapies, represents an evidence-based approach to treat individuals living with an OUD. However, MOUD has not kept up with increased demand and new treatment approaches are needed. One approach is injectable naltrexone, an approved and effective MOUD treatment, provided by pharmacists, who are more geographically accessible and have legal authority to administer it in some states. OBJECTIVES: To explore how different community pharmacists provide injectable naltrexone treatment and identify best practices. METHODS: An exploratory sequential mixed-methods design was used to investigate pharmacy-based naltrexone injection practices, involving a pharmacist questionnaire and interviews with pharmacists, prescribers, and community stakeholders. An inductive/iterative content analysis approach, guided by an initial straw model, was used to identify and explore conceptual categories for the interviews. RESULTS: The final sample included 68 pharmacy surveys and 14 total interviews with pharmacists (n = 9), prescribers (n = 3), and community stakeholders (n = 2). Pharmacies providing naltrexone injections reported administering over 700 injections in the past year. Interviews revealed benefits and barriers to pharmacist-provided injections and the importance of the prescriber-pharmacist relationship in OUD treatment. Three pharmacy treatment delivery models were identified, compared to the initial straw model, and informed development of a best practices checklist for community pharmacies interested in establishing or expanding a naltrexone injection service. CONCLUSIONS: The study demonstrates how community pharmacies developed and implemented a naltrexone injection service. Pharmacists' and prescribers' feedback clearly suggests an untapped interest, as well as resources, in realizing pharmacists' roles as providers of injectable naltrexone treatment. Implementation research could inform the development and evaluation of an intervention based on these best practices to further explore the utility of community pharmacy-based naltrexone injection services.

High dose psilocybin is associated with positive subjective effects in healthy volunteers.

AIM: The aim of the current study was to investigate the relationship between escalating higher doses of psilocybin and the potential psilocybin occasioned positive subjective effects. METHODS: Healthy participants ( n=12) were given three escalating doses of oral psilocybin (0.3 mg/kg; 0.45 mg/kg; 0.6 mg/kg) or (18.8-36.6 mg; 27.1-54.0 mg; 36.3-59.2 mg) a minimum of four weeks apart in a supervised setting. Blood and urine samples, vital signs, and electrocardiograms were obtained. Subjective effects were assessed using the Mystical Experience Questionnaire and Persisting Effects Questionnaire. RESULTS: There was a significant linear dose-related response in Mystical Experience Questionnaire total score and the transcendence of time and space subscale, but not in the rate of a complete mystical experience. There was also a significant difference between dose 3 compared to dose 1 on the transcendence of time and space subscale, while no dose-related differences were found for Mystical Experience Questionnaire total scores or rate of a mystical experience. Persisting Effects Questionnaire positive composite scores 30 days after completion of the last dose were significantly higher than negative composite scores. Persisting Effects Questionnaire results revealed a moderate increase in sense of well-being or life satisfaction on average that was associated with the maximum Mystical Experience Questionnaire total score. Pharmacokinetic measures were associated with dose but not with Mystical Experience Questionnaire total scores or rate of a mystical experience. CONCLUSIONS: High doses of psilocybin elicited subjective effects at least as strong as the lower doses and resulted in positive persisting subjective effects 30 days after, indicating that a complete mystical experience was not a prerequisite for positive outcomes.

Predischarge Injectable Versus Oral Naltrexone to Improve Postdischarge Treatment Engagement Among Hospitalized Veterans with Alcohol Use Disorder: A Randomized Pilot Proof-of-Concept Study.

BACKGROUND: Injectable naltrexone for alcohol use disorders (AUDs) has been efficacious in several studies. It has not been (i) compared head-to-head with oral naltrexone or (ii) examined in the hospital setting as an intervention that might facilitate treatment attendance after hospital discharge. METHODS: Fifty-four hospitalized veterans identified as having DSM-IV-TR alcohol dependence were randomized to receive (i) a 50 mg oral naltrexone plus a 30-day prescription or (ii) a 380 mg intramuscular naltrexone injection prior to discharge. Of 113 veteran inpatients deemed eligible based on screening criteria, 54 met final eligibility criteria and were enrolled and randomized. Baseline data included demographics, alcohol consumption, and comorbidity. Measures of treatment initiation and engagement and alcohol consumption were reassessed at 14- and 45-day follow-ups. RESULTS: Thirty-five participants (64.8%) completed the entire study protocol (received a study medication and completed 14- and 45-day follow-ups). Among those who received a study medication (n = 45), 77.8% completed all follow-up interviews. This pilot study was not designed to have sufficient statistical power for hypothesis testing, and thus, as expected, there were no significant differences between groups in medication adherence (self-report of >80% of daily doses taken in oral group; receipt of second injection in the injection group), treatment engagement (at least treatment 3 visits in the 30 days postdischarge, and 2 or more visits per month in each of the 3 months following discharge) or alcohol consumption at 14 or at 45 days (p > 0.05). The median number of drinks among the entire cohort in the 2 weeks prior to hospitalization (128 drinks) was significantly higher than at day 14 (0 drinks, p < 0.001) or day 45 (0 drinks, p < 0.001). Rates of medication adherence were 62% in the oral group and 61% in the injection group. CONCLUSIONS: Results indicate feasibility for larger, more definitive study. Both groups had significant reductions in alcohol consumption over time and high-treatment engagement rates. Both oral and injectable formulations are feasible to initiate prior to discharge for hospital inpatients identified as having an AUD.

Pharmacokinetics of Escalating Doses of Oral Psilocybin in Healthy Adults.

INTRODUCTION: Psilocybin is a psychedelic tryptamine that has shown promise in recent clinical trials for the treatment of depression and substance use disorders. This open-label study of the pharmacokinetics of psilocybin was performed to describe the pharmacokinetics and safety profile of psilocybin in sequential, escalating oral doses of 0.3, 0.45, and 0.6 mg/kg in 12 healthy adults. METHODS: Eligible healthy adults received 6-8 h of preparatory counseling in anticipation of the first dose of psilocybin. The escalating oral psilocybin doses were administered at approximately monthly intervals in a controlled setting and subjects were monitored for 24 h. Blood and urine samples were collected over 24 h and assayed by a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) assay for psilocybin and psilocin, the active metabolite. The pharmacokinetics of psilocin were determined using both compartmental (NONMEM) and noncompartmental (WinNonlin) methods. RESULTS: No psilocybin was found in plasma or urine, and renal clearance of intact psilocin accounted for less than 2% of the total clearance. The pharmacokinetics of psilocin were linear within the twofold range of doses, and the elimination half-life of psilocin was 3 h (standard deviation 1.1). An extended elimination phase in some subjects suggests hydrolysis of the psilocin glucuronide metabolite. Variation in psilocin clearance was not predicted by body weight, and no serious adverse events occurred in the subjects studied. CONCLUSIONS: The small amount of psilocin renally excreted suggests that no dose reduction is needed for subjects with mild-moderate renal impairment. Simulation of fixed doses using the pharmacokinetic parameters suggest that an oral dose of 25 mg should approximate the drug exposure of a 0.3 mg/kg oral dose of psilocybin. Although doses of 0.6 mg/kg are in excess of likely therapeutic doses, no serious physical or psychological events occurred during or within 30 days of any dose. CLINICAL TRIALS IDENTIFIER: NCT02163707.

Randomized controlled trial of mindfulness meditation and exercise for the prevention of acute respiratory infection: possible mechanisms of action.

Background. A randomized trial suggests that meditation and exercise may prevent acute respiratory infection (ARI). This paper explores potential mediating mechanisms. Methods. Community-recruited adults were randomly assigned to three nonblinded arms: 8-week mindfulness-based stress reduction (N = 51), moderate-intensity exercise (N = 51), or wait-list control (N = 52). Primary outcomes were ARI illness burden (validated Wisconsin Upper Respiratory Symptom Survey). Potential mediators included self-reported psychophysical health and exercise intensity (baseline, 9 weeks, and 3 months). A Baron and Kenny approach-based mediational analysis model, adjusted for group status, age, and gender, evaluated the relationship between the primary outcome and a potential mediator using zero-inflated modeling and Sobel testing. Results. Of 154 randomized, 149 completed the trial (51, 47, and 51 in meditation, exercise, and control groups) and were analyzed (82% female, 94% Caucasian, 59.3 ± SD 6.6 years old). Mediational analyses suggested that improved mindfulness (Mindful Attention Awareness Scale) at 3 months may mediate intervention effects on ARI severity and duration (P < 0.05); 1 point increase in the mindfulness score corresponded to a shortened ARI duration by 7.2-9.6 hours. Conclusions. Meditation and exercise may decrease the ARI illness burden through increased mindfulness. These preliminary findings need confirmation, if confirmed, they would have important policy and clinical implications. This trial registration was Clinicaltrials.gov: NCT01057771.

Community-based treatment for opioid dependent offenders: a pilot study.

BACKGROUND: Primary care opioid substitution treatment (OST) has not been compared to program-based OST for community-supervised offenders. OBJECTIVE: The purpose of this project was to compare primary care to specialist supervised OST for opioid dependent offenders in terms of substance use and HIV risk outcomes. METHODS: This project randomly assigned 15 jail diversion participants to either: (i) primary care buprenorphine OST, (ii) specialist facility buprenorphine OST, or (iii) specialist facility methadone OST. Participation lasted 13.5 months (12-month active treatment plus a post-participation visit). RESULTS: All subjects endorsed 0 days of opioid use in the previous 14 at follow-up. Specialty care reduced HIV risk (Risk Assessment Battery composite score) over 6 months (-.24 ± .17) compared to primary care (.02 ± .14; p = .032). CONCLUSION: Findings support primary care OST feasibility for a community-supervised offender sample. Specialist care may facilitate improvements in secondary outcomes, such as HIV risk behaviors. SCIENTIFIC SIGNIFICANCE: Further research is needed to clarify (i) the role of primary care in addicted offender management, and (ii) the matching of offenders, based upon history and co-morbidity, to care coordination conditions.

Assistant District Attorney decision making when referring to drug treatment court.

BACKGROUND: Contact with the criminal justice system represents a critical point for drug involved offenders to access treatment and prevention services. Treatment and service provision under community supervision are known to be more likely than incarceration to affect positive change in terms of reduced substance use, reduced HIV risk behaviors, and increments in community reintegration. The decision-making process by Assistant District Attorneys (ADAs), frequent primary gate-keepers of jail diversion programming, when referring to diversion programs (as opposed to traditional adjudication) is poorly understood. OBJECTIVE: To contribute to literature regarding the optimization of jail diversion referral practice, the current study sought to investigate what influences such decisions by Dane County ADAs. METHODS: We surveyed 24 ADAs and received 19 completed questionnaires. RESULTS: ADA decision making was in agreement with existing literature regarding offender factors associated with drug court completion, including social factors, criminal history, and primary substance used. ADA beliefs conflicted with current literature regarding drug treatment facilitating reductions in criminal behavior. CONCLUSION: Additional research is needed to further assess the decision-making process by primary diversion program gatekeepers. SCIENTFIC SIGNIFICANCE: Dissemination of relevant findings to prosecutors will facilitate optimization of referral to therapeutic jurisprudence programming and the matching of offenders to services.

Value associated with mindfulness meditation and moderate exercise intervention in acute respiratory infection: the MEPARI Study.

BACKGROUND AND OBJECTIVES: Acute respiratory infection (ARI) is among the most common, debilitating and expensive human illnesses. The purpose of this study was to assess ARI-related costs and determine if mindfulness meditation or exercise can add value. METHODS: One hundred and fifty-four adults ≥50 years from Madison, WI for the 2009-10 cold/flu season were randomized to (i) wait-list control (ii) meditation or (iii) moderate intensity exercise. ARI-related costs were assessed through self-reported medication use, number of missed work days and medical visits. Costs per subject were based on cost of generic medications, missed work days ($126.20) and clinic visits ($78.70). Monte Carlo bootstrap methods evaluated reduced costs of ARI episodes. RESULTS: The total cost per subject for the control group was $214 (95% CI: $105-$358), exercise $136 (95% CI: $64-$232) and meditation $65 (95% CI: $34-$104). The majority of cost savings was through a reduction in missed days of work. Exercise had the highest medication costs at $16.60 compared with $5.90 for meditation (P = 0.004) and $7.20 for control (P = 0.046). Combining these cost benefits with the improved outcomes in incidence, duration and severity seen with the Meditation or Exercise for Preventing Acute Respiratory Infection study, meditation and exercise add value for ARI. Compared with control, meditation had the greatest cost benefit. This savings is offset by the cost of the intervention ($450/subject) that would negate the short-term but perhaps not long-term savings. CONCLUSIONS: Meditation and exercise add value to ARI-associated health-related costs with improved outcomes. Further research is needed to confirm results and inform policies on adding value to medical spending.

Advantage of meditation over exercise in reducing cold and flu illness is related to improved function and quality of life.

PURPOSE: To examine whether apparent advantages following training in meditation over exercise can be attributed to specific symptoms, functional impairments, or quality-of-life indicators assessed by the Wisconsin Upper Respiratory Symptom Survey (WURSS-24). METHODS: Results from the randomized controlled trial "Meditation or Exercise for Preventing Acute Respiratory Illness" showed mean global severity and total days of illness were worse in control (358, 8·9) compared with exercise (248, 5·1) or meditation (144, 5·0). Global severity of illness was estimated using area under the curve from daily self-reported severity scores on the WURSS-24. For this project, we estimated within-group WURSS item-level severity and between-group effect sizes (Cohen's "d" statistic) relative to control. The item-level effect sizes were grouped into (i) symptom and (ii) function and quality of life domains. RESULTS: Among the three groups, mediators showed the lowest severity estimates for 21 of 22 WURSS items. Item-level Cohen's "d" indicated most benefit was evident in WURSS items representing function and quality of life. Compared with exercise, meditation fostered larger reductions in illness severity, although due mostly to improved function and the quality of life domain (d=-0·33, P<0·001) compared with symptom domain (d=-0·22, P<0·001). CONCLUSIONS: The apparent advantage of training in meditation over exercise for reducing cold and flu illness is explained more by improved function and quality of life than by a reduction in symptom severity.

Meditation or exercise for preventing acute respiratory infection: a randomized controlled trial.

PURPOSE: This study was designed to evaluate potential preventive effects of meditation or exercise on incidence, duration, and severity of acute respiratory infection (ARI) illness. METHODS: Community-recruited adults aged 50 years and older were randomized to 1 of 3 study groups: 8-week training in mindfulness meditation, matched 8-week training in moderate-intensity sustained exercise, or observational control. The primary outcome was area-under-the-curve global illness severity during a single cold and influenza season, using the Wisconsin Upper Respiratory Symptom Survey (WURSS-24) to assess severity. Health care visits and days of missed work were counted. Nasal wash collected during ARI illness was assayed for neutrophils, interleukin-8, and viral nucleic acid. RESULTS: Of 154 adults randomized into the study, 149 completed the trial (82% female, 94% white, mean age 59.3 ± 6.6 years). There were 27 ARI episodes and 257 days of ARI illness in the meditation group (n = 51), 26 episodes and 241 illness days in the exercise group (n = 47), and 40 episodes and 453 days in the control group (n = 51). Mean global severity was 144 for meditation, 248 for exercise, and 358 for control. Compared with control, global severity was significantly lower for meditation (P = .004). Both global severity and total days of illness (duration) trended toward being lower for the exercise group (P=.16 and P=.032, respectively), as did illness duration for the meditation group (P=.034). Adjusting for covariates using zero-inflated multivariate regression models gave similar results. There were 67 ARI-related days of-work missed in the control group, 32 in the exercise group (P = .041), and 16 in the meditation group (P <.001). Health care visits did not differ significantly. Viruses were identified in 54% of samples from meditation, 42% from exercise, and 54% from control groups. Neutrophil count and interleukin-8 levels were similar among intervention groups. CONCLUSIONS: Training in meditation or exercise may be effective in reducing ARI illness burden.