Dataset Information

Addressing opioid medication misuse at point of service in community pharmacy: A study protocol for an interdisciplinary behavioral health trial.

ABSTRACT:

Background

>1 in 3 of the 9 million individuals engaged in opioid medication misuse obtain legitimate opioid prescriptions and fill these in community pharmacies, which are subsequently misused. This study is testing the efficacy of a pharmacist-led intervention-Brief Intervention-Medication Therapy Management (BI-MTM)-compared to standard medication counseling (SMC) to address opioid medication misuse.

Methods

Design. This study is a single-blinded 2-group parallel randomized trial within 13 community pharmacies that will enroll 350 individuals. Participant Recruitment. Pharmacy staff approach patients and ask about interest in completing a brief confidential screening tool, which includes opioid medication misuse assessment. Interested patients who report misuse are asked to provide informed consent. Enrolled patients are assessed for behavioral and physical health at enrollment, 2-months post-enrollment, and 6-months post-enrollment.

Interventions

Following baseline assessment, participants are randomized (1:1 ratio) to: SMC, a medication information/counseling intervention or BI-MTM, an intervention comprised by 4 evidence-based components: medication therapy management, brief intervention, naloxone dispensing, and patient navigation.

Analyses

Primary analyses involve estimating 3-level generalized linear mixed models to relate repeated assessments across time of opioid medication misuse (i.e., the Prescription Opioid Misuse Index) to the intervention.

Conclusion

Study results will provide the first critical step towards integrating a highly accessible, low-cost approach to managing risks related to opioid use. Community pharmacies provide an incredibly important setting in which patients can receive high quality care to support health behavior change. Successfully completing this project sets the stage for a large-scale effectiveness study. (NCT#: NCT05141266).

SUBMITTER: Cochran G

PROVIDER: S-EPMC9661693 | biostudies-literature | 2022 May

REPOSITORIES: biostudies-literature

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Publications

Addressing opioid medication misuse at point of service in community pharmacy: A study protocol for an interdisciplinary behavioral health trial.

Cochran Gerald G Shen Jincheng J Cox Nicholas N Field Craig C Carlston Kristi K Sengpraseut Britnee B White Ashley A Okifuji Akiko A Jackman Carina C Haaland Benjamin B Ragsdale Russ R Gordon Adam J AJ Tarter Ralph R

Contemporary clinical trials 20220411

<h4>Background</h4>>1 in 3 of the 9 million individuals engaged in opioid medication misuse obtain legitimate opioid prescriptions and fill these in community pharmacies, which are subsequently misused. This study is testing the efficacy of a pharmacist-led intervention-Brief Intervention-Medication Therapy Management (BI-MTM)-compared to standard medication counseling (SMC) to address opioid medication misuse.<h4>Methods</h4>Design. This study is a single-blinded 2-group parallel randomized tri ...[more]

PMID: 35417771

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Project description:OBJECTIVES:Community pharmacy continues to play a crucial role in the national response to the opioid epidemic. The purpose of this article is to describe the protocol for a pilot study that is examining the feasibility and acceptability of the Motivational Intervention-Medication Therapy Management (MI-MTM) model. This study also examines the preliminary clinical effect of MI-MTM for improving opioid medication misuse and patient activation in self-management of health conditions that increase risk for misuse. DESIGN:MI-MTM is a pharmacy-based integrated care model made up of 4 evidence-based practices: medication therapy management; brief motivational intervention; patient navigation; and naloxone training and referral. To test MI-MTM compared with Standard Medication Counseling (SMC), we are conducting a 2-group randomized single-blinded controlled trial with assessments at 3 time points. SETTING AND PARTICIPANTS:The study is being conducted within a western Pennsylvania university-based community pharmacy with 46 patients with opioid misuse (MI-MTM = 23; SMC = 23). MAIN OUTCOME MEASURES:Feasibility will be measured by capturing patient completion rate of MI-MTM sessions. Acceptability will be measured by administering satisfaction surveys regarding pharmacist and patient navigator services. Acceptability will also be captured by conducting intensive qualitative interviews. Preliminary effect of the intervention on misuse will be measured with the use of the Prescription Opioid Misuse Index and the Opioid Compliance Checklist. Activation in self-management will be measured with the use of the Patient Activation Measure. RESULTS:This project is currently recruiting, and results are to come. CONCLUSION:This study is the first in the United States to implement an evidence-based integrated behavioral intervention into the community pharmacy setting to address opioid medication misuse among pharmacy patients. The results of this study will provide necessary foundational data that allow further testing of this intervention model in a larger trial.

Project description:PurposeMedication expertise and close patient contact position community pharmacists to make significant contributions to combatting the opioid epidemic. This position facilitated the development and initial implementation of the Brief Intervention Medication Therapy Management (BIMTM) model to detect and address patient opioid misuse. BIMTM is an intervention consisting of 9 sessions. One medication management session is delivered by a pharmacist in a community pharmacy setting, and the remaining sessions are delivered telephonically by a patient navigator to follow up with goals established with the pharmacist and address concomitant health concerns that increase risk for misuse.MethodsWe employed the Consolidated Framework for Implementation Research (CFIR) to summarize and present key findings from 4 distinct studies. CFIR domains addressed were (1) intervention characteristics, (2) outer setting, (3) inner setting, (4) process, and (5) characteristics of individuals. The study results show sequential development of evidence for BIMTM.ResultsA multistate cross-sectional pharmacist survey (n = 739) demonstrated limited pharmacist training and/or resources to address misuse, suggesting the need for external intervention development. Our multistakeholder intervention planning project showed limitations of current evidence-based models of care and of intervention implementation, which resulted in construction of the BIMTM. A multisite cross-sectional screening survey of patients (n = 333) established an electronic misuse screening protocol within 4 community pharmacies and identified opioid misuse in 15% of screened patients; among those patients, 98% had concomitant health conditions that contribute to the risk of opioid misuse. Presentation of study results to pharmacy leaders produced commitment for intervention implementation and a partnership to develop a grant proposal supporting this action. Our small-scale randomized trial evinced success in recruitment and retention and BIMTM patient benefit. The small-scale randomized trial likewise showed high levels of satisfaction with BIMTM.ConclusionThe establishment of BIMTM supports community pharmacist identification and intervention with patients engaged in misuse. Continued use of this research-based strategy may further empower pharmacists to address the opioid epidemic.

Project description:Background: Effective treatment of osteoporosis is hindered by poor adherence and lack of persistence with medical therapy. Interventions can be designed to elicit and address patients' concerns about side effects and promote self-management. Objective(s): The aim was to develop and evaluate the impact of a community pharmacy-based medication management intervention on patients' adherence to osteoporosis medicines using both objective and subjective measures of adherence. Secondary aims were to report the proportion of patients that had been referred to their General Practitioner (GP) for assistance with osteoporosis management, and to measure patients' experiences with the service. Methods: This study used a cohort design. Community pharmacy dispensing data were obtained as an objective measure of adherence. Self-reported beliefs about medicines (Beliefs about Medicines Questionnaire) and self-reported adherence (Medication Adherence Reporting Scale 5) were also collected. Data were collected and compared between baseline, 4 weeks after intervention, and endpoint (approximately a year after intervention). Analysis of correlations between measures was also conducted. GP referral percentage and perceived service quality scale (pSQS-SF6) was obtained. Results: Pharmacists and support staff from 26 Australian community pharmacies were recruited and trained to implement the service, and 107 patients were recruited. Of these, 71 were available for follow-up interviews by research team at 4 weeks, and 54 at the endpoint. No changes were found in pre-post analysis for the objective or self-reported measures of adherence. Patients' concerns about osteoporosis medicines were lower at 4 weeks and at the study endpoint compared to baseline. Uptake of pharmacists' referrals to patients' GPs was 48.1% by 4 weeks. Patient experience was rated highly (median pSQS-SF6 = 6.5/7). Conclusions: This study demonstrates the potential of community pharmacy interventions designed to optimize medication adherence by eliciting patients' thoughts and feelings about using osteoporosis medicines and addressing them using motivational interview techniques.

Project description:BackgroundAlthough prescription opioid dispensing rates have continued to decrease, overdose deaths involving prescription opioids have increased during the COVID-19 pandemic. Screening and brief interventions (SBI) are an effective prevention strategy to identify and address opioid misuse and safety risks. Emerging literature on pharmacy-based SBI needs to be systematically appraised to develop robust interventions.ObjectiveOur objective was to conduct a scoping review of the literature regarding pharmacy-based opioid misuse SBI to identify relevant literature that explore the topic, evaluate the patient-centeredness of included studies, and explore the use of dissemination and implementation science in the literature.MethodsThe review was conducted according to Preferred Reporting of Systematic Reviews and Meta-analyses -Scoping reviews (PRISMA-Sc) guidelines. We searched PubMed, CINHAL, PsychInfo, and Scopus for studies regarding pharmacy-based SBI, published in the last 20 years. We also conducted a separate grey literature search. Two of three total reviewers screened each abstract individually and identified eligible full-texts for inclusion. We critically appraised quality of included studies and qualitatively synthesized the relevant information.ResultsThe search resulted in 21 studies (categorized as intervention, descriptive, and observational research) and 3 grey literature reports. Of the recently published 21 studies, 11 were observational research, with six interventions in the pilot stages. Screening tools varied but naloxone was the brief intervention in 15 of the 24 results. Only eight studies had high validity, reliability, and applicability and only five were patient-centered. Implementation science principles were addressed in eight studies (mainly interventions). Overall, the findings suggest high potential for evidence-based SBI to be successful.ConclusionsOverall, the review suggested a strong lack of a patient-centered and implementation science-focused approach to designing pharmacy-based opioid misuse SBI. Findings suggest that a patient-centered, implementation focused approach is needed for effective and sustained pharmacy-based opioid misuse SBI.

Project description:BackgroundPersons with dementia (PWD) have high rates of polypharmacy. While previous studies have examined specific types of problematic medication use in PWD, we sought to characterize a broad spectrum of medication misuse and overuse among community-dwelling PWD.MethodsWe included community-dwelling adults aged ≥66 in the Health and Retirement Study from 2008 to 2018 linked to Medicare and classified as having dementia using a validated algorithm. Medication usage was ascertained over the 1-year prior to an HRS interview date. Potentially problematic medications were identified by: (1) medication overuse including over-aggressive treatment of diabetes/hypertension (e.g., insulin/sulfonylurea with hemoglobin A1c < 7.5%) and medications inappropriate near end of life based on STOPPFrail and (2) medication misuse including medications that negatively affect cognition and medications from 2019 Beers and STOPP Version 2 criteria. To contextualize, we compared medication use to people without dementia through a propensity-matched cohort by age, sex, comorbidities, and interview year. We applied survey weights to make our results nationally representative.ResultsAmong 1441 PWD, median age was 84 (interquartile range = 78-89), 67% female, and 14% Black. Overall, 73% of PWD were prescribed ≥1 potentially problematic medication with a mean of 2.09 per individual in the prior year. This was notable across several domains, including 41% prescribed ≥1 medication that negatively affects cognition. Frequently problematic medications included proton pump inhibitors (PPIs), non-steroidal anti-inflammatory drugs (NSAIDs), opioids, antihypertensives, and antidiabetic agents. Problematic medication use was higher among PWD compared to those without dementia with 73% versus 67% prescribed ≥1 problematic medication (p = 0.002) and mean of 2.09 versus 1.62 (p < 0.001), respectively.ConclusionCommunity-dwelling PWD frequently receive problematic medications across multiple domains and at higher frequencies compared to those without dementia. Deprescribing efforts for PWD should focus not only on potentially harmful central nervous system-active medications but also on other classes such as PPIs and NSAIDs.

Dataset Information

Addressing opioid medication misuse at point of service in community pharmacy: A study protocol for an interdisciplinary behavioral health trial.

Background

Methods

Interventions

Analyses

Conclusion

Publications

Addressing opioid medication misuse at point of service in community pharmacy: A study protocol for an interdisciplinary behavioral health trial.

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