Dataset Information

Addressing the opioid epidemic through community pharmacy engagement: Study protocol for a randomized controlled trial.

ABSTRACT:

Background

Despite the authority to dispense naloxone, pharmacists have been reluctant to offer and dispense it, often due to discomfort communicating about the sensitive topic of opioid overdose. Because existing online naloxone trainings do not sufficiently address how to communicate effectively with patients about naloxone, Nalox-Comm, a training module designed to improve pharmacists' self-efficacy to engage in naloxone discussions, was developed.

Objective

To describe the study protocol to evaluate the effectiveness of the Nalox-Comm training module on naloxone dispensing rates.

Methods

A randomized controlled trial, which began in July 2021, is used to evaluate the pre-post Nalox-Comm training intervention. Sixty pharmacists are being recruited from 62 pharmacies part of a single grocery store chain in rural counties of the southeastern United States. After completing a baseline survey, pharmacists are observed by simulated patients (SPs) who rate the quality of their pre-training naloxone communication. Pharmacists are then invited to complete either a basic online naloxone training module (control group) or a newly developed Nalox-Comm training (experimental group), after which they complete a post-training survey and are observed a second time by SPs. Three months post-training, study participants complete a final follow-up survey. Naloxone dispensing records are obtained from each participating pharmacy to assess change in naloxone dispensing rates.

Conclusion

Informed by rural pharmacist stakeholders, the Nalox-Comm training module addresses communication barriers specific to rural communities. Compared to those in the control group, we hypothesize that pharmacies in the experimental group will dispense more naloxone in the three months post-training intervention.

SUBMITTER: Gamble A

PROVIDER: S-EPMC10731677 | biostudies-literature | 2022 Oct

REPOSITORIES: biostudies-literature

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Publications

Addressing the opioid epidemic through community pharmacy engagement: Study protocol for a randomized controlled trial.

Gamble Abigail A Mashburn Trish T Kennelty Korey A KA Look Kevin A KA Westrick Salisa C SC Evon Donna M DM Tudor Gail G Carpenter Delesha M DM

Contemporary clinical trials 20220910

<h4>Background</h4>Despite the authority to dispense naloxone, pharmacists have been reluctant to offer and dispense it, often due to discomfort communicating about the sensitive topic of opioid overdose. Because existing online naloxone trainings do not sufficiently address how to communicate effectively with patients about naloxone, Nalox-Comm, a training module designed to improve pharmacists' self-efficacy to engage in naloxone discussions, was developed.<h4>Objective</h4>To describe the stu ...[more]

PMID: 36096283

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Project description:BackgroundDespite strong and growing interest in ending the ongoing opioid health crisis, there has been limited success in reducing the prevalence of opioid addiction and the number of deaths associated with opioid overdoses. Further, 1 explanation for this is that existing interventions target those who are opiate-dependent but do not prevent opioid-naïve patients from becoming addicted.ObjectiveLeveraging behavioral economics at the patient level could help patients successfully use, discontinue, and dispose of their opioid medications in an acute pain setting. The primary goal of this project is to evaluate the effect of the 3 versions of the Opioid Management for You (OPY) tool on measures of opioid use relative to the standard of care by leveraging a pragmatic randomized controlled trial (RCT).MethodsA team of researchers from the Center for Learning Health System Sciences (CLHSS) at the University of Minnesota partnered with M Health Fairview to design, build, and test the 3 versions of the OPY tool: social influence, precommitment, and testimonial version. The tool is being built using the Epic Care Companion (Epic Inc) platform and interacts with the patient through their existing MyChart (Epic Systems Corporation) personal health record account, and Epic patient portal, accessed through a phone app or the MyChart website. We have demonstrated feasibility with pilot data of the social influence version of the OPY app by targeting our pilot to a specific cohort of patients undergoing upper-extremity procedures. This study will use a group sequential RCT design to test the impact of this important health system initiative. Patients who meet OPY inclusion criteria will be stratified into low, intermediate, and high risk of opiate use based on their type of surgery.ResultsThis study is being funded and supported by the CLHSS Rapid Prospective Evaluation and Digital Technology Innovation Programs, and M Health Fairview. Support and coordination provided by CLHSS include the structure of engagement, survey development, data collection, statistical analysis, and dissemination. The project was initially started in August 2022. The pilot was launched in February 2023 and is still running, with the data last counted in August 2023. The actual RCT is planned to start by early 2024.ConclusionsThrough this RCT, we will test our hypothesis that patient opioid use and diverted prescription opioid availability can both be improved by information delivery applied through a behavioral economics lens via sending nudges directly to the opioid users through their personal health record.Trial registrationClinicalTrials.gov NCT06124079; https://clinicaltrials.gov/study/NCT06124079.International registered report identifier (irrid)PRR1-10.2196/52882.

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:BackgroundAs the opioid epidemic continues to have a major negative impact across the US, community pharmacies have come under scrutiny from legal systems attempting to hold them accountable for their role in over dispensing and lack of patient intervention. While the most available tool for monitoring patients' opioid use is Prescription Drug Monitoring Programs (PDMP), these do not provide pharmacists with actionable information and decision support. Our study addresses this gap through three objectives: [1] incorporate validated opioid risk metric thresholds into a PDMP platform to create the Opioid Risk Reduction Clinical Decision Support (ORRCDS) tool; [2] assess ORRCDS' ability to reduce patient opioid risk; [3] assess ORRCDS' sustainability and viability for broader dissemination in community pharmacy.MethodsFor objective 1, our team is partnering with leadership from the largest US PDMP organization and a top-five pharmacy chain to implement ORRCDS into the pharmacy chain's workflow following the Guideline Implementation with Decision Support (GUIDES) framework. For objective 2, our team will conduct a type-1 implementation mixed methods study using a 2-arm parallel group clustered randomized design. We anticipate enrolling ~ 6,600 patients with moderate and high opioid use risk during the 6-month enrollment phase across 80 pharmacies. This sample size will provide 96.3% power to detect a 5% or greater difference in responder rate between the intervention and control arm. Responders are patients with moderate-risk at baseline who reduce to low-risk or those with high-risk at baseline who reduce to moderate or low-risk at 180 days post last intervention. To accomplish objective 3, we will use the Consolidated Framework for Implementation Research (CFIR) to develop and execute cross-sectional qualitative interviews with pharmacists (n = 15), pharmacy leaders (n = 15), and PDMP leaders (n = 15) regarding long term adoption and sustainability of the ORRCDS tool.ConclusionsA PDMP tool that addresses moderate- and high-risk opioid use is not available in community pharmacy. This study will implement ORRCDS in a large retail pharmacy chain that will include additional screening and guidance to pharmacy staff to address risky opioid medication use. Our results will make critical advancements for protecting patient health and addressing the opioid epidemic.

Dataset Information

Addressing the opioid epidemic through community pharmacy engagement: Study protocol for a randomized controlled trial.

Background

Objective

Methods

Conclusion

Publications

Addressing the opioid epidemic through community pharmacy engagement: Study protocol for a randomized controlled trial.

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