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A community pharmacy intervention for opioid medication misuse: A pilot randomized clinical trial.

ABSTRACT: 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.

SUBMITTER: Cochran G

PROVIDER: S-EPMC6035879 | biostudies-literature | 2018 Jul - Aug

REPOSITORIES: biostudies-literature

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A community pharmacy intervention for opioid medication misuse: A pilot randomized clinical trial.

Cochran Gerald G Field Craig C Karp Jordan J Seybert Amy L AL Chen Qi Q Ringwald Whitney W Hruschak Valerie V Chickering Sunita S Kincman Joelle J Jaber Amanda A Tarter Ralph R

Journal of the American Pharmacists Association : JAPhA 20180701 4

<h4>Objectives</h4>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 i ...[more]

PMID: 29691197

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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:Oncology clinicians often struggle with managing medications and vaccinations in older adults with cancer. We sought to demonstrate the feasibility and preliminary efficacy of integrating pharmacists into the care of older adults with cancer to enhance medication management and vaccination administration. METHODS:We randomly assigned patients aged ?65 years with breast, gastrointestinal, or lung cancer receiving first-line chemotherapy to the pharmacy intervention or usual care. Patients assigned to the intervention met with a pharmacist once during their second or third chemotherapy infusion. We obtained information about patients' medications and vaccinations via patient report and from the electronic health record (EHR) at baseline and week 4. We determined the number of discrepant (difference between patient report and EHR) and potentially inappropriate (Beers Criteria assessed by nonintervention pharmacists blinded to group assignment) medications. We defined the intervention as feasible if >75% of patients enrolled in the study and received the pharmacist visit. RESULTS:From January 17, 2017, to October 27, 2017, we enrolled and randomized 60 patients (80.1% of patients approached). Among those assigned to the intervention, 96.6% received the pharmacist visit. At week 4, intervention patients had higher rates of acquiring vaccinations for pneumonia (27.6% vs. 0.0%, p = .002) and influenza (27.6% vs. 0.0%, p = .002) compared with usual care. Intervention patients had fewer discrepant (5.82 vs. 8.07, p = .094) and potentially inappropriate (3.46 vs. 4.80, p = .069) medications at week 4, although differences were not significant. CONCLUSION:Integrating pharmacists into the care of older adults with cancer is feasible with encouraging preliminary efficacy for enhancing medication management and improving vaccination rates. IMPLICATIONS FOR PRACTICE:Results of this study showed the feasibility, acceptability, and preliminary efficacy of an intervention integrating pharmacists into the care of older adults with cancer. Notably, patients assigned to the intervention had fewer discrepant medications and were more likely to acquire vaccinations for pneumonia and influenza. Importantly, this work represents the first randomized controlled trial involving the integration of pharmacists into the outpatient oncologic care of older adults with cancer. In the future, a larger randomized trial is needed to demonstrate the efficacy of this care model to enhance medication management and improve vaccination outcomes for older patients with cancer.

Project description:IntroductionOpioid use disorder (OUD) and related comorbid conditions are highly prevalent among patients presenting to emergency department (ED) settings. Research has developed few comprehensive disease management strategies for at-risk patients presenting to the ED that both decrease illicit opioid use and improve initiation and retention in medication treatment for OUD (MOUD).MethodsThe research team conducted a pilot pragmatic clinical trial that randomized 40 patients presenting to a single ED to a collaborative care intervention (n = 20) versus usual care control (n = 20) conditions. Interviewers blinded to patient intervention and control group status followed-up with participants at 1, 3, and 6 months after presentation to the ED. The 3-month Emergency Department Longitudinal Integrated Care (ED-LINC) collaborative care intervention for patients at risk for OUD included: 1) a Brief Negotiated Interview at bedside, 2) overdose education and facilitation of MOUD, 3) longitudinal proactive care management, 4) utilization of the statewide health information exchange platform for 24/7 tracking of recurrent ED utilization, and 5) weekly caseload supervision that incorporated measurement-based care treatment assessment with stepped-up care for patients with recalcitrant symptoms.ResultsOverall, the ED-LINC intervention was feasibly delivered and acceptable to patients. The pilot study achieved >80% follow-up rates at 1, 3, and 6 months. In adjusted longitudinal mixed model regression analyses, no statistically significant differences existed in days of opioid use over the past 30 days for ED-LINC intervention patients when compared to patients receiving usual care (incidence-rate ratio (IRR) 1.50, 95% CI 0.54-4.16). The unadjusted mean number of days of illicit opioid use decreased at the 1-month and 3-month follow-up time points for both groups. ED-LINC intervention patients had increased rates of MOUD initiation compared to control patients (50% versus 30%); intervention versus control comparisons did not achieve statistical significance, although power to detect significant differences in the pilot was limited.ConclusionsThe ED-LINC intervention for patients with OUD can be feasibly implemented and warrants testing in larger scale, adequately powered randomized pragmatic clinical trial investigations.Clinicaltrialsgov NCT03699085.

Project description:ImportancePrescription opioid misuse is a national crisis. Few interventions have improved adherence to opioid-prescribing guidelines.ObjectiveTo determine whether a multicomponent intervention, Transforming Opioid Prescribing in Primary Care (TOPCARE; http://mytopcare.org/), improves guideline adherence while decreasing opioid misuse risk.Design, setting, and participantsCluster-randomized clinical trial among 53 primary care clinicians (PCCs) and their 985 patients receiving long-term opioid therapy for pain. The study was conducted from January 2014 to March 2016 in 4 safety-net primary care practices.InterventionsIntervention PCCs received nurse care management, an electronic registry, 1-on-1 academic detailing, and electronic decision tools for safe opioid prescribing. Control PCCs received electronic decision tools only.Main outcomes and measuresPrimary outcomes included documentation of guideline-concordant care (both a patient-PCC agreement in the electronic health record and at least 1 urine drug test [UDT]) over 12 months and 2 or more early opioid refills. Secondary outcomes included opioid dose reduction (ie, 10% decrease in morphine-equivalent daily dose [MEDD] at trial end) and opioid treatment discontinuation. Adjusted outcomes controlled for differing baseline patient characteristics: substance use diagnosis, mental health diagnoses, and language.ResultsOf the 985 participating patients, 519 were men, and 466 were women (mean [SD] patient age, 54.7 [11.5] years). Patients received a mean (SD) MEDD of 57.8 (78.5) mg. At 1 year, intervention patients were more likely than controls to receive guideline-concordant care (65.9% vs 37.8%; P < .001; adjusted odds ratio [AOR], 6.0; 95% CI, 3.6-10.2), to have a patient-PCC agreement (of the 376 without an agreement at baseline, 53.8% vs 6.0%; P < .001; AOR, 11.9; 95% CI, 4.4-32.2), and to undergo at least 1 UDT (74.6% vs 57.9%; P < .001; AOR, 3.0; 95% CI, 1.8-5.0). There was no difference in odds of early refill receipt between groups (20.7% vs 20.1%; AOR, 1.1; 95% CI, 0.7-1.8). Intervention patients were more likely than controls to have either a 10% dose reduction or opioid treatment discontinuation (AOR, 1.6; 95% CI, 1.3-2.1; P < .001). In adjusted analyses, intervention patients had a mean (SE) MEDD 6.8 (1.6) mg lower than controls (P < .001).Conclusions and relevanceA multicomponent intervention improved guideline-concordant care but did not decrease early opioid refills.Trial registrationclinicaltrials.gov Identifier: NCT01909076.

Project description:Background and aimsPharmacy administration and dispensing of methadone for methadone maintenance treatment (MMT) can expand treatment access for opioid use disorder (OUD). This study investigated the feasibility and acceptability of a novel model permitting an opioid treatment program (OTP) physician to prescribe methadone for OUD treatment through collaboration with a partnered pharmacy.DesignNon-randomized, single-arm, open-label feasibility trial.SettingOne OTP and one community pharmacy in the United States.ParticipantsOne OTP physician, two pharmacists and 20 MMT patients receiving between six and 13 take-home methadone doses at 5-160 mg/day.InterventionPatients' methadone administration and dispensing of take-home doses was transferred from the OTP to the pharmacy for 3 months.MeasurementsPrimary outcome was medication adherence. Secondary outcomes were recruitment, treatment retention, substance use, counseling attendance at the OTP, pharmacist prescription drug monitoring program (PDMP) use, safety and satisfaction.FindingsOf 29 patients eligible at pre-screen, 20 patients (69%) enrolled into the study. Recruitment occurred from 6 August 2020 to 10 October 2020. Treatment retention rate at month 3 was 80% (16 of 20). Two participants returned early to the OTP because of a work/schedule change, one due to pregnancy and one following a non-study-related hospitalization. Medication adherence among 16 patients who were retained was 100%. Intervention fidelity was 100%. All participants attended random call-back visits. None showed evidence of tampering/diversion of methadone. Pharmacists checked the PDMP at all visits. All participants attended psychosocial counseling as planned. There were no positive urine screens for illicit opioid use and no study-related adverse events. All participants endorsed 'pharmacy is the right location for receiving methadone for MMT', 88% endorsed 'convenient or very convenient to receive methadone at the pharmacy' and 88% were satisfied or very satisfied with the quality of treatment offered.ConclusionsThis feasibility trial has found pharmacy administration and dispensing of physician-prescribed methadone for methadone maintenance treatment to be feasible and acceptable.

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A community pharmacy intervention for opioid medication misuse: A pilot randomized clinical trial.

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A community pharmacy intervention for opioid medication misuse: A pilot randomized clinical trial.

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