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临床试验/NCT03149718
NCT03149718已完成不适用

Prescription Opioid Misuse: Pharmacist-Delivered Intervention at Point of Service

University of Utah4 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2017年9月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
46
试验地点
4
主要终点
Intervention feasibility

研究概览

简要总结

Opioid medication misuse and overdose have reached epidemic proportions in the US. Community pharmacy is a potentially valuable resource for addressing opioid medication misuse. This study will manualize and establish the feasibility, acceptability, and clinical effect of a community pharmacist-led intervention aimed at: improving opioid mediation regimen adherence, eliminating misuse, connecting patients to additional care, and safeguarding against overdose.

详细描述

The current small scale single-blinded randomized controlled study will build on our preliminary studies by manualizing and examining the feasibility, acceptability, and clinical effect for the Brief Intervention Medication Therapy Management (BI-MTM) model. BI-MTM is a multicomponent community pharmacy-based intervention. BI-MTM is designed to: (1) promote opioid medication regimen adherence, (2) reduce opioid medication misuse, (3) connect participants with patient navigation (a chronic condition care model) to increase self-management of health conditions that increase risk for misuse, and (4) provide naloxone rescue training referrals. Patients will be screened across 14 months for opioid medication misuse in an urban community pharmacy affiliated with a major medical system. Patients positive for misuse will be randomly assigned to BI-MTM (n=23) or Standard Medication Counseling (n=23). Standard Medication Counseling is the Centers for Medicaid and Medicare Services requirement for pharmacists in the US wherein pharmacy patients filling prescriptions receive information and opt-in counseling. This study will demonstrate feasibility and acceptability of BI-MTM for community pharmacy patients who misuse their opioid medications for future intervention implementation in a fully powered randomized trial. This study will also generate preliminary data regarding opioid medication misuse elimination and increases in participant self-management activation for comorbid health conditions that increase risk for misuse.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Opioid Misuse
  • English speaking

排除标准

  • Are pregnant (given potential pre/post-natal opioid use complications among pregnant women/offspring)
  • Cannot provide collateral contact information for ≥2 contact persons (to ensure consistent contact/follow up)
  • Do not have a reliable landline or mobile phone to be contacted by study staff
  • Are only filling buprenorphine (given some formulations are not indicated for pain)
  • Plan to leave the area for an extended period of time in the next 3 months
  • Have had a psychotic and/or manic episode in the last 30 days

研究组 & 干预措施

SMC (n=23)

Active Comparator

Standard Medication Counseling.

干预措施: Standard Medication Counseling (SMC) (Behavioral)

BI-MTM (n=23)

Experimental

Brief Intervention Medication Therapy Management.

干预措施: Brief Intervention Medication Therapy Management (Behavioral)

结局指标

主要结局

Intervention feasibility

时间窗: Month 21 of Study

Intervention feasibility will be established through delivery of all BI-MTM components to 85% of BI-MTM recipients.

Intervention acceptability

时间窗: Month 21 of Study

Intervention acceptability will be demonstrated though qualitative interviews.

次要结局

  • Opioid Misuse(Month 21 of Study)
  • Patient Self-Management(Month 21 of Study)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jerry Cochran

Associate Professor

University of Utah

研究点 (4)

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