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临床试验/NCT04575155
NCT04575155已完成不适用

Development & Pilot of the Technology-Enabled Alliance for Medication Therapy Management

Northwestern University2 个研究点 分布在 1 个国家目标入组 119 人开始时间: 2020年10月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
119
试验地点
2
主要终点
Medication Reconciliation

研究概览

简要总结

The investigators will link community pharmacy and primary care practices via a shared electronic health record to improve medication therapy management for older patients taking complex prescription (Rx) regimens. The Technology-Enabled Alliance for Medication Therapy Management (TEAM) intervention will link a major, national community pharmacy chain (Walgreens) to primary care practices (Access Community Health Network) via a shared electronic health record (EHR) platform (Epic, Verona WI). Through shared access to patients' medical records, pharmacists can perform comprehensive medication therapy management services, document and communicate patients' Rx challenges for review and action by primary care providers. The aims of this investigation are to:

  1. Evaluate the fidelity and efficacy of the TEAM intervention to promote healthcare provider counseling, medication reconciliation, and safe regimen use among adults taking complex Rx regimens.
  2. Explore patient, healthcare provider (pharmacist, prescriber), community pharmacy and/or primary care practice barriers to implementation.
  3. Determine the costs of the TEAM intervention from both a community pharmacy and primary care practice perspective.

详细描述

The investigators will link community pharmacy and primary care practices via a shared electronic health record to improve medication therapy management for older patients taking complex prescription (Rx) regimens. The Technology-Enabled Alliance for Medication Therapy Management (TEAM) intervention will link a major, national community pharmacy chain (Walgreens) to primary care practices (ACCESS community health network) via a shared electronic health record (EHR) platform (Epic, Verona WI). Through shared access to patients' medical records, pharmacists can perform comprehensive medication therapy management services, document and communicate patients' Rx challenges for review and action by primary care providers.

The investigators will conduct a 2-arm pilot to evaluate the efficacy of the TEAM intervention compared to enhanced usual care. The investigators will enroll a total of 120 English and Spanish-speaking patients prescribed five or more chronic medications. Enrolled patients will complete a follow-up interview two months after their baseline interview.

The TEAM intervention enables a pharmacist to help patients on complex Rx regimens via medication reviews by telephone and clinical decision support. Pharmacists will call patients to conduct a Comprehensive Medication Review (CMR). Pharmacists will be able to document and communicate patients' medication challenges for review and action by primary care providers. A CMR will:

  1. Ensure the primary care physician knows all medications the patient is taking (reconciliation)
  2. Investigate if patients are taking medication as prescribed, in a safe manner (proper use)
  3. Monitor and detect any drug-related adverse effects (ADEs) (surveillance)
  4. Address any questions or concerns patients may have about their medicine (e.g. side effects, treatment alternatives, dietary restrictions, cost, 90 vs. 30 day scripts; education)
  5. Inquire about patients' adherence to regimens, what barriers they may experience (e.g. cost, forgetfulness) and if they need assistance (e.g. synchronization requests, pill box or reminder tools, etc.; adherence).

After performing the CMR, the pharmacist will provide timely notifications via secure, EHR-based messaging direct to prescribers of any medication concerns, based on either 1) pharmacy information (e.g. medications ordered by other prescribers, fill data), 2) patient report of problems during phone-based encounters, or 3) pharmacist review of the patient record.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • 未提供

排除标准

  • Severe, uncorrectable vision
  • Hearing impairments
  • Cognitive impairment (as measured by the 6-item screener)

结局指标

主要结局

Medication Reconciliation

时间窗: Baseline-2 months

Number of medications discrepancies is measured as the sum of omissions (medications listed in the EHR but the patient reported not taking) and commissions (patient reported taking medications not in the EHR) at baseline and 2 months post baseline. Count of discrepancies at the 2 months follow-up is modeled using a multivariate Poisson regression model, with number of prescribed medications as an offset variable. The model is controlled for confounding variables and the number of medication discrepancies at baseline. A discrepancy is considered resolved at the 2 month follow-up if the pharmacist indicated the medication to be removed or added to the medication list.

次要结局

未报告次要终点

研究者

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

Michael S. Wolf

Professor

Northwestern University

研究点 (2)

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