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Completed

NCT Number: NCT04575155

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

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University

Chicago, Illinois, 60611, United States

About this study

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:

  • Ensure the primary care physician knows all medications the patient is taking (reconciliation)
  • Investigate if patients are taking medication as prescribed, in a safe manner (proper use)
  • Monitor and detect any drug-related adverse effects (ADEs) (surveillance)
  • 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)
  • 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.

The aims of this investigation are to:

  • 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.
  • Explore patient, healthcare provider (pharmacist, prescriber), community pharmacy and/or primary care practice barriers to implementation.
  • Determine the costs of the TEAM intervention from both a community pharmacy and primary care practice perspective.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • Patient is age 50 and older
  • Patient is English or Spanish speaking
  • Patient has established care at one of the involved ACCESS health centers (defined as 1 visit within 18 months)
  • Patient is an existing Walgreens customer (had 1 or more medications filled at collocated Walgreens pharmacy within past 12 months)
  • Patient is currently prescribed 5 or more Rx medications (excluding antibiotics); that includes at least one medication from any of the following six therapeutic classes of medications: hyperlipidemia, hypertension, diabetes, multiple sclerosis, hepatitis C, and HIV
  • Patient is primarily responsible for administering own medication

Exclusion criteria

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

Treatment and study plan

TEAM Strategy

Behavioral
  • Pharmacists will have read/write EHR access with established Epic security points
  • Pharmacists will initiate medication reconciliation activities by calling the patient for a Comprehensive Medication Review. Pharmacists will add notes in their medication list for the prescriber, requesting the removal or discontinuation of prescribed drugs that patients report they are not taking and adding medications omitted from the provider's list. The pharmacist will provide notifications via secured Epic messaging direct to prescribers of any patient concerns.
  • At 6 month if poor adherence is determined, the pharmacist will initiate Therapy Management Review which is a call from the pharmacist to the patient specifically about the medication(s) for which they have poor adherence. If necessary, the pharmacist will create notes and send an in-basket message to the prescriber.
  • The prescriber will make changes to the patient's EHR and/or contact the patient as they see fit.

Primary outcomes

  1. Medication Reconciliation

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • ACCESS Community Health Network
  • Gordon and Betty Moore Foundation
  • Walgreens

Registry information

Acronym: TEAM

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 5, 2020
Registry last updated
Nov 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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