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

Not Applicable

Completed

• Conditions: Polypharmacy
• Interventions: Behavioral: TEAM Strategy

• Registration Number: NCT04575155
• Lead Sponsor: Northwestern University

Brief Summary

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.

Detailed Description

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-09-30
• Study First Submitted QC: 2020-09-30
• Study First Posted: 2020-10-05
• Study Start: 2020-10-23
• Primary Completion: 2022-10-31
• Study Completion: 2022-10-31
• Results First Submitted: 2023-09-14
• Status Verified: 2024-11
• Results First Submitted QC: 2024-11-18
• Last Update Submitted: 2024-11-18
• Results First Posted: 2024-11-26
• Last Update Posted: 2024-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 119

Inclusion Criteria

Not provided

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Exclusion Criteria

1. Severe, uncorrectable vision
2. Hearing impairments
3. Cognitive impairment (as measured by the 6-item screener)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TEAM Strategy	TEAM Strategy	Patients randomized to the TEAM intervention arm will receive at least one call from a Walgreens pharmacist to help them with their complex Rx regimens. Pharmacists will have read/write EHR access with established Epic security points. 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. After the pharmacist calls the patient for a Comprehensive Medication Review, they 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.The prescriber will make changes to the patient's EHR and/or contact the patient as they see fit.

Primary Outcome Measures

Name	Time	Method
Medication Reconciliation	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.

Trial Locations

Locations (1)

Northwestern University; 🇺🇸 Chicago, Illinois, United States