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

NCT ID: NCT04575155

Last Updated: 2024-11-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 119 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-23
• Study Completion Date: 2022-10-31

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.

Conditions

Polypharmacy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

TEAM Strategy

Intervention Type: BEHAVIORAL

1. Pharmacists will have read/write EHR access with established Epic security points

2. 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.

3. 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.

4. The prescriber will make changes to the patient's EHR and/or contact the patient as they see fit.

Enhanced Usual Care

Patients randomized to enhanced usual care will have the medical record available to a Walgreens pharmacist with 'read only' access. All patients at the five targeted health centers already have read-only access in place. This means the Walgreens pharmacist will have the capability to review a patient's record as necessary. The pharmacist may refer to the EHR as needed and in a reactive manner; such as if a patient were to request a medication requiring review for billing purposes (i.e. verify insurance, prior authorizations), or if a patient safety concern was raised (e.g. potential drug-drug or drug- disease interaction, therapeutic duplication, etc.). Similarly, read only EHR access means pharmacists must continue to use existing communication channels (e.g. phone, fax) to contact prescribers.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

TEAM Strategy

1. Pharmacists will have read/write EHR access with established Epic security points

2. 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.

3. 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.

4. The prescriber will make changes to the patient's EHR and/or contact the patient as they see fit.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Exclusion Criteria

1. Severe, uncorrectable vision

2. Hearing impairments

3. Cognitive impairment (as measured by the 6-item screener)

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gordon and Betty Moore Foundation

OTHER

Sponsor Role: collaborator

Walgreens

INDUSTRY

Sponsor Role: collaborator

ACCESS Community Health Network

OTHER

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Michael S. Wolf

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Northwestern University

Chicago, Illinois, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

8036

Identifier Type: -

Identifier Source: org_study_id