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

NCT04575155 | Completed Results

• 1 other identifier: 8036
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

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

Conditions

Polypharmacy

Keywords

Medication Adherence

Outcome Measures

Primary Outcomes (1)

• Medication Reconciliation

  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.

  Baseline-2 months

Study Arms (2)

TEAM Strategy

EXPERIMENTAL

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.

Behavioral: TEAM Strategy

Enhanced Usual Care

NO INTERVENTION

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.

Interventions

TEAM Strategy 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.

TEAM Strategy

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

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

Sponsors & Collaborators

• Northwestern University: lead
• Gordon and Betty Moore Foundation: collaborator
• Walgreens: collaborator
• ACCESS Community Health Network: collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Results Point of Contact

• Title: Dr. Michael Wolf
• Organization: Northwestern University

mswolf@northwestern.edu

(312) 503-5592

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 30, 2020
• First Posted: October 5, 2020
• Study Start: October 23, 2020
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: November 26, 2024
• Results First Posted: November 26, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)