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

Polypharmacy Clinical Trial

— TEAM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04575155
• Other study ID #: 8036
• Status: Completed
• Phase: N/A
• Start date: October 23, 2020
• Est. completion date: October 31, 2022

Study information

• Verified date: February 2023
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: October 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

1. Patient is age 50 and older

2. Patient is English or Spanish speaking

3. Patient has established care at one of the involved ACCESS health centers (defined as 1 visit within 18 months)

4. Patient is an existing Walgreens customer (had 1 or more medications filled at collocated Walgreens pharmacy within past 12 months)

5. 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

6. Patient is primarily responsible for administering own medication

Exclusion Criteria:

1. Severe, uncorrectable vision

2. Hearing impairments

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

Related Conditions & MeSH terms

• Polypharmacy

Intervention

Behavioral:
• TEAM Strategy
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.

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (4)

Lead Sponsor	Collaborator
Northwestern University	ACCESS Community Health Network, Gordon and Betty Moore Foundation, Walgreen Co.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication Reconciliation	At each interview, commissions (medications listed in the EHR and the patient reported not taking) and omissions (patient reported medications not in the EHR) will be calculated based on medication lists and patient self-report.	Baseline-2 months