Trial Outcomes & Findings for Development & Pilot of the Technology-Enabled Alliance for Medication Therapy Management (NCT NCT04575155)

NCT ID: NCT04575155

Last Updated: 2024-11-26

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

119 participants

Primary outcome timeframe

Baseline-2 months

Results posted on

2024-11-26

Participant Flow

Participant milestones

Participant milestones
Measure
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.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.
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.
Baseline
STARTED
61
58
Baseline
COMPLETED
61
58
Baseline
NOT COMPLETED
0
0
2 Month
STARTED
61
58
2 Month
COMPLETED
54
54
2 Month
NOT COMPLETED
7
4

Reasons for withdrawal

Reasons for withdrawal
Measure
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.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.
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.
2 Month
Withdrawal by Subject
1
1
2 Month
Lost to Follow-up
5
3
2 Month
Ineligible
1
0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
TEAM Strategy
n=60 Participants
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.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.
Enhanced Usual Care
n=58 Participants
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.
Total
n=118 Participants
Total of all reporting groups
Age, Continuous
61.0 years
STANDARD_DEVIATION 7.4 • n=5 Participants
60.7 years
STANDARD_DEVIATION 6.3 • n=7 Participants
60.8 years
STANDARD_DEVIATION 60.0 • n=5 Participants
Sex: Female, Male
Female
36 Participants
n=5 Participants
29 Participants
n=7 Participants
65 Participants
n=5 Participants
Sex: Female, Male
Male
24 Participants
n=5 Participants
29 Participants
n=7 Participants
53 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
Race (NIH/OMB)
Asian
1 Participants
n=5 Participants
1 Participants
n=7 Participants
2 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
17 Participants
n=5 Participants
17 Participants
n=7 Participants
34 Participants
n=5 Participants
Race (NIH/OMB)
White
40 Participants
n=5 Participants
39 Participants
n=7 Participants
79 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
1 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
Interview Language
English
28 Participants
n=5 Participants
26 Participants
n=7 Participants
54 Participants
n=5 Participants
Interview Language
Spanish
32 Participants
n=5 Participants
32 Participants
n=7 Participants
64 Participants
n=5 Participants

PRIMARY outcome

Timeframe: Baseline-2 months

Population: Participants were excluded from the analysis if they were lost to followup at the 2months post baseline.

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.

Outcome measures

Outcome measures
Measure
TEAM Strategy
n=54 Participants
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. 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.
Enhanced Usual Care
n=54 Participants
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.
Medication Reconciliation
0.14 number of discrepancies per medication
Interval 0.08 to 0.23
0.17 number of discrepancies per medication
Interval 0.1 to 0.29

Adverse Events

TEAM Strategy

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Enhanced Usual Care

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Michael Wolf

Northwestern University

Phone: (312) 503-5592

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place