Polypharmacy
Conditions
Keywords
Medication Adherence
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.
Interventions
BEHAVIORALTEAM 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.
Sponsors
Gordon and Betty Moore Foundation
Walgreens
ACCESS Community Health Network
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 60 |
| 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. | 58 |
| Total | 118 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 2 Month | Ineligible | 1 | 0 |
| 2 Month | Lost to Follow-up | 5 | 3 |
| 2 Month | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Enhanced Usual Care | Total | TEAM Strategy |
|---|---|---|---|
| Age, Continuous | 60.7 years STANDARD_DEVIATION 6.3 | 60.8 years STANDARD_DEVIATION 60 | 61.0 years STANDARD_DEVIATION 7.4 |
| Interview Language English | 26 Participants | 54 Participants | 28 Participants |
| Interview Language Spanish | 32 Participants | 64 Participants | 32 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 17 Participants | 34 Participants | 17 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 39 Participants | 79 Participants | 40 Participants |
| Sex: Female, Male Female | 29 Participants | 65 Participants | 36 Participants |
| Sex: Female, Male Male | 29 Participants | 53 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 61 | 0 / 58 |
| other Total, other adverse events | 0 / 61 | 0 / 58 |
| serious Total, serious adverse events | 0 / 61 | 0 / 58 |
Outcome results
Primary
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.
Time frame: Baseline-2 months
Population: Participants were excluded from the analysis if they were lost to followup at the 2months post baseline.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| TEAM Strategy | Medication Reconciliation | 0.14 number of discrepancies per medication |
| Enhanced Usual Care | Medication Reconciliation | 0.17 number of discrepancies per medication |