Development & Pilot of the Technology-Enabled Alliance for Medication Therapy Management
Phase: NA
Conditions: Polypharmacy
Sponsor: Northwestern University

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PROTOCOL TITLE:  Development & Pilot of the Technology-Enabled Alliance for Medication 
Therapy Management (TEAM)
PRINCIPAL INVESTIGATOR:
Michael Wolf, PhD MPH
Stacy Bailey, PhD MPH
General Internal Medicine
General Internal Medicine
750 N Lake Shore Dr. 
750 N Lake Shore Dr.
10th Floor
10th Floor
Chicago, Il 60611
Chicago, IL 60611
(312) 503-5592
(312) 503-5595
mswolf@northwestern.edu
stacy-bailey@northwestern.edu 
VERSION DATE:
 July 25, 2022
 
STUDY SUMMARY:
Investigational Agent(s) 
(Drugs or Devices)
IND / IDE / HDE # 
Indicate
Special Population(s)
 Children 
 Children who are wards of the state 
 Adults Unable to Consent  
 Cognitively Impaired Adults 
 Neonates of Uncertain Viability 
 Pregnant Women 
 Prisoners (or other detained/paroled individuals) 
 Students/Employees 
Sample Size
120 adults
Funding Source
Gordon and Betty Moore Foundation
Indicate the type of consent 
to be obtained
Written 
Online
Verbal/Waiver of Documentation of Informed Consent
Waiver of HIPAA Authorization 
Waiver/Alteration of Consent Process  
Site
 Lead Site ( For A Multiple Site Research Study)
 Data Coordinating Center (DCC)
Research Related 
Radiation Exposure
Yes 
 No 
DSMB / DMC / IDMC
Yes 
No
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Contents
1.0
Objectives ....................................................................................................4
2.0
Background..................................................................................................4
2.1
Major Consequence of MCC: Polypharmacy...............................................................4
2.2
Patient Perspective: Challenges of Self-Managing Complex Rx Regimens. .........5
2.3
Primary Care Perspective: Challenges of Managing Older Adults with MCC.........5
2.4
Pharmacy Perspective: Challenges of Serving Adults with MCC.............................6
2.5
Solution: Linking Primary Care to Community Pharmacies.......................................6
2.6
TEAM Conceptual Framework .......................................................................................7
2.7
A Patient Perspective on Rx Use...................................................................................7
2.8
Behavioral Theories Guiding TEAM..............................................................................8
2.9
A Healthcare System Perspective.................................................................................8
3.0
Study Endpoints...........................................................................................8
4.0
Study Intervention........................................................................................8
4.1
TEAM Intervention Arm ...................................................................................................8
4.2
Medication Review by Telephone..................................................................................9
4.3
Clinical   Decision   Support ...........................................................................................10
5.0
Procedures Involved ..................................................................................10
5.1 
Performance Sites:.........................................................................................................10
5.2
Phases of the Project.....................................................................................................11
5.3
Study Arms......................................................................................................................12
5.4
Randomization & Blinding.............................................................................................13
5.5
Measurement ..................................................................................................................13
5.6
Process Evaluation ........................................................................................................15
6.0
Data and Specimen Banking .....................................................................16
7.0
Sharing Results with Participants ..............................................................16
8.0
Study Timelines .........................................................................................16
9.0
Inclusion and Exclusion Criteria.................................................................16
9.1
Inclusion Criteria.............................................................................................................16
9.2
Exclusion Criteria............................................................................................................17
10.0
Vulnerable Populations..............................................................................17
11.0
Participant Population(s)............................................................................17
12.0
Recruitment methods.................................................................................17
12.1
Identification of potential participants ......................................................................17
13.0
Compensation for Participation in Research Activities ..............................19
14.0
Withdrawal of Participants .........................................................................19
15.0
Risks to Participants ..................................................................................19
16.0
Potential Benefits to participants................................................................19
17.0
Data Management and Confidentiality.......................................................20
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17.1
Analysis Plan...............................................................................................................20
17.2
Protocol to ensure confidentiality.............................................................................21
17.3
Quality Assurance. .....................................................................................................22
17.4
Study-wide data management..................................................................................22
18.0
Provisions to Monitor the Data to Ensure the Safety of Participants .........22
18.1
Data Safety and Monitoring Board (DSMB) ...........................................................22
19.0
Provisions to Protect the Privacy Interests of Participants.........................22
20.0
Compensation for Research-Related Injury – N/A.....................................23
21.0
Economic Burden to Participants – N/A.....................................................23
22.0
Consent Process........................................................................................23
22.1
Process to Document Consent in Writing...............................................................23
23.0
Non-English Speaking Participants............................................................24
24.0
Protected Health Information (PHI and HIPAA).........................................24
25.0
Qualifications to Conduct Research and Resources Available..................25
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1.0
Objectives
We 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. Our specific aims are to:
Aim 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.
Aim 2
Explore patient, healthcare provider (pharmacist, prescriber), community pharmacy 
and/or primary care practice barriers to implementation.
Aim 3
Determine the costs of the TEAM intervention from both a community pharmacy and 
primary care practice perspective.
2.0
Background
Primary care practices in the U.S. are increasingly challenged to manage the growing number of 
patients living with multiple chronic conditions (MCC). More than a quarter of adults have MCC, 
and this dramatically increases with age. Compared to adults with only one or no chronic health 
condition, those with MCC have worse clinical outcomes, poorer physical function and mental 
health, higher healthcare utilization, including a greater risk of hospitalizations and readmissions, 
worse quality of life, and increased mortality risk. This is clearly detrimental to our healthcare 
system; according to a 2014 AHRQ report, 71% of U.S. healthcare spending is allocated to patients 
with MCC. Not surprising, multiple studies have found a gradient trend in healthcare expenditures, 
with annual outpatient costs increasing with each additional chronic condition. A 2017 study by 
Soni et al. found older adults with MCC had nearly twice the out-of-pocket costs than older persons 
with one or no chronic health condition
2.1
Major Consequence of MCC: Polypharmacy
With such a high prevalence of MCC, it is not surprising to see similar trends in the proportion of 
patients challenged with polypharmacy; most commonly defined as taking ≥5 Rx medications. 
Polypharmacy has dramatically increased 3-fold over the past several years. Among adults age 45-
64, one in five contend with polypharmacy, while >40% of individuals over 65 are self-managing 
complex Rx regimens. These patients are at increased risk for adverse drug events (ADEs), drug 
interactions, inadequate adherence, poorer functional health status (including fall risk), and worse 
chronic disease outcomes.
Adverse Events. Adverse drug events (ADEs) are defined as “any injuries 
resulting from medication use, including physical harm, mental harm, or 
loss of function.” Medication errors refer to “any mistake made by a provider 
or patient that occurs during the process of medication use.” Medication 
errors do not always result in an ADE, but often impact treatment 
effectiveness. Medication errors in ambulatory care are more likely to occur 
in primary vs. specialty care settings, among older patients, and among 
those with MCC.
Inadequate Adherence. Adherence-related problems are estimated to cost 
the US healthcare system up to $300 billion a year, compromising the 
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effectiveness and safety of a patient’s treatment and leading to >125,000 deaths annually. Yet half 
of older patients living with chronic conditions take <80% of prescribed doses. While adherence 
barriers are varied and often depend upon the treatment in question, a number of key root causes   
have   been   identified   across   multiple  contexts   (Table  1); polypharmacy and regimen 
complexity is one of the most frequently cited barriers.
2.2
Patient Perspective: Challenges of Self-Managing Complex Rx Regimens. 
Patients prescribed multiple drugs face many challenges, such as variable Rx fill dates, 
forgetfulness, and cost concerns. All of these may keep patients from filling prescriptions on 
time. Patients also struggle to organize and take daily regimens; studies by our team and others 
have repeatedly shown older patients often misunderstand Rx instructions and overcomplicate 
medication schedules (Figure 3). Yet patients rarely receive explicit guidance from physicians 
or pharmacists on appropriate Rx use. When patient education is given, it is often for a single 
drug as opposed to a full regimen. As a result, patients are unclear on how to organize and 
simplify daily dosing for multiple drugs to support adherence and safe medication use. This is 
increasingly difficult with older age, due to memory lapses, health complications, poor self-
efficacy, and fatigue.
2.3
Primary Care Perspective: Challenges of Managing Older Adults with MCC
Primary care practices, especially FQHCs, contend with diverse patient populations, particularly 
in terms of age and health status. Yet these practices have limited resources to support more 
complex patients. Clinic visit times are typically brief, and patient education and care coordination 
services are minimal compared to subspecialty practices that focus on single conditions. While 
patient-centered medical homes offer more comprehensive services, this reflects a small minority 
(~18%) of primary care settings.
A number of challenges have become increasingly apparent as primary care providers face a 
rising number of older adults taking complex Rx regimens. First, as the number of medications 
prescribed to a patient increases, so does the potential for medication errors, drug-drug 
interactions and ADEs. Problems with inadequate medication reconciliation in ambulatory care 
further complicates this; estimates indicate that 3 out of every 4 patients in ambulatory care may 
have inaccurate medication lists in the EHR. Such inaccuracies increase the risk of inappropriate 
prescribing, as providers have an incomplete picture of which medications the patient is actually 
taking. Finally, medication adherence is rarely assessed systematically in routine primary care, 
which leaves providers questioning whether the root cause of patients not achieving therapeutic 
goals is biologic failure of the Rx regimen or poor self-care. Prior studies have found clinicians 
have difficulty identifying and addressing medication-related concerns, and few clinical resources 
exist to support and monitor patients’ Rx use at home. Poor adherence and other medication 
challenges often go unrecognized and untreated.
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Beyond medication, there is the general criticism that the U.S. healthcare system and our 
evidence-based guidelines do not properly address MCC, but are focused on single conditions 
alone. While primary care providers bear the burden of managing the many health problems of 
these patients, current delivery models lack continuity of care, may not have efficient provider-
provider communication channels (especially if subspecialists are not within the same health 
system, as is true for many FQHCs serving vulnerable populations), and struggle to address 
psychosocial barriers to self-management and find available community resources for referral.
2.4
Pharmacy Perspective: Challenges of Serving Adults with MCC
Community pharmacies also face challenges when providing medication services to older 
patients with complex Rx regimens. An estimated 300 prescriptions are filled daily in U.S. retail 
pharmacies; community pharmacists rarely have time or resources to counsel patients, despite 
state and federal mandates. Even if counseling is provided, it is often incomplete, as most 
pharmacists do not have access to patients’ medical records and therefore lack essential 
information needed to inform counseling (i.e. indication for use, clinical notes). It is also rare for 
pharmacists to be aware of patients’ entire regimen as patients may fill prescriptions at multiple 
pharmacies to reduce costs. This makes it increasingly difficult for pharmacists to identify 
potentially dangerous drug-drug interactions or to provide counseling on a patient’s entire regimen 
instead of a single medication alone. Finally, poor communication channels between community 
pharmacies and primary care practices complicates care coordination; pharmacists often must 
communicate with physicians via fax or phone if a medication safety concern is identified or further 
information is needed to fill a prescription. This can be onerous, and often leads to problematic 
delays.
2.5
Solution: Linking Primary Care to Community Pharmacies
We will address many of these challenges by connecting community pharmacies to primary care 
so they may provide comprehensive medication therapy management for older adults with 
complex Rx regimens. Our 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 (‘ACCESS’)) 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 
TEAM strategy enables a pharmacist to help patients on complex Rx regimens via:
Medication Review by Telephone. A Comprehensive Medication Review (CMR) is when a 
pharmacist reviews with a patient their entire list of medications that they are taking and 
prescribed. Pharmacists will call patients to conduct a CMR. Pharmacists will be able to 
document and communicate patients’ medication challenges for review and action by 
primary care providers. A CMR will:
ensure the primary care physician knows all medications the patient is taking 
(reconciliation)
investigate if patients are taking medication as prescribed, in a safe manner (proper use)
monitor and detect any drug-related adverse effects (ADEs) (surveillance)
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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)
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).
Clinical Decision Support. 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. This may pertain 
to potential issues regarding discrepancies in the medication list, drug-drug or drug-disease 
interactions, therapeutic duplication, patient report of ADEs or inappropriate dosing, Rx 
discontinuation, or inadequate adherence and reasons why (e.g. cost, forgetfulness). Specific 
recommendations will be included to expedite action.
2.6
TEAM Conceptual Framework
The TEAM strategy represents a coordinated healthcare system response to a very challenging set 
of patient behaviors, specific to the self-management of complex Rx regimens. Thus, our 
conceptual framework first deconstructs what is required of patients to properly adhere to and 
sustain Rx treatment; to reduce harm and achieve optimal benefits. However, many of these 
common patient challenges have root causes that are healthcare system-based. Our TEAM 
intervention reflects potentially scalable changes to primary care and community pharmacy 
practices that can reduce cognitive demands of daily Rx use, monitor patients, mobilize care teams, 
promote safe Rx use and adherence, and improve chronic disease outcomes.
2.7
A Patient Perspective on Rx Use
In their Model of Medication Self-Management, Drs. Bailey and Wolf break down the process of 
successfully managing a multi-drug regimen using a health literacy perspective into 6 steps. For 
patients to gain the benefits of drug therapy, they must: 1) fill prescriptions in a timely manner, 2) 
understand Rx instructions, 3) organize and consolidate their regimen to the most efficient, safe 
daily schedule, 4) take each medication as prescribed, 5) monitor Rx use and report any side 
effects or concerns to their provider, and 6) sustain use over time. Studies have repeatedly shown 
patients have problems performing these cognitively-demanding tasks, especially as regimen 
complexity increases and patients get older; both patient and health system barriers likely impact 
proper use. With more informed pharmacists, TEAM can improve patient engagement and regimen 
use.
2.8
Behavioral Theories Guiding TEAM
While non-adherence can be unintentional, failure to take drugs appropriately can also result from 
patients’ deliberate choices. Beyond cost, extensive research has identified important determinants 
that can influence Rx use, such as attitudes or beliefs towards the efficacy of drugs, social 
influences (e.g. family and friends) and low self-efficacy.
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2.9
A Healthcare System Perspective
The many struggles many patients face when contending with polypharmacy and complex daily 
Rx schedules, can in large part be attributed to the manner in which services are provided in 
primary care and pharmacy settings; these are the targets of the TEAM strategy. From a health 
system perspective, TEAM is guided by the Chronic Care Model, which has served as a practice 
standard for thinking about how healthcare systems could improve their approach to addressing 
the increasing numbers of individuals with MCC. It is an organizational approach for preparing 
primary care to manage the care needs of individuals by implementing practical, supportive, 
evidence-based patient-healthcare provider interactions. The underlying premise of this model is 
that the current health system structure is not adequately equipped to manage chronic disease, as 
primary care providers and services are typically time-
limited, lacking in care coordination and any capacity 
to proactively follow-up with patients to optimize 
outcomes and prevent harm. Higher quality healthcare 
is achieved through specific transformations within 
existing 
health 
systems 
and 
more 
productive 
interactions with other healthcare organizations and 
the community served (such as with a community 
pharmacy). The TEAM intervention integrates and 
coordinates 
available 
resources 
at 
community 
pharmacies serving patients from primary care 
practices, bringing the pharmacist into the care team 
for older adults with complex Rx regimens and 
maintaining productive interactions with the primary 
care provider to support clinical decision making and 
provide feedback on patients’ regimen use. 
3.0
Study Endpoints
The primary study endpoint will be the completion of all 
analysis of the Aims.  A secondary study endpoint will be when all patient interviews are completed 
(n=120).
4.0
Study Intervention
4.1
TEAM Intervention Arm
Read/write EHR access with established Epic security points will be granted by ACCESS to 
Walgreens, with permission to more fully access the EHR only for those patients who have 
consented to the study and are specifically randomized to the TEAM study arm. These 
individuals will be referred to a designated Walgreens pharmacist using a report issued by the 
Walgreens Research Analytics Team, which will include Proportion of Days Covered (PDCs) for 
prescribed medications in the following therapeutic medication classes: hyperlipidemia, 
hypertension, diabetes, multiple sclerosis, hepatitis C, and HIV. Pharmacists will also be able to 
view a patient’s record (e.g. problem list, medication list, visit diagnoses, clinic notes, orders, 
etc.) and, with write access, Walgreens pharmacists will be able to initiate medication 
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reconciliation activities, including adding notes in their medication list for the prescriber, 
requesting the removal or discontinuation of prescribed drugs that patients report they are no 
longer taking and adding medications omitted from the ACCESS primary care provider’s list. Any 
medications added by the pharmacist will appear in the chart as “Patient-reported”. Any addition 
of medications or notes to the medication list, will require the acknowledgment of the prescribing 
physician (Epic security point #282). The pharmacist will also be granted the capability of adding 
clinic notes and secured messaging to prescribers (Epic security point #77). For direct 
communications, as with notifying a prescriber of an unfilled order, a secured EHR inbox 
message will be sent by the pharmacist. This was viewed by ACCESS and Walgreens as the 
best means for getting the immediate attention of a prescriber. Figure 6 depicts the TEAM 
Intervention work flow. Specific TEAM activities and their timing are described below: 
4.2
Medication Review by Telephone
The Walgreens Research Analytics Team will be notified of all patients randomized to the TEAM 
intervention on a weekly basis. They will then generate an Adherence Report for all medications 
in the predetermined six therapeutic medication classes, which will include rolling 12 month PDC 
per medication. This Adherence Report will be sent directly to the Walgreens pharmacist prior 
to initiating the CMR by phone. S/he will retrieve contact information for the patient via the EHR 
and attempt to initiate an introduction via telephone, wherein the pharmacist will explain his/her 
role, and establish a time (on the introductory call or scheduled for a later date) to perform a 
medication review. This is estimated to take between 10-45 minutes, depending on the size and 
complexity of the patient’s regimen. The pharmacist will begin by reconciling the Epic EHR 
medication list with the patient, matching up what the patient is currently taking, what has 
been discontinued by a prescriber, what is still prescribed but the patient is not taking (and why), 
and identifying any omissions. Each medication will be reviewed, either in the list or 
identified by the patient, including a brief review of how patients take the medicine to ensure safe 
use. Patients will also be probed on whether they are experiencing any symptoms that could be 
signs of an adverse drug event (ADE). Pharmacists will 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), and assess patients’ adherence. If missed doses or 
premature discontinuation is reported, problems (e.g. cost, forgetfulness) will be discussed and 
assistance offered (e.g. synchronization requests, pill box, reminders).
Pharmacists will document the CMR in real-time based on current practices and chart in the 
EHR afterwards (add any new medications to the medication lists, send secure messages to 
providers, create clinic notes). Any medications proposed to be added or discontinued from the 
medication list will be flagged and accompanied by a clinic note, requiring the prescriber to 
acknowledge the note and update the list. The pharmacist also will have the option in Epic to mark 
in the medication list if the patient reports not taking it at this time even though it is prescribed 
(e.g. intentional non-adherence). Any proposed reconciliation of the medication list will be 
accompanied by a highlighted note/justification in the EHR. In a similar manner, secured Epic 
EHR in-basket messages will be sent to prescribers if an ADE or serious side effect is detected, 
or premature discontinuation of a medication is reported. The pharmacist will generate an overall 
summary of the CMR, including any clinical recommendations or commentary on patient 
adherence, in a clinic note, which will populate as a patient encounter in the chart. Ideally, the 
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CMR will be completed one month post baseline interview and will take place before the follow-
up interview conducted at two months.
Additional contact may be made if the Walgreens pharmacist were to discover a patient was 
recently hospitalized or if serious adherence concerns were detected from pharmacy fill data (see 
below). 
At 6 months, the Walgreens Research Analytics Team will send an additional Adherence Report 
for patients in the TEAM intervention to the community pharmacist. The pharmacist will review 
the report and if a patient has poor adherence for at least one medication, they will initiate 
Therapy Management Review (TMR). This is a call from the pharmacist to the patient checking 
in specifically about the medication(s) for which they have poor adherence. After the TMR call, 
the pharmacist will create notes and send an in-basket message to the prescriber as necessary.
4.3
Clinical   Decision   Support
The   Walgreens   pharmacist   will   provide   timely notifications via secured Epic messaging 
direct to prescribers via the EHR of any patient concerns, based on either 1) pharmacy 
information (e.g. medications ordered by other prescribers, fill data), 2) patient report during 
phone-based encounter, or 3) pharmacist review of patient record. This may pertain to potential 
issues regarding discrepancies in the medication list, potential drug-drug or drug-disease 
interactions, therapeutic duplication, report of ADEs or inappropriate dosing, premature Rx 
discontinuation, inadequate adherence, and reasons why (e.g. cost, forgetfulness). 
Recommendations will be included to expedite a prescriber response.
TEAM components were designed with primary care workflow constraints in mind. Clinic 
staff roles are not modified given limited bandwidth. Instead, community pharmacists will be able 
to initiate medication reconciliation services and more directly communicate with and mobilize the 
medical team.
5.0
Procedures Involved
Our team will build, implement, and field test the TEAM strategy through a partnership between a 
large, multi-site FQHC (Access Community Health Network; ‘ACCESS’) in Chicago and 
Walgreens. 
5.1 
Performance Sites:
ACCESS. Access Community Health Network has been on the frontlines of community-based 
health care in Cook and DuPage counties for 25 years, serving the health needs of underserved 
communities by providing preventive care, chronic disease management, and other support 
services. In 2017, ACCESS served more than 183,000 individuals, including 26,117 patients with 
hypertension and 16,923 patients with diabetes. The patient population is low income and 
racially/ethnically diverse. ACCESS uses the Epic EHR platform (Verona, WI).
Walgreens Co. For 7+ years, our team has partnered with Walgreens on projects centered on 
innovations, medication therapy management (MTM), and partnerships with primary care. In 2018, 
Dr. Wolf (MPI) coordinated a master research agreement between Northwestern and Walgreens. 
We are one of few academic partners formal collaborating with Walgreens through their Center for 
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Health and Wellbeing Research. With >8,000 stores in the US (heavily populated in medically 
underserved areas), Walgreens ranks as the largest retail community pharmacy chain.
The following five ACCESS Health Centers have collocated Walgreens community pharmacies 
and current read-only access for Walgreens pharmacists in place:
1.
ACCESS Grand Boulevard
2.
ACCESS Genesis
3.
ACCESS Hawthorne
4.
ACCESS La Villita
5.
ACCESS Madison
The TEAM intervention will be rolled out initially at the Hawthorne and Genesis sites. If needed, 
the pilot will be rolled out at the Grand Boulevard, La Villita, and/or Madison site. The intervention 
will be rolled out as follows: Walgreens pharmacists will be notified of the enrollment of a patient in 
the intervention by the Walgreens Research Analytics Team. Each pharmacist will conduct 2-3 
CMRs a week at these locations. For this pilot, we will be using trained community pharmacists 
and possibly community pharmacist residents.
5.2
Phases of the Project
The following activities will be performed during the proposed project, by phase:
Design Phase (months 1-9)
1. Organize Northwestern-Walgreens-ACCESS team; establish project milestones, roles.
2. Convene all stakeholders (primary care providers, Walgreens pharmacists and leadership) 
to gather feedback on the initial draft standard operating protocol (SOP) for the 
implementation of TEAM in ACCESS clinics, leveraging Walgreens pharmacists will be 
developed. This is an iterative process with all TEAM users. 
3. Amend existing Walgreens-ACCESS agreements to include new Epic read/write access, 
given the parameters established by the mutually-agreed upon SOP. This includes the 
specification of set security points within the ACCESS EHR (Epic) that both allows and 
controls pharmacist permissions. Our Northwestern team has already worked with ACCESS 
and Walgreens to detail the TEAM protocol (see section 4.0 study intervention). 
4. Devise an implementation evaluation battery capturing process outcomes and also a range 
of patient-reported medication safety-related outcomes. 
Implementation phase (months 10-30) 
5.
‘Beta test’ the TEAM strategy in the clinical environment to confirm the functionality of all 
bi-directional information sharing components. 
6.
Trouble shoot any technical/procedural concerns, modifying the SOP accordingly. 
7.
Orient participating ACCESS clinical sites and Walgreens staff on the final SOP in 
preparation for the live implementation to be conducted in the second project phase. 
8.
Implement the finalized TEAM intervention protocol defined in the Design Phase at 
ACCESS clinic sites. The strategy includes Walgreens pharmacist outreach with identified 
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ACCESS patients to: a) perform medication reviews, b) generate automatic and tailored 
EHR-based alerts; c) provide clinical decision support. 
9.
Enroll 120 patients into the pilot study. 
10. Randomize patients (1:1) to either: 1) the TEAM intervention or 2) enhanced usual care.
11. Conduct baseline (by phone) and 2 month follow-up interview (by phone) with enrolled 
patients. Interviews will include validated measures and will be completed using RedCAP 
software for data quality and safety. Data will also be abstracted from patient EHR records 
at 12 months post-enrollment.
Evaluation Phase (months 31-36)
12. At the completion of the Implementation Phase, conduct structured telephone or in-person 
interviews (as appropriate) with Walgreens pharmacists and its leadership who were 
involved in the TEAM project to capture their project-specific experiences, perceptions of 
benefits, challenges, and other constructive feedback leading to necessary modifications.
13. Collect and merge all pertinent data sources (EHR), Walgreens, pharmacy records, patient 
report (qualitative and quantitative), perform quality assurance activities in preparation for 
formal analyses. 
14. Conduct details analyses in response to Aims 1-3. 
15. Share preliminary analyses with ACCESS, Walgreens and study team.
5.3
Study Arms
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 an ACCESS patient’s record as necessary. ‘Read only’ permissions are 
becoming more commonplace with increased adoption and linkage of health information 
technologies between healthcare organizations. While this health information exchange presents 
opportunity for a pharmacist to engage patients in a more informed manner for MTM, existing 
pharmacy practice workflows will remain unchanged. Pharmacists will not have dedicated effort 
to perform MTM. While they are not prevented from proactively engaging with patients to perform 
medication reviews or contacting ACCESS prescribers to share information, it is a rare 
occurrence due to workflow. At present, 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. These channels can be onerous and inefficient. 
Intervention: TEAM strategy. See section 4.0 Study Intervention. 
5.4
Randomization & Blinding. 
Patient-level randomization will occur within ACCESS health centers. At each site, participants 
will be randomized via a 1:1 scheme to intervention or ‘enhanced usual care’ (N=120; n=60 per 
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arm) in randomized block sizes of 4 or 6 using SAS PROC PLAN. We will blind personnel 
involved in statistical analyses (Ms. Curtis, Ms. Batio) and also the principal investigators (Bailey, 
Wolf) and coinvestigators. Site project managers and RCs will have access to study arm 
assignments to initiate TEAM components to those randomized to receive them.
Limitations to Randomization Scheme. As a ‘diffuse’ intervention that addresses patients and the 
health system (ACCESS), we recognize prescribers at ACCESS sites will be caring for patients 
in both study arms of our trial. While there may be risk of potential contamination, our extensive 
experience working in time-constrained, resource-limited FQHC practices would suggest this to 
be of minimal concern. Other randomization options, either by clinic or by prescriber, are more 
problematic. FQHC practice sites are heterogeneous, and also have prescribing clinicians that 
work across sites. Our team strongly felt that patient-level randomization, wherein we could also 
control the receipt or withholding of TEAM services under study, was the most formidable, 
pragmatic approach. 
5.5
Measurement
Outcomes and covariates collected during study visits are described below:
Patient Characteristics. During interviews, RCs will collect patient socio-demographic and health 
characteristics (including comorbidity and health status) and will administer brief measures of 
social support, anxiety and depression (PROMIS), and health literacy (3-item screener). These 
measures have been used in prior studies by our team, are validated, and have been shown in the 
scientific literature to influence medication use. 
Regimen Characteristics. At each interview, RCs will review the medication list in the patients’ 
EHR and those reported by patients. We will use a structured protocol from prior studies to 
identify medications no longer taken and as well as those prescribed but not on the list. Final 
medications will be grouped by drug class. Regimen complexity will be calculated using the 
validated Medication Regimen Complexity Index.
Intermediary Outcomes. We will assess a series of intermediary outcomes designed to determine 
if the TEAM strategy can reduce patient burden and challenges associated with medication self-
management and increase patient engagement in care. Specifically, the Healthcare Task 
Difficulty (HCTD) scale, an 8-item measure in which patients rate difficulty of particular healthcare 
tasks (e.g. administering medications) will be administered, along with the Treatment Burden 
Questionnaire (TBQ). The TBQ assesses the workload of being a patient and its effect on quality 
of life, and is composed of 15 items measuring burden associated with treatment self-
management (e.g. taking medicine and following doctors’ advice), issues related to healthcare 
visits including laboratory tests, arranging appointments, and costs. We will also assess health 
management related to financial barriers and different tools that may help a patient take their 
medication. Finally, we will measure self-efficacy using the Self-Efficacy for Managing Chronic 
Disease tool, a widely-used 6-item scale and patient engagement via our team’s validated tool, 
the Consumer Health Activation Index (CHAI). We will assess patient experience by asking 
questions on interactions with their provider, pharmacist, and specifically about the TEAM 
intervention.
Effectiveness Outcomes. 
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Healthcare provider counseling
We will ask patients (yes/no) whether their prescriber/nurse/pharmacist counseled them about 
their medications. We will also ask the Health Literacy supplemental items of the Consumer 
Assessment of Health Providers Survey (CAHPS) to evaluate the extent and quality of provider 
verbal counseling on Rx medications. 
For the outcomes described below, we only include chronic Rx medications. Though we 
document them, we exclude PRN or limited duration drugs, as adherence concerns are different. 
All of these measures have been used in multiple studies by our team; results have been 
published extensively.
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.  
Medication knowledge. Medication-specific knowledge will be measured through a series of 
open-ended questions, capturing patients’ knowledge of each of their medication’s: 1) indication 
for use and 2) risks, warnings or potential side effects. Answers will be qualitatively reviewed and 
independently scored as correct/incorrect by two RCs according to medication information 
provided from ACCESS and Walgreens For any that the RCs do not have information on or any 
with discordance between RCs, a pharmacist will qualitatively review and independently score  
as correct/incorrect. 
.
Medication dosing errors. We will use a 24-hour recall procedure utilized extensively by this team 
in prior and current studies to assess Rx dosing errors. At each interview, RCs will review 
medications reported as taken by the patient and those listed in the EHR to create a final list of 
medications prescribed to the patient. RCs will then ask patients to report, one by one, how they 
took each medication over the past 24 hours. Patients will be asked to specify the amount taken 
(i.e. dose) and when taken (to determine frequency and interval between doses). Patients will be 
asked to report whether this was how the medication was prescribed, and if not, will be queried: 
1) to determine the reason for not taking the medication as prescribed (i.e. forgetfulness, ran out 
of medication) and 2) to describe how the medication should be taken. Data from this exercise 
will be used to assess correct dosing (yes/no) based upon the instructions for each medication. It 
will also be used to calculate regimen consolidation, or the total number of time points throughout 
the 24-hour period that a patient reported taking one or more medicines (count variable, range: 1-
24).
Medication adherence. Adherence will be measured using: 1) the Ask-12 survey and 2) the 
proportion of days covered (PDC) according to pharmacy records. The Ask-12 is a brief measure 
of adherence that covers three domains: inconvenience/forgetfulness, treatment beliefs and 
behavior. In prior studies, the tool demonstrated good internal consistency reliability (Cronbach's 
α 0.75) and test-retest reliability (intraclass correlation 0.79); convergent validity was also 
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demonstrated through correlations with multiple other measures (Morisky, SF-12) and pharmacy 
claims data. Ask-12 scores range from 12-60, with higher scores indicating poorer adherence. 
PDC will be calculated by summing the number of days’ supply obtained by a patient during a 
given time period and dividing by the number of days for which the medication was prescribed. 
For each patient, we will assess adherence within drug class. If a patient fills a prescription for a 
drug and switches to another drug within the same class, all prescriptions will be summed in the 
numerator. Adherence will be treated continuously and dichotomously (yes/no;  PDC at disease-
specific threshold based on Pharmacy Quality Alliance (PQA) standards).  PDC data will be 
automatically obtained from Walgreens as part of the TEAM study.
Clinical Markers. We will abstract relevant clinical markers (e.g. HBA1c for patients with 
diabetes, LDL cholesterol for patients with hypercholesterolemia, blood pressure for patients with 
hypertension). Multiple blood pressure measures will be averaged for analyses in accordance 
with current protocols.
5.6
Process Evaluation
We will determine whether the TEAM intervention was implemented as planned (Aim 2) and 
barriers/facilitators to implementation (Aim 3) to optimize the intervention for future dissemination. 
Mixed methods will be employed to obtain data on intervention implementation. We will capture 
data from 5 sources: 1) patients, 2) ACCESS EHR, and 3) pharmacies and staff. 
Patients receiving the TEAM intervention will be asked to report whether they were contacted by 
Walgreens for a medication review and if it was useful (1-10 scale). Patients will be asked about 
their satisfaction with each aspect of the intervention (1-10 scale), whether they refused (yes/no) 
and why. If applicable, they will be asked if clinic staff contacted them to resolve regimen issues 
(yes/no) and to rate the quality of these interactions (1-10 scale; CAHPS).
Data from the EHR will be compared to determine whether adherence concerns were properly 
captured in the EHR (yes/no) and if a clinic response was documented (yes/no). Walgreens fill 
data will be utilized to document timeliness/completion of prescriptions. 
We will conduct focus groups and/or individual interviews with up to 5 participating Walgreens 
pharmacists and pharmacy staff to explore barriers and facilitators to implementing the TEAM 
intervention. All focus groups/interviews will be audio-recorded and transcribed. All participants 
will give informed online consent prior to participation. We will pay pharmacists who complete 
these interviews $150 in a Visa gift card sent a physical copy via mail or and electronic copy via 
email.
Cost Evaluation. 
Throughout the trial, we will track explicit costs of implementing the TEAM intervention, from 
multiple sources (clinics, provider, community pharmacies, patient).
6.0
Data and Specimen Banking
Upon completion of all study activities, a final de-identified dataset will be created. This dataset 
will be stored indefinitely on the GIM server for secondary analyses.  Only authorized personnel 
will have access to the dataset.
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7.0
Sharing Results with Participants
Study results will not be shared with participants or anyone else. 
8.0
Study Timelines
We anticipate the entire study will take 3 years to complete. The design phase will consist of a nine 
month window to finalize legal arrangements, an operational protocol and design and development 
of the evaluation tools. The implementation phase will occur between months 10-30. During this 
time, a brief pilot study (2-3 months) will finalize materials before the full implementation of the 
TEAM approach at ACCESS sites, recruiting 120 adults. Participants will be enrolled during a 20 
month window and followed for a 12-month period. The evaluation phase will occur for the final 6 
months of the study (months 31-36). During this time, quantitative and qualitative data will be 
collected from a variety of patient and provider sources to determine the extent to which the TEAM 
approach was delivered, as well as the impact on clinical workflow and patient outcomes. 
Individual participants will be screened for eligibility (data pulls from ACCESS to identify new 
patients done on a quarterly basis) and if recruited and enrolled, will be active study participants 
for up to 6 months (baseline phone interview, TEAM intervention (if randomized to intervention 
arm) within 1 month of baseline, follow up phone interview at 2 months, potential TMR at 6 months), 
with a final EHR data pull completed 12 months post-baseline. 
9.0
Inclusion and Exclusion Criteria
In order to participate in this study, patients must meet the following eligibility criteria:
9.1
Inclusion Criteria
Patients meeting inclusion criteria 1-5 below will be identified through ACCESS EHR data pulls on 
a quarterly basis. For those who qualify for the study based on these pulls, Northwestern RCs will 
contact these patients by phone to complete an initial phone screener during which time they will 
confirm criteria 1, 2, 5, and 6 as well as ensure that they do not meet any exclusion 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
9.2
Exclusion Criteria
We will further refine the list of eligible patients during the screening and consent process to 
exclude those with:
1) Severe, uncorrectable vision
2) Hearing impairments
3) Cognitive impairment (as measured by the 6-item screener)
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10.0 Vulnerable Populations
Adults unable to consent and prisoners will be excluded from this research.
11.0 Participant Population(s)
Accrual 
Number:
Category/Group:
(Adults/Children 
Special/Vulnerable 
Populations)
Consented:
Maximum Number to be 
Consented or 
Reviewed/Collected/Screened
Enrolled:
Number to Complete 
the Study or Needed 
to Address the 
Research Question
120
120
120
Local
120
120
120
Study-wide
Total:
120
120
120
12.0 Recruitment methods
12.1
Identification of potential participants
Prior to putting the intervention into production, providers and staff at all participating health centers 
will be oriented to the project. The study will be described to physicians at participating clinics.  The 
Epic data pull will generate lists of their potentially eligible patients (by primary language, 
established ACCESS patient, age, # Rx taken, existing on-site Walgreens customer). Physicians 
will receive the list via an inbox message within the EHR; they will indicate if any identified patients 
should not be contacted. Patients deemed ineligible by providers will be removed from the list of 
patients to contact.
12.2 Recruitment procedure 
Due to COVID-19, there need to be multiple recruitment methods in place in order to do what works 
best for ACCESS and their health centers, especially since research staff may still be working 
remotely and not logistically able to perform large recruitment mailings. Therefore, the two 
recruitment methods in place are recruitment calls and/or recruitment letters. For the first two 
weeks of the pilot, we will perform recruitment calls. We will reassess after two weeks to determine 
if we should continue with the recruitment calls or switch to mailing recruitment letters. Regardless 
of whether the initial patient recruitment occurs via phone or mail, all recruitment activities will be 
conducted by CITI-certified ACCESS and Northwestern Research Coordinators (RCs).
Recruitment Calls
An ACCESS RC will call patients identified through the Epic patient pull to read through the 
recruitment letter over the phone. The RC can also email a copy of the recruitment letter if the 
patient would like to review it. During the call, the RC will read a script that clearly explains that if 
they are interested, a RC from Northwestern will call them the following week to see if they are 
eligible for the study and to go through the consent form for this study at that time. The ACCESS 
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RC will obtain verbal permission from the patient to allow a RC from Northwestern to contact them 
about the research study. 
If the patient answers and agrees to being contacted by the Northwestern RC, the ACCESS RC 
will add that patient to the list that will be sent to NU. If the patient answers and would like to opt 
out, the ACCESS RC will remove the patient from the list. If the patient does not answer, the RC 
will leave a voicemail for the patient. The ACCESS RC will make up to four attempts by phone to 
recruit the patient before categorizing them as a passive refusal and removing them from the 
patient list. 
At the end of the week, the ACCESS RC will send a list of patients that agreed to be contacted to 
Northwestern. The Northwestern RC will then screen the patient to determine eligibility (English or 
Spanish-speaking, responsible for administering medication regimen, taking 5+ medications, 
prescribed at least one medication from any of the selected six therapeutic classes (confirmed via 
brief chart review), no severe cognitive, hearing, visual impairment). If eligible, the RC will obtain 
informed online or verbal consent at the end of the call. If the patient is unable to stay on the phone 
to consent, the RC will schedule a follow up call to consent the patient before the baseline will be 
done. During the screening and consent call, the Northwestern RC will schedule the call to conduct 
the baseline assessment and randomize the patient to study arm. Prior to the baseline interview, 
the Northwestern RC will conduct a more thorough review of the patient medication list through 
either receiving a file from ACCESS or through read ability in EPIC for patient charts. 
 
Recruitment Letters
An ACCESS RC will mail a letter to patients remaining on the list, notifying them that a RC from 
Northwestern University will be phoning to invite them to participate in a study. Patients will have 
the opportunity to opt out of being contacted. Ten days after the mailing, the Northwestern RC will 
start to contact patients by phone to ask if they would be interested in participating. If interested, the 
RC will screen the patient to determine eligibility (English or Spanish-speaking, responsible for 
administering medication regimen, taking 5+ medications, prescribed at least one medication from 
any of the selected six therapeutic classes (confirmed via brief chart review), no severe cognitive, 
hearing, visual impairment). If eligible, the RC will obtain informed online or verbal consent at the 
end of the call. If the patient is unable to stay on the phone to consent, the RC will schedule a 
follow up call to consent the patient before the baseline will be done.  During the screening and 
consent call, the Northwestern RC will schedule a phone interview to conduct the baseline 
assessment and randomize the patient to study arm. Prior to the baseline interview, the 
Northwestern RC will conduct a more thorough review of the patient  medication list through either 
receiving a file from ACCESS or through read ability in EPIC for patient charts. 
Training will begin after questionnaire and interview protocols have been refined and standardized. 
The PIs and project manager will lead sessions to orient the research staff to the surveys and study 
protocols (e.g., interview process, use of laptop PCs, data security). All interviewers will be required 
to demonstrate competence in survey administration.  All interviews will be conducted via REDCap, 
a secure, web-based application.  Recruitment outcomes along with identifiable data necessary to 
contact participants will be recorded in NU’s REDCap. Interviews will be conducted by research 
coordinators (RCs) over the phone. RCs will read each question aloud and record patient 
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responses directly onto a password protected laptop or PC computer using REDCap.  Study 
interview data does not contain any identifiable information, and are identified by project staff by 
an assigned study ID. All identifiable information will remain in the secure REDCap system.  
Contacts with enrolled participants will be made via email, USPS and telephone.
13.0 Compensation for Participation in Research Activities
Patients will receive incentives for study visits ($50 gift card or money order for baseline and a $50 
gift card or money order for 2 month follow up phone call). Compensation will be mailed to the 
patient’s home address.
14.0 Withdrawal of Participants
In the case that subjects are unresponsive for 6 months past the date their follow up interview was 
due, they will be labeled as ‘lost to follow up’ and will be withdrawn from the study.   
Participants can choose to withdraw from the study at any time. If a participant chooses to withdraw 
from the research, any data collected up until the point of withdrawal will still be utilized as it will 
not include identifying information.
15.0 Risks to Participants
Participation in the study poses minimal risk of psychological, social and economic harm. Informing 
subjects in advance that they may decline to answer any questions asked during the interview and 
discussion group will mitigate any risks associated with expressing their opinions (e.g., feeling 
uncomfortable). They will also be assured they can terminate their participation in the study at any 
time without penalty. The risk/benefit ratio is low. Minimal to no risk is expected for subjects in this 
study. 
16.0 Potential Benefits to participants
It is possible that subjects enrolled in the intervention study arms may directly benefit in that they 
may have, as a result of this study, a better functional understanding of their medication. The results 
of this study may provide important information regarding how strategies can be implemented via 
the EHR and enhanced provider and pharmacist communication to support safe and appropriate 
medication use. 
17.0 Data Management and Confidentiality
17.1
Analysis Plan
All analyses will be performed in SAS v9.4 (SAS Institute, Cary, NC).  Ms. Batio will perform 
analyses under the direct supervision of Ms. Curtis and Drs. Wolf and Bailey.
Aim 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.
Quantitative analyses will be performed using SAS v9.4 (SAS Institute, Cary, NC). To ensure 
adequate balance across treatment arms, baseline outcomes and potential confounders 
including socio-demographic characteristics, comorbidities, regimen complexity, health literacy 
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level will be compared using ANOVA models and χ2 tests, as appropriate. Variables found to 
have significant differences (p < .05) across treatment groups will be entered as covariates in 
the generalized linear mixed models (GLMMs) used for formal analyses as described below. 
Treatment arm will serve as the primary independent variable. Analyses will be performed using 
PROC GLMMIX in SAS (v.9.4). A binary variable will be included in the model to denote the 
intervention group vs. usual care. As we will use stratified  randomization by site, we will include 
in the GLMM an indicator variable for site and any potential confounding covariates noted in the 
descriptive studies. For outcomes assessed for each medication, 2-level GLMM will be used with 
medications nested in participants. Additionally, as there may be some effect of provider on 
adherence, we will explore the effect of any PCP by including provider as a random-effect. Using 
similar models as described above, we will assess the impact of TEAM on clinical markers 
(HBA1c, blood pressure, cholesterol) among patients with diabetes and hypertension.
Aim 2. Explore patient, healthcare provider (pharmacist, prescriber), community pharmacy and/or 
primary care practice barriers to implementation. 
We will determine the extent to which the TEAM intervention was implemented as planned at each 
site in order to optimize the intervention for future dissemination opportunities. Mixed methods 
will be employed using a convergent parallel design to obtain data on intervention 
implementation. Quantitative and qualitative findings will be synthesized together to yield a more 
comprehensive understanding of: 1) whether the interventions were implemented as planned; 2) 
if (and how) the TEAM intervention might be modified based on user feedback. In this approach, 
both analyses are conducted separately and synthesized for side-by-side data comparisons. For 
quantitative data (patient report, EHR, pharmacy data), frequencies will be generated to determine 
outcomes related to receipt of notifications and feedback and perceived helpfulness of TEAM 
processes. Similar GLM models as described in Aim 1 analyses will be performed, with TEAM 
intervention arm as the primary independent variable.
For qualitative data, the study team will review common themes found throughout the pharmacist 
interviews drawn from the discussion guide and the pharmacists responses. We will use an 
iterative approach to identify and group emergent themes. Pharmacist quotes will be identified to 
highlight themes.  Attention will be paid to facilitating factors and impeding factors identified during 
the interviews. An additional layer within impeding factors would be whether or not factors are 
modifiable, and under facilitating factors, if they are replicable.
Aim 3. Determine the costs of the TEAM intervention from both a community pharmacy and 
primary care practice perspective.
We will directly measure and assess the costs of developing and running the TEAM intervention. 
The incremental cost of both strategies will be estimated relative to usual care and each other 
from both the perspective of the FQHC sites and the Walgreens pharmacies delivering the MTM 
services. The primary resources for running TEAM include from pharmacy: 1) Walgreens 
pharmacist time for contacting patients, conducting medication reviews, documentation, 
messaging prescribers; 2) Walgreens clinical analyst to program adherence reports. Resources 
to implement TEAM from the primary care practice include: 3) discrete ACCESS programming 
time for linking Walgreens pharmacies with read/write access; 4) clinic orientation to the newly-
available TEAM process and available safety  alerts and adherence data, and training on how to 
respond. The costs of the pharmacist, analyst time (for both ACCESS and Walgreens) are easily 
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documented. For costs associated with staff training, estimates will be made, with sensitivity 
analyses performed assuming orientations performed by staff at varying levels of experience 
based on internal data on wages as well as nationally representative estimates from the Bureau 
of Labor Statistics.
We will also include estimates for the cost of programming maintenance at each site for the Epic 
EHR, testing the sensitivity of results to changes in maintenance requirements (in programmer 
hours) along with internal data on wages. Costs associated with diverted time and changes to 
workflow to attend to alerts and messages from the pharmacist will also be estimated, as well as 
changes in the efficiency within a pharmacy due to more rapid communication channels with 
prescribers. Development costs for software and other programming will be separately tracked. 
Staff/programmer costs will be measured using tracked time spent on the intervention and wage 
estimates. We will test the sensitivity of operational costs to different assumptions about potential 
use of variable staff using different salaries but assuming the same proficiency in time required. We 
will also assess the sensitivity of estimates to different proficiency levels that could arise from 
learning by doing. 
17.2
Protocol to ensure confidentiality.
Each subject will be tracked using an Access database. The database, containing identifiers and 
other related information for coordinating research activities (recruitment outcome, interview call 
log and interview visit schedule, etc.) will be kept on the secure Northwestern network drive. Only 
the PI, project manager, and RC will have access to this database. ACCESS participants will be 
additionally tracked in their EPIC EMR system, only accessible by ACCESS study personnel.
Data will be collected via REDCap. REDCap is a secure, encrypted online data collection tool, 
which can only be access by NU authorized personnel listed on the project’s IRB. 
Several methods will be employed to reduce the risk of breach of confidentiality. A study 
identification number will be assigned to each subject in the study. The research data collected 
and stored will have the study identification number and no other identifying information on it. The 
de-identified study data will be kept in a separate locked file cabinet. Using this method, if someone 
were to gain illegal access to the locked filing cabinet with study data, they would have no way to 
link this data to any identifying information. 
17.3
Quality Assurance. 
Training will begin after surveys and interview protocols have been refined and standardized. A 
training session will be conducted by Drs. Wolf and Bailey. The training will include tailored 
discussion of 1) roles and responsibilities; 2) HIPAA and IRB mandates (completion of Human 
Subjects Training Program - CITI; 3) effective recruitment communication and interviewing with 
attention paid to health literacy and culture; and 4) gathering and recording data including 
administering the structured survey electronically.  Role playing will be used to fine tune training 
for obtaining informed consent and interviewing patients.  Institutional Review Board (IRB) approval 
will be attained at both sites prior to any active recruitment efforts.  All interviewers will be required 
to demonstrate competence in survey administration.
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17.4
Study-wide data management.
Data collected includes patient consent forms, data gathered using the ACCESS patient lists, and 
data collected during the study interviews. 
Data Access. The Data Custodian is the Principal Investigator, Dr. Michael Wolf.  Only authorized 
personnel listed on each institutions IRB will have access to the data.  Any information that could 
allow identification of individual participants, including the master list, will be kept strictly 
confidential. 
Local Data Storage. Data will be stored in REDCap, a secure, web-based application, and on the 
Northwestern secure server for the length of the study. The Project Manager or Data Analyst will 
download the de-identified data only from REDCap monthly and save to the “Analytic” folder within 
the TEAM project folder on the FSM department servers which are located in a HIPAA compliant 
data center. These data files do not contain any identifiable information, and are identified by 
project staff by an assigned study ID. All identifiable information for ACCESS patients will remain 
in the secure REDCap system. Upon completion of all study activities, a final de-identified dataset 
will be created and all identifiable information will be deleted. This dataset will be stored indefinitely 
on the GIM server for secondary analyses. Only authorized personnel will have access to the 
dataset. All identifiable information will be deleted upon completion of the study 
18.0 Provisions to Monitor the Data to Ensure the Safety of 
Participants
18.1
Data Safety and Monitoring Board (DSMB)
This study involves no greater than minimal risk. Due to this, we will not be convening a DSMB for 
this study.  
19.0 Provisions to Protect the Privacy Interests of Participants
19.1
Information about study subjects will be kept confidential and managed according to the 
requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). In order 
to preserve participants’ confidentiality rights, research subjects will be assigned code numbers 
that will be used to identify all the information collected. Using these codes, none of the collection 
forms will contain the names of the participants. All electronic data will be stored in on a password-
protected computer. A Microsoft Access master study tracking database will contain information 
linking participants to their study id numbers. This database will be encrypted and kept on a secure 
server and only accessible by study personnel. 
19.2
Survey data will be stored in a REDCap. Individual study identification numbers will be 
assigned to each participant and only this number will appear on the survey. Subjects will be told 
that unless required by law, only the study investigators, members of the project staff, the funding 
agency and representatives of Institutional Review Boards will have the authority to review any 
study records. In such cases, these parties too will be required to maintain confidentiality. The final 
data set will be stripped of identifiers. Data will be shared via presentations at national and 
international meetings and in peer reviewed publications. Furthermore, all results will be shared 
with the funding institute.
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19.3
Participation in the study poses minimal risk of psychological, social and economic harm. 
Informing subjects in advance that they may decline to answer any questions asked during the 
interview will mitigate any risks associated with expressing their opinions (e.g., feeling 
uncomfortable).
19.4
All enrolled participants will provide e-consent, include HIPAA authorization for the 
collection of all data, including review of the patient’s medical record. For those who are unable to 
provide e-consent due to inability to access the required technology, they will undergo verbal 
consent with an alteration of HIPAA Authorization, as described below in sections 22.0 and 24.0.  
19.5
Only authorized personnel listed on each institutions IRB and approved by the PI will have 
access to the data.
20.0 Compensation for Research-Related Injury – N/A
21.0 Economic Burden to Participants – N/A
22.0 Consent Process
22.1
Process to Document Consent in Writing 
Due to COVID-19 in-person interview restrictions, we will complete an online consent with HIPAA 
authorization and complete the baseline by phone after consent is obtained. The RC will send 
patients a link to REDcap either by email or text to be able to read through the consent with the 
RC following the protocol below. If the patient agrees to participate, they will be asked to sign and 
date the online consent. 
If a patient is unable to complete an online consent due to inability to use or access technology 
for online consent, we request a waiver of documentation of informed consent and an alteration 
to obtain verbal HIPAA Authorization. Due to restrictions during the COVID-19 pandemic, we are 
no longer planning to conduct any in-person interviews to protect patients’ safety and to follow 
Northwestern guidelines. Research cannot practicably be conducted without the waiver or 
alteration. For patients that are unable to complete online consent, research cannot practicably 
be conducted without the waiver or alteration. After verbal consent and HIPAA Authorization is 
obtained, the consent date and the name of the research coordinator that obtained the consent 
will be recorded in Redcap by the RC prior to starting the baseline interview. 
Informed online and verbal consent will be viewed as a process, i.e. at several times during 
review of the IRB approved consent document, the subject will be asked to explain in his/her own 
words what his/her understanding of the consent. This will enable the research personnel to enter 
into a dialogue with the subject and ensure that the subject understands that he/she is free to 
withdraw at any time without penalty. Information will be provided to the subjects in terms that 
they can fully understand. There will be no exertion of any overt or covert coercion. They will be 
encouraged to ask questions prior to giving consent.
The participant will be informed that they are free to withdraw at any time without penalty and all 
information will be provided to the subjects in terms that they can fully understand. Once the RC 
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is satisfied that the participant understands the consent process and the nature of their 
participation in the research study, the RC will ask the participant if they would like to participate 
in the study. 
 
For online consents, patients will be informed they can print their screen to keep a copy of the 
consent. For patients that complete a verbal consent, they will be emailed or mailed a blank copy 
of the consent document for their records.
23.0 Non-English Speaking Participants
All study materials are available in both English and in Spanish and our RCs are bilingual. We have 
included Research Support Services as part of the grant to provide Spanish translations for 
materials that have yet to be created. Patients who do not speak either Spanish or English will be 
ineligible to participate. Patients will be asked their language of choice as they are consented. 
Research coordinators will be able to conduct all interviews and schedule phone calls in either 
language. Pharmacists delivering the intervention will do so in the patient’s preferred language. 
24.0 Protected Health Information (PHI and HIPAA)
24.1
Information about study subjects will be kept confidential and managed according to the 
requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). In order 
to preserve participants’ confidentiality rights, research subjects will be assigned code numbers 
that will be used to identify all the information collected. Using these codes, none of the collection 
forms will contain the names of the participants. All electronic data will be stored in on a password-
protected computer. A Microsoft Access master study tracking database will contain information 
linking participants to their study id numbers. This database will be encrypted and kept on a secure 
server and only accessible by study personnel. 
Survey data will be stored in a REDCap. Individual study identification numbers will be assigned to 
each participant and only this number will appear on the survey. Subjects will be told that unless 
required by law, only the study investigators, members of the project staff, the funding agency and 
representatives of Institutional Review Boards will have the authority to review any study records. 
In such cases, these parties too will be required to maintain confidentiality. The final data set will 
be stripped of identifiers. Data will be shared via presentations at national and international 
meetings and in peer reviewed publications. Furthermore, all results will be shared with the funding 
institute.
24.2 
All enrolled participants will provide either  e-consent or verbal consent, which will include 
HIPAA authorization for the collection of all data, including review of the patient’s medical record. 
For patients who are unable to provide e-consent and signed HIPAA Authorization, we are 
requesting an alteration of HIPAA Authorization in order to obtain HIPAA Authorization verbally. 
These patients would otherwise be unable to participate in this research study and therefore this 
research could not practicably be conducted without this alteration in place. Only authorized 
personnel listed on each institutions IRB and approved by the PI will have access to the data.
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Due to restrictions during the COVID-19 pandemic, we are no longer planning to conduct any in-
person interviews to protect patients’ safety and to follow Northwestern guidelines. If a patient is 
unable to complete an online consent due to inability to use or access technology for online 
consent, we request a waiver of documentation of informed consent and an alteration to obtain 
verbal HIPAA Authorization. For these patients that are unable to complete online consent, 
research cannot practicably be conducted without this waiver or alteration. After verbal consent 
and HIPAA Authorization are obtained, the consent date and the name of the research 
coordinator that obtained the consent will be recorded in Redcap by the RC prior to starting the 
baseline interview.
As this research could not practicably be conducted without the waiver or alteration of HIPAA, it 
could also not practicably be conducted without access to and use of PHI. The main intervention 
component of this study involves a pharmacist reviewing the patient’s medications with them and 
making notes (with EPIC security points in place) in their EHR for the patient’s provider to see. It 
would not be feasible to conduct the study and implementation of the intervention without the 
access and use of PHI.  
Identifiers and other related information for coordinating research activities (recruitment outcome, 
research interview call log and interview visit schedule, etc.) will be password protected and kept 
on the secure FSM network drive. Only the PI, project manager, and RAs will have access to this 
database. Identifiers included in the database include: name, MRN, address, phone number, 
DOB. Upon completion of all study-related data collection the Access database will be deleted. 
Study generated data will be stored within REDCap and OneDrive and will be downloaded (void 
of all identifiers) into the project’s Analytic folder on the FSM server. Upon completion of the 
study, a final dataset, void of all identifiers will be created, and stored indefinitely for secondary 
analyses.
PHI will not be used or disclosed to a third party except as required by law, for authorized 
oversight of the research study, or for other research uses and disclosures permitted by the 
Privacy Rule. 
25.0 Qualifications to Conduct Research and Resources Available
25.1 
Team. Drs. Wolf and Bailey, as well as Dr. Parker (Co-Investigator) are internationally 
recognized for their expertise and extensive work in the space of health literacy, medication safety 
and adherence. For more than a decade, Drs. Wolf and Bailey have collaborated and co-led 
numerous NIH, AHRQ, foundation and industry-sponsored pragmatic trials testing health system 
interventions aimed at helping patients better understand, safely use, and adhere to complex 
prescription regimens. Combined, Drs. Wolf, Bailey and Parker have more than 200+ peer-
reviewed publications addressing safe medication use. Dr. Tarn (UCLA) is a member of the study 
team for her medication communication and clinical expertise, as well as her assistance in creating 
opportunities for dissemination within the UCLA Epic platform. Her involvement will facilitate more 
rapid dissemination opportunities and learnings. 
Over the past 3 years, Dr. Wolf has worked to establish a master research agreement with 
Walgreens Co., which is now in effect as of Spring 2018. The goal of the agreement is to allow for 
more expedited project opportunities with Northwestern that support improvements in both medical 
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and pharmacy practices. Drs. Wolf and Bailey, along with Northwestern Memorial Healthcare’s 
Epic Innovations Team, are also leaders in leveraging electronic health records to promote patient 
engagement, medication therapy management, and follow-up opportunities (via portal and other 
modalities) for monitoring medication use, adherence and mobilizing clinical teams if regimen 
concerns arise. In addition to the unique strengths of the Northwestern team and Emory partner, 
Walgreens Co. is one of the largest community pharmacy chains in the world, and the only ‘global’ 
pharmacy with its Walgreens Boots Alliance. The potential for scale is unprecedented. Further, 
Walgreens team members have successfully worked with Dr. Wolf over the past 7 years.
ACCESS also has ample experience working with the Northwestern team, with partnerships with 
Drs. Wolf and Bailey dating back nearly two decades. As one of the largest FQHCs in the country, 
the diversity in their patient population and focus on medically underserved adults offers an 
exceptional environment to test the TEAM strategy and its ability to benefit disparities-affected 
populations.
25.2 
Health Centers. Performance sites will be health care centers affiliated with Access 
Community Health Network. All ACCESS health centers use Epic® EHR (version 2016; Verona, 
WI) to promote quality improvement; Drs. Bailey and Wolf have collaborated extensively in the past 
on EHR-based research projects and have worked on many research studies and proposals with 
ACCESS key personnel. 
ACCESS. Access Community Health Network has been on the frontlines of community-based 
health care in Cook and DuPage counties for 25 years, serving the health needs of underserved 
communities by providing preventive care, chronic disease management, and other support 
services. In 2017, ACCESS served more than 183,000 individuals, including 26,117 patients with 
hypertension and 16,923 patients with diabetes. The patient population is low income and 
racially/ethnically diverse. ACCESS uses the Epic EHR platform (Verona, WI). Data queries 
indicate ~3,900 potentially eligible patients at our six study sites (by age, ≥5 Rx medications, and 
using Walgreens as their primary pharmacy). 
Clinic Space, Orientation and Workflow. Dr. Lazar will coordinate activities and plan space 
needs with clinic liaisons for patient recruitment and study visits. A patient flow chart will be 
developed to detail optimal timing of intervention delivery, recruitment and data collection. All study 
clinics will receive onsite orientation to the study during regularly scheduled business meetings. 
Dr. Lazar will work with clinic liaisons to plan protocol responses to patient regimen issues (e.g. 
discrepancies, ADEs, adherence) communicated to them by the pharmacist.  
25.3
Walgreens. For 7+ years, our team has partnered with Walgreens on projects centered on 
innovations, MTM, and partnerships with primary care. In 2018, Dr. Wolf (MPI) coordinated a 
master research agreement between Northwestern and Walgreens. We are one of few academic 
partners formally collaborating with Walgreens through their Center for Health and Wellbeing 
Research. With >8,000 stores in the US (heavily populated in medically underserved areas), 
Walgreens ranks as the largest retail community pharmacy chain.
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