Transplant Regimen Adherence for Kidney Recipients by Engaging Information Technologies: The TAKE IT Trial
Phase: NA
Conditions: Kidney Transplant
Sponsor: Northwestern University

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PROTOCOL TITLE: Transplant Regimen Adherence for Kidney Recipients by Engaging 
Information Technologies: The TAKE IT Trial 
 
PRINCIPAL INVESTIGATORS: 
Michael Wolf, PhD MPH 
General Internal Medicine 
750 N Lake Shore Dr.  
10th Floor 
Chicago, Il 60611 
(312) 503-5592 
mswolf@northwestern.edu 
 
Daniela Ladner, MD MPH 
Surgery (Organ Transplantation)  
676 N Saint Clair 
Suite 1900 
Chicago, Il 60611 
(312) 695-1703 
    
dladner@northwestern.edu 
 
VERSION NUMBER: 
Version 10.1 
 
VERSION DATE: 
 Mar 8, 2020 
 
NCT NUMBER: 
 
NCT03104868 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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1.0 
Objectives: 
1.1 
Specific Aims and hypotheses are to: 
Aim 1: Test the effectiveness of the TAKE IT strategy, compared to usual care, to 
improve kidney transplant (KT) recipients’: 
H1: treatment knowledge (indications, potential side effects, demonstrated 
proper use) 
H2: medication use (regimen adherence via self-report, pill count, tacrolimus 
levels) 
H3: transplant-specific outcomes (Δ eGFR, quality of life, re-hospitalization) 
H4: chronic disease outcomes (blood pressure, HbA1c) 
 
Aim 2: Examine the persistence of any effects of the TAKE IT strategy on 
outcomes over 2 years among new and established KT recipients.    
 
Aim 3: Evaluate the fidelity of each component of the TAKE IT strategy over time, 
and investigate any patient, provider, or transplant center barriers to 
implementation.   
 
Aim 4: Determine the costs of delivering the TAKE IT strategy from a transplant 
center perspective. 
 
2.0 
Background:  
2.1 
Kidney Transplantation Benefits Individuals with End-Stage Renal Disease.  
Over 26 million adults suffer from chronic kidney disease, and >400,000 have end-stage 
renal disease (ESRD) leaving them dialysis-dependent.1-3 For many ESRD patients, kidney 
transplantation (KT) is the optimal treatment as it provides longer survival, better quality 
of life, less morbidity, and lower hospitalization rates compared to dialysis.2, 4, 5 It also is 
more cost-effective within 2 years of KT compared to dialysis (~$88,000/year).3 
 
2.2 
KT Recipients Must Manage Complex Prescription Drug Regimens.  
In 2015, 17,000+ individuals received a KT either from a deceased or living donor. Despite 
the advantages, a third of KTs fail within 5 years- mostly due to host rejection of the organ 
(graft).6, 7 To prevent this, KT recipients must adhere to immunosuppressive (IS) 
medication regimens that require constant monitoring of therapeutic levels. Failure to do 
so may result in life-threatening, costly complications. For example, under-
immunosuppression (levels too low) may lead to graft rejection, but over-
immunosuppression (levels too high) increases risks of opportunistic infections and 
malignancies.8 IS-related complications can require costly treatments and hospitalizations. 
The most common IS medications are calcineurin inhibitors (CNIs). While effective, they 
have many side effects (electrolyte derangements, neurological complications, weight gain, 
kidney injury, hypertension, diabetes, cognitive/mood changes).9-11 CNIs may interact with 
other drugs, causing life-threatening complications.11, 12  
 

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From a patient perspective, the narrow therapeutic range of IS medications requires 
constant monitoring via multi-weekly or monthly blood draws to achieve ‘target’ drug 
levels, which leads to frequent dose adjustment. Patients are informed of these medication 
changes often by phone and without written instructions; this increases the risk of 
confusion as existing regimen information and Rx labels become outdated. Patients must 
also precisely time their dosing of IS medications with blood draws for drug levels to be 
accurate. Otherwise, dose adjustments may be incorrect and cause further harm. In addition 
to transplant medications, patients are taking other regimens for comorbid conditions often 
prescribed by multiple healthcare providers.11, 13 According to recent pilot data from 
Northwestern, KT recipients take on average 11 Rx medications. 
 
2.3 
Poor Medication Adherence is Common among KT Recipients.  
Problems with medication adherence have long been linked to a variety of negative 
outcomes in a range of chronic disease states. Half of patients living with diabetes or a 
cardiovascular condition take less than 80% of their prescribed doses.14-17 Adherence-
related problems are estimated to cost the US healthcare system up to $300 billion a year, 
compromising the effectiveness and safety of a patient’s treatment, leading to >125,000 
deaths per year.16 
 
Data specific to transplantation is becoming more robust. Recent meta-analyses identified 
the prevalence of ‘poor’ adherence (<80% of prescribed doses taken) to IS medications to 
be high (~35%) among KT recipients.13, 18-20 The consequences are also clear; Nevins et al. 
found that declining medication adherence immediately after KT significantly increased 
risk and frequency of acute rejection.21 Factors associated with poor adherence were 
minority ethnicity, poorer self-reported health, and less social support, although few studies 
examined these or other factors such as health literacy.18, 22 While existing research on 
medication adherence in KT is limited by methodological weaknesses (unequal length of 
follow up, small sample size, retrospective study design, variability in definition of non-
adherence), problems that have been identified mirror those patients face in other chronic 
diseases. Given the complexity of changing regimens, these challenges may be equal or 
greater in KT.13, 23  
 
Numerous studies have shown that socioeconomically disadvantaged patients, the elderly, 
racial/ethnic minorities, those with less education and limited health literacy are more 
likely to experience medication-related problems.24-28 In fact, evidence suggests that 
inadequate medication adherence may be a root cause of many of the negative health 
outcomes experienced by these vulnerable groups.29, 30 As KT recipients are typically older, 
issues of inadequate health literacy are further compounded by cognitive decline either due 
to age or effects of IS medications. But greater involvement of the patient in healthcare and 
decision-making places greater demands on their health literacy and numeracy skills.31 
Patients with low health literacy are less able to adequately communicate with healthcare 
providers.32 A third of patients with chronic kidney disease have low health literacy.33 In 
this population, low health literacy is associated with minority race, low SES, older age, 
and reduced referral for transplantation.32-34 According to the Agency for Healthcare 
Research and Quality (AHRQ), poor health outcomes are due in part to differences in 
patient-provider communication, and poor health literacy.35 A 2016 study by Covert et al. 

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examined post-transplant processes in care. Patients’ inadequate understanding of 
medications was the strongest predictor of non-adherence and 30-day readmissions.20  
 
2.4 
Preliminary Data: Prevalence of Transplant Adherence and Barriers.  
We recently conducted interviews with 99 KT recipients at Northwestern and Emory 
Universities. 24% of participants had limited literacy. Patients were taking an average of 
11 (SD=4) medications; one third (32%) had a medication change in the past month. 1 in 
4 KT recipients could not demonstrate proper regimen use for IS regimens and 35% were 
poorly adherent based on self-report or by tacrolimus level standard deviation. In 
multivariable analyses, fewer months since transplant and limited literacy were associated 
with poor adherence (all p<0.05). In multivariable models, patients over 65 (OR 2.45, 
95%CI 1.20-4.98), non-white race (OR 2.83, 95% CI 1.54-5.20), demonstrating improper 
regimen use (OR 1.15, 95% CI 1.01-1.30) and inadequate adherence (OR 2.10, 95%CI 
1.10-4.01) had a higher post-transplant hospitalization risk.36, 37  
 
2.5 
Evidence of Medication Adherence Interventions in KT is Limited.  
Few interventions to improve medical adherence have been tested among KT recipients. 
In 2 recent systematic reviews examining behavioral/self-management interventions, one 
broadly in solid organ transplant and the other specific to KT recipients (only 12 studies 
per review), very few had a randomized controlled trial design and/or were rated 
methodologically strong by reviewers.38-41 Interventions utilized various strategies such as 
enhanced education sessions, clinical pharmacist services, and electronic monitoring and 
feedback with mixed results. Low and colleagues highlighted that interventions that 
including support tools to help patients remember to take their medicine, as well as 
monitoring strategies were most effective. Both reviews concluded that evidence of 
effective strategies to promote medication adherence were considerably limited.38, 39 
 
2.6 
Conceptual Framework: Deconstructing and Simplifying Medication Use. 
Patients must take several steps to manage multi-drug regimens; each has unique 
challenges impacting adherence.42 The first is to fill their prescriptions. Failure to fill or 
refill prescriptions is common.43, 44 The ability to name, identify and understand how to 
take medications in one’s Rx regimen is also fundamental, yet often an overlooked, part of 
adherence. This is increasingly difficult as patients’ drugs are frequently changed by 
prescribers and/or switched for generic versions by insurers.45, 46 Additionally, patients 
taking complex regimens may confuse one drug for another.47 Studies conducted by 
members of this team found 75% of patients cannot accurately identify their Rx regimen, 
and almost half (46%) misinterpret dose or timing of a prescription.48, 49 These problems 
have been linked to chronic disease outcomes.48 Studies have also repeatedly shown that 
many patients do not organize multi-drug regimens in the most efficient manner to sustain 
adherence.50-53 Next, a fundamental part of adherence is actually taking the medication. 
Many adherence measures only focus on this step.54, 55 But then patients must be vigilant 
and be aware of potential safety concerns and thus monitor regimen use in order to identify 
symptoms and seek appropriate action prior to an adverse event.56 Studies by this team 
found that 54% of patients struggle to comprehend common warnings associated with 
medicines, and <10% routinely attend to this information.57, 58 The final step is to sustain 
safe and appropriate medication use over time. Medications taken to treat chronic 

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conditions are often taken for a lifetime. Patients must come to terms with the need to 
constantly take medications, despite life events, attitudes and beliefs about medications.16 
 
Adapting Health Systems via the Health Literate Care Model.  
Koh et al. proposed a ‘Health Literate Care Model’ (derived from Wagner Care Model), 
which guides health systems in making targeted changes in the delivery of services to better 
engage patients in their care.59 This is necessary, as improving health relies equally on 
patient and provider participation. But many patients have ‘limited health literacy’ and face 
difficulty when attempting to understand their health, act on medical instructions, and 
participate in self-care. Following this model, our intervention assumes all patients have 
information needs, large or small and could benefit from greater support around taking 
prescribed regimens. The Health Literacy Care Model, much like the Care Model60, 
emphasizes the importance of a systems approach, and encourages changes to a health 
system that increases interactions between patients and providers. TAKE IT imparts the 
Health Literacy Care Model by: 1) implementing patient assessments to acquire feedback; 
2) providing easy-to-understand, actionable medication adherence resources; 3) signaling 
to the transplant team via the EHR when concerns are noted. 
 
Improving the Medication Use Process.  
The Institute of Medicine (IOM) deconstructed the medication use process. There are 
several system failures that are salient root causes of poor adherence, medication errors, 
adverse drug events (ADEs), and sub-optimal treatment benefits. TAKE IT was designed 
to address these failures. At prescribing, problems with medication reconciliation are 
prevalent; as many as 67% of patients have inaccurate medication lists in their record.48, 61 
As a result, clinical decision making is less informed. Further down, counseling should 
coincide with treatment decision-making and ordering. This often does not occur, 
especially for side effects/risks. At Rx dispensing, the same concern for counseling exists. 
During the processes of self-administration and monitoring, our research has repeatedly 
shown a high prevalence of patient misunderstanding & errors.48, 49, 53, 62  
 
2.7 
Transplant Adherence in Kidney recipients by Engaging Information 
Technology.  
Complex problems such as poor medication adherence require multifaceted solutions. Yet 
interventions must also be mindful of health system implementation and dissemination 
considerations in order for them to be sustained over time if found effective. Given the lack 
of available guidance from the literature specific to KT on adherence, we offer an evidence-
based, medication adherence monitoring strategy that can activate available transplant 
center resources to intervene with patients earlier and prevent further complications.  
 
3.0 
Inclusion and Exclusion Criteria:  
3.1 
Methods of screening for eligibility 
Patients will be initially screened for eligibility by the recruitment pulls at both sites. At 
Northwestern, a report will be created in the Electronic Data Warehouse (EDW) to 
identify patients within 24 months of KT, who are over 21 years of age. This report will 
contain the patient name, date of KT, phone number, nephrologist and date of upcoming 
clinic visits. At the Mayo Clinic, this report will be created in the patient database. For 

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subjects at Northwestern, a letter will be mailed to eligible participants on the list, 
notifying them that a research coordinator (RC) will be telephoning to invite them to 
participate in a study. Patients will be given the opportunity to opt out of being contacted 
by calling a hotline number and leaving a message. RCs will monitor the messages and 
remove patients who have chosen to opt out. Seven days after the letters have been sent, 
an RC will call patients who did not opt out to introduce the study, confirm eligibility, 
and screen for cognitive impairment, in alignment with the inclusion and exclusion 
criteria (3.2).  
 
3.2 
Inclusion Criteria. Patients will be screened for eligibility during an initial phone 
screener. They must meet the following eligibility criteria:  
1) Patient is age 21 and older  
2) Patient is within 5weeks-24 months of KT  
3) Patient is English speaking 
4) Patient is primarily responsible for administering own medication 
5) Patient owns a cell phone and is comfortable receiving text messages 
6) Patient has access and proficiency using internet at home 
 
3.3 
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  
 
3.4 
Adults unable to consent, individuals under the age of 21, and prisoners will be 
excluded from this research. 
 
3.5 
COVID-19 Survey Eligibility: 
We will include any participant who has consented to participate in the main study and 
who has indicated that they were willing to be contacted for future studies by Dr. Wolf on 
the consent form.  
 
4.0 
Study-Wide Number of Participants: 
4.1 
700 patients will be eligible to be interviewed (n=350 per site).    
 
5.0 
Study-Wide Recruitment Methods: 
5.1 
Identification of potential participants  
 
Northwestern University 
To identify potential participants, a weekly pull of eligible patients will be reviewed by 
Research Coordinators (RC) at each site. At Northwestern, this report will include patient 
name, date of KT, phone number, address, medical record number (MRN), name of 
nephrologist and date of upcoming clinic visits. At Northwestern, this pull will be 
downloaded from the EDW. RCs will also review the Transplant Clinic Schedule in Epic 
to confirm upcoming appointments in the CTC.  RCs will contact nephrologists to notify 
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After obtaining permission from each nephrologist to contact patients, the Director of the 
Kidney Transplant Program, Dr. Leventhal will provide written permission for RCs to 
contact all eligible kidney transplant recipients for the study.  
 
 
 
 
 
Mayo Clinic 
At the Mayo Clinic, the RC will review transplant reports. With assistance from the nurse 
coordinator, RCs will review patient records to identify patients for potential recruitment 
that meet eligibility criteria.  
 
 
 
5.2 
Initial contact of potential participants 
 
Northwestern University:  
As per Northwestern policy, a letter will be sent to patients from Northwestern University 
detailing the study and notifying them that a research coordinator will be telephoning them 
to invite them to participate in the study. The letter will include a hotline number, which 
patients can call if they do not wish to be contacted for the study. Seven days after the 
letters have been sent, RCs will contact patients who did not opt out to introduce the study, 
to confirm eligibility and provide further information on the study. If the patient is eligible 
and interested, the RC will schedule the baseline interview around an upcoming clinic visit, 
where applicable. RCs will review the Transplant Clinic Schedule in Epic to confirm 
upcoming clinic visits in the CTC.  Written consent will be obtained in person at the 
beginning of the baseline interview.  
As part of a supplementary study leveraging TAKE IT patients (STU00209386), patients 
will be informed that they may be approached by a research coordinator from the 
Comprehensive Transplant Center during their upcoming blood draw and will have the 
option to consent to an additional blood draw. Participants will be informed that they can 
refuse to participate in the blood draw, without affecting their participation in the TAKE 
IT study. If the patient is interested in speaking with the IRB-approved coordinator, the 
patient’s name, date of KT, study ID, and MRN will be shared with the study coordinator 
using a secured Sharepoint platform stored on the FSM drive.  
Mayo Clinic: 
In accordance with Mayo clinic policy, Daily Transplant List Report will be used to screen 
and identify de-novo (6 weeks post KT) subjects from the Mayo Clinic and Schedule 
Reports will be used to identify established (up to 24 months post KT) patients. Research 
Coordinators (RC) from the Mayo clinic will telephone identified patients from list asking 
for their participation and allowing them to opt out from being contacted further. Those 

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who are interested will be scheduled to meet with the RC to go over study requirements 
and provide signed consent.   
 
6.0 
Multi-Site Research:  
6.1 
All research activities will be conducted in the internal medicine ambulatory care 
practices affiliated with Northwestern University’s Feinberg School of Medicine 
(Northwestern Medical Group), Northwestern Medicine Comprehensive Transplant Center 
(NMCTC),  and Mayo Clinic Transplant Center. Together, these sites provide geographic 
and socioeconomic diversity among their patient populations ensuring optimal 
generalizability.  All sites will be involved in the development or protocols and in data 
collection.  Northwestern University will also be the data management site.  
 
All in-person research interviews will take place in a private space within the study clinics 
at NMHC, NMCTC, and Mayo Clinic. Telephone calls with patients will take place in a 
private space at each site.  
The University of Pennsylvania (UPenn) will be home to key research collaborators who 
will be involved in the study design, intervention development, and interpretation of 
results, but will not interact with patients and will not have access to data. Northwestern 
Memorial Health Care (NMHC) will be home to pharmacy collaborators who will be 
involved in the design and content of the intervention. They will also play a role in the 
follow-up component of the intervention.  
Weekly meetings with all sites (Northwestern, Mayo Clinic, UPenn, NMHC) will be held 
throughout the study. This time will be used to discuss progress of the study and any 
changes to the protocol or study battery. The project manager will email any modifications 
to the IRB protocol to the team within one day of receiving approval. The project manager 
will hold weekly meetings with project staff to ensure that the protocol is being followed.  
 
6.2 
All required approvals will be obtained at each site prior to project 
implementation. In addition: 
a. Once IRB approval is obtained at Northwestern University for study materials and 
protocol, Mayo Clinic will be sent approved materials via email.  Northwestern will 
send Mayo Clinic any modifications made to be approved prior to implementation. 
Northwestern and Mayo Clinic will have regular conference telephone calls to discuss 
any problems and interim results, and to discuss any possible changes that need to be 
made to study materials and protocol. 
b. All non-compliance with the study protocol or applicable requirements will be reported 
in accordance with local policy. 
 
7.0 
Study Timelines: 
7.1 
We anticipate the entire study will take 5 years to complete.  See study timeline 
below.  
 

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7.2 
An individual patient will be involved in the study for a total of up to 24 months. 
They will complete a screener enrollment interview via phone, a baseline interview in-
person and a 6-week and 6-month interview via phone. A 12-month and an 18 month 
interview will be conducted either in-person or over the phone*, with the remaining 24-
month interview administered via phone. *If the 12-month interview cannot be done in 
person due to the timing of clinic visits, it will be done over the phone and we will attempt 
to do the 18 month interview in person.  
 
7.3 
We anticipate that patient enrollment will actively take place over 2.5 
years. The date by which we expect to complete primary analyses is March 2021.  
 
 
8.0 
Study Endpoints: 
8.1 
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=700). 
 
 
 

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8.2 
Covariates. 
Patient Characteristics. We will include a socio-demographic/health questionnaire, the 
Tangible Social Support survey to assess the extent/quality of social connections63, 
healthcare support will be measured using the Medication Support Survey. The Brief Test 
of Adult Cognition by Telephone (BTACT) and the Consumer Health Activation Index 
(CHAI) will also be included.66 
 
Literacy Assessment: Newest Vital Sign (NVS). Patients are given a copy of a nutrition 
label and asked 6 questions about how they would interpret and act on the information. 
Scores are classified as high likelihood of limited literacy (0-1), possibility of limited 
literacy (2-3), and adequate literacy (4-6).67  
 
Regimen Characteristics. Self-reported medications will be collected and grouped into 
drug class. These will capture important covariates that may be related to outcomes and 
unequally distributed among randomized subjects. 

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8.3 
Fidelity (Process Measures).  
Receipt of Mobile App reminders. At each follow-up, the RC will ask whether patients 
used the mobile app for medication reminders.  
 
Use of Patient Portal. At each follow-up, the RC will inquire whether patients used the 
portal to complete the monthly adherence assessment. We will obtain data for the number 
of times a patient completes the assessment.  
 
Care Alert Notification. We will review EHR data on care alerts, nurse follow up on portal-
assessed adherence concerns. The RC will also ask patients if they received follow up, by 
whom, and what services were provided.  
 
8.4 
Effectiveness Outcomes. We will collect data on an array of knowledge, 
behavioral, and clinical outcomes. 
 
Medication Adherence. Adherence will be measured using: 1) the Ask-12 Scale that 
assesses general medication attitudes and beliefs,71, 72 2) patient self-report of how many 
pills and how often each medicine was taken over the last 24 hours; 3) in-person and/or 
phone pill count using established guidelines employed by our team [R01HS00167; PI 
Wolf]; 4) a biologic measure using tacrolimus levels. For 24 hour recall, correct dosing 
will be measured as yes/no per drug, having properly shown dose (# pills), spacing (hours 
between doses), frequency (times per day), and total pills/day. For pill count, we will assess 
adherence within drug calls. If a patient fills a prescription for a drug in a class and then 
switches to another drug within the same class, all prescriptions will be summed in the 
numerator. Adherence will be treated both continuously and dichotomously (adherent 
≥80%).82,8374  
 
Biologic Measure. Medication adherence to IS medications will also be assessed by 
computing the standard deviation (SD) of a series of tacrolimus levels obtained for routine 
monitoring using validated methods.75-79 Standard clinical practice at participating centers 
includes routine monitoring of tacrolimus levels. Tacrolimus levels obtained during acute 
illness will not be included in the SD calculation. This schedule should result in >30 levels 
in the first 6 months post KT, 12 levels in months 6-12, 6 levels in months 13-18, 6 levels 
in months 19-24; and 6-8 levels per year after the second year. Laboratory methods for 
measurement of whole blood levels are standardized, which should reduce variability 
between sites. SD calculations will be made using ≥4 levels obtained over 6 months based 
on availability.  A higher SD indicates more variability between individual measures, and 
is highly correlated with less stable medication intake (non-adherence) and graft 
rejection.75-77, 80 A SD of the mean levels of ≥ 2.5 will be indicative of non-adherence.77, 81 
This biologic measure of adherence will be calculated at 6 month intervals to correspond 
to interviews. 
 
Composite adherence measure. Each individual measure of adherence has advantages and 
limitations, thus we will use multiple measures as recommended by experts.16, 82 Maximum 

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likelihood estimation will be used to create a composite adherence metric by generating a 
single factor score from the 5 measures of adherence.  
 
Regimen Knowledge: Patient identification of drug names and indication will be assessed 
via assessments used previously by Dr. Wolf and colleagues (ref). Patients will be asked 
about each of these via structured, open-ended items. Understanding of proper dosing will 
be assessed using the 24 hour recall task described above, but patients will be given credit 
if they demonstrate knowledge of how to take their medication correctly regardless of their 
actual behavior. From this assessment, we can also determine how patients are taking their 
entire multi-drug regimen, and if medications are consolidated in the most efficient 
manner. We will examine the total number of times throughout a 24 hour period patients 
indicate they will take medicine.  
 
Quality of Life. We will use Patient Reported Outcomes Measurement Information System 
(PROMIS) Physical Function, Anxiety, Depression and Global Health subscales 83-86. 
 
Clinical Outcomes. will be collected via EHR by site. Transplant-specific outcomes 
include: 1) change in estimated glomular filtration rate (eGFR; ml/mn) over 24 months,87 
2) Re-hospitalization: Acute care hospitalizations 3) Acute Rejection: proven biopsy 
meeting organ-specific Banff criteria;88 4) Toxicity: related to CNI medications 
(hypertension; neuro-toxic events);11, 12 5) Infection: CMV, BKV, bacterial infections 
assessed by laboratory tests and/or biopsies. Blood pressure (continuous SBP; control 
(y/n): SBP<140 & DBP<90) and glycemic control (HbA1c) will also be examined in those 
with hypertension and diabetes.   
 
9.0 
Procedures Involved: 
Immediately at the onset of the project, we will organize the research team, finalize study 
procedures and data collection instruments, and design study databases. The PIs and Co-Is 
will share primary responsibilities for organizing key personnel and staff, plan study 
implementation, establish standard operating procedures per site, and to detail a plan for 
secure data collection/ transfer. 
 
9.1 
Overview & Study Design. 
We will conduct a 2-arm, patient-
randomized controlled trial at two 
large, 
diverse 
transplant 
centers 
(Northwestern 
University; 
Mayo 
Clinic). 700 KT recipients within 2 
years of KT will be recruited and 
followed for 2 years (N=700 patients; 
n=350 per site; n=175 per study arm 
per site. Targeting both new and 
existing KT recipients is important, as 
adherence barriers may be different. As 
a result, we will aim to recruit patients 

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with a wide spectrum of time since transplant, ranging from 5 weeks to 2 years post-
transplant. In-person interviews will be conducted at baseline and 12 or 18 months (see 
Figure 3). To determine proximal effects of the TAKE IT strategy, a telephone interview 
will also be administered 6 weeks post-baseline. Follow-up telephone interviews will be 
conducted at 6, (12 or 18) and 24 months. Electronic health records will be ascertained to 
capture medication adherence measures and clinical outcomes (Aim 1). We will closely 
evaluate the implementation of all components of the TAKE IT strategy from launch 
through 2 years (Aim 2). Our evaluation includes several process outcomes to assess 
intervention reliability and sustainability (Aim 3). These findings will determine whether 
modifications to TAKE IT are necessary. Finally, we will further estimate the incremental 
costs of implementing and sustaining the TAKE IT strategy from the perspective of two 
transplant centers (Aim 4).  
 
Research activities over the 5-year period will be divided into three phases: I) Preparation 
(Months 1-4); II) Implementation (Months 5-58), III) Evaluation (Months 13-60). In 
Phase I we will assemble our research team, orient sites, finalize study materials, and pilot 
test the TAKE IT strategy to ensure it is acceptable to patients, families, transplant 
clinicians and staff - making any necessary modifications. A randomized controlled trial 
will then be conducted and participants tracked for 2 years (Phase II). Our evaluation 
includes summative, process, and cost analyses to fully understand the clinical impact, 
feasibility, and costs of the TAKE IT strategy to guide dissemination efforts (Phase III). 
 
9.2 Research Coordinator Training. A RC at each site will contact participants, engage 
in the consent process, conduct interviews, perform retention activities, follow-up with 
patients and perform quality assurance. Ms. Curtis will oversee project management, 
ensuring all research staff complete human subjects training (CITI); receive intensive 
interviewer training, led by Drs. Wolf and Ladner, as well as for safe data transfer. Training 
will highlight the sensitive nature of assessments. Simulations will monitor interviewer 
proficiencies. 
 
9.3 Computer Programming. We will be using RedCap to collect all data. This allows 
for straightforward electronic entry of participant responses by the RC and generation of 
data files compatible with statistical programs. The database is both encrypted and 
password protected, and is only accessible by approved study personnel at Northwestern. 
Dr. Kwasny (analyst) will oversee the database structure and quality assurance activities. 
 
9.4 Data Safety and Monitoring Board (DSMB).  The DSMB will be formed early in 
the project and be given responsibility to review and approve the methods and analysis 
plan. It will be organized by Drs. Wolf and Ladner and include appropriate research 
methodologists and biostatisticians with related expertise. Meetings will be via video/tele- 
conference to review protocols, procedures, and concerns related to research integrity. 
 
9.5 Trial Registration. We will register the trial protocol at ClinicalTrials.gov. 
 
9.6 Implementation and de-bugging of Monthly Adherence Assessment and Care 
Alert Notifications.  Due to changes to the hospital and ambulatory care practice electronic 

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health record (EHR) within the CTC, the PIs and Co-Is will plan the implementation of the 
EHR tools and web portal linkage within a modified RedCap platform. This will also 
facilitate use of the same platform at both sites. Dr. Ho oversees bioinformatics for the 
Transplant Center at Northwestern; both sites have dedicated programming support for this 
project to facilitate the modified build. Dr. Wolf has implemented the same processes to 
be tested in this study within GE Centricity, Epic and Cerner platforms; each build has 
included: 1)  creation of an ‘untethered’ web portal site that can safely exchange medication 
information with the EHR; 2) use of the portal to assess medication adherence, and generate 
care alert notifications to the nurse coordinator via EHR based on survey responses. We 
have created a web-based assessment using RedCap, with Care Alert Notifications 
informed by responses in the assessment. An automated email functionality within RedCap 
will be used to generate care alert notifications to the nurse coordinator. The architecture 
for OTTR has already been mapped with support from Drs. Ladner, Ho and Abecassis, as 
well as input from the EDW programmer. Informatics analysts at both sites will implement 
all steps. The TAKE IT strategy will first be tested in the electronic test environment; we 
will troubleshoot and communicate with RedCap if necessary.  
 
9.7 
Randomization. Patient-level randomization will occur within site. At each site, 
350 KT recipients (within 5 weeks-24 months of transplantation) will be randomized via a 
1:1 scheme to intervention (TAKE IT) or usual care (n=175 per arm). The result will be 
350 participants randomized to each study arm (N=700). Mr. Hur, working with Dr. 
Kwasny, will facilitate patient assignments via a random number generator application. 
Guided by Friedberg et al.20 we will blind: 1) personnel involved in statistical analyses 
(Dr. Kwasny, Mr. Hur), 2) principal investigators (Wolf, Ladner). Site project managers 
will have access to study arm assignments to initiate TAKE IT components to those 
randomized to receive them. 
 
9.8 
Clinic Space, Orientation and Workflow. Prior to implementation, Dr. Ladner 
will meet with surgeons, nephrologists, nurses, pharmacists and social workers at each of 
the sites to familiarize them with the planned study activities, answer questions, provide a 
printed synopsis of the protocol per site, and give contact information. They will work with 
Drs. Ho (Northwestern) and Sukuraman (Mayo) to coordinate site activities.   
 
 
9.9 
Research Procedures 
 
Research activities will include a baseline interview, and follow-up interviews at 6 weeks, 
6 months, 12 months, 18 months and 24 months. The baseline and either the 12 month or 
the 18 month interview will be conducted in-person*, while the remaining interviews will 
be conducted via phone. To facilitate the geographical diversity of KT patients at the Mayo 
Clinic, measures used in the baseline and 12 month interview can be administered in-
person or via phone. If a pill count needs to be completed over the phone, a pill count tray 
will be sent to the participant prior to the scheduled interview. 
*If the 12-month interview cannot be done in person due to the timing of clinic visits, it 
will be done over the phone and we will attempt to do the 18 month interview in person.  
 

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Pilot Testing and Refinement of Study Procedures. We will pilot test our strategy and 
study protocol, including the evaluation battery and patient materials, among 10 KT 
recipients per site who meet established patient eligibility criteria. Cognitive interviews 
(~45 min.) will be conducted to finalize and/or refine all study materials. We will 1) obtain 
average completion times for the interview, 2) elicit patient comprehension of the interview 
and intervention components. Necessary modifications will be made prior to full-scale 
implementation.  
 
Baseline Interview. After confirming eligibility via phone, the RC will attempt to schedule 
the baseline interview to occur in person following an existing outpatient follow-up visit. 
RCs will review the Transplant Clinic Schedule in Epic to confirm upcoming appointments 
with the patients.  At the baseline interview, the RC will re-introduce the study and obtain 
written consent, before administering the baseline interview. If a clinic visit is not 
scheduled, we will schedule interviews at the convenience of participants as necessary. 
Following the baseline interview, RCs will introduce the ‘Transplant Hero’ mobile 
application to participants with a smartphone. First, the RC will explain the app and its 
functionality in reminding patients to take their medications and provide educational 
information on KT medications. The RC will provide participants with the Transplant Hero 
Information Sheet. The RC will then ask the participant if they are interested in using the 
app as part of the study, and confirm that they have a smartphone (previously identified in 
initial screener and approach). If the participant is interested in downloading the app, the 
RC will assist in downloading the app. The RC will demonstrate entering a medication into 
the app, but will not enter the participant’s entire regimen.  
 
As part of a supplementary study leveraging TAKE IT patients (STU00209386), patients 
will be informed that they may be approached by a research coordinator from the 
Comprehensive Transplant Center during their upcoming blood draw and will have the 
option to consent to an additional blood draw. Participants will be informed that they can 
refuse to participate in the blood draw, without affecting their participation in the TAKE 
IT study. If the patient is interested in speaking with the IRB-approved coordinator, the 
patient’s name, date of KT, study ID, and MRN will be shared with the study coordinator 
using a secured sharepoint platform stored on the FSM drive. 
 
Follow-up Interviews. At Northwestern, an automatic reminder function built into 
Microsoft Access will alert RAs when to schedule follow-up encounters (6 weeks, 6, 12, 
18, and 24 month interviews). Northwestern will send Mayo a weekly list of ID numbers 
and dates, prioritizing patients to schedule based on their windows. Each interview will 
take approximately 45-60 minutes, and subjects will receive $30 for baseline, 6 month and 
12 month interviews, and $50 for the 18 month interview (total $140 compensation; none 
for 6 week or 24 month 20 minute phone interview).  
 
 
9.10 
Intervention: TAKE IT Strategy. 
 
Our strategy is a multifaceted intervention that leverages the existing resources of a 
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simplify KT recipients’ role in managing complex, multi-drug regimens and monitor use 
over time. The goal of the TAKE IT strategy is to optimize adherence and to detect 
problems earlier in order to improve health outcomes – both in transplant-specific 
conditions and for comorbidities. This approach is multifaceted, yet highly scalable due to 
minimal costs and impact on existing transplant center workflow. It includes the following 
4 components: 
 
1. A routine adherence assessment that requests patients to periodically report 
upon their medication use, providing a continuous link between the transplant 
center and patient beyond routine in-person visits. This assessment will 
routinely identify patients at risk of non-adherence and categorize the nature 
of their adherence concern in one of the following areas: cognitive, 
psychological, regimen, medical, social, economic.  
2. Care Alert Notifications directed to the transplant center nurse coordinator if 
an adherence related problem is identified by the routine adherence 
assessment, who can then activate appropriate staff to respond.  
3. Quarterly adherence reports that will automatically calculate a coefficient 
of variance for patients’ tacrolimus levels at routine intervals and impart results 
to transplant nurse coordinators.  
4. Tailored clinical support leveraging transplant center tools to directly target 
the adherence-related concern identified by the routine adherence assessment. 
The study team will focus on leveraging existing transplant center resources, 
including clinical consultation with pharmacists, social workers and transplant 
nurse coordinators, as well as existing technological and educational tools. 
These tools will be bundled and initiated in response to specific patient-
reported adherence concerns.  
 
 
9.11 
Study Arms 
Participants will be randomly assigned to either the TAKE IT strategy, as described in 
section 9.10 or usual care. Usual care refers to the normal standard clinical practices in 
place at either site, immediately post-transplant to the 5 years following. Northwestern and 
Mayo follow similar protocols for follow-up. KT recipients at both sites have lab values 
taken 3 times/weekly for the first 8-10 weeks post-transplant, shifting to weekly lab values 
for the next 3-4 months after, then monthly labs after. Both sites follow a similar tapering 
of weekly, to monthly to annual visits to the transplant nephrologist over the first 3 years. 
Protocol biopsies at both sites are taken between 3-6 months post-transplantation, at 12 
then 24 months. All sites have a transplant nurse coordinator who has primary oversight of 
post-transplant care, full-time pharmacists and a clinical social worker. At Northwestern, 
the pharmacist has a standard visit with patients to review their prescribed regimen at 
discharge from the hospital. Social work and pharmacist visits are referrals as needed 
(PRN). At Mayo, both the pharmacist and social worker engage with patients only upon 
referral. Neither site has an active portal that engages KT recipients for any self-care 
support service. 
 

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9.12 
Data Sources. Data sources for this study will include two in-person interviews 
and four phone interviews with participants, and Electronic Health Record chart review.   
 
9.13 
COVID-19 Survey.  
From a pool of existing studies conducted by Dr. Michael Wolf (LitCog (STU00026255), 
REMinD (STU00203777), COPD Multimorbidity (STU00201640), UMS Portal 
(STU00201639), and TAKE IT (STU00204465), participants will be contacted and invited 
to participate in a one-time brief (5-10 minute) telephone survey to capture one additional 
outcome pertaining to their knowledge, attitudes, and beliefs about the COVID-19 outbreak 
in March 2020. They will also be asked a series of patient-reported health literacy items. 
Participants who complete to COVID-19 survey will receive a $10 gift card in the mail.  
 
Recruitment will be done by phone by trained Northwestern RAs. We will contact anyone 
who has indicated that they were willing to be contacted for future studies run by Dr. Wolf 
on the consent form. Verbal consent will be obtained prior to completing the one time brief 
(5-10 minute) telephone survey. 
 
Data from the COVID-19 survey and patient-reported health literacy items will be captured in 
REDCap.  
  
10.0 
Data and Specimen Banking: 
10.1 
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. 
 
11.0 
Data and Specimen Management: 
11.1 
Analysis Plan. 
All analyses will be performed in SAS v9.4 (SAS Institute, Cary, NC).  Mr. Hur will 
perform analyses under the direct supervision of Drs. Kwasny, Ladner and Wolf. Drs. 
Reese and Serper will also provide guidance. 
 
Aim 1. 
The proposed trial uses a 1:1 randomized design that assigns patients to TAKE IT or usual 
care within each cohort. We will accrue approximately 700 patients (350 de novo, 350 
established) anticipating 90% retention in the de novo cohort (85% established) for follow-
up at 1 year, leaving a minimum 525 patients for primary analyses. High retention will be 
supported through close follow-up, mailed reminders, birthday cards, and a newsletter. 
Given the clinical follow-up necessary for KT recipients, we are confident we will achieve 
this goal. 
 
Regimen adherence at one year is the primary outcome of interest for Aim 1, with Rx 
knowledge and individual adherence measures also of primary interest.  Secondary 
outcomes include quality of life (PROMIS outcomes and FKSI) and the clinical outcomes 
of change in eGFR, and any transplant-related re-hospitalization. Blood pressure control in 
those taking anti-hypertensive medications will also be examined.   Relationships between 

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adherence and potential confounders (age, comorbidity, cognitive ability, regimen 
complexity, internet use, dose of intervention, etc.) will also be examined.  For all 
outcomes, we will use generalized linear models (GLMs), adjusted for confounders and 
study site, specifying the logit link function for binary outcomes and identity link for 
continuous outcomes (quality of life, change in eGFR, SBP). Treatment group will be the 
independent variable of primary interest, with usual care specified as reference group. We 
will also include time since transplant at baseline (in months), baseline value of the 
outcome, and any potential confounding covariates noted in bivariate analysis. For 
outcomes measured per medication, a generalized estimating equation (GEE) approach will 
be employed to adjust standard errors for within-patient correlation.  Should TAKE IT have 
an effect on outcomes, secondary analyses will examine if any of the potential confounders 
considered exhibit any effect modification. 
 
Aim 2. 
Generalized linear mixed models (GLMMs) will be used to examine intervention effects 
over the course of the study. Link functions will be included as described above for the 
GLM models.  Adherence concerns may differ in the two cohorts, thus separate models 
will be employed for each cohort (de novo, established). Treatment group will be the 
independent variable of primary interest, modeled as a fixed effect with the usual care 
group specified as reference group. We will also include fixed effects for site (NU, Mayo), 
time since transplant (in months), and potential confounding covariates noted in bivariate 
analyses. Random participant effects for each participant will be included to account for 
repeated measurements nested within each participant (assuming a compound symmetry, 
although we will fit autoregressive structures as well, comparing fit using AIC and BIC 
criterion). Outcomes recorded at each interview will be analyzed by visit whereas 
adherence measured by tacrolimus levels, along with blood pressure control will be 
analyzed in 6-month intervals as described above. A time-since-transplant-by-arm 
interaction term will be included to examine if outcome trajectories/slopes over time differ 
by study arm. Since prescription knowledge and adherence will be assessed for each 
medication, 2-level GLMM will be used for these outcomes with medications nested in 
participants. For Δ eGFR and re-hospitalization outcomes, GLM models will be used since 
outcomes over 2 years are summarized in a single measurement. In the de novo cohort, 
change in eGFR from transplant to 2 years post-transplant and # hospitalizations (any 
hospitalization, if rare) within 2 years post-transplant will be modeled. For the established 
cohort, the time period for the both measures will span from transplant to 2-year study visit.  
It is possible those who do not complete the 2-year visit will differ in important 
characteristics (e.g. cognition, comorbidity), which could bias results.  We will use 
collected data at prior interviews to understand the extent that individuals who complete 
follow-up differ from those who do not. If differences are found, pattern-mixture models 
will be employed by classifying participants’ drop-out type or pattern (e.g. completed, 
refused, lost to follow up, death). This variable will then be added to mixed effects models 
to account for differences.99, 100    
 

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Power Calculation. The sample size calculation was based on the availability of 700 
transplant patients estimated by the number of transplants conducted in 2012-2014 across 
the two sites.  With the sample size set at 610 accounting for 85-90% retention at 1 year, 
we present the minimum differences we will be able to detect between the intervention and 
usual care arms for each outcome of interest.  For the main outcome of medication 
adherence, we estimate 45% of the sample to be non-adherent using the composite score 
described above taking estimates for each individual measure into account.19, 37 We will 
have sufficient power (≥ 80%) to detect differences of 11% in the entire sample assuming 
a 5% Type I error rate. Should 
TAKE IT be associated with 
potential 
confounders, 
calculations show that an R-
squared of 0.2 between predictors 
(a conservatively high estimate 
under randomization), we would 
still maintain 70% power to detect 
the 11% difference. Although 
adjusting for confounders would 
decrease variability in adherence, 
and increase power. Detectable 
differences for individual adherence measures along with estimates and effect sizes for 
other outcomes of interest are listed in Table 5.84, 87, 101-103 
 
Exploratory Analyses. A single measurement for each exploratory transplant related 
clinical outcome (i.e. acute rejection, toxicity, infection) will be modeled at the end of the 
study indicating the total number of occurrences (or any for rare outcomes) over the course 
of the study using GLM models as described above. We recognize we likely will not have 
sufficient power to find differences in these outcomes.  Intervention effects on blood 
pressure and glycemic control will be examined among those with diabetes and/or 
hypertension.    
 
Aim 3. 
We will determine the extent to which the 
interventions were 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 (Figure 8).104  We will capture 
4 data sources: 1) patient self-report, 2) EHR, 
3) field notes, and 4) clinic staff. Patients 
receiving the TAKE IT strategy arm will be asked whether they received EHR materialsand 
visited the portal. We will examine if receipt of EHR tools increased KT recipient 
knowledge and behaviors. At 12 and 24 month interviews, a random sample of 50 patients 
from the intervention arm will be asked additional, semi-structured questions to explore 1) 
personal challenges with regimen adherence, 2) perceived value of the EHR, SMS, and 

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portal tools, 3) unmet needs and acceptability of other tools and approaches to support 
medication use. Interviews will be audio-recorded and transcribed. EHR data will capture 
whether patients actually receive EHR tools and if identified adherence concerns from the 
portal assessment generated a care alert, if a response was documented, and when. We will 
use field notes to monitor ongoing clinic changes. Ms. Curtis will have monthly calls with 
clinic administrators to document any changes that might have occurred and when. This 
includes relevant changes to clinic staffing, workflow, EHR, or any significant event that 
could potentially alter delivery and subsequent effectiveness of the TAKE IT strategy. 
Discussions groups will be held with staff during business meetings to assess the 
intervention’s impact on workflow. These will be audio-recorded.  
 
Analysis Plan. Quantitative and qualitative findings will be merged to answer 1) whether 
the intervention was implemented as planned (e.g. fidelity), 2) from a user-perspective, do 
interventions require modification and how. In this approach, both analyses are conducted 
separately and merged for side-by-side data comparisons.104 For quantitative data (patient 
report, EHR data), frequencies will be generated to determine overall rate of perceived 
helpfulness of materials, receipt of materials, participation in the Web-based portal to 
report medication use, and the overall rate of EHR notifications. Although we expect a 
high fidelity level, if there are “glitches” that prevent TAKE IT from being implemented 
optimally, we will do an exploratory analysis to determine if fidelity rates had any 
association with improvement in outcomes. For qualitative data, we will review and 
explore the transcribed patient interviews and clinic staff discussions using content and 
ethnographic analysis led by Drs. Wolf, Ladner and Serper.105, 106 Predetermined categories 
will organize feedback from all users: patient, provider, clinic/health system. Within each 
of these categories we will use a predetermined coding approach to quantify the frequency 
of two subcategories: facilitating factors, and impeding factors (Figure 8). An additional 
layer within impeding factors would be whether factors are modifiable or not, and under 
facilitating factors, if they are replicable. Field notes and quantitative findings will be 
integrated. Transcribed interviews and field notes will be examined by Drs. Wolf, Ladner, 
& Serper independently. Analyses will be conducted with NVivo 10 (QSR International).  
 
Aim 4. 
Dr. Walton, working with Drs. Wolf, Ladner, & Reese will directly measure and assess the 
costs of developing and running the TAKE IT Strategy. The incremental cost of TAKE IT 
will be estimated relative to usual care from the perspective of the two sites implementing 
these processes and tools. The primary costs of running TAKE IT technologies in the EHR 
involve the limited expenses around printing (printer ink, paper, staff time) as a result of 
generating MedSheets and the Medlist with the AVS (during clinic visits). SMS monthly 
costs will be easily documented as well as usage. However, we will include estimates for 
programming maintenance for OTTR and Cerner EHRs, and the portal. We will test the 
sensitivity of results to changes in maintenance requirements (in programmer hours). 
Development costs for software and other programming requirements will be separately 
tracked based on programmer hours. Staff costs (nurse coordinator, pharmacist, social 
worker, other clinicians, programmer) 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 

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assuming the same proficiency in terms of time required. We will also assess the sensitivity 
of estimates to different proficiency levels that could arise from learning by doing.  
 
11.2 
Protocol to ensure confidentiality. 
Each subject will be tracked using an Access database. Each site will have a separate 
Access database built using the same template. The databases, 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 and Mayo Clinic network drives respectively. Only the PI, project manager, 
and RCs at each site will have access to this database.  
 
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. An 
affiliate Northwestern Net ID will be generated for the RC at Mayo Clinic to enable data 
entry for Mayo participants. Data access groups will be identified so NU interviews cannot 
access to Mayo’s data and vice versa.  
 
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 consent forms and 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. 
 
 
11.3 
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 Ladner at each site. 
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. 
 
11.4 
Study-wide data management. 
 
Data collected includes patient consent forms, data gathered using the EDW and 
Transplant Report pulls, and data collected during the study interviews.  
 
COVID-19 Survey Data 
By extending existing studies conducted by Dr. Michael Wolf (LitCog (STU00026255), 
REMinD (STU00203777), COPD Multimorbidity (STU00201640), UMS Portal 

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(STU00201639), and TAKE IT (STU00204465) to capture an additional patient-reported 
outcome related to one’s knowledge, attitudes and behaviors related to COVID-19, we can 
link participants’ responses to this cross-sectional survey to a minimum data set of 
participant characteristics that include demographic, socioeconomic, cognitive (including 
health literacy) and health behavioral characteristics. We will then be able to investigate 
determinants of COVID-19 knowledge, attitudes and behaviors without duplicating data 
collection efforts for these variables.  
 
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 and Mayo Clinic secure servers for the length of the study. RCs at 
Mayo Clinic will be provided with an affiliate Northwestern id in order to be granted access 
to NU’s REDCap system.  RCs will be assigned to their own Data Access Group which 
restricts access to their subject’s records.  Each group is blinded to all other data/records. 
For the purposes of creating a clinic alert notification, intervention patients’ name, DOB 
and MRN will be entered into RedCAP and sent to pre-identified clinical staff via RedCAP 
survey function to Northwestern email addresses. For Mayo Clinic patients, name, DOB 
and MRN will also be entered into RedCAP and sent to pre-identified clinical staff via 
RedCAP to Mayo clinic email addresses. The name, DOB and MRN will be stored in the 
Mayo Clinic Data Access Group, which will not be visible to any Northwestern staff. Only 
the RC at the Mayo Clinic will have access to this data in the RedCap Data Access Group. 
 
The Project Manager or Data Analyst will download the de-identified data only for both 
sites from REDCap monthly and save to the “Analytic” folder within the TAKE IT 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 Northwestern 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  
 
Data Transfer to Data Coordination Site.  All survey data collected at the Mayo Clinic site 
will be stored in REDCap and downloaded by the Northwestern project manager or data 
analyst monthly.  For the purposes of creating a clinic alert notification, intervention 
patients’ name, DOB and MRN will be entered into RedCAP and sent to pre-identified 
clinical staff via RedCAP survey function to Mayo Clinic email addresses. The name, DOB 
and MRN will be stored in the Mayo Clinic Data Access Group, which will not be visible 
to any Northwestern staff. Only the RC at the Mayo Clinic will have access to this data in 
the RedCap Data Access Group. Northwestern staff will only have access to de-identified 

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study data from Mayo Clinic.  De-identified data from both sites will be combined into a 
master dataset.  A back-up copy of all transferred data will be maintained at Mayo Clinic. 
 
12.0 
Provisions to Monitor the Data to Ensure the Safety of Participants: 
12.1 
Data Safety and Monitoring Board (DSMB). The DSMB will be formed early in 
the project and be given responsibility to review and approve the methods and analysis 
plan. It will be organized by Drs. Wolf and Ladner and include appropriate research 
methodologists and biostatisticians with related expertise. Meetings will be via video/tele- 
conference to review protocols, procedures, and concerns related to research integrity. 
 
13.0 
Withdrawal of Participants: 
13.1 
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.    
 
13.2 
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. 
 
14.0 
Risk to Participants: 
14.1 
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.  
 
15.0 
Potential Benefits to Participants: 
15.1 
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 mobile and computer technologies to 
support safe and appropriate medication use. 
 
16.0 
Vulnerable Populations: 
N/A 
 
17.0 
Community-Based Participatory Research: 
N/A 
 
18.0 
Sharing of Results with Participants: 
18.1 
Study results will not be shared with participants or anyone else. 
 
19.0 
Setting: 
19.1 
Mayo Clinic Arizona. The Mayo Clinic Transplant Center in the greater Phoenix, 
AZ area provides comprehensive evaluation, medical and surgical treatment, and follow-

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up care for patients with ESRD who may be in need of a KT. The Mayo Clinic Arizona, 
Minnesota, and Florida campuses perform more KTs than any other institution in the U.S. 
At the Arizona site, they have dedicated clinical research staff involved in multiple renal 
transplantation clinical trials including immune-suppressive drug studies and immune 
monitoring trials. This infrastructure will aid Dr. Heilman & Sukumaran in conducting the 
study. 
 
19.2 
Northwestern University. Northwestern Medicine Comprehensive Transplant 
center (NMCTC) is the largest center for kidney transplantation in Illinois and is a leader 
in research, innovation and patient care in the Midwest. There are 4 satellite offices outside 
of Chicago, in Illinois and Indiana, to assure evaluation services closer to patients’ homes. 
This is the largest living donor kidney transplant program in the country. It is also one of 
the most experienced facilities in steroid-free KT. With the Northwestern University 
Transplant Outcomes Research Center, led by Dr. Ladner, we have one of the only health 
services research teams in transplant. 
 
19.3 
All in-person research interviews will take place in a private space within the study 
clinics at NMHC, NMCTC, and Mayo Clinic. Telephone calls with patients will also take 
place in a private space to ensure patient confidentiality.  
 
20.0 
Resources Available: 
20.1 
This study is led by senior health services researchers with expertise in health 
literacy, medication adherence, use of EHR and consumer technologies, patient safety in 
transplant, and complex research designs. Additionally, the project staff have worked on 
similar research projects and have adequate training to carry out the proposed study. 
 
This study is being conducted with patients from clinics within Northwestern Medical 
Healthcare (NMHC), Northwestern Medicine Comprehensive Transplant Center 
(NMCTC), and Mayo Clinic. All physicians within the practice will be informed of the 
study. 
 
21.0 
Prior Approvals: 
21.1 
National Institute of Diabetes and Digestive and Kidney Disease (NIDDK) 
 
22.0 
Recruitment Methods: 
22.1 
Identification of potential participants  
Northwestern University 
To identify potential participants, a weekly pull of eligible patients will be reviewed by 
Research Coordinators (RC) at each site. At Northwestern, this report will include patient 
name, date of KT, phone number, address, medical record number (MRN), name of 
nephrologist and date of upcoming clinic visits. At Northwestern, this pull will be 
downloaded from the EDW. RCs will contact nephrologists to notify them about the study 
and to ask permission to contact all eligible patients for the study. After obtaining 
permission from each nephrologist to contact patients, the Director of the Kidney 
Transplant Program, Dr. Leventhal will provide written permission for RCs to contact all 
eligible kidney transplant recipients for the study.  

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Mayo Clinic 
At the Mayo Clinic, the RC will review transplant reports. With assistance from the nurse 
coordinator, RCs will review patient records to identify patients for potential recruitment 
that meet eligibility criteria.  
 
22.2 
Initial contact of potential participants 
 
Northwestern University:  
As per Northwestern policy, a letter will be sent to patients from Northwestern University 
detailing the study and notifying them that a research coordinator will be telephoning them 
to invite them to participate in the study. The letter will include a hotline number, which 
patients can call if they do not wish to be contacted for the study. Seven days after the 
letters have been sent, RCs will contact patients who did not opt out to introduce the study, 
to confirm eligibility and provide further information on the study. If the patient is eligible 
and interested, the RC will schedule the baseline interview around an upcoming clinic visit, 
where applicable. RCs will review the Transplant Clinic Schedule in Epic to confirm 
upcoming appointments with the patients.  Written consent will be obtained in-person at 
the beginning of the baseline interview.  
Mayo Clinic: 
In accordance with Mayo clinic policy, Daily Transplant List Report will be used to screen 
and identify de-novo (6 weeks post KT) subjects from the Mayo Clinic and Schedule 
Reports will be used to identify established (up to 24 months post KT) patients. Research 
Coordinators (RC) from the Mayo clinic will telephone identified patients from list asking 
for their participation and allowing them to opt out from being contacted further. Those 
who are interested will be scheduled to meet with the RC to go over study requirements 
and provide signed consent.   
22.3 
Recruitment procedure 
Recruitment will be completed over the phone by CITI-certified Northwestern Research 
Coordinators (RCs) and Mayo Clinic RCs as applicable per site. RCs will call eligible 
patients to confirm eligibility and provide further information on the study. If the patient is 
eligible and interested, the RC will schedule the baseline interview around an upcoming 
clinic visit, where applicable. Written consent will be obtained in-person at the beginning 
of the baseline interview.  
 
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 and in-person. RCs will read each question aloud and record patient responses 

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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 outside of in person interviews will be made via USPS 
and telephone. 
 
 
22.4 
Payment for Participation 
 
Research Interview 
Payment 
Form of Payment 
baseline 
$ 30 
cash at close of interview 
6 weeks 
$ 0 
(brief, included in other interviews) 
6 month 
$ 30 
money order mailed via USPS 
12 month 
$30 
cash at close of interview 
18 month 
$50 
money order mailed via USPS 
24 month 
$0 
 
 
COVID-19 Survey: Participants who complete the COVID-19 survey will receive a $10 
gift card in the mail. All participants who verbally consent and complete any portion of the 
telephone interview will be compensated 
 
23.0 
Number of Local Participants: 
23.1 
A total of 350 participants will be enrolled locally (n=700 study-wide) for patient 
interviews.   
 
24.0 
Confidentiality: 
24.1 
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.  
 
24.2 
Local Data Storage. 
Data will be stored in REDCap, a secure, web-based application, and on the Northwestern 
and Mayo Clinic secure servers for the length of the study. RCs at Mayo Clinic will be 
provided with an affiliate Northwestern id in order to be granted access to NU’s REDCap 
system.  RCs will be assigned to their own Data Access Group which restricts access to 
their subject’s records.  Each group is blinded to all other data/records. For the purposes of 
creating a clinic alert notification, intervention patients’ name, DOB and MRN will be 
entered into RedCAP and sent to pre-identified clinical staff via RedCAP survey function 
to Northwestern email addresses. For Mayo Clinic patients, name, DOB and MRN will 
also be entered into RedCAP and sent to pre-identified clinical staff via RedCAP to Mayo 

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clinic email addresses. The name, DOB and MRN will be stored in the Mayo Clinic Data 
Access Group, which will not be visible to any Northwestern staff. Only the RC at the 
Mayo Clinic will have access to this data in the RedCap Data Access Group. 
 
 
The Project Manager or Data Analyst will download the de-identified data only for both 
sites from REDCap monthly and save to the “Analytic” folder within the 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 will remain in the secure REDCap 
system in designated Data Access Groups visible only to authorized staff at Northwestern 
University for Northwestern patients and the Mayo Clinic for Mayo patients.  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. All identifiable information will be deleted upon 
completion of the study.   
 
All survey data collected at the Mayo Clinic site will be stored in REDCap and downloaded 
by the Northwestern project manager or data analyst monthly.  For the purposes of creating 
a clinic alert notification, intervention patients’ name, DOB and MRN will be entered into 
RedCAP and sent to pre-identified clinical staff via RedCAP survey function to Mayo 
Clinic email addresses. The name, DOB and MRN will be stored in the Mayo Clinic Data 
Access Group, which will not be visible to any Northwestern staff. Only the RC at the 
Mayo Clinic will have access to this data in the RedCap Data Access Group. Northwestern 
staff will only have access to de-identified study data from Mayo Clinic.  De-identified 
data from both sites will be combined into a master dataset.  A back-up copy of all 
transferred data will be maintained at Mayo Clinic. 
 
24.3 
Data Transfer to Data Coordination Site. 
All survey data collected at the Mayo Clinic site will be stored in REDCap and downloaded 
by the Northwestern project manager or data analyst monthly.  For the purposes of creating 
a clinic alert notification, intervention patients’ name, DOB and MRN will be entered into 
RedCAP and sent to pre-identified clinical staff via RedCAP survey function to Mayo 
Clinic email addresses. The name, DOB and MRN will be stored in the Mayo Clinic Data 
Access Group, which will not be visible to any Northwestern staff. Only the RC at the 
Mayo Clinic will have access to this data in the RedCap Data Access Group. Northwestern 
staff will only have access to de-identified study data from Mayo Clinic.  De-identified 
data from both sites will be combined into a master dataset.  A back-up copy of all 
transferred data will be maintained at Mayo Clinic. 
 
24.4 
Data Collected. 
The proposed research will include data from 600 patients. Participants will be interviewed 
at baseline, 6 weeks, 6 months, 12 months, 18 months, and 24 months at Northwestern 
University and Mayo Clinic. The final data set will include patient socio-demographic 
characteristics, health status, health literacy and motivation, medication knowledge and 

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adherence behaviors, as well as clinical outcomes (change in eGFR, re-hospitalization, 
acute rejection from biopsy, etc.). The primary outcome is medication adherence at year 1.  
Any identifying information (e.g. personal and/or contact information) will be kept 
separate from other data; all information will be kept in secure, password protected files.  
 
25.0 
Provisions to Protect the Privacy Interests of Participants: 
25.1 
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. For the 
purposes of creating a clinic alert notification, intervention patients’ name, DOB and MRN 
will be entered into RedCAP and sent to pre-identified clinical staff via RedCAP survey 
function to Northwestern email addresses. For Mayo Clinic patients, name, DOB and MRN 
will also be entered into RedCAP and sent to pre-identified clinical staff via RedCAP to 
Mayo clinic email addresses. The name, DOB and MRN will be stored in the Mayo Clinic 
Data Access Group, which will not be visible to any Northwestern staff. Only the RC at 
the Mayo Clinic will have access to this data in the RedCap Data Access Group. 
 
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. 
 
25.2 
Participation in the study poses minimal risk of physical, 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). 
 
25.3 
All enrolled participants will provide written consent, include HIPAA authorization 
for the collection of all data, including review of the patient’s medical record.  
 
25.4 
Only authorized personnel listed on each institutions IRB and approved by the PI 
will have access to the data. 
 
26.0 
Compensation for Research-Related Injury: 

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N/A 
 
27.0 
Economic Burden to Participants:  
N/A 
 
28.0 
Consent Process 
28.1 
Written consent will be obtained for all participants, prior to their participation. The 
consent process will take place in a private clinic space within NMHC, NMCTC, and Mayo 
Clinic. Participants will be provided with a consent form by the RC, who will ask the 
participant to read the consent form in full. Once complete, the RC will reiterate the key 
aims and participant requirements (2 in-person and 4 phone interviews), before giving the 
participant the opportunity to ask any questions they might have. 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. There will be no exertion 
of any overt or covert coercion.  
 
28.2 
Verbal consent process for COVID-19 survey: Subjects will be informed about the 
nature of the study by a CITI-certified RC and asked to provide verbal consent.  They will 
be informed that they may withdraw from the study at any time and given contact 
information for the PI and RC. A verbal consent, or a waiver of documentation of consent, 
is deemed appropriate because the nature of the study involves minimal risk and no PHI 
will be collected. If a patient agrees to participate after the RC reads the consent, the RC 
will record the patient’s name on the consent form and the RC will sign their own name on 
the form. These consent forms will be locked in a file cabinet only accessible to necessary 
research staff. Patients will be given the option to receive a blank consent form for 
reference if they request it.  
 
29.0 
Process to Document Consent in Writing 
Written consent will be obtained for all participants, prior to their participation. The 
consent process will take place in a private clinic space within NMHC, NMCTC, and Mayo 
Clinic. Participants will be provided with a consent form by the RC, who will ask the 
participant to read the consent form in full. Once complete, the RC will reiterate the key 
aims and participant requirements (2 in-person and 4 phone interviews), before giving the 
participant the opportunity to ask any questions they might have. 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 is satisfied 
that the participant understands the consent process and the nature of their participation in 
the research study, the participant will be asked to sign and date the consent form. 
Participants will receive a second signed consent form for their records. After the interview, 
signed consent forms will be stored in locked cabinets in General Internal Medicine.  
 
30.0 
Drugs or Devices: 
N/A 
 
 

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