AKI in Care Transitions (ACT) Trial
Phase: NA
Conditions: Acute Kidney Injury
Sponsor: Mayo Clinic

 
 
 
 
 
 
 
 
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General Study Information 
 
Principal Investigator:       Erin Barreto 
 
 
 
 
 
 
 
 
Study Title:    AKI in Care Transitions (ACT) Trial 
 
Protocol version number and date:     Version 1 and 12-21-2021 
 
Research Question and Aims 
 
Aim 1: Evaluate the feasibility and acceptability of the AKI in Care Transitions pilot and iteratively 
refine the intervention. Feasibility of the pilot will be quantified by the percentage of randomized AKI 
survivors who receive the full ACT intervention (nurse education visit, laboratory testing, pharmacist visit, 
primary care provider visit).  Using encounter video recordings, and qualitative interviews with patients and 
clinicians, we will assess user interactions with the pilot intervention, tool fidelity, and acceptability of the 
intervention for patients and clinicians. Based on identified barriers and facilitators, the intervention will be 
iteratively refined for scaling and testing in a larger prospective clinical trial. 
 
Aim 2: Generate preliminary estimates of the ACT intervention on clinical and patient-reported 
outcomes. We will conduct a pilot clinical trial in 50 patients over 18-months. Patients with severe AKI will be 
randomized 1:1 (25 per group) to either the control group (usual care) or the intervention group (ACT). In the 
intention-to-treat population, we will assess change in AKI knowledge from baseline to 30-days using a 
validated scale. Differences in other patient-reported and clinical outcomes will be characterized. The use of 
nephrotoxins will be quantified from reconciled medication lists. We hypothesize that the intervention group will 
experience improved AKI-related knowledge, processes of care, and outcomes compared to control patients. 
 
Background and Significance 
 
Significance 
AKI affects approximately 1 in 5 hospitalized patients, with the risk much higher in patients with sepsis, shock, 
major surgery, or in the developing world1,2.  In the hospital, AKI contributes to a 6.5-fold higher mortality, a 
3.5-day longer length of stay, and $5 billion in hospital costs annually in the United States1,3.  In the 80-90% of 
individuals who survive an AKI episode, the risk of chronic kidney disease (CKD) is 1.5-2.5-fold higher4.  Even 
in those who have seemingly ‘recovered’ after AKI, 15% develop new stage 3 CKD 2.5 years after the event. 
This corresponds to a 3.8-5.9-fold higher risk than in patients without AKI5,6.  Cardiovascular disease is also a 
frequent AKI complication.  The pooled risk of major acute cardiovascular events was 1.4-fold higher in those 
with AKI than those without7. In addition to long-term, potentially irreversible CKD or cardiovascular disease, 
49% of patients are rehospitalized within one year8, a major contributor to poorer quality of life.  In studies 
where a health utility indicator of 0 is consistent with death and 1 is perfect health, mean health utility scores in 
AKI survivors 2-6 months after the episode are between 0.4 and 0.68, significantly worse than age- and sex-
matched controls in the general population9–12.  
 
AKI survivors at care transitions experience gaps in kidney-focused care that may affect long-term outcomes.  
Interventions that modify the transition conditions and provide a structured framework for post-AKI care can 
close gaps in quality.  In patients with complex care needs, we and others have instituted care transitions 
programs that successfully limit deleterious outcomes.  Generally, these programs include interventions that 
begin in the hospital and continue for 1-3 months after discharge.  Efforts are targeted at medication self-

 
 
 
 
 
 
 
 
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management, use of a patient-centered health record to facilitate care continuity, completion of timely follow-up 
with primary or specialty care, and knowledge of “red flag” symptoms and how to respond13.  Care transition 
models like these, including those described by our team14, have reduced emergency department visits, 
rehospitalizations, costs, and improved quality of life and self-rated health13,15–17. These cost-effective team-
based strategies could be successfully leveraged to deliver better care for AKI survivors.   
 
Preliminary data 
Using data from the Rochester Epidemiology Project, we demonstrated that 30% of AKI Survivors (stage II or 
III, moderate or severe, respectively) failed to have a serum creatinine assessment and a healthcare visit in the 
30-day interval after discharge.  These would be considered basic elements of kidney health follow-up.  
Nephrology visits occurred in less than one-fourth of individuals, even when the time horizon was extended to 
one year or high-risk patients were considered (i.e., CKD, diabetes) (Manuscript in press at Am J Nephrol).  
Nephrotoxins are also a particular area of concern in AKI survivors, given they are one of few potentially 
modifiable determinants of long-term complications.  We demonstrated that 87% of AKI survivors receive at 
least one potentially nephrotoxic medication in the 3-years after discharge.  Each additional nephrotoxin was 
associated with a 1.3-fold higher risk of new or progressive CKD within 3-years (Manuscript under review at 
Am J Nephrol).   
 
To address this unmet need for AKI survivor care, we developed the AKI in Care Transitions (ACT) 
intervention with feedback from stakeholders in Nephrology, Pharmacy, Primary Care, Nursing, Informatics, 
and Administration. The focus is on the delivery of post-AKI care in the patient’s medical home, primary care.  
This multicomponent strategy includes 1) use of an electronic health record (EHR) indicator to identify high-risk 
AKI survivors based on biochemical markers (serum creatinine increase, urine output decline), 2) Education 
about kidney health before discharge by nephrology nurses, 3) kidney function testing in the 7-14-days after 
discharge, 4) a post-hospital visit by a pharmacist within 7-14-days after discharge, and a 5) post-hospital visit 
by a primary care provider within 7-14 days after discharge (may be combined with the pharmacist visit).  
Specialty nephrology follow-up is at the discretion of the inpatient nephrologists or patient’s PCP. The ACT 
intervention is a transitions of care support strategy where these bundle elements are recommended and made 
available to the care teams using electronic orders and clinical decision support, but ultimately at the discretion 
of the treating providers.  
 
Pilot testing of each component of the ACT intervention began in April 2020 (IRB 20-004204).  During the first 
phase of testing, the electronic health record indictor was optimized to identify candidate individuals for the 
ACT intervention.  Alerts were manually validated and cross-referenced with clinical notes and nephrology 
service rosters.  During the second phase of testing, the feasibility of the nurse education visit was evaluated.  
A nephrology nurse liaison successfully visited all 18 patients targeted for education. The nephrology 
consultation service, and by extension the nurse liaison, was not previously following 7 (39%) of these 
individuals. In the third testing phase, 11 individuals consented to participate and were placed on the AKI 
survivor care path.  Of these individuals, one died before discharge, one was discharged on dialysis, and one 
did not receive education from the nurse liaisons before discharge.  In the remaining eight patients, 100% 
completed an encounter with the PCP, a serum creatinine evaluation, and urinalysis within two weeks of 
discharge [median time to follow up 2 (IQR 1, 6) days].  Six (75%) completed an encounter with a pharmacist 5 
(1, 10) days after discharge.  Two (25%) patients consulted with an outpatient nephrologist on day one and day 
22 after discharge, respectively.  Over time, kidney health knowledge improved in the majority of patients. In 
the majority of patients who received education [from a nurse (phase 2) or a nurse + primary care provider +/- 
pharmacist (phase 3)], knowledge scores improved immediately after education delivery and remained 
improved for 2-4 weeks thereafter.    
 
Study Design and Methods 

 
 
 
 
 
 
 
 
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Overall Design: We will conduct a single center randomized trial at the patient level comparing the ACT 
intervention to usual care in patients with Stage III AKI during a hospitalization.  The study will assess the 
feasibility of the ACT intervention, and obtain preliminary estimates of its impact on kidney care quality metrics, 
patient-reported, and clinical outcomes.  Also, as part of this trial, we will assess user interactions with the ACT 
intervention, tool fidelity, and acceptability of the intervention for patients and clinicians through direct 
observation and qualitative interviews. Data collection will include medical record review, interviews, and 
video/audio recording of the clinical encounters. 
 
Setting: This pilot randomized clinical trial will occur at Mayo Clinic in Rochester, an academic medical center 
in Minnesota.   
Sample, recruitment:  
Clinicians: All clinicians responsible for caring for eligible patients will be considered for inclusion in the 
qualitative research.  The research team has secured buy in from relevant stakeholder groups across the 
institution to pilot the ACT intervention.  This includes support from leadership teams from hospital internal 
medicine, family medicine, subspecialty service lines (i.e., surgical services, cardiology), community internal 
medicine and primary care, nephrology, nursing, desk operations, and pharmacy, as well as relevant 
operational committees at the institutional level.  Potential clinician candidates (e.g., nurse educators, 
physicians or advanced practice providers in primary care or nephrology, pharmacists) will be approached for 
participation before conducting an interview, direct observation, or recording an encounter with an ACT patient. 
Oral consent for participation will be obtained and only needs to occur one time per clinician (prior to the first 
study encounter they engage in).  The clinician will have the option to consent to an interview, and/or direct 
observation or recordings (video/audio or audio only) of clinical encounters with enrolled patients.  If the 
clinician agrees to recording of the clinical encounters at the time of oral consent, they may still decline at the 
time that the clinical encounter occurs.  If the clinicians and patients agree to the recording, the study 
coordinator will start the recording before leaving the room. The participants can stop this recording (video, 
aimed at the desk, or audio when the video camera is aimed at the ceiling) at any time (the device has a large 
red start/stop button and an on/off indicator light). If the clinician declines to do the recording, they are still 
eligible for participation in other qualitative aspects of the study, including direct observations of the encounter 
with note taking by a qualitative analyst or a qualitative interview.  Similarly, if the clinician declines to 
participate, the patient is still eligible for the study, but qualitative evaluations will be omitted. Clinicians will be 
informed that there is no monetary or other sort of reimbursement for participating in the trial and that 
participation will not affect their current or future employment or be shared with their supervisor. 
Patients: Participants will be recruited from those identified by a developed electronic health record list 
of patients with AKI.  Included individuals that populate the list are those with stage III AKI (severe) during a 
hospitalization based on serum creatinine rise or urine output decline18 from Olmsted County. The EHR list 
which includes these criteria was developed, tested, and refined for accuracy and completeness as part of IRB 
20-004204 (see above preliminary data). Screened individuals with dementia, those who are non-English 
speaking, or expected to dismiss to a skilled nursing facility at discharge will be excluded.  Individuals who are 
expected to need dialysis at discharge or who are discharging on hospice will be excluded.  If the patient is 
actively enrolled in the Primary Care Transitions Program at hospitalization they will be excluded.  Recipients 
of any transplant, including solid organ, hematopoietic stem cell, or CAR-T, within 100-days of enrollment will 
also be excluded.  Individuals may only be enrolled in the trial one time.  Trained study team members will 
approach potential candidates during their hospitalization to obtain written informed consent. Individuals will be 
provided with information about the research, HIPAA Authorization, and IRB approved consent forms for 
review. Sufficient time will be allowed for discussion and patient questions. Patients will be informed that 
declining to participate in the study will not impact the care that they receive. Consent will be obtained in 
person where possible, but may be obtained via telephone call depending on the safest mode of contact due to 

 
 
 
 
 
 
 
 
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COVID-19.  All consenting patients will be included in the clinical trial. No reimbursement or remuneration will 
be provided for participation. 
Randomization: Should the patient consent to participate, the individual will randomly be assigned 1:1 to one of 
two groups, the ACT group (intervention) or usual care (control).  Randomization will occur via sealed 
envelopes which will contain the randomization information. Based on our preliminary data, randomization will 
be stratified according to hospital service/source: hospital medicine/family medicine or other services.  
Individuals will be randomly allocated equally to the intervention or control groups within each stratum using a 
permuted block design with varying block sizes of between 2 and 4.  The target sample size is 50 (25 per 
group).  The study coordinator will disclose the group allocation to patients after completing standard informed 
consent for participation in clinical research including permission to use protected health information.   
Intervention: The ACT intervention was approved by the Mayo Midwest Clinical Practice Committee 
and local discipline specific subcommittees (nephrology, primary care, pharmacy).  The intervention workflow 
was developed and pilot tested as part of IRB 20-004204.  A description of the intervention is undergoing peer-
review for publication (Barreto, et al.).  As outlined in the preliminary data, patients randomized to the ACT 
intervention receive a multicomponent transitional support bundle including 1) a consultation from nurse 
educators before discharge to deliver kidney health education using approved materials available for use by 
any Mayo Clinic provider or patient (http://intranet.mayo.edu/charlie/nephrology-hypertension-
rst/education/patient/ , https://askmayoexpert.mayoclinic.org/topic/clinical-answers/cnt-20114555/sec-
20114604 ), 2) coordinated appointments for post-discharge laboratory testing (serum creatinine and urinalysis 
with microscopy), a primary care provider visit, and a pharmacist visit within approximately two weeks of 
discharge.  Each of these elements would be considered standard for an AKI survivor, but the ACT intervention 
aims to operationalize them more cohesively and consistently to facilitate the care transition.  A note will be 
entered into the patient’s EHR to communicate enrollment to the healthcare providers.  As an example, a note 
that may be entered for an intervention patient could be as follows:  
“The patient has been enrolled in the ACT (AKI in Care Transitions) trial because they were identified 
as having biomarker changes consistent with severe AKI (creatinine elevation or oliguria/anuria) and 
are not expected to leave the hospital on dialysis. They will receive kidney health education from a 
dedicated team nurse and the ACT team will prepare dismissal orders for a kidney function panel 
(extended electrolyte panel that includes serum creatinine), a urinalysis with microscopy, a visit with the 
primary care provider and a visit with an ambulatory care pharmacist for your consideration at dismissal 
summary signing.  Please contact Erin Barreto 127-14124 if there are any questions or concerns.”   
A failsafe EHR clinical decision support tool exists to prompt these dismissal orders for care teams should they 
be discontinued.  Individuals will also be enrolled in a ‘care path.’ This tool operates based on embedded rules 
in the EHR to deliver context appropriate prompts and resources for providers.  The benefits of a ‘care path’ is 
that it is not affiliated with a specific encounter.  It remains active for the patient regardless of setting (inpatient 
or outpatient) until the rule-based criteria are fulfilled (i.e., education delivered, visits ordered and scheduled, 
visits and tests completed).  In the post-hospital primary care provider and pharmacist visits, a passive Epic 
‘best practice advisory’ has been created to encourage care providers to address kidney function, education, 
medication management, blood pressure assessment and sick day counseling.19  Institutional provider or 
patient resources on AKI survivor care are available for use in these visits 
(http://intranet.mayo.edu/charlie/nephrology-hypertension-rst/education/patient/ , 
https://askmayoexpert.mayoclinic.org/topic/clinical-answers/cnt-20114555/sec-20114604 ).  A structured 
documentation template for visits has been developed.  If deemed appropriate, nephrology referral will be 
coordinated by the PCP. 
Control. Participants in the control group will receive no specific study-related intervention. AKI 
identification, patient education, and follow-up care will be at the discretion of the primary treating team. It is 
customary for these patients to receive some degree of laboratory monitoring and clinical follow-up in the post-

 
 
 
 
 
 
 
 
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discharge period, but for this group, timing and components will not be standardized. Care providers have 
access to the same educational materials for providers and patients as in the intervention group.  These are 
published on the Mayo Clinic intranet (http://intranet.mayo.edu/charlie/nephrology-hypertension-
rst/education/patient/ , https://askmayoexpert.mayoclinic.org/topic/clinical-answers/cnt-20114555/sec-
20114604 ).   
 
Data collection 
Individuals that consent to participate will be captured in the REDCap system.  Those found to be ineligible or 
eligible but decline participation will be captured in a recruitment tracking log.  Data sources for the study 
include medical record review, interviews, and direct observations or video/audio recordings of the clinical 
encounters.  An overview of the data collection plan is outlined in Table 1. 
 
Data will be abstracted from the EHR on patient demographics, comorbidities, attributes of the hospitalization, 
details about the episode of AKI and the degree of recovery by discharge, follow-up processes of care 
(laboratory assessments, visits), and clinical outcomes.  Core data to be collected will include age, sex, height, 
weight, race/ethnicity, socioeconomic status, health literacy (using the Brief Health Literacy Screen), history of 
hypertension, diabetes, cardiovascular disease, chronic kidney disease, or other vascular diseases, hospital 
and intensive care unit length of stay, reason for admission (non-operative, operative), discharge disposition, 
whether nephrology was involved with the patient’s care during the hospitalization, the severity of AKI, need for 
dialysis, and discharge kidney function. Select medication data will be collected at baseline (preadmission 
based on the documented medication list in the EHR), discharge, and 30-day follow-up.  This will include the 
use of angiotensin converting enzyme inhibitors/angiotensin receptor blockers (ACEi/ARBs), sodium glucose 
co-transporter 2 inhibitors (SGLT2i), metformin, GLP-1 receptor antagonists, sulfonylureas, insulin, loop 
diuretics, thiazide diuretics, statins, aspirin, non-steroidal antiinflammatory drugs (NSAIDs).  The total number 
of medications at discharge will be evaluated.  Using previously described methods, EHR documentation for 
patients who complete a follow-up encounter with a health care provider (provider, pharmacist, or other), will 
be reviewed to identify medication discrepancies and drug therapy problems.20  These will be catalogued for all 
medications and specifically nephrotoxic or renoprotective medications.  Drug therapy problems will be 
categorized as pertaining to effectiveness, indication, safety, or adherence.  Additional data elements may be 
abstracted from the electronic health record to support the study aims.  Data will be collected in a secure 
REDCap database designed expressly for this study.  REDCap (https://redcap.mayo.edu/redcap/index.php) is 
a secure, web-based application that is HIPA compliant and available 24 hours per day. Data will be managed 
by the trial statistician and the principal investigator.   
 
Outcomes  
Feasibility and acceptability: To assess the feasibility of the ACT intervention, we will evaluate the 
number of patients able to be successfully randomized during the study timeframe (intention to treat group).  
We will also determine the proportion of those randomized to the intervention group who complete the nurse 
education visit, laboratory testing, pharmacist visit, and primary care provider visit (per protocol group).  For 
those who do not complete the full ACT intervention, we will characterize the attrition [i.e., change in goals of 
care/clinical status, inability to deliver education during hospitalization, inability to schedule post-dismissal 
visits, patient did not complete the post-dismissal visit(s)]  Acceptability of the ACT intervention will be 
determined through the use of the “Was it worth it?” survey at follow-up21,   qualitative interviews with 
consenting clinicians and patients and an analysis of recordings (video/audio or audio) of the clinical 
encounter.  Using a semi-structured interview guide, interviewees will be asked to describe their experiences 
with the structure and process of the ACT intervention and their sense of their outcomes.  Interviews will be 
conducted in-person or over the phone. All interviews will be audio-recorded with permission and immediately 
transferred to secure and password-protected servers from which only authorized research personnel can 
conduct evaluations.  Audio files will be transcribed verbatim by an approved Mayo Clinic transcription service. 

 
 
 
 
 
 
 
 
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The data will be held confidential and shared among the team members. Transcripts will then be reviewed by a 
trained qualitative analyst and codes will be assigned.  Both deductive analysis (informed by theoretical 
frameworks) and inductive analysis (identification of emerging themes) will occur. Themes identified from 
patients and clinicians will be compared. The data will be used to refine the ACT intervention for future testing. 
Study team members will review video/audio recordings to assess the impact of the ACT intervention on the 
encounter.  Reviewer(s) will watch the video (if available) and read the transcripts for the clinical encounter.  
Based on the literature, encounters will be primarily evaluated for six elements of kidney health follow-up for 
AKI survivors: Kidney function, advocacy/education, medication reconciliation/review, blood pressure, sick day 
counseling, and a follow-up plan.22,23  Twenty percent of the recorded encounters will be reviewed by two study 
team members independently and in duplicate.  Concordance between individuals in assigned ratings of the 
six elements will be evaluated.  If greater than 0.8, reviewers will be considered concordant and one study 
team member will evaluate the remaining encounters. If concordance is not met, an additional 20% of the 
included encounters will be evaluated in duplicate.  The duration of time (minutes) spent on each element will 
be catalogued.  Reviewers will record whether the clinician utilized the ACT ‘best practice advisory’ in the 
electronic health record, or any AKI or kidney health handouts or print or electronic materials during the clinical 
encounter.  In primary care encounters, occasions where kidney health was discussed will be catalogued as 
clinician-initiated or patient-initiated.   
Patient-reported outcomes: We will evaluate patient knowledge about AKI measured with an adaptation 
of the Kidney Knowledge Survey (modified KiKS; mKiKS). mKIKS assesses participants’ objective knowledge 
about AKI causes, risk factors, and management.25 Unanswered questions (missing data) on the mKiKS are 
assigned a score of 0, and the total score is used for comparisons.  mKIKS will be evaluated at randomization 
and 30  +/- 7 days post-discharge in all patients.  Quality of life will be assessed at randomization and 30 +/- 7 
days post-discharge in all patients using the PROMIS Global 10 tool (v1.2).  The aforementioned “Was it worth 
it?” survey will be performed at 30 +/- 7 days post-discharge.21  Patient-reported outcomes will be collected in 
person or over the phone by a study team member (estimated time to complete in pilot testing is 15 minutes). 
Clinical and process outcomes: Participants will be followed for 1 year post-discharge or until death or 
loss of follow-up within that timeframe. At 90-days, clinical outcomes to be assessed include Major Acute 
Kidney Event (MAKE) at 90-days, unplanned emergency department visit or rehospitalization.  Incidence of de 
novo or progressive chronic kidney disease or death up to 12-months after discharge will be documented. 
Number of nephrotoxic medications, medication discrepancies, and drug therapy problems will be described.  
Process outcomes will include kidney laboratory assessments and their timing, clinician visits (e.g. with primary 
care provider, pharmacist, nephrologist), visit type (in-person vs telemedicine/virtual), and timing.  
 
Table 1. Summary of study measures 
Element 
Source 
Admission 
Randomization 
Discharge 
Study follow-up 
visit (intervention 
patients only) 
30-days 
90-
days 
1-year 
Sociodemographic 
factors, comorbidities 
EHR 
X 
 
 
 
 
 
 
Attributes of 
hospitalization and AKI 
episode 
EHR 
 
 
X 
 
 
 
 
Medication utilization 
EHR 
X 
 
X 
 
X 
 
 
Brief Health Literacy 
screen 
Patient 
self-report 
 
X 
 
 
 
 
 
mKiKS 
Patient 
self-report 
 
X 
 
 
X 
 
 

 
 
 
 
 
 
 
 
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PROMIS 10 
Patient 
self-report 
 
X 
 
 
X 
 
 
Was it worth it? 
Patient 
self-report 
 
 
 
 
Xa 
 
 
Encounter observation 
+/- video/audio 
recording 
Direct 
observation 
 
 
 
Xa 
 
 
 
Qualitative interviews 
Patient or 
clinician 
self report 
 
 
 
 
Xa 
 
 
MAKE, unplanned ED 
visit, rehospitalization 
EHR 
 
 
 
 
 
X 
 
CKD or death 
EHR 
 
 
 
 
 
 
X 
Kidney laboratory 
assessments, outpatient 
clinician visits 
EHR 
 
 
 
 
 
X 
 
a: Intervention patients only 
 
Statistical analysis 
Analysis plan: To describe the feasibility of ACT and generate preliminary estimates of the effect on 
patient reported and clinical outcomes, descriptive analyses will be conducted in three groups 1) the intention 
to treat population (anyone randomized), 2) the per protocol population (randomized patients who receive the 
assigned study intervention; in the case of ACT patients this would include completion of nurse education, 
laboratory testing, pharmacist visit, and primary care provider visit), and 3) the complete follow-up population 
(the per protocol population with follow-up patient reported outcomes at 30 +/- 7 days).  Baseline 
characteristics will be described with means and standard deviations and counts and percentages and 
compared using t-tests and chi-squared tests, respectively.  Any baseline imbalances (p<0.05) will be explored 
as a possible factor to adjust for when the outcome measures are analyzed.  The CONSORT guidelines will be 
followed to transparently report study results. 
AKI knowledge will be described between groups with the mean mKiKS score. In patients with incomplete 
follow-up, model imputation will be used to impute follow-up scores.  Mean between-group differences in the 
total baseline and follow-up scores will be compared using the t-test or non-parametric Mann Whitney U test. 
An exploratory multivariable linear regression model will be fit with group assignment as the independent 
predictor of interest, mean follow-up knowledge scores as the dependent variable, and baseline scores as a 
covariate. Other variables to be considered will include age, sex, baseline health literacy, socioeconomic 
status, and baseline comorbidities, specifically CKD. Clinical outcomes up to 12-months will be compared with 
Cox proportional hazards models. 
Sample Size: As a pilot clinical trial, we will include all eligible candidates during the enrollment period. 
Based on preliminary feasibility data, we estimate approximately 1-2 patients per week will be identified with 
the EHR trigger, of which 70% will be eligible, agree to participate in the trial, and have evaluable outcomes 
data. We, therefore, estimate enrollment of approximately 25 patients per group (50 total) during the 18-month 
study timeframe. A sample size of 25 participants per group would be sufficient to detect a mean difference of 
2 points on the mKiKS score (12.5%), using a two-tailed alpha of 0.05 and 80% power, assuming a standard 
deviation of 15%. Results from this study will provide the necessary pilot data to inform future investigations.  
Data safety monitoring plan 

 
 
 
 
 
 
 
 
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This study will employ a Data Safety and Monitoring Plan (DSMP) to guide our efforts to monitor participant 
safety, data completeness and adherence to study protocol. This study does not plan to employ a Data Safety 
Monitoring Board (DSMB). The decision not to establish a DSMB is based on the fact that: (1) this is not a 
Phase III clinical trial; (2) the study will not employ a high-risk intervention; (3) the study is not blinded 
(masked); and (4) the study does not involve vulnerable populations. The DSMP will monitor participant safety, 
data integrity, participant privacy, data confidentiality, and study documentation.  The trial steering committee 
will review the plan during meetings (at least quarterly) until data collection and analysis are completed.  Any 
potential adverse events will be entered into the study database and the Mayo Clinic IRB will be notified.   
Protection of human subjects 
This research could not practicably take place without the use of human subjects. Study launch, recruitment, 
participant consent, and data collection will be performed by study personnel with human subjects training and 
approvals. Study staff from Mayo Clinic will be responsible for coordinating human subjects research approvals 
and consent procedures for all participants. 
The risks to participants are minimal. Study procedures include education, laboratory specimen collection and 
a healthcare visit consistent with routine clinical care. The ACT intervention aims to operationalize them more 
cohesively and consistently to facilitate the care transition.  A potential risk to participants is a loss of 
confidentiality. This risk will be minimized by research procedures that outline consent requirements and 
processes, and data collection and data transfer systems that ensure secure storage and transmission and 
restrict access to approved members of the study team. This includes use of HIPAA compliant electronic data 
capture tool hosted by Mayo Clinic (Research Electronic Data Capture [REDCap]). Any research material 
outside of what is stored within this web-based interface will be maintained on a secure server beyond the 
Mayo Clinic firewall or in locked file cabinets All data collection and management will be obtained specifically 
for research purposes and only approved research personnel will have access to identifiable private 
information. Participants will be assigned a unique study number, which bears no relationship to personal 
identifiers including name, initials, address, telephone number, social security number, or patient number. This 
unique study ID will be used to identify participants in all computer files and analyses to maintain 
confidentiality. Completion of study questionnaires will be performed in private areas of the medical center 
either face-to-face or over the phone, to ensure the privacy of the research participant.  Findings will be 
summarized and reported in aggregate without patient identifiers. Given the confidentiality measures outlined 
above and the measures proposed to protect against this risk, we believe the likelihood of a confidentiality risk 
to research subjects would be minimal. 
 
 

 
 
 
 
 
 
 
 
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