Deprescribing for Older Dialysis Patients
Conditions: Kidney Failure, Chronic
Sponsor: Duke University



emailed to participants who prefer this, or a physical copy of the signed consent mailed to the participants’ 
home address. For patients who will be approached about this study, the consent process will be 
conducted in their home or in a private manner in the dialysis unit. If there is concern about privacy by the 
potential subject, the study team will accommodate the potential subject to enhance privacy (e.g., privacy 
curtain at the dialysis chair or private room in the dialysis unit). 
 We will conduct semi-structured interviews with patients to understand why patients may hold specific 
attitudes towards deprescribing and to identify preferences in delivery method and approaches to patient 
engagement in a deprescribing intervention. If patients participating in interviews have a caregiver or 
spouse who assists with their medications, the caregiver will be asked if they would be willing to 
participate in the interview with the patient to assist them in answering any of the interview questions. 
There will be some specific questions to engage caregivers in order to understand their values with respect 
to potential adverse events from medications in their loved one and their potential role in the deprescribing 
process. The caregiver / spouse will be asked to sign an information sheet  with a brief explanation of the 
study, the purpose of their participation in the interview, a statement that the interview will be audio 
recorded, and a statement explaining that research is voluntary. By signing the information sheet, the 
caregivers agree to participate in the interview and allow their voice to be audio recorded. Beside the audio 
recording, no PHI will be obtained from spouses / caregivers. Interviews will be will be held at local dialysis 
units or at their home or other location on a day/time convenient for study subjects.  We anticipate each 
interview would last up to one hour, be audio recorded, and later transcribed by an experienced research 
transcriptionist. We anticipate theme saturation will be achieved after 12-15 unique patient interviews with 
patients age 65 and older, and 12-15 interviews with patients age 55-64.
We will conduct separate focus groups (and/or interviews) with nephrologists, pharmacists, primary care 
providers, and dialysis staff. In these sessions, we will explore ways to increase shared decision-making 
between nephrologists, patients, and other providers; attributes of a deprescribing intervention that would 
be acceptable and feasible (including study protocol training); and concerns from providers about risk 
associated with deprescribing specific PIMs (i.e., adverse drug withdrawal events). Focus group sessions 
(or semi-structured interviews) will be held at local dialysis units or other location on a day/time 
convenient for study subjects. Each group will include 8-12 participants per session. Sessions would last up 
to one hour and will be led by study team members, audio recorded, and later transcribed by an 
experienced research transcriptionist. When a focus group cannot be assembled, study team will conduct 1:
1 interviews. During the course of the study, we will conduct key informant interviews with the 
following types of providers: 1) individuals with particular experience and/or expertise in 
pharmacist-led interventions, deprescribing, dialysis medication therapy management, or other 
related topics, and 2) individuals who are unable to complete focus group but express desire to 
until theme 
 
contribute perspectives to the study. Focus groups and/or interviews will continue
saturation is achieved (which is anticipated after 2-3 focus groups of each provider type).
Data collection: The study team will collect the following information from nephrologists, pharmacists, 
PCPs, and dialysis staff 
 demographics, 
quantity of older 
who consent for this study: 
 
email address,
dialysis patients in their practice, 
length of 
, 
practice setting, proportion of time spent in patient care
time in their current role, and their role on the dialysis care team (for dialysis staff) (e.g., social worker, 
physician, nurse, nurse manager, and administrator).
Study team members will collect the following information from patients by  medical record, in person (eith
by study team, or by REDCap survey link provided to 
 
er at the dialysis clinic, or at the subject’s home)
each subject.:
Demographics
Contact information (phone, mailing address, email address)
Dialysis characteristics (from medical records 
length of time on 
 
and/or patient self-report:
dialysis, type of dialysis, dialysis access type, cause of end-stage renal disease, dialysis schedule)
Clinical characteristics [comorbidities from medical records (per Charlson index categories) and/or 
,
self-report]
Medications by self-report, bottle review, and/or medical records (including pharmacy records); If 
recruiting from a dialysis unit, we will conduct medication reconciliation by comparing 
participants’ medication bottles to the dialysis unit’s medication list. If there is significant 
discrepancy, we will discuss the medication reconciliation process with dialysis staff to 
identify the source and ways to minimize discrepancies. 
Cognitive evaluation (using Trails Making Test A and B, and Saint Louis University Mental 
 instrument),
Status (SLUMS)
functional status (basic and instrumental activities of daily living)
falls history
the revised Patient Attitudes Towards Deprescribing (rPATD) questionnaire.
Delirium assessment by 3DCAM instrument

Symptoms index using Question#2 from the IPOS-renal 7 day recall instrument, and additional 
symptoms commonly managed by opioids, benzodiazepines, muscle relaxants, and anticholinergic 
medications (e.g., anxiety, depressed mood, muscle cramps, and headaches)
There will be no follow-up for this study aim.
*Recruitment for Aim 1 has now been completed.*
Specific Modifications During COVID-19 Pandemic
Recruitment letters will be mailed out to patients. 
Utilizing a HIPAA compliant phone script, a follow up call will be made to the patient and the details 
of the study and participation will be reviewed. Patients will be given at least one day to consider 
participation if needed. Verbal consent will be obtained by phone, as allowed by a waiver of 
documentation.
A copy of the unsigned consent will be mailed or emailed to the patient if they desire.
Patient interviews will be done remotely by phone and audio recorded. If a spouse / caregiver 
would like to participate, they will be informed that the interview will be audio recorded, and verbal 
permission to record their voice will be obtained on the phone.
Medication reconciliation will be done over the phone by comparing the patient’s medications listed 
in the DaVita Falcon EMR to what the patient verbally says they are taking. 
Since the TRAILS and SLUMS tests require patients to complete a written portion, these tests will 
not be administered during the COVID-19 restrictions.
An alternative cognitive assessment, a modified MOCA test, will be administered over the telephone 
during COVID-19 restrictions.  
We will not administer the chair stand test during COVID-19 restrictions.
After the physical distancing orders are lifted, we will attempt to complete any incomplete study 
procedures in-person: memory testing with modified MOCA (or the TRAILS and SLUMS tests), as 
well as the chair stand test required for assessment of frailty in subjects age 55-64.
Aim 2 -  
We used the qualitative data from Aim 1 to design a deprescribing quality improvement program (QIP) for 
dialysis patients. We are seeking IRB approval for evaluation of this deprescribing QIP.  
Brief Description of Deprescribing QIP: The dialysis deprescribing team (pharmacist, nurse, physician) will 
conduct the process of deprescribing in patients aged 55 and older who have been undergoing dialysis for 
at least 3 months and have regular use of a PIM based on their Duke electronic medical record (EMR). 
PIMs for deprescribing will include antihypertensive PIMs (alpha blockers and central alpha agonists) and 
psychoactive 
medications, such as gabapentinoids, muscle relaxants, and Z-drugs (e.g., zolpidem). The team will also 
conduct chart review to discern if the patient is a candidate for deprescribing the specific PIM. After 
identification of eligible patients, the deprescribing team will provide a deprescribing recommendation 
(including instructions for deprescribing the PIM) to the nephrologist (or other dialysis provider). If a 
patient agrees to attempt deprescribing a PIM, the team will supervise implementation and monitoring of 
the deprescribing. 
Deprescribing PIMs is considered a best practice for providing care to older adults with multiple 
comorbidities. It can improve quality of life, reduce medication related problems and lower financial burden 
to patients.  It is consistent with the American Geriatrics Society’s guiding principles to make clinical 
1
decisions that optimize benefit and minimize harm.  Deprescribing, as part of routine geriatrics care, 
2
carries minimal risk. It is not routine for dialysis clinics; however, a Canadian dialysis deprescribing QIP 
demonstrated favorable preliminary outcomes on reducing polypharmacy.  
3
1.
Woodford HJ, Fisher J. New horizons in deprescribing for older people. 
2019;48
Age and Ageing. 
(6):768-775.
2.
Boyd C, Smith CD, Masoudi FA, et al. Decision Making for Older Adults With Multiple Chronic
Conditions: Executive Summary for the American Geriatrics Society Guiding Principles on the Care of Older
Adults With Multimorbidity. 
2019;67(4):665-673.
J Am Geriatr Soc. 
3.
McIntyre C, McQuillan R, Bell C, Battistella M. Targeted Deprescribing in an Outpatient
Hemodialysis Unit: A Quality Improvement Study to Decrease Polypharmacy. American Journal of Kidney
2017;70(5):611-618.
Diseases. 
Aim 2 Research Activities. Because personnel designated to conduct deprescribing decision-making has not 
been clearly defined in dialysis units, we want to evaluate the program with and without team assistance 
with shared decision-making. We plan to evaluate the QIP when delivered in two formats: 

Deprescribing steps 
QIP - Provider communication 
only
QIP - Provider/Patient 
communication
Identify eligible patients
(medication review)
Deprescribing team reviews medical 
records to identify potential patients 
Deprescribing team gives 
recommendation to nephrologist (or 
other dialysis provider).
Deprescribing team reviews medical 
records to identify potential patients
Deprescribing team gives 
recommendation to nephrologist.
Deprescribing team waits for 
nephrologist approval.
Decision-making
The nephrologist decides whether to 
proceed with the recommendation 
and  talk with the patient on their 
own. 
Research activity: Questions to 
nephrologist about acceptability of 
the recommendation (see text)
If approval from nephrologist, study 
team talks to patient about 
recommendation and that nephrologist 
supports the recommendation. 
education to patient about medication 
risk and process for deprescribing. 
Team asks if patient is willing to 
proceed with deprescribing
Deprescribing
If patient agrees, 
will 
Nephrologist 
provide instructions for 
deprescribing.  
Research activity: Questions to 
nephrologist about acceptability of 
the recommendation (see text) and 
deprescribing attempts
Research activity: After a patient 
decides (either for or against 
deprescribing), they will be 
approached for consent for an 
interview and/or survey. This 
approach will be by recruitment 
letter mailed and/or provided in 
person at the dialysis clinic.
We will document deprescribing in 
medical record and to pharmacy.
If patient agrees, the deprescribing 
 will provide instructions for 
team
deprescribing. 
Research activity: After a patient 
decides (either for or against 
deprescribing), they will be approached 
for consent for an interview. This 
approach will be by recruitment letter 
mailed and/or provided in person at 
the dialysis clinic. 
We will document deprescribing in 
medical record and to pharmacy.
Monitoring
Deprescribing team will assist 
patient with any issues during 
deprescribing step AND contact 
patient after a month to check on 
progress and ask about symptoms.  
Deprescribing team will assist patient 
with any issues during deprescribing 
step AND contact patient after a month 
to check on progress and ask about 
symptoms.  
1.  
2.  
QIP- Provider Communication Only: Deprescribing team communicates only with the dialysis 
providers. Dialysis providers leads decision-making with patient.  
QIP- Provider/Patient Communication: Deprescribing team includes either a pharmacist or a nurse 
who communicates with providers and patients.  After dialysis provider buy-in, the deprescribing 
team leads decision-making with patient.
Whether a patient falls into the Provider Communication Only or Provider/Patient communication is based 
on availability of the nurse or pharmacist. For example, if the team nurse or pharmacist is available only 
on Tuesdays and Thursdays, then the patients and providers that they can communicate with on those two 
days will be part of Provider/Patient Communication QIP.
The table below delineates deprescribing steps for each format (QIP – Provider Communication Only and 
QIP – Provider / Patient Communication) in parallel to demonstrate similarities and differences (italics):
Aim 2 Data collection: We are collecting data for program evaluation. we will assess demand, 
deprescribing attempts, change in PIM burden (number of PIMs) and feasibility (acceptability and 
practicality), 
Demand: We will assess demand from chart review and define demand as the proportion of patients with a 
specific PIM divided by all patients with PIMs. 

Deprescribing Attempts: We will assess number (and %) of deprescribing attempts in each format of the 
QIP. The denominator would be total number of patients who were approached for deprescribing decision-
making. The approach for each format:
QIP – Provider Communication Only: We will ask dialysis providers if the patient agreed to 
deprescribe after a month. 
QIP – Provider / Patient Communication: We will collect information from the deprescribing team on 
whether the patient agreed to deprescribe.  
participants who agreed to deprescribed were called after 3 months to see if they remained off PIM or at a 
lower dose of the PIM
Change in PIM burden: We will assess change in PIM burden as measured by Sustainability at 3 months; of 
those who can be reached, proportion of patients who remain off PIM at at a lower dose at 3 months. 
Participants who agree to deprescribe will be called after 3 months to see if they remain off PIM or at a 
lower dose of the PIM.
Time frame: 3 months.
Provider Acceptability: For the QIP-Provider Communication only format, we want to assess provider 
acceptability of the QIP recommendation. Specifically,  When the nephrologist (or other dialysis provider) 
receives the recommendation from the deprescribing team, they will receive a short survey with two 
primary questions: 1) Will you implement this deprescribing plan? 2) If not, would you support 
implementation of this deprescribing plan if you had assistance from the deprescribing team? At the end of 
the month, we will ask the nephrologist some questions about the deprescribing plan:  What worked about 
the deprescribing program recommendation? What did not work?
Patient acceptability: In both formats, we will assess patient acceptability. After a patient decides (either 
for or against deprescribing), they will receive a recruitment letter (either mailed to them, or given to 
them by a member of their care team) or may be called or approached in-person at the dialysis clinic to 
invite them to participate in an interview and a set of surveys. Patients will be able to choose to participate 
in data collection alone (baseline surveys and again at 3 months), or complete both an interview and the 
surveys. The consent process and interview will either be by phone or in person at the dialysis clinic. A 
description of the logistics for interviews is as described for Aim 1. The interviews will be audio recorded 
and later transcribed by an experienced transcriptionist. We expect to conduct interviews in 12-15 
subjects. The focus of the interviews will be on acceptability of the clinical program (e.g., experience, 
perceived burden, negative consequences or side effects). 
Practicality: We can assess practicality in the QIP – across both Provider Only and Provider/Patient 
communication formats in the following measures:
Time (in days) spent awaiting provider response to recommendation
Time (in days) to initial patient communication 
Number of attempts to reach patient, number of conversations, and length of conversations
Additional data collected for Aim 2 is listed below. This data will be obtained from the medical record and 
through patient communication for the clinical program. We will also assess for clinical events by self-
report and/or medical records.:  
Age / DOB (if age >89, will record as age 90)
Gender
Race 
Ethnicity
PIM prescription
Length of time on dialysis 
Comorbidities
Medication counts
Presence of adverse drug withdrawal event (ADWE), type of ADWE, and if associated with 
unscheduled clinic visit and/or serious adverse event. 
Geriatric Assessment: Recent studies suggest that decisions around medications are related to other 
geriatric problems, such as mobility, cognitive dysfunction, and patient preferences. Therefore, we plan to 
ask patients to complete a geriatric assessment. The geriatric assessment will be administered via REDCap 
survey. Either study staff will assist patients with completion of the assessment remotely (via telephone 
call or zoom), or patients may complete the assessments on their own via an emailed REDCap link. 
Surveys include: geriatric assessment of mood, medication adherence, nutritional status, social support, 
what matters most, and mobility via the following survey instruments: Patient Health Questionnaire-9, 
Morisky Medication Adherence Survey, Health Outcomes Priorities, CDC Falls risk checklist, Modified 
Medical Outcomes Study Social Support Scale, Received Social Support & Satisfaction Measure, Simplified 

1.  
2.  
3.  
4.  
5.  
6.  
7.  
8.  
9.  
We aim to recruit a total of 24-30 patients for Aim 1. Duke does not have an outpatient dialysis unit, but 
we expect at least 50% of Aim 1 patients also receive care from Duke (n=27).) We will identify dialysis 
patients from 9 local DaVita hemodialysis units:
 
DaVita Durham Dialysis (Hood Street)
DaVita Southpoint Dialysis
DaVita Durham West Dialysis
DaVita Research Triangle Park
DaVita Bull City Dialysis
DaVita Durham Regional
DaVita Roxboro
DaVita Kerr Lake
DaVita Vance County
 
We have received approval from DaVita Clinical Research to conduct research in DaVita dialysis units. We 
have two unique approaches to recruitment and data collection described below:1) independent of DaVita 
units, and 2) engagement of DaVita units. 
Independent of DaVita units: We may recruit patients who were previously enrolled in past dialysis studies 
and are known to the Research Coordinator. Recruitment letters may be mailed and / or a phone call may 
be made by the coordinator to inquire about interest in participation. Alternatively, eligible patients may be 
identified by Duke attending physicians in the Division of Nephrology who care for these patients. 
Recruitment letters may be provided to these patients on behalf of the nephrologist. The consent process 
will occur outside of the dialysis unit setting. If consent is subsequently obtained, all study activities will be 
conducted outside of the dialysis unit. 
Engagement of DaVita units: We will identify eligible patients with the help of each unit’s dialysis care 
providers (e.g., social worker, dietician, physician, nurse, or mid-level clinical provider (physician 
assistant, nurse practitioner) by utilizing a list of subjects previously enrolled in past dialysis studies, or via 
screening of medical records.  To introduce the study to potential subjects at the dialysis clinics, a primary 
dialysis care provider or social worker who knows the patient will talk to the patient and hand out the 
recruitment letter in person. The letter will include a description of the study and a telephone number for 
the potential subject to call and inform the research team if they are, or are not, interested in additional 
research contact. When the care provider offers a copy of the letter and the patient is not interested, the 
study team will not approach the patient. If the patient is interested, the care provider will inform the 
study team, and the study team will proceed with recruitment. Only interested patients will be contacted 
by the research team about participating in the study. This contact will be by phone or in person at the 
dialysis clinic. In this initial contact, the research team will screen the subjects for eligibility, describe the 
study to eligible patients, and conduct the consenting process. If this initial contact occurs at the dialysis 
clinic, the research team will first communicate with a member of the dialysis care team (e.g., nurses, 
technicians, social work, or physician) to confirm if timing of contact is appropriate and does not interfere 
with standard dialysis care protocols. If consent is subsequently obtained, study activities may occur at the 
dialysis unit or another location preferred by patient. 
In order to identify frailty in patients aged 55-64 we will use the SOF Frailty Index. Frailty defined by the 
SOF index is identified by the presence of 2 or more of the following 3 components: 1.) Weight loss 
(irrespective of intent to lose weight) of 5% or more within the last year  2.) The subject’s inability to rise 
from a chair 5 times without using their arms  3.) Reduced energy level, as identified by an answer of “no” 
to the question, “Do you feel full of energy?” on the Geriatric Depression Scale.  At least 2 of the 3 
components must be present for the patient to be considered frail.
Specific Modifications for Recruiting and Consenting During COVID-19 Pandemic:
After screening for eligibility from a DaVita census list at each unit, recruitment letters will be 
mailed out to patients. Patient addresses will be obtained from their medical record, as per the 
waiver for screening and recruitment.
Patients will be given at least one week to opt out before a phone call will be made to determine 
their interest.
Utilizing a HIPAA compliant phone script, a follow up call will be made to the patient and the details 
of the study and participation will be reviewed. The patient will be given the opportunity to ask 
questions. 
Patients will be given at least one day to consider participation if needed. Verbal consent will be 
obtained by phone, as allowed by a waiver of documentation.
A copy of the unsigned consent will be mailed or emailed to the patient if they desire.
These modifications apply to both Aim 1 and Aim 2

, a geriatrician who is not associated with the program, will serve as Safety 
.  ADWEs will be reviewed with him quarterly. We will adjust the protocol if needed.
Monitor
Additional concerns are
  The study team has outlined procedures for 
 Loss of Protected Health Information:
data management to protect against loss of data (detailed below). Breaches in data security will be 
reported within 24 hours of detection, and a plan for management of the breach and modification of data 
security procedures will be developed within 3 business days, if applicable. 
Additional Oversight and Reporting: The PI, Dr. Hall, will be responsible for the operation of this research 
study according to the study’s protocol and IRB policies. In addition to adverse events described 
above,  The PI (or designee) will submit complaints, withdrawals, and protocol violations to the Duke 
University IRB.