Impact Collaboratory Transforming Dementia Care - Can Value Champions Reduce Inappropriate Prescribing for People With Dementia?
Phase: NA
Conditions: Dementia, Med: Dementia
Sponsor: Kaiser Permanente

Protocol Template, Version 2.0  
Title:  Can Value Champions Reduce Inappropriate Prescribing for People With 
Dementia? 
 
NCT: NCT05359679 
 
Dated: 9/13/2021 
 
Last updated: 9/26/2023 
 
 

Protocol Template, Version 2.0 
 
Clinical Interventional Study  
Protocol Template 
 
 

Protocol Template, Version 2.0 
 
PREFACE 
The Clinical Intervention Study Protocol Template is a suggested format for clinical trials 
sponsored by the National Institute on Aging (NIA). Investigators are encouraged to use this 
format, as appropriate, when developing protocols for their studies. Large multi-site 
observational studies will also benefit from this protocol template. 
Note that instructions and explanatory text are indicated by italics and should be replaced in 
your protocol with appropriate text.  Section headings and template text formatted in regular 
type should be included in your protocol document as provided in the template. 
The goal of this template is to provide a general format applicable to all single- and multicenter 
clinical intervention trials (e.g., drug, surgery, behavioral, nutritional, device, etc).  
As you can see the version number and date are on the bottom of each page. When making 
changes to an approved and “final” protocol, please provide a summary of the changes, with the 
date, at the front of the protocol. 
 
 

Protocol Template, Version 2.0 
 
 
CAN VALUE CHAMPIONS REDUCE INAPPROPRIATE PRESCRIBING 
FOR PEOPLE WITH DEMENTIA? 
 
Study Chairman or Principal Investigator: 
Lorella Palazzo, PhD 
Senior Investigator 
Kaiser Permanente Washington Health Research Institute 
Supported by: 
The National Institute on Aging 
Study Intervention Provided by:  
N/A  
Sponsor of IND/IDE:  
N/A 
Version 2 
October 20, 2022

Protocol Template, Version 2.0 
4 
TABLE OF CONTENTS 
Page 
PREFACE ...................................................................................................................................... ii 
FULL PROTOCOL TITLE ............................................................ Error! Bookmark not defined. 
TABLE OF CONTENTS ............................................................................................................. 4 
PRÉCIS .......................................................................................................................................... 7 
Study Title ................................................................................................................................... 7 
Objectives ................................................................................................................................... 7 
Design and Outcomes ................................................................................................................. 7 
Interventions and Duration ......................................................................................................... 7 
Sample Size and Population........................................................................................................ 7 
STUDY TEAM ROSTER............................................................................................................. 8 
Principal Investigator: Name .................................................................................................... 8 
Co-Investigators: Name............................................................................................................ 8 
PARTICIPATING STUDY SITES ............................................................................................. 8 
1 
Study objectives ................................................................................................................... 10 
1.1 
Primary Objective ......................................................................................................... 10 
1.2 
Secondary Objectives.................................................................................................... 10 
2 
BACKGROUND AND RATIONALE .............................................................................. 10 
2.1 
Background on Condition, Disease, or Other Primary Study Focus ............................ 10 
2.2 
Study Rationale ............................................................................................................. 10 
3 
STUDY DESIGN ................................................................................................................. 12 
4 
SELECTION AND ENROLLMENT OF PARTICIPANTS .......................................... 13 
4.1 
Inclusion Criteria .......................................................................................................... 13 
4.2 
Exclusion Criteria ......................................................................................................... 13 
4.3 
Study Enrollment Procedures ....................................................................................... 14 
5 
STUDY INTERVENTIONS .............................................................................................. 15 
5.1 
Interventions, Administration, and Duration ................................................................ 15 

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5.2 
Handling of Study Interventions ................................................................................... 15 
5.3 
Concomitant Interventions ............................................................................................ 15 
5.3.1 Allowed Interventions ............................................................................................... 15 
5.3.2 Required Interventions .............................................................................................. 15 
5.3.3 Prohibited Interventions ............................................................................................ 15 
5.4 
Adherence Assessment ................................................................................................. 16 
6 
STUDY PROCEDURES .................................................................................................... 16 
6.1 
Schedule of Evaluations ................................................................................................ 16 
6.2 
Description of Evaluations ............................................................................................ 17 
6.2.1 Screening Evaluation ................................................................................................ 17 
6.2.2 Enrollment, Baseline, and/or Randomization ........................................................... 18 
6.2.3 Follow-up Visits........................................................................................................ 18 
6.2.4 Completion/Final Evaluation .................................................................................... 18 
7 
SAFETY ASSESSMENTS ................................................................................................. 19 
7.1 
Specification of Safety Parameters ............................................................................... 19 
7.2 
Methods and Timing for Assessing, Recording, and Analyzing Safety Parameters .... 19 
7.3 
Adverse Events and Serious Adverse Events ............................................................... 19 
7.3.1 Reporting Procedures ................................................................................................ 20 
7.3.2 Follow-up for Adverse Events .................................................................................. 21 
7.4 
Safety Monitoring ......................................................................................................... 21 
8 
INTERVENTION DISCONTINUATION........................................................................ 21 
9 
STATISTICAL CONSIDERATIONS .............................................................................. 22 
9.1 
General Design Issues ................................................................................................... 22 
9.2 
Sample Size and Randomization .................................................................................. 22 
9.2.1 Treatment Assignment Procedures ........................................................................... 23 
9.3 
Interim analyses and Stopping Rules ............................................................................ 23 
9.4 
Outcomes ...................................................................................................................... 23 
9.4.1 Primary outcome ....................................................................................................... 23 
9.4.2 Secondary outcomes ................................................................................................. 24 
9.5 
Data Analyses ............................................................................................................... 24 
10 DATA COLLECTION AND QUALITY ASSURANCE ................................................ 25 
10.1 
Data Collection Forms .................................................................................................. 25 
10.2 
Data Management ......................................................................................................... 25 
10.3 
Quality Assurance ......................................................................................................... 25 
10.3.1 
Training ................................................................................................................. 25 

Protocol Template, Version 2.0 
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10.3.2 
Quality Control Committee................................................................................... 25 
10.3.3 
Metrics .................................................................................................................. 25 
10.3.4 
Protocol Deviations ............................................................................................... 25 
10.3.5 
Monitoring ............................................................................................................ 26 
11 PARTICIPANT RIGHTS AND CONFIDENTIALITY ................................................. 26 
11.1 
Institutional Review Board (IRB) Review .................................................................... 26 
11.2 
Informed Consent Forms .............................................................................................. 26 
11.3 
Participant Confidentiality ............................................................................................ 26 
11.4 
Study Discontinuation ................................................................................................... 26 
12 ETHICAL CONSIDERATIONS ....................................................................................... 27 
13 COMMITTEES................................................................................................................... 27 
14 PUBLICATION OF RESEARCH FINDINGS ................................................................ 27 
15 REFERENCES .................................................................................................................... 27 
16 SUPPLEMENTS/APPENDICES ...................................................................................... 27 
 
I. Procedures Schedule 
  
II. Informed Consent Form Template 
  
III. Other  
 
 

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PRÉCIS 
Study Title  
Can Value Champions Reduce Inappropriate Prescribing for People with Dementia?  
Objectives  
The primary objective is to assess the effectiveness of training a clinician to be a ‘value 
champion’ within their clinical setting to decrease the use of three classes of potentially 
inappropriate prescription medications (PIMs) among people living with dementia. 
(PLWD) Secondary objectives include determining if the intervention is associated with 
a reduction in emergency department (ED) visits or hospitalizations due to a fall, and 
examining five implementation outcomes: appropriateness, feasibility, fidelity, 
penetration, and equity.  
Design and Outcomes   
This study is a pragmatic cluster-randomized trial to test the effectiveness of a primary 
care clinician value champion for de-implementing potentially inappropriate medications 
among patients 65 years of age and older with a diagnosis of dementia. Medicare Part D 
pharmacy claims data will be analyzed at the end of the 12-month intervention for the 
primary outcome, the medication possession rates (MPR) for three groups of potentially 
inappropriate medications: antipsychotic medications, benzodiazepines, and 
hypoglycemic medications (sulfonylureas and insulin). In a similar fashion, a hospital 
admission, or an emergency department visit for a fall will be assessed at the end of the 
intervention using Medicare claims data. Finally, the five implementation outcomes – 
Appropriateness, Fidelity, Feasibility, Penetration and Equity - will be evaluated through 
analysis of interviews conducted with participating clinician value champions. 
Interventions and Duration  
Primary care clinics within each of the two participating ACOs will be randomized to 
either the intervention or control arms of the study. Prior to random assignment, we will 
stratify practices based on high versus low historic prescribing rates, with the cut-point 
for including a clinic in the study based on the distribution of overall rates for all 3 
therapeutic classes using data for 2019-2020. A primary care clinician from each clinic 
selected for the trial in the intervention arm (n=30 across the two ACOs) will be recruited 
as a clinician value champion for their clinic. They will participate in twice monthly 
clinician value champion training webinars for six months and then launch a 12-month 
initiative within their clinic to reduce PIM prescribing among PLWD. Study outcomes will 
be assessed 12 months after they launch their initiative. 
Sample Size and Population  
Medicare beneficiaries from claims data provided by each ACO will be included in the 
final outcome analysis if they meet all of the following criteria prior to the start of the 
intervention: a) they are seen by a clinician at a participating clinic as evidenced by one 
or more evaluation and management claims, b) they have continuous coverage in 
Medicare Parts A, B and D and no months of Part C (Medicare Advantage), and c) they 
have two or more claims with an ICD-10 diagnosis for Alzheimer’s or Alzheimer’s related 
dementia 30 days apart or 1 inpatient stay with a principal diagnosis of Alzheimer’s. We 
anticipate a total of approximately 5,000 patients will be included in this final analysis 
across both ACOs. 

Protocol Template, Version 2.0 
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STUDY TEAM ROSTER  
Principal Investigator: 
Lorella Palazzo, PhD 
KPWHRI 
1730 Minor Ave, Suite 1600 
Telephone: 206-287-2173 
Fax: 206-287-2871 
lorella.g.palazzo@kp.org 
Main responsibilities/Key roles: Dr. Palazzo will provide scientific direction and supervision 
for all aspects of the study. She will be responsible for the management and integrity of the 
design, conduct, and reporting of the study and for managing, monitoring, and ensuring the 
integrity of collaborative relationships between all participating organizations.  
Dr. Palazzo will take an active part in manuscript preparation. 
PARTICIPATING STUDY SITES  
Brandeis University 
Co-Investigators: 
 
Jennifer Perloff, PhD 
Heller School for Social Policy and Management 
 
415 South St. MS035 
Waltham, MA  02453-2728 
Telephone: 781-736-3935 
Fax: N/A 
perloff@brandeis.edu 
 
Main responsibilities/Key roles: Dr. Perloff will work with Drs. Parchman and Palazzo to 
develop a detailed study design, help create prescription reporting templates for participating 
ACOs, join in data collection activities related to fidelity assessment and implementation and 
lead the data analysis in close collaboration with Brandeis biostatistician, Dr. Ritter. 
 
Institute for Accountable Care  
Co-Investigators: 
  
 
Robert E. Mechanic 
601 13th Street NW, Suite 900 South 
Washington, DC  20005 
Telephone:  202-640-2648 
Fax: 
rmechanic@institute4ac.org 
 
 
Main responsibilities/Key roles: Mr. Mechanic will serve a co-Investigator for this study 
and lead the IAC subcontract. In this capacity, he will oversee the work of the IAC statistical 
analysis as well as provide the team with feedback on the design and results of the study. Mr. 
Mechanic will also join in team meetings and contribute to written reports and manuscripts. 

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1 
STUDY OBJECTIVES 
1.1 Primary Objective 
The Primary Outcome is medication possession rates (MPR) per quarter, for any of the 3 
classes of potentially inappropriate medications. Our hypothesis is that for each 
medication class, the intervention will produce clinically relevant decreases in mean 
possession rates of 10% of a standard deviation in patients seen in intervention clinics 
compared to those who are seen in control group clinics. 
1.2 Secondary Objectives 
As a secondary outcome, we will also assess the incidence of emergency department 
visits or hospitalizations due to a fall during the study window. 
2 
ADDITIONALLY, DATA COLLECTED THROUGH TWO INTERVIEWS WITH 
APPROXIMATELY 8 CLINICIAN VALUE CHAMPIONS WILL PROVIDE US WITH THE 
MEASURES WE NEED TO ASSESS FIVE IMPLEMENTATION OUTCOMES: 
APPROPRIATENESS, FIDELITY, FEASIBILITY, PENETRATION AND EQUITY. 
BACKGROUND AND RATIONALE  
2.1 Background on Condition, Disease, or Other Primary Study Focus 
For people living with dementia (PLWD) the overuse of Potentially Inappropriate 
Medications (PIMs), those for which the potential for harm outweighs benefit, remains a 
persistent problem despite evidence-based guidelines supporting their de-adoption.1,2  A 
group of geriatric experts convened by the Choosing Wisely initiative identified three 
classes of PIMs for PLWD: antipsychotics, benzodiazepines, and hypoglycemics 
(sulfonylureas and insulin) with adequate glycemic control.1,3 In a systematic review the 
prevalence of PIMs when cognitive impairment was reported ranged from 20.6% to 
80.5%.1  Approximately 14.3% of Medicare Part D enrollees with dementia residing in the 
general community are prescribed an antipsychotic.4 The prevalence of potentially 
inappropriate benzodiazepine prescriptions has been reported to be as high as 20% 
among elderly persons with dementia living in the community.5 The proportion of elderly 
patients with an A1c < 7% who received a prescription for sulfonylurea, insulin or 
combined insulin and sulfonylurea therapies was 35.2%, 24.2% and 16.3% respectively 
and was as prevalent in those with dementia as in those without.6 Park and colleagues 
compared rates of prescribing low-value medications in the elderly from 2006-2015 in both 
traditional Medicare and Medicare Advantage.7 Not only was there no difference in rates 
between the two groups, there was also no evidence of any decline in rates of prescribing 
over time, including use of benzodiazepines in PLWD. 
Study Rationale 
The rationale for decreasing the use of PIMs is that their use in this population of 
patients results in a greater likelihood of harm than benefit. Documented harms in the 
medical literature includes falls, worsening cognitive impairment, hospital admission, 
functional impairment, and death.  
Name and Description of the Intervention: 
This embedded pragmatic trail will test the effectiveness of a Clinician Value Champion 
on the primary outcome by randomizing primary care practices within two accountable 
care organizations to the intervention or control arm of the study. One clinician value 
champion from each clinic in the intervention arm will complete a value champion 
training program led by the P.I. and then implement care redesign activities in their 
practice to reduce the use of low value prescribing in older adults with dementia. The 6-

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month training phase (months 4-9 of the study) will consist of twice monthly webinars 
followed by a 12-month project phase. A formative and summative evaluation of a 
recently completed Robert Wood Johnson funded Value Champion Fellowship program 
resulted in the development of a training curriculum comprised of 10 learning modules 
(see Table 1) for the training phase of the intervention and a project workbook to guide 
the value champion during the 12-month project phase. Following the 6 months of 
training, value champions will participate in a monthly 1-hour shared learning webinar to 
share successes, challenges, and brainstorm solutions for 12 months (months 10-22 of 
the study). We will invite former value champion fellows and faculty from the RWJF 
fellowship to participate in these meetings to support this new cohort of value 
champions. 
  
Table 1: Value Champion Learning Modules 
Module 1: High Value Care and Health Equity Understanding the intersection between “value” and 
“equity” can inform conversations between value champions, leadership and stakeholders and inform 
project planning. 
Module 2: Engaging Leadership for High Value Care Provides participants with an overview of how 
to engage leadership throughout the project and provides practical tips on how to create and sustain this 
engagement 
Module 3: So Many to Consider: Choosing an Overused Service Overuse of low-value care is 
common, selecting a target area of overuse requires careful consideration of multiple factors that will 
impact subsequent success 
Module 4: How to Conduct a Stakeholder Assessment and Why it Is Important Identifying, 
assessing and engaging stakeholders who will be impacted by reducing the use of a service is critical to 
project success. 
Module 5: The patient voice: engaging patient participation in your project This module explains 
why incorporating the patient voice is important in reducing overuse and provides examples of how to 
do so. 
Module 6: Measurement, data and trust: Supporting change with data This module discusses 
common challenges and a range of solutions for collecting and reporting overuse data when taking 
action on overuse 
Module 7: Engaging health care professionals: the Taking Action on Overuse Change Package  
The framework and change package provides suggested key activities to select from when designing an 
intervention 
Module 8: Strategies Employed by Value Champions This module provides examples of intervention 
strategies used by clinician value champions in their setting to engage providers, staff, and patients in 
change efforts 
Module 9: Choice Architecture and Overuse Reduction This module helps participants understand 
how concepts from the field of behavioral economics can be applied to their overuse reduction initiative. 
Module 10: Planning for Sustainment  An understanding of how value champions can incorporate 
plans for sustainment into every aspect of their overuse reduction initiative is provided in this module 
 
Justification for the Intervention:  
Training and supporting a clinician value champion is a simple and pragmatic approach 
that any health system can deploy to address overuse of PIMs in their PWLD population. 
They are front-line clinicians who can advocate for and influence practice-driven change 
and may be particularly effective in de-implementing PIMs because they can: 1) be a 
trusted source of information about the potential harms of PIMs, 2) provide feedback and 
discuss prescribing behaviors with their colleagues, 3) serve as a role model for how to 

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provide guideline-concordant care for PLWD, and 4)  identify contextual barriers and 
facilitators and leverage them to reduce PIMs use in their local setting. The clinician 
champion model is widely recognized as effective in implementing evidence-based 
practices in health care settings.  
 
3 
STUDY DESIGN 
Type/Design of Trial:  
We will conduct a pragmatic cluster-randomized clinical trial of this simple non-pharmacologic 
intervention by training a cohort of Clinician Value Champions in primary care clinic settings 
across two large accountable care organizations (ACOs); Oschner Health, and United States 
Medical Management (USMM).  
Primary & Secondary Outcomes by Specific Aim: 
Specific Aim #1: The primary outcome for this study will be medication possession rates (MPR) 
per quarter, for the 3 therapeutic classes of PIMs - antipsychotics, benzodiazepines, and 
hypoglycemics using currently available Medicare claims data from each participating ACO. 
These beneficiary-level measures are calculated as quotients with denominator equal to the 
length of the quarter and the numerators equal to the days supply for prescriptions within the 
class filled during the quarter, plus excess days-supply from the previous period minus excess 
days-supply remaining at the end. Unlike many studies using medication possession rates to 
exam adherence, we are interested in reducing, not increasing, the percent of days covered.  
Specific Aim #2: As a secondary outcome, we will also assess the incidence of falls during the 
study window. Falls are difficult to monitor using claims data, but Min and colleagues have 
developed a method that IAC and Brandeis staff (Co-Investigator Perloff) have helped test for 
ICD-10.9 We will use the most conservative definition that looks for the presence of fall ‘reason 
for visit’ code on ED, ambulatory, or inpatient visit as indicated by a clinician bill (Part B). 
Specific Aim #3: The five important implementation outcomes: appropriateness, fidelity, 
feasibility, and penetration will be assessed by analysis of interviews conducted with a group 
(approximately 8) of clinician value champions who have completed the webinar training. 
 
Study Population:  
Clinician practices within each ACO will be eligible for participation in the study if they include 3 
or more primary care providers (defined as a primary care physician (specialty code of 08 or 
11), nurse practitioner (specialty code = 50) or physician’s assistant (specialty code = 97)) and 
treat 10 or more Medicare beneficiaries with Alzheimer’s or Alzheimer’s related dementia in the 
base years (2019-2020). Medicare beneficiaries within the claims data provided by the two 
ACOs will be included in the study if they meet all of the following criteria during the intervention 
year: a. they are seen by a clinician at a participating practice as evidenced by one or more 
evaluation and management claim, b. they have continuous coverage in Medicare Parts A, B 
and D and no months of Part C (Medicare Advantage), they have two or more claims with an 
ICD-10 diagnosis for Alzheimer’s or Alzheimer’s related dementia 30 days apart or 1 inpatient 
stay with a principal diagnosis of Alzheimer’s. Specific ICD-10 diagnoses to identify 
beneficiaries with Alzheimer’s or Alzheimer’s related dementia will be derived from a 
forthcoming paper by Dr. Julie Bynum and colleagues from the Technical Data Core of the 
Impact Collaboratory (personal communication, April 4, 2021). This definition is more inclusive 
than the CMS Chronic Condition Data Warehouse (CCW) definition of Alzheimer’s and was 

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specifically designed for ICD-10. Patients with a diagnosis of metastatic cancer or enrolled in 
hospice any time in the 6 months before the start of the intervention will be excluded. 
 
Randomization:  
The unit of randomization will be the primary care practice. We anticipate 32 out of 39 teams 
from USMM to meet eligibility and 26 out of 28 practices for Ochsner. Within each ACO, we will 
randomly select half of the practices for participation in the value champion training and the 
remaining practices will continue with care as usual. Prior to random assignment, we will stratify 
all clinics/practices based on high versus low historic prescribing rates, with the cut-point for 
inclusion in the study based on the distribution of overall rates for all 3 therapeutic classes using 
data for 2019-2020. Once randomized, a clinician value champion will be recruited from each of 
the clinics randomized to the intervention arm of the study in partnership with the ACO 
leadership. 
 
Study Locations: Primary care clinics within each of the two participating ACOs. 
 
Duration of Enrollment and Follow-up: Using Medicare claims data for our primary outcome, 
with a follow-up period of one year after completion of the 6-months of value champion training, 
and with mediation possession rates calculated per patient each quarter, we will have 
approximately 4 MPR observations per patient or 8,000 observations per group for USMM 
analyses and 2,000 per group for Ochsner. 
 
4 
SELECTION AND ENROLLMENT OF PARTICIPANTS  
4.1 Inclusion Criteria  
Clinician practices within two ACOs will be eligible for participation in the study if they meet 
the following criteria: 
a. They include 3 or more primary care providers (defined as a primary care 
physician (specialty code of 08 or 11), nurse practitioner (specialty code = 50) or 
physician’s assistant (specialty code = 97)) and  
b. They have clinical encounters with 10 or more Medicare beneficiaries with 
Alzheimer’s or Alzheimer’s related dementia in the base years (2019-2020).  
 
Medicare beneficiaries will be included in the study if they meet all of the following criteria 
during the intervention year:  
 
a.  They are seen by a clinician at a participating practice as evidenced by one or 
more evaluation and management claim,  
b.  They have continuous coverage in Medicare Parts A, B and D and no months of 
Part C (Medicare Advantage),  
c. 
They have two or more claims with an ICD-10 diagnosis for Alzheimer’s or 
Alzheimer’s related dementia 30 days apart or 1 inpatient stay with a principal 
diagnosis of Alzheimer’s.  
 
4.2 Exclusion Criteria  
For our analytic sample from secondary Medicare claims data we will exclude:  
a. Medicare beneficiaries with a diagnosis of metastatic cancer or  

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b. Medicare beneficiaries enrolled in hospice any time in the 6 months before the 
start of the intervention 
 
4.3 Study Enrollment Procedures  
Patient Subjects 
We will partner with two ACOs with primary care clinic locations. Prior to random 
assignment, we will stratify all clinics/practices based on high versus low historic 
prescribing rates, with the cut-point for inclusion in the study based on the distribution of 
overall rates for all 3 therapeutic classes using data for 2019-2020. These clinics will be 
randomized 1:1 to either the intervention or control arms of the study. We will work closely 
with leadership in each ACO over months 1-3 of the study to recruit an appropriate 
clinician from each clinic in the intervention arm of the study to participate in the study. A 
total of 30 clinicians across the two ACOs will participate in the intervention, with 30 clinics 
in the control group without a clinician value champion. 
 
We will request a waiver of informed consent and waiver of HIPAA authorization for 
including patient data in this study. The intervention will be embedded within the health 
care system at the clinic level as a training program for clinicians. No patients will be 
recruited into this study. Although data from human subjects are involved, no contact will 
ever be made with patients as this project involves the use of secondary data only. 
Attempting to obtain authorization or consent would not be feasible as this study will involve 
a study population of an estimated 5,000 patients. Consent and authorization of patients for 
enrollment in this study would create bias, generate prohibitive study costs rendering the 
study unfeasible, and produce results that would not be generalizable to other health care 
organizations. Furthermore, contacting 5,000 subjects for written consent would increase 
the only risk for patients - breach of confidentiality. We will ensure subjects’ protection 
against risk by following the measures outlined in the section below.  
 
Clinician Subjects: 
Clinical leaders at the two ACOs with an understanding of the scope of the project will 
identify and approach clinicians at each intervention clinic to take part in the Value 
Champions training sessions. Clinical leadership will support VCs participation in the 
project in re: time needed for training and de-implementation efforts.  
 
The clinician VCs are the de-implementation intervention. The control group (clinics) have 
no clinician VC embedded at the clinic. We   will conduct 2 interviews with approximately 8 
VCs that have completed the webinar training to measure implementation outcomes. Each 
VC who agrees to be interviewed will be interviewed approximately 5-7 months after 
webinar training is complete, and a second time approximately 10-12 months after training 
is complete. The implementation measures are not used to assess the VCs themselves (no 
personal information, or health information about the VCs will be collected). These 
interviews will be analyzed to provide insight into the de-implementation process at each 
ACO; how the de-implementation intervention was tailored and taken up in the clinical 
setting, for example. We will report each implementation outcome, both within each ACO 
and across the two ACO. 
 
An email with an information sheet attached will be sent to the Value Champions after they 
are identified by clinical leaders, and before the first Webinar training. Included in this email 
is contact information to ask questions. At the first Webinar training session, we will start 

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the meeting by reminding Value Champions about the information sheet, ask if there are 
questions, and provide contact information to use in order to ask questions privately. 
 
We are requesting a waiver of documentation of consent to enrolled clinician Value 
Champions in the study. 
 
We will mention the interviews to the clinician champions during the monthly shared 
learning phone calls, and in emails reminding the group of the upcoming phone calls. We 
will then send an email inviting the clinician Value Champions to participate, with an 
information sheet explaining the interviews. The email and information sheet will note that 
they may opt out of the interviews. The email and information sheet will also give contact 
information if the clinicians have questions about the interviews.  
 
If we have not reached recruitment goals (at least 4 clinicians at each ACO – 8 clinicians 
total) in one week, we will ask clinical leaders at the ACOs to remind clinicians to respond 
to the emails by opting in or out. If we still have not reached recruitment levels two weeks 
after the invitation email is sent, we will ask the clinic manager to forward the recruitment 
email to ask for a response. 
We are seeking a Waiver of Documentation of Consent in order to conduct these 
interviews. 
 
5 
STUDY INTERVENTIONS  
5.1 Interventions, Administration, and Duration  
No drugs or devices will be studied. The intervention is a quality improvement strategy 
consisting of a clinician value champion who will engage other clinicians within their clinic 
in an effort to decrease the use of PIMs in PLWD. Typical methods of engagement include 
educational meetings, facilitating conversations about evidence of harm, providing current 
provider-specific data on rates of prescribing, etc.   
 
5.2 Handling of Study Interventions  
No drugs, devices or dietary or nutritional supplements will be used in this study. No 
patient level interventions will be used either.  
 
5.3 Concomitant Interventions 
N/A. 
5.3.1 Allowed Interventions 
N/A 
5.3.2 Required Interventions  
N/A 
5.3.3  Prohibited Interventions 
N/A 

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5.4 Adherence Assessment  
There is no adherence assessment for enrolled patients, as this study uses secondary 
data only. Although Clinician Value Champions are not study subjects, they are key to the 
intervention and will take part in study activities as part of their clinical care. The study 
team will work closely in partnership with ACO leadership to facilitate study participation 
and retention of the clinician value champion from each clinic in the intervention arm of the 
study. In addition, each champion will be assigned a mentor from the former value 
champion fellows to increase the likelihood of engagement. 
 
6 
STUDY PROCEDURES 
There are no study visits, no patient-level evaluation or schedule of such evaluations 
planned. We will use existing Medicare claims data from each ACO to inform selection of 
clinics for randomization. The primary outcome (Specific Aim #1) and one of the 
secondary outcomes (Specific Aim #2) will be evaluated using secondary Medicare claims 
data 12 months after completion of the clinician value champion training program. The 
secondary outcome for Aim #3 will be evaluated by analyzing interviews with 
approximately 8 value champions conducted following the completion of the training 
program.   
 
6.1 
Schedule of Evaluations 
 
 
Assessment 
Months 1-3: 
Selection of Clinics 
for Randomization 
Months 18-24: 
Evaluation of Primary 
& Secondary 
Outcomes 
Medicare Claims for each 
ACO   
X 
  
Rates of Prescribing of 
PIMs (Specific Aim #1) 
from Medicare Claims 
 
 X 
ED Visits or Hospitalization 
for a fall (Specific Aim #2) 
from Medicare Claims 
 
 X 
Implementation Outcomes 
From Clinician Interviews 
(Specific to Aim #3) 
 
X 

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6.2 Description of Evaluations  
6.2.1 Screening Evaluation 
Screening for eligibility will be done by review of existing Medicare claims data from 
each ACO as described in Section 4.1 above. 
Consenting Procedure 
Patient Subjects 
We are seeking a Waiver of Informed Consent in order to identify and include patients in 
the study. Although data from human subjects are involved, no contact will ever be made 
with patients as this project involves the use of secondary data only. Attempting to obtain 
authorization or consent would not be feasible as this study will involve a study 
population of an estimated 5,000 patients. Consent and authorization of patients for 
enrollment in this study would create bias, generate prohibitive study costs rendering the 
study unfeasible, and produce results that would not be generalizable to other health 
care organizations. Furthermore, contacting 5,000 subjects for written consent would 
increase the only risk for patients - breach of confidentiality. 
Clinician Subjects: 
We are seeking a Waiver of Documentation of Consent in order to enroll clinician Value 
Champions in the study. The study PI (the initial PI at the time the study commenced), 
Michael Parchman, will send an email prior to training webinars with an attached study 
information sheet. During the first webinar, VC clinicians will be reminded of the 
information sheet by Dr. Parchman. He will provide contact information both in the email 
and during webinar in case VCs have questions. 
We are seeking a Waiver of Documentation of Consent in order to conduct a series of 2 
interviews with clinician who have completed the Value Champions webinar training 
series. We will mention the interviews to the group during the shared learning phone 
calls, and in emails reminding the group of the upcoming phone calls. We will then send 
an email inviting the Value Champions to participate, with an information sheet 
explaining the interviews. The email and information sheet will note that they may opt out 
of the interviews. The email and information sheet will also give contact information if the 
clinicians have questions about the interviews. 
 
If we have not reached recruitment goals (at least 4 clinicians at each ACO – 8 clinicians 
total) in one week, we will ask clinical leaders at the ACOs to remind clinicians to 
respond to the emails by opting in or out. If we still have not reached recruitment levels 
two weeks after the invitation email is sent, we will ask the clinic manager to forward the 
recruitment email to ask for a response. 
Screening   
 
Patient Subjects: 
Screening of eligible participants will be done by the programmer/analyst at IAC by 
applying study inclusion / exclusion criteria as described above in Section 4.1. This 
screening and selection will take place months 1-3 of the study prior to the value 
champion intervention. All Medicare beneficiaries at eligible ACOs will be included if they 

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meet eligibility criteria during the intervention year.  
Clinician Subjects 
Clinician Value Champions in the intervention clinics will be identified by ACO 
leadership, prior to the first webinar. The ACO leadership, in consultation with Dr. 
Parchman, will determine the suitability of specific clinical staff for study participation. 
We will enroll at least four Clinical Value Champions from the two ACOs to be 
interviewed twice after they have completed the webinar training. Clinicians will be 
enrolled on a first come basis. All clinicians that have completed the webinar series will 
be eligible. 
6.2.2 Enrollment, Baseline, and/or Randomization 
Enrollment 
 
Patient Subjects 
We are using secondary data to identify Medicare beneficiaries at eligible ACO clinics, 
and thus seek a waiver of informed consent. Medicare beneficiaries will be enrolled in 
the study when they are identified, after we receive the waiver of informed consent. 
Clinician Subjects 
We are seeking a waiver of documentation of consent to enroll clinician Value 
Champions at the intervention clinics. Clinician Value Champions will be considered 
enrolled when their questions about the study have been answered, and they take part 
in the webinar trainings. 
We are seeking a waiver of documentation of consent to enroll clinician Value 
Champions for 2 interviews from among clinicians who participated in the Value 
Champions training. Clinician Value Champions will be considered enrolled in the 
interviews when they indicate their willingness to participate, their questions about the 2 
interviews have been answered, and they take part in the interviews. 
 
Baseline Assessments 
N/A 
Randomization 
We will start our sample identification by identifying clinics at each ACO that meet 
eligibility criteria. Half of the eligible clinics will be randomized to an intervention group, 
and half to usual care group.  
 
6.2.3 Follow-up Visits 
N/A-there are no follow-up visits since we are using secondary Medicare claims data to 
measure our primary outcome. 
 
6.2.4 Completion/Final Evaluation 
Patient Subjects: 

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We will not assess Medicare beneficiaries at a clinic visit. Rather, the primary outcome 
(Specific Aim #1) and one of the secondary outcomes (Specific Aim #2) will be evaluated 
using secondary Medicare claims data 12 months after completion of the clinician value 
champion training program. 
 
Clinician Subjects: 
A clinician value champion will have completed the study once the training and shared 
learning sessions are over. If they have chosen to participate in the interviews, they will 
have completed the study once the second interview is complete. 
 
7 
SAFETY ASSESSMENTS  
 
7.1 Specification of Safety Parameters 
There are no known risks to discontinuing these potentially inappropriate medications. 
Instead, the purpose of discontinuing these medications is to lower the risk of an adverse 
event due to the medication such as a fall, changes in cognitive status, or acceleration of 
the course of dementia. In addition, the data used to measure the primary outcome, 
pharmacy claims data, is de-identified and contains no PHI, lowering the risk due to loss of 
confidentiality. 
These three classes of medication pose significant risks to older patients with dementia 
including falls, changes in cognitive status, and potentially accelerating the course of their 
dementia. The risk of these adverse events is significantly lowered by discontinuing these 
medications. Each of the risks described above also has the potential to create a cascade 
of adverse experiences such as fractures or head trauma from falls, resulting in 
hospitalization and the need for skilled nursing care instead of returning home.  
7.2 Methods and Timing for Assessing, Recording, and Analyzing Safety Parameters 
As data used to measure the primary outcome is de-identified, contains no PHI, and is 
collected after the intervention is completed. However, to ensure that we capture any 
unexpected AEs, we will ask each clinician champion to monitor for any unexpected 
adverse events and complete an adverse event form if they see one. Once each month, 
clinician value champions will be asked to send all adverse event forms to the study 
coordinator. No SAEs are expected as described above. All deaths within the study cohort 
will also be reported along with a cause of death 
 
7.3 Adverse Events and Serious Adverse Events  
AE Definition: AE is any untoward or unfavorable medical occurrence in a human study 
participant, including any abnormal sign (e.g. abnormal physical exam or laboratory finding), 
symptom, or disease, temporally associated with the participants’ involvement in the 
research, whether or not considered related to participation in the research.  
 
AEs for this study include: There are no known expected or unexpected adverse events. 
Rather, discontinuing these medications lowers the risk of an adverse event from these 
medications. 
 

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SAE Definition: SAEs consist of any adverse event that results in death; is life threatening 
or places the participant at immediate risk of death from the event as it occurred; requires 
or prolongs hospitalization; causes persistent or significant disability or incapacity; results in 
congenital anomalies or birth defects; is another condition which investigators judge to 
represent significant hazards 
 
SAEs for this study include: None  
As there are no expected AEs or SAEs, we will not capture solicited AEs or SAEs. 
Unsolicited AEs and SAEs will be noted during clinical care. Once each month, clinician 
value champions will be asked to send all adverse event forms to the study coordinator. 
No SAEs are expected as described above. All deaths within the study cohort will also be 
reported along with a cause of death 
7.3.1 Reporting Procedures 
All data and safety monitoring reporting will classify SAEs and AEs as to their severity, as 
per the definitions below:  
 
• 
Mild: Awareness of signs or symptoms, but easily tolerated and are of minor 
irritant type causing no loss of time from normal activities. Symptoms do not 
require therapy or a medical evaluation; signs and symptoms are transient. 
• 
Moderate: Events introduce a low level of inconvenience or concern to the 
participant and may interfere with daily activities, but are usually improved by 
simple therapeutic measures; moderate experiences may cause some interference 
with functioning 
• 
Severe:  Events interrupt the participant’s normal daily activities and generally 
require systemic drug therapy or other treatment; they are usually incapacitating. 
 
All data and safety monitoring reporting will classify SAEs and AEs as to potential 
relatedness to the study intervention as per the definitions below:  
 
• 
Definitely Related:  The adverse event is clearly related to the investigational 
agent/procedure – i.e. an event that follows a reasonable temporal sequence from 
administration of the study intervention, follows a known or expected response 
pattern to the suspected intervention, that is confirmed by improvement on 
stopping and reappearance of the event on repeated exposure and that could not 
be reasonably explained by the known characteristics of the subject’s clinical state. 
• 
Possibly Related:  An adverse event that follows a reasonable temporal 
sequence from administration of the study intervention follows a known or 
expected response pattern to the suspected intervention, but that could readily 
have been produced by a number of other factors. 
• 
Not Related:  The adverse event is clearly not related to the investigational 
agent/procedure - i.e. another cause of the event is most plausible; and/or a 
clinically plausible temporal sequence is inconsistent with the onset of the event 
and the study intervention and/or a causal relationship is considered biologically 
implausible.  
 

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7.3.2 Follow-up for Adverse Events 
 
Adverse event reporting schedule: Once each month, clinician value champions will be 
asked to send all unexpected adverse event forms to the study coordinator. No SAEs are 
expected as described above. All deaths within the study cohort will also be reported 
along with a cause of death. 
 
• 
All adverse events that are both serious (SAE) and unexpected (i.e., have not 
been previously reported for the study’s intervention) will be reported to the IMPACT 
Collaboratory Regulatory and Data Team Leader (Julie Lima PhD), Advarra IRB, NIA 
IMPACT Collaboratory PO (Dr. Partha Bhattacharya), and the IMPACT Collaboratory 
DSMB Chair within 48 hours of the study’s knowledge of SAE.  
 
• 
The summary of all other SAEs will be reported to IMPACT Collaboratory Regulatory 
and Data Team Leader (Julie Lima PhD), Advarra IRB, NIA IMPACT Collaboratory PO 
(Dr. Partha Bhattacharya), and the IMPACT Collaboratory DSMB Chair quarterly, 
unless otherwise requested by the DSMB Chair.  
 
• 
All deaths will be reported to IMPACT Collaboratory Regulatory and Data Team 
Leader (Julie Lima PhD), Advarra IRB, NIA IMPACT Collaboratory PO (Dr. Partha 
Bhattacharya), and the IMPACT Collaboratory DSMB Chair and to the DSMB Chair 
within 24 hours of study’s knowledge of death. 
  
• 
AEs will be reported per IRB policies and also to IMPACT Collaboratory Regulatory 
and Data Team Leader (Julie Lima PhD), Advarra IRB, NIA IMPACT Collaboratory PO 
(Dr. Partha Bhattacharya), and the IMPACT Collaboratory DSMB Chair and to the 
DSMB Chair at minimum every 6 months, or at a frequency requested by NIA and/or 
by the DSMB.  
7.4 Safety Monitoring 
The Principal Investigator (PI) will be responsible for ensuring participants’ safety on a 
daily basis. In addition, the NIA IMPACT Collaboratory DSMB will oversee all data and 
safety monitoring activities for this study. The number of DSMB members will be 
determined by NIA, and one will be designated the Chairperson. DSMB members will be 
appointed by the NIA Director. This DSMB will act in an advisory capacity to the NIA 
Director to monitor participant safety, to evaluate the progress of the study, and to review 
procedures for maintaining the confidentiality of data, the quality of data collection, 
management, and analyses. Advarra IRB will conduct the ethical review required for the 
protection of human subjects.  NIA PO, in consultation with DSMB chair, will make a 
determination regarding the level and format of data and safety monitoring this study 
requires.  
8 
INTERVENTION DISCONTINUATION  
Patient Subjects: 
N/A – The goal of the value champion intervention, deprescribing of potentially 
inappropriate medications, is considered acceptable and standard clinical care at 

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intervention clinics. We will analyze secondary data of all eligible Medicare beneficiaries 
whether or not they reduce use of the targeted medications in response to the value 
champion interventions, and thus it is not possible for subjects to discontinue early. 
Reduction in use is likely to improve overall health, and we do not expect needed follow up 
for those who reduce their use of these medications. 
Clinician Subjects: 
Value Champions may end participation in the study for any reason. In that case, an 
alternative clinician Value Champion may be identified to replace the VC at that clinic if 
feasible considering the timing of withdrawal during the study period. 
9 
STATISTICAL CONSIDERATIONS  
9.1 General Design Issues  
Our hypothesis is that for each medication class, the intervention will produce clinically 
relevant decreases in mean possession rates of 10% of a standard deviation in patients 
seen in intervention clinics compared to those who are seen in control group clinics. 
The study design was chosen to meet the requirements of the funder for a non-
pharmacologic/non-device intervention for people living with dementia, conducted in a 
health system setting. The 24-months of funding is for a demonstration project, intended 
to demonstrate the feasibility and acceptability of the intervention, but with the stipulation 
by the funder that the trial must be a randomized controlled trial, one with a control group. 
In response, we proposed a cluster-randomized trial where the intervention will be 
randomized at the primary care clinic level, not the patient level, and existing health 
systems claims data will be used to address our primary outcome (Specific Aim #1) and 
one of our secondary outcomes: Specific Aim #2: emergency department visits and 
hospitalizations for a fall. 
 
The primary outcome measure for this study will be medication possession rates (MPR) 
per quarter, for the 3 therapeutic classes of medications - antipsychotics, 
benzodiazepines, and hypoglycemics - that are considered low-value for beneficiaries with 
dementia. Unlike many studies using medication possession rates to exam adherence, we 
are interested in reducing, not increasing, the percent of days covered. Following an 
intent-to-treat design, claims data from all Medicare beneficiaries meeting our dementia 
eligibility criteria prior to the start of the value champion intervention will be included in the 
analysis. To determine the impact of the intervention, we will construct hierarchical models 
with time period observations nested within patient. These models will be random effects 
or generalized estimating equations (GEE) with robust standard errors, and will be either 
linear, if original MPRs are used as outcome, or generalized linear, if transformation 
necessary. The key variable of interest in these models will be the treatment indicator 
(assigned based on practice randomization to intervention or control group). 
 
9.2 Sample Size and Randomization 
Our sampling plan anticipates enrolling at least 30 of the 39 practices in USMM and 26 of 
the 28 practices in Ochsner. Based on Medicare enrollments of 39,000 members in 
USMM with a 20 percent dementia rate in 2019, and 10,000 members in Ochsner with 
approximately 10 percent of members diagnosed with dementia om 2019, we should have 

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at least 2,000 patients per treatment group for USMM and 500 patients per treatment 
group for Ochsner. For our primary outcome, with a follow-up period of one year and with 
mediation possession rates calculated per patient each quarter, we will have 
approximately 4 MPR observations per patient or 8,000 observations per group for USMM 
analyses and 2,000 per group for Ochsner. Even after assuming significant correlation 
across time within patient and modest correlation between patients within a practice, 
which will reduce effective sample sizes by 20%, we should have the equivalent of 6,400 
observations per treatment group for our USMM analyses and 1,600 observations per 
treatment group for Ochsner.  
 
The expectation of our intervention is that for each medication class, it will produce 
clinically relevant decreases in mean possession rates of 10% of a standard deviation. If 
the effect size is this large for a medication class and using a 5% level of significance, our 
Ochsner sample (with effective size of at least 1,600 per group) will have 80% power to 
discern a significant difference, while our larger USMM sample (with effective size of at 
least 6,400 per group) will have almost 100% power. Indeed, our USMM sample will have 
80% power to find a significant difference, even if the effect size is only 5% of a standard 
deviation 
9.2.1 Treatment Assignment Procedures 
The unit of randomization will be the primary care practice or team. We anticipate 32 out of 
39 teams from USMM to meet eligibility and 26 out of 28 practices for Ochsner. Within 
each ACO, we will randomly select half of the practices for participation in the value 
champion training and the remaining practices will continue with care as usual. Prior to 
random assignment, we will stratify practices based on high versus low historic prescribing 
rates. We will select practices for randomization and inclusion using a cut-point based on 
the distribution of overall rates for all 3 therapeutic classes using data for 2019-2020. Once 
randomized, a clinician value champion will be recruited from each of the clinics 
randomized to the intervention arm of the study in partnership with the ACO leadership. 
9.3 Interim analyses and Stopping Rules 
N/A – No interim analyses are planned. The proposed activities involve the collection and 
analysis of secondary automated system patient data for Specific Aims 1 & 2, and 
interviews with clinician value champions for Specific Aim #3. 
9.4 Outcomes  
9.4.1 Primary outcome   
The primary outcome for this study (Specific Aim #1) will be medication possession rates 
(MPR) per quarter, for the 3 therapeutic classes of medications - antipsychotics, 
benzodiazepines, and hypoglycemics -  that are considered low-value for beneficiaries 
with dementia. These beneficiary-level measures are calculated as quotients with 
denominator equal to the length of the quarter and the numerators equal to the days 
supply for prescriptions within the class filled during the quarter, plus excess days-supply 
from the previous period minus excess days-supply remaining at the end. Unlike many 
studies using medication possession rates to exam adherence, we are interested in 
reducing, not increasing, the percent of days covered. As a first choice, we will try to use 
originally-valued MPR variables in regression modeling, but if they don't reflect adequate 

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fit, we will transform them or possibly convert them to ordinal variables instead. For 
example, Benner and colleagues in their study of statin adherence defined non-adherence 
as MPRs within 0-20 percent, low-adherent as between 21-79 percent and high 
adherence as 80 percent or higher.8 In addition to MPRs, we will also calculate and 
analyze the number of 30-day prescriptions per time-period for each beneficiary in the 
study.  
9.4.2 Secondary outcomes   
As a secondary outcome, for Specific Aim #2, we will also assess the incidence of falls 
during the study window. Falls are difficult to monitor using claims data, but Min and 
colleagues have developed a method that IAC and Brandeis staff (Co-Investigator Perloff) 
have helped test for ICD-10.9 We will use the most conservative definition that looks for 
the presence of fall ‘reason for visit’ code on ED, ambulatory, or inpatient visit as indicated 
by a clinician bill (Part B). Key covariates in all of our regression models will include age 
and sex, both derived from the Medicare beneficiary summary files, house at IAC. 
 
For Specific Aim #3, the five important implementation outcomes: appropriateness, 
fidelity, feasibility, and penetration will be assessed by analyzing interviews with clinician 
value champions. The Clinician interviews will provide us with data we need to assess the 
implementation outcomes.  
9.5 Data Analyses 
Following an intent-to-treat design, all Medicare beneficiaries meeting our dementia 
eligibility criteria will be included in the study, regardless of level of engagement with 
practice clinicians. Data analysis will begin with descriptive statistics, comparing the mix of 
patients at each practice including demographics, chronic conditions, and incident versus 
prevalent dementia. This will allow us to check for balance between treatment and control 
practices and inform subsequent modeling. To determine the impact of the intervention, 
we will construct hierarchical models with time period observations nested within patient. 
These models will be random effects or generalized estimating equations (GEE) with 
robust standard errors, and will be either linear, if original MPRs are used as outcome, or 
generalized linear, if transformation necessary. The key variable of interest in these 
models will be the treatment indicator (assigned based on practice). Since there could well 
be a time effect of treatment, we will explore several model specifications, such as discrete 
indicators for the time periods or a single continuous variable. Interactions of treatment 
with time period will also be explored. By examining various different specifications 
involving time, we should be able to determine whether the intervention leads to a one-
time change, a gradual trend over time, or a combination of both (an immediate jump with 
a further change, as time passes). Finally, we will explore the impact of this intervention on 
health inequities by stratifying our primary analysis by race/ethnicity. 
 
Specific to Aim #3: Current approaches to evaluating implementation outcomes are still 
nascent, with few measures that have validated psychometric properties. Conceptually, 
these measures are inter-dependent, and are connected with service outcomes, such as 
patient safety.  We will use data collected from interviews with the Value Champions to 
conduct a thematic analysis of the five implementation outcomes using a deductive 
approach. 

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10 
DATA COLLECTION AND QUALITY ASSURANCE 
10.1 Data Collection Forms 
We have two primary data sources: the 100% Medicare claims files from each ACO, and 
interviews with clinicians conducted by staff at KPWHRI and Brandeis. . Secondary data 
from Medicare Part D pharmacy claims data will provide us with our primary outcome data: 
cumulative exposure to any of the PIMs among an inception cohort of PLWD. In addition, 
Medicare claims data will be used for the third exploratory aim: rates of ED visits or 
admissions for a fall. This data will be identified and collected by the study programmer / 
analyst at AIC. 
The Clinician interviews will provide us with the data we need for our implementation 
outcomes. A interview protocol is submitted for review. Data Management  
Clinical Site Responsibilities: The two participating ACO organizations have Data Use 
Agreements with the Institute for Accountable Care, to access their 100% Medicare 
Claims data for purposes of the secondary data analyses for Specific Aims #1 & 2.  
The Institute for Accountable Care will be responsible for data management of the 
secondary Medicare claims data. Their programmers will create a de-identified analytic file 
for Drs. Perloff and Ritter to use to test hypotheses for Aims #1 & 2.  
The clinician interviews will be conducted and recorded by staff at KPWHRI and Brandeis 
University. The recorded interviews will be transcribed, and the transcriptions will be 
analyzed by staff at both Brandeis and KPWHRI. 
10.2 Quality Assurance  
10.3.1 
Training 
Dr. Lorella Palazzo’s Current Human Subjects Training: 
04/26/2021 
CITI: Responsible Conduct of Research  
04/30/2021 
CITI: Level 1- Investigator-Initiated Behavioral Intervention 
 
10.3.2 Quality Control Committee  
N/A . 
10.3.3 Metrics 
N/A. 
10.3.4 Protocol Deviations 
We will document number of training sessions completed by each clinician value 
champion. Each value champion will have an assigned mentor who will conduct a 
monthly check-in visit to overcome challenges if they deviate from the training program 
and their project to tackle overuse of inappropriate medications. Mentors will keep notes 
of these meetings and share them with the PI and study team monthly.   

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10.3.5 Monitoring 
See above regarding Protocol Deviation for our monitoring plan regarding compliance 
with the protocol.  
11 
PARTICIPANT RIGHTS AND CONFIDENTIALITY  
\. 
11.1 Institutional Review Board (IRB) Review 
This protocol and any subsequent modifications will be reviewed and approved by the IRB 
or ethics committee responsible for oversight of the study.   
11.2 Informed Consent Forms 
 
N/A – We seek a waiver of informed consent to include secondary claims data from 
Medicare beneficiaries (patient subjects) in the study. We will seek a waiver of 
documentation of consent for enrolled clinician subjects before the start of study activities . 
We will provide clinician subjects an opportunity to ask questions about the study in 
private, and contact information if they have questions. 
 
We will seek a waiver of documentation of consent for enrolled clinician subject before 
conducting interviews. (NOTE: As the interview data collection was added after consent 
process was completed for the enrolled clinicians, we will conduct separate consent 
procedures for the interviews.) 
 
11.3 Participant Confidentiality  
Multiple steps will be taken to protect participant confidentiality. Access to electronic files 
will be restricted to study staff on a need-to-know basis, and subject to the same security 
protections as other confidential health plan data. All data containing identifying 
information will be kept on password-protected computers using password-protected files. 
Identifiable information will be kept in a separate file from data used in analysis. Data used 
for analysis will be identified by unique study identifiers. Study data will be transferred 
between sites using secure methods, and appropriate Data Use agreements will be 
established between sites as needed. The clinician interviews will not contain any PHI or 
information about care specific to individual patients. No publications or reports will include 
any information identifying study participants. 
11.4 Study Discontinuation  
The study may be discontinued at any time by the IRB, the NIA, the OHRP, the FDA, or 
other government agencies as part of their duties to ensure that research participants are 
protected.  

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12 
ETHICAL CONSIDERATIONS 
 
We will adhere to the NIH Clinical Center researchers seven main principles of the 
conduct of ethical research: 
• 
Social and clinical value 
• 
Scientific validity 
• 
Fair subject selection 
• 
Favorable risk-benefit ratio 
• 
Independent review 
• 
Informed consent (in this case, obtaining a waiver of informed consent) 
• 
Respect for potential and enrolled subjects 
13 
COMMITTEES 
N/A 
14 
PUBLICATION OF RESEARCH FINDINGS 
Any presentation, abstract, or manuscript will be made available for review by the sponsor 
and the NIA prior to submission. 
 
 
15 
REFERENCES 
1. 
Redston MR, Hilmer SN, McLachlan AJ, Clough AJ, Gnjidic D. Prevalence of potentially 
inappropriate medication use in older inpatients with and without cognitive impairment: A 
systematic review. J Alzheimers Dis. 2018;61:1639-52.  Epub 2017/12/28. 
 
2. 
Delgado J, Bowman K, Clare L. Potentially inappropriate prescribing in dementia: a 
state-of-the-art review since 2007. BMJ open. 2020;10:e029172.  Epub 2020/01/05. 
PMCID: PMC6955517. 
3. 
American Geriatrics Society. Ten things clinicians and patients should question.  
Philadelphia, PA: Choosing Wisely, ABIM Foundation; 2013 [updated April 23, 2015; 
cited 2021 April 20];  Available from: https://www.choosingwisely.org/societies/american-
geriatrics-society/. 
4. 
U.S. Government Accountability Office. Antipsychotic drug use: HHS has initiatives to 
reduce use among older adults in nursing homes, but should expand efforts to other 
settings.  Washington, DC; 2015 [cited 2021 March 17];  Available from: 
https://www.gao.gov/assets/gao-15-211.pdf. 
5. 
Dionne PA, Vasiliadis HM, Latimer E, Berbiche D, Preville M. Economic impact of 
inappropriate benzodiazepine prescribing and related drug interactions among elderly 
persons. Psychiatr Serv. 2013;64:331-8.  Epub 2012/12/18. 
6. 
Hambling CE, Seidu SI, Davies MJ, Khunti K. Older people with Type 2 diabetes, 
including those with chronic kidney disease or dementia, are commonly overtreated with 
sulfonylurea or insulin therapies. Diabet Med. 2017;34:1219-27.  Epub 2017/05/13. 
7. 
Park S, Jung J, Burke RE, Larson EB. Trends in use of low-value care in traditional fee-
for-service medicare and medicare advantage. JAMA Netw Open. 2021;4:e211762.  
Epub 2021/03/18. PMCID: PMC7970337. 
 

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8. 
Benner JS, Glynn RJ, Mogun H, Neumann PJ, Weinstein MC, Avorn J. Long-term 
persistence in use of statin therapy in elderly patients. JAMA. 2002;288:455-61.  Epub 
2002/07/23. 
9. 
Min L, Tinetti M, Langa KM, Ha J, Alexander N, Hoffman GJ. Measurement of fall injury 
with health care system data and assessment of inclusiveness and validity of 
measurement models. JAMA Netw Open. 2019;2:e199679.  Epub 2019/08/23. PMCID: 
PMC6707014. 
 
SUPPLEMENTS/APPENDICES 
 
Study information sheet provided to clinician subjects 
Advance email sent to clinician subjects