De-implementation of Low Value Castration for Men With Prostate Cancer - Living Well With Prostate Cancer
Phase: NA
Conditions: Prostate Cancer
Sponsor: University of Michigan

Study Title: De-Implementation of Low-Value Castration for Men with Prostate 
Cancer - Living Well with Prostate Cancer
PI:  Sameer Saini, MD, MS
Co-PI: Ted Skolarus, MD, MPH
NCT: NCT06199986
Protocol ID: 1656029
Protocol Version IRB Approval Date: 11/30/2023

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De-IMPLEMENTATION OF LOW-VALUE CASTRATION 
FOR MEN WITH PROSTATE CANCER -  
LIVING WELL WITH PROSTATE CANCER
A pilot randomized implementation trial comparing an ADT order check attestation with a provider 
script intervention to reduce chemical castration as localized prostate cancer treatment and treatment 
for non-metastatic biochemical recurrence with low PSA levels in Veterans. 
DEADT – LIVING WELL PILOT MANUAL 
Funding: NIH’s National Cancer Institute 
VA Ann Arbor Healthcare System (506) 
Principal Investigator: 
Sameer Saini, MD, MS
Co-Principal Investigator: 
Ted Skolarus, MD, MPH 
Co-Investigators: 
Megan Caram, MD
Anne Sales, PhD, RN
Kristian Stensland, MD
Study Team: 
Tabitha Metreger, MA – Co-PM
Jordan Sparks, MPH – Co-PM
Jennifer Burns, MHSA
Kathleen Swalwell
Consultants: 
John Leppert, MD, MS
Danil Makarov, MD, MHS
Jeremy Shelton, MD, MS
Gabriel Solomon, MD, MS
David Elliott, MD
Shawna Smith, PhD
Yehuda Bechar, MBA

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Table of Contents 
(Click to follow link to section) 
ABSTRACT ............................................................................................................................................................ 4 
ACRONYMS/ABBREVIATIONS ........................................................................................................................... 5 
STUDY PERSONNEL ............................................................................................................................................ 6 
NARRATIVE .......................................................................................................................................................... 7 
PROTOCOL ......................................................................................................................................................... 23 
STUDY OVERVIEW ............................................................................................................................................. 23 
STUDY DESIGN .................................................................................................................................................. 24 
TIMELINE ............................................................................................................................................................. 26 
PILOT SITE SELECTION .................................................................................................................................... 27 
PILOT SITE IMPLEMENTATION OVERVIEW .................................................................................................... 27 
IDENTIFYING LOW-VALUE ADT IN PILOT ....................................................................................................... 29 
PILOT TARGET ADT ORDER IDENTIFICATION (OR) ...................................................................................... 32 
PILOT TARGET CLINIC VISIT IDENTIFICATION (SC) ...................................................................................... 32 
IMPLEMENTATION EDUCATION SESSION (IES) ............................................................................................ 33 
ADT ORDER CHECK ATTESTATION (OR) INTERVENTION ........................................................................... 33 
CPRS INSTRUCTIONS FOR OR INTERVENTION ............................................................................................. 34 
OPENING CPRS .................................................................................................................................................. 34 
PLACING A HEALTH FACTOR ........................................................................................................................... 35 
DOCUMENTING PLACEMENT OF HEALTH FACTOR – EXCEL SPREADSHEET .......................................... 35 
REMOVING HEALTH FACTORS IN CPRS ......................................................................................................... 35 
DOCUMENTING PLACEMENT OF HEALTH FACTOR – DASHBOARD - TBD ................................................. 35 
SCREENSHOT OF CPRS ORDER CHECK ........................................................................................................ 36 
PROVIDER SCRIPT (SC) INTERVENTION ........................................................................................................ 36 
PROGRESS NOTE .............................................................................................................................................. 36 
CLINIC HANDOUT ................................................................................................................................................... 37 
CPRS INSTRUCTIONS FOR SC INTERVENTION ............................................................................................. 38 
ASSIGNING A PROGRESS NOTE ..................................................................................................................... 38 
CPRS PROVIDER PROGRESS NOTE TEMPLATE .......................................................................................... 41 
PILOT CLINIC AND ADT PROVIDER ASSESSMENTS .................................................................................... 43 
PILOT DATA COLLECTION ............................................................................................................................... 43 
INSTRUCTIONS FOR PHONE FORWARDING AND VOICEMAIL ................................................................... 44 
PILOT STUDY FLOW CHART ............................................................................................................................ 45 
PILOT RANDOMIZED IMPLEMENTATION TRIAL ............................................................................................ 46 
TRIAL SITE SELECTION ..................................................................................................................................... 46 
TRIAL SITE RECRUITMENT & RANDOMIZATION ............................................................................................ 46 
TRIAL OR/SC IMPLEMENTATION ...................................................................................................................... 46 
TRIAL DATA COLLECTION ................................................................................................................................ 47 
RECORDS CONTROL AND DISPOSITION ....................................................................................................... 48 

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APPENDICES ...................................................................................................................................................... 48 
APPENDIX I: LETTERS OF SUPPORT FROM SITE CHAMPIONS .................................................................. 49 
APPENDIX II: PILOT EMAIL TEMPLATES ........................................................................................................ 52 
APPENDIX III: CRCT EMAIL TEMPLATES ........................................................................................................ 65 
APPENDIX IV: PATIENT DASHBOARD FOR ELIGIBILITY SCREENING EXAMPLE ..................................... 81 
APPENDIX V: CLINIC HANDOUT (ANN ARBOR) ............................................................................................. 82 
APPENDIX VI: CRCT ORGANIZATIONAL ASSESSMENTS ............................................................................ 83 
APPENDIX VII: STUDY INFORMATION SHEET ............................................................................................... 87 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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ABSTRACT 
Project Background: Prostate cancer is the leading male cancer. One in three men with prostate cancer is 
chemically castrated at some point with long-acting injectable drugs (i.e., androgen deprivation therapy or 
ADT). This impacts the well-being of thousands of men annually. Although some patients benefit in terms of 
survival and symptom improvement, chemical castration with ADT is also commonly performed when there 
are little to no health benefits to patients raising questions of low value care. A growing awareness of 
castration harms (e.g., heart attack, osteoporosis, loss of sexual function) creates patient safety concerns. 
Despite this, ADT use in low value cases, such as for localized prostate cancer treatment and biochemical 
recurrence in non-metastatic disease persists. 
 
Ineffective and harmful practices such as chemical castration of prostate cancer patients with ADT outside 
of the evidence base are ideal targets for de-implementation. De-implementation, or stopping low value 
practices, has the potential to improve patient outcomes and decrease healthcare costs. For example, 
stopping low value chemical castration could prevent harm, limit spending, and maintain survival. However, 
provider preferences regarding de-implementation are not well understood, and possible de-implementation 
interventions range from blunt formulary restriction policies to shared decision-making. Blunt policy 
interventions such as formulary restriction of ADT (e.g., pre-authorization, order templates) might seem 
warranted given patient safety concerns, yet could result in significant provider resistance and work-
arounds if introduced poorly. More nuanced, patient-centered interventions such as shared decision-
making (e.g., decision aid, talking points) likely involve extra clinical time. Both intervention strategies need 
tailoring based on provider input for acceptability and feasibility in clinical practice, including piloting prior to 
trialing. As many medical practices lack evidence and cause harm, robust, behavioral theory-based 
methods for incorporating provider preferences into de-implementation strategy development will advance 
both implementation research and practice. 
 
Project Objectives: This study will compare two different de-implementation strategies that vary in 
delivery, impact, and expected results for reducing low value ADT use. 
 
Research Plan/Methods: Compare two tailored de-implementation strategies to reduce chemical 
castration as localized prostate cancer treatment and treatment for non-metastatic biochemical recurrence 
with low PSA levels.  
Our specific Aim is to evaluate the implementation of an ADT order check (Or) versus a provider script (Sc) on 
decreased low-value ADT use after six months. We will first examine low-value ADT use for up to 6 months of 
early piloting at 4 VA sites, as well as refine our proposed RE-AIM implementation outcomes and ascertainment, 
study of moderators (e.g., fidelity) and causal mechanisms underlying implementation interventions. The work 
will inform the subsequent 4 site pilot randomized implementation trial by addressing preferences and concerns 
through pilot tailoring. Based on the early pilot work, we will refine our site engagement strategies and study 
protocol methods and materials for the trial. This work will advance de-implementation science for low value 
cancer care. 
 
 
(Please double click the correct box below): 
  This Study WILL use the VA electronic health record (EHR) or EHR Data on or after March 2022 
(for example:  entering notes; entering consults; ordering labs, medications, procedures, imaging, etc.; 
eligibility screening with EHR chart review or CDW; using CDW data; etc.). 
 
  This Study will NOT use the VA electronic health record (EHR) or EHR Data on or after March 
2022 (for example:  entering notes; entering consults; ordering labs, medications, procedures, 
imaging, etc.; eligibility screening with EHR chart review or CDW; using CDW data; etc.). 

 
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ACRONYMS/ABBREVIATIONS 
ADT: Androgen Deprivation Therapy 
AUA: American Urological Association 
BCR: Biochemical Recurrence  
BNED: Biochemically No Evidence of Disease 
BRPC: Biochemically Recurrent Prostate Cancer 
BCW: Behavior Change Wheel 
CAC: Clinical Applications Coordinator 
CCMR: Center for Clinical Management Research  
CDW: Corporate Data Warehouse 
CHIO: Chief Health Informatics Officer 
CMS: Centers for Medicare & Medicaid Services 
COM-B: Behavior Change Model ('Capability', 'Opportunity', 'Motivation' and 'Behavior') 
CROC: Clinical Reminder Order Check 
CRPC: Castration-Resistant Prostate Cancer 
DeADT: De-Implementation of Low Value Castration for Men with Prostate Cancer, development work title 
DeADT-Living Well With Prostate Cancer: Pilot/cRCT title 
DCE: Discrete Choice Experiment 
IES: Implementation Education Session 
LVADT: Low-Value Androgen Deprivation Therapy 
mPCa: Metastatic Prostate Cancer 
NLP: Natural Language Processing  
Or: ADT Order Check Attestation Intervention 
PC/PCa: Prostate Cancer 
PSA: Prostate Specific Antigen 
RE-AIM: Implementation Outcomes - Reach, Effectiveness, Adoption, Implementation, Maintenance 
RP: Radical Prostatectomy 
Sc: ADT Provider Script Intervention 
TDF: Theoretical Domains Framework 
VSSC: VHA Support Service Center 
 

 
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STUDY PERSONNEL 
 
* All Investigators represented in this project have submitted an OGE-450 Alt VA for review by the VA Ann 
Arbor COI Administrator. The person designated to conduct fCOI reviews at the VA Ann Arbor have 
completed fCOI review for the investigators and identified no conflicts of interest. 
 
 
 
 
 
 
 
 
 
 
 
 
NAME/EMAIL 
ROLE 
ACCESS TO 
PHI 
RECRUITMENT 
AFFILIATION 
STATUS 
Sameer Saini, MD, MS 
PI* 
YES 
NO 
AAVA 
VA/UM 
Ted Skolarus, MD, MPH 
Co-PI* 
YES 
NO 
University of 
Chicago 
WOC 
Megan Caram, MD 
Co-I* 
YES 
NO 
AAVA 
VA/UM 
Anne Sales, PhD, RN 
Co-I* 
YES 
NO 
University of 
Missouri 
WOC 
David Elliott, MD 
Co-I* 
YES 
NO 
AAVA 
VA/UM 
Kristian Stensland 
Co-I* 
YES 
NO 
University of 
Michigan 
WOC 
Tabitha Metreger, MA 
Co-PM 
YES 
YES 
AAVA 
VA 
Jordan Sparks, MPH 
Co-PM 
YES 
YES 
AAVA 
VA 
Jennifer Burns, MHSA 
Data 
Manager 
YES 
NO 
AAVA 
VA 
Kathleen Swalwell 
Study 
Coordinator 
YES 
YES 
AAVA 
VA 
John Leppert, MD, MS 
Consultant 
NO 
NO 
Palo Alto VAMC 
VA 
Danil Makarov, MD, MHS 
Consultant 
NO 
NO 
VA New York 
Harbor HCS 
VA 
Jeremy Shelton, MD, MS 
Consultant 
NO 
NO 
VA Greater LA 
HCS 
VA 
Gabriel Solomon, MD, MS 
Consultant 
NO 
NO 
AAVA 
VA 
Shawna Smith, PhD 
Consultant 
NO 
NO 
University of 
Michigan 
UM 
Yehuda Bechar 
Consultant 
YES 
NO 
AAVA 
VA 

 
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NARRATIVE 
 
Introduction 
A1. Evidence for castration as prostate cancer treatment 
Because prostate cancer cells are dependent on androgens, i.e., 
testosterone, depriving them of this hormone through castration 
can improve clinical outcomes, for some patients.1 The highest 
levels of evidence for chemical castration with androgen 
deprivation therapy (ADT) injections to treat prostate cancer occur 
in two scenarios: 1) high risk localized disease in combination with 
radiation therapy, and 2) metastatic cancer with spread to bones or 
other organs causing symptoms.2-4 However, a significant amount 
of castration in Medicare and integrated delivery systems (e.g., 
VA), occurs outside scenarios where high levels of benefit exist.5,6 
For example, using castration for the primary treatment of localized 
prostate cancer is likely ineffective and harmful, yet remains 
common in VA with five-fold variation across facilities (Figure 1). 
Neither long-term studies nor current guidelines support castration 
as primary treatment for localized prostate cancer.1,3,4 Many times, this castration is continued indefinitely.   
Additionally, the efficacy of using castration for treatment of biochemical recurrence in non-metastatic 
disease is not well supported by long-term studies nor current guidelines, particularly in patients with lower 
risk of disease progression. 
 
A2. There is a disconnect between the value and use of castration in prostate cancer 
A2.1 Surgery to remove testicles is no longer needed for castration 
The discovery that castration could be used as palliation for 
patients with metastatic prostate cancer revolutionized the 
oncology field in 1941.8 Depriving prostate cancer cells of 
testosterone to relieve urinary tract blockage and decrease 
bone pain from metastatic lesions ushered in a new way to 
think about treating the disease that continues to fuel treatment 
approaches today. However, surgical castration via orchiectomy 
(i.e., testicular removal) fell by the wayside in the 1990s as 
long-acting injectable approaches to androgen deprivation 
(GnRH agonists) became available, and even lucrative, leading 
to dramatic increases in use across all stages of the disease 
(Figure 2).9-11 This phenomenon essentially lowered the 
threshold for treatment with ADT injections due to ease of use, 
patient acceptability as they no longer needed their testicles 
removed, biological plausibility, and low appreciation for side effects of chemical castration among the 
surgical specialists prescribing ADT (i.e., urologists) with little training in primary care. 
A2.2 Lucrative business practice thwarted by Medicare payment reform 
The story of Medicare reimbursement for ADT is a fascinating example of how financial incentives can drive 
medical overuse.9 In short, Medicare reimbursed providers at 95% of the average wholesale price for these 
injections throughout the 1990s making it profitable since many providers acquired the drug at 82% or less 
of the average wholesale price.12 Up to 40% of urology practice revenues were derived from this business 
practice in some cases.13 Orchiectomy was driven out of practice, and thresholds for castration were 
lowered such that nearly half of prostate cancer patients received ADT by 2000.10 Despite a stable 
evidence-base, more patients were getting injections in cases where there was no evidence to support use 
(e.g., primary treatment) alongside a growing awareness of harms. When the Medicare Part B tab for ADT 
injections reached $1 billion in 2003, the practice came under intense scrutiny.14 As a result, the Medicare 
Modernization Act reduced payments by approximately 50% leading to significant reductions in 
inappropriate use as published in the New England Journal of Medicine by Co-Investigator Dr. Shahinian.9,15 
Despite a decrease in what was termed ‘inappropriate use’ of ADT for localized prostate cancer through this 

 
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policy intervention, such use persists today indicating other interventions are needed. 
A2.3 Growing recognition of castration harms has led to patient safety concerns 
Not surprisingly, the side effects of castration are common and impact a host of physiologic mechanisms 
that rely on the male hormone testosterone.16 Castration results not only phenotypic changes due to 
feminization, but also osteoporosis, metabolic syndrome, cardiovascular disease, loss of sexual function, 
and decrements to overall quality of life.17 Evidence also suggests the risks of diabetes,18 cataracts,19 
deep vein thrombosis,20,21 stroke22 and even acute cardiac death23 all increase for men receiving ADT. 
This led the American Cancer Society and American Heart Association to issue a 2010 consensus 
statement on the importance of secondary preventative measures for men treated with ADT.24 
A2.4 Reasons castration harms overlooked by providers and patients 
ADT decreases the serum PSA level, a biomarker of prostate cancer activity, falsely reassuring people 
there is a ‘remission’ of the prostate cancer. This is potentially harmful in at least 2 ways. First, depriving 
prostate cancer cells of testosterone too early in the disease process may foster castration resistance, 
limiting effects when it is actually needed (e.g., metastatic setting).25,26 Second, PSA is a poor surrogate 
marker for survival in localized disease. That is, lowering PSA in localized disease is not associated with 
improved overall survival, creating false optimism.6,27 In addition, surgical specialists are prescribing a drug 
with devastating metabolic and cardiovascular effects creating a disconnect between treating PSA levels 
and the consequences, often dealt with in primary care. While lowering PSA might make sense on the 
surface, understanding beliefs and preferences for using ADT is a critical step in stopping its low value use. 
In many respects, this is an ideal model for understanding de-implementation of low value cancer care. 
 
A4. The benefits of unlearning ineffective, low value clinical practices and ties to behavior change 
Unlearning routinized clinical practices is challenging even if they are no longer or never were considered 
effective.32,33 This is particularly true when it comes to treating patients with cancer where provider 
reluctance to hold off on treatment is often a significant barrier to stopping or not initiating treatment when 
there are no symptoms. Unlearning clinical behaviors such as prescribing ADT in low evidence settings can 
have substantial benefits. First, patients are no longer subjected to treatment harms with little to no benefit. 
Second, unlearning misaligned castration practices can provide opportunity for more efficient, higher value 
use of specialists. Last, acquiring the skill of unlearning can increase flexibility and willingness to adapt to 
evidence more proactively.33 We believe unlearning is captured in the Behavioral Regulation domain of the 
Theoretical Domains Framework (TDF), our behavior change framework, for which there are evidence- 
based behavior change techniques to consider. This novel TDF connection to a limited unlearning literature 
may play a significant role in advancing de-implementation science. 
 
A3. Strategies to stop chemical castration as prostate cancer treatment are sorely needed 
De-implementation, or stopping practices that are not evidence-based, has tremendous potential to improve 
patient outcomes and mitigate rising healthcare costs.29,30 This is important given recent campaign attempts 
to curb overuse of services. In fact, one group has called for including castration as primary prostate cancer 
treatment in the next generation of Choosing Wisely.34 De-implementation efforts have addressed 
analgesic35 and antibiotic36 use, glucose control,37 and blood transfusions.38 For this study, stopping low 
value castration might help prevent fractures, heart disease, and metabolic syndrome, preserve sexual 
function, in addition to freeing up provider time and decreasing pharmacy spending.  
A3.1 De-implementation categories and tailored de-implementation strategies 
Three categories have been proposed when deciding what and how to de-implement: 1) contradicted, 
established, 2) unproven, and 3) novel medical practices.29 Most indications for castration fall into the 
second category. Given the limited evidence base for castration in primary prostate cancer treatment, its 
cost, harms and ubiquity in other low value settings (e.g., non-metastatic biochemical recurrence), 
understanding how best to de-implement low value initial and ongoing castration could yield significant 
benefits. De- implementation strategies for unlearning castration practices will need to be tailored to 
provider preferences, facilitators, and barriers to maximize effectiveness.31,39-44 Even though we have 
identified two very different strategies for de-implementation (i.e., order check, informed decision-making), 
these are broad strategies, with considerable space in each for tailoring. In this study, we are using the term 
“tailoring,” often used to describe approaches to fitting implementation interventions to local context or site 
characteristics, to mean designing specific aspects of each strategy to increase acceptability and likelihood 
of effectiveness.45 Barriers and preferences, including facilitators, for operationalization of two different de- 

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implementation interventions represent clinically-relevant knowledge gaps this proposal will inform in 
preparation for a comparative effectiveness trial. We believe our prior work has delineated the most 
important factors influencing ADT treatment for inclusion in our tailoring approaches. 
A4. Impact: This innovative approach to de-implementation strategy development is directly aligned with state-
of- the-art complex implementation intervention development and implementation science. We believe this study 
will transform how and why chemical castration is performed for men with prostate cancer through combining 
trans- disciplinary expertise, rigorous assessment of provider preferences, and de-implementation strategy 
tailoring. This work will broadly advance de-implementation science for low value cancer care, and foster 
participation in our de-implementation evaluation trial by addressing barriers, facilitators, and concerns through 
pilot tailoring. Our proposal has implications for the following cancer care stakeholders: 
•
Implications for patients: Due to the large population of prostate cancer patients, enhancing safety by
promoting evidence-based use of chemical castration promotes quality care and quality of life.
•
Implications for providers: Understanding how providers unlearn ineffective clinical behaviors is a
critical step towards optimizing prostate cancer care and de-implementation of low value services.
•
Implications for low value cancer care policy: This proposal will address important issues
surrounding provider behavior change and serve as a model to decrease overtreatment more broadly.
This is especially relevant given Choosing Wisely and a growing need for effective de-implementation.
A5. Innovation: Our focus on understanding barriers and facilitators to and priorities for de-implementation 
of low value services is highly innovative. Despite the call for a better understanding of how to de-implement 
practices shown to have more harm than benefit (including many cancer-related services such as 
mammography, lung cancer and PSA screening), little applied research has been conducted to inform 
tailoring of strategies to be most acceptable and effective for stakeholders. In addition to the topic, this 
proposal is innovative in that it advances cancer care and implementation science by: 
•
Building the evidence base for de-implementing medical interventions with unclear or no benefits. This is
novel and critical given our increasing healthcare costs and the harms of overtreatment.29,30
•
Using a systematic, theory-based approach to tailor effective, reliable de-implementation interventions
and strategies. Our prior work linking the TDF to behavior change techniques is especially innovative
and has enhanced the tailoring of interventions significantly.46,47 This project will enhance our ability to
map causal relationships to professional behavior change and advance implementation science.
•
Better understanding acceptable ways to stop aggressive, low value cancer care. This is necessary
across disease types to maximize patient welfare and control spending.
B. PRELIMINARY STUDIES
Our multi-disciplinary team is exceedingly well-positioned to successfully carry out the proposed work. We
have collaborated previously. We have extensive expertise in clinical prostate cancer care, implementation
research, survey methods, qualitative & quantitative analyses, decision-making, informatics tools,
pharmacy applications, and theory-based intervention design and tailoring.
B1. Variation in low value castration rates indicate the need for ADT de-implementation 
In our prior work in preparation for the pilot and cluster randomized controlled trial (cRCT), we identified 
trends in ADT use as primary treatment for localized prostate cancer (Figure 1) and for treatment of non-
metastatic biochemical recurrence. We found persistent low value ADT and marked variation in facility level 
rates. While some might argue relatively low numbers of patients are unnecessarily treated, patients are 
routinely committed to lifelong ADT injections once the treatment decision is made. Better understanding 
de-implementation of ADT also opens the door to stopping additional low value use (e.g., duration of 
greater than 18 months of adjuvant ADT with radiation therapy in high risk prostate cancer).4 
B2. American Cancer Society Prostate Cancer Survivorship Guidelines highlight ADT harms 
As lead author of the guidelines,17 Dr. Skolarus (Co-PI) led a team to develop clinical follow-up care 
guidelines for primary care clinicians. The harms of castration were stressed as they impact most long-
term effect domains. In addition, Drs. Skolarus (Co-PI), Caram (Co-I), Shahinian (Co-I) co-authored a 
manuscript on ADT- associated bone disease emphasizing restriction of castration to evidence-based 
settings to limit unnecessary harms.51 Drs. Skolarus (Co-PI) and Hawley (Co-I) have also work closely on 
a randomized trial of tailored self-management strategies to address prostate cancer treatment side 
effects including those of ADT. 

 
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5
Barrier attribute 
TDF Domain 
Behavior change 
technique 
Value of 
physician 
autonomy 
Professional role 
\ identity 
Education, 
modeling, 
persuasion 
Evidence for 
appropriate 
use 
Knowledge 
Education 
Clinical time, 
patient 
education 
Environmental 
context / 
resources 
Training, 
restriction, 
restructuring 
Table 1. Examples of barriers and TDF domains linked 
to evidence-based behavior change techniques for 
de-implementation strategy development47 
 
B3. De-implementation of cancer care: the case of bilateral mastectomy overuse 
The growing rate of contralateral prophylactic mastectomy among women with breast cancer raises 
concerns about overtreatment driven by extra-scientific factors such as payment policy and media coverage 
akin to the ADT castration story. As highlighted by Dr. Hawley (Co-I) in peer-reviewed and media outlets,52 
and reinforced by Montini & Graham’s Implementation Science paper on de-implementation of entrenched 
practices,30 contextualizing provider perceptions is critical to any de-implementation strategy. 
 
B4. Extensive prior collaborations to understand prostate cancer provider behavior 
Drs. Skolarus (Co-PI), Hollenbeck (Co-I) and Shahinian (Co-I) have characterized prostate cancer care 
delivery over the last decade including castration with ADT in the Medicare population.10,28,53-55 They found 
urologists prescribed 95% of ADT as initial treatment,28 low bone health surveillance for ADT,56 as well as 
significant provider-level variation in ADT use among patients unlikely to benefit from treatment.57 
 
B5. Theory-driven barrier assessment and intervention development 
Dr. Sales (Co-I) has conducted several implementation research studies within and outside VA. She has 
developed numerous tools to guide theory-based implementation, including reminders, provider led clinics, 
and feedback reports.58-61 Dr. Hawley (Co-I) also has extensive experience with theory-based cancer 
decision-making interventions and clinical trials.62-65 
 
B6. Which de-implementation factors are most important 
for limiting ADT-based castration? 
Currently, priority setting for which barriers and facilitators to 
address during implementation strategy development is many 
times a matter of convenience, gestalt and ignorance as to 
which are the most common barriers versus most 
important.31,40,47,61,70 The TDF was recently used to direct 
development of an instrument that could readily identify hand- 
hygiene barriers and link them to evidence-based behavior 
change techniques.31 While this advanced theory-based barrier 
assessment exists, there are no current tools to guide tailoring 
of (de-) implementation interventions to the most important 
barriers, stakeholder preferences, and facilitators. In our prior work, we asked local urologists who treat 
prostate cancer to identify potential barriers to stopping castration. We identified barriers and mapped 
them to TDF domains and candidate evidence-based behavior change techniques (Table 1). Conducting 
qualitative work across facilities and using a quantitative discrete choice technique to prioritize barriers in 
our prior work has informed tailoring of our two intervention strategies. 
 
B7. Informatics tools to de-implement low value prostate cancer clinical practices 
Dr. Skolarus (Co-PI) collaborates with Dr. Shelton (Consultant) and his informatics team at the Greater Los 
Angeles VA Medical Center. They recently developed and implemented a highly-specific computerized 
clinical decision support alert to remind providers, at the moment of PSA screening order entry, of current 
guidelines against screening elderly men for prostate cancer – essentially de-implementation of PSA 
screening. In a prospective study involving over 30,000 patients published in Journal of General Internal 
Medicine, the screening rate decreased by over 30%.71 Dr. Shelton and his team are fully supportive of 
development of an EMR-based intervention for de-implementation of low value ADT (Appendix I). 
 
B8. Decision-making to inform prostate cancer treatment selection 
This team has tremendous clinical and research expertise in decision-making for cancer care. Dr. Skolarus 
(Co-PI) updates an evidence- and expert opinion-based shared decision-making tool for prostate cancer 
decision making endorsed by the American Urological Association. In addition, Dr. Hawley (Co-I) has led 
decision aid studies in both breast and colorectal cancer.62,64 She also has experience with using Option 
Grid™, a clinical encounter decision support tool.72 In addition, Dr. Makarov (Consultant) chaired the 
American Urological Association’s 2015 White Paper on ‘Implementation of Shared Decision-Making into 
Urological Practice’73 and will support intervention development and piloting (Appendix I). 
 
C. APPROACH   

 
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C1. Overview and conceptual model 
It is useful to consider the following conceptual model for piloting of de-implementation strategies tailored to 
provider behavior change techniques. Based on the results of our development work, we highlight several 
TDF domains and constructs in our conceptual model that may contribute to organizational, provider, and 
patient behavior in the setting of ADT for localized prostate cancer. In addition, our qualitative approach 
allowed for flexibility as we conceptualize the main issues when it comes to chemical castration. Last, the 
quantitative discrete choice methods used in our prior work created significant opportunities to examine 
interactions among domains and constructs allowing us to select, tailor and pilot the most informed 
organizational and individual level de-implementation interventions. 
 
Figure 3. Conceptual model for de-implementation strategy development 
 
 
 
 
 
 
 
 
 
 
           
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
           
 
 
 
 
 
 
 
 
 
 
C1.0 Study population 
Sampling, participant identification and recruitment 
To compare the interventions, providers who prescribe ADT (urologists, medical oncologists, and radiation 
oncologists) at participating sites will see order checks and/or a note template in CPRS for their patients 
identified as receiving ADT as primary treatment for localized prostate cancer or for non-metastatic 
biochemical recurrence with low PSA levels.  Prior to implementation of the interventions, study staff will 
send providers an email with an attached Information Sheet informing them of their ability to opt out as well 
as information on the Implementation Education Session (IES). (See protocol section below for detailed 
descriptions of interventions and study protocol procedures). 
We will administer a survey to assess feasibility and acceptability of the intervention, determine 
organizational structure and support, and assess fidelity in the interventions. We will work with study 
consultants throughout the pilot to further refine the survey, inviting the consultants/Site Champions at each 
of the 4 pilot sites to test the preliminary survey at baseline and 6 months in VA Qualtrics to understand how 
 Barriers and facilitators to castration  
de-implementation (Qualitative) 
Theoretical Domains Framework (TDF) assessment 
Barrier and facilitator assessment interviews  
Provider engagement 
   Pilot de-implementation intervention strategy testing (Tailored) 
Decision-making pilot  
Options 
- Brief in-office pro/con 
Option Grid™ decision aid 
- Provider training in 
communication, values 
elicitation 
- Informed consent for ADT  
Pilot de-implementation outcomes 
Feasibility, acceptability, scalability, recruitment 
Patient outcomes 
Decreased use of ADT as primary prostate cancer treatment 
Theory-based, tailored de-implementation interventions & strategies 
Formulary restriction – Organizational level 
Decision-making – Provider/patient level 
Barrier prioritization and de-implementation strategy tailoring  
(Quantitative) 
Discrete Choice 
Experiment 
Prioritize key factors 
using urologist survey  
Formulary restriction pilot  
Options 
- Prior authorization  
- Oncology consultation  
- Pharmacy review 
- EMR order template 
- Selected prescribers  
- Medication safety policy 
Evidence-based behavior 
change technique selection and 
intervention tailoring 
TDF-driven and tailored to 
prominent barriers 
Organizational Factors* 
Environmental context and resources 
 
 
Provider Factors* 
Beliefs about consequences  
Professional role & identity 
Emotion, Goals, Time 
Behavioral regulation 
Breaking habits 
To R37-funded cluster randomized comparative effectiveness de-implementation trial 
Selection/T
ailoring 
Tailoring  
Selection/T
ailoring 
Patient Factors* 
Emotion, social influences   
*Theoretical Domains Framework 
domains and constructs 
Tailoring  

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best to use the survey in our cRCT. The purpose of piloting the survey with the consultants/Site Champions 
is to help inform further refinement of survey questions as well as implementation procedures in preparation 
for the cRCT. During the cRCT, selected providers and stakeholders at the 20 participating sites will be sent 
an email at baseline and 6 months inviting them to participate in the survey. The email will contain a link to 
an anonymous survey hosted in VA Qualtrics.  
C2.0. Broad intervention categories require tailored design: Formulary restriction & decision-making 
There are several potential implementation interventions to de-implement low value castration within each 
broad intervention category we identified for this study. We focus on an order check and physician 
communications during the informed decision-making because of their difference in key attributes, including 
likelihood of quick success vs. long-term sustainment and effort required by clinicians. We describe some 
possible intervention design features briefly for each intervention type in Table 2. While several options 
exist, there is no existing evidence to inform which is the best approach from the provider perspective. Our 
early work has informed which of these specific approaches is likely to be most acceptable to clinicians, and 
provided data needed to tailor these broad interventions. For 
example, we do not know how a blunt formulary restriction can 
be implemented at a national level. Nuances around order 
restriction need to be addressed and order checks programmed 
to only trigger when a patient meets certain criteria based on 
their medical record data without burdening providers with 
additional steps even when prescribing ADT within guidelines. 
While formulary restriction of ADT for localized prostate cancer 
seems warranted, we may find that it is widely considered 
unacceptable to providers. Nor do we know how informed 
decision- making can be efficiently operationalized in a clinical 
setting for providers considering castration for localized disease 
or for non-metastatic biochemical recurrence. By tailoring each 
intervention strategy using behavior change techniques and 
barrier solutions derived from our prior work, we believe we have 
designed strategies that will be accepted by providers, but still 
allow us to test differences in the widely varying mechanisms of 
action. We have refined these approaches through robust efforts 
in our prior work and the expertise of our trans-disciplinary, multi-
site investigative team, and will continue to refine these 
approaches based on this pilot study. 
C2.1 Selection and tailoring of formulary restriction and decision-making pilot interventions 
C2.1.1 Formulary restriction interventions available in the integrated delivery system 
The VA Pharmacy Benefits Management Services uses several tools to encourage optimal use of 
medications including: 1) National Formulary, 2) Prior Authorization, 3) Criteria for Use, and 4) VA Center 
for Medication Safety. ADT is currently listed on the VA National Formulary as a standard pharmacy benefit 
to eligible patients. No prior authorization is necessary to ensure ADT use is appropriate. For this pilot, we 
plan to test implementation of a CPRS order check at the facility level. An order check was selected 
because it will flag prescribers that ADT may not be guideline supported for the Veteran, but it will not be a 
hard stop – providers can move through the order restriction to order ADT without additional delays upon 
entering the indication (or any text) into a text field. To reduce burden on providers as much as possible, 
this flag will only be triggered for Veterans with localized prostate cancer getting primary ADT or Veterans 
getting ADT for non-metastatic biochemical recurrence with a low PSA level. We note that this approach 
makes this a benign intervention: providers are not required to cross administrative hurdles to be able to 
order ADT if they feel they have good reason to do so. 
C2.1.2 Tailoring a formulary restriction strategy for ADT de-implementation 
Our formulary restriction intervention involves a refined version of the current EMR order check template 
developed and in use by Dr. Shelton and Dr. Skolarus (Co-PI) at the VA Ann Arbor to limit inappropriate 
prostate cancer screening.71 In general, these templates vary widely across the system, can be made more 
or less extensive, and can build in limited forms of decision support to specialists prescribing ADT. This is a 
very flexible, widely used approach, for which the technology already exists and is integrated into the EMR. 
Table 2. Examples of potential pilot interventions
Formulary restriction
Prior authorization 
Oncology consultation 
Pharmacy review 
Used in infectious 
disease 
Criteria for Use 
EMR order template 
Selected prescribers 
Currently used for 
restricted drugs 
Medication Safety 
(VAMedSAFE) 
Evaluate, educate and 
prevent adverse events 
Decision-making 
Decision aid using a brief 
in-office pro/con (e.g., 
Option Grid™) 
Commercialized shared 
decision-making for 
prostate cancer 
Provider training in 
communication and 
values elicitation 
Evidence-based 
practice though difficult 
to implement/sustain 
Informed consent for ADT 
VA iMed consent 

 
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We used the taxonomy outlined by Wright et al.84 to describe the decision support content and the Template 
for Intervention Description and Replication (TIDieR) checklist guided the refinement and tailoring.85 For 
example, when an ADT injection is ordered, a brief interruptive message tailored to our prioritized barriers 
TDF themes and behavior change techniques (e.g., persuasion, training, education) based on our prior 
work, will be shown on the ordering screen. This will allow the provider the option of proceeding or 
cancelling the order, with or without justification. To ensure this formulary restriction approach is ‘smart’ we 
will use the following criteria as we begin and explore options during refinement: 1) injectable ADT order in 
pharmacy claims (e.g., leuprolide J9217), 2) prostate cancer diagnosis (ICD-9 185, ICD-10 C61), and 3) low 
PSA level (e.g., levels <2 ng/mL are consistent with non-metastatic disease4). We will continue to refine 
these criteria throughout the pilot with the investigative team. We will vary alert criteria (e.g., prior ADT 
injection, PSA level) to ensure the number of triggers are acceptable to providers as done previously. We 
will pilot our theory-based messaging, presentation, and approach, at the VA Ann Arbor Healthcare System, 
VA Greater Los Angeles Healthcare System, and VA NY Harbor Healthcare System, with ongoing 
refinement. These pilot sites have been selected because we have study team member presence to help 
facilitate implementation and assessment. 
C2.1.3 Decision-making interventions to de-implement low value care Informed and shared decision-
making are increasingly recognized components of high quality care.63,73,86 This approach has been 
associated with less decisional regret and conflict, increased adherence to a treatment plan, 
empowerment, higher satisfaction with care, and more realistic expectations.73 One relevant example is a 
randomized trial of shared decision making leading to an absolute 25% decrease in antibiotic use for 
acute respiratory illness.88 Similarly, treatment of localized prostate cancer and non-metastatic 
biochemically-recurrent prostate cancer with ADT are ideal conditions for improving patient-centered care 
through better decision-making as continuous chemical castration with ADT is not guideline 
recommended in most cases. There are numerous treatment options in the case of localized disease: 
observation (i.e., watchful waiting, active surveillance), surgery, and different types of radiation therapy—
each with different risks and benefits (e.g., oncological “cure” vs. potential urinary or sexual dysfunction). 
We plan to explore provider factors associated with the decision to continue or stop ADT for localized 
prostate cancer and for non-metastatic biochemical recurrence, and believe ADT prescribing is a prime 
candidate for at least 2 reasons. First, it is not guideline recommended in most cases for localized and 
non-metastatic recurrent disease. Second, there are significant harms that may be under appreciated 
prior to using our decision-making approach therefore decreasing ADT use through our interventions. 
Therefore, our interventions to de-implement low-value ADT include: 1) Brief provider training in 
communication and values elicitation, 2) talking points for providers embedded into a CPRS note 
template, and 3) clinic handout entitled “Living well with prostate cancer – is hormone therapy still right 
for you?” (Appendix II). Most of these are not routinely used in practice but could decrease ADT use. We 
include information about the harms of ADT with a focus on alternative treatment options in the clinic 
handout. Decision aids are one approach to help communication about treatment options thereby 
enhancing informed decision-making, and in some cases decreasing overtreatment especially when risks 
outweigh benefits.73   
As with the formulary restriction, we argue that this is a benign intervention focused on the provider. 
Education is a common event in health care settings, and this is designed to be brief, non-intrusive, and 
focused on a well-accepted practice of sharing elements of decision-making with patients. 
C2.1.4 Tailoring the decision-making strategy to de-implement low value ADT 
We are tailoring our intervention for castration with ADT as primary treatment in localized disease and for 
non-metastatic biochemical recurrence. Our extensive experience with the University of Michigan Center for 
Health Communications Research and its tailored approaches to health care behavior change for Drs. 
Skolarus’ and Hawley’s prostate cancer survivorship trial, social marketing in health literature,90-92 and Dr. 
Sriram, all indicate that, in fact, the way information is presented in our intervention could lead providers to 
withhold ADT in the face of risks dramatically outweighing benefits, in addition to perceptions of 
organizational support to decrease low value treatment with ADT. We involved several experts during 
development including Dr. Hawley, expert in breast and colon cancer decision-making, Dr. Makarov 
(Consultant), Chair of the American Urological Association’s Shared Decision-Making White Paper, and 
marketing expert Dr. Sriram to ensure our interventions are in line with state-of-the-art decision-making and 
marketing evidence. We will continue to refine the intervention and theory-based messaging, presentation, 
and approach as needed based on the pilot work. 
 

 
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The pilot work plays a critical role to help us understand the acceptability, feasibility, and scalability of these 
complex interventions in preparation for the full-scale randomized de-implementation evaluation trial.45 In 
fact, the UK Medical Research Council guidance indicates piloting is essential to complex intervention 
development and testing prior to large-scale evaluation.93 The main goal of both interventions will be to 
decrease castration rates for patients with localized prostate cancer and patients with non-metastatic 
biochemical recurrence, but to do this in a way that is acceptable to the clinicians who treat these patients. 
We are purposely choosing intervention strategies from opposite ends of the behavior change continuum 
because of their evidence-based potential to change provider behavior. Specifically, we are selecting one 
approach (formulary restriction policy – order check) that operates at the site level and is widely perceived 
as a forcing function, asking providers to provide a reason regarding their clinical decision. The other, 
physician communication during the informed decision-making process, operates at an individual and 
dyadic level, and is perceived as maximizing the opportunity for clinical discussions. The first approach 
requires little to no learning on the part of providers, while the second requires considerable upfront learning 
(“cost” to the provider). This approach sets up a testable hypothesis for our comparative effectiveness trial, 
that a blunt de-implementation policy may be effective in the short term but that it will lose its effects as 
providers learn work-arounds. Conversely, an informed decision-making approach to de-implementation 
might take longer to observe measurable decreases in castration rates, but its effects will create 
sustainable change as providers internalize and routinize this clinical practice.94  
 
(See protocol section below for detailed descriptions of interventions and study protocol procedures). 
 
C3.1 Methodological issues to be addressed in de-implementation pilots A well-designed pilot study 
has many purposes, including testing methods of recruitment; selecting the most appropriate primary 
outcome; testing acceptability of the intervention by stakeholders; ironing out feasibility and fidelity issues; 
refining the full study protocol; and estimating sample size for a full trial.45,95 As highlighted in 
implementation literature, preparation and planning are central to successful intervention development and 
implementation. The need for clear outcomes (e.g., castration rate), systematic, theory-based interventions 
to change provider behavior, and a timetable are necessary to successfully set up our full- scale evaluation 
trial. Further refinement in the pilot work will allow us to explore outcomes including the total number of 
ADT injections as we will also be working to stop treatment with low-value ADT. As illustrated in Table 3 
below, the piloting of the intervention strategies will focus on 4 major methodological issues.45 We will 
examine issues surrounding recruitment, acceptability, feasibility, scalability, and data collection for the full-
scale trial. 
Table 3. Methodological issues requiring pilot evaluation prior to a full-scale de-implementation trial 
Issue 
Assessment 
Potential outcome 
Recruitment 
randomization 
scalability 
Monitor proposed recruitment strategy at each facility; check practicality of 
cluster randomization of facilities; identify issues of participation refusal or 
withdrawal; acceptability of randomization; number of eligible participants 
per month; compare clinic flow across recruitment strategies 
Select most effective recruitment and 
randomization strategy; trial messaging to sites; 
discern patient, provider and cluster sample 
sizes; refining eligibility screening 
Acceptability of 
intervention 
Check acceptability of interventions with ADT prescribers and clinic staff at 
pilot sites; settings for each intervention; consent and documentation 
practices; tailoring strategies are acceptable; timing of intervention relative 
to visit 
Identify acceptable components of each 
intervention in clinical practice; consent 
processes; efficient documentation practices 
Feasibility in 
clinical practice 
Assess burden on clinic staff and providers to participate; monitor clinical 
time and workflow; assess adherence to intervention; technical 
performance of EMR-based intervention(s); participants representative of 
those expected in full-scale trial; intervention fidelity 
Time and resources needed to roll out in 
randomized sites; learn research and clinic 
administrative staff roles for trial; 
standardization; scheduling practices 
Data collection 
and outcome 
assessment 
Monitor follow up practices for patients on ADT; monitor for asymmetric 
attrition/retention across intervention sites; missing data; review choice of 
primary outcome, study design; effect variability 
Willingness to participate by intervention 
preference; effect size; consider hybrid study; 
duration; full-scale protocol 
 
C3.2 Study populations 
We will conduct pilot testing at 4 sites with multi-disciplinary review by study team members to confirm 
target clinic visits prior to engagement with site provider. Dr. Skolarus (Co-PI) will lead the pilot efforts at the 
VA Ann Arbor Urology Clinic with Dr. Caram leading pilot efforts at the VA Ann Arbor Urologic Oncology 
clinic and Dr. Elliott leading the efforts in the VA Ann Arbor Radiation Oncology clinic. Drs. Shelton, and 
Makarov, each with urologic oncology practices, will lead pilot efforts at their respective VA sites (Greater 
LA and NY Harbor). The number of patients receiving primary ADT for localized prostate cancer and 
receiving ADT for non-metastatic biochemical recurrence with low PSA levels at each site should be 
adequate for piloting based on preliminary data. However, the primary purpose of the pilot is to assess for 

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issues in the implementation process in order to further refine the intervention plan. The pilot testing will 
play a critical role to help us understand the acceptability, feasibility, and scalability of these strategies in 
order to conduct the full-scale pilot randomized implementation trial. In particular, we expect to learn best 
practices in introducing both strategies to sites in the most efficient, least intrusive ways. 
For the 4-site pilot randomized implementation trial, we will recruit sites from the VA facilities with the 
highest levels of low-value ADT use. We will target facilities with high rates of low-value ADT for localized 
prostate cancer and non-metastatic biochemical recurrence. Sites will be identified through a combination 
of CDW data pulls and chart reviews, with expert multi-disciplinary review by study team members prior to 
moving forward with site providers. We will also match our 4 intervention sites with up to 8 control sites 
acting as contemporary controls for ADT overuse and our effectiveness outcomes.  
C3.3 Data sources and analysis 
We anticipate conducting the pilots for six months. For the pilot, our research team will host regular calls 
between Drs. Skolarus (Co-PI), Caram (Co-I), Shelton (Consultant), Leppert (Consultant), Makarov 
(Consultant), the Ann Arbor project team, other Co-I’s and consultants to discuss issues. We will take notes 
during these calls. At the beginning, we anticipate calls will occur weekly to deal with barriers and 
complications. By the end of the interventions, we anticipate that calls will be shorter and less frequent, and 
will focus more on achievements and lessons learned regarding methodological issues as we prepare for 
the pilot randomized implementation trial. We will extract data on ADT use from VA and Medicare data to 
remain informed and updated about the status of chemical castration as primary treatment and treatment 
for non-metastatic biochemical recurrence across VA (including the pilot sites). This will allow us to monitor 
secular trends in performance and assess possible changes in chemical castration over the pilot period in 
our pilot sites. We will collect and maintain descriptive data, which is most appropriate for pilot studies.95 We 
will use content analysis methods to assess key issues arising from conference call field notes. We will use 
bivariate analyses (t-test or chi-squared test) to assess the parameters (central tendency and variation) for 
pilot intervention variables including patient and provider demographics.90 In preparation for our pilot 
randomized implementation trial, we will use national VA data to identify potential sites. Data collection and 
analysis procedures will be further refined during the pilot. 
D. Human Subjects
D1. Risk to subjects 
D1.1 Human subject involvement and characteristics 
Prior to commencement of study activities, we will obtain VA Ann Arbor Institutional Review Board approval, 
requesting exemption under categories 2 (survey), 3 (benign behavioral interventions), and 4 (secondary data 
analysis). As an exempt project, all project modifications will be submitted to the VA Ann Arbor Research & 
Development Committee for approval.  
We will conduct pilot testing among clinicians who prescribe ADT at VA Ann Arbor Healthcare System, VA 
Greater Los Angeles Healthcare System, and VA NY Harbor Healthcare System. Drs. Skolarus (Co-PI), Caram 
(Co-I), Shelton (Consultant), Leppert (Consultant), and Makarov (Consultant) will serve as champions for the 
pilot sites, working with the Ann Arbor project team to help with implementation. This includes providing 
information on site workflow, regular status updates, and feedback on implementation. For the pilot 
randomized implementation trial, the study team will recruit Site Champions (e.g., Urology Chiefs) at each of 
the participating sites. All clinicians who prescribe ADT at participating sites will be eligible to receive the 
interventions. Ann Arbor team members will send clinicians an email with an attached Research Information 
Sheet providing an opportunity to opt out of participation. Opting out means that they will not be asked to 
participate in surveys or other approaches to measuring provider responses and the interventions will not be 
triggered for any of their patients or clinic visits. 
No other inclusion or exclusion criteria will be applied. No patients will be recruited for either the pilot testing or 
pilot randomized implementation trial; however, identifiable data will be collected from national VA CDW, 
Central Cancer Registry, Vital Status, and CMS data, and chart reviews will be conducted using 
CPRS/Capri/JLV/ WebVRAM, to identify target clinic visits and assess outcomes. Identifiers will be stripped as 
early as possible, once analytic data sets are created. 

 
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D1.2 Sources of materials 
As part of our development efforts, we have created real-time ‘smart’ criteria to support streamlined 
implementation. We will collect data using CDW/Cancer Registry/Vital Status/CMS data from October 1, 1999 
to June 30, 2024 on up to 100,000 patients to identify low value ADT use at pilot testing sites and to determine 
eligibility of implementation trial sites. While the cohort will be defined using 2020 – 2022 data, the remaining 
data is needed to properly identify target clinic visits and ensure the alert criteria (e.g., prior ADT injections) 
triggers are acceptable to providers. We will develop and test the intervention strategies focusing on major 
methodological issues including: provider engagement, acceptability, feasibility, scalability, and data collection 
for the full-scale trial. Dr. Skolarus (Co-PI) and the research team, with the support of weekly study team 
meetings, will be responsible for each pilot assessment and provider engagement. There will be regular calls 
between Dr. Skolarus (Co-PI), the pilot Site Champions/Study Consultants, the Ann Arbor project team, Co-I’s 
and consultants to discuss common issues or concerns during the pilot. We will take field notes during these 
calls. At the beginning, we anticipate the calls will occur weekly and deal with barriers and complications. By 
the end of the intervention, we anticipate that calls will be shorter and less frequent, and will focus more on 
achievements and lessons learned regarding methodological issues as we prepare for the randomized 
evaluation trial. We will extract data on ADT use from VA and Medicare data to remain informed about the 
status of chemical castration as primary treatment for localized prostate cancer and treatment for non-
metastatic biochemical recurrence across VA (including pilot sites). This will allow us to monitor secular trends 
in performance over this period, and to assess possible changes in chemical castration over the pilot period. 
We will collect and maintain descriptive data, which is most appropriate for pilot studies. We will use content 
analysis methods to assess issues arising in each site from the conference call field notes. All data will be 
collected specifically for the purposes of proposed research.  
 
 
 
Table. D1.2 Sources of Materials 
 
 
 
Engagement, 
randomization, 
Scalability 
 
 
Acceptability of 
intervention 
 
 
Feasibility in clinical 
practice 
 
 
Data collection and 
outcome assessment 
Monitor proposed engagement strategy at each 
facility; check practicality of cluster randomization of 
facilities; identify issues of participation refusal or 
withdrawal; number of eligible clinic visits per month; 
compare clinic flow across engagement strategies. 
 
Check acceptability of interventions with providers clinic 
staff at pilot sites; settings for each intervention; 
documentation practices; tailoring strategies acceptable; 
timing of intervention relative to visit 
Assess burden on clinic staff and providers to participate; 
monitor clinical time and workflow; assess adherence to 
intervention; technical performance of EMR-based 
intervention(s); participants representative of those 
expected in full-scale trial; fidelity to each intervention; 
monitor for asymmetric attrition/retention across 
intervention sites; missing data; review choice of primary 
outcome, study design; variability in effects 
Select most effective engagement and 
randomization strategy; messaging of trial to 
potential sites; discern patient, provider and 
cluster sample sizes; eligibility screening 
refinement 
 
Identify acceptable components of each 
intervention in clinical practice; efficient 
documentation practices 
 
Time and resources needed to roll out in 
randomized sites; learn research and clinic 
administrative staff roles necessary for trial; 
standardization of intervention; identify 
scheduling practices 
Willingness to participate may depend on 
intervention preference; estimates of effect 
size; consider hybrid study; duration; full- 
scale protocol 
Pilot 

 
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D1.3 Potential risks 
Risks for participating providers include possible slight disruption of clinical workflow and a low likelihood of 
psychological distress. These risks will be site- and intervention-dependent. We are requesting exemption 
under categories 2 (survey), 3 (benign behavioral interventions), and 4 (secondary data analysis). Providers 
will be emailed a Research Information Sheet with details of the study. The right of providers to discontinue 
their involvement in the research at any time will be fully disclosed in the Information Sheet. We are also 
requesting a waiver of HIPAA authorization for access to PHI. The proposed research qualifies for this waiver 
because it involves no more than minimal risk to subjects and the waiver will not adversely affect the rights or 
welfare of subjects. In addition, the research could not practicably be carried out without the waiver. In order to 
be granted the waiver, we demonstrate procedures (outlined below) that protect patient identifiers from 
improper use and disclosure. 
 
The investigative team has considerable experience in maintaining the confidentiality of large datasets and has 
established procedures in place to ensure data confidentiality. All investigators and research staff will have met 
training requirements for handling protected health information as defined by the Health Insurance Portability 
and Accountability Act (HIPAA), data security, and privacy. All data storage and handling will follow defined 
protocols at the VA Ann Arbor Healthcare System. All data collected from VA CDW/Cancer Registry/Vital 
Status/CMS records and CPRS/Capri/JLV/ WebVRAM will reside on VINCI and in an access-restricted study 
folder on the AAVA OI&T secure drive. Paper records created for chart review purposes will be labeled with a 
study ID only and stored in locked filing cabinets in the locked 3rd floor CCMR suite in VA-rented space at 
NCRC. Once data is digitized, the paper copies will be placed in the VA’s secure shredder bin. Survey data will 
be collected anonymously in VA Qualtrics and downloaded into the access-restricted study folder for additional 
analyses. 
 
D2. Adequacy of protection from risk  
D2.1 Recruitment and informed consent 
Providers, service leadership, and staff involved with ADT prescribing at the participating sites will be given an 
overview of the site-specific intervention, highlighting the nature and purpose of the proposed research, as 
well as what they should expect to encounter during routine clinical care should they agree to proceed with the 
study. Providers will be sent an email with a Research Information Sheet (attachment) attached informing 
them of their ability to opt out and inviting them to the Implementation Education Session (IES) (attachment).  
 
D2.2 Protection against risk 
All study staff will have met local training requirements for handling protected health information. All data will 
be stored on VINCI and in an access-restricted study folder on a secure server at the Ann Arbor VA, or in VA 
Qualtrics, accessible only by authorized study team members. Individual real social security numbers (SSNs) 
will be needed to link individual data across data sources (e.g., CDW-Oncology to clinical data) and to conduct 
chart reviews. An electronic cross-walk file will be used when accessing large datasets for analyses. Access to 
the cross-walk file will be restricted to authorized personnel, who have met the security criteria necessary for 
access to patient identifier mapping files at the VA’s Austin Automation Center. As VA employees, all study 
staff members are subject to the Federal Privacy Act. Site Champions will not use coercion in their role and 
will not be privy to names of providers opting out of the research. 
 
D3. Potential benefits of the proposed research to the subject and others 
Though participation in the research study may not directly benefit participants, the data collected will benefit 
future providers and patients by improving the quality of prostate cancer care in and eventually outside the VA 
through theory-based interventions to reduce low value cancer care. Due to the expanding population of aging 
men with prostate cancer, enhancing safety by promoting evidence-based use of chemical castration promotes 
quality care and likely will improve quality of life. It is possible that providers taking part in the interventions will 
gain knowledge about better use of chemical castration for prostate cancer patients, particularly with respect to 
localized disease and non-metastatic biochemical recurrence. Moreover, understanding how providers unlearn 
ineffective clinical behaviors is a critical step towards optimizing cancer care and de-implementation of low 
value services. Unlearning clinical behaviors such as prescribing ADT in low evidence settings can have 
substantial benefits. First, patients are no longer subjected to treatment harms with little to no benefit. Second, 
unlearning misaligned castration practices can provide opportunity for more efficient, higher value use of 
specialty care providers. Last, acquiring the skill of unlearning can increase flexibility and willingness to adapt 
to evidence more proactively. The risks posed to research participants are minimal, consisting of potential 

 
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breaches in confidentiality. We believe we have procedures in place that will minimize these risks, and that the 
overall project has a highly favorable risk:benefit ratio. 
 
 
D4. Importance of knowledge to be gained 
Many men with prostate cancer are castrated with long-acting injectable drugs (i.e., androgen deprivation 
therapy or ADT). Although some patients benefit, it is also used in patients with little or nothing to gain. The 
best ways to stop, or de-implement, low value cancer care are unknown. A significant scientific and clinical 
knowledge gap remains in prioritizing which barriers to stopping castration in low value settings need to be 
targeted for effective de-implementation. We will compare two different approaches for reducing low value 
ADT use. In doing so, this study will address important issues surrounding provider behavior change and serve 
as a model to decrease overtreatment more broadly. This is especially important given Choosing Wisely and 
the need for effective de-implementation strategies. Throughout this study, we will keep a broad focus so that 
our work lays a foundation for transforming how and why castration is performed for prostate cancer treatment 
across the globe. This work will address provider preferences and concerns through pilot tailoring and advance 
de-implementation science for low value care through our subsequent de-implementation evaluation trial. 
 
D5. Data Safety and Monitoring Plan 
Drs. Saini (PI) and Skolarus (Co-PI) will be responsible for reporting all adverse events that might arise 
during the course of the study to the Ann Arbor Veterans Affairs Health System IRB as well as to the ISSO 
and PO as appropriate. Adverse events during this study would likely consist only of breaches in 
confidentiality. As outlined above, precautions have been taken to prevent this. However, should such 
breaches occur, Drs. Saini (PI) and Skolarus (Co-PI) will report these occurrences to the overseeing IRBs as 
well as the ISSO and PO within 48 hours of discovery. 
 
D6. Inclusion of Women and Minorities 
For provider recruitment, no exclusions will be made on the basis of gender, race or ethnicity. The only 
eligibility requirement is that participants be providers with experience caring for prostate cancer patients 
on ADT. 

 
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PROTOCOL 
 
STUDY OVERVIEW 
We are using theory-based, mixed methods to approach de-implementation of low-value androgen 
deprivation therapy (ADT). Based on our prior work (DeADT RDC-2017-1070/ IRB-2017-1047) involving 
behavioral theory-based qualitative analyses and national provider survey and discrete choice experiment 
(DCE), we selected competing de-implementation strategies for multi-site pilot testing in preparation for an 
innovative 4-site pilot randomized implementation trial to decrease low-value cancer care. This study is 
funded by NIH National Cancer Institute with the VA Ann Arbor Center for Clinical Management Research, 
an HSR&D Center of Innovation, providing all necessary resources, space, and support for conducting this 
research. 
 
During our development work, we engaged our team to identify and create the competing de-
implementation strategies based on our prior qualitative research eliciting stakeholder input. We chose an 
ADT order check attestation (Or) versus an ADT provider script (Sc) as a communication aid to be used and 
documented as an accountable justification in the electronic medical record. Sites receiving the Sc 
intervention will also receive an educational handout that providers may elect to share with patients during 
clinic visits. Both strategies have a strong evidence-base for changing provider behavior and are tailored 
based on the COM-B and DCE survey. The work from pilot testing will play a critical role to help us 
understand the acceptability, feasibility, and scalability of these strategies in order to conduct the full-scale 
pilot randomized implementation trial. We will conduct pilots for up to six months across 3 VA sites and the 
pilot implementation trial across 4 VA sites. 
 
The main goal of both interventions will be to decrease ongoing low-value ADT use for patients with 
prostate cancer, but to do this in a way that is acceptable to the clinicians who treat these patients. From a 
scientific perspective, we are purposely choosing to trial strategies from opposite ends of the behavior 
change continuum because of their evidence-based potential to change provider behavior. Specifically, we 
are selecting one approach (Or) that operates as an organizational constraint and a competing approach 
(Sc) that operates at an individual and dyadic level to build individual capacity, perceived to maximize 
ability of providers to communicate effectively. The first approach requires little to no learning on the part 
of providers, while the second requires upfront learning (“cost” to provider). 
 
As illustrated in Figure 2, this approach sets up a testable hypothesis: 
that a blunt de-implementation organizational approach may be 
effective in the short-term, but that it will lose its effects as providers 
learn work-arounds. Conversely, an individual capacity building 
approach to de-implementation using a script might take longer to 
observe measurable decreases in castration rates, but its effects will 
create sustainable change as providers internalize and routinize this 
clinical practice. 
 
 
 
 
 
 

 
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STUDY DESIGN 
Pilot testing will be done at 3 VA facilities and the pilot randomized implementation trial will be conducted 
at 4 VA facilities that care for prostate cancer patients with localized disease and non-metastatic 
biochemically-recurrent prostate cancer with low PSA levels receiving ADT injections. Our rigorous prior 
research demonstrates opportunities at the organizational level to address ongoing systematic use of ADT, 
as well as at the provider level where barriers to individual behavior change need to be addressed.  
 
We will pilot the Or vs. Sc de-implementation strategies for up to six months across 3 sites to reduce low-
value ADT use in prostate cancer patients with localized disease and non-metastatic biochemically-
recurrent prostate cancer with low PSA levels. This pilot work will play a critical role to help us understand 
the acceptability, feasibility, and scalability of these strategies to conduct the 4-site pilot randomized 
implementation trial. Using the RE-AIM framework, we will evaluate methods of recruitment and 
acceptability of the intervention by stakeholders, identify and troubleshoot any feasibility and fidelity 
issues, and refine the study protocol and power analysis for the pilot implementation trial. 
 
We have the following specific aim: 
 
Aim 1: To evaluate the implementation of an ADT order check (Or) versus a provider script (Sc) on 
decreased low-value ADT use after six months. We will first examine low-value ADT use during 6 months 
of pilot testing at 3 VA sites, as well as refine our proposed RE-AIM implementation outcomes and 
ascertainment, study of moderators (e.g., fidelity) and causal mechanisms underlying implementation 
interventions. This work will inform the subsequent 4-site pilot randomized implementation trial by 
addressing preferences and concerns through tailoring during pilot testing. Based on pilot testing, we will 
refine our site engagement strategies and study methods and materials for the trial.  
 
Data collection 
All 3 pilot test sites will be followed for up to 6 months. To implement the interventions and assess for 
issues in the implementation process in order to further refine the intervention plan, information will be 
collected regarding the process of ADT ordering at each site, including who is involved, through 
conversations with the Site Champion (who is also a project consultant) or their designee. Additionally, 
information regarding implementation status as well as any changes in site processes around prescribing 
ADT will be discussed at regular team meetings with the project consultants (including Site Champions). For 
both the pilot and implementation trial, outcomes will be collected from VA CDW/Cancer Registry/Vital 
Status/CMS records and CPRS/Capri/JLV/WebVRAM for all clinic visits documented as providing low-value 
ADT at baseline, 3 and 6 months. An organizational survey will be developed and refined throughout the 
pilot. For the pilot implementation trial, an anonymous clinic assessment survey will be administered to Site 
Champions at baseline and an ADT provider assessment will be administered to participating site providers 
at baseline and 1-month post-intervention through VA Qualtrics (Appendix VI).  
 
Outcomes Analyses 
Primary analyses: Comparing the effectiveness of two de-implementation strategies, Or vs. Sc, on 
continued low-value ADT use after six months. Our primary outcome is stopping ADT injections, which will 
likely be evaluated through a combination of chart reviews and informatics data generated through the 
ordering process. We will also explore the feasibility and impact of six-month outcomes during pilot testing 
to increase study efficiency and timeliness. 
 

 
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Secondary outcomes: RE-AIM implementation outcomes, changes from baseline measures, total ADT 
injections per arm at 6 months post implementation. (Table 4). We will examine moderators of strategy 
effectiveness (e.g., fidelity) and causal mechanisms underlying the strategies through content analysis from 
study team and pilot site meeting documents and discussion and based on our organizational assessment. 
 
 
Table 4. Implementation Outcomes (based on the RE-AIM framework) 
 
 
Domain 
Order entry 
Script 
Reach 
(1 - # ADT providers opt out) / 
(total ADT providers) 
(1 - # ADT provider opt out) / 
(total ADT providers) 
Effectiveness *** 
 
(primary implementation 
outcome, and primary outcome 
of trial) 
Low value ADT (LVADT) prescription order decrease 
 
(LVADT candidate expected orders – LVADT not ordered) / 
(LVADT got order + LVADT stopped order) 
 
Adoption 
(provider level) 
At least 1 order fired and signed 
(provider level) 
At least 1 script signed  
(provider level) 
 
Penetration 
Adoption (order level) 
(# times order entry justified) / 
(# times order went through 
anyway) 
 
 
# scripts signed / 
(LVADT got order + LVADT 
stopped order) 
 
Implementation 
Did implementation vary? 
- 
Differential adoption/penetration in medical oncology vs 
radiation oncology vs urology 
- 
Measure adoption/penetration at different time points (e.g., 
3/6 months) 
- 
Number of sites that withdraw from participation (e.g., 3/6 
month withdrawal rates) 
 
Fidelity 
- 
Were the justifications 
appropriate? (i.e., was 
something entered, or 
was no reasoning put in 
(enter n/a, etc)) 
 
- 
Was the script edited? 
(i.e., not just signed) 
 
Maintenance (site/setting level) 
Proportion of sites that would elect to continue intervention, if 
available 
 
 
 
 
 
 
 
 
 
 
 
 

 
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TIMELINE  
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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PILOT SITE SELECTION 
• 
The Or and Sc interventions will be piloted at the study PI and consultants’ sites as follows:   
Site  
Site Champions 
Intervention 
VA Ann Arbor Healthcare System  
Ted Skolarus, MD (co-PI) 
Or & Sc 
VA Greater Los Angeles Healthcare System 
Jeremy Shelton, MD 
Or 
VA New York Harbor Healthcare System  
Dan Makarov, MD 
Or 
 
PILOT SITE IMPLEMENTATION OVERVIEW 
• 
Drs. Shelton, Makarov, and Leppert are all consultants who have agreed to serve as Site Champions for the 
pilot work. 
o Study consultants do not have access to identifiable data or the study folder and are not “engaged” in 
study activities. 
 
• 
Pilot sites will not be randomized. 
 
• 
The ADT Order Check Attestation Intervention (Or) will be implemented at all sites, as this intervention requires 
engagement with other services, such as CAC, pharmacy, etc., and its procedures are most in need of 
refinement. 
 
• 
The ADT Provider Script Intervention (Sc) will be implemented at Ann Arbor.  
 
• 
The official start date for the pilot begins when we have started adding HF’s and/or assigning progress notes. 
Pilot sites will be followed for up to 6 months.  
 
• 
Facility Notifications & Approvals  
o Site Champions will be asked to seek approval from the Medical Center Director and notify chiefs of 
Urology, Oncology, Radiation Oncology, and Pharmacy (as needed) at their respective sites.  
o Study staff will provide Site Champions with email templates (Appendix II).  
 
Email templates will be tailored to each facility, as needed, and revised based on provider feedback 
o The Site Champions will be asked to direct any replies to the study group email 
VHAANNLivingWell@va.gov. Unless otherwise specified, the site champions will be included on all 
correspondence with staff at their site 
 
• 
CHIO/CAC’s Notifications & Approvals 
o Once the Site Champion has notified the Chiefs of Urology, Medical Oncology, Radiation Oncology, and 
Pharmacy, study staff will reach out to CHIO/CACs at each facility (Appendix II) to begin discussions on 
implementing the Order Check (Or). Study staff will also ask CACs at Ann Arbor to create a new Provider 
Script (Sc) progress note. 
o Our experience with the CACs at pilot sites will inform development of a CAC instruction guide to program 
the CPRS order check and progress note to be used in the cRCT.  
 
• 
Baseline ADT Prescribing Meetings 
o Information will be collected regarding the process of ADT ordering at each site, including who is involved, 
through conversations with the Site Champion or their designee. 

 
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o Site Champions and Section Chiefs will be asked about the ADT ordering process for their department, if 
they are in the Sc Arm this will include planning on how to best make the patient handout available to 
providers who prescribe ADT. 
o This information is needed to ensure the intervention is tailored to fit the sites’ existing workflow, to know 
who at the site should be informed of the intervention, and to learn baseline workflow so we are aware of 
changes outside of our intervention that may impact ADT ordering. 
o Site Champions and Section Chiefs will also be asked for a list of providers who prescribe ADT at their site 
(including fellows and residents). 
 
If names of the fellows/residents are unknown, we will leave it up to the Site Champions and 
Section Chiefs to notify them about the study.  
 
If departments outside of the Site Champion’s department also prescribe ADT, we will request this 
information from their department chief (or designee) as well (e.g., Medical Oncology, Radiation 
Oncology) 
o Site Champions will be asked for names of the site CHIO/CACs (if unknown). 
 
• 
Implementation Education Session (IES) 
o Study staff will work with Site Champions to schedule a virtual IES. 
o The purpose of the IES will be to explain the importance of the study, describe the light touch 
interventions, and encourage use of the tools provided with the interventions. We will also field questions 
and address any concerns from providers.  
o The IES will ideally be scheduled during Grand Rounds, tumor boards, or another regularly scheduled 
clinical department meeting. 
o The IES will be around 10-15 minutes and will include a PowerPoint presentation (see attached). 
 
The IES presentation will be tailored to each facility, as needed, and revised based on provider 
feedback. 
 
The Study Co-PI plans to facilitate the IES, but it may also be conducted by study staff or designee 
chosen by site leadership at their request. 
 
• 
Confirm List of ADT Providers  
o Once the Site Champions have obtained/provided all necessary approvals/notifications and the IES has 
been scheduled, study staff will contact the Site Champion and/or department chiefs to confirm the final 
list of providers in each department who prescribe ADT.  
 
• 
Intervention Kick-Off 
o Study staff will send providers an email with an attached information sheet and information about the 
upcoming IES (if IES has not already occurred) (Appendix II). 
 
Site Champions will also email providers to encourage participation in the IES (Appendix II). 
 
Site Champions will be careful to promote the study at their sites without being coercive.  
 
Providers will have a week from the email being sent to opt out. Providers may opt out by emailing 
the study team at: VHAANNLivingWell@va.gov. 
 
Site Champions will not be informed of any providers opting out. 
 
• 
Ongoing Communications 
o Once the intervention is successfully implemented at the site, study staff will communicate with Site 
Champions/site staff as needed. These communications may include: 
 
Monthly automated email inquiring about any site changes (including changes in providers and 
procedures), feedback from other staff, or site needs. 

 
Version 6, 10/04/2023 
 
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 
Other communications as needed. 
 
• 
This pilot work will help us refine our protocol, troubleshoot unforeseen issues in the project, and determine 
whether our interventions are feasible as designed. 
 
• 
We will also pilot the preliminary organizational assessment survey by inviting the Site Champions to complete 
the survey in VA Qualtrics. 
 
IDENTIFYING LOW-VALUE ADT IN PILOT 
      CDW/CENTRAL CANCER REGISTRY/VITAL STATUS/CMS  
 
• 
We will collect data using CDW/Cancer Registry/Vital Status/CMS data from October 1, 1999 to June 30, 2024  
 
• 
Study Data Manager will identify the low-value ADT cohort using 2020 - 2022 VA CDW/Central Cancer 
Registry/Vital Status/CMS data. 
o 
Real SSNs will be necessary in order to link data across databases and to conduct chart reviews. 
 
• 
Target clinic visits appropriate for low-value ADT de-implementation will be identified using CDW/Cancer 
Registry/Vital Status/CMS data based on patient diagnosis, PC treatment, and treatment dates. 
 
• 
We developed real-time ‘smart’ criteria to support streamlined implementation including:  
1.  Injectable ADT order within 14 months of the current date (e.g., leuprolide J9217) 
2.  Prostate cancer diagnosis (ICD-9 185, ICD-10 C61) 
3.  Low and non-rising PSA levels consistent with localized disease or treated non-metastatic biochemically-
recurrent prostate cancer (<2 ng/mL) 
 
• 
Clinic visits identified as appropriate for ADT de-implementation will include all those with patients undergoing 
ADT monotherapy as well as those with non-metastatic prostate cancer after definitive treatment, and those 
receiving continuous ADT for biochemical recurrence.  
 
o 
ADT monotherapy/primary ADT is defined by: 
1. Never had evidence of metastatic disease (including bones and lymph nodes) 
2. No treatment with castration-resistant prostate cancer (CRPC) medications (e.g., abiraterone, 
enzalutamide)  
3. No definitive treatment with radiation (+/- adjuvant ADT), RP, or cryotherapy, and has no immediate 
plan for definitive treatment  
4. Receiving ongoing ADT at the VA  
5. Current PSA ≤2 and not rapidly rising (no PSADT <10 months) 
 
o 
Biochemical recurrence is defined by: 
1. Never had evidence of metastatic disease (including bones and lymph nodes) 
2. No treatment with CRPC medications (e.g., abiraterone, enzalutamide) in the last two years 
3. Has completed definitive treatment with radiation (+/- adjuvant ADT), RP, or cryotherapy 
 The course of adjuvant ADT not within 3 years of definitive treatment   
4. Rise in PSA level after definitive treatment  
 2 ng/mL over nadir for those with history of radiation treatment 

 
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o nadir = lowest PSA after treatment 
 >0.2 ng/mL for those with radical prostatectomy (RP) 
5. Receiving ongoing ADT at the VA for biochemically recurrent prostate cancer 
6. Not on adjuvant ADT with salvage radiation 
 
o 
nmPCa after local/definitive treatment defined by: 
1. Never had evidence of metastatic disease (including bones and lymph nodes) 
2. No treatment with CRPC medications (e.g., abiraterone, enzalutamide) in the last two years 
3. Has completed definitive treatment with radiation (+/- adjuvant ADT), RP, or cryotherapy 
4. Receiving ongoing ADT at the VA  
5. No rise in PSA level after definitive treatment  
 
Current PSA ≤2 and not rapidly rising (no PSADT <10 months) 
 
• 
Throughout the pilot, the data manager will complete data pulls at different time intervals (e.g., weekly, bi-weekly, 
monthly, etc.) to determine how often the data may need to be refreshed during the RCT. Data such as patient 
appointment cancellations, changes in PSA scores, new drug names, variations of appointments/treatments, etc. 
are important to keep updated as they can impact patient eligibility.  
MPCA NATURAL LANGUAGE PROCESSING (NLP) TOOL USE IN VINCI 
• 
We will use a validated NLP tool developed by the VA Salt Lake City Healthcare System Prostate Core to identify 
Veterans with metastatic prostate cancer (mPCa) in real time. This will enable us to further refine our cohort by 
excluding all mPCa patients.  
o 
The Prostate Core has provided a data dictionary for definitions of the variables. 
o 
We will inform the Prostate Core if any of our definitions are different (e.g., prostate cancer, mPCa, etc.).  
o 
In the event we find mPCa patients after we complete chart reviews, we will inform the Prostate Core team.  
o 
Study staff will view the NLP data output in a VINCI worksheet. 
 
• 
The PCa Data Core table/list is updated monthly by VINCI (we should receive email notifications from VINCI when 
the list has been updated).  
CHART REVIEWS 
• 
Study staff will also conduct chart reviews using CPRS/Capri/JLV/WebVRAM to confirm target ADT orders 
and clinic visits. 
o 
Study staff will apply for local CPRS access at participating sites through WebVRAM, though Capri/JLV may 
also be used to conduct chart reviews 
 
• 
As the ADT injections occur serially at 1, 3, or 6 month intervals, an individual provider could have multiple 
opportunities to be exposed to the intervention during the 6-month study period. 
 
• 
Low-value ADT injections must have occurred within 14 months prior to data pull.  
 
• 
In consultation with Co-PI Dr. Skolarus, a fellowship-trained urologic oncologist, and Co-I Dr. Caram, an expert 
prostate cancer medical oncologist, and Co-I Dr. Elliott, Chief of Radiation Oncology at AAVA, we will provide 
multi-disciplinary review for questionable low-value ADT use.  
 
• 
Clinic visits identified during chart reviews or multi-disciplinary review as involving proper justification for ADT use 
will not be considered appropriate for ADT de-implementation.  
 

 
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• 
When identifying clinic visits as appropriate for the ADT de-implementation interventions, no interventions will be 
triggered on any clinic visits for providers who opted out of the study. 
 
• 
We will track numbers of identified low-value ADT injections each week per site. 
 
• 
Paper records created for chart review purposes will be labeled with a study ID only and stored in locked filing 
cabinets in the locked 3rd floor CCMR suite in VA-rented space at NCRC. Once data is digitized, the paper copies 
will be placed in the VA’s secure shredder bin. 
PATIENT DASHBOARD IN CPRS 
• 
See Appendix IV for screenshots of an example dashboard. 
 
• 
We will work with Yehuda Bechar, MBA, our consultant technology developer and study team member, to create a 
patient dashboard accessible through AAVA CPRS.  
 
• 
The dashboard will enable the study team to:  
o 
View upcoming clinic visits identified as appropriate for ADT de-implementation. 
o 
Know when we can assign the progress note template to providers who have an upcoming clinic visit 
identified as appropriate for ADT de-implementation. 
o 
Determine when a patient has an order for ADT in CPRS. 
o 
Complete quality checks (e.g., to know which patient records to look at to confirm the order check was 
generated). 
 
• 
Once a site is randomized, the Data Manager will run a new data pull for that site. She will create a file with the list 
of potentially eligible patients from CDW to upload to the dashboard. A separate Excel spreadsheet will be created 
for each site. The data files will be saved here: I:\Skolarus 2017\DeADT\5. Identifiable Data\RCT Data\Files for 
Upload. Data files will be uploaded to the dashboard.  
 
• 
Dashboard administrators will download export data files from the dashboard and save here: I:\Skolarus 
2017\DeADT\5. Identifiable Data\RCT Data\Dashboard Export Files. These data will then be imported into the 
database. This will also need to be done when changes to the dashboard data fields are made, as the export fields 
need to match the database import fields.  
 
• 
Prior to chart review screening, the study team will ask Yehuda to run the program that looks for the most recent 
clinic visits – these will be added to the “next screen date” column.   
 
• 
Study team will ask site CHIO and/or CAC’s to add the dashboard link to their CPRS tools menu. The FID in the 
URL will need to be updated for each site. Quotation marks are required at the beginning and end of the 
link when being programmed. The link should not include any additional spaces or characters – this can cause a 
user access error. Dashboard link: 
 
”https://vhav10appmedrc1.v11.med.va.gov/AviOutpatient/AdHoc/AdHocList.aspx?U=%DUZ%20M=%DFN%20FID=XXX
%20R=%MREF” 
 
• 
A server error may occur when CAC’s try to open the link from an active Outlook email (“active” meaning the CAC 
copied the link from a new reply email). When the CAC copies the link from an active email, the system adds 
https://gcc02.safelinks.protection.outlook.com/?url= to the dashboard link. The CAC will need to copy the link as 

 
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regular text (paste as “text only”) and then highlight the text but select copy hyperlink to get it to take that part 
out.  
 
• 
The dashboard may be accessed via the Tools menu in CPRS (all on VA servers behind the firewall) 
o 
Locations for Pilot Sites 
o AAVA CPRS: Tools >> Specialty Clinics Apps… >> Oncology/Hemoc >> AviTracks (light) 
o GLA CPRS: Tools >>Additional References/Resources >> Living Well ADT Dashboard 
o NYH CPRS: Tools>>More Surgery >> Living Well with Prostate Cancer Dashboard 
o 
Locations for RCT Sites may be found in the chart review guide. 
 
• 
If space in the Tools menu is limited, we will work with sites to determine an alternative location to place the 
dashboard link in CPRS. 
 
• 
Study team will notify Yehuda each time a site adds the dashboard to their CPRS tools menu.  
 
• 
Administrators (Jenny and Jordan) will oversee the list of dashboard users and export data files. 
 
PILOT TARGET ADT ORDER IDENTIFICATION (OR) 
• 
Prior to launch, we will pull a cohort from each facility to identify target ADT orders for the Or intervention. 
 
• 
Due to the delay in Cancer Registry data availability, we will need to pull data for an 18-month period to build our 
sample (e.g., for January 2022 launch, we will pull from January 2020 to July 2021). 
 
• 
Study staff will conduct chart reviews using CPRS/Capri/JLV/WebVRAM to confirm all ADT orders qualifying as 
low-value ADT within the study cohort at each facility. 
 
• 
Questionable cases will be subject to multi-disciplinary review during the weekly study team meeting: 
o 
Questionable bone metastases 
o 
Intermittent ADT 
o 
Other questionable cases 
 
• 
All target ADT orders confirmed will be subject to the Or Intervention (see below). 
PILOT TARGET CLINIC VISIT IDENTIFICATION (SC) 
• 
Every week, the study team will review the list of potentially eligible clinic visits for providers’ clinic schedules the 
following Monday-Friday. 
 
• 
Study staff will screen the list of clinic visits throughout the implementation period to identify target clinic visits for 
the Sc intervention. 
 
• 
Questionable cases will be subject to multi-disciplinary review during the weekly study team meeting: 
o 
Questionable bone metastases 
o 
Intermittent ADT 
o 
Other questionable cases 
 
• 
All target clinic visits confirmed will be subject to the Sc Intervention (see below). 

 
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IMPLEMENTATION EDUCATION SESSION (IES) 
• 
Study staff will work with Site Champions to schedule a virtual IES. 
• 
The IES will ideally be scheduled during Grand Rounds or another regularly scheduled meeting. 
• 
The IES will be ~10 - 15 minutes and include a PowerPoint presentation (see attached). 
o The IES presentation will be tailored to each facility, as needed, and revised based on provider feedback 
o The Study PI plans to facilitate the IES, but it may also be conducted by study staff or designee chosen by 
site leadership at their request 
• 
The purpose of the IES will be to explain the importance of the study, describe the light touch interventions, 
and encourage use of the tools provided with the interventions. We will also field questions and address any 
concerns from providers.  
 
INSTRUCTIONS FOR SCHEDULING IES MEETINGS  
NOTE: Be mindful of the different time zones when scheduling  
• 
Request the meeting organizers send calendar invitations to the following email addresses: 
o Site Champion’s email 
o Dr. Skolarus’ VA and UM emails 
o Living Well group email 
• 
We will provide the meeting organizers a copy of the PPT upon request.  
• 
Update site status in database with date and time of scheduled IES. 
• 
Add IES meetings to the shared Living Well calendar.  
• 
When IES’s are scheduled by the study team, include the information below in the meeting invite: 
Purpose 
Dr. Ted Skolarus, Research Investigator at the VA Ann Arbor Healthcare System, will be presenting an 
overview of his project, “Living Well with Prostate Cancer” which will be piloted at the <<insert site>>. 
This study is focused on limiting low-value Androgen Deprivation Therapy (ADT). The purpose of this 
presentation is to explain the importance of the study, describe the light touch interventions, and address 
any questions or concerns from providers.   
 
Meeting Information 
https://www.zoomgov.com/j/16142416824?pwd=TWx2UTN6OVh6OC90WmZrcVpNSUZhQT09 
Meeting ID: 161 4241 6824 
Passcode: 669953 
 
INSTRUCTIONS FOR SCHEDULING AD-HOC MEETINGS 
• 
Make sure site champion has CAC programming instruction guide for Or and screenshots of progress notes. 
• 
Update site status in database with date and time of scheduled ad-hoc meetings. 
• 
Add ad-hoc meetings to the shared Living Well calendar. 
 
ADT ORDER CHECK ATTESTATION (OR) INTERVENTION 
• 
The pilot work will be used to refine the Order Check Attestation Intervention for use in the cRCT, as needed. 
 
• 
The Or intervention will not be implemented in departments using Vista Chemotherapy Manager (VCM) or another 
separate ordering system where the order check will not be seen by providers. 
 

 
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• 
The screenshot below shows the latest version of the clinical reminder order check (CROC) developed in 
coordination with Dr. Gabe Solomon, ACOS Informatics, and Joye Allen, Clinical Pharmacy Specialist, CAC, VA Ann 
Arbor Healthcare System. 
 
• 
Study staff and/or the AAVA CAC will email site CAC’s a coding guide to implement the CROC in CPRS. The coding 
guide is written to start in test mode so the Study Team can use test patients to ensure the CROC is triggering 
correctly.  
 
• 
When the local CAC is ready, study staff will put them in contact with Joye (joye.allen@va.gov), who will send them 
a VISTA file with the CROC to install and update according to the coding guide. In the event Joye isn’t available, 
Erica Montressor (erica.montressor@va.gov) or Cindy Shepler (mary.shepler@va.gov) can send the VISTA file if we 
provide them with the local CACs VISTA email. 
 
• 
Study staff will request CAC to change the CROC to live mode when the intervention is set to start.  
 
• 
Once the CROC has been switched to live mode, study staff will place a “Living Well ADT” health factor in the EMR 
of patients whose clinic visits study staff have confirmed to be targets for ADT de-implementation. We will enter 
health factors as we identify eligible patients. This health factor combined with a low PSA level (most recent PSA < 
2ng/mL) will trigger the ADT Order Check Attestation Intervention (Or) when the provider places an order for ADT 
(Lupron, Eligard, Viadur, Goserilin, and Zolodex). 
 
• 
Providers may override the CROC by entering a number from the order check text that corresponds to the reason 
they are overriding the order check. Providers are also able to enter text if a numbered reason is not listed.  
 
• 
If providers opt-out after the health factor was placed for one of their patients, study staff will remove the health 
factor in CPRS. For a provider who opts-out, the Study Data Manager will run a query in our Access tracking 
database to pull a list of his/her patients. The Study Team will not place a health factor in the EMR of patients 
whose provider has opted out. 
 
• 
Study staff will do periodic quality control checks to ensure the intervention is working as expected and work with 
the site CAC’s to make adjustments as necessary.  
 
• 
Appropriate use of the indication will be tracked for fidelity. We will track comments entered by providers to 
override order checks. The Study Data Manager will periodically pull comments from order checks (there are data 
tables for order checks that contain text for open field that are stored in CDW).  
o 
Using a combination of progress notes and other CPRS data, study staff will check to determine whether 
the patient received the injection. 
• 
Deimplementing Or – study staff will remove HFs for intervention patients. We’ll ask site to remove study HF from 
their CPRS.  
CPRS INSTRUCTIONS FOR OR INTERVENTION  
OPENING CPRS 
• 
Go to “VA Shortcuts” (star icon on desktop) 
• 
Select “CPRS _Launcher” (rocket icon) 
• 
Select: VISN 03 or VISN 22 
• 
Select site: Ex - Manhattan, NY  
• 
Launch CPRS button 

 
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PLACING A HEALTH FACTOR 
While in a patient record in CPRS: 
• 
Click on the “Notes” tab (bottom of screen) 
• 
Select (highlight) the note that makes most sense to you to add the health factor.  Ideally this will be 
the last progress note by the provider who prescribes this patient ADT.  Note: it shouldn’t hurt 
anything to add this to another encounter if the last progress note by the provider who prescribes ADT 
isn’t an option – the only consequence of this health factor is triggering our order check while the 
order check is live at the site. 
• 
Click on the “Encounter” button (far right over tabs). 
• 
Click “Edit Note Encounter” button in the “Select and Encounter to Edit” pop-up menu.  
• 
Select “Health Factors” tab at the top of the Encounter Form pop-up menu.  
• 
Select “Other Health Factor…” button in the middle left side of the pop-up menu.  
• 
Enter “Living Well ADT” (or some portion of this) into the category box in the “Other Health Factors” 
pop-up menu.  
• 
Select “Living Well ADT” by clicking on it in the “Category:” menu so that it is highlighted.  
• 
Click “OK.” The “Living Well ADT” health factor should show up under “Selected Health Factors.” 
• 
Click “OK” again until pop-ups close and the progress note screen is again fully visible.  
• 
You can see in the bottom box under the progress note text “Health Factors: LIVING WELL ADT” to 
verify the health factor was added to the encounter. 
 
DOCUMENTING PLACEMENT OF HEALTH FACTOR – EXCEL SPREADSHEET 
• 
Update column “X” with date and full name of the encounter you added health factor. 
o Ex: “Yes – Oct, 13, 2022 UROLOGY CLINIC NOTE, GI/UROLOGY…” 
• 
Update column “Y” with date health factor was added. 
• 
Update column “AA” to indicate whether the dashboard was updated. 
 
REMOVING HEALTH FACTORS IN CPRS  
• 
Click on the “Notes” tab (bottom of screen) 
• 
Select (highlight) the note where you added the health factor.  
• 
Click on the “Encounter” button (far right over tabs). 
• 
Click “Edit Note Encounter” button in the “Select and Encounter to Edit” pop-up menu.  
• 
Select “Health Factors” tab at the top of the Encounter Form pop-up menu.  
• 
Find and select the “Living Well ADT” health factor in “Selected Health Factors.” 
• 
Click “Remove.” 
• 
You should no longer see in the bottom box under the progress note text “Health Factors: LIVING 
WELL ADT” to verify the health factor was removed from the encounter. 
 
DOCUMENTING PLACEMENT OF HEALTH FACTOR – DASHBOARD - TBD 
 
 
 
 
 
 
 
 

 
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SCREENSHOT OF CPRS ORDER CHECK  
 
 
 
 
PROVIDER SCRIPT (SC) INTERVENTION 
• 
The pilot work will be used to refine the Provider Script Intervention for use in the cRCT, as needed. 
 
• 
The purpose of the script is to enable providers to: 
o Improve interpersonal skills 
o Increase confidence in the evidence base and communication surrounding low-value care 
 
• 
It is up to the discretion of the provider whether/how to incorporate the script into the clinic visit discussion. 
PROGRESS NOTE 
• 
We will work with Erica Monstressor (Erica.Montressor@va.gov), or another, AAVA CAC, to develop the progress 
note template. We will also create an instruction guide for CACs at other sites to upload the note template file in 
CPRS.  
 
• 
Erica, or another AAVA CAC will send the note template via VISTA email to local CACs with directions to install. In 
the event Erica is not available, Joye Allen (joye.allen@va.gov), or Cindy Shepler (mary.shepler@va.gov) can send 
the VISTA file if we provide them with the local CAC’s VISTA email. 
• 
This is the exact entry for the reminder dialog they would need unless we make any updates to it between now 
and then.  
 
 
  

 
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• 
Study staff will enter a CPRS progress note approximately one business day prior to a target low-value ADT clinic 
visit. Notes will not be assigned for ADT injection-only visits. The note includes talking points for the provider to 
help with a discussion with the Veteran.   
o 
The note can be edited and signed by the provider, giving a quick and simple way to document the 
discussion. The progress note will prompt providers to indicate whether patient prefers to continue or 
discontinue ADT.  
 
• 
The progress note will include links to the clinic handout which will be posted on CCMR’s external website (outside 
VA firewall).  
 
• 
Providers may modify, ignore, or delete the progress note.   
 
• 
Appropriate use of the indication will be tracked for fidelity. We will track how many notes are placed. We will also 
be able to run a report of all signed and unsigned progress notes.  
 
• 
At the end of the intervention period, Ann Arbor CAC’s will delete/remove all unsigned progress notes. Unsigned 
notes will need to be reassigned at the end of the study. Erica, or another AAVA CAC will run a report of unsigned 
notes by our note title for Ann Arbor. The CAC will change the note author back to a member of the study team, 
which we can then remove from CPRS. We will ask the Data Manager to reassign the note in CDW for other sites or 
ask the site CAC if necessary. 
o 
If providers delete an unsigned note, it’s unlikely to appear in a TIU progress note report.  
CLINIC HANDOUT 
• 
The clinic handout will be tailored to each individual facility, e.g., with site name (Appendix V). 
 
• 
Prior to each site’s scheduled IES, study staff will provide clinic handouts to the clinic point person identified by the 
Site Champion (the clinic point person may also be the Site Champion). We may use one or more of the following 
approaches: 
o 
By mail: hardcopies of the handout will be mailed to the clinic point person (as requested). Each clinic will 
receive 50 copies of the handout.  
o 
By email: copies of the handout will be emailed to clinic point person (this may happen when we send Site 
Champions the email templates or in a separate email). Each clinic will be instructed to print 50 copies of 
the handout. 
o 
By website: a copy of the handout will be accessible on CCMR’s website (outside the VA firewall). A link to 
the website will be included in the progress note.  
 
• 
If requested by sites, the study will provide supplies to sites to display the clinic handouts. Study staff will check in 
to ensure handouts were received and are being displayed and/or made accessible to providers and to address 
any issues that come up. 
 
• 
It is up to the discretion of the provider whether/how to incorporate the handout into the clinic visit discussion. 
 
 
 

 
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CPRS INSTRUCTIONS FOR SC INTERVENTION  
ASSIGNING A PROGRESS NOTE  
1. Open TWO files: 
a. CPRS 
b. *Database  
i. Note: Starting 8/10, Kathy will assign progress notes for Columbia and Phoenix patients. 
ii. Note: Starting 8/14, Kathy will update the appointment list for eligible patients each week (on 
Mondays). The database will list dates of upcoming appointments in chronological order.  
2. While in a patient record in CPRS: 
a. Confirm patient name and SSN match what’s in the database (you’re just confirming that you’re looking at 
the correct person in CPRS). 
b. In CPRS, go to “Appointments” in the “Cover Sheet” to confirm that the appointment listed in the database 
matches what’s listed in CPRS.  
i. 
If the date and/or name of an upcoming appointment in CPRS is different than what is in the 
database, update the “Visit datetime” and “Clinic” name in the database.  
 
c. In CPRS, confirm the MOST RECENT PSA has not increased beyond 2ng/ml.  
i. 
IF the patient has a PSA <2ng/ml, skip to Step 2d.  
ii. 
IF the patient has a PSA >2ng/ml, go back to the database, open the form for the patient, click 
“View/Edit Chart Reviews” and edit the Patient Chart Review page: 
1) HF/Note Comments – add reason for not assigning progress note (i.e., why patient is 
ineligible) – comment should read as: “Prior to assigning note, it was confirmed the 
patient’s most recent PSA on [DATE] was [PSA value].  
2) Not Elig. At Visit box – check this box 
3) Exclusions – select “Yes” next to “Current PSA >2 or rapidly rising 
4) Inclusions – mark all three inclusions “No” 
5) Notes – add reason for not assigning progress note (yes, you will repeat step 2.c.i.1) – 
comment should read as: “Prior to assigning note, it was confirmed the patient’s most 
recent PSA on [DATE] was [PSA value].  
6)  Outcomes – mark “Not Eligible” 
7) Click “Save” 
iii. 
Note: If the patient is ineligible for another reason (i.e., patient is deceased, provider opted out, etc.) 
follow steps 1)-7) to update this page. The details should be relevant to the specific situation.  
d. In CPRS, confirm all other eligibility criteria. The patient must NOT meet any of the exclusion 
criteria prior to assigning a note.  
e. In CPRS, click on the “Notes” tab (bottom of screen).  
f. 
In CPRS, click on the “New Note” tab. Location for Current Activities dialog box will open.  
g. In CPRS, click on the “New Visit” tab (far right over tabs). 
i. 
[PILOT] For Ann Arbor, enter “AA GM-LETTER-X” to attach the note 
ii. 
[RCT] Enter the following to attach the note: 
1) Columbia – WJB RESEARCH NOTES 
2) Phoenix – ADMINISTRATIVE CONTACT 

 
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 ADT discussion 
 ADT injection only appointment  
h. Time of visit should be set to “Now” (do NOT check the “Historical Visit” button). 
i. 
Click “OK.” 
j. 
**In Progress Note Properties box, enter “ADVISORY-ADT FOR LOCALIZED/NON-METASTATIC 
PROSTATE CANCER”. Once you see the note title in the menu, click to highlight it, and then click 
“OK.”  
k. Reminder Dialog Template: Advisory - ADT for Localized/Non-Metastatic Prostate Cancer box will 
open. Click “Finish.”  
l. 
Primary Encounter Provider box may open. Enter the name of the provider. Once you see the 
provider’s name in the menu, click to highlight it, and then click “OK.” 
m. Tailor the note for each patient: 
i. 
Delete one of the options in the first sentence “based on multidisciplinary review…” prior to 
assigning the note (primary ADT or BCR). Refer to the database to see the patient’s eligibility.  
n. In the event you need to manually enter PSA lab values and ADT injection information, please include data 
for the three most recent PSA labs and ADT injections within the last year.   
i. 
The best place to find this information is in the progress notes for an ADT injection appointment 
(they may include “Uro” or “Onc” in the title – do not assume information about an ADT injection is 
not available just because a note doesn’t include “Uro” or “Onc” in the title). You can also find 
information about ADT injections in the progress notes and in the Meds tab.  
 
 
 
ii. 
If the patient doesn’t have three ADT injections in the last year, just add the two most 
recent injections.  
iii. 
Refer to the progress note template to see what information should be included and how 
the section should be formatted.  
1) At a minimum, the name of the medication, dosage, location of injection and date of 
administration should be included.  If you can include additional information about the 
medication (expiration date and Lot #), include that in the note as well. If that information 
is not available, delete the Exp. Date/Lot# titles. 
2) Remove excess space between paragraphs. Make sure asterisks (***) line up at the bottom 
of the note.  
o. Click “Change…” box at top right of screen. 
p. Click on arrow at right of “Author:” drop down menu in Progress Note Properties note and select 
the provider who makes decisions about ADT for this patient. 
q. Click “OK” 
3. After assigning the note, update the Chart Review form in the database for the patient. To do this, open 
the form for the patient, click “View/Edit Chart Reviews” and edit the Patient Chart Review page.  
a. 
Add date you assigned progress note to “Date HF/Note Assigned.”  
b. 
Add comment in the “HF Note Comments” AND “Notes” fields. The “Notes” field is at the bottom 
of the page. 
i. The comment for COLUMBIA should read: “Progress note assigned to Dr. [name] on [date] by 
[your initials] to WJB Research Notes encounter.” 
ii. The comment for PHOENIX should read: “Progress note assigned to Dr. [name] on [date] by 
[your initials] to [name of Phoenix encounter TBD] encounter.” 
c. 
Select “Eligible – Note Assigned” under “Outcomes.”  
d. 
Click “Save” then close out of the screen. 
 

 
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Patient Chart Review Page (Database) 
 
 
Important Notes: 
 
1. *Check the database every morning to determine if a progress note needs to be assigned for an 
appointment the following day.  
 
2. If a note is mistakenly assigned to the wrong provider, or for a patient who is ineligible, notify Jordan and 
Ted immediately.  
 
3. Provider transitions – If you need to assign notes for eligible patients whose ADT prescriber is no longer in 
CPRS (and there’s no other indication of who patients will be meeting with for their upcoming 
appointment), ask Site Champion if they wish to have those notes assigned to them or transfer them to 
another provider on our list.  
 
4. **When selecting note from CPRS “Progress Note Properties” box, you will see two notes with the same 
title in the list. It’s not a duplicate note, it’s a quirk of CPRS that displays the note twice.  It has to do with 
how more titles are created and that note titles can have a print name that is different. Whenever we 
create a note title, it creates 2 lines in CPRS that make it look that there are two titles but there’s only the 
one. You may select either note with our title.  
 
5. Do not assign notes for ADT injection-only visits.  
 
6. Once you have assigned this unsigned progress note to an author that isn’t yourself, only that person will 
see this unsigned progress note in CPRS. Notes signed by the author will be visible to everyone in CPRS. 
 
7. If you try to select a new patient or exit CPRS with an unsigned note, it will prompt you to see if you want to sign it 
or proceed and delete it. 
 

 
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8. If you accidentally select “Add Chart Review” in the patient form in the database, thereby creating a new 
duplicate record, just go into the table and find the row that’s the duplicate and delete it. 
 
CPRS PROVIDER PROGRESS NOTE TEMPLATE  
Available in AAVA CPRS: Shared template>> ZZ considered>>ericas test>>prostate study note 
 
Mock data (dates, results, etc.) shown in note 
Original Template Version  
 
 
 
 

 
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   Updated 7/27/2023 – changes made to information displayed in the ADT injections section.                                         
 
 
 
 
 
 
 
 
 
 

 
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PILOT CLINIC AND ADT PROVIDER ASSESSMENTS  
 
• 
For the pilot, we will ask the Site Champions/Study Consultants to test the assessment surveys and provide 
feedback to help refine the survey and implementation procedures for the cRCT. 
 
PILOT DATA COLLECTION 
• 
Feedback from Site Champions/Study Consultants regarding pilot site implementation will be collected 
informally during study meetings. 
 
• 
The organizational assessment survey will be fielded to Site Champions/Study Consultants and refined 
throughout the pilot. 
o Outcome measures in Table 4 will be assessed and approaches to ascertainment, tracking, and analyses 
refined during the pilots. 
 
• 
Outcomes will be collected from VA CDW/Cancer Registry/Vital Status/CMS records and 
CPRS/Capri/JLV/WebVRAM for all clinic visits documented as providing low-value ADT at baseline, 3 and 6 
months. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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INSTRUCTIONS FOR PHONE FORWARDING AND VOICEMAIL  
 
Study Contact Information is the designated study phone in Kathy Swalwell’s office: 734-845-3667. 
 
Phone Forwarding 
The instructions for forwarding will depend on the phone, but for the ones currently in the office: 
1) Select a line and press FORWARD ALL 
2) Dial the number that you want to forward to  
To deactivate, press FORWARD OFF 
 
Checking Study Voicemail  
1) Dial study phone number (from jabber or any phone) 
2) Once voicemail starts, select * 
3) Instruction’s state: “Enter your ID followed by pound” enter phone number: xxxxx# 
4) Instruction’s state: “Enter your pin followed by pound” enter pin: xxxxx# 
 
(Note: PIN #’s are required to be changed often, study staff will add a 1 to pin each time it needs to be updated. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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PILOT STUDY FLOW CHART 
S 
 
 
 

 
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PILOT RANDOMIZED IMPLEMENTATION TRIAL 
TRIAL SITE SELECTION  
• 
We will update national VA and Medicare data to identify eligible sites for the cRCT. 
• 
All VA sites with high rates of low-value ADT from 2020 – 2022 will be considered eligible to participate in the 
study. 
• 
We will start with the 40 facilities with the highest rates of low-value ADT and continue down the list as 
necessary. 
• 
We will exclude sites requiring translated materials (e.g., Puerto Rico). 
• 
If feasible, we will exclude sites scheduled to transition to Cerner prior to the end of the cRCT. 
• 
We will randomize 4 VA facilities with high rates of low-value ADT use.   
TRIAL SITE RECRUITMENT & RANDOMIZATION 
• 
The top 4 sites with high rates of low-value ADT use and meeting above criteria will be invited to participate in 
the study. 
• 
All invited sites that agree to participate will be included. 
• 
We expect 80% participation by eligible sites. 
• 
If sites are unwilling or unable to participate, we will continue down the list of sites until we reach a maximum 
of 4 participating sites. 
• 
Study staff will send an email from the study Co-PI to Urology Chiefs to recruit as Site Champions. 
o If we are unable to contact Urology Chiefs, or if we do not receive a response from the Urology Chief 
after two formal email contacts, we may reach out to the Chief of Surgery, Chief of Med/Onc, or Chief 
of Rad/Onc (and copy the ACOS/R) about serving as Site Champion. 
o If the Urology Chief declines to serve as Site Champion, we may ask if they have any suggestions for an 
alternate designee. 
o In the event we are unable to recruit a Site Champion, all Site Champion communications will come 
from the study team. 
• 
Once Site Champions have obtained approval from the MCD, each site will be randomized to the Or or Sc arm. 
The Data Manager will work with our Consultant, Dr. Shawna Smith on randomizing sites.  
o Our current plan will be to stratify sites by availability of Radiation Oncology to ensure there is an even 
distribution of Radiation Oncology in both intervention arms. We intend to randomize sites in blocks of 
2-4. 
• 
Once site Clinical Health Information Officer has agreed to implementation the intervention at their site, study 
staff will apply for site CPRS access.  
o Note: Once you have CPRS access for a site, set an Outlook reminder to log in to each site every 30 
days. 
TRIAL OR/SC IMPLEMENTATION  
• 
Implementation procedures will be similar to those of the pilot but refined as needed based on pilot outcomes 
and needs specific to trial site implementation. 
• 
Interventions will be implemented for up to 12 months at each site. 
• 
Study staff will apply for CPRS access at each site once we receive approval from either the Medical Center 
Director or Site Champion.  
• 
Baseline ADT Prescribing Meetings – these meetings with Site Champions or their designees will not be 
mandatory for the RCT. We will move forward with our trial implementation even if we haven’t collected 
information regarding the ADT ordering process.  

 
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• 
Implementation Education Session (IES) – to make scheduling easier on the study team, we may implement 
one IES per site instead of each department. We will move forward with implementing the interventions after 
scheduled IES’s, even if they have been cancelled.  
• 
There is a possibility that patients will receive ADT injections more than once during the intervention period. If 
this is the case, then the intervention will be triggered more than once for the same patient.  
TRIAL DATA COLLECTION  
• 
Data sources for our primary, implementation and secondary fidelity outcomes will be refined during the pilot. 
Data collection and outcomes analyses plan will also be further developed during the pilot. 
• 
We will likely assess Or fidelity using informatics data generated through the ordering process.  
• 
We will use chart review to identify Sc documentation in the EMR, in addition to other informatics approaches. 
• 
We will match our 4 intervention sites with up to 8 control sites with comparable departments and numbers of 
patients. We will complete chart reviews for control sites twice. The first review will look at ADT injections at the 
start of the intervention for the matching intervention site(s) to confirm whether patients would have been 
eligible at the intervention launch site we are not looking after the date the intervention started. The second 
review will occur again at the end of the 6-month intervention period for the matching intervention site.    
• 
Providers and Site Champions at participating facilities will be asked to complete anonymous assessments in 
Qualtrics at baseline and 1-month post-intervention.  
• 
We will examine relationships between survey and trial outcomes in exploratory analyses to assist with 
understanding the generalizability of our findings.  
 
     TRIAL CLINIC AND ADT PROVIDER ASSESSMENTS 
 
• 
We will obtain national Union review for conducting assessments. For the cRCT, Site Champions and providers 
will be invited to complete the surveys (Appendix VI). The Ann Arbor Study Team will revise the survey as 
needed based on piloting feedback and outcomes.  
 
The Site Champion Clinic Assessment  
We will administer surveys to our Site Champions upon MCD approval. Survey data will be collected 
anonymously via VA Qualtrics. The survey includes questions about ADT ordering and clinic practices; the 
survey should take about 5 minutes to complete.   
o We will ask Site Champions to complete a survey at baseline. The exact timing of the survey will be 
decided during the pilot testing period.  
 
The ADT Provider Assessment  
We will administer surveys at baseline and 1-month post-intervention period to ADT prescribers. Survey data 
will be collected anonymously via VA Qualtrics. The survey includes questions about ADT ordering and clinic 
practices; the survey should take about 5 minutes to complete.   
o Baseline survey - we will ask providers to complete the baseline survey during the IES’s. Providers 
will be able to access the survey by scanning a QR code on their phone (code will be available in the 
IES PPT), or via a link the study team will enter in the Zoom meeting chat.  
o 1-Month post-intervention survey – at the end of the intervention period, we will email providers 
with a link to the follow up Qualtrics survey.  

 
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RECORDS CONTROL AND DISPOSITION 
• 
At the study’s conclusion, all personally identifying information (PII) will be moved to an access restricted folder 
on the Ann Arbor VA OI&T network, accessible only to the HSR&D data manager.  
• 
Members of the study team will no longer have access to these data.  
• 
Data will be destroyed by the data manager according to RCS 10-1, 6 years following the end of the fiscal year 
after completion of the research project.  
• 
All research data will be presented in aggregate form only. 
• 
Publications from this research will be made available to the public through the National Library of Medicine 
PubMed Central website within one year after the date of publication. 
• 
Prior to final data disposition according to RCS 10-1, deidentified final data sets underlying all publications 
resulting from the proposed research will be shared outside VA. Members of the scientific community who 
would like a copy of the final data sets (i.e., data sets underlying any publication) from this study can request a 
copy by e-mailing Jennifer Burns at jennifer.burns@va.gov.  They should state their reason for requesting the 
data and their plans for analyzing the data. Final data sets will be copied onto a CD. The CD will be sent to the 
requestor via FedEx. Each data set will be accompanied by documentation that lists all variables described in 
the publication and links them with variable names in the data set. De-identified data will be provided after 
requesters sign a Letter of Agreement detailing the mechanisms by which the data will be kept secure and 
access restricted to their study team. The agreements will also state the recipient will not attempt to identify 
any individual whose data are included and will not share the data with anyone outside of their research team. 
The dataset will not include PII and all dates will be changed to integers to allow for calculation of time 
periods.  
 
 
APPENDICES 
I. 
Letters of Support from Site Champions/Consultants 
II. 
Pilot Email Templates  
• 
Template Email to MCD  
• 
Template Email to Pharmacy Chief  
• 
Template Email to Clinical Department Chiefs  
• 
Template Emails to CHIO/CACs 
• 
Template email to Providers 
III. 
RCT Email Templates  
• 
Template Email to Recruit Site Champion  
• 
Template Emails to MCD  
• 
Template Email to Pharmacy Chief  
• 
Template Email to Clinical Department Chiefs  
• 
Template Email to Providers  
• 
Template Emails to CHIO/CACs 
• 
Template Emails to Providers 
IV. 
Patient Dashboard Example 
V. 
Clinic Handout  
VI. 
cRCT Organizational Assessment(s) 
 
 
 

 
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APPENDIX I: LETTERS OF SUPPORT FROM SITE CHAMPIONS 
 
 

 
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APPENDIX II: PILOT EMAIL TEMPLATES  
 
Pilot Email Templates for Site Champions 
• To MCD 
• To Pharmacy Chief 
• To Clinical Department Chiefs 
• To Providers 
Pilot Study Team Email Communications 
• To CHIO/CACs 
• To Clinical Department Chiefs 
• To Providers 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Template Email to MCD from Site Champion 
Attachments:  AA IRB Exemption Approval Letter  
Subject: <<Insert site name>> Participation in study, “Living Well with Prostate Cancer” 
 
Dear <<Insert Medical Center Director name>>, 
 
The purpose of this email is to request your support for participation in a research project funded by the NIH 
National Cancer Institute and coordinated by the VA Ann Arbor Healthcare System.  The overall objective of this 
project, entitled “Living Well with Prostate Cancer”, is to encourage de-implementation of low-value Androgen 
Deprivation Therapy (ADT) in a way that is acceptable to the clinicians treating these patients.  Low-value ADT (not 
supported by guidelines) includes primary treatment for localized prostate cancer and non-metastatic biochemically 
recurrent prostate cancer with low PSA levels.  I will be acting as site champion, helping to support the Ann Arbor VA 
study team by getting them in touch with the appropriate clinic staff at our site.   
 
The goal of this project is to pilot <<insert for NY Harbor and WLA: one of>> two tools to support providers in potential 
de-implementation of low-value care.  Our participation will last for 6 months. At the <<insert site name>> VA we will be 
piloting an ADT order-check (only triggered when orders meet criteria for low-value care.) <<insert for Ann Arbor: 
Additionally, we will pilot a CPRS note template for clinic visits meeting criteria for low-value care. The note includes 
talking points for the provider to help with a de-implementation discussion with the Veteran. It can be edited and 
acknowledged by the provider, giving a quick and simple way to document a discussion. Handouts for patients about 
ADT use will be supplied for providers to use at their discretion.>>  
Piloting these tailored de-implementation strategies will allow the study team to test acceptability, feasibility, and 
scalability for a subsequent randomized controlled trial to determine which de-implementation strategy is most effective 
in reducing low-value ADT use. 
Providers are not required to change their prescribing habits and will still be able to order ADT.  We will simply be 
providing a light-touch intervention to encourage providers to follow standard of care and provide a quick and easy 
mechanism for documenting treatment decisions. <<insert for Ann Arbor: Providers are not required to use the CPRS 
note template, it can be edited/signed, deleted, or ignored. The Ann Arbor study team will delete any unsigned versions 
of the template at the end of the study period.>> 
 
The VA Ann Arbor IRB has determined that our project meets federal criteria for exempt minimal risk research under 
categories 2 (survey procedures), 3 (benign behavioral interventions), and 4 (secondary research).  I do not believe our 
VA to be engaged in research for the following reasons: 
• 
The [site] VA will not be intervening or interacting with research subjects for research purposes, including obtaining 
informed consent. 
• 
The [site] VA will not have access to study data. 
• 
Please note that The Office for Human Research Protections (OHRP) stipulates that permitting investigators from 
another institution to use your facility to conduct research does not constitute engagement. 
(https://www.hhs.gov/ohrp/regulations-and-policy/guidance/guidance-on-engagement-of-institutions/index.html). 
 
Therefore, we do not believe there is a need for local RDC/IRB approval. However, I think this study will be of value to 
our site and I hope you will support this effort.   
 
Please reply to this email to confirm your support, or to let me know if you have any concerns.  If you would like 
additional information on the project, the intervention, or the informed consent procedures that the Ann Arbor team will 
follow when contacting our staff, please do not hesitate to ask me. You can also reach the Ann Arbor study team at 
VHAANNLivingWell@va.gov  
 
Best regards, 
<<Insert site champion signature line, including contact information>> 

 
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Template Email to Site Pharmacy Chief from Site Champion 
Attachments:  Example order check and AA IRB Exemption Approval Letter 
Subject: Notification: “Living Well with Prostate Cancer” Pilot Study 
 
Dear <<Insert Pharmacy Chief name>>,  
 
This is for notification only. 
 
Please see below and attached, we will be piloting a study here focused on limiting low-value ADT using a CPRS order 
check in one of the study arms. Our plan is to begin the pilot this Spring. 
 
Please let me know if you have any questions.  
 
Thank you, 
<<Insert site champion signature line, including contact information>> 
 
 
This email is to let you know that our VA will be participating in a project funded by the NIH National Cancer Institute and 
coordinated by the VA Ann Arbor Healthcare System. The overall objective of this project, entitled, “Living Well with 
Prostate Cancer,” is to encourage de-implementation of low-value Androgen Deprivation Therapy (ADT) in a way that is 
acceptable to the clinicians that treat these patients. Low-value ADT (not supported by guidelines) includes primary 
treatment for localized prostate cancer and non-metastatic biochemical recurrence with low PSA levels. I will be acting as 
site champion, helping to support the Ann Arbor VA study team by getting them in touch with the appropriate clinic staff at 
our site.   
 
Goals of this project include: 
1. Provide education to providers on the benefits vs. harms of ADT as primary treatment for prostate cancer and non-
metastatic biochemical recurrence. 
2. Provide a tool in CPRS to support providers in potential de-implementation of low-value care. The tools have been 
informed by qualitative interviews of VA providers who prescribe ADT and discrete choice experiments with VA 
urologists. Our site will receive:  
• 
An ADT order-check (only triggered for Veterans meeting criteria for low-value care). 
3. To pilot tailored de-implementation strategies (including an order check) for acceptability, feasibility, and 
scalability. 
4. To determine which of two de-implementation strategies (an order check or a CPRS note template) is most 
effective in reducing low-value ADT use. 
 
An example of the proposed de-implementation tool (order check) is attached. Providers are not required to change their 
prescribing habits and will still be able to order ADT. We are simply providing a tool to encourage evidence-based care, 
and to provide a quick and easy mechanism to document if there is a reason 1) they are deviating from guidelines 
(example – patient preference/anxiety), or 2) that they are following guidelines (that this is not in fact low-value care). 
 
If you have any concerns or would like additional information, please do not hesitate to ask. You can also reach the Ann 
Arbor study team at VHAANNLivingWell@va.gov.  
 

 
Version 6, 10/04/2023 
 
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Template Email to Clinical Department Chiefs from Site Champion 
Attachments: <<Insert for all Sites: Example order check and AA IRB Exemption Approval Letter>> 
 <<Insert for Ann Arbor: Example progress note, patient handout, example order check, and AA IRB Exemption 
Approval Letter>> 
Subject: Notification: “Living Well with Prostate Cancer” Pilot Study 
 
Dear <<Insert name of site Chief of Urology/Chief of Medical Oncology/Chief of Radiation Oncology>>,  
 
This is for notification only. 
 
Please see below and attached, we will be piloting a study here focused on limiting low-value ADT use. I am a Site 
Champion for the study and excited to launch it here.  
 
With your cooperation, our team would like to coordinate a brief, 10-minute introduction to the pilot study this Spring with 
your providers. We will reach out in the coming weeks to schedule. 
 
Thank you, 
<<Insert site champion signature line, including contact information>> 
 
 
This email is to let you know that our VA will be participating in a project funded by the NIH National Cancer Institute and 
coordinated by the VA Ann Arbor Healthcare System. The overall objective of this project, entitled “Living Well with 
Prostate Cancer”, is to encourage de-implementation of low-value Androgen Deprivation Therapy (ADT) in a way that is 
acceptable to the clinicians treating these patients. Low-value ADT (not supported by guidelines) includes primary 
treatment for localized prostate cancer and non-metastatic biochemically recurrent prostate cancer with low PSA levels. I 
will be acting as site champion, helping to support the Ann Arbor VA study team by getting them in touch with the 
appropriate clinic staff at our site.   
 
The goal of this project is to pilot one or two tools to support providers who prescribe ADT (e.g., urologists, medical 
oncologists, and radiation oncologists) in potential de-implementation of low-value care. Our participation will last up to 6 
months. We will be piloting an ADT order-check (only triggered when orders meet criteria for low-value care.) Additionally, 
the Ann Arbor VA will be piloting a CPRS note template for clinic visits meeting criteria for low-value care. The note 
includes talking points for the provider to help with a de-implementation discussion with the Veteran. It can be edited and 
acknowledged by the provider, giving a quick and simple way to document a discussion. Handouts for patients about ADT 
use will be supplied for providers to use at their discretion. 
 
Providers are not required to change their prescribing habits and will still be able to order ADT. We will simply be 
providing a light-touch intervention to encourage providers to follow standard of care and provide a quick and easy 
mechanism for documenting treatment decisions. Providers are not required to use the CPRS note template, it can be 
edited/signed, deleted, or ignored. The Ann Arbor study team will delete any unsigned versions of the template at the end 
of the study period. 
 
A Research Information Sheet about the study will be emailed to providers; this email will include the option to opt-out of 
the study. An implementation education session will also be offered to providers to inform them of the study and give 
them an opportunity to ask questions.  
 
I think this study will be of value to our site and I hope you will support this effort.   
 
An example of the proposed order check is attached and will only be triggered for low-value ADT orders. <<Insert for Ann 
Arbor:  An example of the handout is attached.>> If you have any concerns or would like additional information, please do 
not hesitate to ask. You can also reach the Ann Arbor study team at VHAANNLivingWell@va.gov  
 
Best regards, 
<<Insert site champion signature line, including contact information>> 

 
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Template Email to Providers from Site Champion (Kick-off email)  
Attachments: Example order check <<insert for Ann Arbor: Example note template, patient handout>> 
Subject:  New order check for ADT <<insert for Ann Arbor: and new note “<<insert note title as tailored for site>>”>> will 
take effect on <<insert implementation date>> 
 
Dear <<insert provider name>>, 
 
I would like to remind you that the study “Living Well with Prostate Cancer” will be starting at the <<insert site name>> VA 
on <<insert implementation date>>.  If you have responded to the email about this study from the Ann Arbor VA study 
team to opt-out, please disregard this message.   
 
[IF APPLICABLE:] A brief optional implementation education session will be held at <<insert site location or 
videoconference link>> on <<insert date>> at <<insert time>>.  Information about the study and implementation 
of the study tools will be presented, and there will be an opportunity to ask questions.  
 
As a reminder, the overall goal of this project is to assist providers in de-implementing low-value ADT by:  
1. piloting tailored de-implementation strategies for acceptability, feasibility, and scalability, and  
2. determining which de-implementation strategy is most effective 
 
Between <<insert implementation date>>and <<insert de-implementation date>>, you may see an order check when 
ordering ADT for a Veteran getting primary ADT for localized prostate cancer or getting ADT for non-metastatic 
biochemically recurrent prostate cancer.  You can still order ADT, but you will be asked to add the indication in a text field 
before proceeding.  <<insert for Ann Arbor: You also may see a note template titled “<<insert note title as tailored for 
site>>” has been assigned to you in CPRS for your patient approximately one working day before a scheduled visit with 
you.  This note will be generated by a study team member at the Ann Arbor VA for patients who may be getting primary 
ADT for localized prostate cancer or ADT for non-metastatic biochemically recurrent prostate cancer with low PSA levels.  
The note includes talking points to help facilitate an ADT de-implementation discussion with the Veteran. It can be edited 
and signed, providing a quick way to document a discussion and decisions made. It can also be deleted or ignored.  If it is 
ignored, it will be deleted by the Ann Arbor study team at the end of the study. There are also patient handouts “Living 
well with prostate cancer: is hormone therapy still right for you?” that are available to you at <<insert location as tailored 
for site>> – you may use these at your discretion. 
 
A screen shot of the order check as it will appear in CPRS is attached.  <<Insert for Ann Arbor: Additionally, a screen shot 
of the note template and a copy of the patient handout are attached.>> 
 
Providers are not required to change their prescribing habits and will still be able to order ADT.  We will simply be 
providing a tool to encourage evidence-based care, and to provide a quick and easy mechanism for documentation. 
 
If you have any questions or concerns, please contact me using the contact information in my signature line 
below.  You may also contact the Ann Arbor study at VHAANNLivingWell@va.gov with questions or if you would like 
to opt-out of the study. 
 
Thank you for your help. 
<<Insert site champion signature line, including contact information>> 
 
 
 
 
 
 
 
 
 
 
 

 
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Template Email to Clinical Department Chiefs from Study Team to Schedule Baseline ADT Prescribing Meeting 
Attachments: None 
Cc: VHAANNLivingWell@va.gov 
Subject Line: Meeting Request “Living Well with Prostate Cancer” Pilot Study 
 
Dear Dr. <<insert name of provider>>,   
 
Thank you for your interest in our study. We are excited to move forward. 
 
We are hoping you can take about 30 minutes to describe to us the process of prescribing ADT in your department and 
who is involved. This will help us tailor the intervention(s) to be a good fit with your existing workflow, let us know who 
on your team to keep informed, and answer any questions about the project. 
 
Can you please send us some potential times that you are available to meet virtually via Zoom or Microsoft Teams? 
 
Best regards, 
 
The Living Well with Prostate Cancer Study Team 
XXXXXXXX  <<Insert team member name>> 
XXXXXXXX  <<Insert team member name>> 
XXXXXXXX  <<Insert team member name>> 
Center for Clinical Management Research 
VA Ann Arbor Healthcare System (152) 
VHAANNLivingWell@va.gov 
(XXX) XXX-XXXX 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Template Email to Clinical Department Chiefs to Request List of Providers  
Attachment: Information Sheet  
Subject: Confirmation requested: Provider List for <<insert department name>> for the Living Well with Prostate Cancer 
Study 
 
 
Dear Dr. <<insert name of department chief>>, 
 
We are about ready to send the attached information letter to providers who prescribe ADT in <<site>>.  Will you 
please confirm that our list below for <<clinical department>> is accurate and complete? Additionally, please let us 
know if you would like fellows and/or residents to receive these information letters. If yes, please either add their 
names to the list below, or let us know who we can contact to get this information. 
 
<<insert site name and clinical department name>> who may prescribe ADT: 
 
 
Thank you,  
 
Best regards, 
The Living Well with Prostate Cancer Study Team 
XXXXXXXX  <<Insert team member name>> 
XXXXXXXX  <<Insert team member name>>  
XXXXXXXX  <<Insert team member name>> 
Center for Clinical Management Research 
VA Ann Arbor Healthcare System (152) 
VHAANNLivingWell@va.gov 
(XXX) XXX-XXXX 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Email to Providers from Study Team (Information Sheet) 
Attachment: Research Information Sheet 
Subject:  Request for your participation in study “Living Well with Prostate Cancer” 
 
Dear <<Insert provider name>>, 
 
The <<Insert site name>> is one of 3 VA sites participating in a research project funded by the NIH National 
Cancer Institute and coordinated by the VA Ann Arbor Healthcare System.  The overall objective of this project, 
entitled “Living Well with Prostate Cancer”, is to encourage de-implementation of low-value Androgen Deprivation 
Therapy (ADT) in a way that is acceptable to the clinicians treating these patients.  Low-value ADT (not supported by 
guidelines) includes primary treatment for localized prostate cancer and non-metastatic biochemically recurrent 
prostate cancer.   
 
This project involves piloting light-touch interventions supporting evidence-based care that have been tailored to work 
within your site’s existing workflow. The following will be implemented at your site on <<insert implementation date>>.  
The intervention will be in effect for six months.  
 
• 
An ADT order-check which is only triggered when orders meet criteria for low-value care. You can still order 
ADT, but you will be asked to add the indication in a text field before proceeding. 
• 
<<Insert for Ann Arbor and Palo Alto: A CPRS note template for clinic visits meeting criteria for low-value care.  
The note includes talking points to help with a de-implementation discussion with the Veteran.  You can edit 
and acknowledge the note, giving a quick way to document the discussion. It can also be deleted or ignored. If 
it is ignored, it will be deleted by the Ann Arbor study team at the end of the study.>> 
 
You are not required to change your prescribing habits and will still be able to order ADT.  We will simply be providing 
a tool to encourage evidence-based care. 
 
Please find attached a Research Information Sheet with additional details about this study.  If you have any 
questions or concerns you can contact the Ann Arbor study team at VHAANNLivingWell@va.gov. If you would 
like to opt-out of this study, please contact the Ann Arbor study team at VHAANNLivingWell@va.gov, or call 
(XXX) XXX-XXXX.   
 
A brief optional implementation education session will be held at <<insert site location or videoconference link>> on 
<<insert date>> at <<insert time>>.  Information about the study and implementation of the study tools will be 
presented, and there will be an opportunity to ask questions.  
 
Best regards, 
The Living Well with Prostate Cancer Study Team 
XXXXXXXX  <<Insert team member name>> 
XXXXXXXX  <<Insert team member name>>  
XXXXXXXX  <<Insert team member name>> 
Center for Clinical Management Research 
VA Ann Arbor Healthcare System (152) 
VHAANNLivingWell@va.gov 
(XXX) XXX-XXXX 
 
 
 
 
 
 
 
 
 

 
Version 6, 10/04/2023 
 
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Email to Site Champions/Clinical Department Chiefs from Study Team to Schedule IES Session  
Attachments: None 
Subject: Request to Schedule “Living Well with Prostate Cancer” Study Education Session  
 
Dear <<Insert site champion name>>, 
  
Thank you for meeting with our team on <<insert baseline ADT meeting date>> and providing information on how we 
can move forward with the Living Well with Prostate Cancer Study. We are excited to move forward. 
  
As a next step, we would like to schedule a 15-minute virtual meeting with other cancer care providers to explain the 
importance of the study, describe the light touch interventions, and encourage the use of the tools provided with the 
interventions. We will also field questions and address any concerns.   
  
You previously suggested <<insert number>> of possible meetings to schedule our presentation: 
  
1. <<insert example>> 
2. <<insert example>> 
  
Can you please let us know the best way to proceed with setting up a meeting with Urologists? Alternatively, would it 
be possible to request to present at a tumor board meeting to catch providers from Urology, Medical Oncology and 
Radiation Oncology? 
  
If you have any questions or concerns, please let us know. 
  
  
The Living Well with Prostate Cancer Study Team 
XXXXXXXX  <<Insert team member name>> 
XXXXXXXX  <<Insert team member name>> 
XXXXXXXX  <<Insert team member name>> 
Center for Clinical Management Research 
VA Ann Arbor Healthcare System (152) 
VHAANNLivingWell@va.gov 
(XXX) XXX-XXXX 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
Version 6, 10/04/2023 
 
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Initial Email to CHIO and CAC(s) from Study Team 
Attachments: Screen shots of Ann Arbor order check and “low-value ADT” health factor, instructions from Joye Allen, 
AAVA CAC 
Subject: Request for information regarding potential order check on ADT: Please reply by <<date 1 week away>> 
 
Good morning <<insert name of site CHIO and site CAC(s)>>, 
 
We are working on a project with Dr(s). <<insert name(s) of site champion and other team members/leadership who have 
committed to project>> to try to reduce low-value use of Androgen Deprivation Therapy (ADT) such as leuprolide and 
goserelin (Lupron/Zolodex/Eligard/Viadur). Low-value use includes prescribing for localized prostate cancer and non-
metastatic biochemical recurrence, where it is not supported by guidelines in most instances.  ADT does, however, have 
significant side effects. 
 
We hope to decrease use of low-value ADT (or learn why it is still being prescribed in these cases) by implementing an 
order check. The goal is to notify the provider that they may want to consider stopping ADT, and to provide a 
quick/convenient mechanism to document why ADT is being prescribed.  Attached is an example of how we have 
implemented this in Ann Arbor with instructions from our pharmacy CAC. This can be completed within 15 minutes. To 
minimize the burden to providers, we only want the order check to be triggered for Veterans who are getting low-value 
ADT. So we are also hoping you will set up a health factor for “LIVING WELL ADT”.  A member of the Ann Arbor project 
team with access to CPRS at your site will complete this health factor for Veterans meeting the criteria.  
 
We would like to talk with you to see if the Ann Arbor example is a good way to accomplish our goals at your 
site, or if there is a different way that may better fit the current workflow at your site. We are also hoping to learn 
the following information about the <<insert name of site>> VA: 
 
• 
Are there currently any order checks/cover sheets/etc. for ordering ADT? 
• 
Is it reasonable for you to implement this at the <<insert name of site>> VA? 
o If yes, how much notice do you need prior to the date we would like the new note template to go 
live? 
 
 
If we can provide any additional information please let us know. If it is easier to talk by telephone please let us know a 
good time to contact you, or you can reach us at <<(XXX) XXX-XXXX>>. 
 
Thank you, and we look forward to hearing back from you by <<date – ~1 week>> via telephone or email. 
 
The Living Well with Prostate Cancer Study Team 
XXXXXXXX  <<Insert team member name>> 
XXXXXXXX  <<Insert team member name>> 
XXXXXXXX  <<Insert team member name>> 
Center for Clinical Management Research 
VA Ann Arbor Healthcare System (152) 
VHAANNLivingWell@va.gov 
(XXX) XXX-XXXX 
 
 
 
 
 
 
 
 
 
 
 

 
Version 6, 10/04/2023 
 
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Additional Email to CHIO and CAC(s) from Study Team                               
Ann Arbor Only 
Attachments: Screen shots of Ann Arbor note template “ADT discussion and acknowledgement” and instructions from 
Erika 
Subject: Request to add note template 
 
Good morning <<insert name of site CHIO and site CAC(s)>>, 
 
We are working on a project with Dr(s). <<insert name(s) of site champion and other team members/leadership who have 
committed to project>> to try to reduce low-value use of Androgen Deprivation Therapy (ADT) such as leuprolide and 
goserelin (Lupron/Zolodex/Eligard/Viadur). Low-value ADT use includes prescribing for localized prostate cancer and 
non-metastatic biochemical recurrence, where it is not supported by guidelines in most instances.  ADT does, however, 
have significant side effects. 
 
At the <<insert name of site>> VA we hope to decrease use of low-value ADT (or learn why it is still being prescribed in 
these cases) by providing a note template for clinicians. The goal of this template is to provide talking points that 
providers can use to facilitate a discussion with Veterans about ADT, to provide a quick mechanism for providers to 
document what was discussed and the outcome of the discussion.  Attached is an example of how we have implemented 
this in Ann Arbor.  Our CAC can export this template for you. 
 
We would like to talk with you to see if the Ann Arbor example is a good way to accomplish our goals at your site, or if 
there is a different way that may better fit the current workflow at your site. 
 
If we can provide any additional information please let us know. If it is easier to talk by telephone please let us know a 
good time to contact you, or you can reach us at <<(XXX) XXX-XXXX>>. 
 
Thank you, and we look forward to hearing back from you by <<date – ~1 week>> via telephone or email. 
 
The Living Well with Prostate Cancer Study Team 
XXXXXXXX  <<Insert team member name>> 
XXXXXXXX  <<Insert team member name>> 
XXXXXXXX  <<Insert team member name>> 
Center for Clinical Management Research 
VA Ann Arbor Healthcare System (152) 
VHAANNLivingWell@va.gov 
(XXX) XXX-XXXX 
 
 
 
 
 
 
 
 
 
 
 
 

 
Version 6, 10/04/2023 
 
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Follow-up Email to CAC(s) from Study Team 
Attachments: none 
Subject: Request to add order check on ADT 
 
Hello <<insert name of local CAC(s)>>, 
 
Thank you for <<your reply or talking with us>> about the order check for ADT for Veterans with localized prostate cancer 
and non-metastatic biochemical recurrence. 
 
As a summary, <<insert summary of what was discussed>>. 
 
<<Insert next steps based on correspondence – for example – “I will be in touch closer to our planned implementation 
date of   /  /     >>.  <<Please contact us with any questions or concerns in the meantime or Thank you for connecting us 
with the chair of the committee responsible for decisions regarding order restrictions; we have requested a time to present 
our proposal at their next meeting.>> 
 
Best, 
 
The Living Well with Prostate Cancer Study Team 
XXXXXXXX  <<Insert team member name>> 
XXXXXXXX  <<Insert team member name>> 
XXXXXXXX  <<Insert team member name>> 
Center for Clinical Management Research 
VA Ann Arbor Healthcare System (152) 
VHAANNLivingWell@va.gov 
(XXX) XXX-XXXX 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
Version 6, 10/04/2023 
 
Page 64 of 88 
 
 
 
Additional Follow-up Email to CAC(s) from Study Team                    
Ann Arbor Only 
Attachments: none 
Subject: Request to note template and health factor 
 
Hello <insert name of local CAC(s)>>, 
 
Thank you for <<your reply or talking with us>> about the addition of a note template and health factor for Veterans with 
localized prostate cancer and non-metastatic biochemical recurrence. 
 
As a summary, <<insert summary of what was discussed.>> 
 
<<Insert next steps based on correspondence – for example –we will be in touch closer to our planned implementation 
date of   /  /     >>.  <<Insert: Please contact us with any questions or concerns in the meantime or Thank you for 
connecting us with the chair of the committee responsible for decisions regarding the addition of a note template; we have 
requested a time to present our proposal at their next meeting.>> 
 
Best, 
 
The Living Well with Prostate Cancer Study Team 
XXXXXXXX  <<Insert team member name>> 
XXXXXXXX  <<Insert team member name>> 
XXXXXXXX  <<Insert team member name>> 
Center for Clinical Management Research 
VA Ann Arbor Healthcare System (152) 
VHAANNLivingWell@va.gov 
(XXX) XXX-XXXX 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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APPENDIX III: CRCT EMAIL TEMPLATES  
 
 
cRCT Email Templates for Site Champions  
• To MCD 
• To Pharmacy Chief 
• To Clinical Department Chiefs 
• To Providers 
cRCT Study Team Email Communications 
• To Recruit Site Champion 
• To Clinical Department Chiefs 
a. Baseline ADT prescribing meeting 
b. Confirm list of providers 
• To CHIO/CACs 
• To Site Champion/Department Chiefs to Schedule IES 
• To Providers 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
Version 6, 10/04/2023 
 
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Template Email to MCD from Site Champion 
Cc: Site ACOS of Research  
Attachments: AA IRB Exemption Approval Letter 
Subject: <<Insert site name>> Participation in study, “Living Well with Prostate Cancer” 
Dear <<Insert Medical Center Director name>>, 
The purpose of this email is to request your support for participation in a research project funded by the NIH 
National Cancer Institute and coordinated by the VA Ann Arbor Healthcare System. The overall objective of this 
project, entitled “Living Well with Prostate Cancer”, is to support decreased use of low-value Androgen Deprivation 
Therapy (ADT) in a way that is acceptable to the clinicians treating these patients. Low-value ADT (not supported by 
guidelines) includes primary treatment for localized prostate cancer and non-metastatic biochemically recurrent 
prostate cancer with low PSA levels. I will be acting as site champion, helping to support the Ann Arbor VA study team 
by getting them in touch with the appropriate clinic staff at our site. 
 
The goal of this project is to test one of two tools to support providers in decreasing low-value care. Our participation 
will last for up to 12 months. At our site we will be testing <<insert for Or site: an ADT order-check (only triggered when 
orders meet criteria for low-value care.)>> or <<insert for SC site:  a CPRS note template for clinic visits meeting 
criteria for low-value care. The note includes talking points for the provider to help with a de-implementation discussion 
with the Veteran. It can be edited and signed by the provider, giving a quick and simple way to document a discussion. 
Handouts for patients about ADT use will be supplied for providers to use at their discretion.>> 
 
Testing these strategies will allow the study team to determine which strategy is most effective in reducing low-value 
ADT use. 
 
Providers are not required to change their prescribing habits and will still be able to order ADT. We will simply be 
providing a light-touch intervention to encourage providers to follow standard of care and provide a quick and easy 
mechanism for documenting treatment decisions. <<insert for Sc sites: Providers are not required to use the CPRS 
note template, it can be edited/signed, deleted, or ignored. The Ann Arbor study team will delete any unsigned 
versions of the template at the end of the study period.>> 
 
The VA Ann Arbor IRB has determined that our project meets federal criteria for exempt minimal risk research under 
categories 2 (survey procedures), 3 (benign behavioral interventions), and 4 (secondary research). I do not believe our 
VA to be engaged in research for the following reasons: 
• 
Our VA will not be intervening or interacting with research subjects for research purposes, including 
obtaining informed consent. 
• 
Our VA will not have access to study data 
• 
Please note that The Office for Human Research Protections (OHRP) stipulates that permitting investigators 
from another institution to use your facility to conduct research does not constitute engagement 
(https://www.hhs.gov/ohrp/regulations-and-policy/guidance/guidance-on-engagement-of-institutions/index.html). 
 
Therefore, we do not believe there is a need for local RDC/IRB approval. However, I think this study will be of value to 
our site and I hope you will support this effort. 
 
Please reply to this email to confirm your support, or to let me know if you have any concerns. If you would like 
additional information on the project, the intervention, or the informed consent procedures that the Ann Arbor team will 
follow when contacting our staff, please do not hesitate to ask me. You can also reach the Ann Arbor study team at 
VHAANNLivingWell@va.gov 
 
Best regards, 
<<Insert site champion signature line, including contact information>> 

 
Version 6, 10/04/2023 
 
Page 67 of 88 
 
 
 
Template Follow-up Email to MCD from Study Team (non-responders) 
Attachments: AA IRB Exemption Approval Letter 
Subject: <<Insert site name>> Participation in “Living Well with Prostate Cancer” – Reply Requested 
 
 
Dear <<Insert Medical Center Director name and or designee(s)>>, 
 
We are following up to see if you have any questions or need any additional information about the Living Well with 
Prostate Cancer study that Dr. <<site champion>> emailed you about. 
 
Please reply to this email to confirm your support of the <<site>> VA participating in this project. 
Thank you, 
The Living Well with Prostate Cancer Study Team 
XXXXXXXX  <<Insert team member name>> 
XXXXXXXX  <<Insert team member name>> 
XXXXXXXX  <<Insert team member name>> 
Center for Clinical Management Research 
VA Ann Arbor Healthcare System (152) 
VHAANNLivingWell@va.gov 
(XXX) XXX-XXXX 
 
 
<<include email to MCD from Site Champion below>> 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Template Email to Site Pharmacy Chief at Or sites from Site 
Champion  
Attachments: Example order check and AA IRB Exemption Approval Letter 
Subject: Notification: “Living Well with Prostate Cancer” Study 
 
Dear <<Insert Pharmacy Chief name>>, 
This is for notification only. 
Please see below and attached, we will be testing an order check here focused on limiting low-value ADT use.  
Please let me know if you have any questions. 
Thank you, 
<<Insert site champion signature line, including contact information>> 
 
 
This email is to let you know that our VA will be participating in a project funded by the NIH National Cancer Institute 
and coordinated by the VA Ann Arbor Healthcare System. The overall objective of this project, entitled, “Living Well 
with Prostate Cancer,” is to support decreased use of low-value Androgen Deprivation Therapy (ADT) in a way that is 
acceptable to the clinicians that treat these patients. Low-value ADT (not supported by guidelines) includes primary 
treatment for localized prostate cancer and non-metastatic biochemical recurrence with low PSA levels. I will be acting 
as site champion, helping to support the Ann Arbor VA study team by getting them in touch with the appropriate clinic 
staff at our site. 
 
Goals of this project include: 
1. Provide education to providers on the benefits vs. harms of ADT as primary treatment for prostate cancer and 
non-metastatic biochemical recurrence. 
2. Provide a tool in CPRS to support providers in potential de-implementation of low-value care. The tools have 
been informed by qualitative interviews of VA providers who prescribe ADT and discrete choice experiments 
with VA urologists. Our site will receive: 
• 
An ADT order-check (only triggered for Veterans meeting criteria for low-value care). 
3. To determine which of two de-implementation strategies (an order check or a CPRS note template) is most 
effective in reducing low-value ADT use. 
 
An example of the proposed de-implementation tool (order check) is attached. Providers are not required to change 
their prescribing habits and will still be able to order ADT. We are simply providing a tool to encourage evidence-based 
care, and to provide a quick and easy mechanism to document if there is a reason 1) they are deviating from guidelines 
(example – patient preference/anxiety), or 2) that they are following guidelines (that this is not in fact low-value care). 
 
If you have any concerns or would like additional information, please do not hesitate to ask. You can also reach the 
Ann Arbor study team at VHAANNLivingWell@va.gov. 

 
Version 6, 10/04/2023 
 
Page 69 of 88 
 
 
 
Template Email to Clinical Department Chiefs from Site Champion 
Attachments: <<Insert for all Or sites: Example order check and AA IRB Exemption Approval Letter>> 
<<Insert for Sc sites: Example progress note, patient handout, and AA IRB Exemption Approval Letter>> 
Subject: Notification: “Living Well with Prostate Cancer” Study 
 
Dear <<Insert name of site Chief of Urology/Chief of Medical Oncology/Chief of Radiation Oncology>>, 
This is for notification only. 
Please see below and attached, we will be leading a study here focused on limiting low-value ADT use. I am a Site 
Champion for the study and excited to launch it here. 
 
With your cooperation, our team would like to coordinate a brief, 10-minute introduction to the study with your 
providers. We will reach out in the coming weeks to schedule. 
 
Thank you, 
<<Insert site champion signature line, including contact information>> 
 
 
This email is to let you know that our VA will be participating in a project funded by the NIH National Cancer Institute 
and coordinated by the VA Ann Arbor Healthcare System. The overall objective of this project, entitled “Living Well with 
Prostate Cancer,” is to support decreased use of low-value Androgen Deprivation Therapy (ADT) in a way that is 
acceptable to the clinicians treating these patients. Low-value ADT (not supported by guidelines) includes primary 
treatment for localized prostate cancer and non-metastatic biochemically recurrent prostate cancer with low PSA 
levels. I will be acting as site champion, helping to support the Ann Arbor VA study team by getting them in touch with 
the appropriate clinic staff at our site. 
 
The goal of this project is to test one of two tools to support providers who prescribe ADT (e.g., urologists, medical 
oncologists, and radiation oncologists) in potential de-implementation of low-value care. Our participation will last 9-12 
months. We will be testing <<insert for Or site: an ADT order-check (only triggered when orders meet criteria for low-
value care.)>> or <<insert for SC site:  a CPRS note template for clinic visits meeting criteria for low-value care. The 
note includes talking points for the provider to help with a de-implementation discussion with the Veteran. It can be 
edited and signed by the provider, giving a quick and simple way to document a discussion. Handouts for patients 
about ADT use will be supplied for providers to use at their discretion.>> 
    
Providers are not required to change their prescribing habits and will still be able to order ADT. We will simply be 
providing a light-touch intervention to encourage providers to follow standard of care and provide a quick and easy 
mechanism for documenting treatment decisions. <<insert for Sc site: Providers are not required to use the CPRS note 
template, it can be edited/signed, deleted, or ignored. The Ann Arbor study team will delete any unsigned versions of 
the template at the end of the study period.>> 
 
A Research Information Sheet about the study will be emailed to providers; this email will include the option to opt-out 
of the study. An implementation education session will also be offered to providers to inform them of the study and give 
them an opportunity to ask questions. 
 
I think this study will be of value to our site and I hope you will support this effort. 
 
<<insert for Or site: An example of the proposed order check is attached and will only be triggered for low-value ADT 
orders. <<Insert for Sc site: An example of the CPRS note template and the patient handout are attached.>> If you 
have any concerns or would like additional information, please do not hesitate to ask. You can also reach the Ann 
Arbor study team at VHAANNLivingWell@va.gov.  
 
Best regards, 
<<Insert site champion signature line, including contact information>> 

 
Version 6, 10/04/2023 
 
Page 70 of 88 
 
 
 
Template Email to Providers from Site Champion (Kick-off email) 
Attachments: <<insert for Or site: Example order check>> or <<insert for Sc site: Example note template, patient 
handout>>  
Subject: <<insert for Or site: Reminder: New order check for ADT <<insert for Sc site: New note “<<insert note 
title as tailored for site>>”>> will take effect on <<insert implementation date>> 
 
Dear <<insert provider name>>, 
 
I would like to remind you that the study “Living Well with Prostate Cancer” will be starting at your site on <<insert 
implementation date>>. If you have responded to the email about this study from the Ann Arbor VA study team to 
opt-out, please disregard this message. 
 
A brief optional implementation education session will be held at <<insert site location or videoconference link>> 
on <<insert date>> at <<insert time>>. Information about the study and implementation of the study tools will be 
presented, and there will be an opportunity to ask questions. 
 
As a reminder, the overall goal of this project is to assist providers in decreasing low-value ADT by 
  determining which of two de-implementation strategies is most effective 
 
Over the next 12 months, you may see <<insert for Or site: an order check when ordering ADT for a Veteran getting 
primary ADT for localized prostate cancer or getting ADT for non-metastatic biochemically recurrent prostate cancer. 
You can still order ADT, but you will be asked to add the indication in a text field before proceeding. <<insert for Sc 
site: a note template titled “<<insert note title as tailored for site>>” has been assigned to you in CPRS for your 
patient approximately one working day before a scheduled visit with you. This note will be generated by a study 
team member at the Ann Arbor VA for patients who may be getting primary ADT for localized prostate cancer or 
ADT for non-metastatic biochemically recurrent prostate cancer with low PSA levels. The note includes talking 
points to help facilitate an ADT de-implementation discussion with the Veteran. It can be edited and signed, 
providing a quick way to document a discussion and decisions made. It can also be deleted or ignored. If it is 
ignored, it will be deleted by the Ann Arbor study team at the end of the study. There are also patient handouts 
“Living well with prostate cancer: is hormone therapy still right for you?” that are available to you at <<insert location 
as tailored for site, if available>> – you may use these at your discretion.>> 
 
<<insert for Or site: A screen shot of the order check as it will appear in CPRS is attached.>> <<Insert for Sc 
site: Add screen shot of the note template and a copy of the patient handout are attached.>> 
 
Providers are not required to change their prescribing habits and will still be able to order ADT. We will simply be 
providing a tool to encourage evidence-based care, and to provide a quick and easy mechanism for 
documentation. 
 
If you have any questions or concerns, please contact me using the contact information in my signature 
line below. You may also contact the Ann Arbor study at VHAANNLivingWell@va.gov with questions or if 
you would like to opt-out of the study. 
 
Thank you for your help. 
<<Insert site champion signature line, including contact information>> 
 
 
 
 
 
 
 
 
 
 
 

 
Version 6, 10/04/2023 
 
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Initial Email to Urology Chiefs/ADT Providers from Study Team to Recruit as Site Champions  
Subject: Help us stop low-value ADT by serving as Site Champion for the “Living Well with Prostate Cancer” study 
Attachments: AA IRB Exemption Approval Letter 
 
Dear Dr. <<Insert name>>, 
 
I’m writing to request your participation as Site Champion for a study that aims to decrease the use of low-value 
androgen deprivation therapy (ADT). Our targets of low-value ADT include primary treatment for prostate cancer and 
non-metastatic biochemically recurrent prostate cancer. I believe that stopping or scaling back low-value ADT use is 
an integral step in improving prostate cancer care quality. Therefore, I am leading a NIH National Cancer Institute 
funded trial to test two interventions to decrease low-value ADT for prostate cancer in a way that supports clinicians.  
 
Given its significant long-term effects on cardiovascular, sexual, and bone health, ADT should only be used when 
there is evidence its benefits outweigh its side effects. As you know, the use of ADT for localized prostate cancer and 
non-metastatic biochemically recurrent disease goes against the standard of care guidelines published by the 
American Urological Association and National Comprehensive Cancer Network. Our goal is to help the medical 
profession focus on increasing the use of standard of care and decrease harms to patients. Your service as Site 
Champion will help your site reduce low-value ADT and continue to support the mission of the VHA.  
 
We understand that with competing demands, time is precious. This study will be conducted from Ann Arbor, which 
means we will implement the study intervention and manage regulatory approvals. I’m asking you to act as Site 
Champion to help support the Ann Arbor VA study team by getting them in touch with the appropriate clinic 
staff at your site, and to help assure the intervention is tailored to fit well with your site’s existing workflow. 
 
Participating sites will be randomized to one of two interventions: 
 
1) ADT Order Check Arm: Providers will see an order check when placing an order for ADT as notification that 
the Veteran may not be getting guideline-concordant care.  Providers may continue with the order by selecting 
a reason for continuing. The order check will be triggered only for Veterans identified by the Ann Arbor study 
team as potentially getting low-value ADT. Cases that are not clear will be decided upon by a multidisciplinary 
team including a urologist, a medical oncologist, and a radiation oncologist. 
 
2) Provider Script Arm: Providers will be assigned a progress note in CPRS just ahead of a Veteran’s visit only 
when Veteran has been identified by the Ann Arbor study team as potentially getting low-value ADT. This note 
can be used by the provider as a quick way to document either the indication for prescribing ADT or the 
decision to stop ADT. The note can also be ignored or deleted.  A patient handout “Living well with prostate 
cancer – is hormone therapy still right for you?” to support providers in these discussions will be linked in the 
note template.  
 
If you are interested in serving as a Site Champion, I will ask that you work with the Ann Arbor project team 
to: 
1) Notify your facility’s Leadership team about the study (email templates will be provided) 
2) Promote the study among your department’s clinicians (email templates will be provided) 
3) Assist in the scheduling of an education session with providers and staff involved with prescribing of ADT  
4) Provide a list of clinicians and staff involved with prescribing of ADT so that the project team may reach out to 
them as needed 
5) Consider taking a brief survey regarding ADT practices at your site 
 
This study is operationalized in such a way to avoid research “engagement” by VA personnel at your site. All study 
activities will be performed by Ann Arbor VA study staff under AAVA RDC oversight. No local VA personnel will have 
access to identifiable data. As such, we feel that no local oversight is necessary. Please see the attached memo from 
the AAVA RDC and let us know if you would like to discuss further. 
 
Please reply to this email if you have any questions about the research project, or to let us know your interest 
in acting as Site Champion. If you agree to participate, we will send you a site engagement packet with additional 
information about the study. If we do not hear from you, we will try to reach out to you by phone or Microsoft Teams. 
Thank you for your consideration!  

 
Version 6, 10/04/2023 
 
Page 72 of 88 
 
 
 
 
Best, 
Ted A. Skolarus, MD, MPH, FACS 
VA Ann Arbor Healthcare System 
 
Research Investigator 
VA HSR&D Center for Clinical Management Research 
Adjunct Professor of Urology 
University of Michigan Health System 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
Version 6, 10/04/2023 
 
Page 73 of 88 
 
 
 
Template Email to Clinical Department Chiefs from Study Team to Schedule Baseline ADT Prescribing Meeting 
Attachments: None 
Cc: VHAANNLivingWell@va.gov 
Subject Line: Meeting Request “Living Well with Prostate Cancer” Study 
 
Dear Dr. <<insert name of provider>>, 
Thank you for your interest in our study. We are excited to move forward. 
 
We are hoping you can take about 15 minutes to describe to us the process of prescribing ADT in your department 
and who is involved. This will help us tailor the intervention(s) to be a good fit with your existing workflow, let us know 
who on your team to keep informed, and answer any questions about the project. 
 
Could you please send us some potential times you are available to meet virtually via Zoom or Microsoft Teams? If you 
are not available, is there someone else on your team we can schedule this discussion with? 
 
 
Best regards, 
 
The Living Well with Prostate Cancer Study Team 
XXXXXXXX  <<Insert team member name>> 
XXXXXXXX  <<Insert team member name>> 
XXXXXXXX  <<Insert team member name>> 
Center for Clinical Management Research 
VA Ann Arbor Healthcare System (152) 
VHAANNLivingWell@va.gov 
(XXX) XXX-XXXX 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
Version 6, 10/04/2023 
 
Page 74 of 88 
 
 
 
 
Template Email to Clinical Department Chiefs from Study Team to Request List of Providers  
Attachment: Information Sheet  
Subject: Confirmation requested: Provider List for <<insert department name>> for the Living Well with Prostate 
Cancer Study 
 
 
Dear Dr. <<insert name of department chief>>, 
 
We are about ready to send the attached information letter to providers who prescribe ADT in <<site>>.  Will you 
please confirm that our list below for <<clinical department>> is accurate and complete? Additionally, please let us 
know if you would like fellows and/or residents to receive these information letters. If yes, please either add their 
names to the list below, or let us know who we can contact to get this information. 
 
<<insert site name and clinical department name>> who may prescribe ADT: 
 
 
Thank you,  
 
Best regards, 
The Living Well with Prostate Cancer Study Team 
XXXXXXXX  <<Insert team member name>> 
XXXXXXXX  <<Insert team member name>>  
XXXXXXXX  <<Insert team member name>> 
Center for Clinical Management Research 
VA Ann Arbor Healthcare System (152) 
VHAANNLivingWell@va.gov 
(XXX) XXX-XXXX 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Initial Email to CHIO and CAC(s) from Study Team 
Attachments: <<insert for Or site: Install instructions from Joye Allen, AAVA CAC>> or <<insert for Sc site: screen 
shots of progress note template>> 
Or Subject: Request for information regarding potential order check on ADT: Please reply by <<date 1 week 
away>>  
Sc Subject: Request for information regarding potential ADT advisory progress note: Please reply by <<date 1 
week away>>  
Good morning <<insert name of site CHIO and site CAC(s)>>, 
We are working on a project with Dr(s). <<insert name(s) of site champion>> to try to reduce low-value use of 
Androgen Deprivation Therapy (ADT) such as leuprolide and goserelin (Lupron/Zolodex/Eligard/Viadur). Low-value 
use includes prescribing for localized prostate cancer and non-metastatic biochemical recurrence, where it is not 
supported by guidelines in most instances. ADT does, however, have significant side effects. 
 
We hope to decrease use of low-value ADT (or learn why it is still being prescribed in these cases) by implementing 
one of two interventions. Your site will test <<insert for Or site: an ADT order check.>> or <<insert for Sc site: a 
progress note for the provider to document a discussion with a patient about discontinuing ADT.>> The goal is to 
notify the provider that they may want to consider stopping ADT, and to provide a quick/convenient mechanism to 
document why ADT is being prescribed.  
 
<< Insert for Or site: Attached is an example of how we have implemented this in Ann Arbor with an installation 
guide from our CAC. This can be completed within 15 minutes. To minimize the burden to providers, we only want 
the order check to be triggered for Veterans who are getting low-value ADT. We are also hoping you will set up a 
health factor for “LIVING WELL ADT”.A member of the Ann Arbor project team with access to CPRS at your site will 
assign this health factor to Veterans meeting the criteria.>> 
 
<< Insert for Sc site: Attached is an example of the progress note. >> 
 
In addition to the staff mentioned above, we will also be working with <<insert name(s) of relevant department chiefs 
to make sure providers are educated about the study and the intervention.>>  We would like to talk with you to 
see if the Ann Arbor example is a good way to accomplish our goals at your site, or if there is a different 
way that may better fit the current workflow at your site. We are also hoping to learn the following 
information: 
 
• Are there currently any order checks/cover sheets/etc. for ordering ADT active at your site? 
• <<insert for Sc site: Should we use current, past, or non-billable encounters to attach the progress note? Or 
should we create a current encounter?>> 
• <<insert for Sc site: Is there a link to a progress note status report you can share?>> 
• Is it reasonable for you to implement our intervention at your site? 
o If yes, how much notice do you need prior to the date we would like the new order check or note template 
to go live? 
• << Insert for Or site: The study team will need access to your site’s CPRS to enter health factors. Can 
you let us know how to request CPRS access? 
• <<insert for Sc site: The study team will need access to your site’s CPRS to assign progress notes to 
providers. Can you let us know how to request CPRS access? 
 
If we can provide any additional information please let us know. If it is easier to talk by telephone please let us know a 
good time to contact you, or you can reach us at <<(XXX) XXX-XXXX>>. 
 
Thank you, and we look forward to hearing back from you by <<date – ~1 week>> via telephone or email. 
 
The Living Well with Prostate Cancer Study Team 

 
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Page 76 of 88 
 
 
 
XXXXXXXX  <<Insert team member name>> 
XXXXXXXX  <<Insert team member name>> 
XXXXXXXX  <<Insert team member name>> 
Center for Clinical Management Research 
VA Ann Arbor Healthcare System (152) 
VHAANNLivingWell@va.gov 
(XXX) XXX-XXXX 
 
 
 
 
Follow-up Email to CAC(s) from Study Team 
Attachments: none 
Subject: Request to add order check on ADT 
 Hello <<insert name of local CAC(s)>>, 
Thank you for <<your reply or talking with us>> about the <<insert for Or site: order check>> or <<insert for Sc site: 
progress note for ADT for Veterans with localized prostate cancer and non-metastatic biochemical recurrence. 
 
As a summary, <<insert summary of what was discussed>>. 
 
<<Insert next steps based on correspondence – for example – “I will be in touch closer to our planned 
implementation date of / / >>. <<Please contact us with any questions or concerns in the meantime or Thank 
you for connecting us with the chair of the committee responsible for decisions regarding order restrictions; we 
have requested a time to present our proposal at their next meeting.>> 
 
Best, 
 
The Living Well with Prostate Cancer Study Team 
XXXXXXXX  <<Insert team member name>> 
XXXXXXXX  <<Insert team member name>> 
XXXXXXXX  <<Insert team member name>> 
Center for Clinical Management Research 
VA Ann Arbor Healthcare System (152) 
VHAANNLivingWell@va.gov 
(XXX) XXX-XXXX 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Email to Site Champions/Clinical Department Chiefs from Study Team to Schedule IES Session  
Attachments: None 
Subject: Request to Schedule “Living Well with Prostate Cancer” Study Education Session  
 
Dear <<Insert site champion name>>, 
  
Thank you for meeting with our team on <<insert baseline ADT meeting date>> and providing information on how 
we can move forward with the Living Well with Prostate Cancer Study. We are excited to move forward. 
  
As a next step, we would like to schedule a 15-minute virtual meeting with other cancer care providers to explain the 
importance of the study, describe the light touch interventions, and encourage the use of the tools provided with the 
interventions. We will also field questions and address any concerns.   
  
You previously suggested <<insert number>> of possible meetings to schedule our presentation: 
  
1. <<insert example>> 
2. <<insert example>> 
  
Can you please let us know the best way to proceed with setting up a meeting with Urologists? Alternatively, would it 
be possible to request to present at a tumor board meeting to catch providers from Urology, Medical Oncology and 
Radiation Oncology? 
  
If you have any questions or concerns, please let us know. 
  
  
The Living Well with Prostate Cancer Study Team 
XXXXXXXX  <<Insert team member name>> 
XXXXXXXX  <<Insert team member name>> 
XXXXXXXX  <<Insert team member name>> 
Center for Clinical Management Research 
VA Ann Arbor Healthcare System (152) 
VHAANNLivingWell@va.gov 
(XXX) XXX-XXXX 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Email to Providers from Study Team (Information Sheet) 
Attachment: Research Information Sheet 
Subject: Request for your participation in study “Living Well with Prostate Cancer” 
Dear <<Insert provider name>>, 
Your site is one of~20 VA sites participating in a research project funded by the NIH National Cancer 
Institute and coordinated by the VA Ann Arbor Healthcare System. The overall objective of this project, entitled 
“Living Well with Prostate Cancer”, is to support decreased use of low-value Androgen Deprivation Therapy (ADT) 
in a way that is acceptable to the clinicians treating these patients. Low-value ADT (not supported by guidelines) 
includes primary treatment for localized prostate cancer and non-metastatic biochemically recurrent prostate 
cancer. 
 
This project involves light-touch interventions supporting evidence-based care that have been tailored to work 
within your site’s existing workflow. The following will be implemented at your site on <<insert implementation 
date>>. The intervention will be in effect for up to 12 months. 
 
• 
<<insert for Or site: An ADT order-check which is only triggered when orders meet criteria for low-value 
care. You can still order ADT, but you will be asked to add the indication in a text field before 
proceeding.>> 
• 
<<Insert for Sc site: A CPRS note template for clinic visits meeting criteria for low-value care. The note 
includes talking points to help with a de-implementation discussion with the Veteran. You can edit and 
acknowledge the note, giving a quick way to document the discussion. It can also be deleted or ignored. If it 
is ignored, it will be deleted by the Ann Arbor study team at the end of the study.>> 
 
You are not required to change your prescribing habits and will still be able to order ADT. We will simply be providing 
a tool to encourage evidence-based care.  Patients are not being enrolled into this study, so there is no need for a 
consent form. As a provider, you do not need to do anything to participate.  However, you can opt-out of this study if 
you do not wish to participate. 
 
Please find attached a Research Information Sheet with additional details about this study. If you have any 
questions or concerns you can contact the Ann Arbor study team at VHAANNLivingWell@va.gov. If you would like to 
opt-out of this study, please contact the Ann Arbor study team at VHAANNLivingWell@va.gov, or call 
(XXX) XXX-XXXX 
 
A brief optional implementation education session will be held at <<insert site location or videoconference link>> on 
<<insert date>> at <<insert time>>. Information about the study and implementation of the study tools will be 
presented, and there will be an opportunity to ask questions. 
 
Best regards, 
 
The Living Well with Prostate Cancer Study Team 
XXXXXXXX  <<Insert team member name>> 
XXXXXXXX  <<Insert team member name>> 
XXXXXXXX  <<Insert team member name>> 
Center for Clinical Management Research 
VA Ann Arbor Healthcare System (152) 

 
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VHAANNLivingWell@va.gov 
(XXX) XXX-XXXX 
 
 
 
 
 

 
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APPENDIX IV: PATIENT DASHBOARD FOR ELIGIBILITY SCREENING 
EXAMPLE 
 
 
 
 
Dashboard: Main display for a selected patient (data displayed is for a test patient) 
 
 
 
 
 
 

 
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APPENDIX V: CLINIC HANDOUT (ANN ARBOR) 
 
 
 
 
 
 

 
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APPENDIX VI: CRCT ORGANIZATIONAL ASSESSMENTS 
 
Living Well Prostate Cancer Survey – Site Champion Clinic Assessment  
 
Thank you for your willingness to participate in this survey supported by the NIH National Cancer Institute 
(PI: Skolarus/Saini; R37CA2228).  
 
We are interested in learning more about the role of androgen deprivation therapy (ADT) in the management of 
prostate cancer patients in your clinic. 
 
Your participation in this survey is purely voluntary and you may choose not to answer any questions. This is an 
anonymous survey, meaning we will not collect any personally identifiable information from or about you. Results will 
be reported in aggregate in any reports.  
 
This 4-question survey should take about 5 minutes to complete.  
 
Click the Next button to continue. 
 
Q1. Please indicate your clinical specialty from the list below:  
 
 
o Urologist 
o Medical Oncologist 
o Radiation Oncologist 
o If other, please specify:  
 
 
 
Q2. For patients with prostate cancer in your practice who are currently on ADT, please complete the following table:  
 
How often do the following types of providers order ADT in the electronic medical record for these patients?  
 
 
Not 
Applicable 
Never 
Sometimes 
Most of the 
time 
Always 
I order ADT for my 
patients 
o  
o  
o  
o  
o  
Urology 
o  
o  
o  
o  
o  
Medical Oncology 
o  
o  
o  
o  
o  
Radiation Oncology 
o  
o  
o  
o  
o  
Nurse 
Practitioner/Physician’s 
Assistant 
o  
o  
o  
o  
o  
Resident/Fellow 
o  
o  
o  
o  
o  
If other, please specify:  
 
o  
o  
o  
o  
o  
 
Q3. For patients with prostate cancer in your practice who are currently on ADT injections, when is the order for 
ADT written? 
 
Day of injection 
 
1 day before injection 
 
2-7 days before injection  
 
More than 7 days before injection 
 

 
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No consistent pattern or unknown   
 
Q4. For patients in your clinic currently on ADT injections for prostate cancer, how often do they typically receive 
the following? 
 
 
Unsure  
1 month  3 months  6 
months 
12 months 
Other time 
interval  
ADT injection 
o  
o 
o  
o 
o  
o  
PSA level blood 
test 
o  
o 
o  
o 
o  
o  
Clinic visit for 
prostate cancer  
o  
o 
o  
o 
o  
o  
 
 

 
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Living Well Prostate Cancer Survey –  
ADT Provider Assessment Tool 
(Baseline, 1 month post-intervention completion) 
 
Thank you for your willingness to participate in this survey supported by the NIH National Cancer Institute 
(PI: Skolarus/Saini; R37CA2228).  
 
We are interested in learning more about the role of androgen deprivation therapy (ADT) in the management of 
prostate cancer patients in your clinic. 
 
Your participation in this survey is purely voluntary and you may choose not to answer any questions. This is an 
anonymous survey, meaning we will not collect any personally identifiable information from or about you. Results will 
be reported in aggregate in any reports.  
 
This 3-question survey should take about 5 minutes to complete.  
 
Click the Next button to continue. 
 
 
Q1. Please indicate your agreement with the following statements: 
 
 
Strongly 
disagree 
Disagree Neutral 
Agree 
Strongly 
agree 
I find that patients are worried about the 
effect that stopping ADT will have on their 
cancer 
o 
o 
o 
o 
o 
I find talking about stopping ADT 
challenging 
o 
o 
o 
o 
o 
I do not have adequate time for discussion 
about ADT 
o 
o 
o 
o 
o 
I want to give ADT recommendations 
consistent with those of my peers 
o 
o 
o 
o 
o 
I put a lot of weight on guideline 
recommendations regarding use of ADT 
(e.g., AUA or NCCN) 
o 
o 
o 
o 
o 
I have concerns about side effects and 
castration resistance in patients with long-
term use of ADT 
o 
o 
o 
o 
o 
I like to consider options other than ADT to 
manage patients with localized and 
biochemically recurrent, non-metastatic 
prostate cancer (e.g., definitive treatment, 
watchful waiting) 
o 
o 
o 
o 
o 
 
Q2. For patients presenting to your practice already on ADT monotherapy for localized prostate cancer with a low PSA, 
would you recommend stopping ADT? 
 
o Yes    
o Probably Yes 
o Probably No 
o No 
 
Q3. For patients presenting to your practice on ADT for biochemically-recurrent, non-metastatic prostate cancer with a 
low PSA would you recommend stopping or intermittent ADT? 

 
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o Yes    
o Probably Yes 
o Probably No 
o No 
 
This concludes the survey. Thank you for your participation!  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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APPENDIX VII: STUDY INFORMATION SHEET 
 
 
 
 
 

 
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