Reducing CNS-Active Medications to Prevent Falls and Injuries in Older Adults
Phase: NA
Conditions: Aging, Accidental Fall
Sponsor: University of Washington

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Instructions 
•
This Application is to be used in conjunction with the IRBNet Core Data Form and Study Team Form. 
•
Complete items in this application with concise, non-technical language. 
•
Enter your responses to each question directly below each question in the open text field.  
•
Define all acronyms. 
•
Fill out all relevant tables.  
•
Double clicking on the checkboxes opens a window where you can select “check” 
•
When completing this application, if a question does not apply to your study then enter “N/A.” 
•
Submit other documents as necessary 
•
Guidance: Red text throughout this application is guidance or special instructions. 
•
PI signature is required in IRBNet 
•
If the research includes any of the following activities complete and include the following 
Supplements (available in IRBNet Form – IRB Supplements All): 
Protocol Title & PI 
Study/Protocol Title
Reducing CNS-active Medications to Prevent FALLS and injuries in older adults (STOP-FALLS) 
Principal Investigator  
  Benjamin Balderson, PhD 
Version Date
December 1, 2022 
Form Author
  Monica Fujii 
Investigator Assurance 
Submission of this application in IRBNet indicates that the named PI: Is responsible for the conduct of 
this research at KP Washington; certifies that the statements herein are true, complete and accurate to 
the best of his/her knowledge; will report any serious or unanticipated adverse effects, problems, or 
protocol deviations; will not make changes without prior approval from the IRB; will renew this 
application with the IRB as directed by the IRB; will conduct the research project in compliance with the 
IRB conditions of approval; will only implement procedures in the original grant application if they are 
Consent Wavier/HIPAA Authorization Waiver 
Supplement A
Research use of electronic media or devices, and/or internet or email    
Supplement B
Family history or secondary subject data 
Supplement C 
Biological specimens, genetics, and GINA 
Supplement D 
Children 
Supplement E 
Other Potentially Vulnerable Populations 
Supplement F 

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also described in this application and approved by the IRB; and will not start the research or use 
confidential records, data or specimens until the research receives final approval from the IRB. 
1. Funding Information  
1.1 Funding Source(s).  
Provide the following information for current or pending funding source for this research 
application. Add boxes for each additional source of funding.  
Funding Type:
Research Grant 
Fellowship   
 Training Grant      
  Contract    
 Other, specify:        
Funding Agency:
CDC
Principal Investigator (on proposal):
Elizabeth Phelan, MD, MPH and Shelly Gray, Pharm D
Grant Number:
RNG209845
Proposal Title:
Reducing CNS-active Medications to Prevent 
FALLS and injuries in older adults (STOP-FALLS) 
Status:
New 
Competing continuation 
 Non-competing continuation 
Start Date:
9/30/2018
End Date:
9/29/2023   
Funded:  
YES  
NO
Is the source of this funding federal?
YES  
NO
Is the Department of Defense funding 
this project? 
YES  
NO
If YES, contact the IRB staff for guidance.
What institution is the prime recipient 
of these funds? 
University of Washington
If KPWA is the prime recipient, list all 
institutions that will be sub-recipients 
of funds on this award: 
2. Study Purpose, Overview, & Background
Guidance: This section of the application provides the IRB reviewer(s) with an overview of the project. 
Detailed descriptions of study procedures, including recruitment and consent processes, are requested 
in other sections of the application.  
2.1 Objectives 
Describe in plain language the purpose, specific aims, or objectives and indicate the primary goal(s) 
of the study (e.g. safety, tolerability, effectiveness, feasibility, pilot study, etc.).  State the 
hypotheses to be tested. State primary and any secondary study endpoints. 

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The overall objective of STOP-FALLS is to implement a patient-centered 
medication reduction program that focuses on CNS-active medications to reduce 
falls and unintentional injury among older adults. Our aims are as follows: AIM 1: 
Adapt and Obtain Feedback on approaches necessary for adoption and 
implementation of evidence-based medication reduction strategies (intervention) 
for use in an integrated health care system. AIM 2: Implement and Evaluate the 
intervention using a cluster randomized trail design. Aim 3: Assess barriers and 
facilitators to intervention adoption, implementation, and maintenance.   
2.2 Background 
a. Scientific Background 
Provide the scientific or scholarly background for, rationale for, and significance of the research 
based on the existing literature and how will it add to existing knowledge. A short list of references 
or bibliography must be included as part of this document, uploaded separately, or provide the 
relevant page number(s) of the grant where references or bibliography can be found.  
Falls are a growing public health problem. Falls and fall-related injuries constitute a 
critical, and growing, public health problem. One in three community-dwelling adults 
aged 65 and older, and one in two aged 80 and older, sustains a fall each year. About 
half of all falls result in an injury. Treatment of injurious falls is expensive, costing over 
$30 billion annually. As the aging population grows, the adverse impacts of falls 
(fractures, functional dependency, permanent nursing home residence) will occur with 
increased frequency, and costs will rise substantially. Systems-based approaches that  
address the prevention of falls are thus urgently needed. An increased emphasis on fall 
prevention in clinical practice will greatly enhance the quality of ambulatory care of older 
adults and stem the rising tide of fall-related healthcare use and costs.  
Centrally acting medications are a contributor to falls. Medications, particularly those that 
affect the central nervous system (CNS), have been consistently linked to falls. Common 
side effects of CNS-active medications include dizziness, sleepiness, and impaired 
balance and coordination. Use of CNS-active medications is common, with up to one-
quarter of older adults in the community taking at least one of these medications.   
Importantly, research has found that reduction in these medications can reduce falls. 
Current practice guidelines recommend that prescribers review all medications with their 
older patients to minimize polypharmacy and the use of CNS-active and other high-risk 
medications. However, this practice is not routinely followed due to multiple key barriers: 
lack of (patient, provider, pharmacist) awareness that medications can cause falls, 
multiple prescribers, multiple pharmacies, guidelines that induce polypharmacy, patient 
belief in the need for medication, provider reluctance to change prescriptions, even in 
the face of patients prompting discussion, and lack of sustainable methods to promote 
interactions between prescribers, pharmacists, and patients. 
b. Benefit to Society 

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Provide a brief description (a few sentences) of the study’s potential benefit to society. 
The STOP-FALLS Intervention has the potential to reduce falls and fall-related injuries in 
adults aged 60 and older using a minimal-risk method. This intervention may also reduce 
other adverse events including unintentional overdoses and motor vehicle crashes. If it 
proves to be successful, then this simple intervention could be readily disseminated and at a 
low cost. 
c. Preliminary Data 
Provide a brief description of the preliminary data/studies. If there are IRBNet files for those studies, 
please include the title and number.  
Best practices for reducing use of CNS-active medications exist but are underutilized. In 
preparing this project, we completed a thorough review of the literature and identified 
two interventions with strong evidence for efficacy in reducing CNS-active medications. 
We describe these just below.  
Eliminating Medications through Patient Ownership of End Results (EMPOWER) is 
a direct-to-patient educational intervention to reduce use of benzodiazepines in older 
adults. A randomized trial conducted in partnership with community pharmacies that 
recruited community-dwelling older adults taking a benzodiazepine found a 27% 
discontinuation rate at six months. The intervention empowered patients to discuss 
deprescribing of these medications with their physician or pharmacist but did not engage 
healthcare providers directly. The investigators found that providers tended to dismiss 
safety concerns about benzodiazepine use in the context of patient-initiated discussions 
and believe that this explains why higher discontinuation rates were not achieved (C. 
Tannenbaum, personal communication). 
Developing Pharmacist-led Research to Educate and Sensitize Community 
Residents to the Inappropriate Prescription Burden in the Elderly (D-PRESCRIBE)
combined the EMPOWER intervention with a pharmacist-initiated, prescriber-directed, 
evidence-based decision support tool. This approach achieved a doubling of the six-
month discontinuation rate seen with EMPOWER alone.  
In summary, evidence suggests that older adults can be educated and empowered to 
engage in discussions with their providers that result in favorable changes in their 
medication risk profile (including medications viewed as being difficult to discontinue, 
i.e., benzodiazepines). Prescriber-directed decision support can also improve the safety 
of medication regimens. Yet, there remains a need for a pragmatic model that 
simultaneously engages patients, pharmacists, and prescribers in the context of real-
world, daily healthcare delivery to efficiently and safely reduce the use of CNS-active 
medications. Moreover, models that can sustain prescribing changes over time are 
paramount to achieve effects on health outcomes such as falls and fall-related injuries, 
as resumption of medications may otherwise occur.  
In STOP-FALLS, we will adapt the EMPOWER patient-directed educational brochure 
together with the prescriber-directed decision support tool used in D-PRESCRIBE for 
use within the integrated healthcare delivery system at 9 KPWA clinics. If STOP-FALLS 
is successful, we expect it to significantly reduce the incidence of falls, fall-related 
injuries, and healthcare costs for injury care.

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d. Data Analysis 
Provide a brief description of the main data analysis plan. 
Aim 2 
Overview. Statistical analyses will be performed using statistical software (R, SAS, or 
STATA). Descriptive statistics will be computed and appropriate graphical summarizations 
(histograms, boxplots, scatterplots) will be made for all variables across the intervention 
clinics and usual care clinics to assess the comparability of the baseline characteristics and 
follow-up time of each group. Although we stratified our randomization on size and location 
of clinics and expect the KPWA population to stay relatively stable over the study time 
period, any patient characteristics which we find to be different (either clinically or 
statistically at P-value <0.10) between groups at baseline, known to be related to the 
outcome or likelihood of disenrollment from the health plan will be adjusted for in analyses. 
We will always include age, sex, and indicator of prior falls in the adjusted models. Statistical 
significance will be indicated by a P-value <0.05 and all tests and confidence intervals will 
be two-sided. 
Primary Outcome. To compare the primary outcome of reduction in number of medically 
treated falls between intervention and usual care groups over 12 to 24 months, we will run a 
Poisson regression model with indicator of intervention or usual care clinic and other 
adjustment variables.  A participant’s follow-up time within a clinic will start when they were 
sent a mailing (intervention group) or comparably for the usual care clinics we will mimic 
when they would have been sent a mailing if they were in the intervention group and start 
their follow-up time at that point. To account for differential follow-up time per participant we 
will include an offset term that is observed follow-up time and accounts for censoring due to 
disenrollment from the health plan (e.g., offset will be either to the end of the study period 
between 12-24 months depending on clinic and patient roll-out timing or time enrolled in the 
health plan over their clinics follow-up periods). To account for cluster randomization at the 
clinic level we will use generalized estimating equations (GEE) with a robust sandwich 
variance to account for clinic-level correlation. We will conduct similar models for 6- and 12-
month follow-up times which are secondary time points. Further, to explore the timing of 
when the intervention effect may have occurred, we will run a Poisson model with three 
indicators of time periods (0-6 months (reference group), 6-12 months, 12-18 months, and 
18-24 months) including interactions with time periods and indicator of intervention or usual 
care clinic. Each participant has up to 4 different outcome measures (less only if censored) 
in the model and the offset is determined by the time observed in a given time period. To 
account for multiple outcomes for a participant and cluster randomization we will apply 
Poisson regression with GEE and a robust sandwich variance.        
Secondary Outcomes. To examine the effect of the intervention on unintentional overdose 
up to 24 months, we will create a binary measure of any healthcare episode for overdose 
over 24 months. Similar to the analysis of the primary outcome, a Poisson regression model 
will be used to account for differential follow-up time per participant. We will also examine 
the effect of the intervention on this outcome every 6 months to explore intermediate trends 
over time. Motor vehicle crash-induced injuries will also be assessed following the primary 
outcome analysis. For direct costs of the intervention at 24 months amongst the intervention 
cohort we will just provide an average cost per patient, standard deviation and range. 
 Aim 3 

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Overview. Aim 3 will involve targeted analyses of likely key factors affecting adoption, 
implementation and maintenance of our intervention. The goal is to generate knowledge that 
would inform other health systems in their attempts to implement this intervention by obtaining 
purposely sampled perceptions of delivery system stakeholders (pharmacists, primary care 
providers, and clinic leadership) of the intervention to inform adoption decisions; describing 
contextual factors that influence implementation of the intervention; and considering the 
influence of program costs on intervention maintenance. All data for this aim will be 
observational (no data collected on patients or providers) to promote feasibility and limit the 
extent to which self-report measures bias findings, and they will align with established reporting 
recommendations, wherever possible.  
Implementation Strategy Tracking. A published method for tracking strategies will be applied 
across project meetings to capture information on implementation strategies including: 
operationalization of each strategy by reporting on the actor of the strategy, the action being 
performed, the target of the action, temporality, dose, outcome affected, and rationale for 
strategy selection. We will used structured minute-taking during meetings to capture the 
information. Strategies will be coded to align with published compilations and reveal novel 
strategies, consistent with Dr. Lewis’ application of this method in an ongoing R01. The richness 
of the data allows for an understanding of factors affecting implementation, strategies used by 
whom and how often to achieve what. This information is critical to any form of implementation 
guide and can allow understanding of any variation in implementation that may be linked to 
outcomes.  
Clinical Leadership. Clinic-level leaders (typically middle managers) are usually the individuals 
most influential over implementation processes as they are the conduit between high level 
administrators and front-line providers. Ways in which they shape thinking about and the 
ultimate form that the STOP-FALLS program takes and how it is integrated into existing 
workflows will be assessed by ongoing observations of the Implementation Team, with these 
observations relayed to the research team as part of monthly meetings of the Implementation 
Team and the research team. Consistent with emerging literature, we will classify the degree to 
which clinic leaders demonstrate proactive, knowledgeable, supportive, and perseverant 
leadership for the STOP-FALLS implementation. We will analyze the degree to which these 
influences helped or hindered intervention adoption and implementation across the KPWA 
delivery system. We will do this by first classifying clinics as low, moderate, or high performers 
and then describe leadership characteristics of each clinic group.
 Adaptability Analysis. Adaptability of an intervention is important in order to maximize 
program impact in different settings. We will systematically identify possible adaptations to our 
intervention and assess whether they might maintain or alter program fidelity, guided by 
principles of Planned Adaptation. The basic tenet of Planned Adaptation is the imperative to 
identify core program components, or “elements of a program that fundamentally define its 
nature and that account for the program’s effects”, and provide information on potential 
adaptations of the program (i.e., ways in which the program can be adapted and ways in which 
it should not be adapted; identifying cultural modifications that do not conflict with the program 
theory). Adaptations at the clinic level will be tracked by the KPWA Implementation Team, with 
this information relayed to the research team during joint monthly meetings. We will code 
adaptations according to an established framework for characterizing adaptations of evidence-
based practices post implementation to indicate whether an adaptation was made to the 

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context, content, or implementation support. We will use adaptation resources (adaptation 
guidelines, fidelity monitoring tools) to facilitate this process. From this analysis we will make 
explicit the core components of our intervention and describe ways in which it could be 
realistically adapted for use in different clinical settings and/or with different patient and provider 
populations.
Implementation Costs. Contemporaneously, information on direct costs to implement the 
intervention will be tracked. Costs will be categorized as start-up or maintenance. Start-up costs 
will include costs to adapt the intervention, time needed to bring the delivery system on-board, 
staff time needed to identify and invite (mailed letters) eligible patients to participate in the 
program, overhead (space rental, utilities, supplies), equipment, and personnel costs. 
Pharmacist time to assess and monitor medication regimens of intervention patients as a result 
of referrals as well as time to interact with providers will be calculated according to methods 
used previously. Cost information will be estimated from project invoices, Implementation Team 
discussions with clinical staff regarding time estimates, and administrative records. We will use 
descriptive statistics and summarize cost data in terms of a mean intervention cost per patient. 
2.3 Study Design Overview  
a. Overview/snapshot 
Describe the overall approach of the study (e.g. prospective, interventional, observational, 
retrospective, etc.).  If your study includes more than one group, arm, or subject population, 
describe that here (for example, a study of both subjects and their caregivers, or a study with both a 
prospective interventional arm and a retrospective chart review arm).  
The STOP-FALLS Project is a Multi-phase Study that involves 3 distinct phases of 
activities. Phase 1 activities involve a 1-time web-based survey of KPWA Primary Care 
Providers (MD, DO, Pa-C, ARNP) who provide care to older adults aged 65+ to assess 
their attitudes towards and self-efficacy for deprescribing our medications of interest. 
Phase II involves holding 3 focus groups with patients’ representative of our target 
population to help ensure that the Patient Brochures created and curated by our study 
team are patient-centered (Aim 1).  
Phase III (Study Intervention) is a Cluster Randomized Controlled Trial testing whether 
providing educational brochures to older adults aged 60+ and their providers has an 
effect on medication usage, fall-related healthcare use (primary outcome), and other 
(secondary) injury outcomes (Aim 2). In Phase III (Study Intervention), we will also do a 
targeted evaluation of key factors affecting adoption, implementation and maintenance 
of the intervention (Aim 3). We are not collecting any information on individual providers 
and are not collecting any provider outcomes as a part of Phase II or Phase III activities. 
To meet our objectives in Phase III, we will collect and analyze patient-level data 
including automated data in the KPWA Virtual Data Warehouse on health care 
utilization, prescription medication fills, demographics, and diagnoses. Patient-reported 
outcomes on symptoms relevant to the medications of interest and their potential 
deprescribing (pain, depression, anxiety, and insomnia) will also be extracted and 
analyzed from Clarity and Natural Language Processing of the clinical notes field in 
EPIC. Additionally, we will collect 3 self-reported questions from all participants 
regarding the type of brochure they received, it’s perceived helpfulness and whether the 

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participant will initiate a conversation with their doctor. This current application is 
seeking permission for Phase II and Phase III activities only because Phase I is 
already approved in IRBNet (Project ID: 1375781-3). 
For the PHASE II (Focus Groups), we used a focus group model to help ensure that 
our patient brochures are patient-centered. There are 5 patient brochures (1 for each 
study medication class; Opioids, Sedative/hypnotic (Benzo), Tricyclic Antidepressants 
(TCA), Muscle Relaxers, and Antihistamines that will be used in this study, but we will 
only be vetting 3 of these brochures in patient focus groups (Opioids, TCAs, Muscle 
Relaxers). The reason for only hosting focus groups for three of our 5 brochures is that 
these brochures wee created by modifying brochures created by our consultant team 
members in Canada (the CaDeN Group). Intensive focus groups were held in the 
making of these brochures, so we anticipated there will be minimal changes required. 
We submitted any changes as a modification prior to using the brochures in the 
intervention phase (Phase III). The brochures to be used in the focus groups are: 
 
190916_OpiodsPatientBrochure_FG and Intervention_Submitted 
 
190916_SMRPatientBrochure_FG and Intervention_Submitted 
 
190916_TCAPatientBrochure_FG and Intervention_Submitted 
The other 2 patient brochures and ALL provider Evidence-Based Pharmaceutical 
Opinions (EBPO) are FINAL. 
This activity was completed in December of 2019. 
This current application is seeking permission for Phase II and Phase III activities 
only because Phase I is already approved in IRBNet (Project ID: 1375781-3).
b. Study Intervention 
If the study includes a behavioral, educational, or other type of intervention briefly describe the 
intervention or provide a thorough overview of the intervention. Explain whether the intervention is 
standard of care at KPWA or elsewhere and whether testing the intervention is part of the study 
design. One paragraph is adequate here, section 7 (question 7.1.d), asks a detailed description of the 
intervention.   
Phase III of the STOP-FALLS Study involves an educational intervention designed to guide 
safer use of medications by older adults. With the input and assistance from our KPWA 
delivery system collaborators, the study team created and curated educational brochures for 
each CNS-active medication class that is a target of the intervention. The target medication 
classes are: opioids, sedative hypnotics (also known as benzodiazepines and Z-drugs), 
skeletal muscle relaxants, tricyclic antidepressants (TCAs), and antihistamines as well as fall 
prevention. For each medication class, we have created a Patient Brochure packet that will 
be mailed to patients using the medication on a chronic (>3 months) basis and a related 
decision support tool, referred to as an Evidence-Based Pharmaceutical Opinion (EBPO), 
that will be sent to the patient’s provider. Prior to October 2020, the EBPOs were sent to 
providers using secure fax.  After December 2020, a link to the online version of the EPBO’s 
will be sent to the providers using Epic Staff Messaging.  The Patient Brochures contain 
information about the potential risks of the target medication, alternative, safer methods of 
symptom management and fall prevention. The brochures also contain a sample tapering 
schedule which the patient may decide to follow as well as repeated encouragement to 

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discuss reducing the dose and/or stopping the medication with his/her healthcare providers.
The Provider EBPOs describe the risks associated with the medication and alternative 
evidence-based treatments that could be tried to help the patient reduce their use of the 
target medication.  
Additionally, the study team in collaboration with the clinic will identify, a “Clinic Champion” 
who will function as a liaison between the STOP-FALLS study team and the clinic. The clinic 
champion will forward the Deprescribing Pearls (via email) to the providers at the clinic. The 
Deprescribing Pearls will be sent every 2 weeks for the first 4-5 months of the study 
(currently we have 15 tip sheets/posters). These contain information drawn from the EBPO’s 
related to medication deprescribing. If they choose, the clinic champion may highlight 
information from the Deprescribing Pearls in morning huddles/team meetings.  Additionally, 
the clinic champion can communicate with the study team about issues that might come up 
at their clinic regarding the study. 
All patient and provider materials have been carefully cross-referenced with KP Guidelines 
and reviewed by leaders in the KPWA delivery system so that all information and 
recommendations are concordant with KPWA Guidelines and the fall prevention brochure 
has been developed by our funder and is widely available in the public domain. 
Approximately 1 month after the brochure is mailed out, participants will receive a follow-up 
postcard inquiring about the helpfulness of the brochure and whether the participant will 
initiate a conversation with their provider.   
Detailed Steps: Patients are identified as being in the correct age for their medication class, 
receiving primary care or assigned to a primary care provider at one of our intervention 
clinics, and taking at least 1 of CNS-active medications of interest on a chronic (>3 month) 
basis. Patients are mailed an educational brochure about a CNS-active medication class 
that they are currently taking (verified by KPWA pharmacy data) and a fall prevention self-
help sheet. The patient’s primary care provider will be sent an Evidence-Based 
Pharmaceutical Opinion Brochure (EBPO) synchronous with the patient mailing goes out.  
Additionally, we will mail all participants an antihistamine brochure because there is high 
utilization of over-the-counter antihistamine use, but prescriptions in automated data 
sources is low. An associated EBPO will not be sent synchronous with this antihistamine 
brochure mailing except when the patient is identified as taking prescription antihistamines 
on a chronic basis. In order to ensure that KP providers are not confused by these 
communications, we will inform providers at the Intervention Clinics about this study and 
materials that they can expect to receive through morning huddles and/or brown bag 
lunches as deemed appropriate by the clinic managers. 
Approximately 1 month after the brochure is mailed out, participants will receive a follow-up 
postcard inquiring about the helpfulness of the brochure and whether the participant will 
initiate a conversation with their provider. 
Patients will receive brochures for each medication class that they are prescribed, with 
subsequent brochures being mailed out 3 months after the previous one. We anticipate that 
less than 10% of participants are on 2 or more CNS medication classes.  Additionally, we 
will mail all participants an antihistamine brochure because there is high utilization of over-
the-counter antihistamine use, but prescriptions in automated data sources is low. 
No other follow-up is conducted by the study team until it is time to pull automated patient 
data to measure outcomes as described in this application.

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c. Flow diagram (if needed) 
If the study design is complicated (i.e, has multiple populations, data sources, subject pathways, 
etc.), insert a flow diagram here or upload it as a separate document if the format is incompatible 
with this form. 
NOTE: Update March 2021 - Due to initial delays due to COVID 19 and changes to procedures based on 
feedback from our intervention clinics (during both the first two recruitment waves and during our study 
overview sessions at clinics), our overall study time is going to be delayed significantly including pulling 
participants and collecting outcomes data, therefore we need to extend the date range for both sample 
identification and data collection by 1 year. This only applies to PHASE III (Study Intervention):The 
intervention will be rolled out monthly to clinics and persist for 12 months as depicted in the table 
below.  
Clinic 
Apr-
2021 
May-
2021 
Jun-
2021 
Jul-
2021 
Aug-
2021 
Sep-
2021 
Oct-
2021 
Nov-
2021 
Dec-
2021 
Jan-
2022 
Feb-
2022 
Mar-
2022 
Apr-
2022 
May-
2022 
Jun-
2022 
Jul-
2022 
1  
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
2  
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
3 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
4 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
5 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
6  
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
7 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
8 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
9 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
2.4 Other IRBNet file(s) 
Guidance: If the project has multiple aims or phases that a) do not begin at the same time and have 
different data sources/sites consult with the IRB on how best to submit the overall project. 
Are there other IRBNet files that have activities or subprojects that are part of this 
grant/contract/study?    
  YES 
  NO 
If YES, please attach the form entitled “Summary Table of IRBNet Files for One Funding Source.” 
3. Study Population 
3.1 Study Population Tables 

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Provide the expected number of subjects for this study. Complete this/these table(s) or use your 
own. If there are multiple subject populations or multiple sub-studies, create separate tables for 
each population/site.  
3.2 Secondary Subjects 
Guidance: Secondary subjects exist when the study team asks for private information about a third 
party from the primary study subject. For example, medical history of relatives, or information about 
patients’ providers. If this study includes secondary subjects include them as a population in section 
1.3 above and throughout the remainder of the application.  
Do you plan to include data from secondary subjects?   
  YES 
  NO 
If YES, complete Supplement C. 
3.3 Inclusion and Exclusion Criteria 
a. Inclusion criteria  
Specify inclusion criteria (age, health condition, etc.) for each population. If this varies by study site 
please group sites separately.  
Phase II (Focus Group) inclusion criteria: 
We will include patients aged 65-80 years of age who are chronic users (defined as 
pharmacy dispensings that cover at least 70 days of the last 90 days) of 1 or more of the 
targeted CNS-active medications. We will limit our sample to patients with 1+ primary care 
visit to KPWA clinics in Seattle (Capitol Hill, Northgate, Downtown) within the last 12 months 
or who reside (determined crudely with zip code) within 5 miles of KPWA’s Capitol Hill clinic 
(where the focus groups will be held). Phase II work was completed in 2019. 
Phase III (Trial) inclusion criteria: 
The study sample for each clinic will be identified at the time the intervention (or matched 
date for control clinic) is rolled out at the clinic.  
For opioid and sedative mediations, we will include patients aged 60+ years of age who are 
chronic users (defined as pharmacy dispensings that cover at least 70 of the last 90 days) of 
1 or more of the CNS-active medications of interest (opioids or sedatives) and who are 
either assigned to a primary care provider or had 1+ visits in the prior year to a primary care 
provider at one of the 18 KPWA clinics participating in this study.  
For benzodiazepines, TCAs and antihistamines, we will include patients aged 65+ years of 
age who are chronic users (defined as pharmacy dispensings that cover at least 70 of the 
KPWA Population
Population
Anticipated Number of subjects 
to be screened/invited 
Anticipated Number of subjects
to be enrolled 
Focus Group Participants
400
40- enrollment complete
Cluster Randomized Trial 
Participants 
5000
~5000
Total: ~5040
Total: 5040

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last 90 days) of 1 or more of the CNS-active medications of interest and who are either 
assigned to a primary care provider or had 1+ visits in the prior year to a primary care 
provider at one of the 18 KPWA clinics participating in this study 
Eligible subjects seen in multiple PC clinics will be assigned to the clinic where they had the 
most PC visits in the prior year. Subjects assigned to an intervention clinic will be considered 
the Intervention Group and subjects assigned to control clinics will be considered the 
Control Group. The sample will be static or unchanged throughout the study. 
b. Exclusion criteria
Specify exclusion criteria (age, health condition, etc.) for each population. If this varies by study site 
please group sites separately.  
Phase II (Focus Group) Exclusion Criteria: 
Patients will be excluded for any one of the following: a) diagnosis of dementia/Alzheimer’s 
disease or a pharmacy dispensing for a medication(s) used to treat dementia (i.e., a 
cholinesterase inhibitor or memantine); b) reside in a skilled nursing facility; c) cancer 
diagnosis in the prior 12 months; d) receiving hospice or palliative care; e) legally blind 
(unable to see print materials); f) unable to read English (unable to understand and 
comment on the print materials); g) unable to hear and/or speak English (unable to hear 
focus group questions and respond); h) unavailable at the date/time of the focus group, i) 
lacking transportation to get to and from the focus group and j) uncomfortable or unwilling to 
participate in a group discussion.
After inclusion and exclusion criteria are applied for the focus group sample, we will select a 
random-weighted sample (weighted on age, sex, and race/ethnicity) of 400 potential 
participants. Phase II work was completed in 2019  
Phase III (Trial) Exclusion Criteria: 
 For the opt-out protocol (July 2020-October 2020) 
Individuals will be excluded for any one of the following: a) diagnosis of 
dementia/Alzheimer’s  or a pharmacy dispensing for a medication(s) used to treat dementia 
(i.e., a cholinesterase inhibitor or memantine), b) reside in a skilled nursing facility; c)  
metastatic cancer diagnosis in the prior 12 months; e) receiving hospice or palliative care;  f) 
legally blind (unable to read print materials); g) indication in the KPWA VDW demographics 
table that the patient requires a translator (cannot read materials printed in English); h) 
enrolled in SMART (IRBnet 1220346,  PI Larson) or  STRIPE (IRBnet 1295096 , PI 
Boudreau); i) enrolled in KPWA COMET initiative; a pharmacy based initiative to lower 
opioid dosing. 
For the waiver of consent protocol (December 2020-): 
Individuals will be excluded for any one of the following: a) diagnosis of 
dementia/Alzheimer’s  or a pharmacy dispensing for a medication(s) used to treat dementia 
(i.e., a cholinesterase inhibitor or memantine), b) reside in a skilled nursing facility; c)  
metastatic cancer diagnosis in the prior 12 months; e) receiving hospice or palliative care;  f) 
legally blind (unable to read print materials); g) indication in the KPWA VDW demographics 
table that the patient requires a translator (cannot read materials printed in English); h) 
enrolled in SMART (IRBnet 1220346,  PI Larson) or  STRIPE (IRBnet 1295096 , PI 

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Boudreau); i) enrolled in KPWA COMET initiative; a pharmacy based initiative to lower 
opioid dosing; i. a code for opioid use disorder 
3.4 Equitable Representation 
a. gender and minority representation  
Will participant population include equitable gender and minority representation?  
  YES 
  NO 
If NO, explain. 
b. Population oversampling, omission  
Will any groups are being oversampled, omitted, or targeted?  
  YES 
  NO 
If YES, explain. 
3.5 Participant Languages 
Is it possible that this study may include non-English speaking participants?  
  YES 
  NO 
If YES, list possible language(s) and complete Supplement F. 
3.6 Minors 
Does this study include subjects under the age of 18? 
  YES 
  NO 
If YES, list the ages of the children involved in this research and complete Supplement E.
3.7 Prisoners 
Guidance: If this study includes prisoners you must contact the IRB staff for guidance before 
completing this application.  
Does this study include prisoners? 
  YES 
  NO 
3.8 Other Potentially Vulnerable Populations 
Does this study include other subjects who might be considered vulnerable?  For example, 
vulnerable populations include, but are not limited to 

Individuals with questionable capacity to consent/decisionally impaired 

Individuals who are seriously or terminally ill 

Native Americans and/or Alaska Natives 

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
Identifiable communities 

Veterans 

Employees of the institution conducting the research 

People of low socio-economic status 
  YES 
  NO 
If YES, list populations and Complete Supplement F.
4. Procedures – Identification of Subjects 
Guidance: If the study includes multiple populations (patients, providers, care givers, multiple 
intervention groups, etc.) you must respond to each question for each group. List each group in the 
answer or create tables for each population as relevant. 
4.1 Subject Identification 
How will the study team identify potential study subjects? Describe the procedures for identifying 
potential subjects.  If you plan to re-contact participants from a previous or active study, describe 
these procedures and submit the consent form for that study.  Note where in the consent you have 
permission to (re) contact participants for this new study.   (Use active voice and specify who will do 
what, (e.g., “a KPWA research programmer will identify eligible subjects from the VDW data”, etc.) 
For Phase II (Focus Groups), a KPWHRI study programmer will identify potential study 
participants from the KPWA automated data systems (i.e., Virtual Data Warehouse). Phase 
II work was completed in 2019. 
For and Phase III (Trial) a KPWHRI study programmer will identify potential study 
participants from the KPWA automated data systems (i.e., Virtual Data Warehouse). To 
exclude participants from STRIPE and SMART, the study programmers on those projects 
will send the STOP FALLS study programmer a file containing the CHSIDs or MRNs of 
enrolled study participants on a regular basis until the STRIPE and SMART studies have 
finished enrolling participants.  To exclude COMET participants, the study programmer will 
receive an email from Melissa Sturgis (KPWA Clinical Pharmacy Operations Coordinator) 
with a list of MRNs of enrolled COMET participants.   
4.2 Data for Identification 
List the key information/variables collected from medical records and/or other KPWA electronic 
sources that will be used to identify potential study subjects. We are expecting to see a robust list or 
description of the variables.  Use the table(s) below or attach a table or chart abstraction form of 
your own. Indicate the date range of interest. Use the second table (below) if data will be obtained 
from institutions other than KPWA. 
This is applicable to the PHASE II Focus Groups which was completed in 2019: 
Data from KPWA, or a KPWHRI Study, to identify potential study subjects 
Source (specify) 
List of electronic data that will be used 
to identify potential subjects 
Date Range  

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(i.e., from KPWA, or an 
existing or previous 
study, etc.) 
KPWA electronic data 
sources  
Healthcare Utilization: Primary care visits 
(inclusion criteria) Palliative care, hospice 
care, and skilled nursing facility care 
(exclusion criteria) 
 start of health plan 
enrollment – 
12/1/2020 
KPWA electronic data 
sources 
Pharmacy Dispensing Data:  drug name, 
date of dispensing, quantity, days supply, 
and prescriber id for the medications 
classes of interest (opioids, 
benzodiazepines, antidepressants, 
antihistamines, Z-drugs for sleep, other 
sedative hypnotics) and cholinesterase 
inhibitors and other drugs used to treat 
dementia/Alzheimers (exclusion criteria) 
11/1/2018 – 12/1/2020 
KPWA electronic data 
sources 
Diagnosis Codes:  Alzheimers, dementia, 
cancer, legally blind, and ICD procedure 
codes for cancer treatment (exclusion 
criteria) 
start of health plan 
enrollment 12/1/2020 
KPWA electronic data 
sources 
Demographics: age, race, sex, and 
ethnicity   
start of health plan 
enrollment 2/1/2020 
KPWA electronic data 
sources 
Tumor Registry: dates of all cancer 
diagnoses (exclusion criteria)  
start of health plan 
enrollment 2/1/2020 
KPWA electronic data 
sources 
Enrollment start and stop dates 
start of health plan 
enrollment – 
2/1/2020 
KPWA electronic data 
sources 
Referral for nursing homes and/or 
hospice (Exclusion Criteria) 
start of health plan 
enrollment – 
2/1/2020 
KPWA electronic data 
sources 
Hospice admissions database (Exclusion 
Criteria to confirm that these patients are 
not receiving hospice care) 
start of health plan 
enrollment – 
2/1/2020 
Providers are not subjects in this research. We are not collecting any individual data on 
providers.

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This is Applicable for PHASE III Intervention: 
For the opt-out protocol: (July 2020-October 2020) 
Data from KPWA, or a KPWHRI Study, to identify potential study subjects 
Source (specify) 
(i.e., from KPWA, or an 
existing or previous 
study, etc.) 
List of electronic data that will be used 
to identify potential subjects 
Date Range  
KPWA electronic data 
sources 
Healthcare Utilization: all outpatient 
visits, dates, provider id 
9/30/2018 – 10/31/2020 
KPWA electronic data 
sources 
Pharmacy Dispensing Data: drug name, 
NDC, strength, quantity, days supply, 
prescriber id, and date dispensed for all 
medications of interest (opioids, 
benzodiazepines, tricyclic 
antidepressants, Z-drugs, other sedative 
hypnotics, muscle relaxers, 
antihistamines) and medications to treat 
Alzheimers/dementia (exclusion criteria) 
9/30/2018 – 10/31/2020 
KPWA electronic data 
sources 
Diagnosis Codes:  all fall and fracture 
related diagnoses and dates of diagnoses  
9/30/2018 –10/31/2020 
KPWA electronic data 
sources 
Demographics: age, sex, race, and 
ethnicity  
9/30/2018 – 10/31/2020 
KPWA electronic data 
sources 
Tumor Registry: dates of all cancer 
diagnosis (exclusion criteria)  
9/30/2018 – 10/31/2020 
KPWA electronic data 
sources 
Procedures:  all fall and fracture related 
procedure codes and dates of procedure 
9/30/2019 – 10/31/2020 
KPWA electronic data 
sources 
Enrollment: enrollment start and stop 
dates 
9/30/2019 – 10/31/2020 
KPWA electronic data 
sources 
Provider table: provider id, specialty, 
provider type 
9/30/2019 – 10/31/2020 
KPWA electronic data 
sources 
Referral for nursing homes and/or 
hospice (Exclusion Criteria) 
9/30/2019 – 10/31/2020 

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KPWA electronic data 
sources 
Hospice admissions database (Exclusion 
Criteria to confirm that these patients are 
not receiving hospice care) 
9/30/2019 – 10/31/2020 
SMART study 
CHSIDs or MRNs of enrolled participants 
4/1/2020- 10/31/2020 
STRIPE study  
CHSIDs or MRNs of enrolled participants 
4/1/2020- 10/31/2020 
COMET intervention 
MRNs of enrolled participants 
4/1/2020- 10/31/2020 
For the waiver of consent protocol (December 2020-): 
Data from KPWA, or a KPWHRI Study, to identify potential study subjects 
Source (specify) 
(i.e., from KPWA, or an 
existing or previous 
study, etc.) 
List of electronic data that will be used 
to identify potential subjects 
Date Range  
KPWA electronic data 
sources 
Healthcare Utilization: all outpatient 
visits, dates, provider id 
9/30/2018 – 6/30/2023 
KPWA electronic data 
sources 
Pharmacy Dispensing Data: drug name, 
NDC, strength, quantity, days supply, 
prescriber id, and date dispensed for all 
medications of interest (opioids, 
benzodiazepines, tricyclic 
antidepressants, Z-drugs, other sedative 
hypnotics, muscle relaxers, 
antihistamines) and medications to treat 
Alzheimers/dementia (exclusion criteria) 
9/30/2018 – 6/30/2023 
KPWA electronic data 
sources 
Diagnosis Codes:  all fall and fracture 
related diagnoses and dates of diagnoses, 
all opioid use diagnoses codes and dates 
(exclusion criteria)  
9/30/2018 –6/30/2023 
KPWA electronic data 
sources 
Demographics: age, sex, race, and 
ethnicity  
9/30/2018 – 6/30/2023 
KPWA electronic data 
sources 
Tumor Registry: dates of all cancer 
diagnosis (exclusion criteria)  
9/30/2018 – 6/30/2023 
KPWA electronic data 
sources 
Procedures:  all fall and fracture related 
procedure codes and dates of procedure 
9/30/2019 – 6/30/2023 

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KPWA electronic data 
sources 
Enrollment: enrollment start and stop 
dates 
9/30/2019 – 6/30/2023 
KPWA electronic data 
sources 
Provider table: provider id, specialty, 
provider type 
9/30/2019 – 6/30/2023 
KPWA electronic data 
sources 
Referral for nursing homes and/or 
hospice (Exclusion Criteria) 
9/30/2019 – 6/30/2023 
KPWA electronic data 
sources 
Hospice admissions database (Exclusion 
Criteria to confirm that these patients are 
not receiving hospice care) 
9/30/2019 – 6/30/2023 
SMART study 
CHSIDs or MRNs of enrolled participants 
4/1/2020- 6/30/2023 
STRIPE study  
CHSIDs or MRNs of enrolled participants 
4/1/2020- 6/30/2023 
COMET intervention 
MRNs of enrolled participants 
4/1/2020- 36/30/2023 
Providers are not subjects in this research. We are not collecting any individual data on 
providers.
4.3 Waiver Requests to Identify Potential Subjects 
Are you requesting waivers to identify subjects for this study? 
  YES 
  NO 
If YES, complete Supplement A. 
5. Procedures – Screening and Recruitment 
Guidance: If the study includes multiple populations (patients, providers, care givers, multiple 
intervention groups, etc.) you must respond to each question for each group. List each group in the 
answer or create tables for each population as relevant. 
5.1 Screening Activities 
Will you conduct screening or any other research procedures before obtaining informed consent for 
the main study activities?  
  YES 
  NO 
IF YES, briefly describe any data collection/screening or other research procedures that you will use 
to determine eligibility in the study (e.g., phone screening, chart abstraction, blood tests, wearing 
activity devices, attending office visits, etc.) before obtaining full informed consent. Also complete 
the table below. 
Brief Description:   Phase II (Focus Group): Prior to obtaining Informed consent from focus 
group participants, our KPWHRI study programmer accessed KPWA automated data to 
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mailed focus group invitation letters to this group and eligibility was confirmed by Survey 
Phone Room   during a brief phone screening. We expected approximately 10% of potential 
subjects will participate (N~40) in the 3 focus groups. Phase II work was completed in 2019.  
Phase III (Trial):
In this application we describe the procedures for the Opt-Out Protocol (July 2020-October 
2020) group and the Waiver of Consent/HIPAA Authorization Protocol (December 2020-) 
group.   
The “Opt-Out Protocol (July 2020-October 2020)” refers to the participants who were 
recruited during the period of July 2020 until October 2020. During that time, the opt-out rate 
from the intervention arm was approximately 15% and the study team put recruitment on 
pause as they worked with the biostatistician to determine if this rate was a fatal flaw, which 
it turned out to be.  At this time, the study team made the decision to change procedures by 
asking for a waiver of HIPAA authorization and consent for both intervention arm and 
regular care participants. No participants were enrolled until the waiver requests are 
granted. 
The “Waiver of Consent/HIPAA Authorization Protocol (December 2020-) group” refers to 
the participants who will be enrolled after the modification for a waiver of HIPAA 
authorization and consent is granted.  
Opt-Out Protocol (July 2020-October 2020) 
We are requesting a waiver of documentation of consent for Phase III trial (intervention) 
activities.  Prior to receiving the Study Information Sheet, our KPWHRI study programmer 
will access KPWA automated data (VDW) and use lists of participants enrolled in the 
STRIPE and SMART studies and enrolled in COMET, to assemble our sample of Phase III 
participants. There is no further screening for eligibility or primary data collection.  Patients 
receiving care in clinics assigned to the Intervention Group will be mailed a Study 
Information Sheet with their first patient brochure. The Information Sheets provide an opt out 
number to call if patients prefer to not have their data included in the study or they do not 
want to receive patient brochures.   
Waiver of Consent/HIPAA Authorization Protocol (December 2020-)We are requesting a 
waiver of consent for Phase III trial (intervention) activities consisting of both regular care 
and intervention arm participants. A  KPWHRI study programmer will access KPWA 
automated data (VDW), and use lists of participants enrolled in the STRIPE and SMART 
studies and enrolled in COMET, to assemble our sample of Phase III participants. There is 
no further screening for eligibility or primary data collection. Patients receiving care in clinics 
assigned to the Intervention Group will be mailed a notification letter about the research 
study occurring in their clinic, patient brochure and self-help information sheets.   
Source (specify) 
List of primary data collection that will be 
used to identify and determine eligibility 
of potential subjects 
Date Range(s) 

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(i.e., screening phone 
survey, activity monitor 
results, lab tests, etc.) 
Phone screening (for 
Phase II focus groups 
only) 
See attached screening questions and 
phone script 
n/a 
5.2 Screening and Recruitment Process 
a. Step-by-Step Description 
Describe the overall recruitment process, including screening if applicable, for each study 
population. Include step-by-step detail using active voice to explain where, when and how the study 
team recruit and enroll participants. Include information about the use of letters, flyers, email 
message, phone calls, etc. (Upload all recruitment materials documents into IRBNet.) 
Phase II (Focus Group):  
A KPWHRI Study Programmer will access KPWA automated VDW data to identify 
potentially eligible participants and randomly select n=400 (weighted-random sample on age 
(5-year groups), sex (F, M), and race/ethnicity (Caucasian, Black/African American, Asian, 
Other, Hispanic)). The KPWHRI Programmer transfers the sample to the survey research 
program programmer. The survey research program prints focus group recruitment letters 
and mails them to potential participants (n=400). Between 5-10 days post mailing, the 
survey research program call room staff calls potential participants, explain the study, and 
reads through the Oral Consent for telephone screening. If the potential participant agrees 
to answer our focus group screening questions, the survey research program phone room 
staff will lead the potential participant through the screening questions, which ends in a 
determination of eligibility for focus group participation. If the participant is eligible and is 
willing to participate, the survey research program phone room staff will schedule the 
participant for one of our focus groups. The study project manager will send participants a 
reminder letter with the details of the focus group. Two days prior to the focus group, the 
participant will receive a reminder phone call from the study Project Manager and/or focus 
group facilitator. Informed consent will be obtained in-person prior to the start of the focus 
group. The goal is 3 focus groups with 8-12 participants per focus group. Phase II work was 
completed in 2019.  
Phase III (Trial): 
Opt-Out Protocol (July 2020-October 2020)
At clinic roll-out, the KPWHRI Study Programmer will access KPWA automated data (VDW 
tables) and receive data files from STRIPE, SMART and COMET to identify the eligible 
Intervention Group (see section 3.3 for eligibility criteria). The KPWHRI Programmer loads 

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the sample into the study database. Every month, the KPWHRI programmer updates the 
medication lists for the Intervention Group and runs an algorithm to select which patients in 
the Intervention Group are mailed to that month (see Figure in section 7.1.e on the selection 
of who is mailed to each month). The KPWA survey research program will print invitation 
letters, study information sheet, and relevant patient brochures and mail these materials to 
patients.  
At the same time, the Research Specialist will print and send, via secure fax, EBPOs on the 
same medication class to the patient’s PC provider. In order to ensure that KP providers are 
not confused by this communication, we will inform providers at the Intervention Clinics 
about this study and materials that they can expect to receive through morning huddles 
and/or brown bag lunches as deemed appropriate by the clinic managers. 
One month after the initial brochure is sent, the KPWA survey research program will send 
out the postcard mailer.
The same process of identifying the sample will occur for usual care clinics at the time the 
matched intervention clinic goes live, but the Control Group and their respective providers 
will not receive any  of the educational materials.   
Waiver of Consent/HIPAA Authorization Protocol (December 2020-)
At clinic roll-out, the KPWHRI Study Programmer will access KPWA automated data (VDW 
tables) and receive data files from STRIPE, SMART and COMET to identify the eligible 
Intervention Group (see section 3.3 for eligibility criteria). The KPWHRI Programmer loads 
the sample into the study database. Every month, the KPWHRI programmer updates the 
medication lists for the Intervention Group and runs an algorithm to select which patients in 
the Intervention Group are mailed to that month (see Figure in section 7.1.e on the selection 
of who is mailed to each month). The KPWA survey research program will print notification  
letters and relevant patient brochures and mail these materials to patients. At the same time, 
the Research Specialist will send the Epic Staff Message, a message letting the provider 
know their patient was included in the study and a link to the EBPO of the same medication 
class. In order to ensure that KP providers are not confused by this communication, we will 
inform providers at the Intervention Clinics about this study and materials that they can 
expect to receive through morning huddles and/or brown bag lunches as deemed 
appropriate by the clinic managers. 
One month after the initial brochure is sent, the KPWA survey research program will send 
out the postcard mailer.
The same process of identifying the sample will occur for usual care clinics at the time the 
matched intervention clinic goes live, but the Control Group and their respective providers 
will not receive any of the educational materials.   
Providers: 
Providers are not subjects in this research. We are not screening or recruiting providers for 
this study.  

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Prior to clinic rollout, the research team will explain the study to providers at team huddles 
and meetings (whichever individual clinics prefer) and the information to be shared at these 
huddles/meetings has been uploaded in IRBNet.  
 Providers are alerted when one of their patients is included in the study. The study RS will 
contact them by Epic Staff Messaging. We chose this method after receiving feedback from 
our first clinic, Capitol Hill, that the previous method of faxing and dealing with hard copies 
not only does not fit in with their usual workflow, but also goes against the current COVID 
policies for reducing physical paperwork. We have also vetted this process with SERT and 
the process and accompanying materials have been approved by SERT on 12/1/2020. 
Although, there is no follow-up from the research team once the staff message has been  
sent, SERT told us that if providers reply to the staff message with questions, then the study 
team needs to be able to reply to their questions in Epic Staff Messaging; we cannot force 
them to call us on the telephone.  
b. Recruiter(s) 
List position/title of the people who will be recruiting, screening, and enrolling participants. 
Kanichi Nakata Research Specialist III 
Monica Fujii, Project Manager II 
Survey Research Program Staff 
5.3 Screening Data 
Describe the plan for use/destruction of data collected during screening/recruitment in the event of 
a screen failure or when a potential subject is contacted but refuses participation or does not 
respond (e.g. destroyed immediately, destroyed at end of study, retained so that subjects are not 
contacted repeatedly about participation after they have declined, etc.). 
Phase II (Focus Group): Potential participants will be called a max of 6 times after the 
recruitment letter goes out. A tracking database will be used to record the date of the invite 
letter, date and number of recruitment calls, whether contact was made, screening status, 
eligibility, active versus passive refusals, participation, and incentives provided. Potential 
participants who choose to opt-out will be coded as a refusal and no further data will be 
collected or calls made. Phase II work was completed in 2019.
Phase III (Trial): 
Opt-Out Protocol (July 2020-October 2020) 
 There is no screening for the trial. Subjects in the Intervention Group that opt out will be 
removed from the sample, no further data will be collected, and they will not receive the 
study educational brochures. 
Waiver of Consent/HIPAA Authorization Protocol (December 2020-)
There is no screening for the trial. 

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6. Informed Consent 
6.1 Consent and HIPAA Authorization Overview 
Which of the following typical consent processes at KPWA will be used for this study? Check those 
that apply to both eligibility screening and study activities.  
Activity 
What to Submit 
If you are requesting a waiver of written documentation of 
consent &/or a waiver or alteration of HIPAA Authorization.
This will often be the case when a study involves a non-signed 
consent process (like oral consent, or web screening) and no signed 
HIPAA Authorization form, plus an information statement (e.g., for 
eligibility screening)
- Supplement A
-Information Sheet 
-Oral consent script 
(or web screening 
questions ) 
Written informed consent & separate HIPAA Authorization Form 
A written signed consent form and separate written signed HIPAA 
authorization form (Required for more than minimal risk studies)
-Consent form 
-HIPAA 
authorization 
Written informed consent & HIPAA Authorization as one 
document 
A written signed consent form that includes HIPAA authorization 
language in the consent form  
-Consent form 
Applicable for 
Patient Focus 
Groups Only 
Waiver of informed consent & waiver of HIPAA Authorization (very 
rare) 
No subject consent or HIPAA Authorization from subjects
-Supplement A
Use of Legally Effective Electronic signature  
Only for studies that use legally effective docu-sign software. 
Consult with IRB if you have questions.    
-Certification from 
issuing company 
Other (explain):      
Contact HRSC staff 
6.2 Informed Consent Process 
a. Consent Process 
Describe the informed consent process for this study in detail (including who will administer the 
consent, when, and where.)  Address each study population separately.  
  Phase II (Focus Groups): This activity has 2 phases of consent. The first will be to collect Oral 
Consent for Eligibility Screening. These telephone eligibility questions confirm that the potential 
participant is available during the hours of our focus group, is comfortable speaking in a group 
setting, and is able to read materials written in English and hear our focus group questions and 
participate in discussion. The Study Research Specialist and/or Project Manager will call potential 
participants who have been sent a recruitment letter to see if he/she is interested in learning more 
about our study and if he/she is willing to answer 5 questions (see Focus Group Screening 

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Questionnaire and Script) to find out if he/she is eligible to come to our focus group. Participants 
who are willing to be screened will be asked our 5 eligibility questions and if eligible, will be 
scheduled for the focus group appropriate for his/her medication type. The second consent is 
Informed Consent + HIPAA. Informed consent will be administered by the study RS and/or Project 
Manager prior to the start of the focus group. This will be done in-person in a private location close 
to the focus group location. Phase II work was completed in 2019.
Phase III – Intervention Clinic Patients:  
Opt-Out Protocol (July 2020-October 2020) 
Participants receiving care at our  Intervention Clinics will be sent a study information sheet with our 
study patient brochures. The Information Sheet will explain study procedures and how to opt-out of 
this study.  
Waiver of Consent/HIPAA Authorization Protocol (December 2020-)
All participants (both intervention arm and usual care) are enrolled under waiver of consent and 
HIPAA authorization.   
b. Ongoing Consent 
Describe your process to ensure ongoing consent. 
 Ongoing consent is not applicable for this study.  
c. Undue Influence and Coercion 
Describe what steps will be taken to minimize the possibility of coercion or undue influence? 
Opt-Out Protocol (July 2020-October 2020) 
 All materials are developed to encourage participation while making it clear that patients do 
not have to participate and that their choice to not participate will not impact their care or 
insurance at KP. We engaged the KPWA EAGLEs team to review all study materials and 
provide suggestions for making the materials more transparent and readable. We provide a 
modest monetary incentive for participating in the focus groups and provide no monetary 
incentive for participating in the trial.   
Waiver of Consent/HIPAA Authorization Protocol (December 2020-)
All materials are developed to encourage participation while making it clear that patients do 
not have to discuss the study materials with their providers. We engaged the KPWA 
EAGLES team to review all study materials and provide suggestions for making the 
materials more transparent and readable. We provide a modest monetary incentive for 
participating in the focus groups and provide no monetary incentive for participating in the 
trial.   

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d. Consent Form in EHR 
Guidance: If study records will be placed in EHR, this information must be included in the consent 
form.  
Will the study place a copy of the study consent form in the subject’s medical record?  
  YES 
  NO 
6.3 Assent of Children and Parent Permission 
Does this study involve assenting/consenting youth and/or parental consent?  
  YES 
  NO 
If YES, complete Supplement E. 
6.4 Non-English-Speaking Subjects  
Does this study involve consenting subjects who do not speak English?   
  YES 
  NO 
If YES, complete Supplement F. 
6.5 Decisionally Impaired Subjects 
Does this study involve consenting/assenting subject who may be unable to consent due to 
decisional impairment?  
  YES 
  NO 
If YES, complete Supplement F. 
7. Procedures – Primary Study Activities  
7.1 Randomization, Interventions, and Clinical Procedures 
a. Randomization  
Will subjects be randomized to receive procedures, activities, interventions, etc.? 
  YES 
  NO – 
If YES, please describe the randomization. 
This is applicable to PHASE II (Intervention) ONLY:  
The unit of randomization is at the clinic level (stratified randomization by size and location 
of clinic), so individuals are not the unit of randomization. However, subjects are randomized 
to receive the intervention according to their assigned clinic. Of the 18 clinics identified for 
the trial, 9 clinics will be randomized to the intervention and 9 to usual care. The clinic pairs 
for the stratified randomization are as follows (approved by delivery system leaders): 
Intervention Clinics
Control Clinics
Capitol Hill
Northgate
Veradale
Lidgerwood

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Tacoma Medical
Steele St.
Burien
Renton
Bellevue
Redmond
Silverdale
Port Orchard
Lynnwood
Everett
Poulsbo
Kent 
Federal way
Northshore 
b. Clinical Trial 
Is this study a clinical trial as defined by National Institutes of Health (NIH)?  
NIH defines a clinical trial as “A research study in which one or more human subjects are 
prospectively assigned to one or more interventions (which may include placebo or other control) 
to evaluate the effects of those interventions on health-related biomedical or behavioral 
outcomes.”
  YES 
  NO 
c. Study Interventions and/or Other Clinical Procedures  
Does your study include any behavioral, educational or medical interventions, or any other clinical 
procedures (e.g., blood draw, blood pressure, training workshops)? 
  YES 
  NO 
If YES, continue.  If NO skip to 7.2 
d. Summary of Intervention/Clinical Procedures  
Please check boxes below and/or summarize intervention activities and/or other clinical procedures. 
Check all that apply.  
Educational/behavioral intervention (e.g., counseling program, clinical decision aid) 
Medical intervention (includes prescribing or administering drugs) 
Drug or medical device. IF CHECKED, complete Supplement B.  Also contact IRB Office staff 
for required additional forms and information and check all boxes below that apply. 
FDA-approved drug or device will be used for a purpose consistent with the existing labeling 
IND/IDE not required (attach letter from FDA)  
Study involves other FDA regulations (e.g., CLIA, mobile devices, etc.):  IF CHECKED, please 
list.        

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Other (explain):        
Study procedures involving radiation (e.g., mammograms, bone density measurements, 
etc.). If checked, provide assurance that KP Washington’s Radiation Safety Committee approval 
will be obtained. 
Other clinical procedures (please describe briefly – e.g., blood pressure, BMI measurements, 
wearing fitbits, monitoring devices, fasting before glucose test, etc.):        
Biological specimen collection (blood, urine, saliva, fecal, etc.):        
Other activities not listed above (please describe briefly):        
e. Detailed Description of Intervention  
Describe the intervention activities in excruciating detail. If there is a separate manual, submit that 
also.  
There is no intervention in Phase II (Focus Group) 
Phase III of the STOP-FALLS Study involves an educational intervention designed to guide 
safer use of medications by older adults. With the input and assistance from our KPWA 
delivery system collaborators, the study team created educational brochures, self-help 
sheets for each CNS-active medication class that is a target of the intervention and curated 
a fall prevention self-help sheet. The target medication classes are: opioids, sedative 
hypnotics (also known as benzodiazepines and Z-drugs), skeletal muscle relaxants, tricyclic 
antidepressants (TCAs), and antihistamines. For each medication class, we have created a 
Patient Brochure that will be mailed to patients using the medication on a chronic (>3 
months) basis and a related decision support tool, referred to as an Evidence-Based 
Pharmaceutical Opinion (EBPO), that will be sent via Epic Staff Messaging to the patient’s 
provider. Additionally, we will mail all participants an antihistamine brochure because there 
is high utilization of over-the-counter antihistamine use, but prescriptions in automated data 
sources is low. An associated EBPO will not be sent synchronous with this antihistamine 
brochure mailing except when the patient is identified as taking prescription antihistamines 
on a chronic basis. The Patient Brochures contain information about the potential risks of 
the target medication and alternative. The brochures also contain a sample tapering 
schedule which the patient may decide to follow as well as repeated encouragement to 
discuss reducing the dose and/or stopping the medication with his/her healthcare providers. 
The self-help sheets contain safer methods of symptom management and fall prevention.
The Provider EBPOs describe the risks associated with the medication and alternative 
evidence-based treatments that could be tried to help the patient reduce their use of the 
target medication. All patient and provider materials have been carefully cross-referenced 
with KP Guidelines and reviewed by leaders in the KPWA delivery system so that all 
information and recommendations are concordant with KPWA Guidelines 
Prior to the start of Intervention activities at each Intervention Clinic, study team members 
will attend huddles or team meetings (to be chosen by clinic leadership) to explain the 

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research study and introduce providers and staff to our materials and method of distribution 
to patients and providers. . 
Additionally, the study team in collaboration with the clinic will identify, a “Clinic Champion” 
who will function as a liaison between the STOP-FALLS study team, and the clinic. The 
clinic champion will forward the Deprescribing Pearls (via email) to the providers at the 
clinic. The Deprescribing Pearls will be sent every 2 weeks for the first 6 months of 
intervention implementation in each Intervention Clinic. If they choose, the clinic champion 
may highlight information from the Deprescribing Pearls in morning huddles/team meetings.  
Additionally, the clinic champion can communicate with the study team about issues that 
might come up at their clinic regarding the study. 
The STOP-FALLS patient brochures, self-care sheets, provider EBPOs and Deprescribing 
Pearls are not currently a part of the standard of care at KPWA, however, our team of 
clinicians (geriatrician, pharmacists, and clinical psychologist) adapted/developed them in 
consultation with KPWA guidelines and KPWA delivery system (including primary care and 
pharmacy) leaders and curated the fall prevention self help sheet from the funder/public 
domain. Dr. Ben Balderson, a clinical psychologist at KPWPMG, and KPWHRI EAGLES 
Team also contributed heavily to the development of materials. All recommendations were 
cross-referenced with KPWA Guidelines so that all information contained within the 
brochures reflects and does not conflict with KPWA Guidelines and available treatment 
options. 
The patient brochures, but not the fall prevention sheet,  were vetted during the facilitated 
and recorded Focus Groups (Aim 1 of Phase II) where older adult patients who are taking 
these medications were asked to share their thoughts on the readability, content, and format 
of the materials as well as their overall impression and suggestions for improvement. The 
research team summarized recordings and notes from the focus groups and use this 
information to modify the patient materials accordingly. For examples of these materials, see 
patient brochures and provider EBPOs that are included with this application.  
Eighteen clinics will be randomized to either intervention (n=9 clinics) or usual care (n=9 
clinics). Patients meeting the eligibility criteria (see section 3.3) and either assigned to a 
primary care provider in one of the 9 intervention clinics or receiving primary care in one of 
the intervention clinics (defined as 1+ visits to the clinic in the year prior to intervention roll-
out) are the study intervention group. The study control group will be defined similarly with 
respect to eligibility criteria and assignment/visits to the usual care clinics. The sample is 
static (identified once at of the time of study roll-out at the particular intervention clinic and 
matched usual care clinic) throughout the study.  
The intervention will be rolled out at a rate of 1-3 clinics each month (tentative start date of 
July 2020) and the intervention will persist in each clinic for up to 12 months (see Table in 
Section 2.3.c for roll-out schedule).   
In order to ensure that KP providers are not confused by this communication, we will inform 
providers at the 9 Intervention Clinics about this study and materials that they can expect to 
receive (via Epic Staff Messaging) by attending morning huddles and/or brown bag lunches 
as deemed appropriate by the clinic managers. During the intervention period, intervention 

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group participants (and their providers) will receive brochure(s) specific to the medication 
class or classes they are currently taking. A maximum of approximately 35-95 intervention 
participants per clinic will receive mailings each month for opioids, z-drugs, skeletal muscle 
relaxers, TCA, and prescription antihistamine users. We refer to this herein as our “max cap” 
per clinic each month (this number represents ~15% of monthly clinic visits by the 
intervention sample and has been agreed upon with by the KPWA delivery system). The 
maximum number has a range because it will vary by clinic according to total eligible patient 
participants and the expected number of patient visits per month. For the mailing of 
antihistamine brochures to all participants, except those who already received one because 
they were identified as prescription antihistamine users, the max cap will not apply. We will 
mail the antihistamine brochure once to all eligible patients who have not already received 
an antihistamine brochure due to a chronic (>3 months) antihistamine prescription.   
From the intervention group at each clinic, we will sample the max cap number each month 
over the course of the intervention period opioid, z-drug, skeletal muscle relaxer, TCA, and 
prescription antihistamine users. We will prioritize which patient in the intervention group at 
each clinic gets mailed a brochure (and the class-concordant EBPO to the patient’s 
provider) as follows: Patients with a PC visit scheduled in the next 8-38 days will be 
prioritized in filling the max cap each month. This provides time for the patient and provider 
to receive and read the materials prior to the visit and optimizes the chances of a discussion 
about the medication being held as part of the visit (i.e., prepared patient and prepared 
provider as per the Chronic Care Model). If the max cap is not met for an intervention clinic 
in a given month, a random sample of the study intervention group will then be selected to 
fill the max cap for mailings that month. 
Patients will receive only one brochure related to a given medication class during the 
intervention period. Patients taking >1 medication classes of interest will receive no more 
than one unique patient brochure every 3 months for a maximum of 4 brochures over the 
12-month intervention period. If patients are using more than one of the five medication 
classes, the brochures mailed will be prioritized as 1) opioids; 2) benzodiazepines/Z-drugs; 
3) muscle relaxants; 4) TCAs and; 5) antihistamines. Additionally, we will mail all participants 
an antihistamine brochure because there is high utilization of over-the-counter antihistamine 
use, but prescriptions in automated data sources is low. 
One month after sending the brochure, patients will receive a postcard mailer with 3 self-
reported questions regarding the type of brochure they received, it’s perceived helpfulness 
and whether the participant will initiate a conversation with their doctor.   
Sending EBPOs to providers are triggered by the mailing of the patient brochure and will 
follow a similar logic. For the mailing of antihistamine brochures to patients without a 
prescription for antihistamines, we will have the clinic champion disseminate one final 
clinical pearl with a link to the EPBO for antihistamines to all providers.  
The intent of these materials is to start a conversation between the patient and provider that 
will improve health outcomes via dose reduction and/or discontinuation of the medication. 
The process by which deprescribing occurs will be determined by the provider and patient 
and with the involvement of a clinical pharmacist at the discretion of the patient’s PCP.  

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The process/algorithm for selecting which patients in the Intervention Group receive 
mailings each month is detailed below. 
Opt-Out Protocol (July 2020-October 2020) 
1. Every month after clinic launch through 12-months post, update the current chronic high-
risk medication use among the Intervention Group.   
2. Create a pool of eligible patients to mail to from each clinic’s Intervention Group. Pool 
includes:  
a. Current chronic users of 5 high-risk medication classes of interest with no prior 
mailing for that medication class. Multiple records per person. 
i. Sort by order of priority of target medication classes (opioid, benzo/z-
drug, muscle relaxant, tca, antihistamine) and keep only one record per 
patient if multiple. For example, a current chronic user of opioids and 
benzos with no prior mailings of either would go into the mailing selection 
pool as an opioid user.  
b. No mailings in the prior 3 months.  
c. Exclude anyone who has been withdrawn from the study on file as deceased, or 
previously had a “bad address”. 
3. Sample eligible patients for mailings (set max cap at 15% of sample for that clinic).  
a. Prioritize those with a PC appointment to a provider in that clinic in the next 8-38 
days.  
i. FaxEBPO to provider the visit is scheduled with 
b. Prioritize those with no prior mailings to fill up the rest of the max cap for mailing.  
i. Mail to the most frequent prescriber of the medication (prior 12-months). 
Waiver of Consent/HIPAA Authorization Protocol (December 2020-) 
1. Every month after clinic launch through 12-months post, update the current chronic high-
risk medication use among the Intervention Group.   
2. Create a pool of eligible patients to mail to from each clinic’s Intervention Group. Pool 
includes:  
a. Current chronic users of 5 high-risk medication classes of interest with no prior 
mailing for that medication class. Multiple records per person. 
i. Sort by order of priority of target medication classes (opioid, benzo/z-
drug, muscle relaxant, tca, antihistamine) and keep only one record per 
patient if multiple. For example, a current chronic user of opioids and 
benzos with no prior mailings of either would go into the mailing selection 
pool as an opioid user.  
b. No mailings in the prior 3 months.  
c. Exclude anyone who is on file as deceased, or previously had a “bad address”. 
3. Sample eligible patients for mailings (set max cap at 15% of sample for that clinic).  
a. Prioritize those with a PC appointment to a provider in that clinic in the next 8-38 
days.  

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i. Send staff message to with link to EPBO to provider the visit is scheduled 
with 
b. Prioritize those with no prior mailings to fill up the rest of the max cap for mailing.  
i. Send staff with message with link to EPBO to the most frequent 
prescriber of the medication (prior 12-months). 
4. After all participants have received their mailing, mail antihistamine brochure to everyone 
a. No mailings in the prior 3 months.  
b. Exclude anyone who is on file as deceased, or previously had a “bad address”. 
c. Exclude anyone who received an antihistamine mailing already due to chronic 
use of prescription antihistamines  
f.  Alternative Procedures 
Guidance: If there are alternative treatments or procedures that might be advantageous to the 
participant it should be included in the consent form.  
Are there alternative procedures or treatments that might be advantageous to the participant? 
  YES 
  NO 
If YES, please describe briefly.  
g. Denial of Procedures or Treatment 
Guidance: If participants are denied access to certain procedures or treatments during the course of 
the study, this information must be included in the consent form.  
Are there any procedures or treatments that the participant will be denied access to? 
  YES 
  NO 
If YES, please describe briefly.  
h. Relationship to Clinical Care 
 If this study is a clinical trial, pragmatic trial, or a study that in any way interfaces with clinical care, 
please describe exactly which procedures will be conducted for the research as opposed to 
procedures the subjects would undergo (in the exact manner described in the protocol, if there is a 
protocol) even if they were not participating in the study. 
This is applicable to PHASE III (Intervention) ONLY:
The intervention does not directly interface with clinical care. We will send, via staff message 
with a url to the  EBPOs to providers whose patients receive educational brochures for the 
target medication classes. Our goal is to educate patients and providers on the risks of 
these medications for older people, to provide guidance about safer alternatives, and to 
share information about safe deprescribing. The conversations and actions taken by 
providers and patients as a result of the intervention materials will be determined by the 
provider and patient. Our materials may result in increases in PC visits at these clinics and 
potentially referrals to pharmacy for assistance with deprescribing. The delivery system is 
aware and onboard with this potential uptick in services because it is a KPWA goal to 
reduce use of these medications by elderly enrollees. We set our max cap of mailings each 
month to a number that is consistent with delivery system capacity (per conversations and 
approval of delivery system leaders).   

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i. Study Records in EHR 
Guidance: If study records will be placed in EHR, this information must be included in the consent 
form.  
Will you place a copy of study information (e.g., study participation, study-initiated test results, 
messages to physicians, genetic test results, incidental findings) in the subject’s medical record? 
  YES 
  NO 
If YES, describe here what information will be put in the subject’s medical record. 
j. Return of Results/Lab Tests to Subjects or Providers  
Guidance: Sharing results with subjects and/or providers must be described in the consent form. 
Will study results, or individual subject results, such as results of standard or research lab tests (and 
genetic tests) be shared with subjects or their providers? 
  YES 
  NO 
If YES, please describe briefly. 
k. Patient Initiated Withdrawal 
Describe procedures that will be followed when subjects withdraw from the research, including 
withdrawal from intervention but continued data collection. 
Phase II (Focus Group): Because participation in Phase II involves attending a 1-time focus 
group, the only option for withdrawing from the study is to leave in the middle of the focus 
group. Participants are allowed to do this if they choose.  We will still use any data we have 
collected in the focus group up to the time they choose to leave.
Phase III (Trial): 
Opt-Out Protocol (July 2020-October 2020) 
If a participant in Phase III withdraws form the study, we will remove his/her study ID 
from future data pulls but will keep data previously obtained. This means that although 
they received the initial brochure, we will not mail future patient brochures (or 
accompanying EBPOs to their providers) to patients who opt out/withdraw from the 
study. 
Waiver of Consent/HIPAA Authorization Protocol (December 2020-)
Participants will not be able to withdraw from the study. We have included clarifying language in 
the notification of study letter that they may receive multiple informational brochures and 
postcards and that they do not have to act on the materials. We have requested a waiver of 
consent and HIPAA authorization for the collection of the EMR from which participants cannot 
opt out of.  
l. Investigator Initiated Withdrawal 
Describe any anticipated circumstances under which subjects could be withdrawn from the research 
without their consent.   

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Not applicable for this study.
m. Orderly Termination 
Describe any procedures for orderly termination of the study, if applicable. 
Not applicable
7.2 Other Research Procedures 
Guidance: Activities checked in this section should be included in the consent form.
Check all that apply:   
a. Surveys, questionnaires, interviews, focus group 
Check if this project includes, surveys, interviews, focus groups.  
How will surveys/questionnaires/interviews be done?  (CHECK ALL THAT APPLY) 
By mail 
 
By mail with telephone follow-up 
By telephone 
By email 
 
By internet  
In-person 
Other (Please describe):   
b. Videotaping, audio recording, photography, or court reporter 
Videotaping, audio taping, using a court reporter, or photographing study participants:  
IF CHECKED, explain what type of recordings you will make, how long you will keep them, how they 
will be stored, and if anyone other than the members of the research team will be able to see or 
hear them. 
We will audio-record the in-person patient focus groups. These audio-recordings will be 
stored on the KPWHRI G-drive folder for media storage that is dedicated only to STOP-
FALLS Study Team members with a need to access these files for research purposes only.   
c. Technology/Devices 
 Using technological software/devices (e.g., websites, software applications, smart phones, 
laptop computers, tablets, Fitbits, iPads, etc.)  
IF CHECKED, complete Supplement B.
d. Specimens
 Specimen collection, storage or use  
IF CHECKED, complete Supplement D.
CHECK ALL THAT APPLY 
 Existing (i.e. previously collected) specimens, such as stored blood, pathology slides, etc.  
 Blood draw or collection of other biological specimens (saliva, colon tissue, pap smears, etc.) 
 Establishing a specimen repository. If CHECKED, consult with the IRB Staff. 
e. Genetic Testing 
 Genetic testing or collection of genetic information including DNA or any sequence of base pairs 
(i.e., SNPs, RNA, chips, arrays, microsatellites, STRs, etc.) 
IF CHECKED, describe this below and complete Supplement D.

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f. Family Medical History/Pedigree 
Guidance: If the study includes family medical history/pedigree be sure to include family member in 
responses to 3.1 and 3.2 of this form. 
Family medical history information obtained from study participants  
IF CHECKED, complete Supplement C.
g. Observation 
Data collection via observation of subjects. Briefly describe:  
h. Other 
 Other data collection from or about subjects, not already described above. Briefly describe: 
7.3 Data Collection from EHR and/or Other Records 
a. Data Collection for EHR and/or Other Records 
Does the study include the collection of information from medical records and/or any other records 
for ongoing study activities and/or outcomes? 
  YES 
  NO 
If YES, continue.  If NO, skip to 7.4
b. Direct Identifiers & CHSID 
Check all of the direct identifiers that will be collected or included in the analytic data files, the study 
linking file, or other study records at KPWA.  
Names 
Dates 
Postal address 
Geocode 
Phone numbers 
Fax numbers 
Email address 
Social Security Numbers 
Medical record numbers 
Health plan numbers 
Account numbers 
License/Certificate numbers
Vehicle ID numbers 
Device identifiers/Serial 
numbers 
Web URLs 
IP address numbers 
Biometric identifiers (e.g., 
finger prints, voice prints, retina 
scans) 
Facial Photos/Images 
Any other unique identifier(s) 
specify: Auditory recordings of 
focus groups 
None  
Will this study use CHSID as a linking file? 
  YES 
  NO  
If NO, explain. 

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c. Data Sources 
Check boxes below for each data source that will be used for this study.  
 KPWA medical records and administrative/warehouse data 
KPWA other data collection activities, (e.g., chart abstraction or validation, 
 retrieving scans, etc.)  
 Chart abstraction – chart abstraction form is attached 
 Chart abstraction – chart abstraction form will be submitted as a future modification
 Chart validation only – no data collection 
 Films (e.g., x-ray, CT scans, etc.)
 Other (describe): 
Adverse Drug Withdrawal Chart Validation (Safety Monitoring) 
Adverse drug withdrawal events (ADWE) are possible side effects of our intervention if participants 
decide to taper their medications. For the purpose of safety monitoring, we will conduct medical record 
review to determine if any serious ADWE’s occurred in our study population for both the intervention 
and usual care group in participants with prescriptions ford opioids and/or benzodiazepines.  We define 
serious as  ADWE that require an emergency department visit or hospitalization. 
 Data from another institution’s patient medical records (specify institution[s]): 
 Individual medical charts
 Electronic warehouse/administrative data
 Other (explain): 
Data from a previous study
IF CHECKED, specify study title and principal investigator’s name and IRBNet #; explain consent 
provisions; attach the previous consent form. 
Data from the SMART and STRIPE studies will only be used to ensure that participants from those 
studies are excluded from being selected as participants in this study. Data will not be used for any other 
uses or analyses. Information on SMART and STRIPE below.  
Systematic Multi-Domain Alzheimer’s Risk (SMART). PI: Larson. IRBnet# 1220346 
The consent process for SMART is: 
1)
SRP staff will administer oral informed consent on the phone for the following: to ask 
eligibility screening questions, to schedule an in-person baseline visit, and to mail an 
ActiGraph to be worn one week prior to the baseline visit.   

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2)
At the start of the baseline visit, the research specialist will obtain written informed consent 
for measurement visits, HE contacts if applicable, and post-study activities. 
3)
If the participant is randomized to the SMARRT intervention arm, the health coach will mail 
a copy of the intervention addendum ahead of the first coaching contact. The coach will 
obtain written informed consent for intervention activities at the first coaching contact. 
4)
For both SMARRT and HE, if a participant shows possible signs of dementia, we will ask to 
conduct additional testing, as described in the main consent form. 
5)
For both SMARRT and HE, if a participant develops dementia and progresses to a point of 
needing a legally authorized representative (LAR) to assist in their continued participant, the 
LAR will be asked to sign the LAR addendum for the participant to continue.  Study staff will 
seek assent from the participant as well if s/he is able to provide assent.  The LAR will also 
be asked to sign HIPAA authorization for continued medical record use.  The LAR will be 
given a copy of the consent form and HIPAA authorization that their loved one had signed. 
The consent form is included in this package- Consent form at measurement visit-MPE V2  and 
Consent form addendum intervention MPE v2 2019-08-08 
Pain Self Management Training for Opioid Taper (STRIPE). PI: Boudreau. IRBnet# 1295096 
The participant receives a study information sheet prior to recruitment calls. At the time of 
recruitment call the  study research specialist reads a script with all the consent element and then 
obtains oral consent to participate in the study. The second screening script which includes the oral 
consent language and the information sheet is included in this package- STRIPE Round 2 Screening 
Script and STRIPE Info Sheet_20190207 
 Data from non-medical sources (e.g., motor vehicle records, genetic data from dbGAP, 
 school records, etc.):  
IF CHECKED, describe the sources.  
 Other (describe): COMET  
   The Clinical Pharmacist Opioid Management Team or COMET, is a Kaiser Permanente Washington 
Delivery System Pharmacy based initiative to lower opioid dose. 
d. Key Information/Variables 
Guidance: If there are multiple subject populations please provide information and tables for each 
group.  
Use the table(s) below to list the key information/variables collected from medical records and their 
source. If the tables below cannot adequately capture your data please attach a table or chart 
abstraction form of your own. Indicate the date range of interest. Use the second table (below) if 
data will be obtained from institutions other than KP Washington. 

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Opt-Out Protocol (July 2020-October 2020) 
Data from KP Washington or KPWHRI Study 
Source (specify) 
(i.e., from KPWA, 
or an existing or 
previous study, 
etc.) 
Key Information/Description of Variables 
Date Range  
KPWA VDW 
Diagnosis and procedure codes 
6/1/2019 – 6/30/2022 
KPWA VDW 
All healthcare utilization such as primary 
care visits, specialty visits, emergency 
department visits, inpatient stays, nursing 
homes, etc.  
6/1/2019 – 6/30/2022 
KPWA VDW 
Pharmacy dispensing data data on all 
medications (drug name, date of 
dispensing, strength, quantity, days supply, 
provider id, NDC) 
6/1/2019 – 6/30/2022 
KPWA VDW 
Demographics (e.g., age, sex, race) 
6/1/2019 – 6/30/2022 
KPWA Clarity 
Patient reported outcome scores and dates 
questionnaire was administered – pain 
(PEG), anxiety (GAD), depression (PHQ-9), 
insomnia (ISI) 
6/1/2019 – 6/30/2022 
KPWA clinical 
notes in the EMR 
(extracted with 
natural language 
processing) 
Mention of symptoms (yes, no) or scores 
for symptom questionnaires on pain, 
anxiety, depression, and insomnia. Date of 
mention or administration of 
questionnaire.   
6/1/2019 – 6/30/2022 
KPWA EMR 
Date and provider of scheduled PC visits 
6/1/2019 – 6/30/2022 
KPWA EMR 
Referrals to pharmacy (y, n) and date 
6/1/2019 – 6/30/2022 
KPWA VDW 
Provider ID, Specialty, Provider Type, 
primary practice clinic. Data collected so 
that we can determine who the patients’ 
PCP is for faxing the EBPO to the correct 
provider). 
Intervention Launch to 
Intervention End 

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Waiver of Consent/HIPAA Authorization Protocol (December 2020-) 
Data from KP Washington or KPWHRI Study 
Source (specify) 
(i.e., from KPWA, 
or an existing or 
previous study, 
etc.) 
Key Information/Description of Variables 
Date Range  
KPWA VDW 
Diagnosis codes: 
For outcomes including: 

Injury diagnostic codes 

Fall-related diagnostic codes 

Motor vehicle crash (MVC)-related 
diagnostic codes 

Unintentional overdose-related 
diagnostic codes 

Adverse drug withdrawal event 
(ADWE) diagnostic codes 
For chronic conditions associated with 
falls, e.g.: 
arthritis, back pain, knee pain, alcohol use 
disorder, chronic lung disease, congestive 
heart failure, diabetes, heart disease, hip 
fracture, hypertension, obesity, peripheral 
neuropathy, osteoporosis, Parkinson’s 
disease, stroke, urinary incontinence, 
impaired vision, impaired hearing, memory 
problems, non-melanoma cancers, frailty 
For other diagnoses related to medication 
prescription for the following conditions:  
anxiety, depression, insomnia, chronic pain
6/1/2019 – 9/30/2024 

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KPWA VDW 
All healthcare utilization for the outcomes 
(falls, MVC, overdose, ADWEs) such as 
primary care visits, specialty visits, 
emergency department visits, inpatient 
stays, nursing homes.. 
6/1/2019 – 9/30/2024 
KPWA VDW 
Pharmacy dispensing data (drug name, 
date of dispensing, strength, quantity, days 
supply, provider id, NDC) for the following 
intervention target medication classes:  
benzodiazepines, z-drugs, opioids, muscle 
relaxants, antihistamines, tricyclic 
antidepressants.  
In addition, the following medication 
classes are needed to examine whether 
target medications were  substituted with 
equally unsafe medications as a result of 
the intervention: Gabapentinoids, other 
sedative hypnotics, other antidepressants, 
steroids, second generation 
antihistamines, NSAIDs,  topical pain 
medications, and injectable pain 
medications (e.g., cortisone injection) 
6/1/2019 – 9/30/2024 
CESR VDW 
CESR Med Order Table information (e.g. 
instruction for usage, prescription date, 
medication type) 
6/1/2019 – 9/30/2024 
KPWA VDW 
Demographics (e.g., age, sex, gender,  race, 
marital status) 
6/1/2019 – 9/30/2024 
KPWA Clarity 
Patient reported outcome scores and dates 
questionnaire was administered – pain 
(PEG), anxiety (GAD), depression (PHQ-9), 
insomnia (ISI) 
6/1/2019 – 9/30/2024 
KPWA clinical 
notes in the EMR 
(extracted with 
Mention of symptoms (yes, no) or scores 
for symptom questionnaires on pain, 
anxiety, depression, and insomnia. Date of 
6/1/2019 – 9/30/2024 

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natural language 
processing) 
mention or administration of 
questionnaire.   
KPWA EMR 
Date and provider of scheduled primary 
care, physical therapy and mental health 
visits 
6/1/2019 – 9/30/2024 
KPWA EMR 
Referrals to pharmacy (y, n) and date 
Referrals to acupuncture (y,n) and date 
Referrals to COMET (y,n) and date 
Referrals to pain clinic (y,n) and date 
Referrals to massage (y,n) and date 
Referral to mental health (y,n) and date 
Referrals to sleep clinic (y,n) and date 
Referrals to pain clinic (y,n) and date 
6/1/2019 – 9/30/2024 
KPWA VDW 
Provider ID, Specialty, Provider Type, 
primary practice clinic. Data collected so 
that we can determine who the patients’ 
PCP is for Epic Staff Messaging the EBPO to 
the correct provider). 
Intervention Launch to 
Intervention End 
e. Other Data 
Describe any other data collection activities not already mentioned above.  For example, using 
aggregate data to describe the study sample (provide a table for this activity).  
7.4 Subject Time Commitment, Payments, and Costs  
a. Time Commitment 
How much time will be required for subjects to participate in the study? (Include subject’s time for 
all study procedures and data collection activities. Feel free to use your own table. Be sure duration 
of participation is included in the consent form.)  
Phase II (Focus Group) 
By mail:  
 
5 minutes 
By telephone: 
10 minutes 
 
In person:  
2 hours 
By email:   
By internet:   
Other:  
 
Total:  
 
2 hours, 15 minutes 

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Phase III (Trial) 
By mail:  
 
30 
By telephone: 
 
In person:  
By email:   
By internet:   
Other:  
 
Total:  
 
30    
b. Deception/Incomplete Disclosure 
Does this study include deception or incomplete disclosure? 
  YES 
  NO 
If YES, please explain why this is needed and state whether subjects will be debriefed at the end of 
the study. 
c. Subject Costs 
What costs will subjects incur as a result of participating in this study?  Check all that apply and 
describe in the consent form. Participants must be informed of these costs prior to their enrollment 
in the study. 
Subjects will be responsible for their own transportation to the focus groups. Parking will be 
reimbursed.  
Any co-pays, co-insurance, or deductibles for mediations or office visits that occur as a result of the 
educational study materials sent to patients and providers are the responsibility of the patient. This 
is in the information sheet sent to patients with their first educational brochure.  
None 
Transportation 
Meals  
Parking 
Co-pays, co-insurance, deductibles 
Charges for clinical procedures/treatment (specify type of procedure/treatment) 
Other (describe):   
d. Subject Payment(s) 
Will subjects be paid for their participation in the study?  
None 
Direct monetary payment (specify amount and timing of incentives(s)):   $50.00 for Focus 
Group Participation   
Non-monetary payment (specify type, value and timing of incentives)):   
7.5 Sequential Description  

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Provide a detailed (excruciatingly detailed) sequential description of the study activities for a 
typical subject. The information in this section should describe what will happen (including collecting 
data from records) from a research participant’s perspective. Use active voice, “The study team 
mails an invitation to the potential subject. A research specialist calls the subject…etc.” rather than 
passive voice, “The subject will receive a phone call”.  
Be sure to: 
Briefly describe of all study procedures, 
tests, treatments, and collection of data 
from records 
Explain who will collect data  
Indicate where study activities will take 
place 
Describe different subject groups or phases 
separately 
If the study is complex and has multiple 
sites, populations, or phases include a flow 
chart.  
Phase II (Focus Group): 
1)
The KPWHRI study programmer creates a study sample per our inclusion/exclusion criteria listed 
above in Section 3.3 and uploads this sample to our study database. 
2)
The study team mails an invitation letter to the potential focus group participant. 
3)
The study team RS or PM calls the potential participant, explains the study, administers oral 
consent for eligibility, and if potential participant is willing, administers telephone eligibility 
questionnaire. 
4)
If participant is eligible and willing to participate, study team schedules participant for the focus 
group that corresponds to the patient’s medication type (e.g., muscle relaxer, tricyclic 
antidepressant, etc.) 
5)
2 days prior to focus group, study team makes a reminder call about focus group time, location 
(at Central KP on Capitol Hill), and parking 
6)
Day of focus group, study team greets participant and administers Informed Consent 
7)
The study team conducts the focus group (See Focus Group Guide), where the following 
brochures will be discussed:   
 
190916_OpiodsPatientBrochure_FG and Intervention_Submitted 
 
190916_SMRPatientBrochure_FG and Intervention_Submitted 
 
190916_TCAPatientBrochure_FG and Intervention_Submitted 
8)
 The audio recorder is turned on by the study team. A study team member will take notes during 
the focus group, capturing patient suggestions for editing purposes. 
9)
At the end of the focus group, the audio recorder is turned off and the study team hands out 
parking vouchers and $50 incentive. 
10) The study team will analyze the focus group data and make changes to patient brochures as 
necessary.  
11) All changes to brochures will be sent to the IRB as a modification 
Phase II work was completed in 2019
Phase III (Trial): 
Opt-Out Protocol (July 2020-October 2020) 

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1.
In order to ensure that KP providers are not confused by this communication, we will inform 
providers at the 8 Intervention Clinics about this study and materials that they can expect to 
receive through morning huddles and/or brown bag lunches as deemed appropriate by the clinic 
managers. 
2.
The KPWHRI study programmer creates study sample per our inclusion/exclusion criteria listed 
above in Section 3.3 and uploads this sample to our study database. 
a.
Sample created on the date the intervention is rolled-out (2 of the 8 clinics rolled out 
each month) to a particular intervention clinic and the matched usual care clinic  
3.
The study team mails the information sheet, invitation letter, first brochure, and relevant self-
care handout(s) to a subgroup of the Intervention Group from each intervention clinic each 
month. The Control Group receives nothing.  
4.
Corresponding EBPOs sent via secure fax to the patient’s provider.  
5.
One month after sending the patient brochure, the study team mails the postcard mailer 
6.
Repeat process for subsample each month for 12-months.  
a.
Patients (and accompanying materials to their providers) receive only one brochure per 
medication class during the study period 
b.
Patients taking multiple medication classes of interest will receive no more than one 
brochure every 3 months for a max of 4 brochures in 12 months. 
Extract automated data from table 7.3.d (opt out protocol)  from KPWA VDW on Intervention and 
Control Group to assess outcomes at 24 months post roll-out into the intervention clinic and matched 
usual care clinic.  
Waiver of Consent/HIPAA Authorization Protocol (December 2020-)
1.
In order to ensure that KP providers are not confused by this communication, we will inform 
providers at the 8 Intervention Clinics about this study and materials that they can expect to 
receive through morning huddles and/or brown bag lunches as deemed appropriate by the clinic 
managers. 
2.
The KPWHRI study programmer creates study sample per our inclusion/exclusion criteria listed 
above in Section 3.3 and uploads this sample to our study database. 
a.
Sample created on the date the intervention is rolled-out (2 of the 9 clinics rolled out 
each month) to a particular intervention clinic and the matched usual care clinic  
3.
The study team mails the notification of study letter, first brochure, and relevant self-care 
handout(s) to a subgroup of the Intervention Group from each intervention clinic each month. 
The Control Group receives nothing.  
4.
Urls for corresponding EBPOs sent via Epic Staff Messaging to the patient’s provider.  
5.
One month after sending the patient brochure, the study team mails the postcard mailer 
6.
Repeat process for subsample each month for 12-months.  
a.
Patients (and accompanying materials to their providers) receive only one brochure per 
medication class during the study period 
b.
Patients taking multiple medication classes of interest will receive no more than one 
brochure every 3 months for a max of 4 brochures in 12 months. 
Collect deprescribing information.   

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1.
Exploratory work: the KPWHRI study programmer will look in the CESR Med Order Table to 
ascertain availability of deprescribing information for all participants for the medications of 
interest.  
2.
 Chart validation: the KPWHRI study programmer and project manager will conduct chart 
validation on a subset (up to 20%) of study participants to look for concordance between what is 
in the CESR Med Order Table and what is in the chart. 
3.
Refine code to collect deprescribing information based on #1 and #2 and pull data to assess 
outcomes at 24 months post-roll out into the intervention clinic.  
Extract automated data from KPWA VDW on Intervention and Control Group to assess outcomes at 24 
months post roll-out into the intervention clinic and matched usual care clinic.  
Ascertain ADWE for the purpose of safety monitoring. We will conduct medical record review to 
determine if any serious ADWE’s occurred in our study population for both the intervention and usual 
care group in participants with prescriptions ford opioids and/or benzodiazepines.  We define serious as  
ADWE that require an emergency department visit or hospitalization. 
1.
The study programmer will identify potential ADWEs using electronic data sources 
2.
The KPWA chart abstractor will review the medical records to ascertain if a serious ADWE 
occurred. They will enter information regarding the event into a chart abstraction tool in 
REDCap. 
3.
The KPWA chart abstractor will send redacted medical record information about the event to 
Dr. Elizabeth Phelan using the KPWA secure file transfer site. A material and data transfer 
agreement will be in place prior to sending this information  
4.
Dr. Phelan will conduct her own independent review of the potential ADWE and enter the 
information into the chart abstraction tool in REDCap 
5.
At the end of chart redaction, the results of the double chart abstraction will be compared. Any 
discordance in outcomes will be adjudicated by a third party- Dr. Shelly Gray. 
8. Risks & Benefits 
8.1 Benefits 
a. Direct Benefits (For PHASE II Focus Groups): 
Check boxes below for all potential direct benefits to participants. 
None 
Potential improvement in physical health due to the following:  
Clinical intervention, such as counseling, exercise, etc.  
Medical procedure or treatment (not including medications)  
Administration of medication(s)  
Other (please describe briefly):    
a. Direct Benefits (PHASE III Intervention): 

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Check boxes below for all potential direct benefits to participants. 
None 
Potential improvement in physical health due to the following:  
Clinical intervention, such as counseling, exercise, etc.  
Medical procedure or treatment (not including medications)  
Administration of medication(s)  
Other (please describe briefly):     As a result of patients receiving the educational 
brochures and providers receiving the EBPOs, patients may achieve safer medication usage 
thereby reducing their risk of falls and fall-related injuries.
b. Benefits by Population 
If any of the benefits listed in above apply to only certain cases or subgroups within the study, 
please describe here.   
The direct benefits apply only to patients receiving care at primary care clinics randomized 
to be an Intervention Clinic.
b. Indirect benefits 
Check boxes below for all potential indirect benefits. (For PHASE II and PHASE III):
Increase in scientific knowledge for society 
Other (please describe briefly):  
8.2 Risks 
a. Potential risks (PHASE II Focus Group ONLY): 
Check boxes below for all potential study risks 
Discomfort at answering personal questions or psychological distress due to research procedures 
Breach of confidentiality 
Physical adverse effects from the following:  
Blood draw 
Clinical intervention, such as exercise program, in-person counseling 
Medical procedure, such as X-ray, strength measure, screening tests, etc.  
Medication(s) given as part of research 
Other (describe briefly): 
a. Potential risks (PHASE III Intervention): 
Check boxes below for all potential study risks 
Discomfort at answering personal questions or psychological distress due to research procedures 
Breach of confidentiality 
Physical adverse effects from the following:  
Blood draw 
Clinical intervention, such as exercise program, in-person counseling 
Medical procedure, such as X-ray, strength measure, screening tests, etc.  
Medication(s) given as part of research 
Other (describe briefly): 

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b. Unforeseeable Risks 
Which procedures, if any, may have risks to the subjects that are currently unforeseeable? Explain 
  NA 
c. Risks by Population 
If any of the risks listed in above apply to only certain cases or subgroups within the study, please 
describe here.   
  NA 
d. High-Risk Methods or Clinical Procedures 
Does this study involve any high-risk methods or clinical procedures (e.g., investigational drugs, 
devices, or procedures; radiation exposure; or other intervention with patients, etc.)?  
  YES 
  NO 
If YES, Describe the probability, magnitude, duration, and reversibility of the risks. Describe any 
physical, psychological, social, legal, and economic risks and how they will be managed? 
d. Coordination of Care with Provider(s) 
Will the patient undergo any clinical procedures or receive any medications that might require 
coordination of care with the patient’s health care provider(s)? 
  YES 
  NO 
If YES, please briefly describe what steps you will take so the study participant’s health care is not 
negatively affected (e.g., how you will track care to follow-up on a research intervention if needed, 
etc.)  
e. Sensitive Topics 
Please check whether data will be collected on any of the following topics:  
Sensitive aspects of subjects’ behavior, such as drug use, sexual behavior or use of alcohol 
Any information that could put subjects at risk of criminal or civil liability 
Any information that, if disclosed, would likely have negative consequences to the participants 
or damage their financial standing, employability, insurability or reputation 
f. Reporting of Risk of Harm or Abuse 
Indicate whether you are collecting, or are likely to learn incidentally, information about the 
following: 
Child abuse, elder abuse, or spouse abuse 
Risk of harm to self or others (i.e., suicidal ideation, threats to others) 
If you checked either of these items, describe the reporting plan here and, if applicable, in the 
consent form. 
g. Incidental Findings 
Does the study carry a risk of incidental findings? 

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  YES 
  NO 
If YES, describe your plan for evaluating these and determining whether and how subjects or their 
providers will be given this information. 
h. Previously Unknown Condition 
Is it possible that you will discover a previously unknown condition (disease, genetic predisposition, 
etc.) in a subject as a result of study procedures?  
  YES 
  NO 
If YES, explain how you will handle this situation:  
i. Electronic Communication(s) and Data Transmission 
Will the internet, email, or any other electronic communication, be used to communicate with 
participants, OR collect and/or transmit data (other than de-identified datasets) inside or outside of 
KP Washington? (Examples include websites, software applications, smart phones, laptop 
computers, tablets, Fitbits, iPads, etc.) 
  YES 
  NO 
If YES, Complete Supplement B.
If YES, how will you verify the participant’s identity? 
9. Adverse & Unanticipated Events 
9.1. Management of Adverse/Unanticipated Events 
Who will handle any adverse/unanticipated events for this study? 
KPWHRI PI, Benjamin Balderson, PhD, and Project Manager Monica Fujii will handle any 
adverse/unanticipated events.
9.2 Data Safety Monitoring Plan 
Is a data safety monitoring (DSM) plan required by the sponsor or otherwise planned?
  YES 
  NO 
If YES, Describe the provisions for data and safety monitoring (DSM) to ensure safety of research 
participants. Please indicate the following details in your DSM plan:  
• 
adverse event (AE) grading scale 
• 
plan for unanticipated AE reporting 
• 
plan for anticipated AE reporting 
• 
plan for safety review (by whom and what frequency) 
• 
plan for ongoing review of results (if appropriate) 
9.3 Data Safety Monitoring Board 
Is a data and safety monitoring board (DSMB) required by the sponsor or otherwise planned?
  YES 
  NO 

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If YES, provide details of the DSMB.  
9.4 Financial Responsibility for Injury  
Guidance: Please make sure that the study contract and/or KP Washington policies support any 
language regarding physical injuries. If the study is greater than minimal risk, information about who is 
responsible for treatment of physical injuries caused by the study is required in the consent form.   
a. Responsible Party 
Who will be financially responsible for treatment of physical injuries resulting from study 
procedures?  
Study sponsor  
Subject or subject’s insurer 
Not applicable 
Other, explain: 
b. Financial Responsibility and Consent Form  
Does the consent form explain who will be financially responsible for treatment of physical injuries 
resulting from study procedures?   
Not applicable 
 YES continue  
 NO please explain: 
10. Privacy, Confidentiality, Data Storage, & Data Security 
10.1 Subject Privacy During Participation 
Describe the steps that will be taken to protect subject privacy during recruitment, consent and 
study procedures (e.g., will subjects be recruited in a private space, where will you keep written 
study materials, etc.) 
Phase II (Focus Group): Patients will have privacy during our study recruitment and 
screening calls because they will be called at their preferred contact number. Our study staff 
will always ask if this is a good time for learning more about our study and answering 
question to see if he/she is eligible to participate in one of our focus groups. If the participant 
agrees to participate in the focus groups, informed consent will be administered individually 
in a private room adjacent to the focus group meeting room.  
Phase II work was completed in 2019. 
Phase III (Trial):
Opt-Out Protocol (July 2020-October 2020) 
Study recruitment materials accompanied by a Study Information Sheet, will be mailed to 
individuals. Potential participants can choose to open the letter at a time that is appropriate 
for him/her. There are no recruitment or screening calls for this Phase. If a participant 
chooses to opt out of the study by calling our study line, the participant can choose to make 
that call at any time when it feels right for him/her. There is no informed consent for Phase III 
activities, we are asking for a waiver of documentation of consent for these activities.    

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Waiver of Consent/HIPAA Authorization Protocol (December 2020-) 
Study recruitment materials will be mailed to individuals. Potential participants can choose to 
open the letter at a time that is appropriate for them. There are no recruitment or screening 
calls for this Phase There is no informed consent for Phase III activities, we are asking for a 
waiver of documentation of consent for these activities.    
10.2 Data Storage at KPWA 
a. Storage Location 
Where will the data be stored? 
All data will be stored on the KPWHRI secure network folders accessible only to research 
study team members. 
Chart review data for ADWE’s will be stored on KPWA’s REDCap, behind the KPWA 
firewall.  
b. Who Can Access Data? 
Who will have access to the identifiers/linking file? 
Only the KPWHRI study programmer will have access to the linking file. The KPWHRI 
study programmer, Research Specialist, and Project Manager will have access to identifiers 
so that they can recruit patients, mail out study materials, track patients who opt out of the 
study by refusing to allow their data to be accessed for use in this study and review their 
medical record in Epic for ADWE chart review.
c. Identifier/Link Destruction Date 
When (month/year) will the identifiers, and the link to identifiers, be destroyed? 
All identifiers will be destroyed 3 years after the end of the study which is 8/29/2026.
d. Other Security Measures 
Describe any other steps that will be taken to ensure security (e.g., password protection, encryption, 
separation of identifiers from data, certificates of confidentiality, etc. 
Computer files will be password protected with access restricted to staff using this information 
to perform study-related activities.  All analytic data files will be password protected. Data tables 
with any identifiers needed for mailing the patient brochures (i.e., name, address) or recruitment 
into the focus groups (i.e., name and phone number) will be kept separate from all other study 
data tables.   All employees at KPWHRI routinely sign a confidentiality form that covers access 
to all data encountered.
10.3 Data Destruction or Retention  
a. Destruction or Retention of Data  
Describe the plan to destroy/archive or retain data at the end of the study. 
We plan to keep de-identified data indefinitely. All identifiers will be destroyed 3 years after 
the end of the study which is 9/29/2026.

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b. Retention beyond 5 years 
If you propose to keep identifiers beyond a limited data set indefinitely, or for more than 5 years 
past the study end date (typically the end of the funding period for the grant) provide a justification 
for this. 
  NA 
10.4 Future Use(s) of Study Data  
Guidance: If you plan to create a registry, repository or biobank, consult with the IRB.   
Will identifiable or coded data be used for future research after this study is complete?  
   YES  Describe below 
   NO Continue  
11. Disclosure of Identifiable Health Care Information & Data Sharing  
11.1 Disclosure and/or Sharing 
Will anyone not employed by KP Washington have access to, or be given, any of the identifiers listed 
below in Question 11.2 (with or without health information)?  
  YES continue 
  NO skip to section 12 
11.2 Identifiers to be Released 
What identifiers will be released outside of KP Washington? (CHECK ALL THAT APPLY) 
1. Name(s) 
2. Any geographic subdivision smaller than a state (including street address, city, county, 
precinct, ZIP code, and their equivalent geocodes), except for the initial 3 digits of a ZIP code 
3. Any dates (other than year only) directly related to an individual, (for example, birth date, 
admission date, discharge date, date of death, visit date, diagnosis date, etc.) and any ages over 89 
4. Telephone number(s)  
5. Fax number(s)  
6. Email address(es)  
7. Social security number(s)  
8. Medical record number(s)  
9. Health plan beneficiary number(s)  
10. Account number(s)  
11. Certificate/license number(s)  
12. Vehicle identifiers and serial numbers, including license plate numbers 
13. Device identifier(s) and serial number(s)  
14. Web universal resource locators (URLs)  
15. Internet protocol (IP) address number(s)  
16. Biometric identifier(s), such as, finger or voice prints, body geometry, iris or retina scans 
17. Full face photographic image(s) and any comparable image(s)  

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18. DNA or any identified sequence of chemical base pairs 
19. Geocode 
20. Any other unique identifying number, characteristic, or code (not including a study number 
assigned for this project as long as the study number is not a combination of identifiable numbers 
that could be decoded by the recipient) 
11.3 External Organizations/Individuals 
List which person(s) and/or organization(s) will have access to, or be given, these identifiers and 
what health information they will have along with the identifiers. List each person and/or 
organization separately. (NOTE: If you plan to share fully identifiable PHI outside of KPWA, you must 
talk with the IRB first.) 
11.4 Data Transfer 
Describe how this information will be transferred securely (for example, Secure File transfer). 
11.5 Storage at External Site(s) 
Describe how this information will be stored at the other sites and how the site will protect the 
confidentiality of shared data. 
11.6 Consent for Sharing Identifiable Data 
Are you obtaining written signed consent for the release and/or sharing of data described above? 
  YES continue  
  NO Explain. If you are requesting a waiver of informed consent complete Supplement A. Note 
that this project may require disclosure tracking. 
12. Sharing of De-Identified or Aggregate Data 
12.1 Sharing De-Identified or Aggregate Data 
Will anyone not employed by KP Washington have access to or be given de-identified or aggregate 
data?  
  YES continue 
  NO skip to section 13 
12.2 External Organizations/Individuals  
List which person(s) and/or organization(s) will have access to, or be given, de-identified or 
aggregate data. List each person and/or organization separately.   
University of Washington: 
Shelly Gray, PharmD 
Elizabeth Phelan, Md, MPH 
12.3 Data Transfer 

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Describe how this information will be transferred and stored securely (for example, Secure File 
transfer).
We will transfer de-identified analytic dataset to our two UW investigators using our 
KPWHRI Secure File Transfer Site.
12.4 Storage at External Site(s) 
Describe how this information will be stored at the other sites and how the site will protect the 
confidentiality of shared data. 
This de-identified analytic dataset will be stored in a password protected UW file only 
accessible by the Principal Investigators, Shelly Gray, PharmD and Elizabeth Phelan, MD, 
MPH.
13. Required Data Sharing & Data Contributions to Repositories 
13.1 Required Data Sharing 
a. Funder Required Sharing   
Is data sharing required by your funding agency? 
  YES 
  NO 
b. Contribution to a Repository 
Guidance: If you are contributing data to a required repository consult with IRB staff.
Will data from this study be contributed to a repository?  
  YES continue 
  NO skip to section 14 
13.2 Data Sharing Plans 
a. Overview of Data Sharing Plan 
If data sharing is required by your funding agency, or if you plan to establish or contribute 
information to a repository, please describe plans for sharing final research data for use by other 
researchers.  
b. Confidentiality 
Describe the steps that will be taken to ensure the confidentiality of subjects and security of their 
data (e.g., password protection, encryption, separation of identifiers from data, certificates of 
confidentiality, etc) 
c. Storage 
Where will the data be stored and for how long? 
d. Access to Data 
Who will have access to the data and how? 

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e. Data Release Procedures 
Describe the procedures to release data to other researchers, including: the process to request a 
release, approvals required for release, who can obtain data, and the data to be provided. 
14. Involved Organizations, Investigators, & IRBs 
Guidance: If this application includes multiple study phases or subprojects, please answer the following 
questions separately for each phase or subproject. Note: Sometimes arrangements are possible when 
multiple IRBs are reviewing the same study. Contact the Human Subjects Office if this seems relevant to 
your study. 
14.1 External Institutions, PIs, and Activities 
List all institutions involved in this study and the PI at the site, provide a brief description of activities 
occurring at each site, and identify which IRB will be reviewing for each site if required. Complete the 
table below.   
List all Institutions 
Involved 
PI at Institution
Briefly describe activities 
conducted at the site or by 
site personnel (e.g., study 
design, recruitment, data 
collection, consultation, etc.) 
List the IRB reviewing for 
the institution or N/A to 
confirm that the site PI 
has determined that no 
IRB review is needed at 
that site.  
KPWHRI 
Benjamin 
Balderson 
Responsible for overall study 
conduct at KPWA. Participate 
in study design, recruitment, 
data collection, intervention 
implementation, , data 
analysis and interpretation of 
results, manuscript drafting, 
and 
presentation/dissemination 
of results 
KPWA IRB 
University of 
Washington 
Shelly Gray and 
Elizabeth Phelan 
Study design, design 
intervention materials, 
participate in data analysis 
and interpretation of results, 
manuscript drafting, and 
presentation/dissemination 
of results 
KPWA IRB 

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14.2 KPWA Collaborators 
List any KP Washington staff persons (outside of KPWHRI) who are collaborating on this project (i.e., 
KP Washington clinic staff, pharmacy staff, laboratory staff, etc.) 
Drs. Kim Painter, Andrea Chun, Angela Sparks, Sharon Burks, Janet Kim, and Paul Brock 
were involved in helping with study design, materials development, and assisting with clinic 
selection and intervention feasibility. While these collaborators have been instrumental in 
helping to ensure this intervention is possible within KPWA, they will not have access to 
study data or know which patients are participating in this study.
14.3 Other Consultants or Institutions 
List any other consultants and/or institutions involved in this study not mentioned above.
 NA  
15. Training in the Protection of Human Subjects  
Guidance: All KP Washington research staff are required to complete training on the protection of 
human subjects EVERY 3 YEARS. This training may be completed on the web through the CITI training 
site at www.citiprogram.org by signing in under KP Washington. Instructions for linking your CITI training 
certificate to your IRBNet profile are available in IRBNet at irbnet.org.  
15.1 KPWA PIs, COIs, and PMs 
Guidance: All KP Washington investigators, co-investigators, and project managers must: 
1) Be listed in the Study Team form wizard in IRBNet and  
2) Have their human subjects training records and CVs available in IRBNet via the linking process from 
IRBNet to CITI  
15.2 Non-KPWA PIs, COIs 
Guidance: All non-KP Washington investigators and co-investigators, who are relying on KP 
Washington for IRB review, must: 
1) Be listed in the Study Team form wizard in IRBNet and  
2) Have their human subjects training records and CVs available in IRBNet. These may be linked to CITI 
training or an uploaded certificate.  
15.3 Other KPWA Study Staff 
 Check this box to confirm that all other study staff (at KPWA-or at other sites if relying on KPWA 
for IRB review) who have access to identifiable data, or who interact with participants (e.g., 
programmers, research specialists, survey interviewers, interventionists, etc.) have up-to-date 
human subjects training records.   

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Attachments   
Mark the following attachments below: 
A = attached (in this application or in IRBNet) 
F = will follow later 
N/A = not applicable. 
Recruitment materials 
   NA   Recruitment flow chart  
 NA     Flyers/Brochures/Advertisements  
 A     Letter to physician(s) concerning patient contact  
 A     Postcard/email/Letter of invitation to subjects 
   A   Recruitment script(s) 
      Other 
Consent/HIPAA Authorization materials 
  A    Written consent form(s)  
 A     Oral consent script(s) 
   A   Consent script for assessing study eligibility 
 A     HIPAA authorization form for use and release of health information 
   A   Study Information Sheet 
 NA     Certification from the source of the electronic signature that the software is compliant 
with Washington state laws 
Data collection instruments 
 A     Questionnaire or survey questions 
  NA    In-person interview questions 
 A     Focus group guide 
 A     Medical record abstraction form 
  A    Intervention materials 
      Other 
Email Communication 
   A  Scripts (sent via Outlook, Epic secure messaging, etc.) 
Other materials 
 A     KP Core Data Form Wizard 
 A     KP Study Team Form Wizard 
  A    Summary Table of IRBNet Files for One Funding Source (if relevant) 
  NA    Letters of Support from KP Washington sponsor or collaborator (if available) 
  NA    Emails from KP Washington’s Privacy, Security, and Legal offices with their comments on 
the use of electronic devices proposed in this application.   

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  NA    Email exchange with Tech Risk Review (including the form you completed, their questions, 
answers, determinations and any comments on the use of electronic systems or devices proposed 
in this application) (if relevant)  
   A   Complete grant application/funding proposal (required) 
  NA    Study protocols (e.g., suicide risk protocol, high blood pressure protocol, study intervention 
protocols, etc.) 
  NA    Complete clinical protocol, case report form, and Investigator’s Brochure. This is required 
if study is FDA regulated.  
 NA     IND/IDE Letter/Email from the FDA stating that the study is exempt from IND/IDE 
regulations 
 A     Investigator CV and training linked in IRBNet. *If KP Washington is the IRB of record for 
other sites, please also make sure the CV and human subjects training for each lead investigator 
at those sites is linked in IRBNet. 
  A    Summary Table of IRBNet Files for One Funding Source (if relevant)
 NA     Prior approvals.  Provide any documentation from prior approvals for this research  
(e.g., school, external site, laboratory, radiation safety, biosafety approval, etc.)  
Other (describe or list):