Shared Decision Making in Rural Primary Care Lung Cancer Screening and Smoking Cessation
Phase: NA
Conditions: Lung Cancer, Smoking Cessation
Sponsor: University of Colorado, Denver

Pragmatic Implementation Science Approaches to Assess and Enhance Value of 
Cancer Prevention and Control in Rural Primary Care 
 
 
NCT04897568 
 
January 24, 2022 

PI:   Glasgow, Russell
Protocol #:   19-1706 
Version Date:  1/24/2022  
1 
 
Amendment Version 01.24.2022 
P50 Pragmatic Implementation Science Approaches to Assess and Enhance Value of Cancer Prevention 
and Control in Rural Primary Care
Protocol Number: 
National Clinical Trial 
(NCT) Number: 
 
 
19-1706 
 
 
NCT04897568 
Principal Investigator:
 
 
Russell Glasgow 
13199 E. Montview Blvd., Ste 300 
Aurora, CO 80045  
Coordinating Center 
and Lead Principal 
Investigator:  
Funded by:  
The National Cancer Institute 
PROTOCOL AMENDMENT HISTORY 
Version
Date
Description of Change 
Brief Rationale  
07.09.2019 
11.25.2019 
Original Phase 1 only 
For JIT submission, one day turn 
around. 
03.09.2020 
03.09.2020 
All years 1 & 2 activities added Needed to add years 1 & 2 
additional activities to original 
submission.  
02.0210.2021 02.0210.2021 Alzheimer’s disease and 
related diseases (ADRD) and 
Care Partners supplemental 
grant activities added 
 
Please see page 38-40 for more 
details.Small details added to 
Project 1, Phase 2 protocol. 
Dates adjusted to reflect 
delayed start due to COVID-19. 
The purpose of this amendment is to 
include a supplemental project, led 
by Hillary Lum, MD, PhD. To avoid 
confusion, we will refer to and 
highlight the proposed amendments 
as “ADRD Supplement” throughout 
the document where appropriate. 
Please note, the activities listed in 
this supplement are closely related 
to Project #3.Dates needed to be 
adjusted due to COVID-19 delays. 
Details are just process items that 

PI:   Glasgow, Russell
Protocol #:   19-1706 
Version Date:  1/24/2022  
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Version
Date
Description of Change 
Brief Rationale  
This work will now continue 
into year 3. 
have been worked out in the 
meantime.  
03.18.2021 
03.18.2021 
Requested a change of IRB 
protocol from EXEMPT to 
EXPEDITED   
In order to be able to register in 
clinicaltrials.gov our IRB protocol 
cannot be EXEMPT. 
04.28.2021 
04.28.2021 
Added screening phase to the 
pilot trial 
 
Change of eligibility criteria 
In order to invite patients to 
participate, we need to screen for 
eligible patients. 
 
Based on the new USPSTF 
recommendation, we are adjusting 
eligibility criteria to follow their 
new recommendation for LCS  
05.27.2021 
05.27.2021 
Revised screening variables 
 
Revised recruitment details 
Added all collected screening 
variables 
Specified planned minimum and 
maximum of recruited patients per 
practice  
10.08.2021 
10.08.2021 
New flyer 
Revised recruitment materials 
Revised eligibility 
Specific to the ADRD Supplement 
10.08.2021 
10.08.2021 
Social Determinants of Health 
(SDOH) supplemental grant 
activities added.  
The purpose of this amendment is to 
include a supplemental project, led 
by Andrea Nederveld, MD, MPH. 
To avoid confusion, we will refer to 
and highlight the proposed 
amendments as “SDOH 
Supplement” throughout the 
document where appropriate. 
NCT04897568

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Version Date:  1/24/2022  
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Version
Date
Description of Change 
Brief Rationale  
10.08.2021 
10.08.2021 
Project 1 change from stepped 
wedge trial design to pre-post. 
Slow uptake in recruitment due to 
Covid and limited eligible patients 
for trial. 
11.10.2021 
11.10.2021 
Adding “fax” to recruitment 
methods 
If preferred clinics will fax 
participant lists instead of saving via 
Egnyte as planned originally 
01.24.2022 
01.17.2022 
Revised eligibility 
Specific to ADRD Supplement 
 
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TABLE OF CONTENTS 
STATEMENT OF COMPLIANCE............................................................................................................................. 6
PARTICIPATING SITES............................................................................................................................................ 7
1 
PROTOCOL SUMMARY ............................................................................................................................... 7
1.1 
SYnopsis .............................................................................................................................................. 7
1.3  
STUDY schema ................................................................................................................................ 12
2 
INTRODUCTION..........................................................................................................................................14
2.1 
STUDY RATIONALE ........................................................................................................................ 14
2.2 
BACKGROUND ................................................................................................................................. 14
2.3
rISK/BENEFIT ASSESSMENT.......................................................................................................15
2.3.1
Known Potential Risks ......................................................................................15
2.3.2
Known Potential Benefits..................................................................................16
2.3.3
assessment of potential risks and benefits ....................................................16
3 
OBJECTIVES AND ENDPOINTS .............................................................................................................. 16
4 
STUDY DESIGN ........................................................................................................................................... 17
4.1 
OVERALL Design ............................................................................................................................ 17
4.2 
SCIENTIFIC RATIONALE FOR STUDY DESIGN ....................................................................... 18
4.3 
end of study definition ................................................................................................................... 18
5 
STUDY POPULATION ................................................................................................................................ 18
5.1 
Inclusion Criteria ............................................................................................................................. 18
5.2 
Exclusion Criteria ............................................................................................................................ 19
5.3 
lIFESTYLE CONSIDERATIONS ..................................................................................................... 19
5.4 
SCREEN FAILURES ........................................................................................................................ 19
5.5 
STRATEGIES FOR RECRUITMENT AND RETENTION ........................................................... 20
6 
STUDY INTERVENTION ............................................................................................................................ 21
6.1 
Study INTERVENTION(S) ADMINISTRATION ........................................................................... 21
Audit and feedback: Sites, clinics, and individual clinicians will receive audits and feedback on their LCS 
services, including SDM and smoking cessation efforts. Information on use of the PtDA, delivery of smoking 
cessation advice and counseling/referral (most likely to be to the state Quit line) will come from either EHR or 
chart review of eligible patients as appropriate to each setting. Reports will be produced and disseminated 
monthly during the intervention phases.6.1.1
STUDY INTERVENTION DESCRIPTION 
22 
6.2 
study intervention compliance .................................................................................................... 23
7 
STUDY INTERVENTION DISCONTINUATION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL .................................................................................................................... 23
7.1 
discontinuation of study intervention (Study stopping rules) ............................................. 23
7.2 
PARTICIPANT DISCONTINUATION/WITHDRAWAL FROM STUDY ..................................... 24
7.3 
lost to follow-up ............................................................................................................................... 24
8 
STUDY PROCEDURES .............................................................................................................................. 24
8.1 
study procedures/evaluations ..................................................................................................... 24
8.2 
Study schedule ................................................................................................................................ 25
8.2.3 
INtervention visits .............................................................................................. 25
8.2.4 
Follow-up visIts .................................................................................................. 25
8.2.5 
Early Termination Visit ...................................................................................... 26
8.2.6 
Schedule of Events Table ................................................................................. 26
8.3.1 
Definition of Adverse Events (AE).................................................................... 27
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8.3.2 
Definition of Serious Adverse Events (SAE) ................................................... 27
8.3.3 
CLASSIFICATION OF AN ADVERSE EVENT ................................................... 27
8.3.3.1
severity of event................................................................................................. 27
8.3.3.2
Relationship to Study INTERVENTION ............................................................27
8.3.3.3 
Expectedness ..................................................................................................... 28
8.3.4 
time period and frequency for event assessment and follow-up ................. 29
8.3.5 
Adverse Event Reporting ................................................................................. 29
8.3.6 
serious adverse event reporting ..................................................................... 29
8.3.7  
events of special interest ..................................................................................30
8.3.8  
reporting of pregnancy......................................................................................30
8.4 
UNANTICIPATED PROBLEMS......................................................................................................30
8.4.1
Definition of Unanticipated Problems (UAP)...................................................30
8.4.2
REPORTING of Unanticipated Problems.........................................................30
9
statistical considerations .............................................................................................................................31
9.1 
Statistical Hypotheses ...................................................................................................................31
9.2  
sample size determination ............................................................................................................ 33
9.3  
population for analyses ................................................................................................................. 33
9.4  
STATISTICAL ANALYSES ............................................................................................................. 34
9.4.1 
General Approach ............................................................................................. 34
9.4.2 
Analysis of the Primary Efficacy Endpoint(s) ................................................ 34
9.4.3 
Analysis of the Secondary Endpoint(s) .......................................................... 35
9.4.4 
Safety Analyses................................................................................................. 35
9.4.5 
Baseline Descriptive Statistics ....................................................................... 35
9.4.6 
Planned Interim Analyses ................................................................................ 35
9.4.8 
Tabulation of Individual PARTICIPANT Data ................................................. 35
9.4.9 
Exploratory Analyses ....................................................................................... 35
9.5 
Enrollment/randomization/masking procedures ..................................................................... 35
10
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS .............................. 36
10.1  
regulatory, ethical, and study oversight considerations ...................................................... 36
10.1.1 
informed consent process ............................................................................... 36
10.1.1.1
Consent/assent and Other Informational Documents Provided to 
Participants 
36
10.1.1.2
Consent Procedures and Documentation ......................................................36
10.1.2  
STUDY DISCONTINUATION AND CLOSURE ................................................... 37
10.1.3 
confidentiality and privacy................................................................................37
10.1.4 
future Use of Stored Specimens or Data ........................................................ 38
10.1.5 
key roles and governance ................................................................................ 38
10.1.6 
safety oversight................................................................................................. 38
10.1.7 
clinical monitoring ............................................................................................ 39
10.1.8 
quality assurance and quality control ............................................................ 39
10.1.9 
data handling and record keeping .................................................................. 40
10.1.9.1
data collection and management responsibilities......................................... 40
10.1.9.2
study records retention .................................................................................... 40
10.1.10
protocol deviations ............................................................................................ 40
10.1.11
publication and data sharing policy................................................................. 41
10.1.12
conflict of interest policy ................................................................................. 41
11
 references ..................................................................................................................................................... 41
NCT04897568

PI:   Glasgow, Russell
Protocol #:   19-1706 
Version Date:  1/24/2022  
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STATEMENT OF COMPLIANCE 
This is an investigator-initiated study.  The principal investigator (PI), Russell Glasgow, is 
conducting the study and acting as the sponsor.  As the sponsor-investigator, both the legal/ethical 
obligations of a PI and those of a sponsor will be followed. 
 
The trial will be carried out in accordance with Good Clinical Practice (GCP) as required by 
applicable United States (US) laws and applications, including but not limited to United States 
(US) Code of Federal Regulations (CFR) applicable to clinical studies (45 CFR Part 46). 
 
 
The PI will assure that no changes to the protocol will take place without documented approval 
from the Institutional Review Board (IRB). All personnel involved in the conduct of this study 
have completed Human Subjects Protection Training.  
 
I agree to ensure that all staff members involved in the conduct of this study are informed about 
their obligations in meeting the above commitments.  
Sponsor-Principal Investigator:  Russell Glasgow 
Print/Type Name  
Signature:
Date:    
 
  
NOTE FOR REVIEWERS: 
Being a Center, our program of research involves multiple smaller studies which fall into 
differing review categories. This submission is all encompassing for Years’ 1 & 2 & now year 3 
Center activities that involve human subjects. We have delineated each activity below and noted 
throughout as to which activity is being presented. Some activities do not share certain 
components (i.e. one activity does not involve an intervention and therefore is not represented in 
the intervention information section).  
 
NCT04897568

PI:   Glasgow, Russell
Protocol #:   19-1706 
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PARTICIPATING SITES
Rural primary care practices associated with our SNOCAP practice based research network. 
Specific practices not yet identified.  
1
PROTOCOL SUMMARY 
1.1 
SYNOPSIS  
Protocol Title:
Pragmatic Implementation Science Approaches to Assess and 
Enhance Value of Cancer Prevention and Control in Rural Primary 
Care
Initial center projects recalled by the numbers below:
Project #1. Shared decision making in rural primary care lung cancer screening and smoking 
cessation  
 
Expedited: Category 62 
Project #2. Cost collection template in order to objectively capture cost in implementation activities 
of project #1 
 
Exempt: Category 2 
Project #3. Qualitative assessment of value and benefits of shared decision making for lung cancer 
screening and smoking cessation in rural primary care as defined by the RE-AIM 
framework, across multiple stakeholder groups. 
 
Exempt: Category 2 
Project #4 ADRD Supplement: Stakeholder experiences of shared decision making for cancer 
screening and prevention activities in rural primary care: Impact of Cognitive Impairment 
Project # 5 SDOH Supplement:  Colorado ISC3 Environmental Scan for Health Equity - 
Administrative Supplement
Objectives:
 Primary Objective:
1. We will use qualitative and quantitative methods to assess 
the availability and existing infrastructure related to lung 
cancer screening (LCS) in rural areas. Using this 
information, we will develop a patient decision aid (PtDA) 
for lung cancer screening (LCS) and implement in Colorado 
rural primary care (State Networks of Ambulatory Practices 
and Partners, SNOCAP) after rapid-cycle design 
prototyping. In later years, results will be replicated in a 
national primary care network, National Research Network.
2. We will refine our published cost capture template to 
categorize costs associated with the various RE-AIM 
outcomes and pilot test the revised templates in three local 
primary care practices varying on size, geographic location, 
and history of involvement in PBRN research that are 
delivering LCS and smoking cessation services. 
3. A. Through qualitative interviews and surveys, we will strive 
to understand the perspectives and values rural stakeholders 
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hold about LCS. We will establish the perceived costs and 
benefits of using shared decision making in LCS and LCS 
itself.
3.    B. Develop and pilot a brief survey of preferences related to 
the relative importance of RE-AIM outcomes (e.g., reach, 
implementation, maintenance) to assess benefits of various 
RE-AIM outcomes across stakeholders (patients, providers, 
and staff). Assess relationships between RE-AIM outcome 
preferences and selection of different CPC programs. Use 
rapid human-centered design procedures to develop and 
pilot a graphical value feedback display 
4. A. Identify experiences related to shared decision making for 
cancer prevention and control activities in rural primary care 
settings from the perspective of patients with mild cognitive 
impairment or early dementia, care partners of persons with 
dementia, and primary care stakeholders (health care 
provider or staff member).
4.B. Identify how primary care clinics adapt shared decision 
making or communication approaches to cancer screening 
and smoking cessation to meet the specific needs of patients 
and care partners affected by dementia.
5 A. Conduct an environmental scan of SDOH within site-
specific geographic areas and supplement the cross-ISC3 
standard data extraction. 
5 B. Survey clinician-patient dyads during wellness-focused 
visits to evaluate the influence of SDOH on cancer 
prevention and screening decision processes among primary 
care clinicians and patients. 
Endpoint: 
 Primary Endpoint: 
1. Determine the best processes for implementation and the 
feasibility of a future trial of implementation of a PtDA for 
LCS program in a national, rural practice based research 
network-based study. 
2. Evaluate and compare the feasibility and results of applying 
the cost templates via interview, observation, and staff 
tracking methods.
3. Compare and contrast perspectives of stakeholder groups 
related to values, perspectives, costs and benefits around 1) 
LCS, shared decision making and smoking cessation, and 2) 
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different decision aids for shared decision making for LCS. 
Findings will be replicated across national rural primary care 
practices and data will be analyzed in the same way in years 
3-5 of Center programming.  
4. Evaluate SDOH needs across the 7 ISC3 network sites.  
5. See endpoint 3. 
 
 Secondary Endpoints: 
1. Improved LCS practice in rural primary care with the use of 
a formal PtDA that we provide.  
2. After rapid modification as needed, we will compare the 
perspectives of providers, staff and patients on the cost of 
delivering smoking cessation and lung cancer screening 
activities in up to 10 different SNOCAP practices. 
3. Standardized assessment approaches and interview guides 
that can be shared with other research groups 
 
Population: 
Population information below encompasses all Center 
activities over years 1 & 2 & part of 3: 
 Sample size 
o Maximum number of participants that can be enrolled in 
all projects within our program is 500 (allow for screen 
failures and drop out)  
o Minimum number of participants to be enrolled 100 
(number of participants needed to answer scientific 
question/aims) 
 Gender Male and Female 
 Age Range 18-100 (generally for UCCC studies this will be 18-
100) 
Demographic group  
English or Spanish speaking;  
Patients: eligible for lung CA screening – Age 50-80, 
English or Spanish speaking, asymptomatic, tobacco 
smoking history of 20+ pack-years; current smoker or quit 
within 15 years, . 
Clinicians: Physicians and advanced practice providers; 
Staff: Nurses, administrators, medical assistants, social 
workers, and other clinic personnel;  
Leaders of rural clinics, hospitals, and radiology sites serving 
patients from the rural clinics.  
 Family and/or caregivers: People living with or caring for 
patients as detailed above. General health status asymptomatic; 
tobacco smoking history of 20+ pack-years; current smoker or 
quit within last 15 years
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 Geographic location 30-40 rural clinics and approximately 10 
urban clinics from our State Networks of Colorado Ambulatory 
Practices & Partners (SNOCAP) practice-based research 
network (PBRN) 
ADRD Supplement:  
As above, with slight modifications:  
 Patients: Age 55+; Diagnosis of mild cognitive impairment 
or dementia in the medical record [e.g. Alzheimer’s disease, 
vascular dementia, dementia, dementia associated with 
Parkinson disease, dementia not otherwise specified (NOS), 
etc.; Seen in one of the clinic practices in the past year 
 Family and/or care partners: Care partner of a patient with 
ADRD who has ability to provide informed consent; or, care 
partner of a person with dementia who lacks decision 
making capacity to provide informed consent to participate 
in the study 
Clinicians: Physicians and advanced practice providers; 
Staff: Nurses, administrators, medical assistants, social 
workers, and other clinic personnel;  
 
Geographic location: 2-4 rural clinics from SNOCAP (same as 
above) and 2-4 rural clinics from the National Research Network; 
community members responding to study flyer, regardless of 
location  
 
SDOH Supplement: 
As above with slight modifications: 
 Patients: Age 45+; Seen in one of the clinic practices in the 
supplemental funding period. 
 Clinicians: Physicians and advanced practice providers; 
 
Geographic location: 4-6 rural clinics from SNOCAP (same as 
above) 
  
 
 
Phase:
Various across projects as listed.
Participating Sites: 
To be defined: State Networks of Ambulatory Practices and Partners 
& National Research Network 
Description of Study 
Intervention: 
The intervention is within Projects #1 & 2 only. Project #3, #4 & #5 do
not have an intervention component. 
Aim1b.
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Our implementation package includes three interrelated interventions 
being implemented simultaneously. We aim to improve adherence to the 
LCS guidelines and CMS coverage criteria to conduct SDM and provide 
smoking cessation services in rural primary care practices. 
Lung CA Screening Guideline: The USPSTF recommends annual LCS 
with low-dose CT in adults aged 50 to 80 (CMS coverage up to 77) 
years who have a 20 pack-year smoking history and currently smoke 
or have quit in the past 15 years.  
Lung CA PtDA: CMS mandates use of shared decision making and our 
intervention will help clinicians meet this mandate using our 
adaptation of an effective lung cancer PtDA and strategies tailored to 
sites. 
 
Locally appropriate smoking cessation counseling and/or referral. The 
evidence-based smoking cessation strategies in our implementation 
package will be developed with input from project investigators and 
advisors with many years of combined experience studying tobacco 
cessation. 
Aim2a. 
Implementation of a cost collection tool to better assess cost data with 
respect to SDM in LCS and smoking cessation.  
 
Revise/Adapt cost collection template for 4 stakeholder groups. 
 
Compare observation vs. interview cost collection methods 
 
Project #5 SDOH Supplement: 
Cross-ISC3 Aim 1: to conduct an environmental scan of social 
determinants of health within site-specific geographic areas of all 7 
ISC3 sites.
Brief Approach to Cross-ISC3 Aim 1:  Final measures will be 
selected and collected by the end of the first quarter of the award 
period and will be updated each quarter over the funding period. The 
final quarter of the project will be spent on data cleaning, 
development of the cross-center data repository, and publications, 
presentations, and pilot project planning. 
COISC3 Supplement Aim 1: To supplement the cross-ISC3 standard 
data extraction on SDOH measures with enriched metrics of food 
insecurity, transportation access, and social isolation from the rural 
Western Colorado regions served by the n=4-6 PEACHnet practices 
that are part of our ISC3 Implementation Laboratory. 
COISC3 Supplement Aim 2: Informed by the 5 As framework, we 
will survey clinician-patient dyads in our Colorado COISC3 rural 
primary care clinics during a wellness-focused visit to evaluate the 
influence of SDOH on cancer prevention and screening decision 
processes among: 
• 
Aim 2a: primary care clinicians  
•
Aim 2b: patients
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Brief COISC3 Supplemental Aim 1 Approach: We will access 
additional population-level data for the rural regions served by our 6 
purposively selected PEACHnet clinics in rural Western Colorado.  
Our COISC3 analyst will add these to the database containing the 
other social needs data for these regions that were captured by the 
cross-ISC3 aim.  
Brief COISC3 Supplemental Aim 2 Approach: Using the procedures 
and processes that our Implementation Laboratory have found to be 
feasible, we will survey clinicians and patients in 4-6 rural Colorado 
ISC3 sites. We will work with practices that are geographically 
diverse and have established screening processes for unmet social 
needs. 
 
Study Duration: 
5 year 
Participant Duration:  No more than 3 years (Patients ~2 yrs; Staff ~3 yrs; over all 
activities – any one person should only be involved for a maximum 
of one year.) 
1.3  
STUDY SCHEMA  
Aim 1a & 1b Schema (Project #1)
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Aims 2a-2e Schema (Project #2 & 3 & 4)
 
 
Activity
Description
Refine stakeholder based cost capture procedures   (Aim 2a)
Revise/adapt cost collection 
templates for 4 stakeholder types 
to assess costs by RE-AIM 
dimension 
Cost assessment methods study 
(Aim 2a) 
 
Compare observation vs. interview 
cost data collection methods 
Benefits – Qualitative assessment 
(Aim 2b and Project 4: ADRD supplement) 
 
Interviews and focus groups to 
understand stakeholder 
perspectives on benefit of each of 
RE-AIM outcomes 
Benefits – Quantitative assessments – Phase I (SNOCAP)      (Aim 2b)   
 
a. Qualitative interviews of 
different stakeholders 
perceptions of benefits of 
LCS by RE-AIM dimension 
survey  
b. Pilot test of survey with 
n=4 SNOCAP practices 
Benefits – Quantitative assessments – Phase II (NRN) 
(Aim 2b)
 
National survey of approximately n 
= 80 NRN and SNOCAP practices – 
compare involvement in and 
perceived benefit of providers vs. 
delivery staff vs. patients; 
comparing LCS, colorectal cancer 
screening and smoking cessation 
activities; and across RE-AIM 
dimensions 
Study relationship of benefit priorities to choice of cancer 
interventions.   (Aim 2c) 
ADRD Supplement: As above with condition “as well as relationship 
with dementia severity to choice or adaptation” 
 
Mixed methods study to identify 
relationships between stakeholder 
perspectives on value to selection 
of different RTIPS programs varying 
on RE-AIM outcomes 
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Protocol #:   19-1706 
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ADRD Supplement: As above with 
condition “including impact of level 
of dementia on choice of CPC 
approaches and/or potential 
adaptations” 
Develop Value feedback procedures and displays  
(Aim 2d)
 
Rapid human-centered design 
procedures to develop and pilot 
graphical value feedback methods 
(based on RE-AIM dimensions) to 
aid in CPC decision making 
2  
INTRODUCTION                        
2.1 
STUDY RATIONALE
We developed an administrative and leadership structure that ensures our Developing 
Implementation Science Cancer Control Center (ISC3) integrates our Implementation Studies 
and Methods Units to enhance the inclusion of value from multiple perspectives in 
implementation science models, measures, and methods. This structure also integrates our 
Implementation Laboratory to both advance the study of value in dissemination and 
implementation science (D&I) and enhance our knowledge of cancer prevention and control 
(CPC) implementation in rural settings. This, along with our original submission, covers all 
Center activities. Further amendments will be written to address later phases, but they are 
included in figures below to provide context. 
2.2 
BACKGROUND
Lung cancer is the leading cause of cancer death, with over 155,000 deaths annually in the US. 
In December 2013, the United States Preventive Services Task Force recommended annual 
screening for lung cancer with low-dose computed tomography (LDCT) with a grade B 
recommendation following the positive results of the National Lung Screening Trial. However, 
LDCT is associated with a high rate of false positives and a large number of patients who screen 
positive will receive unnecessary and invasive procedures. As such, the Center for Medicare & 
Medicaid Services (CMS) mandated both shared decision making and smoking cessation 
counseling as part of their coverage criteria for LDCT. 
According to the National Health Interview Survey, of the 6.8 million smokers eligible for 
LDCT screening in 2015, less than 4% received it. This raises two questions: 1) What factors 
contribute to the low LDCT screening rates? and 2) How can we facilitate the implementation of 
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SDM and smoking cessation to improve the perceived value of LCS among patients and 
practices? This pilot project will address these two questions in our Implementation Laboratory 
of rural primary care practices, as well as advance the field by leveraging our initial methods 
projects.  
ADRD Supplement: With the increasing prevalence of dementia of different etiologies, 
especially Alzheimer’s disease, shared decision making related to CPC activities must 
appropriately meet and adapt to the needs of these older adults who already or will eventually 
lack decision making capacity. There is limited guidance available to primary care settings for 
selecting, adapting, and implementing evidence-based CPC programs for individuals with 
ADRD and their care partners, who often serve as surrogate decision makers. The potential 
burden and challenges of unwanted or over-screening for cancer may be quite substantial, 
affecting the individual, family care partners, and healthcare systems. Importantly, under-
screening for individuals with ADRD is also possible in the context of prognostic uncertainty 
related to dementia trajectory and potential clinician or care partner biases that limit shared 
decision making. Evidence-based cancer prevention approaches like smoking cessation 
interventions are critically important given that smoking is a modifiable risk factor for cancers 
and dementia.
SDOH Supplement: A recent statement from the National Academies of Science, Engineering, 
and Medicine calls for health care system activities at both the individual and community level to 
facilitate the integration of social care into health care delivery. A 5 As framework is proposed, 
which includes awareness, assistance, adjustment, alignment and advocacy. At the individual 
patient level, and in a primary care context, the most crucial are awareness, assistance, and 
adjustment. In the rural medical practices in our Colorado ISC3 (COISC) implementation 
laboratory, and in many other states, there are increasing efforts to screen patients for social 
needs such as food, transportation, and social isolation (awareness); connect those with needs to 
resources (assistance). This supplement from the COISC3 will meet this challenge by partnering 
with the six other ISC3 centers to create a set of outer context common data elements (OC-CDE) 
that will be collected for all centers. 
 
2.3 
RISK/BENEFIT ASSESSMENT
2.3.1 KNOWN POTENTIAL RISKS 
We believe this research study presents no more than minimal risk to all participants. We will 
collect basic demographics (age, gender, educational level, health insurance status, employment), 
and other pertinent medical history, as well as health literacy and subjective numeracy. We will 
also have data on practice characteristics to provide qualitative contextual information. These 
data will allow us to report the representativeness of patients who receive this intervention. 
Participants in key informants interviews or focus groups will be audio recorded with their 
consent though no identifying information will be collected. Their participation would not affect 
their employability or adversely impact their health or safety. 
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2.3.2 KNOWN POTENTIAL BENEFITS 
Using a mixed methods design to engage multiple stakeholders (patients, care partners,
providers, staff, LCS related leaders) our initial pilot projects will generate high-quality 
preliminary data to inform our national dissemination study (years 3-5) and advance the field by 
testing pragmatic methods and tools developed by our Methods Unit. Successful implementation 
of PtDA could streamline work flows in rural primary care and provide higher levels of care to 
patients. There will be no immediate benefit to participants.  
 
2.3.3 ASSESSMENT OF POTENTIAL RISKS AND BENEFITS  
We believe this research study presents no more than minimal risk to all participants. The 
pilot test of our qualitative assessment of stakeholder perspectives on costs, benefits and 
preferences across RE-AIM outcomes provides a novel application of mixed methods to 
advance the measurement and understanding of significant contextual and system factors 
that continue to be a challenge in implementation science. 
REQUIRED TEXT:
The risks to participants are reasonable in relation to the anticipated benefits to participants and/or 
society, and in relation to the importance of the knowledge that may reasonably be expected to 
result, thereby falling in favor of performing the study: 
 To Participant: There are no more than minimal risks to all participants. This 
study only intends to collect opinions and considerations from participants. 
 To Society: Engaging multiple stakeholders will generate high quality preliminary 
data to inform our national dissemination study and advance the field by testing 
pragmatic methods and tools developed by our Methods Unit. 
 Justify the importance of the knowledge gained: The pilot test of our qualitative 
assessment of stakeholder preferences across RE-AIM outcomes provides a novel 
application of mixed methods to advance the measurement and understanding of 
significant contextual and system factors related to perceptions of cost, benefit 
and value that continue to be a challenge in implementation science and health 
care in general. 
 
3 
OBJECTIVES AND ENDPOINTS 
OBJECTIVES 
ENDPOINTS
JUSTIFICATION FOR 
ENDPOINTS 
Primary
 
 
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We will use quantitative and 
qualitative methods to assess 
the availability and existing 
infrastructure related to LCS 
in rural areas.
 Establish the availability 
of infrastructure related to 
LCS in rural areas.
Elicit and understand 
values and perspectives 
around LCS, shared 
decision making and 
smoking cessation in 
these rural settings. 
 
Engaging multiple 
stakeholders will generate 
high quality preliminary data 
to inform our national 
dissemination study and 
advance the field by 
developing and testing 
pragmatic methods and tools 
developed by our Methods 
Unit.
4 
STUDY DESIGN  
4.1 
OVERALL DESIGN
Our pilot test of shared decision-making and smoking cessation guidelines for LCS will provide 
a practical test of our initial methods project to refine, develop and validate methods to measure 
both cost and benefit components of value from multiple stakeholder perspectives. First, though, 
in this initial pilot, we will refine the pragmatic implementation and replication cost 
measurement tools our team has already developed, and use these tools in the LCS pilot. A 
necessary first step is understanding what costs and outcomes are important to different 
stakeholders and we will develop and test methods to assess preferences of patients, providers 
and staff across multiple RE-AIM outcomes in the LCS pilot. A cost capture template will be 
piloted and refined during the local implementation of the PtDA. Each project, PtDA for LCS, 
cost capture template and quantitative/qualitative assessment of value and perspective, will 
inform our nation dissemination of the PtDA in years 3-5. This will also inform generalizability 
of the methods and measures developed with respect to other modes of cancer screening. 
Our pilot intervention will engage no more than 216 patients using a pragmatic, pre-post design 
guided by our enhanced RE-AIM/PRISM framework. The primary goal of this intervention is to 
improve LCS practice by offering a formal SDM process and smoking cessation support aligned 
with the CMS coverage criteria. We will conduct a type II effectiveness implementation hybrid 
trial using a pre-post design to evaluate the effectiveness (co-primary outcomes of LCS and 
decision quality) and implementation at four rural clinics. Space precludes discussion of 
pragmatic design features, but we have designed this study to be pragmatic using the PRECIS-2 
criteria and it scores highly on almost all PRECIS-2 dimensions. 
 
 
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4.2 
SCIENTIFIC RATIONALE FOR STUDY DESIGN
Lung cancer is the leading cause of cancer death, with over 155,000 deaths annually in the US. 
In December 2013, the United States Preventive Services Task Force recommended annual 
screening for lung cancer with low-dose computed tomography (LDCT) with a grade B 
recommendation following the positive results of the National Lung Screening Trial. However, 
LDCT is associated with a high rate of false positives and a large number of patients who screen 
positive will receive unnecessary and invasive procedures. As such, the Center for Medicare & 
Medicaid Services (CMS) mandated both shared decision-making and smoking cessation 
counseling as part of their coverage criteria for LDCT.  
According to the National Health Interview Survey, of the 6.8 million smokers eligible for 
LDCT screening in 2015, less than 4% received it. This raises two questions: 1) What factors 
contribute to the low LDCT screening rates? and 2) How can we facilitate the implementation of 
SDM and smoking cessation to improve the perceived value of LCS among patients and 
practices? This pilot project will address these two questions in our Implementation Laboratory 
of rural primary care practices, as well as advance the field by leveraging our initial methods 
projects.   
ADRD Supplement: As above with condition “including impact of level of dementia on choice 
of CPC approaches and/or potential adaptations” 
4.3 
END OF STUDY DEFINITION 
The end of this phase of our Center’s activities is defined by a saturation of major themes 
collected and organized, applied to the design of a successful PtDA and cost capture template. 
Readiness for national dissemination will be the endpoint and compilation of these first 3 
projects in the program. 
5 
STUDY POPULATION 
5.1 
INCLUSION CRITERIA 
REQUIRED TEXT: 
In order to be eligible to participate in this study, an individual must meet all of the following 
criteria 1-4 and at least one of the criteria 5-9: 
1. Provision to sign and date the consent form. 
2. Stated willingness to comply with all study procedures and be available for the duration 
of the study. 
3. All participants: Be a Male or Female aged 18 – 100 (50-80 for patients) 
4. All participants: English or Spanish speaking 
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5. Patient participants: Asymptomatic; tobacco smoking history of 20+ pack-years; current 
smoker or quit within last 15 years  
6. Clinicians: Physicians or advanced practice providers 
7. Staff: Nurses, administrators, medical assistants, social workers, or other clinic personnel.  
8. Leaders of rural clinics, hospitals, or radiology sites serving patients from the rural 
clinics.Care partner participants: patient family member, non-paid companion, or a 
designated health care proxy 
ADRD Supplement:  
All of the above, with the following conditions:  
 Patients: Age 55+; Diagnosis of mild cognitive impairment or dementia in the medical 
record [e.g. Alzheimer’s disease, vascular dementia, dementia, dementia associated with 
Parkinson disease, dementia not otherwise specified (NOS), etc.;  
 Seen in one of the clinic practices in the past year or community member responding to 
study flyer 
 Family and/or care partners: Care partner of a patient with ADRD who has ability to 
provide informed consent; care partner of a person with dementia who lacks decision 
making capacity to provide informed consent to participate in the study 
SDOH Supplement: 
As above with slight modifications: 
 Patients: Age 45+; Seen in one of the participating practices for a wellness focused visit 
during the supplemental funding period. 
 Clinicians: Physicians and advanced practice providers; 
5.2 
EXCLUSION CRITERIA
REQUIRED TEXT: 
An individual who does NOT meet the criteria listed in 5.1 will be excluded from participation in 
this study. 
5.3 
LIFESTYLE CONSIDERATIONS 
N/A 
5.4 
SCREEN FAILURES  
Those who appear to meet inclusion criteria but fail to screen for our Project #1, Phase 1 pilot will 
be excluded then.  
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5.5 
STRATEGIES FOR RECRUITMENT AND RETENTION
Phase 1. Practices within the SNOCAP practice based research network have agreed to partner in 
University of Colorado programs of research by their involvement in the PBRN. 
Practice personnel and patients will be approached in person, via phone, or email to enroll them in 
the program.  
We will conduct key informant interviews until we reach saturation for each group and anticipate 
completing up to 180 interviews (7-8 per group) or until we reach saturation. (Up to 60 interviews 
per project) 
Phase 2. Practice staff and care managers will be asked to assist in recruitment by identifying 
eligible patients under their care that meet the requirements for LCS. This will be done using 
screening for eligibility criteria from their EHR. We will recruit a minimum of 9 patients and 
maximum of 12 patients per practice during each of the four 2-month time blocks for survey 
completion for a total to not exceed 216 patients across 4 practices. Potential participants will be 
informed and consented by network/research staff.
 
Practices will be asked to assist in recruitment by identifying eligible patients through review of 
the EHR, and follow-up with PBRN research staff.
o Option 1: PBRN research staff works with clinic scheduler to strategically identify eligible 
patients who have upcoming appointments. A list of appointment dates of eligible patients is 
provided to PBRN research staff including gender, age, smoking status and smoking history 
(as described in patient eligibility criteria) and contact information. 
o
Option 2: PBRN research staff mail out letters to eligible patients offering them an opportunity 
to reach out to us if interested to learn more about the study during their next visit, or a phone 
call.   
o Option 3: When conducting reminder calls, clinic staff offer patients the opportunity to 
participate. Nurses will then share a list of patients who showed interest for PBRN research 
staff to reach out.  
o Option 4: PBRN research staff traditionally recruit in the waiting room using a flyer or other 
tool. In past experience, however, this has not been the most efficient strategy given current 
pandemic restrictions.   
A maximum of three (3) attempts will be made to contact participants if non-responsive after 
recruitment (i.e. phone, email). 
ADRD Supplement 
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 Post flyer in community-based setting where allowed by the organization. 
Accept self-referrals from care partners and patients who respond to flyers. These 
people do not have to be patients of our participating practices.  
SDOH Supplement 
 Execute a data use agreement with HealthLandscape to provide SDOH data 
 Use same process as outline in options above for Phase 2 trial to survey clinicians and 
patients.  
 
 
6 
STUDY INTERVENTION  
6.1 
STUDY INTERVENTION(S) ADMINISTRATION 
(The intervention component is only within Projects #1 & 2) 
The study intervention will begin toward the end of our year one activities and after its formative 
development in phases 1 and 2.  
We will follow a multi-faceted implementation strategy that our team has used on similar 
studies, including: 
 
Basic clinician education: All clinics will receive education on: 1) lung CA screening; 2) 
SDM, and 3) innovative smoking cessation strategies that integrate with busy primary care 
workflows. 
 
Fidelity to core intervention elements and adaptation to local context: Our study will achieve 
an appropriate balance between fidelity and local adaptation. We will emphasize fidelity to 
core components of the interventions (e.g., PtDA delivered before or during an encounter; 
delivered by staff or providers at the clinic) and produce both a study protocol made 
available through clinicaltrials.gov and an implementation and adaptation guide. We will 
consult on and document adaptation to local settings as necessary for successful 
implementation using procedures validated by Rabin et al.  
 
Centralized patient identification: Eligible patients will be identified through a central 
procedure at each site, utilizing site-based EHR system reports, and eliminating reliance on 
the clinician. As noted above, we will use the approaches of the Moonshot-funded cessation 
smoking C3I to obtain accurate smoking history data, as well as the extensive experience of 
Drs. Nease and Ritzwoller with EHRs and patient registries.
 
Audit and feedback: Sites, clinics, and individual clinicians will receive audits and feedback 
on their LCS services, including SDM and smoking cessation efforts. Information on use of 
the PtDA, delivery of smoking cessation advice and counseling/referral (most likely to be to 
the state Quit line) will come from either EHR or chart review of eligible patients as 
appropriate to each setting. Reports will be produced and disseminated monthly during the 
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intervention phases. Audits may be conducted in the form of pre/post surveys, direct 
observation, and/or brief interview about progress (if in-person observation is not allowed).  
6.1.1 STUDY INTERVENTION DESCRIPTION
Project #1 & 2 within our program of research include an intervention: the PtDA for shared 
decision making in LCS and cost collection tool.  
PtDA: Modification of the LCS PtDA and smoking cessation procedures for rural primary care 
will occur simultaneously with the phase one key informant interviews. We will review existing 
PtDAs with stakeholders and develop a modified version for use in rural primary care in 
collaboration with Tanner Caverly and colleagues at the University of Michigan28,29 who 
developed an existing LCS tool for use during a primary care encounter using “designing for 
dissemination” principles30,31,32.  We will follow the stepwise method (see Study Schema) in 
modifying the SDM content for our LCS pilot.12
Step 1: The initial content will be based on a review of existing PtDAs using the International 
Patient Decision Aid Standards (IPDAS).33 Testing of Dr. Caverly’s LCS PtDA showed 
significant improvements in knowledge, decision conflict, and improved concordance 
between patients’ preferences and screening recommendations.28  
 Step 2: Based on existing lung cancer PtDAs, we will draft a low-fidelity paper or digital 
version allowing for rapid iteration. We will incorporate a host of innovations that we have 
found facilitate implementation. Our iterative development process follows a user-centered 
design perspective for the purpose of improving acceptability among end-users, facilitating 
future implementation.39 The PtDAs are intended to be used by different end-users, and 
should be meaningful, helpful and accepted by all. Not only does this provide additional 
feedback, it creates investment among end users.  Additionally, we provide “gist” language 
to supplement statistics to improve understanding among patients with lower literacy.40
 Step 3: We will iteratively review a paper-based or digital PtDA with the multiple 
stakeholders engaged in phase one. This review will occur immediately after the qualitative 
interview.  
Step 4: Once modifications are complete, we will draft a high-fidelity, encounter-based 
version using graphic design resources available at ACCORDS in the Colorado Program for 
Patient-Centered Decisions.  
 Step 5: The tool will undergo a final review with leaders of the rural Colorado PBRNs, front 
line staff, patients, and the cancer center to assure that the resultant PtDA meets the needs of 
these stakeholders.
 Step 6: Participating site staff will determine the best work flow strategy after our 
implementation process detailed above. We will follow the progress of implementation of the 
intervention. 
 Step 7: Pre-Implementation Survey – practice staff will complete a pre-implementation 
survey capturing items related to decision aid use and practice culture. Patients will complete 
a survey directly following their first appointment assessing the use of decision support 
during their visit and their view on the decisions made.  
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 Step 8: Audit & Feedback – Center staff will audit intervention progress by either in-person 
observation or short call with practice staff, compile responses, and deliver feedback in the 
form requested by the practice. 
 Step 9: Post-Implementation Survey - practice staff will complete a post-implementation 
survey capturing items related to decision aid use and practice culture. Patients will complete 
a survey directly following a last appointment in the study period assessing the use of 
decision support during their visit and their view on the decisions made. 
Cost Collection Template:  
 
Step 1: We will conduct a scoping literature review to identify published approaches to 
stakeholder-based cost, benefit and value assessment methods.
Step 2: We will conduct a scoping review of LCS procedures and develop a flow diagram to 
represent specific activities within shared decision making for LCS and smoking cessation.  
 
Step 3: We will refine our published cost capture templates (which assess costs from 
provider/clinic; staff; and patient/family perspectives) to categorize costs associated with the 
various RE-AIM outcomes, and pilot test the revised templates in three SNOCAP practices 
varying on size, geographic location, and history of involvement in PBRN research that are 
delivering LCS and smoking cessation services. This step will evaluate and compare the 
feasibility and results of applying the cost templates as described in Rhodes et al62 via 
interview, observation, and staff tracking methods. After rapid modification as needed, we 
will compare the perspectives of providers, staff and patients on the cost of delivering 
smoking cessation and lung cancer screening activities in 10 different SNOCAP practices. 
 
Step 4: We will use the cost capture template during the implementation project described 
above to summarize and feedback cost information to participating clinics.   
6.2 
STUDY INTERVENTION COMPLIANCE
Study intervention compliance will be assessed by diary review completed by experienced 
interviewers.
7 
STUDY INTERVENTION DISCONTINUATION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL 
7.1 
DISCONTINUATION OF STUDY INTERVENTION (STUDY STOPPING RULES)
We do not anticipate the need to discontinue the intervention. However, the Sponsor-Investigator 
has the right to discontinue the intervention at any time. Reasons for discontinuation may include, 
but are not limited to, the following: 
o Intervention not feasible, after multiple iterations, to incorporate into work flows 
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7.2 
PARTICIPANT DISCONTINUATION/WITHDRAWAL FROM STUDY
REQUIRED TEXT:
Participants are free to withdraw from participation in the study at any time upon request. 
In addition, the investigator has the right to withdraw a patient from the study at any time. Reasons 
for withdrawal from the study may include, but are not limited to, the following: 
o
Patient withdrawal of consent at any time
o
Patient non-compliance
o
Lack of resource (patients or practices) to carry out intervention 
o Patient’s unwillingness to participate in shared decision making 
o Any medical condition that the Sponsor-Investigator determines may jeopardize the 
patient’s safety if he or she continues in the study. 
o Sponsor-Investigator determines it is in the best interest of the patient 
Patients must discontinue study intervention if they experience any of the following: 
o Discomfort in answering the questions 
Every effort should be made to obtain information on patients who withdraw from the study. The 
primary reason for withdrawal from the study should be documented on the appropriate eCRF.  
7.3 
LOST TO FOLLOW-UP  
There will be 3 attempts to contact participants, after which time they will be excluded from the 
study. 
8 
STUDY PROCEDURES
8.1 
STUDY PROCEDURES/EVALUATIONS
Through the course of our year 1 pilot projects, primary care practice personnel and patients will 
be enrolled to participant in interviews. We will continue to interview participants throughout 
this period until we reach 180 total interviews or saturation is reached among major themes 
surrounding the availability and cost/benefits of existing LCS infrastructure. (up to 60 interviews 
per project). In years 2 and 3 an additional 216 total patients will be surveyed 2 times within our 
Phase 2 pilot trial. A minimum of 6 and maximum of 18 practice staff will be surveyed 2 times 
throughout the Phase 2 pilot trial.  
ADRD Supplement: At least four rural primary care clinics that have the capacity to identify 
patients with ADRD, care partners, and primary stakeholders. We plan to engage two SNOCAP 
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clinics that have a high prevalence of older patients and two National Research Network (NRN)
practices, which have more lung cancer screening experience.
SDOH Supplement: The study team will receive a de-identified dataset from an external 
contractor with affiliation to AAFP to accomplish the environmental scan of SDOH. Each center 
in the ISC3 will receive similar data under this agreement. We will also perform a paired 
clinician-patient survey in a convenience sample during routine clinical visits. We plan to engage 
up to 6 clinics in the SNOCAP network. 
8.2 
STUDY SCHEDULE 
8.2.1 Screening Within participating rural sites, we will identify and approach a convenience 
sample of clinicians, staff, and decision makers and invite patients meeting the above criteria to 
participate in an interview- within 18 months of program start. Patient ID will differ depending 
on resources available at practice sites. We will work with our rural PBRN partners to use EHR 
abstraction when available or other means if not.  
8.2.2 Enrollment/Baseline Participants screened for the study will be approached and offered 
up to $100 compensation for their participation in key informant interviews or focus groups, 
including brief surveys. This will establish a baseline for the participant population highlighting 
preferences and perceptions of costs, benefit, and value with respect to shared decision making in 
lung cancer screening and smoking cessation and cost capture methodology. This will take place 
within 18 months of program start. 
ADRD Supplement: Patient and care partners will each receive a $50 gift card for participating 
in a 1-hour interview. Primary care stakeholders will receive a $100 gift card. Each clinic will 
receive $2,000 for their assistance. 
SDOH Supplement: Participating clinics will be provided a $500 stipend for collecting paired 
clinician-patient surveys over a two-week period. Patients will receive a $5 gift card for 
completing the survey.  
8.2.3 INTERVENTION VISITS  
The study team will schedule an initial visit for educational purposes and how to appropriately 
implement our PtDA and cost capture tool. 
8.2.4 FOLLOW-UP VISITS
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The study team will schedule up to 4 follow-up visits with participating sites to deliver audit and 
feedback, and ensure fidelity to the key elements of the study. 
8.2.5 EARLY TERMINATION VISIT
NOT APPLICABLE 
8.2.6 SCHEDULE OF EVENTS TABLE 
Table 2: Timeline and pre-post design for Phases 1-2
 
Year 1
Year 2
Year 3
Aim 1a – Decision Needs 
Aim 1b Adaptation phase–
PtDA modification
 
 
 
 
Aim 1b Implementation 
phase – Data collection  
 
 
 
 
 
SNOCAP clinic #1
C 
C
C
I 
I
I
 
SNOCAP clinic #2
 
 
C 
C 
C
/I 
I 
I 
 
PEACHnet clinic #3 & 4* 
 
 
C 
C 
C
/I 
I 
I 
 
C=Comparison (pre-implementation); I=Intervention (post-
implementation)
*Rationale for practice combination: only one provider participating from each and within the 
same health system. 
Table 4. Methods Unit Study Initial Project Activities by Time Period
Activity 
Months
Description
Refine stakeholder based cost 
capture procedures   (Aim 2a) 
1-3 
Revise/adapt cost collection templates for 3 stakeholder types 
to assess costs by RE-AIM dimension 
Cost assessment methods 
study 
(Aim 2a)
4-9 
Compare observation vs. interview cost data collection methods
Benefits – Qualitative 
assessment 
(Aim 2b and Project 4: ADRD)
10-12
Interviews and focus groups to understand stakeholder 
perspectives on benefit of each of RE-AIM outcomes 
Benefits – Quantitative 
assessments – Phase I 
(SNOCAP)      (Aim 2b)  
13-18
a) Human-centered design rapid development of quantitative 
benefits by RE-AIM dimension survey  
b) Pilot test of survey with n=6 SNOCAP practices
Benefits – Quantitative 
assessments – Phase II 
(NRN) 
(Aim 2b) 
16-27
National survey of approximately n = 80 NRN and SNOCAP 
practices – compare perceived benefit ratings of providers vs. 
delivery staff vs. patients; and across RE-AIM dimensions. 
Surveys administered based on participant’s preference (online, 
paper or phone) with up to 3 reminders. 
Study relationship of benefit 
priorities to choice of cancer 
interventions.   (Aim 2c) 
25-32
Mixed methods study to identify relationships between 
stakeholder perspectives on value to selection of different 
RTIPS programs varying on RE-AIM outcomes 
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Develop Value feedback 
procedures and displays  
(Aim 2d) 
31-36
Rapid human-centered design procedures to develop and pilot 
graphical value feedback methods (based on RE-AIM 
dimensions) to aid in CPC decision making 
8.3
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS  
8.3.1 DEFINITION OF ADVERSE EVENTS (AE) 
REQUIRED TEXT: Being key informant interviews or focus groups, shared decision making 
and cost capture practices, we do not anticipate any adverse events.
ADRD & SDOH Supplements: n/a 
8.3.2 DEFINITION OF SERIOUS ADVERSE EVENTS (SAE) 
REQUIRED TEXT: Being key informant interviews or focus groups, shared decision making 
and cost capture practices, we do not anticipate any serious medical, adverse events.
ADRD & SDOH Supplements: n/a 
8.3.3 CLASSIFICATION OF AN ADVERSE EVENT 
N/A 
8.3.3.1 
SEVERITY OF EVENT  
REQUIRED TEXT
N/A 
8.3.3.2 
RELATIONSHIP TO STUDY INTERVENTION 
REQUIRED TEXT: Being key informant interviews or focus groups, shared decision making 
and cost capture practices, we do not anticipate any serious medical, adverse events.
The clinician’s assessment of an AE’s relationship to study procedure is part of the documentation 
process, but it is not a factor in determining what is or is not reported in the study. If there is any 
doubt as to whether a clinical observation is an AE, the event should be reported. All AEs must 
have their relationship to the study procedure assessed. To help assess, the following guidelines 
are used.  
 Related – The AE is known to occur with the study procedure, there is a reasonable 
possibility that the study procedure caused the AE, or there is a temporal relationship 
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between the study procedure and event. Reasonable possibility means that there is 
evidence to suggest a causal relationship between the study procedure and the AE. 
 Not Related – There is not a reasonable possibility that the study procedure caused 
the event, there is no temporal relationship between the study procedure and event 
onset, or an alternate etiology has been established.
OR
For all collected AEs, the clinician who examines and evaluates the participant will determine the 
AE’s causality based on temporal relationship and his/her clinical judgment. The degree of 
certainty about causality will be graded using the categories below.
 Definitely Related – There is clear evidence to suggest a causal relationship, and other 
possible contributing factors can be ruled out.  
 Probably Related – There is evidence to suggest a causal relationship, and the 
influence of other factors is unlikely.  
 Possibly Related – There is some evidence to suggest a causal relationship (e.g., the 
event occurred within a reasonable time after study procedure). However, other factors 
may have contributed to the event (e.g., the participant’s clinical condition, other 
concomitant events). Although an AE may rate only as “possibly related” soon after 
discovery, it can be flagged as requiring more information and later be upgraded to 
“probably related” or “definitely related”, as appropriate.
Unlikely to be Related – A clinical event, whose temporal relationship to study 
procedure makes a causal relationship improbable (e.g., the event did not occur within 
a reasonable time after study procedure) and in which other factors provide plausible 
explanations (e.g., the participant’s clinical condition, other concomitant treatments). 
Not Related – The AE is completely independent of study procedure, and/ or evidence 
exists that the event is definitely related to another etiology. There must be an 
alternative, definitive etiology documented by the clinician. 
8.3.3.3 
EXPECTEDNESS  
REQUIRED TEXT: Being key informant interviews or focus groups, shared decision making 
and cost capture practices, we do not anticipate any serious medical, adverse events.
The principal investigator will be responsible for determining whether an AE is expected or 
unexpected. An AE will be considered unexpected if the nature, severity, or frequency of the event 
is not consistent with the risk information previously described for the study intervention. 
 
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8.3.4  TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND FOLLOW-UP  
REQUIRED TEXT: Being key informant interviews or focus groups, shared decision making 
and cost capture practices, we do not anticipate any serious medical, adverse events.
The occurrence of an AE or SAE may come to the attention of study personnel during study visits 
and interviews of a study participant presenting for medical care, or upon review by a study 
monitor. All AEs including local and systemic reactions not meeting the criteria for SAEs will be 
captured on the appropriate CRF. Information to be collected includes event description, time of 
onset, clinician’s assessment of severity, (if applicable) relationship to study intervention (assessed 
only by those with the training and authority to make a diagnosis), and time of resolution/ 
stabilization of the event. All AEs occurring while on study must be documented appropriately. 
All AEs will be followed to adequate resolution. 
Any medical condition that is present at the time that the participant is screened will be considered 
as baseline and not reported as an AE. However, if the study participant’s condition deteriorates 
at any time during the study, it will be recorded as an AE. UAPs will be recorded in the data 
collection system throughout the study. 
Changes in the severity of an AE will be documented to allow an assessment of the duration of the 
event at each level of severity to be performed. AEs characterized as intermittent require 
documentation of onset and duration of each episode. 
The PI will record all reportable events with start dates occurring any time after informed consent 
is obtained until 30 (for non-serious AEs) or until resolution or stabilization (for SAEs) after the 
last day of study participation. At each study visit, the investigator will inquire about the 
occurrence of AE/ SAEs since the last visit.  
8.3.5   
ADVERSE EVENT REPORTING  
REQUIRED TEXT: The investigator must record non-serious adverse events and report to 
DSMC and IRB according to timetable for reporting specified in section 10.1.6.  
8.3.6   
SERIOUS ADVERSE EVENT REPORTING  
REQUIRED TEXT: The investigator must record all serious adverse events and report to 
DSMC and IRB according to timetable for reporting specified in section 10.1.6.   
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 Other SAEs will be submitted to the National Cancer Institute within 72 hours of site 
awareness.
 
8.3.7 EVENTS OF SPECIAL INTEREST
N/A 
8.3.8  REPORTING OF PREGNANCY
N/A 
8.4  
UNANTICIPATED PROBLEMS 
8.4.1 DEFINITION OF UNANTICIPATED PROBLEMS (UAP)
REQUIRED TEXT FOR SINGLE-SITE STUDIES: 
This study will use the COMIRB definition of UAP. An unanticipated problem is any event or 
information that was unforeseen and indicates that the research procedures caused harm 
(including physical, psychological, economic, or social harm) to participants or others or 
indicates that participants or others are at increased risk of harm than was previously known or 
recognized.  
8.4.2 REPORTING OF UNANTICIPATED PROBLEMS  
REQUIRED TEXT FOR SINGLE-SITE STUDIES: 
This study will follow COMIRB’s guidance for UAP reporting and the DSMC’s requirements 
(discussed below). AEs, noncompliance and protocol violations will be recorded and reported as 
required either promptly (within 5 days of Sponsor-Investigator’s knowledge) or at the time of the 
study’s continuing review.  
 
It is the responsibility of the PI to report incidents or events that meet the criteria for UAPs 
reporting to their IRB using the IRB’s standard UAP form. The PI is responsible for reporting the 
UAP to the UCCC DSMC.  
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9 
STATISTICAL CONSIDERATIONS 
9.1  
STATISTICAL HYPOTHESES
Reach: We will assess the percentage of eligible patients that receive one or more elements of 
the intervention. Representativeness will be assessed by comparing participants to those who opt 
out on available demographic and clinical indicators (e.g., age, gender, comorbidities) from chart 
review.  
Effectiveness: We will assess the measures at the time points indicated in Table 3. Patients will 
be consented and provided a small incentive to answer surveys about their experiences. The 
primary outcomes will be: 
o SDM rates: We will use single item measures of decision predisposition, choice, and 
enactment. We will also perform EHR/chart review as appropriate to each setting to 
document receipt of SDM. 
o Decision quality: Decision quality is defined as “the extent to which the implemented 
decision reflects the considered preferences of a well-informed patient.”56 It consists of two 
domains: knowledge and values. Knowledge will be measured using a measure validated by 
Dr. Caverly and team.28 Value-treatment concordance will be measured using the values-
clarity sub-scale of decision conflict.57 Across all projects and for all measures, we will use 
versions validated in Spanish, and when not available, the scales will be translated into 
Spanish, back translated and tested for cultural appropriateness by our Cancer Center 
Outreach staff.  
o Receipt of smoking cessation advice/counseling/referral: We will obtain information from 
both EHR extracts or chart reviews and patient surveys. 
Additionally, we will collect the following secondary outcomes: 
o IPDAS process measures: We will use six questions based on key domains of decision 
process as outlined in the IPDAS background document. Dr. Matlock used these questions 
and found they had high internal consistency (Cronbach’s alpha of 0.78).58
o
The Decision Conflict Scale (DCS):  DCS assesses decisional uncertainty.57 DCS reliability 
measures include test-retest correlation and Cronbach’s alpha coefficients exceeding 0.78-
0.90. It discriminates between groups who make and delay decisions. 
o Understandability and acceptability: will be measured using the Ottawa Acceptability Scale 
(OAS). The OAS consists of 8 questions on a 5-point Likert scale.59 
Patient characteristics data we collect will include basic demographics (age, gender, educational 
level, health insurance status, employment), and other pertinent medical history, as well as health 
literacy 60 and subjective numeracy.61 We will also have data on practice characteristics to 
provide qualitative contextual information. These data will allow us to report the 
representativeness of patients who receive this intervention. 
Adoption: RE-AIM defines adoption as the absolute number, proportion, and representativeness 
of a) settings and b) staff who are willing to initiate a program. We will measure adoption by the 
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number of clinics participating (3) divided by the number we invite, and similarly the number of 
staff who participate vs. those invited. We will also describe the representativeness of 
participating clinics, compared to other SNOCAP rural primary care clinics, and complete the 
Expanded CONSORT figure to transparently report on generalizability.19 
Implementation: RE-AIM defines implementation as the extent to which the intervention is 
implemented as intended. Consistency of PtDA delivery will be assessed across SNOCAP 
clinics, patient subgroups, and time via surveys, EHR data and chart reviews. Additionally, we 
assess organizational factors associated with variation in implementation. Key informant 
interviews will be conducted at baseline and after implementation of the intervention with the 
clinic director and other staff involved. The goals of these interviews are to identify issues 
related to implementation/adaptation using procedures of Hall et al (2017) and Rabin et al (2018) 
and to explore strategies that may be useful in the refinement of subsequent roll-outs and future 
dissemination. Patients will complete a survey evaluating if and how the patients used the PtDAs 
with their clinicians. Finally, we will evaluate costs of the intervention and the implementation 
strategies using the time driven activity-based costing methods used by Drs. Ritzwoller and 
colleagues4,62 adapted as described in the Methods Unit below. 
Maintenance: This will be assessed primarily by exploring whether each of the 3 clinics decides 
to continue; drop, or adapt/modify using the PtDAs and smoking cessation actions at the end of 
the study.  
 
SDOH Supplement: 
We anticipate generating descriptive data characterizing the outer contextual environment of the 
ISC3 network across the seven identified domains. Our overall analytic approach for this will 
consist of summarizing SDOH measures using descriptive statistics and data visualization 
methods to characterize the outer context across CHCs in our laboratories. We will examine the 
relationship between outer context and cancer prevalence, cancer-related behaviors, and 
policies across the ISC3 network, likely at the zip code and state level, since this would reflect 
the local and state-level policy context. We will examine the relationship between the seven 
contextual domains and cancer prevention behaviors (e.g. are cancer preventive behaviors 
better in jurisdictions that have lower levels of food and housing insecurity and other social 
needs?), and cancer-relevant policies (e.g. are cancer-relevant policies more prevalent in 
jurisdictions with more or fewer social needs?). We also anticipate comparing SDOH and health 
outcomes across several Centers at the relationship between outer context and cancer 
prevention outcomes, with analyses conducted at the practice-level.  For example, we will 
assess the association between outer context measures and practice variation in rates of 
cervical and colorectal cancer screenings and smoking cessation intervention in practices 
located in specific states, including within and across state variation using multi-level modeling.  
We will also collect survey responses from clinicians and patients to investigate the 
relationships between cancer screening tests and being referred for, accepting or declining 
these tests.  
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9.2  
SAMPLE SIZE DETERMINATION 
Using the approach described by Hussey, et. al,63 we find that our proposed sample size (n=108) 
will provide >80% power to detect a .91 effect size difference between controls and intervention 
patients on continuous outcomes. While this study is not powered to detect smaller differences, it 
will be useful to obtain estimates of means, variability, and intraclass correlation for key 
outcomes to aid in planning the future study. 
We have since added calculation for the Phase 2 trial and our proposed sample size of 216 
participants will provide >80% power to detect a .58 effect size. Being a pilot, this feasibility 
data will be sufficient to lead to a larger trial aimed to produce a greater effect. 
9.3  
POPULATION FOR ANALYSES
1. Patients: Age 50 - 80; English or Spanish speaking, asymptomatic; tobacco smoking history 
of 20+ pack-years; current smoker or quit within last 15 years. 
2. Clinicians: Age 18-100; English or Spanish speaking; Physicians and advanced practice 
providers 
3. Staff: Age 18-100; English or Spanish speaking; Nurses, administrators, medical assistants, 
social workers, and other clinic personnel.  
4. Leaders of rural clinics, hospitals, and radiology sites serving patients from the rural clinics; 
Age 18-100; English or Spanish speaking. 
 
ADRD Supplement:  
1. Patients: Age 55+; English or Spanish speaking, Diagnosis of dementia in the medical record 
[e.g., Alzheimer’s disease, vascular dementia, dementia associated with Parkinson disease, 
dementia NOS (not otherwise specified), etc.].
2. Care Partners: Age 45+; English or Spanish speaking, care partner of a person with ADRD 
defined as family member, non-paid companion, or a designated health care proxy 
SDOH Supplement: 
As above with slight modifications: 
1. Patients: Age 45+; Seen in one of the clinic practices in the supplemental funding period. 
2. Clinicians: Physicians and advanced practice providers 
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9.4  
STATISTICAL ANALYSES
9.4.1  
GENERAL APPROACH
Analysis of qualitative data will be a continuous process beginning with initial interviews and 
continuing throughout and beyond the data generation period.  
9.4.2  
ANALYSIS OF THE PRIMARY EFFICACY ENDPOINT(S)
A multidisciplinary team led by Drs. Matlock and Huebschmann, and guided by Dr. Holtrop will 
begin the analysis process with repeated readings of the transcripts to achieve immersion. The 
team will then develop and apply a list of codes using an emergent rather than a priori approach, 
to emphasize interviewee perspectives and de-emphasize team member speculations. All coded 
data will be entered into ATLAS.ti v 8.0 (GmbH, Berlin) for data management. Coded 
transcripts will be analyzed by the qualitative analyst within and across sites and settings to 
develop the major themes or concepts reported. The trustworthiness of study results will be 
enhanced through triangulation of the data and an “audit trail” throughout the data collection and 
analysis process. Analysis results will inform both the design of the implementation for the 
second study phase, and the initial methods projects. 
RedCap or similar software will be used to conduct surveys and store survey data. The same 
team (above) with the addition of Dr. Dickinson will lead the quantitative analysis. Multiple 
outcomes from each individual on the five RE-AIM outcomes will produce repeated measures as 
we wish to compare ratings across outcomes; general linear mixed models can accommodate 
both levels of clustering. Since primary effects of interest are between individuals within clinics 
(or within individuals), the intraclass correlation coefficient will have less impact than in the case 
of between-clinic comparisons and is not considered here. Adjusted for multiple comparisons 
(providers vs. staff vs. patients), a sample size of 6 to 10 individuals per clinic (2 - 3 providers, 2 
- 3 staff, 2 - 3 patients) from 80 clinics (160 to 240 per stakeholder type, 480 to 720 total) will 
provide a power of >80%  to detect an effect size of 0.3 SD to .37 SD. For differences across 
respondent types on a single RE-AIM dimension. For the RE-AIM dimensions within 
individuals, adjusted for multiple comparisons, this sample size will provide .80 power to detect 
a .24 to .30 effect size difference between any two RE-AIM outcome dimensions. 
In Phase 2, no less than 9 patients per clinic per step and 2-3 practice staff from up to 6 clinics 
will provide a power of  >80% to detect a effect size of 0.58. SD will vary depending on final 
number of clinics enrolled. Being a small feasibility trial, we will enroll clinics up to 6, to 
achieve our goal of understanding feasibility of the use of our PtDA in a larger, national trial.
SDOH Supplement: 
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We will conduct separate models for different cancer preventive care outcomes as the outer 
context may have differential impact. We will consider random effects for state to account for 
clustering, and will utilize several statistical criteria to determine relative contributions of multi-
level factors, including but not limited to: interpretations of measures of relative risk (e.g., odds 
ratios, rate ratios) and effect sizes, statistical significance, explained variation for GLMMs, and 
model diagnostics. Paired survey data will be analyzed primarily using descriptive statistics. 
9.4.3  
ANALYSIS OF THE SECONDARY ENDPOINT(S) 
N/A 
9.4.4  
SAFETY ANALYSES 
N/A 
9.4.5   
BASELINE DESCRIPTIVE STATISTICS
N/A 
9.4.6  
PLANNED INTERIM ANALYSES 
N/A 
9.4.7  
SUB-GROUP ANALYSES 
N/A 
9.4.8  
TABULATION OF INDIVIDUAL PARTICIPANT DATA 
N/A 
9.4.9  
EXPLORATORY ANALYSES
N/A 
9.5 
ENROLLMENT/RANDOMIZATION/MASKING PROCEDURES 
Project #1 - Shared Decision Making in Lung Cancer Screening and Smoking Cessation 
Intervention: We considered three potential designs for this trial. A classic patient-level 
randomization is not ideal since practices (rather than patients) are the primary targets. A 
traditional cluster randomized trial would be disadvantaged by the small number of sites. 
Therefore, we propose a multicenter trial with a pre-post design where all the groups will receive 
the intervention. This design has been effectively used with rural Colorado PBRN practices. We 
propose a pilot study using a pre-post design with two time blocks of approximately 3 months 
each (Table 2) and will enroll approximately 36-48 patients per practice over a 12-month period 
for a total of 144-192 patients across all four practices. We will not exceed 6 practices and 216 
patients.  
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SDOH Supplement: No randomization planned. 
10 
SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS 
10.1   REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS
10.1.1
INFORMED CONSENT PROCESS
Participants will be consented using an IRB approved post card consent form with verbal consent before 
enrolling. 
 
10.1.1.1  
CONSENT/ASSENT AND OTHER INFORMATIONAL DOCUMENTS 
PROVIDED TO PARTICIPANTS 
REQUIRED TEXT:  
Consent forms describing in detail the study procedures, and risks will be offered to the participant 
and written documentation of informed consent is required prior to starting intervention/ 
administering study.  
10.1.1.2  
CONSENT PROCEDURES AND DOCUMENTATION 
REQUIRED TEXT:  
Informed consent process will be initiated prior to the individual’s agreeing to participate in the 
study and continues throughout the individual’s study participation. Extensive discussion of risks, 
though minimal and possible benefits of participation will be provided to the participants and their 
families.  
Consent forms will be IRB-approved and the study team with read and review the document with 
the participant. The investigator will explain the research study to the participant and answer any 
questions that may arise. All participants will receive a verbal explanation in terms suited to their 
comprehension of the purposes, procedures, and potential risks of the study and of their rights as 
research participants. Participants will have the opportunity to carefully review the consent form 
and ask questions prior to consenting. The participants will have the opportunity to discuss the 
study with their surrogates or think about it prior to agreeing to participate. The participant will 
sign the informed consent document or give verbal consent via audio recording prior to any 
procedures being done specifically for the study.  
 
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ADRD Supplement:  
For individuals with diagnosis of ADRD, the informed consent process will use a functional 
demonstration of decision making capacity through a teach-back method. The “teach-back” 
method maximizes the ability of older adults with early dementia to participate and protects those 
individuals who cannot “teach-back” consent information in their own words. 
 
The participants may withdraw consent at any time throughout the course of the trial. A copy of 
the informed consent document will be offered to the participants for their records. The rights and 
welfare of the participants will be protected by emphasizing to them that the quality of their 
medical care will not be adversely affected if they decline to participate in this study. 
The study allows the inclusion of Spanish speaking and non-reading participants. Witnesses to 
these consent processes will be individuals not associated with the trial and will not have a 
conflict of interest. 
 
SDOH Supplement: Same as center above.
10.1.2 
STUDY DISCONTINUATION AND CLOSURE  
We do not anticipate discontinuation of these pilots.  
10.1.3  
CONFIDENTIALITY AND PRIVACY 
REQUIRED TEXT:  
Participant confidentiality is strictly held in trust by the participating investigators, their staff, 
and the sponsor-investigator(s) and their agents. Therefore, the study protocol, documentation, 
data, and all other information generated will be held in strict confidence. No information 
concerning the study or the data will be released to any unauthorized third party without prior 
written approval of the sponsor. 
The study monitor, other authorized representatives of the sponsor-investigator, or 
representatives of the IRB may inspect all documents and records required to be maintained by 
the investigator, including but not limited to, medical records (office, clinic, or hospital) for the 
participants in this study. The clinical study site will permit access to such records. 
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The study participant’s contact information will be securely stored at each clinical site for 
internal use during the study. At the end of the study, all records will continue to be kept in a 
secure location for as long a period as dictated by local IRB and Institutional regulations. 
Study participant research data, which is for purposes of statistical analysis and scientific 
reporting, will be transmitted to and stored on the secured server at the University of Colorado’s
Adult and Child Consortium for Health Outcomes Research and Delivery Science. This will not 
include the participant’s contact or identifying information. Rather, individual participants and 
their research data will be identified by a unique study identification number. At the end of the 
study, all study databases will be de-identified and archived at the University of Colorado Cancer 
Center.
10.1.4 
FUTURE USE OF STORED SPECIMENS OR DATA
REQUIRED TEXT :
Data collected for this study will be analyzed and stored on the secured server at ACCORDS, 
under the supervision of the Program Manager, for use by other researchers including those outside 
of the study. Some data may be shared or collaborated upon using the University’s Egnyte server, 
a HIPAA compliant, cloud based server service provided by the university.  
10.1.5 
KEY ROLES AND GOVERNANCE 
Data collected for this study will be analyzed and stored on the secured server at ACCORDS, 
under the supervision of the Program Manager, for use by other researchers including those 
outside of the study. Some data may be shared or collaborated upon using the University’s 
Egnyte server, a HIPAA compliant, cloud based server service provided by the university. 
Egnyte automatically compiles a log of changes to data detailing who made changes and when 
they were made. 
If preferred, practices can fax their patient lists versus sharing via Egnyte.  Faxes can be sent to 
the Department of Family Medicine (DFM) fax line.  In accordance with HIPAA regulations, 
practices will use a cover sheet.  The fax will be addressed to a member of the study team that is 
part of the High Plains Research Network (HPRN), which is housed in DFM.  The HPRN study 
team will coordinate with practices choosing to fax information to ensure a member of the team 
is present to receive the fax and to confirm receipt.  The fax will be scanned, and the electronic 
version will be saved on Egnyte.  Hard copies will be locked in a cabinet in the study team 
member’s office, which is also locked. Hard copies will be shredded upon completion of 
recruitment.
10.1.6 
SAFETY OVERSIGHT  
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REQUIRED TEXT FOR SINGLE-SITE STUDIES: 
Non-Interventional IIT (No Additional Risk)
The principal investigator will be responsible for the conduct of this study, overseeing participant 
safety, executing the data and safety monitoring (DSM) plan, and complying with all reporting 
requirements to local and federal authorities. This oversight will be accomplished through 
additional oversight from the Data and Safety Monitoring Committee (DSMC) at the University 
of Colorado Cancer Center (CU Cancer Center).  The DSMC is responsible for ensuring data 
quality and study participant safety for all trials at the CU Cancer Center.   A summary of the 
DSMC’s relevant activities is as follows: 
 Conduct of internal audits 
 May submit recommendations for corrective actions to the CU Cancer Center’s 
Executive Committee 
Study audits conducted by the DSMC will consist of a review of the regulatory documents, 
consent forms, and source data verification.  Documentation of the audit conducted by the 
DSMC will then need to be submitted to the IRB of record at the time of the IRB’s continuing 
review of this trial (if applicable). 
10.1.7 
CLINICAL MONITORING 
REQUIRED TEXT:  
Clinical site monitoring will be conducted to ensure that the rights and well-being of human 
participants are protected, that the reported trial data are accurate, complete, and verifiable, and 
that the conduct of the trial is in compliance with the currently approved protocol/ amendment(s), 
with GCP, and with applicable regulatory requirement(s). Monitoring for this study will be 
performed by ACCORDS staff in accordance with the clinical monitoring plan (CMP). 
 
10.1.8 
QUALITY ASSURANCE AND QUALITY CONTROL 
REQUIRED TEXT: 
Quality Control (QC) procedures will be implemented beginning with the data entry system and 
data QC checks that will be run on the database will be generated. Any missing data or data 
anomalies will be communicated to the site(s) for clarification/ resolution. 
Following written SOPs, the study monitor will verify that the clinical trial is conducted and data 
are generated, documented (recorded), and reported in compliance with the protocol, GCP, and the 
applicable regulatory requirements. 
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The investigational site will provide direct access to all trial-related sites, source data/ documents, 
and reports for the purpose of monitoring and auditing by the DSMC audit team, and inspection 
by local and regulatory authorities. 
10.1.9 
DATA HANDLING AND RECORD KEEPING 
Data handling and record keeping will be done within a secured Egnyte file-sharing platform. 
This storage is IRB/HIPAA compliant and encrypted. 
Any faxed data will be locked in a secure location within Academic Office 1 and will be 
shredded upon the culmination of the pilot work.  
10.1.9.1  
DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES
REQUIRED TEXT: 
Data collection is the responsibility of the clinical trial staff at the site under the supervision of the 
site PI. The PI is responsible for ensuring the accuracy, completeness, legibility, and timeliness of 
the data reported. 
10.1.9.2  
STUDY RECORDS RETENTION
REQUIRED TEXT: 
Study documents will be retained for a minimum of 7 years per HIPAA regulations. These 
documents will be retained for a longer period, however, if required by local regulations or 
institutional policies. No records will be destroyed without the written consent of the sponsor-
investigator.  
  
 
10.1.10 PROTOCOL DEVIATIONS 
REQUIRED TEXT: 
A protocol deviation is any noncompliance with the clinical trial protocol, GCP, or SOP 
requirements. The noncompliance may be either on the part of the participant, the investigator, or 
the study site staff. As a result of deviations, corrective actions are to be developed by the site and 
implemented promptly. These practices are consistent with ICH E6, sections: 
 4.5 Compliance with Protocol, sections 4.5.1, 4.5.2, and 4.5.3. 
 5.1 Quality Assurance and Quality Control, section 5.1.1. 
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 5.20 Noncompliance, sections 5.20.1 and 5.20.2. 
It is the responsibility of the study team to use continuous vigilance to identify and report 
deviations within 7 working days of identification of the protocol deviation, or within 30 
working days of the scheduled protocol-required activity. All deviations must be addressed in 
study source documents, reported to the DSMC and COMIRB. Protocol deviations must be sent 
to the local IRB per their guidelines. The site PI/ study staff is responsible for knowing and 
adhering to their IRB requirements. Further details about the handling of protocol deviations will 
be included in the -SOP and/or study procedures manual.  
10.1.11 PUBLICATION AND DATA SHARING POLICY
REQUIRED TEXT: 
This study will ensure that the public has access to the published results of this research, and also 
meet obligations of the NCI funder.  
10.1.12  
CONFLICT OF INTEREST POLICY 
REQUIRED TEXT: 
Independence of this study from any actual or perceived influence, such as by the pharmaceutical 
industry, is critical. Any actual conflict of interest of persons who have a role in the design, 
conduct, analysis, publication, or any aspect of this trial will be disclosed and managed.by the 
University of Colorado Denver’s (UCD) Office of Regulatory Compliance Conflict of Interest and 
Commitment Management (COIC) program. Persons with a perceived conflict of interest will have 
such conflicts managed in a way that is appropriate to their participation in the trial. Conflict of 
Interest management plans are project-specific and are reviewed at least annually. UCD has 
integrated the institutional conflict of interest management program with its existing program.
 
 
11 
 
REFERENCES  
References – Research Program 
 
1. 
Neumann Peter J. S, Gillian D., Russell, Louise B., Siegel, Joanna E. and Ganiats, 
Theodore G.,. Cost-Effectiveness in Health and Medicine. New York, NY: Oxford 
University Press; 2017. 
2. 
Garrison LP, Jr., Pauly MV, Willke RJ, Neumann PJ. An Overview of Value, Perspective, 
and Decision Context-A Health Economics Approach: An ISPOR Special Task Force 
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Report [2]. Value in health : the journal of the International Society for 
Pharmacoeconomics and Outcomes Research. 2018;21(2):124-130. 
3. 
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11. 
Holtrop JS, Rabin BA, Glasgow RE. Qualitative approaches to use of the RE-AIM 
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Matlock DD, Spatz ES. Design and testing of tools for shared decision making. 
Circulation Cardiovascular quality and outcomes. 2014;7(3):487-492. 
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Therapy Left Ventricular Assist Device. JACC: Heart Failure. 2015;3(12):965-976. 
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El-Jawahri KA, Paasche-Orlow WM, Matlock FD, et al. Randomized, Controlled Trial of 
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Heart Failure. Circulation. 2016;134(1):52-60. 
15. 
Tate CE, Matlock DD, Dalton AF, et al. Implementation and Evaluation of a Novel 
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journal on quality and patient safety. 2018;44(6):353-360. 
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Project Plan - Alzheimer's disease supplement 
 
Settings 
At least four rural primary care clinics that have the capacity to identify patients with Alzheimer's disease and 
related dementias (ADRD), care partners, and primary care stakeholders. We plan to engage two HPRN clinics that 
have a high prevalence of older patients (which may have more colon cancer screening experience) and two NRN 
practices (which have more lung cancer screening experience) 
 
Participants  
 
Patients with mild cognitive impairment (MCI)/early dementia (3-4 per clinic) 
 
Care partners of those with MCI/early dementia (3-4 per clinic; recruited as dyads; interview sequentially) 
 
Care partners of patients with advanced dementia (2-3 per clinic)  
 
Primary care clinicians (MD, NP, PA) (2-3 per clinic); primary care team members (care managers, RN, 
SW) (2-3 per clinic) 
Lay Summary: What are the experiences of persons with mild cognitive impairment/early dementia, family care partners, and 
primary care team members in rural areas related to:  
a) risks, benefits, burdens of cancer prevention and screening (such as lung cancer screening, colon cancer screening, and 
smoking cessation) (all stakeholders); 
b) communication and shared decision making, especially in the context of cognitive impairment and involvement of care 
partners (all); 
c) barriers to screening and dementia care services in rural areas (care partner, primary care perspectives) 
d) if/how primary care processes for colon/lung cancer screening are adapted to meet the needs of patients/ families living with 
dementia (primary care stakeholder perspectives)?  
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Eligibility 
Patients with mild cognitive impairment/early dementia AND decision making capacity, defined as the ability to 
provide informed consent to study participation (n=12-16 patients in total, or 3-4 per clinic) with the following 
inclusion criteria: 
 
Age 55+; English or Spanish speaking, 
 
Seen in one of the clinic practices in the past year, and 
 
Diagnosis of dementia in the medical record [e.g., Alzheimer's disease, vascular dementia, dementia 
associated with Parkinson's disease, dementia NOS (not otherwise specified), etc.]. 
Care partners, defined as someone the patient agrees to as their study partner, such as a family member, non-paid 
companion, or a designated health care proxy. (n=20-26 care partners in total)  
 
Care partner of a patient with early dementia who has the ability to provide informed consent (12-16 care 
partners, as part of patient-care partner dyads). These care partners will be recruited with the patient. 
OR 
 
Care partner of a person with dementia who lacks decision making capacity to provide informed consent 
to participate in the study (n=8-10 care partners, or 2-3 per clinic). These care partners will be directly 
recruited, and then the person with ADRD (if available) can participate by providing assent. 
Primary care stakeholders (n=25, or approximately 4-6 clinicians or staff based on clinic size): 
 
Clinicians (n=8-12): Physicians and advanced practice providers 
 
Staff (n=8-12): Social workers, case managers, nurses, clinic administrators, or others.  
 
Recruitment 
 
HPRN team and/or PRAs will identify and work with clinic champions to purposively sample for 
participants with diverse racial/ethnic, and social determinants of health backgrounds.  
 
Identified patients and/or care partners will be contacted by phone or text (if appropriate) using approved 
scripts. 
 
Patient and care partner reasons for declining to participate will be monitored. 
 
Informed consent – patients and care partners 
Patients will be contacted by phone, screened for eligibility, and invited to participate using a modified informed 
consent process (postcard consent) to promote understanding. The informed consent process uses a functional 
demonstration of decision making capacity through a teach-back method. The "teach-back" method maximizes the 
ability of older adults with early dementia to participate and protects those individuals who cannot "teach-back" 
consent information in their own words.  
Patients who are able to provide consent will be asked to provide a name of a "care partner" who could be a family 
member, friend, companion, or designated health care proxy who will also be contacted for consent to participate 
in the study.  
Care partners and practice members will be consented in accordance with good clinical practice guidelines as well. 
 
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