Electronic Proactive Outreach for Smokers With COPD: Engaging Patients to Quit (CDA 19-081)
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive, Smoking
Sponsor: VA Office of Research and Development

 
Proactive Protocol V2.1  11/20/23 
 
Research Protocol 
 
Title 
Proactive Tobacco Treatment for Patients with COPD who Smoke: A Pilot 
 
Investigator 
Principal Investigator: Anne Melzer MD, MS 
 
Specific Aims/Purpose 
Overview: Many patients with chronic obstructive pulmonary disease (COPD) due to smoking continue to 
smoke.  Proactive tobacco treatment interventions, where individuals who smoke are targeted in a tailored 
fashion outside of a routine clinic visit are a method of patient engagement that appears to be highly effective 
in this population.  However, proactive tobacco treatment programs are rarely implemented, in part due to high 
workload associated with phone-based methods. Electronic outreach programs may be effective and cost-
effective and allow additional tailoring to the target patient population.  We will perform a pilot evaluation of 
proactive patient engagement for smoking cessation among veterans with COPD, piloting this program to 
determine feasibility and estimate effectiveness. 
 
Scientific Rationale and Significance  
Veterans carry a high burden from chronic obstructive pulmonary disease (COPD), driven by high rates of 
tobacco use.  The majority of Veterans have a history of tobacco use, and one in 10 carries a COPD 
diagnosis1 which is higher than the national prevalence.1  Unfortunately, patients with COPD smoke at rates 
nearly double the national and VA averages,5 with rates of tobacco use from 30-40%.2,3  Quitting smoking is 
beneficial even in cases of advanced disease,6 leading to improved symptoms4,5 and decreased risk of death 
from multiple smoking-related causes.6-8   
 
Smokers with COPD have significant barriers to cessation. Though these patients have an urgent need to quit, 
they have many barriers to successful cessation including: high levels of addiction to nicotine,9 low 
socioeconomic status,10,11 medical and psychiatric comorbidities,12 and low motivation.13  However, they are 
also prompted to quit by the presence of respiratory symptoms, which may increase motivation to participate in 
treatment.14,15  Evidence suggests that smokers with COPD can quit successfully at rates similar to their 
healthy counterparts if they receive the guideline-recommended combination of counseling and medication.16,17  
 
In practice, few patients receive any support during a quit attempt,18 and even fewer use both pharmacologic 
and behavioral support despite being considered best-practices.19,20  In a large cohort of Veterans admitted for 
COPD exacerbations, we found that only 15% had any tobacco cessation medication within 90 days of 
discharge.23  The cause of this failure to provide best-practice tobacco treatment is multifactorial, attributable to 
both patient and provider factors, including patient misconceptions,21,22 low motivation, lack of time and training 
for front-line providers,23,24 and the lack of support for system-wide cessation initiatives.25,26   
 
Proactive patient engagement is an effective method of increasing participation in tobacco treatment. Proactive 
patient engagement involves systematically identifying and contacting a group of smokers, providing a 
motivational and educational intervention, assessing their interest in quitting, and connecting them with 
appropriate quit resources.  It has been tested to positive effect as a strategy in a number of patient 
populations including hospitalized smokers,27,28 low income smokers,29,30 and Veterans in both primary care31 
and mental health clinic settings.32   
 
Despite evidence of effectiveness from several trials, proactive patient engagement is rarely implemented as 
part of clinical tobacco treatment programs. This is likely due to several barriers including: the perception that 
these interventions would be burdensome, lack of clarity regard staffing or funding, and concerns around the 
best target population.  Using the principles of implementation science, we can analyze and overcome barriers 
to the implementation of proactive patient engagement in a way that is tailored to the environment and needs 
of the patients and staff.  
 

 
Proactive Protocol V2.1  11/20/23 
Electronic methods of communication such as text messaging are an attractive option, allowing for broad reach 
with low cost.  Patient engagement interventions through electronic portals have been found to be effective for 
increasing participation in other health behaviors.33 Most Veterans are interested in using the internet to 
receive health information from the VA,34,35 and have access to cell phones and e-mail36,37 While limited 
electronic health literacy38 is a concern in patients with COPD over the age of 50, use of technology among 
older adults is rapidly climbing.36 In addition, the population of smokers with COPD at the VA is slowly shifting, 
as more smokers from Operation Enduring Freedom (OEF)/Operation Iraqi Freedom (OIF) are enrolling. These 
younger Veterans may be more open to electronic health communication.  
We conducted a survey and interview of technology use and communication preferences among Veterans with 
COPD who smoke and found that most (71%) have text-capable phones, and few (<25%) use the secure 
patient portal. Therefore, we have elected to use text messaging as the mode of delivery for our intervention. A 
pilot study will provide essential information about the utility of electronic methods for patient engagement 
among older, medically-ill Veterans.  
Because it is not possible to assess population-level efficacy in the context of a single center pilot, we will 
instead focus on feasibility, which will be assessed by the number of patients engaged into tobacco treatment 
through the intervention and their interactions with the texting program. Because we hypothesize that cost and 
burden on staff will be perceived as significant barriers to implementation of proactive tobacco treatment, we 
will also estimate the cost and workload associated with the intervention. This will allow us to compare our 
intervention with other previously studied proactive interventions, and to prepare for a formal cost-effectiveness 
analysis in the context of a future larger trial.  
Study Objectives: 
1) Establish feasibility and estimate effect size for proactive tobacco treatment for patients with 
COPD who smoke offered a via motivational texting program.  
2) Assess acceptability of the motivational program to further tailor content for larger scale 
studies.  
Research Design and Methods: 
Design: We will conduct a randomized controlled pilot of proactive tobacco treatment delivered through a 
motivational texting program.  
Population and Setting: We will randomize up to 250 MVAHCS patients in a ratio of 2:1 intervention: control.  
Inclusion Criteria (EHR): 
1) Adults >=18 participating in care, defined as a primary care or pulmonary visit within the past 2 
years.  
2) Past-year smoking status in the electronic health record defined by health factors indicating current 
smoking (Via validated VA algorithm) 
3) ICD-10 diagnoses of COPD within the past 2 years 
4) Not already enrolled in VA tobacco treatment (pharmacist treatment, tobacco groups, mental health 
tobacco treatment). Patients taking only tobacco cessation medications without counseling will be 
included.  
5) Not enrolled in hospice 
6) No diagnosis of advanced dementia 
Exclusions (phone eligibility assessment):  
1) Unable to communicate by phone in English 
2) No text-capable phone 
3) Already quit smoking 
4) Already participating in tobacco treatment program (note: if using OTC meds without counseling, 
will not be excluded)  
5) Decline to be in study but would prefer to receive care coordination immediately 
 
Eligibility, Sampling and Recruitment: We will screen and enroll patients who meet the eligibility criteria, 
applying the above criteria initially using the EHR, confirming criteria during phone contact. Patients will be 
randomized irrespective of their intention to quit smoking.  

 
Proactive Protocol V2.1  11/20/23 
Women and Racial Minorities: To increase representation of these groups, we will oversample eligible women 
and racial/ethnic minority patients with a goal of 14% female patients and 24% minority patients invited to 
participate.     
 
Study Procedures:  
Screening:  Research coordinator will screen patients for possible eligibility using a secure electronic 
application located behind the VA firewall.  
 
Invitation: Study is minimal risk and will be conducted under a waiver of HIPPA and documentation of 
informed consent.  Eligible participants will be sent an “opt out” letter that describes the study and contains the 
necessary elements of informed consent.  Eligible patients will have the opportunity to opt out at this time by 
calling the study team.  
 
Recruitment: Patients will be recruited 
by phone starting 1 week after letter is 
mailed. Patients will be called up 
to 6 times at different times of the 
day to make contact. Once 
contacted, research coordinator 
(RC) will confirm eligibility and 
obtain verbal consent to study 
procedures. For consenting 
patients, RC will administer the 
baseline survey and verbally 
consent them to participation in 
the VA “Annie” program and 
motivational texting program.  
Documentation of verbal consent 
to Annie participation is required 
by the VA Office of Connected 
Care. Annie consent language 
has been approved by MVAHCS  
representative (Lara Carson, RN, 
MyHealtheVet coordinator). 
Verbal consent will be 
documented in CPRS in a 
Research Participant Note 
utilizing the “Annie Consent” 
template. Patients who decline to complete baseline and immediately have care coordination will be 
considered ineligible. PCP and PACT pharmacist will be notified by co-signature to a research participant note. 
 
Baseline Assessment:  
Phone survey will assess: current tobacco use, motivation to quit, prior quit experiences, use of technology, 
and severity of shortness of breath.  See table of measures.  Charlson comorbidity index and history of mental 
health diagnoses will be pulled from the CDW.  
Annie Enrollment:  
All consenting participants will be enrolled in the VA “Annie App” and will receive an initial text message 
informing them of this enrollment. The Annie App is the VA’s text-message-based health promotion platform 
used to provide education, self-management and clinical protocols. Participants will need to reply once to this 
message to confirm enrollment. Participants already enrolled in the Annie App will have this participation 
confirmed in the Annie portal.  
Randomization:  
Consenting participants will be randomized 2:1 to the intervention versus usual care using the enrollment 
application. To maintain balance in race and gender, randomization will be stratified by these characteristics; 
within strata, randomization will employ randomly permuted balanced blocks of size 2, 4, and 6. 
Figure 1:  Study flow diagram of the randomized pilot evaluation 

 
Proactive Protocol V2.1  11/20/23 
Usual Care:  
Participants in the usual care arm will be managed per usual as directed by their medical team.  
Intervention:  
Participants randomized to the intervention will be enrolled in a longitudinal motivational text-messaging 
program designed to increase quit attempts and participation in tobacco treatment.  In collaboration with the 
MVAHCS Annie representative, the motivational protocol was adapted from a nationally available protocol 
available to all clinicians in the Annie App. Tailoring of the content included the addition of COPD-specific 
motivational quotations and information, inclusion of the local number to contact the study team, as well as the 
option for a “call back” from the team. 
The Annie protocol will deliver approximately 30 motivational messages and a weekly “check in” over a 12 
week period. The program will initially text participants once daily for 2 weeks, then approximately once every 
three days for 4 weeks, then every week until 12 weeks. Participants can opt out at any time from Annie by 
texting “stop” or by calling the study team to be discharged from the protocol.  Protocol will encourage 
participants to call the study team to connect them to evidence-based tobacco cessation treatments or to call 
the VA quitline. 
Care Coordination:  
All treatments offered are standard of care within the VA and are offered in the context of routine clinical care. 
Study number is a secure VA number with voicemail that will be monitored. Participants who call back or 
request a call back via the Annie App will receive a return phone call as soon as possible, within a week. 
Request for callback and date will be logged in study log. For those participants who indicates a readiness to 
quit but do not call either the study team or their primary care physician, a study team member will call the 
participant when they are next monitoring participants within the Annie Program. 
 
Both PI and RC are trained in motivational interviewing. At least 6 attempts will be made to return all calls at 
different times of the day. If participants are unable to be reached after 6 attempts, a letter will be sent 
encouraging them to call back, to call the quitline, or to contact their primary care provider.  
Participants will be encouraged to enroll in an available MVAHCS quit program that provides both counseling 
and medication management. Phone script will encourage enrollment in more intensive programs first.  Offered 
programs will include:   
• 
Primary Care/Mental Health integration (PMCI) tobacco cessation management (if enrolled in mental 
health) 
• 
Tobacco cessation class with pharmacist co-management 
• 
Pharmacist tobacco clinic 
• 
Quitline with primary care or pharmacist medication management 
• 
Stay Quit Coach App or SmokeFreeVet texting (VA tobacco treatment programs) and primary care 
medication management 
 
For participants still unwilling to enroll in treatment, they will be offered a stress relief program and can request 
a one-time callback in a month.  
Once the participant has elected which program they would prefer, study staff will place the appropriate referral 
within CPRS, addending the research participant note to document the selection and discharging the 
participant from the Annie protocol. 
• 
Pharmacist: Direct co-signature to PACT pharmacist in CPRS  
• 
Cessation class or PCMI: notification to Dyani Saxby, tobacco lead clinician 
• 
Quitline + primary care medication management: notification to Dyani Saxby (Tobacco Lead 
Clinician)+ documentation that patient consents to quitline call + co-signature notifying PCP 
• 
Direct enrollment in SmokeFreeVet on smokefree.gov website 
• 
Assistance with downloading of StayQuit Coach 
Patients who select to enroll in treatment will be called in approximately a month to ensure they have 
connected with care and have no further questions.  
Final Survey, Biochemical Confirmation of Abstinence, and Qualitative Assessment:  

 
Proactive Protocol V2.1  11/20/23 
Survey: All participants will be surveyed 6 months after randomization to determine participation in any tobacco 
treatment (primary outcome), current self-reported tobacco use, quit attempts, and acceptability and feedback 
of the texting program. Completion via phone will be prioritized but participants will be provided the option to 
complete the survey via Qualtrics link via email or paper copy. Participants will be contacted 3 times via phone. 
If they are unable to be reached, they will be sent a letter encouraging them to call the study team to complete 
the survey.  
EHR: Data will be pulled from the CDW supplemented by limited chart review to identify: prescriptions for 
tobacco-cessation medications, tobacco-treatment-related visits.  Tobacco treatment visits will be identified by 
combining ICD-10 codes for tobacco use and treatment with note titles and visit types for pharmacists, 
psychologists, and primary care providers.  
Biochemical Confirmation of Abstinence: The Society for Research on Nicotine and Tobacco 
recommends obtaining biochemical confirmation of abstinence whenever possible.  We will obtain 
confirmation of abstinence among participants reporting 7-day abstinence in their follow-up survey 
using exhaled carbon monoxide (CO) levels.  We will utilize the  iCO™ Smokerlyzer®. The iCO™ 
Smokerlyzer® is a handheld device that is FDA approved for clinical and research settings to 
provide feedback on CO levels as part of a smoking cessation program or for confirmation of 
abstinence in research. The device connects to the patient’s smartphone and uses an interactive 
smartphone application to collect a breath test to provide instant biofeedback on exhaled carbon 
monoxide (CO) levels. Exhaled CO is an effective measure of combustible tobacco consumption 
and is a recommended test for confirming abstinence, particularly among patients who are likely to 
use nicotine replacement longer term which can lead to misclassification among tests that rely on 
measuring nicotine metabolites. The protocol for iCO™ Smokerlyzer distribution and collection is 
in the attached Biochemical Confirmation of Abstinence protocol. All participants who agree to 
provide biochemical verification via the iCO Smokerlyzer will be compensated with an additional 
$30.  
Interview: Participants will be asked their willingness to participate in a qualitative assessment of their 
participation in the texting program. Participants will be purposively sampled to ensure variation in 
characteristics. Participants will complete a brief (<30 minutes) semi-structured interview conducted by PI or 
RC to obtain feedback on the content, frequency, acceptability and ease of use of the texting program. 
Interviews will be recorded directly into a VA computer and housed behind the VA firewall and transcribed 
using the Word automated transcription function. Study staff will also take notes during the interviews.  
Cost Analysis:  We will prospectively capture information on cost associated with performing the proactive 
tobacco treatment intervention. To estimate the cost associated with implementation, we will capture time 
spent building any templates and electronic tools, and training staff. To estimate cost associated with staffing 
the program once it is created, for one month during the pilot, all study staff will enter daily the time spent in the 
clinical tasks associated with delivering the intervention into a spreadsheet, excluding activities that are related 
only to research administration. To estimate cost related to an increase in use of tobacco treatments 
attributable to the program, we will estimate the difference in use of tobacco treatments in addition to the 
intervention-related costs.  
 
Measurements and Data Source:  
See Table 1 for full list of measurements and data sources. 
 
Table 1: Measures 
Measures 
  
Baseline Measures 
Survey 
Demographics: Age, gender, race, ethnicity, education, income, health literacy 
Health Measures: Self-reported health, respiratory symptoms questionaire, diagnosis of COPD, 
Audit-C 
Access to Technology: Access to devices, access to internet, use of e-mail, use of secure patient 
portal, frequency of texting, electronic health literacy scale 
Tobacco Measures: current tobacco product use, heaviness of smoking index, past-year quit 
attempts and use of cessation resources, ever use of cessation resources, quit confidence scale, 
motivation to quit, intention to quit 

 
Proactive Protocol V2.1  11/20/23 
 
Analysis Plan:  
We will perform descriptive analysis of the demographic and health history measures to describe the 
participants in the study overall, and in each study arm, as well as by outreach contact and receipt of any 
treatment and combination behavioral and pharmacological treatment. We will also summarize these 
measures by gender and race. Our primary aim is to assess the feasibility of implementing a larger trial of the 
electronic patient engagement intervention. Our primary focus then will be estimating rates, along with 95% 
confidence intervals, of outreach contact and treatment referral in the text outreach arm and of receipt of any 
and combination behavioral and pharmacological treatment in each study arm; additional analyses will weight 
observations by sample inclusion probabilities according to gender and race so that sample results are 
reflective of the overall population. While the study is not powered for detecting differences in cessation, we will 
explore potential differences in cessation between the two arms using likelihood ratio chi-square tests.  
In addition to the descriptive information on the composition of the study population, we will identify the 
characteristics of those who respond, receive cessation treatment and those who attain abstinence in each 
arm, again assessing significance of differences in outcomes using logistics regression analyses and likelihood 
ratio chi-squared tests. This information will be valuable for planning a future study comparing the electronic 
proactive outreach intervention with previous studies of phone outreach. We will also descriptively analyze the 
Annie data to further tailor the protocol.  
Power and Sample Size:  
A sample size of approximately 167 participants in the intervention arm will be sufficient to estimate rates of 
contact, referral, and enrollment in behavioral and pharmacologic treatment with a precision (standard error)  of 
+/- 3.9% and the control arm of 5.4%, which will be informative for planning future research.  However, if 
feasible we will continue recruitment to attain more precision. Similarly, we will be able to estimate eligible 
population sizes, outreach connection rates, referral rates, rates of behavioral treatment enrollment and rates 
of pharmacologic treatment separately, and related facets of the intervention delivery to within similar degrees 
of precision. We will have enough variation in patient characteristics to stratify uptake on key variables, 
including age and disease severity. We may not have sufficient power to determine a statistically significant 
increase in enrollment in behavioral and pharmacologic treatment or smoking cessation, but these will be 
examined as aims of future research. 
Cost Analysis: Estimates of time and workload for each staff member and clinical role involved in implementing 
and staffing the program will be combined with regional VA salary information to generate total costs for the 
proactive program. We will combine this also with regional estimates of pharmacy costs and the prevalence of 
EHR 
Charlson comorbidity index, mental health diagnoses 
Outcome Measures  
Study Recorded and 
EHR 
Response to the program (via telephone, via Annie App), timing of response to program, 
Acceptance of referral, choice of referral program, cessation medications (varenicline, bupropion, 
nicotine replacement single/combination), documented tobacco treatment visits (pharmacist, 
class, mental health, primary care) or warm handoff to quitline 
Survey  
Primary outcome: Use of any tobacco treatment  
Secondary Outcomes: Use of combination treatment (behavioral + pharmacotherapy), individual 
treatment choice (program, medications), heaviness of smoking, quit attempts (y/n and number), 
7 day and 30 day abstinence, Stage of change, quit confidence   
Additional Outcomes: Acceptability of text messaging program, feedback on messages, 
agreement to qualitative interview 
Annie App 
Opted out (y/n), number of messages received, Participant responses received through the app 
Cost Measures 
Staff recorded 
Program-associated costs: hours/week for patient identification, number of weekly phone calls, 
average call duration, time spent coordinating care, technology costs (patient identification 
queries, development of eligibility app)  
Treatment-associated costs: medication costs, pharmacy processing costs, average number, type 
and duration of counseling visits (groups, quitline, pharmacist counseling, tobacco-related primary 
care visits, mental health treatment) 
Abbreviations: COPD=chronic obstructive pulmonary disease, EHR: Electronic Health Record 

 
Proactive Protocol V2.1  11/20/23 
COPD and tobacco use at the MVAHCS to produce an overall estimate of cost for the program should it be 
implemented for the total population. 
Qualitative Analysis:  Transcribed interviews and notes will be analyzed using directed content analysis with 
NVIVO software, with constructs based on the technology adoption model and the consolidated framework for 
implementation research.  
Expected Outcomes and Deliverables:  
We expect that an electronic proactive patient engagement program will be feasible and will result in more 
patients enrolling in tobacco treatment. We also expect variation in response to the program by age and 
baseline technology use. We expect to find that the budget impact of the intervention itself is small and that 
most of the increase in cost will be due to increased utilization of existing quit resources. 
Informed Consent 
Participation will be performed under a waiver of documentation of informed consent. The opt-out letter will 
contain all the essential elements of information for informed consent. During the baseline enrollment call, 
subjects will affirm consent to study procedures and Annie protocol and be given the opportunity to ask 
questions related to the study. Subjects will have the option to opt out of further contact at any point.  
 
Withdrawal of Subjects: Participation may be ended by the investigator without regard to the subject’s 
consent at the investigators’ discretion, or if we cannot contact them. Participants may drop out of this study at 
any time without prejudice to any future medical care with the institution or with the Department of Veterans 
Affairs (DVA). The investigator may continue to review the data already collected for the study prior to the 
participant’s withdrawal but cannot collect further information, except from public records data. If at any time a 
patient wishes to drop out of the study, they may contact the PI or the RC.  
 
Risks and Side Effects 
Potential Risks:  The risks of the study include possible breach of confidentiality, lost time, and inconvenience 
associated with participating in a research study, and discomfort with study questions. Veteran subjects may 
feel uncomfortable completing questionnaires or discussing experiences with smoking cessation or use of 
technology—experiences which may have been frustrating. There is a risk of breach of confidentiality if 
information gathered for research purposes is inadvertently shared.  
 
Protection Against Risk 
The study will be designed to minimize potential risks to participants, predominantly risk of breach of 
confidentiality related to research study participation. All study data will be stored on VA servers in restricted 
access files. Study data will be stored and administered using a VA-created secure research database behind 
the VA firewall for recruitment and within Qualtrics for survey data. Each study subject will be assigned a 
unique Study ID. For each study, a single master list (“crosswalk”) will contain subject names, last 4-digits of 
social security number, phone numbers, and unique Study ID. The crosswalk will be stored on a restricted 
access folder on the Center for Care Delivery and Outcomes Research (CCDOR) server and kept separately 
from other study data. In all other study data, subjects will be identified by Study ID only. Only trained and 
approved study personnel will have access to study data. If Veterans experience discomfort while completing 
study procedures, they may skip uncomfortable questions or procedures. Because patients participating in this 
study will have COPD, it is possible that they may experience adverse health events related to their disease. It 
is not expected that participation in the study will lead to any increased risk of adverse health events. We will 
be including Veterans with all severities of COPD, and some may have severe respiratory impairment. If during 
study procedures, the study staff identifies concerns related to a patient’s mental or physical health, the study 
staff will notify Dr. Melzer who will determine the need for further evaluation and notify the patient’s primary 
care provider as necessary.  
 
Monitoring Safety  
Complications of study procedures will be recorded in study logs. Participants will be asked to report any 
adverse events that occur during the study, and adverse events will be recorded in study logs. 
Benefits   

 
Proactive Protocol V2.1  11/20/23 
Participation may have significant benefit for the Veterans if they attempt to quit smoking successfully.  There 
is a small stipend for participation in the surveys and or interview.   
 
Protected Health Information 
This study will use subjects’ Protected Health Information (PHI). PHI collected will be name, address, 
telephone numbers, e-mail, eligibility, and SSNs (last 4 only), as well as dates of care. These are used to 
contact the patient and confirm eligibility. The last four of the SSN is used to document eligibility on the EHR.  
 
Costs to Subjects 
There is no cost to participate in this study.   
 
Subject Compensation  
Participants will be paid $20 per survey for a total of $40 to be paid at the completion of the follow up survey. 
The subset of participants who participate in the interview following the completion of the intervention will be 
paid $30 for their time. Subjects will be paid $30 for providing biochemical confirmation. Participants will not be 
compensated for participation in the text messaging program. Participants will be asked if they already 
participate in EFT. For those not participating, they will be sent the EFT paperwork in the mail after they 
consent to be in the study. This will include all EFT paperwork, a letter explaining how to complete the 
paperwork, and a return address envelop for returning the paperwork to study staff. Study staff will scan and 
send via an encrypted email the EFT paperwork to the Agent Cashier office. In the 5th month of study, study 
staff will confirm EFT paperwork have been completed correctly and resend the EFT paperwork if it has not. 
 
Project Management and Research Team Coordination:   
As PI, Dr. Melzer will lead all activities related to the study, in collaboration with co-investigators and the research 
coordinator.  
 
Data and Safety Monitoring Plan 
The proposed research will be overseen by the Minneapolis VA IRB.  The PI will be responsible for monitoring 
safety, minimizing risks related to data and safety, protecting the confidentiality of subject data, and reviewing 
and reporting adverse events and unanticipated problems to the IRB. 
 
The principal investigator will review reports of adverse events and unexpected problems during the conduct of the 
research. The principal investigator will report all adverse events including breach of confidentiality to the 
MVAHCS IRB. The principal investigator will ensure that any IRB recommendations and actions related to 
monitoring are enacted.  
 
Data will be maintained in accordance with MVAHCS protocols.  Electronic information will be housed behind the 
VA firewall and physical files will be kept within locked file cabinets in locked offices.  We are applying for a waiver 
of HIPPA and waiver of documentation of informed consent.  Other patient identifiers will be kept in the separate 
crosswalk.   
 
 
 
 
 
 
 
 
 
 
 

 
Proactive Protocol V2.1  11/20/23 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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