Implementation Intervention to Improve Care for Unhealthy Alcohol Use (CDA 20-057)
Phase: NA
Conditions: Alcohol Drinking, Alcohol Use Disorder
Sponsor: VA Office of Research and Development

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Implementation Intervention to Improve Care for Unhealthy Alcohol Use 
Principal Investigator: Rachel Bachrach, PhD 
Funding Agency: HSR&D 
 
VA Ann Arbor Healthcare System – (506) 
 
11/21/2023 
 
 

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Abstract 
 
Please Note, Dr. Bachrach transferred from the Pittsburgh VA to the Ann Arbor VA, 
HSR&D Center for Clinical Management Research (CCMR) in August 2023. All research 
activities for AIM 1, AIM 2 and the recruitment, enrollment, and intervention activities of 
AIM 3 were completed at the Pittsburgh VA before her station transfer to the Ann Arbor 
VA. We are requesting regulatory approval for the remaining research activities for AIM 3 
only. These activities are limited to completing the extraction, cleaning, and analysis of 
AIM 3 outcome data from the VA’s electronic health record (via the Corporate Data 
Warehouse). Additionally, the study team may pull data from CAPRI/Joint Legacy Viewer 
(JLV) to examine notes, charts, dates of AUDIT-C administration and other details to 
validate the accuracy of our AIM 3 dataset.  
Objectives: Unhealthy alcohol use is common among Veterans and a significant risk 
factor for numerous negative health consequences, including chronic disease, injury, 
mortality, and suicide. It is also linked to increased financial and societal costs (e.g., 
higher healthcare utilization, criminal justice expenses). Due to these burdens, effective, 
evidence-based care for Veterans with unhealthy alcohol use was implemented in VA 
primary care (PC) settings. However, significant gaps in this care have been identified, 
indicating that a substantial proportion of Veterans in need of help are not receiving it. 
This study used an evidence-based implementation strategy called practice facilitation, 
at the VA Pittsburgh, to pilot test whether practice facilitation has the potential to improve 
the quality of PC-based alcohol-related care. 
Research Plan: We are requesting IRB approval for the remaining research activities for 
AIM 3 only. These activities are limited to completing the extraction, cleaning, and 
analysis of AIM 3 outcome data from the VA’s electronic health record (via the Corporate 
Data Warehouse). All research activities for AIM 1, AIM 2 and the recruitment, 
enrollment, and intervention activities of AIM 3 were completed at the Pittsburgh VA. 
 
Methods: Aim 1(completed at the Pittsburgh VA) utilized qualitative methods to assess 
Veteran and PC stakeholders to understand barriers and facilitators to high-quality 
alcohol care, which was then used to help refine and hone the practice facilitation 
intervention. Aim 2 (completed at the Pittsburgh VA) included focus groups with a 
sample of PC providers to assess the acceptability and feasibility of the refined practice 
facilitation intervention. Aim 3 pilot tested the finalized practice facilitation intervention in 
the full PC clinic (this pilot implementation intervention was completed at the Pittsburgh 
VA) to understand whether practice facilitation improves the quality of PC-based alcohol-
related care. The AIM 3 outcome data analysis will take place at the Ann Arbor VA 
utilizing the VA electronic health record (via the Corporate Data Warehouse). 
 
(Please double click the correct box below): 

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  This Study WILL use the VA electronic health record (EHR) or EHR Data on 
or after Jan. 2019 (for example:  entering notes; entering consults; ordering labs, 
medications, procedures, imaging, etc.; eligibility screening with EHR chart 
review or CDW; using CDW data; etc.). 
 
  This Study will NOT use the VA electronic health record (EHR) or EHR Data 
on or after March 2022 (for example:  entering notes; entering consults; ordering 
labs, medications, procedures, imaging, etc.; eligibility screening with EHR chart 
review or CDW; using CDW data; etc.). 
 
 

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List of Abbreviations 
Provide a list of all abbreviations used in the protocol and their associated meanings. 
AUD: Alcohol use disorder 
AUDIT-C: Alcohol use disorders identification test- Consumption survey 
BI: Brief intervention 
CCMR: VA Center for Clinical Management Research 
CDW: VA Corporate Data Warehouse 
DART: VA Informatics and Computing Infrastructure Data Access Request Tracker 
DoD: Department of Defense 
HIPAA: Health Insurance Portability and Accountability Act 
HSR&D: VA Health Services Research and Development Service 
IRB: Institutional Review Board 
PACT: Patient Aligned Care Teams 
PC: VA primary care 
PHI/PII: Protected Health Information/Personally Identifiable Information 
PTSD: Post-traumatic stress disorder 
OI&T: VA Office of Information and Technology 
SSN: Social Security Number  
VA: Veterans Affairs 
VHA: Veterans Health Administration 
VINCI: VA Informatics and Computing Infrastructure 
 

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Contents 
Protocol Title: ............................................................................................................................. 6 
1.0 
Study Personnel .............................................................................................................. 6 
2.0 
Introduction ..................................................................................................................... 6 
3.0 
Objectives ....................................................................................................................... 7 
4.0 
Resources and Personnel ............................................................................................... 7 
5.0 
Study Procedures ............................................................................................................ 8 
5.1 Study Design .................................................................................................................... 8 
5.2 Recruitment Methods.......................................................................................................11 
5.3 Process of Obtaining Informed Consent and Protecting Patient Privacy ..........................11 
5.4 Inclusion/Exclusion Criteria ..............................................................................................12 
5.5 Risk/Benefit Assessment .................................................................................................12 
5.6 Study Evaluations ............................................................................................................12 
5.7 Data Analysis ..................................................................................................................12 
5.8 Withdrawal of Subjects ....................................................................................................13 
6.0 
Reporting ........................................................................................................................13 
7.0 
Privacy and Confidentiality .............................................................................................13 
7.1 Records Control and Disposition……………………………………………………………  14 
8.0 
Communication Plan ......................................................................................................14 
9.0 
References ...................................................................................................................14 
 

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Protocol Title:  
Implementation Intervention to Improve Care for Unhealthy Alcohol Use 
1.0 
Study Personnel 
 
Personnel 
Project Role 
 
Affiliation/employee 
status 
Principal Investigator 
Rachel Bachrach, 
PhD 
 
Ann Arbor VA 
employee 
Co- Investigator/CDA 
Primary Mentor 
Mark Ilgen, Phd 
 
Ann Arbor VA 
employee 
Co- Investigator/CDA 
Secondary Mentor 
Paul Pfeiffer, MD, 
MS 
 
Ann Arbor VA 
employee 
Co- Investigator/CDA 
Secondary Mentor 
Kara Zivin, PhD 
 
 
Ann Arbor VA 
employee 
Research support staff 
Project Manager 
Barbara 
Stanislawski, 
MSW, MPH 
 
Ann Arbor VA 
employee 
Data Analyst  
Brittany Porath, 
MPH 
 
Ann Arbor VA 
employee 
 
 
 
2.0 
Introduction 
 
Unhealthy alcohol use is common among Veterans and a significant risk factor for 
numerous negative health consequences, including chronic disease, injury, mortality, 
and suicide. It is also linked to increased financial and societal costs (e.g., higher 
healthcare utilization, criminal justice expenses). Due to these burdens, effective, 
evidence-based care for Veterans with unhealthy alcohol use was implemented in VA 

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primary care (PC) settings. However, significant gaps in this care have been identified, 
indicating that a substantial proportion of Veterans in need of help are not receiving it. 
 
3.0 
Objectives 
Previous work on this study conducted at the Pittsburgh VA included utilizing qualitative 
interviews with Veteran and PC stakeholders to understand barriers and facilitators to 
high-quality alcohol care and to help refine and hone a practice facilitation intervention 
(AIM 1), conducting focus groups with a sample of PC providers to examine the 
acceptability and feasibility of the practice facilitation intervention (AIM 2), and 
conducting a pilot test of the finalized intervention in the full PC clinic (AIM 3). Research 
activities at the Ann Arbor VA that Dr. Bachrach will be conducting are limited to 
completing the extraction, cleaning, and analysis of AIM 3 outcome data from the VA’s 
electronic health record (via the Corporate Data Warehouse). Additionally, the study 
team may pull data from CAPRI/Joint Legacy Viewer (JLV) to examine notes, charts, 
dates of AUDIT-C administration and other details to validate the accuracy of our AIM 3 
dataset. 
 
4.0 
Resources and Personnel 
 
Project Team 
Rachel Bachrach, PhD, Principal Investigator 
Dr. Bachrach is a Research Scientist and Clinical Psychologist at the VA Ann Arbor Health 
Services Research & Development (HSR&D) Center for Clinical Management Research 
(CCMR), and an Assistant Professor in the Psychiatry Department at the University of Michigan. 
As the PI, Dr. Bachrach will be responsible for all aspects of the project, which include 
managing and supervising research staff, implementation of the research plan, quality control 
checking, analysis of data, and contribute to report and manuscript preparation. She will have 
access to PHI. 
 
Mark Ilgen, PhD, Co-Investigator/Primary Mentor 
Dr. Ilgen is a VA Research Career Scientist and Core Investigator at the VA Ann Arbor HSR&D 
Center for Clinical Management Research (CCMR), Professor in the Psychiatry Department at 
the University of Michigan, and Director of the University of Michigan Addiction Treatment 
Services (UMATS). As primary mentor in Ann Arbor, Dr. Ilgen will advise on CDA-related 
research and training goals. Dr. Ilgen will also help Dr. Bachrach with staffing needs and provide 
guidance in managing research projects at CCMR, including onboarding research staff, study 
management, and troubleshooting research-related issues as they arise. He will also contribute 
to report and manuscript preparation. He will have access to PHI. 
 
Paul Pfeiffer, MD, MS, Co-Investigator/Secondary Mentor 
Dr. Pfeiffer is a Research Scientist at CCMR, the Susan Crumpacker Brown Research 
Professor of Depression, and Associate Professor in the Psychiatry Department at the 
University of Michigan. He also directs the Mental Health Innovation, Services, and Outcomes 
(MHISO) program and supervises a team of investigators who are interested in mental health 

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services research at the VA Ann Arbor. As a secondary mentor in Ann Arbor, Dr. Pfeiffer will 
advise Dr. Bachrach on using her CDA findings as pilot data for a multi-site implementation 
science trial. He will also contribute to report and manuscript preparation. He will not have 
access to PHI. 
 
Kara Zivin PhD, Co-Investigator/Secondary Mentor 
Dr. Zivin is a Research Career Scientist at the Center for Clinical Management Research 
(CCMR) in the VA Ann Arbor Health System and a Professor of Psychiatry at the University of 
Michigan. As a secondary mentor in Ann Arbor, Dr. Zivin will advise Dr. Bachrach on using 
electronic health record data to evaluate her implementation intervention and career 
development issues as they arise. They will meet regularly to determine data analysis needs for 
AIM 3 of the project. She will also contribute to data interpretation and manuscript preparation. 
She will have access to PHI. 
 
Barbara Stanislawski, MSW, MPH, Project Manager 
Ms. Stanislawski is a Project Manager at the VA Ann Arbor HSR&D CCMR. For this study, Ms. 
Stanislawski will have day-to-day responsibility for the oversight of administrative activities 
throughout the remainder of the project. She will be responsible for the preparation and 
maintenance of all regulatory applications and approvals. She will have access to PHI. 
 
 
Brittany Porath, Data Analyst 
Under the supervision of Drs. Bachrach and Zivin, Ms. Porath will conduct data analyses for 
AIM 3 and assist with manuscript preparation. She will have access to PHI. 
 
5.0 
Study Procedures 
 
5.1 
Study Design 
AIM 1: Ann Arbor regulatory approval is not requested for this AIM. All study activities 
were completed at the Pittsburgh VA.  Aim 1 was conducted to further understand 
barriers and facilitators to high-quality alcohol care, and to use the findings to develop 
and hone the practice facilitation intervention. Recruited from a single primary care clinic 
at the Pittsburgh VA, remote-based, semi-structured and open-ended, 1-on-1, interviews 
with key clinical stakeholders and Veteran patients with unhealthy alcohol use were 
conducted. Clinical stakeholder interviews focused on clinicians’ prior experiences 
working with Veterans with unhealthy alcohol use, elicit perceptions and attitudes 
towards alcohol-related care, and elicit feedback on using practice facilitation to improve 
alcohol-related care. Interviews with Veterans asked about preferences and needs 
related to alcohol use and to explore how primary care can best support Veterans in 
achieving goals related to cutting back or abstaining from drinking. Feedback on the 
practice facilitation helped to ensure that providers, staff, and Veterans were receptive to 
the practice facilitation content.  
AIM 2: Ann Arbor regulatory approval is not requested for this AIM. All study activities 
were completed at the Pittsburgh VA. Aim 2 delivered the refined practice facilitation to a 
group of primary care providers and staff, recruited to assess its feasibility and 

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acceptability. Based on participant feedback, the practice facilitation was revised again 
in preparation for the pilot implementation intervention in Aim 3.  The facilitator 
conducted the focus groups with recruited PC staff and providers as a way to practice 
delivering the material, refining the material, and to assess whether material was 
acceptable and feasible in the primary care setting. 
AIM 3: Ann Arbor regulatory approval is being requested for only the data analysis 
portion of AIM 3 (extraction, cleaning, and analysis of AIM 3 outcome data from the VA’s 
electronic health record (via the Corporate Data Warehouse). All AIM 3 recruitment, 
enrollment, intervention, and survey activities were completed at the Pittsburgh VA. AIM 
3 recruited providers and staff in the primary care clinic at the Pittsburgh VA. The 
facilitator met with primary care staff/providers as a group to introduce the final version 
of the practice facilitation. During the early months of the intervention, the facilitator, 
observed clinicians as they cared for patients with unhealthy alcohol use. It was 
essential for better understanding clinic workflow and where gaps in knowledge occur.  
While the facilitator observed clinic workflow, she excused herself when providers or 
patients requested it. She observed providers use of the electronic health record and 
typical workflow as providers triaged and treated patients with unhealthy alcohol use. 
Additionally, the facilitator conducted ongoing monthly meetings with a small subset of 
primary care participants interested in championing this care and communicated 
regularly via email with the clinic champions for ongoing support. Ongoing meetings 
discussed ways to improve alcohol-related care, based on “Plan Do Study Act” or 
“PDSA” cycles, to help providers identify gaps in alcohol care and test solutions to 
optimize care quality.1  Educational handouts for providers and patients were developed 
and distributed and training sessions regarding evidence-based alcohol care (e.g., 
medications for alcohol use disorder, motivational interviewing overview to improve brief 
interventions) was offered when providers expressed a desire for more training and 
education on this topic. Any trainings that occurred were based on VA/DoD clinical 
guidelines for treating substance use disorders, thus part of routine clinical activity. 
Evaluation of the Practice Facilitation Intervention: Implementation and Clinical 
Outcomes. 
Aim 3 implementation and clinical-specific outcomes were derived guided by the RE-AIM 
(Reach, Effectiveness, Adoption, Implementation, and Maintenance) evaluative 
framework, often used to guide implementation evaluations.2 RE-AIM will be assessed 
using EHR data pulled from VA’s Corporate Data Warehouse (CDW). The data pull will 
include data from January 1, 2019 – December 31, 2023, to evaluate these outcomes, 
which includes the pre-intervention period, the active facilitation intervention period, and 
the post-facilitation intervention period (i.e., 3-, 6-, and 12-months after active 
implementation). RE-AIM constructs are defined as follows: 
Reach of alcohol-related care will be assessed at the patient level using EHR data, 
pulled from VA’s CDW. Reach outcomes will be expressed as a rate, with the 

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denominator (for all outcomes) defined as all Veterans with a visit to the Pittsburgh VA 
primary care clinic during the practice facilitation intervention. The numerator for 
each Reach outcome is as follows: the number of Veterans who screened positive for 
unhealthy alcohol use (AUDIT-C ≥ 5) AND had any documented brief intervention, 
encounters with primary care-mental health integration (PC-MHI), encounters with 
PACT/ Whole Health clinical pharmacists, specialty addictions treatment (inpatient and 
outpatient clinic visits for substance use disorder treatment encounters with an 
accompanying AUD diagnosis), or pharmacotherapy for AUD (any filled prescription for 
FDA-approved medications: acamprosate, disulfiram, or oral/injectable naltrexone or 
non-FDA approved effective medications: gabapentin, baclofen, or topiramate) in the 30 
days following a positive screen. Denominators will also be derived to represent specific 
subpopulations (e.g., women, Black and Hispanic Veterans). Rates at the start of the 
practice facilitation intervention and at 3- and 6-months post intervention will be 
calculated to examine change in Reach outcomes over time. 
Adoption is identified as the percentage of providers from the PC clinic who deliver 
alcohol-related care when a Veteran screens positive for unhealthy alcohol 
use. Specifically, we will use data available in the EHR to examine delivery of brief 
interventions, consults placed to PC-MHI/clinical pharmacists or specialty addictions 
treatment and providing pharmacotherapy for AUDs at the provider and clinic level. 
Rates of alcohol-related care pre-intervention (2019-2022), during the course of the 
practice facilitation intervention (July 2022-December 2022), after the intervention (e.g., 
3- and 6-months post intervention (Jan 1, 2023-March 31, 2023, and Jan 1, 2023-June 
30, 2023 respectively) will be used to measure whether adoption rates of alcohol-related 
care increased over time. 
Maintenance is defined as the extent to which evidence-based alcohol care becomes 
routine and part of the PC culture (care sustained over time). Reach and Adoption 
outcomes using EHR data will be assessed at 12-months post intervention (Jan 1, 2023-
Dec. 31, 2023) to examine whether high-quality alcohol care was sustained. 
Effectiveness is defined as the prevalence of unhealthy alcohol use at 12-months post-
intervention (Jan 1, 2023-Dec. 31, 2023) as measured by AUDIT-C scores pulled from 
the EHR. This variable will also be expressed as a rate with the denominator defined as 
all Veterans with a visit to PC during the practice facilitation intervention (same as for 
Reach outcomes). The numerator will be the number of Veterans with an encounter in 
PC who screened positive for unhealthy alcohol use (AUDIT-C ≥ 5) at 12-months post 
facilitation intervention. While it is unlikely that a pilot study will have a measurable 

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impact on clinical outcomes, measuring effectiveness will serve as pilot data for a larger 
trial. 
 
5.2 
Recruitment Methods 
Ann Arbor regulatory approval is being requested only for the data analysis portion of 
AIM 3 (extraction, cleaning, and analysis of AIM 3 outcome data from the VA’s electronic 
health record via the Corporate Data Warehouse). All recruitment, enrollment and 
intervention activities were completed at the Pittsburgh VA.  
Approximately 10,000 Veterans' data will be pulled from the CDW to examine 
implementation and clinical outcomes. Data to evaluate implementation and clinical 
effectiveness outcomes will be obtained electronically and securely from already 
collected administrative databases, using scrambled SSN or Patient ICN to link data 
together. Data sources will include the CDW, Health Factors (AUDIT-C and Brief 
Intervention information), Vital Status File to obtain DOB for calculating age of Veterans, 
and Prescription/Pharmacy information (for data on whether medications for alcohol use 
disorder were prescribed). Other specific records include: sociodemographics (e.g., sex, 
gender identity, marital status, indicator of socioeconomic status, race/ethnicity, sexual 
orientation), past-year diagnoses (Alcohol use disorder diagnosis, Substance use 
disorder diagnoses, Tobacco use disorder diagnosis, Mental Health disorder diagnosis 
(Depression, anxiety, PTSD, Bipolar, Psychotic-spectrum)), index of medical complexity 
(e.g., Charlson index, VA CAN score) utilization of primary care services pre-
implementation (2019-2022), during (July 2022 - Dec. 2022) and post-implementation 
intervention (Jan 2023 - Dec. 2023), referral and utilization of substance use services in 
the past year (yes/no), and referral and utilization of past-year mental health services 
(yes/no). Data may also be reviewed within CAPRI/Joint Legacy Viewer (JLV) to allow 
study team members to look into potential data anomalies from our dataset. In addition, 
members of the study team may review notes, charts, dates of AUDIT-C administration, 
etc. to verify the accuracy of our Aim 3 dataset. 
 
 
5.3 
Process of Obtaining Informed Consent and Protecting Patient 
Privacy 
We are requesting a Waiver of Informed Consent and a HIPAA waiver for full access to 
PHI to complete this work. There will be no participant contact. All data will be stored in 
VINCI (VA Informatics and Computing Infrastructure) or in a restricted access study 
folder located on the Ann Arbor VA secure server. All study team members are current 
on their human subjects protection, HIPAA privacy, and data security training. 

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In accordance with HIPAA, only approved Study Team Members will have access to 
protected health information (PHI).  Computerized data will be stored in an electronic 
folder maintained on the VA Server or behind the VA Firewall. 
5.4 
Inclusion/Exclusion Criteria 
We will include all Veterans with a visit to the Pittsburgh VA primary care during 
the practice facilitation intervention. 
 
 
5.5 Risk/Benefit Assessment 
The risk of accessing identifiable data on VINCI (VA Informatics and Computing 
Infrastructure) or in a restricted access study folder located on the Ann Arbor VA secure 
server is minimal, while the benefit is potentially great. Veterans who are included in 
secondary data analysis may benefit indirectly by improvements in their alcohol-related 
care. In addition, the potential to contribute to scientific knowledge outweighs the 
minimal risks. Unhealthy alcohol use is common and leads to adverse consequences, 
including suicide risk and early mortality. VA has invested in alcohol-related care in 
primary care, however, past implementation gaps have been identified and hypothesized 
to contribute to lower quality and access. The study is aligned with VA and HSR&D 
research priorities focused on access to care, suicide prevention, and implementation 
science and with VA’s commitment to providing patient-centered care for unhealthy 
alcohol use. If effective, the implementation intervention could be scaled throughout VA 
primary care settings, which may optimize return on VA’s large investment in this care. 
 
5.6 Study Evaluations 
Not applicable. 
5.7 Data Analysis 
Implementation Outcomes: Reach outcomes will be reported descriptively (e.g., 
percentage of patients with an AUDIT-C≥ 5 who were offered a BI or pharmacotherapy 
for AUD) and compared pre- (2019-2022) and post-implementation (at 3- and 6-months) 
to see whether Reach of alcohol care increased over time. Adoption outcomes via EHR 
will be descriptive, and include percentages, frequencies, and means (SD) of alcohol-
related care by provider and clinic to understand whether Adoption of high-quality 
alcohol-related care increased over time. Descriptives will be examined and compared at 
the start of Active Implementation and at 3- and 6-months post Active Implementation. 
Reach and Adoption rates will again be examined at 12-months post Active 
Implementation and compared to rates at 3- and 6-months to see if high-quality alcohol-
related care was sustained (Maintenance). Effectiveness outcomes: Effectiveness will 
be assessed via a time-series analysis, where the intervention site will serve as its own 
control, and we will investigate whether Veterans’ with an encounter in Pittsburgh VA 
Primary Care during the implementation intervention reduced their drinking 12-months 
post intervention using AUDIT-C scores in the EHR. Time-series analysis was chosen 
because historical trend is accounted for in the analytic model, results can be displayed 
graphically, and the size of the effect can be estimated at different times post 

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intervention. The outcome (AUDIT-C scores) will be modeled using a regression model 
with an indicator for practice facilitation (pre- vs. post-), a continuous term for time (days 
since practice facilitation dissemination) and the interaction between the two. The 
indicator variable will assess immediate changes in AUDIT-C scores post 
implementation intervention, while the interaction term will assess if there is a change in 
the slope of AUDIT-C scores pre- and intervention at 12-months. While there is 
controversy over whether pilot studies should assess clinical efficacy or effectiveness,3,4 
we decided to examine it here as a training opportunity and as preparation for a possible 
hybrid effectiveness-implementation Merit trial investigating practice facilitation as a way 
to improve alcohol-related care on a larger scale. 
Personal identifiers will be required to pull the dataset from VA databases and link data 
across databases. However, once the data are extracted, merged, and cleaned for 
analyses, the identifiers (such as scrambled Social Security number, or patient ICN) will 
be removed from the dataset and replaced with a unique study ID. We will however 
maintain the linkage between study IDs and scrambled Social Security number or patient 
ICN in the form of a separate crosswalk file stored in VINCI (VA Informatics and 
Computing Infrastructure) or in a restricted access study folder located on the Ann Arbor 
VA secure server until the study is complete. All study team members are current on 
their human subjects protection, HIPAA privacy, and data security training. Only 
approved Study Team Members will have access to the data.  
 
5.8 Withdrawal of Subjects 
Not applicable. 
6.0 
Reporting 
In the unlikely event that a data breach occurs, the study team will notify the Ann 
Arbor VA IRB, Privacy Officers, and Information System Security Officers as 
soon as the breach is identified. 
7.0 
Privacy and Confidentiality 
All study staff accessing the data is approved for VA research and are up-to-date 
on all mandatory annual trainings in data security and human subjects 
protections and are educated in the use of all data security procedures 
necessary to ensure patient privacy and data security. All information will be 
maintained in accordance with the security requirements of 38 CFR section 
1.466 or more stringent requirements. The data analyst will be responsible for 
creating analytic datasets for investigators; these datasets will be de-identified 
per HIPAA guidelines. All resulting research data will be presented in aggregate 
only and will not identify any individual patient in any report of the research, or 
otherwise disclose patient identities. No data will be disclosed outside the VA. 
 

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7.1 
Records Control and Disposition 
Data will be destroyed by the data manager 6 years following the end of the fiscal 
year after completion of the research in accordance with VA policy as described in 
VHA Records Control Schedule 10-1. 
8.0 
Communication Plan (if applicable) 
Not applicable. 
9.0 
References 
 
1. Glass JE, Bobb JF, Lee AK, et al. Study protocol: A cluster-randomized trial 
implementing Sustained Patient-centered Alcohol-related Care (SPARC trial). Implement 
Sci. 2018;13(1):108-120. 
2. Glasgow RE, Vogt TM, Boles SM. Evaluating the public health impact of health 
promotion interventions: The RE-AIM framework. Am J Public Health. 1999;89:1322-
1327. 
3. Leon A, Davis L, Kraemer H. The role & interpretation of pilot studies in clinical research. 
PsyRes 2011;45. 
4. Moore CG, Carter RE, Nietert PJ, et al. Recommendations for Planning Pilot Studies in 
Clinical and Translational Research. Clin Transl Sci. 2011;4(5):332-337.