Video-Enhanced Care Management for Medically Complex Veterans
Phase: NA
Conditions: Multimorbidity, Cognitive Impairments
Sponsor: VA Office of Research and Development

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       Version AMD7 IRB Approved 10.5.17 
 
 
Protocol: 
Video Enhanced Care Management for Medically Complex Veterans 
 
 
ClinicalTrials.gov ID: NCT02962687 
 
 
 
 
Most recent updates approved by IRB:  10/5/2017 
Most recent Continuing Review approval:  10/8/2018 
 
 
 

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       Version AMD7 IRB Approved 10.5.17 
 
 B. BACKGROUND 
B.1. Unrecognized CI is common, especially among older adults with chronic medical illness. Cognitive 
impairment that does not meet the threshold of dementia affects approximately 22% of the adults older than 
70, in the United States.8 The diagnosis of cognitive impairment is often missed in primary care clinics.9,10 This 
may be due, in part, to the high prevalence of co-existing medical conditions that compete for a provider’s time 
and attention. Among VA primary care users >= 65, who have lower health status and higher comorbidity 
compared to age-matched counterparts who don’t receive VA care, 42.5% of primary care users >= 65 were 
found to have previously unrecognized cognitive impairment (total n=630; n=21 with dementia, n=247 with 
cognitive impairment, no dementia [CIND]).2 In a recent study of Veterans with heart failure, a prevalent 
condition associated with high self-care needs, the prevalence of unrecognized CI was 58%.11 Although 
universal screening for CI is not recommended, a targeted case-finding approach in groups with higher-than-
average risk is widely cited as a good strategy.12 Older adults with medical complexity certainly constitute such 
a high risk group. 
B.2. CI is directly related to acute care use and adverse health outcomes. In a recent study in the VA 
system, patients who screened positive for CI had twice the number of hospitalizations and their mean length 
of stay was nearly four times as long as those who screened negative.13 Patients with CI are more likely to 
have functional impairments; in a national sample, 45% of individuals with CI were found to have one or more 
impairments in an instrumental activity of daily living.1 Moreover, patients with CI develop dementia at a greater 
rate than those with normal cognition.8  Dementia is well-known to be associated with higher health care costs 
and increased severity of co-morbid illnesses and potentially avoidable hospitalizations.14 Hospitalizations are 
not only costly; they also constitute a significant burden on patients and families. A large proportion of chronic 
illness care relies on principles of self-management and patients with CI likely need increased support in order 
to comply with complicated medication and care regimens, and avoid subsequent unnecessary emergency 
department (ED) and hospital use.  
B.3. Unmet needs and opportunities for intervention. 
B.3.a. Poorly coordinated care. Patients with medical complexity and CI receive care that often is fragmented, 
inefficient, and ineffective. For example, the risk of potentially avoidable inpatient admissions or preventable 
complications in an inpatient setting increases dramatically with the number of chronic conditions among older 
adults.15 People with multiple chronic conditions (MCC) are seen by health care providers frequently and in 
multiple settings (hospitals, EDs, outpatient and specialty clinics, nursing homes, home health care 
providers).The need to receive, process, and integrate information from multiple settings and providers is 
especially difficult for patients with CI. Thus, care coordination, which recognizes the diversity of the full 
spectrum of disease burden in older adults, rather than trying to manage each condition in isolation, is an 
essential component of improving care in this population.16 Care coordination directly addresses medical 
complexity through reducing workload burden.4 
B.3.b. Risk of progression to dementia. CI progresses to dementia at an annual rate of 12%.8  Thus, protecting 
cognitive health is an essential goal in this population. The Institute of Medicine recently endorsed three 
evidence-based strategies for promoting cognitive health: 1) increasing physical activity; 2) reducing 
cardiovascular risk factors including hypertension, diabetes, and smoking; and 3) managing medications and 
health conditions that could affect cognition.6 Interventions to promote cognitive health directly address 
complexity through enhancing capacity.3 
B.3.c. New care models need to be integrated with primary-care and scalable. Given the increasing number of 
affected individuals, specialized medical homes for complex-needs patients in communities throughout the 
U.S. are not likely to be feasible.17 In VA, the majority of patients with MCC are cared for in traditional PACTs; 
thus it is essential to develop care models that are integrated with primary care. The geographic dispersion of 
Veterans receiving care throughout VHA makes it imperative to develop care models beyond traditional face–
to-face encounters.  
B.4. Previous studies of interventions for patients with medical complexity and CI. A recent review 
highlighted the fact that few dementia care management programs have targeted patients with mild cognitive 
deficits; the majority of interventions have focused on caregivers and none specified reducing hospitalizations 
as a primary aim, although reducing hospitalizations among older persons with CI is an explicit goal of Healthy 
People 2020.18  

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       Version AMD7 IRB Approved 10.5.17 
B.4.a. Rising rates of internet use and video visits with older adults. Among older adults who use the internet, 
71% go online every day or almost every day, and an additional 11% go online three to five times per week. 
These older internet users also have strongly positive attitudes about the benefits of online information in their 
personal lives. Rates of internet use among older adults are rising rapidly, at an annual rate of 6-10% per 
year.19 A 2013 study compared video visits to in-person visits in patients with Parkinson’s disease (mean age 
67, 22% female) and found them to be feasible (93% completed as scheduled) with no difference in clinical 
outcomes between the groups.20 Video visits on mobile devices afford the opportunity to assess a patient’s 
environment, thereby replicating certain aspects of home visits, and are currently used to provide clinical care 
for geriatric populations within VA, such as Home Based Primary Care. 
Key conclusions from evidence review   
 
1. CI is prevalent and often unrecognized among medically complex patients.  
 
2. There is a need for new interventions aimed at reducing acute care utilization among patients with CI. 
3. Increasing numbers of older adults use the internet and are open to technology-enhanced interventions. 
4. There is some evidence supporting the feasibility of video visits in older adults; but it is uncertain 
whether video visits offer advantages over telephone-based care management in this population. 
B.5. Conceptual Framework. The 
conceptual model by Shippee and 
colleagues provides the theoretical 
framework for designing the care 
management program to support patients 
with medical complexity and CI 
(illustrated in Figure 1).3 Patients with 
chronic conditions face many treatment 
demands, including managing 
appointments and advice from multiple 
treating providers, following medication 
schedules, self-monitoring their condition, 
and practicing proactive health 
behaviors. These constitute a patient’s 
workload. Other demands/factors that 
may limit capacity include financial 
concerns, access (transportation) problems, low health literacy, lack of social support, and prevalence of 
mental health disorders like depression and CI.4  We will target patients with high cumulative complexity 
by enrolling older patients with high Care Assessment Need (CAN) scores and identifying those with 
the additional, significant capacity-limiting factor of CI. Our intervention will focus on both pathways that 
interact to lead to poor health outcomes: healthcare workload demands, and factors that limit patient capacity. 
Consistent with the model’s emphasis on social support as an essential factor in overall complexity, we will 
engage and incorporate a Care Partner (friend, family member, or caregiver) as a critical member of the patient 
care team.  
B.6. Alignment with VA Goals and Objectives. The study directly addresses a major priority for VHA as 
outlined in the VHA Blueprint for Excellence, Transformational Action 1.2.a. Enhance Coordination-of-Care and 
the use of Patient-Aligned Care Teams (PACT) for Veterans with the Most Complex Care-Needs and 
Transformational Action 3.2.d. Proactively identify individual patients at risk for undesirable outcomes such as 
death, hospitalization, or preventable medical complications and identify specific interventions that are most 
likely to reduce risk.7 
B.7. Preliminary studies led by research team members. 
B.7.a Studies of nurse-led interventions in high-risk populations and studies enrolling dyads. Together the team 
has extensive experience conducting trials of nurse-led care management and transitional care interventions. 
Dr. Hastings leads Discharge Information and Support for Patients Receiving Outpatient Care in the 
Emergency Department (DISPO ED; HSR&D 12-052, PI Hastings), an ongoing clinical trial examining a nurse-
led telephone care program for Veterans treated and released from the ED who are at high risk for repeat ED 
visits.21 To date, the study has enrolled 490 of 514 Veterans, ahead of the planned enrollment schedule, with 
96% of patients completing all follow-up measures. Dr. Van Houtven leads and Dr. Hastings is a key co-
investigator of an ongoing RCT testing an innovative informal caregiver support training program aimed at 
odel 

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       Version AMD7 IRB Approved 10.5.17 
increasing days at home for Veterans referred for home-based care services (Helping Invested Families 
Improve Veterans’ Experiences Study (HI FIVES).22 Practical, feasible, IRB-approved procedures were 
established for enrolling the dyads and to date HI-FIVES has successfully enrolled 230 patient/caregiver 
dyads. The V-STITCH study (VA HSR&D IIR 20-034, Co-PI Oddone) was an RCT conducted in the Durham 
VAMC’s primary care clinics (N=588) that 
tested a behavioral intervention involving a 
nurse contacting patients by telephone 
every 2 months for 24 months. HINTS (VA 
HSR&D IIR 04-426, Co-Is Oddone and 
Van Houtven) was a 4-arm RCT with a 
nurse telephone intervention component 
aimed at improving BP control (N=591). Dr. 
Hendrix led a study to train informal 
caregivers of hospitalized Veterans (VA 
HSR&D PPO 09-272, Co-Is Hastings, Van 
Houtven) that included a telephone call 
from a nurse within 24-72 hours of hospital 
discharge. The post-discharge telephone 
call was successfully delivered to 94% of 
subjects. Thus, the proposed team has 
broad experience delivering nurse-led 
interventions, including recruiting and enrolling dyads of medically complex Veteran patients. 
B.7.b Estimates of cognitive impairment in patients with multiple chronic conditions (MCC). In order to collect 
preliminary data for the current proposal, we administered the Telephone Interview of Cognitive Status, 
modified version (TICS-m) to 35 participants in DISPO ED, a clinical trial that enrolls patients with a history of 
high health care utilization and MCC.21 Figure 2 displays TICS-m score, according to age. Overall 34% of 
respondents scored in the range of 20-29, suggestive of mild CI.23 
B.7.c. Acceptability of Video-Enhanced Intervention: Survey of Veterans with MCC and Caregivers. As part of 
Dr. Hastings’ DISPO ED study and Dr. Van Houtven’s HI-FIVES study we examined prevalence and 
characteristics of internet use, and attitudes about new technology in Veterans and caregivers aged 65 and 
over (n = 59; see Table 1).  We found that 58-75% of Veterans and caregivers aged 65 or over had used the 
Internet in the last year, and both groups indicated a high level of comfort with it (mean 4.2 on 5-point scale).  A 
key finding was that Veterans ages 65 and over indicated high levels of willingness to communicate with a 
health team using videoconferencing software on a cellphone, tablet or laptop (mean 4.3 on 5-point scale). 
Table 1.  Older Veterans and Caregivers – Attitudes about and Use of Technology 
 
DISPO ED:  Veterans 
Age >65, n=40 
HI-FIVES: Caregivers 
Age>65, n=19 
Age, mean (SD) 
69.6 (5.1) 
72.4 (5.4) 
Gender (% male) 
97.5% 
0% 
% White 
70.% 
60% 
% African American 
30.% 
45% 
Education1 (% w/ HS or less) 
 
27.5% 
36.8% 
Economic Situation2  (% insecure) 
37.5% 
31.6% 
Used internet in last year (% yes) 
75% 
57.9% 
   If yes, Comfort level with using internet (1 – 5 scale; 
mean) 
4.2 
4.2 
   Frequency of internet use (% once per week  
   or more) 
63.4% 
100% 
   Cell 
32.5% 
5.3% 
   Tablet 
27.5% 
21.1% 
   Laptop 
32.5% 
21.1% 
   Other computer in home 
40% 
42.1% 
   Computer outside home 
5% 
10.5% 
0
5
10
15
20
25
30
35
40
45
50
60
65
70
75
80
85
90
TICS Score
Age

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C. SIGNIFICANCE 
This pilot study will 
provide important 
information about 
the feasibility, 
acceptability and 
usability of a novel care management program for a large and vulnerable group of Veterans, who are high 
utilizers of the health care system and at risk for adverse health outcomes. In 2012, over 52% of the 6.2 million 
Veterans receiving primary care in VA were age 65 years or older; thus, if proven effective, the care 
management program for medically complex Veterans with CI could have a direct impact on the way care is 
delivered to a large number of Veterans. This study is extremely timely timely and innovative in its use of a 
population-based screening approach to identify patients for a multi-faceted, non-disease based intervention, 
and its exploration of video visits in patients with CI and a self-identified Care Partner.D. APPROACH 
D.1. Overview of Study Design. We propose a pilot study to test a 12-week video-enhanced nurse care 
management program for medically complex older Veterans with CI, delivered via telephone or through video 
visits. This study will test a 12-week intervention; in a larger RCT, we plan to continue the intervention for 12-
months. Veterans aged 65 or older with Care Assessment Need (CAN) scores >=75will be contacted by phone 
and screened for CI using the TICS-m. Respondents with scores in the range of 20-29 (predictive of cognitive 
deficits in the mild range)23 will be invited to participate in the study. Following informed consent and baseline 
data collection, participants will be randomized (1:1) to receive the intervention via telephone or through video 
visits on iPads. The program will consist of monthly telephone or video calls enabled by the Pexip Infinity 
application (version 12.2) on iPads, with the goal of providing structured information and support in two key 
areas: (1) care coordination (reduce workload) and (2) protecting cognitive health (build capacity).All subjects 
will participate in an outcome assessment call at week 14, consisting of survey items and a semi-structured 
interview. Study team will also conduct qualitative interviews with participants and their care partners after the 
14 week assessment. These calls will be recorded and transcribed.  At the beginning of each call, study staff 
will capture each patient’s and care partner’s assent to record the phone call.  Study flow is illustrated in Figure 
3. The study will enroll 40 dyads (Veteran participants and Care Partners).  
 
 
D.2 Participant eligibility criteria. 
D.2.a. Inclusion Criteria (Veteran). To be included in the study, patients must meet all of the following: 
1. Receive primary care from a Durham VAMC affiliated primary care clinic (≥ 1 visit within the previous 
12 months)  
2. Age > 65 
3. CAN score > 75  
4. Participant must have a valid email address 
5. Valid telephone number in the medical record 
6. Identifies a friend or family member that we may contact for study participation as the Care Partner 
7. TICS-m score 20-31 
Use of Skype/FaceTime/ 
videoconferencing software (% yes) 
40% 
26.3% 
Willingness to videoconference with health team (1 – 5 scale; mean): 
   Using a cellphone/smartphone 
4.3 
3.7 
   Using a tablet 
4.3 
3.8 
   Using a laptop 
4.3 
4.4 
   Using another computer in the home 
4.1 
4.2 
   Using a computer outside the home 
3.2 
2.7 
Figure 3. Study Flow 

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       Version AMD7 IRB Approved 10.5.17 
D.2.b. Rationale for targeting patients age ≥65 years with high CAN score. As a validated tool that has been 
successfully implemented throughout VHA nationally, CAN risk scores provide an ideal way to identify a 
medically complex population. The CAN score (v. 2.0) is derived using predictive analytics from 36 input 
variables captured from various Corporate Data Warehouse (CDW) domains.24 CAN scores provide an 
estimated probability of hospital admission or death within a specific time frame (either 90 days or 1 year). The 
score is expressed as a percentile and is reflective of how a given patient compares with other VA patients in 
terms of probability of hospitalization or death. For this study, we will use the model calibrated for predicting 
hospitalization within 1 year, and focus on Veterans with CAN score of >75.We target individuals 65 and older 
due to higher prevalence of CI in this population. 
D.2.c. Cognitive Screening Procedures. The TICS-m (9-11 min administration time) is a 50-point global 
cognitive screening tool that has been well-validated for use in multiple populations and was specifically 
designed for use over the telephone (i.e. no visually mediated items). TICS-m scores in elderly populations 
have been shown to be normally distributed and without evidence of a ceiling effect which limits the ability of 
other instruments to detect early CI.25 TICS-m has been used as a reference standard for telephone-based 
detection of cognitive impairment.26,23 Participants with score between 20 and 31 (education-adjusted) will be 
eligible for the study, because scores in this range have been shown to correlate with cognitive impairment in 
the mild range23 and to differentiate normal from impaired individuals when adjustment for education level is included. 
The small number of patients who scored in the 30-31 range and did not initially meet criteria for eligibility in the first 
months of study enrollment (original TICS criteria range = 20-29) will be re-contacted by study staff and offered 
participation. The VHA “Screening for Cognitive Impairment” directive does not recommend screening for 
cognitive impairment in asymptomatic older adults. The directive also states clinicians should be alert to early 
signs or symptoms of cognitive impairment and evaluate as appropriate. Therefore, at each nurse encounter, 
participants will have a note entered into the electronic health record (CPRS) notifying the patient’s primary 
care team of any relevant clinical issues. If symptoms of cognitive impairment are noted by either the nurse 
manager or care partner an alert notifying the team of the noted symptoms will also be included in the CPRS 
progress note.  
D.2.d. Exclusion criteria (Veteran).  Patients will be excluded if they meet any of the following:  
1. CI or dementia (identified via ICD diagnosis codes or PCP note in previous 2 years) 
2. Enrolled in or have an active consult for a special population PACT (e.g. GeriPACT, Home Based 
Primary Care, Mental Health, Post-Deployment, etc.) 
3. Are enrolled in a study that prohibits participation in another study 
4. Serious mental illness defined as diagnosis of psychosis of any type, schizophrenia, bipolar disorder, 
psychiatric hospitalization in the previous year or current high-risk suicide flag in their CPRS medical 
record 
5. Are currently hospitalized or incapacitated for any reason 
6. Active substance abuse, documented in the medical record within the previous year 
7. Eligible for hospice, palliative care, or prognosis of less than 6 months to live 
8. Lack decision-making capacity, documented in the medical record 
9. Referred to institutional care or residing in nursing home 
10. Unable to communicate on the telephone, or no telephone access for duration of study  
11. Care Partner fails six-item screener or has no access to phone, and no other Care Partner available 
At the clinical discretion of the study physician (PI), subjects may be enrolled in the study with an exclusion criteria if the 
clinical criteria (#1, 4, 7) is determined not to affect eligibility (for example, a previous dementia diagnosis in a patient 
whose clinical record notes do not indicate evidence of dementia). 
D.2.e. Care Partners. The Veteran participant will identify their Care Partner of choice. Care Partners must be 
aged 18 or older, able and willing to provide informed consent for study participation (must score 5 or higher on 
a brief and reliable 6-item cognitive screen),26 and able to communicate by telephone. In order to serve as the 
Veteran’s Care Partner, an individual must be willing to join the Veteran for telephone or video calls and 
participate in outcome assessment calls. We propose to enroll dyads for three key reasons.  First, the study 
focuses on older Veterans with CI; the participation of a partner can help the Veterans to understand and 
implement care recommendations, as well as access the technology required for video visits. Second, in our 
pilot studies, many Veterans expressed to us that their usual and preferred manner of receiving health 
information is through a spouse or adult child.21 Third, this is consistent with the growing literature about the 

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       Version AMD7 IRB Approved 10.5.17 
important role of companions in medical care, and expert recommendations that care be better integrated with 
family and caregivers.16,27 
 
 
D.2.f. Recruitment Pool. The number of Veterans who would have been eligible for this study in March, 2015 
based on age, CAN score >=90, and no pre-existing diagnosis of dementia is listed in Figure 4. In our pilot 
work, we examined the prevalence of other eligibility criteria and found that 1.3% did not have a valid 
telephone number, 1.7% were nursing home residents, and 1.9% were unable to talk on the telephone. 
Therefore, taking additional exclusions into account and anticipating 34-40% will score between 20 and 29 on 
the TICS-m, we project that 475-600 Veterans will meet all study eligibility criteria. It is anticipated that because 
the population of patients selected for this study will have at least a CAN score > 75, they may seek additional 
medical care for events related to their diseases (and care may involve hospitalizations).  They may also 
experience seasonal health issues such as flu or allergies.  It is also anticipated that during study participation, 
they may seek medical assistance to recover from accidents or planned surgical procedures. 
 
D.3. Enrollment Procedures. Using an automated data pull, study staff will first identify the patients who meet 
criteria for age and CAN score and apply exclusion criteria based on 
clinic stop and diagnosis codes available in CDW. Study staff will 
then conduct a brief medical record review to check for exclusions 
that are not readily available in CDW (e.g. residential status). During 
the medical record review study staff will determine if the patient has 
“decision-making capacity” by searching the medical record notes 
section using the key term “capacity”. The patient will be considered 
initially eligible if study staff finds that the patient has decision-
making notated in the medical record. The patient will not be initially 
eligible if the term or similar term “lack of decision-making capacity” 
is found in the record. If term “capacity” is not found, study staff will 
assume decision-making capacity is intact. Of those eligible, we will 
mail introductory recruitment letters signed by the PI (see Sample 
Letter; Appendix).  Patients will be provided a toll-free number to 
contact if they do not wish to be contacted further.  Starting about one week after mailing recruitment letters, a 
member of the study staff will call patients to ascertain eligibility and obtain informed consent from the Veteran 
participant and Care Partner. During the phone screen process, study staff may use their discretion with the in-
put of the Care partners to further determine whether the patient’s decision-making capacity is intact. For the 
Care Partner, the Six Item Screener (SIS), a cognitive assessment instrument, will be administered by trained 
study staff prior to Care Partner consent.  If there is any question as to whether or not a potential adult subject 
has decision-making capacity, study staff will consult with a qualified practitioner (i.e., the study physician or 
study RN) about the individual’s decision-making capacity before proceeding with the informed consent 
process.  Because the screening and enrollment is entirely telephone based, we will seek a waiver of 
documentation of informed consent, as approved by the Durham VAMC IRB in our ongoing studies using 
similar recruitment methods.   
  Figure 4.  Study Recruitment Pool 
D.3.g. Rationale for Enrollment and Screening over the Telephone. We have opted not to enroll Veterans at a 
primary care visit or other in-person visit for a number of reasons. First a telephone-based strategy expands 
the reach of the intervention by allowing enrollment from multiple community-based outpatient care clinics and 
not just the main hospital clinic. Most importantly this strategy mimics more closely how this intervention would 
be implemented if effective. We will track number of attempts to contact, and examine differences between 
patients who enrolled or refused and those we were unable to contact to inform future implementation efforts.  
D.3.h. Randomization Procedure. Once patients and Care Partners have provided verbal consent and 
completed the baseline measurement battery, study staff will randomize the Veteran to Telephone-Based Care 
Management (Section D.4) or Video-Enhanced Care Management (Section D.5).  Randomization assignments 
will be performed by the study statistician and the entire study randomization will be done before patient 
enrollment begins.   We will stratify randomization based on whether or not patients are ‘experienced with 
relevant technology’. Participants will be considered ‘experienced with relevant technology’ if they indicate use 

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       Version AMD7 IRB Approved 10.5.17 
of a tablet to regularly access the internet OR experience using videoconferencing/videochat platforms. This 
definition was based on review of prevalence data in an ongoing RCT. 
D.4. Arm 1: Telephone-Based Care Management Intervention. The core components of the intervention 
(delivered to both arms) are listed in Table 2. Based on a strong conceptual framework,12 the care 
management program features monthly calls to deliver information related to improving care coordination28 
(e.g. assistance with medication and appointment management) and protecting cognitive health13 (e.g. 
promoting physical activity and smoking cessation). Consistent with the literature on the most effective care 
coordination models, the study nurse will also accompany patients to one PCP visit (for those who have one 
scheduled during the study period), and provide additional calls and support after any ED visits or hospital 
admissions.  For patients randomized to Arm 1: Telephone-Based Care Management Intervention all study 
contacts (excepting the PCP visit) will occur over the telephone. 
 
 
D.4.a. Structure and timing of nurse contacts. Scheduled calls with the study nurse will begin 2 weeks after 
randomization (to reflect the time needed for the Pexip test call, Section D.5.a), and occur every 4 weeks 
thereafter. Beyond having a more sustained intervention period, we anticipate that more frequent contacts may 
be beneficial; however, in this feasibility pilot we will limit the intervention to a total of 4 scheduled calls. We will 
explore the potential benefits of more frequent calls in the qualitative interviews post-study completion (Section 
D.6.b). The Care Partner will be encouraged to participate in all calls. Also as noted in Table 2, the nurse will 
make additional telephone calls to patients as needed for acute events (e.g. ED visits), and will accompany the 
patient to a PCP visit, for those patients who have one scheduled during the intervention period.  
 
Table 2. Summary of Core Components of Care Management Intervention and Related Evidence 
Care Coordination5 
Evidence-based Recommendation 
Core Components of Care Management 
Program 
Additional Strategies in Video-Enhanced 
Intervention 
Supplementing telephone calls to 
patients with in-person meetings 
N/A 
Supplementing telephone calls to patients 
with video calls allows for eye contact, 
reading facial expressions, improved ability 
to assess patient comprehension of new 
information 
Occasionally meeting in person with 
providers 
Accompanying patient to a PCP visit 
N/A 
Acting as a communications hub for 
providers 
Notes in CPRS to communicate with 
PACT team 
N/A 
Delivering evidence-based education 
to patients 
Strong emphasis on physical activity 
promotion  
Ability to demonstrate recommended 
exercises and environmental assessment 
for potential hazards  
Medication management 
Medication reconciliation and providing 
medication adherence aids 
Direct observation of patient performing 
tasks such as filling pill box, using Metered 
Dose Inhalers, etc. 
Providing transitional care after 
hospitalizations 
Telephone and/or video call with patient, 
Care Partner, and PACT after 
hospitalizations or ED visits, available 
by telephone for “acute health events” 
Visual assessment of health condition 
following acute events 
Protecting Cognitive Health, from Institute of Medicine6 
Encourage physical activity.  
Strong emphasis on physical activity 
promotion and referrals to exercise 
programs, c/w evidence-based benefits to 
physical and cognitive health 
Assess physical abilities to tailor program 
referrals 
Reduce and manage cardiovascular 
disease risk factors (including 
hypertension, diabetes, and 
smoking). 
Individualized education for chronic 
disease management; smoking cessation 
counseling and referral to programs to 
support cessation 
Direct observation of patient or Care 
Partner checking BP, measuring blood 
glucose, administering insulin 
Review medications that might 
influence cognitive health  
Patient education about potentially risky 
medications; note in CPRS to provider 
when potentially inappropriate 
medications (PIMs, according to Beers’ 
criteria) are identified 
Visual inspection of over the counter 
medications and those prescribed by 
outside providers as possible PIMs 
 

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D.4.b. Content and delivery of nurse calls. Following procedures in use in HI-FIVES, intervention content will 
include both core and tailored content, selected according to participants’ individual needs.22 Core topics 
delivered to all participants will include medication management (medication reconciliation, adherence 
counseling and aids if needed, and physical activity promotion (education about recommended physical activity 
levels and walking, personal goal-setting and program referrals (e.g. Silver Sneakers, MOVE, Gerofit). In 
addition, the nurse will conduct a medication review and provide a report to PCPs when potentially 
inappropriate medications are identified. The medication review will utilize explicit criteria (Beer’s) updated by 
the American Geriatrics Society in 2015 focusing on medications that worsen cognition.29  We focus on 
medications and physical activity given the evidence of both physical and cognitive benefits of improving care 
in these domains. The study nurse will select the topic for the 3rd call, based on needs and preferences 
expressed by the participant and Care Partner Consistent with our conceptual framework (Section B.5) and 
guiding principles for the intervention content (Table 2), other potential topics include smoking cessation, blood 
pressure management, diabetes care, informal care support programs, sleep patterns, and falls prevention.  
Following each telephone or video visit, the study nurse will enter a note in CPRS documenting the 
information reviewed and referrals made. All notes will be copied to the patients’ PCP and PACT Nurse. 
Following procedures in use in DISPO ED, the study nurse will enter unsigned orders, if needed, for the PCP 
to review and accept (sign).  Examples include orders for exercise program referrals. This approach has been 
used successfully with very high uptake of recommendations (93%) in a previous VA study.29  
The study nurse will use software already developed for previous Durham HSR&D Center of Innovation 
(COIN) studies including DISPO ED, to guide content delivery during calls, including scripts and questions for 
patients. This software adheres to current VA information security standards, and will be linked with a secure 
SQL Server database, following procedures developed by COIN IT staff and used successfully by numerous 
COIN investigators. Patients are offered printed and mailed information about the topics discussed if they 
desire, including how to reach the study nurse for additional questions or issues. Each call will end with open-
ended questions, allowing Veterans to describe additional needs that were not addressed. In order to 
understand staff time needed for the full intervention, we will carefully track interventionist time spent on calls 
(including attempted and incomplete calls), reviewing medical records, and documenting and making referrals. 
D.5. Arm 2: Video-Enhanced Care Management Intervention. Patients randomized to Arm 2: Video-
Enhanced Care Management Intervention will receive the same number of contacts delivered on the same 
schedule and focused on the same key components as the telephone-based program. The primary difference 
in the video-enhanced intervention is that the nurse will communicate with the patient and Care Partner using 
video visits in secure Virtual Meeting Rooms, facilitated through the Pexip Infinity applications (version 12.2)) 
on iPads. We will use tablets (instead of desktop or laptop computers) so that participants can move them 
around easily if needed to facilitate observation of the Veteran or some aspect of their home environment; iPad 
is a tablet approved for use with the Pexip Infinity application (version 12.2). Table 2 summarizes the 
supplemental strategies that may be used in the video-enhanced intervention. Any scheduled video visits not 
able to be completed due to a technology problem will be conducted over the telephone. The nature and type 
of any technology limitations will be closely tracked. 
D.5.a. Installing software for video calls.  Participants who have their own iPad will be able to utilize it for the 
study. Patients who do not have access to an iPad will be loaned one for use during the study. All participants 
will be provided with detailed instructions for installing the Pexip Infinity application (version 12.2) application or 
have the application pre-installed on their device) and will have access to IT support over the telephone or in-
person at the Durham VA with a study staff member and the facility telehealth coordinator if needed. 
Consistent with current clinical policy for video visits, study staff will collect participant emails addresses to 
send an encrypted email to facility telehealth team for scheduling purposes. Emails addresses will not be 
stored in VA research databases. Research staff will not directly send or receive any emails to patients. All 
patients will participate in a test call with facility telehealth staff before scheduling their first study nurse call. We 
allot 2 weeks from the time of enrollment for the Pexip installation and completion of a test call. If the patient 
cannot complete the Pexip Infinity application (version 12.2) installation within this 2-week time frame (for any 
reason), the intervention will continue using telephone calls only. All patients in the Video-Enhanced Care 
Management Program (Arm 2) will be provided with an iPad cover with built-in stand and keyboard to make 
logging into Pexip easier and quality of video interaction better. 
D.5.b. Technology solution for video calls. We have selected the Pexip Infinity application (version 12.2) for the 
video calls for several key reasons: 1) this technology meets all VA security standards and is currently in use 

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       Version AMD7 IRB Approved 10.5.17 
for in-home video telehealth encounters throughout VHA (FaceTime, Skype, etc. are not approved for use by 
VA clinicians); 2) facility telehealth coordinators can provide ongoing IT support (see Telehealth Coordinator 
letter of support); and 3) use of a tablet (iPad) enables mobility of the device to expand the applications of the 
video link to viewing aspects of the users home environment.  
D.6. Measures and Data Sources 
D.6.a. System Usability Scale. We will use the simplified language version of the System Usability Scale (SUS; 
see Appendix) to measure usability of video visits via iPad. The SUS is a widely-used, simple but reliable 
method to evaluate the usability of new technologies.30 The SUS is well-validated and consists of 10 Likert-
scaled items with scores ranging from 0 to 100.31  
D.6.b. Participant and study staff feedback. Patients and Care Partners will participate in semi-structured 
interviews regarding perceived benefits and challenges of the care management program.  Interviewer scripts 
will include open-ended questions about barriers and facilitators of success in the program, including 
technology-related, and as well as more specific questions to elicit stakeholder perspectives on intervention 
content, and recommendations for improvement (see Evaluation Table; Appendix). We will also seek feedback 
from primary care providers and study staff. 
D.6.c. Measures of intervention effectiveness. In preparation for a future RCT, we will collect outcome 
measures we anticipate using to test intervention effectiveness. Patient reported outcomes will be examined at 
baseline and the 14-week follow-up call (immediately following completion of the 12-week intervention period 
that begins at week 2; Figure 3). Consistent with our conceptual framework, the balance of workload demands 
and capacity directly affect utilization and outcomes; thus we plan to focus on hospitalizations, ED visits, and 
patient-reported outcomes recommended for use in patients with MCC,16 that may be responsive to the 
intervention.  
Hospitalizations and ED visits. To calculate this outcome, we add the total number of days a patient is 
in the emergency department (ED), or hospital. In order to avoid double-counting events, we only count ED 
visits as a discrete day if the ED visit did not lead to hospital admission. We include observation stays as 
hospital days. Data from the outpatient and inpatient files from the CDW will be used to generate counts of 
days associated with emergency care (treat and release), observation stays, and inpatient care, over the 14 
week observation period. ED visits will be identified through the outpatient files according to clinic stop codes 
(130, 131, 102130 and 102131).32  Inpatient encounters will include total days in the hospital (DISDAY minus 
ADMITDAY). 
PROMIS-29. The Patient-Reported Outcomes Measurement System 29-item Health Profile (PROMIS-
29) has good evidence of reliability and responsiveness, and is suitable for telephone administration. PROMIS 
has published its results in 20000+ adults, many with MCC, and has been recommended by the Working 
Group on Health Outcomes for Older Persons with Multiple Chronic Conditions, an expert panel convened by 
the  National Institute of Aging in collaboration with Agency for Healthcare Research and Quality.1611.16 The 
tool has also undergone extensive valuation work enabling translating PROMIS-29 responses into quality-
adjusted life-years.33  
Physical Activity Scale for the Elderly (PASE).  The PASE is a self-report, 12-item scale that measures 
occupational, household, and leisure activity during a one-week period.34 This scale was developed for use 
among older adults and has been validated for use via telephone.  
Medical Outcomes Study: Short Form Social Support Survey Instrument. This  8-item measure reflects 
how often a person looks to others for companionship, assistance, or other types of support, and is well-
validated.35 
Depression and anxiety. It is important to note that eligibility for the current study depends on the 
results of a cognitive screener administered on one occasion and this does not constitute a formal diagnosis of 
any cognitive disorder. Nevertheless, we expect that some participants will be referred for further testing and 
may receive a diagnosis in a clinical setting. There have been no studies reporting harm related to receiving a 
diagnosis of CI; however, some groups have raised concerns about this possibility. Thus we will measure 
symptoms of depression (Patient Health Questionnaire [PHQ]-9) and anxiety (General Anxiety Scale [GAD]-7) 
at baseline and the 14 week follow-up call. The PHQ-9 is a nine item depression scale that is well validated 
and documented in a variety of populations including a geriatric populations and primary care settings.36 The 
GAD-7 is a 7-item anxiety scale with good reliability, as well as criterion, construct, factorial, and procedural 
validity.37 We will utilize a safety protocol to address suicide risk identified during the administration of study 
measures (Appendix). 

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       Version AMD7 IRB Approved 10.5.17 
Other Measures. We will collect information on patient socio-demographics, chronic medical conditions, 
self-rated health, health literacy, and sleep questions. We will review patient medical records to determine 
actions taken by the PCP as a result of the TICS-m score progress note (e.g. Geriatrics, Neurology referrals, 
Neuropsychology testing, scheduling a follow-up visit, etc.) and new diagnoses of CI or dementia. 
D.7. Analyses 
D.7.a. Aim 1:  Examine the feasibility and acceptability of a 12-week care management program for medically 
complex Veterans with CI, delivered via telephone or through video visits. Feasibility will be examined by 
calculating overall rates of eligibility and enrollment, as well as rates of attrition, adherence to nurse calls or 
video visits, and interview completion. Clinical and personal characteristics associated with enrollment and 
study completion will be explored as well via contingency tables and regression analyses.  Acceptability will be 
assessed using in-depth interviews with study participants (Veterans and Care Partners), primary care 
providers, and study staff (Section D.6.b.). We will conduct a formative evaluation of the intervention in order to 
elicit information about ways to enhance acceptability and effectiveness of the intervention in anticipation of 
testing it in a larger study.38 Collecting qualitative data from relevant stakeholders including study participants, 
PCPs and study staff, will provide additional rich context for interpreting other quantitative study results.39 
Tasks and methods for each evaluation stage are described in the Appendix.  
D.7.b. Aim 2: Assess the usability and perceived value of video-enhanced care management, compared to 
telephone-based, among older Veterans with medical complexity and CI. We will administer the SUS at the 14-
week outcome call to participants randomized to Arm 2 (video-enhanced.), care partners, and clinical staff. If 
any participants choose to withdraw from this Arm, we will administer this measure prior to withdrawal. We will 
examine overall sample mean, median, and distributions of scores according to established thresholds (e.g. 
>70 = excellent usability among those aged ≥65 years).  Additionally, we will look at responses to individual 
items to see if certain items are more frequently endorsed (e.g. technical support item) to make refinements 
prior to a larger RCT. We will calculate means (or medians, as appropriate) and distributions of 
hospitalizations, ED visits, and patient-reported outcomes (PROMIS 29, PASE, MOS Social Support, PHQ-9, 
GAD-7) across time points, as well as changes between baseline and 14-week follow-up, as appropriate.  
Because of the small sample size, we will not conduct statistical testing.  However, our descriptive analyses 
will allow us to evaluate whether there are clinically relevant differences in mean study outcomes between the 
two Arms (video-enhanced vs. telephone-based).  Perceived value associated with each delivery method will 
be explored through questionnaires and in-depth interviews with study participants and study staff. 
D.7.c. Sample size considerations.  This is an exploratory pilot study that is not intended to test efficacy.  While 
the sample size chosen must reflect the pragmatics of recruitment during a short enrollment period, we will 
have adequate sample size to provide meaningful confidence intervals for our estimates of feasibility, and 
comparisons between video and telephone delivery methods, and will have sufficient diversity of input on the 
intervention to plan refinements, if needed, prior to testing it in a larger RCT. 
D.8. Dissemination and Implementation Plan  
The results of this pilot study will provide essential information about the feasibility, acceptability, usability, and 
perceived value of a care management program for medically complex Veterans with CI, delivered via 
telephone or through video visits on iPads. By using these preliminary data to refine study methods and 
optimize the intervention protocol prior to conducting a large RCT, we will enhance the efficiency and overall 
value of the subsequent trial. Specifically this pilot study addresses the important question of whether providing 
care management via video visits is feasible in this population, and if so, whether it offers added benefits, 
compared to telephone. To examine video visits, we will use the Pexip Infinity application  which is currently 
approved and in preliminary clinical use in VHA, making rapid implementation highly feasible, if proven 
effective.  
D.9. Project Management Plan 
D.9.a. Summary of Research Team Experience. The research team is comprised of investigators from the 
HSR&D COIN for Health Services Research in Primary Care; the Geriatrics, Research, Education and Clinical 
Center (GRECC) at the Durham VA, the Duke University Center for the Study of Human Aging and 
Development and Alzheimer’s Disease Research Center. We have assembled a multidisciplinary study team 
with a track record of productive collaboration, as well as relevant experience with all the methodology, data 
sources and analytic techniques described in the current proposal.  

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       Version AMD7 IRB Approved 10.5.17 
D.9.b. Timeline. We propose a 1 year study. As illustrated below, we expect to begin enrollment in month 4 
and complete data collection by month 10. The remainder of the study period will be dedicated to analysis of 
the data, dissemination of study results, and preparation of an IIR to test the intervention in an RCT. 
 
 
 
 
 
 
 
Month 
 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
12 
Project Start Up 
Finalize IRB 
X 
X 
 
 
 
 
 
 
 
 
 
 
Develop study database and procedures 
X 
X 
X 
X 
 
 
 
 
 
 
 
 
Intervention Implementation 
Enroll patients  
 
 
 
X 
X 
X 
X 
 
 
 
 
 
Intervention and outcome assessments 
 
 
 
 
X 
X 
X 
X 
X 
X 
 
 
Data Analysis 
Planning for data analysis 
 
 
 
 
 
 
 
 
X 
X 
X 
X 
Data analysis and reporting/ Prepare IIR 
 
 
 
 
 
 
 
 
 
 
X 
X 
 
D.10. Data Management  
 
The Durham HSR&D CoE adheres to VA policy and Durham VAMC IRB requirements, but has also developed 
additional Standard Operating Procedures for data security which have been designed to ensure continued 
confidentiality, integrity, and availability of research data. These procedures, which protect both paper and 
computer based records, have been used successfully in many studies, and will be followed for the proposed 
study.  
With respect to all data, these procedures mandate the following to ensure confidentiality and safe handling of 
all data: (1) Access to all participant data and information will be restricted to authorized personnel; (2) 
Participants will not be identified by name in any reports or publications, nor will data be presented in such a 
way that the identity of individual participants can be inferred; (3) Each participant will be assigned an 
anonymous study ID which will be used on all study forms; and (4) All study personnel will maintain certification 
with the Durham VAMC IRB that they have completed training in research ethics and confidentiality.  
With respect to paper based records, these procedures mandate the following: (1) All study records that 
contain participant information will be kept in secured locked areas when not in use; and (2) In addition, such 
materials, when in use, will be kept safe from public scrutiny. With respect to computer based records, the 
following practices are followed: (1) All research data are stored on VA-administered servers which are 
physically secured in a Durham VAMC server room; (2) Individual computer accounts, password protected, are 
issued to staff members; and (3) Access to computer data is granted by OI&T personnel after confirming 
appropriate documentation through the IRB, per CoE policies. Utilization data will be downloaded directly from 
national files to the Durham HSR&D CoE servers. Of study personnel, only the study Statisticians and 
Economist will have access to these data, which will not be moved from this secured environment. 
The key linking the study ID numbers to the patients identifying information will be stored in a password 
protected electronic database and maintained on a password protected VA server, with access only available 
to approved study staff and investigators.  The name and phone number of family members identified by the 
subject will also be recorded here. 
 
 
 

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       Version AMD7 IRB Approved 10.5.17 
 
 
 
 
 
 
 
 
 
D.10. a. Lists of Data Reviewed and/or Collected for Screening/Recruitment and Conduction of Study:  
 
The Personal Health Information that will be used or shared for this study includes:   
Identifier(s) 
Source(s) of Health Information 
 Names 
 Medical history & physical exam information 
 All geographic subdivisions smaller than a 
State, including street address, city, county, 
precinct, and zip code  
 Photographs, videotapes, audiotapes, or 
digital or other images 
 All elements of dates (except year) for dates 
directly related to an individual, including birth date, 
admission date, discharge date, visit or treatment 
dates, etc.; and all ages over 89  
 Biologic specimens (e.g., blood, tissue, 
urine, saliva) 
 Telephone numbers 
 Progress notes 
 Fax numbers 
 Diagnostic / Laboratory test results 
 Electronic mail addresses 
 Operative reports 
 Social Security Numbers 
 Imaging (x-ray, CT, MRI, etc.) 
 Medical record numbers 
 Discharge summaries 
 Health plan beneficiary numbers 
 Survey / Questionnaire responses 
 Account numbers 
 Billing records 
 Certificate and/or license numbers  
 HIV testing or infection records 
 Vehicle identifiers and serial numbers, including 
license plate numbers  
 Sickle cell anemia information 
 Device identifiers and serial numbers 
 Alcoholism or alcohol use information 
 Web Universal Resource Locators (URLs) 
 Drug abuse information 
 Internet Protocol (IP) address numbers 
 Mental health (not psychotherapy) notes 
 Biometric identifiers, including finger & voice 
prints 
 Psychological test results 
 Full-face photographic images and any 
comparable images 
 Genetic testing 
 Any other unique identifying number, 
characteristic, or code, describe:  Study ID 
Numbers 
 Other, describe:        
 
All non-Veterans enrolled in this study will receive the VA Notice of Privacy Practices (NOPP) and are 
requested to sign the acknowledgment form.  The signed acknowledgment form will be maintained 
with the research records. 
 
1. Data and/or Specimen Acquisition:   
Data for this study will be collected through: 
  Prospective data and/or specimen collection obtained from participants.  Please see section D.3 – D.6.for a 
description of the data collection process.     . 
  Retrospective data collection and/or specimens obtained from medical chart review/data access.  Describe 
how data will be obtained (e.g., fileman, CDW, etc.):  Please see section D.3 – D.6.for a description of CDW 
data and medical chart review used to screen for eligibility, Utilization data will be downloaded directly from 
national files to the Durham HSR&D CoE servers.. 

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       Version AMD7 IRB Approved 10.5.17 
  Retrospective data collection and/or specimens obtained from an IRB-approved data and/or specimen 
repository.  Indicate the repository source including name, VA location, and IRB number:       . 
 
2. Level of Data:   
The following level(s) of data will be acquired/maintained for this study (check all that apply): 
  Identified (e.g., names, addresses or other identifiers included)  
  Coded (direct and/or all identifiers removed, but study code/ID included)  
  De-Identified (all HIPAA 18 and study ID/code removed): 
  Verified Statistically  
 
OR 
  Verified by Absence or Removal of HIPAA 18 and study ID  
  Limited Data Set 
  Other: Describe:        
 
3. Location of Data and/or Specimens, and Data Retention Plan:   
A. Data and/or Specimen Location:  VHADURSQLH5.v06.med.va.gov (SQL database server) and 
\\vhadurhsrdfile1.v06.med.va.gov\$projects\SECSI( shared document folder)   
 
  Data will be also be placed at the VA Informatics and Computing Interface (VINCI; 
http://vaww.vinci.med.va.gov/vincicentral/VINCIWorkspace.aspx).   
 
B. Data Retention Plan 
  Current VA regulations regarding research records retention does not allow for the discarding of records. 
After the close of the protocol if VA records and retention regulations allow for the destruction of paper 
research records, files will be shredded in accordance with VA records control requirements and information in 
electronic format will be deleted or purged from data files in accordance with VA records control requirements.   
 
  Other data retention plan, describe:        
 
4. Data Access and Data Recipients:   
Only VA research study personnel will have access to identifiers and coded data, in accordance with VA policy, 
on the requirements of Federal privacy and information laws and regulations, VA regulations and policies, and 
VHA policy. This will only be done behind VA firewalls.  All study personnel who are VA employees working 
within the VA system have fulfilled all required HIPAA and other VA security and privacy policy training 
requirements and have agreed to follow guidelines pertaining to the protection of patient data. All research staff 
sign VA Rules of Behavior, and all study staff are up-to-date with VHA Privacy Policy Training and the VA 
Office of Cyber and Information Security Awareness Training Course. The data security and privacy 
procedures summarized in that course include logging off or locking the computer when walking away from it; 
no sharing of access codes, verify codes or passwords; not allowing anyone else to use the computer under 
one’s password; and disposing of sensitive information using VA-approved methods (e.g., shredder bins).  
Access to study data will be removed for all study personnel when they are no longer part of the research 
team. 
 
 
5. Data and/or Specimen Transportation and/or Transmission for all data and/or specimens involved 
in the study:   
 
Data will not be transported or transmitted outside of the VA. 
  
I. 
  Data and/or specimens will not be transported or transmitted outside of Durham VAMC 
environment. 
 
II. 
   Data and/or specimens will be transmitted to other VA sites using the following method(s): 
 

15 
 
 
       Version AMD7 IRB Approved 10.5.17 
A. Data 
  Data are de-identified and thus will be sent via unencrypted e-mail or unencrypted disk (encryption is 
optional). 
  Data are coded or contain identifiers and thus will be sent <chose method of transfer such as:  PKI or RMS 
encrypted e-mail, FIPS 140-2 encrypted disk (with VA-authorized carrier and tracking), or FIPS 140-2 
encrypted external drive (with VA-authorized carrier and tracking). You may identify a primary and secondary 
method>. 
  Other, describe:        
B. Specimens 
  Specimens are de-identified and thus will be sent via standard carrier (tracking is optional). 
  Specimens are coded or contain identifiers and thus will be sent via VA-authorized carrier with tracking.   
  Other, describe:        
III. 
  Data and/or specimens will be transported to non-VA/VHA sites (e.g., academic affiliates, 
laboratories, etc.) using the following method(s): 
A. Data 
  Data are de-identified and thus will be sent via unencrypted e-mail or unencrypted CD. 
  Data are coded or contain identifiers and thus will be sent via <chose method of transfer such as FIPS 
140-2 encrypted CD or FIPS 140-2 encrypted hard drive/flash drive> using VA—approved carrier with tracking.   
  Data are coded or identified and will be uploaded to sponsor website using electronic case report form 
(eCRF)  
 Other, describe:       
B. Specimens 
  Specimens are de-identified and thus will be sent via standard carrier (tracking is optional) or will be hand-
delivered by research study personnel.  Specify method of delivery:        
  Specimens are coded and thus will be sent via VA-approved carrier with tracking or will be hand-delivered 
by research study personnel.  Specify method of delivery:        
 
In accordance with the HIPAA and the Privacy Act, for any coded or identifiable data or specimens released 
from the Durham VAMC (with the exception of Limited Data Sets), an Accounting of Disclosure (AOD) will be 
maintained (e.g., in a database or spreadsheet) that includes the participant’s name, date of the disclosure, 
description of the nature of the Individually Identifiable Information (III) disclosed, purpose of each disclosure, 
and the name and address of the person/agency to whom the disclosure was made. 
6. Risk Mitigation Strategies:   
  Data are fully de-identified (stripped of HIPAA 18 and study ID/code) before being shared outside of 
Durham VAMC. 
  Specimens are fully de-identified (stripped of HIPAA 18 and study ID/code before being shared outside of 
Durham VAMC. 
  Direct identifiers will be maintained separately from data and or specimens by using a code to “identify” 
subjects.  In a separate database (i.e., a “linking” or “cross-walk” database) this code will be linked to 
identifying subject information.  
 
The patients’ right of privacy and the confidentiality of the protected health information will be guarded through 
strict controls and safeguards for access of the data to members of the research team.   All study data will be 
stored on VA servers maintained by OI&T staff to comply with VA information security requirements. This 
includes study tracking and Datstat Ilume survey databases on server VHADURSQLH5.v06.med.va.gov, and 
project shared document folder \\vhadurhsrdfile1.v06.med.va.gov\$projects\SECSI (usallly mapped on users' 
systems as  P:\SECSI).  Access to database and file systems is granted to research personnel via membership 
in Active Directory security groups created by OI&T; limited to individuals on the IRB staff listing.  Members are 
removed from the security group when they no longer require access to study data. Data will not be stored on 
desktop or laptop computer hard-drives.   Only VA approved staff will have access to the data file for data 
analysis.  The PI will have ultimate responsibility of access to the data. Furthermore, data will be kept in 
accordance with VA records control schedule.  
  
  Other, specify:        

16 
 
 
       Version AMD7 IRB Approved 10.5.17 
7. Suspected Loss of VA Information: 
Should any incident such as theft or loss of data, unauthorized access of sensitive data or non-compliance with 
security controls occur it will be immediately reported according to VA policy. All incidents regarding 
information security/privacy incidents will be reported to the ISO and PO within 1 hour of acknowledgement of 
issue and done so using the VHADUR Research Events Report e-mail group 
(VHADURResearchEventReport@va.gov). 
8. Reporting of Results:   
  Reporting of results, such as in scientific papers and presentations, will never identify individual subjects.  
Data will be presented in aggregate and individual-level data will not be published. 
  Other results reporting plan, describe:       
 
 
Data Analysis and Statistical Considerations 
 
Due to the small sample size, statistical analysis will not be performed on the sample. 
 
References 
Provide references, if applicable.   
 
N/a