Dashboard Activated Services and Tele-Health for Heart Failure
Phase: NA
Conditions: Heart Failure With Reduced Ejection Fraction
Sponsor: VA Greater Los Angeles Healthcare System

1 
 
   Dashboard Activated Services and tele-Health for Heart Failure (DASH-HF) Study  
 
Study Protocol 
 
 
 
Principal Investigator:  
Boback Ziaeian, MD, PhD, FACC, FAHA 
 
 
 
 
Assistant Professor of Medicine 
 
 
 
 
David Geffen School of Medicine at UCLA 
 
 
 
 
VA Greater Los Angeles Healthcare System 
 
Trial Statistician: 
 
Boback Ziaeian, MD, PhD, FACC, FAHA 
 
Protocol Authors: 
 
Aradhana Verma, MD 
 
 
 
 
Boback Ziaeian, MD PhD 
 
SAP Version:  
 
1.0 
 
NCT Number:  
 
Not assigned 
 
Date:  
 
 
7/20/21 
 
 
 

2 
 
Table of Contents 
1.  
Abbreviations and Definitions 
 
 
 
 
 
 
3 
2. 
Introduction  
 
 
 
 
 
 
 
 
4 
3.  
Study Objectives 
 
 
 
 
 
 
 
 
5 
4. 
Study Methods 
 
 
 
 
 
 
 
 
7 
 
4.1  
General Study Design and Plan 
 
4.2  
Inclusion-Exclusion Criteria and General Study Population 
 
4.3  
Randomization and Blinding 
5. 
Safety 
6. 
Adverse Events 
7. 
References 
 
 
 
 
 
 
 
 
 
15 
8.  
Listing of Tables, Listings, and Figures 
 
 
 
 
 
16 
9. 
Supplemental Materials 
 
 
 
 
 
 
 
17 

3 
 
1 
Abbreviations and Definitions 
ACE 
 
angiotensin-converting enzyme inhibitor  
ADHFD  
Academic Detailing Heart Failure Dashboard 
AKI 
 
acute kidney injury 
ARB 
 
angiotensin II receptor blockers 
ARNI  
angiotensin receptor neprilysin inhibitor 
HF 
 
heart failure 
HFrEF  
heart failure with reduced ejection fraction 
LVEF 
 
left ventricular ejection fraction 
MRA  
mineralocorticoid receptor antagonist 
SGLT2i  
sodium-glucose cotransporter-2 inhibitor  
 
 
 
 
 
 
 
 
 
 
 

4 
 
2 
Introduction 
 
The TELEhealth and Dashboard Activated Health Services outreach (TELE-DASH) study is a pragmatic randomized 
controlled trial of a quality improvement (QI) intervention of a prospective panel management intervention to 
optimize medical treatment for Veterans with heart failure with reduced ejection fraction (HFrEF) compared to 
the receipt of usual VA health care services over a 6-month period of observation. The study will incorporate 
the existing VA Academic Detailing Heart Failure Dashboard (ADHFD) to target actionable patients with gaps in 
performance measures for guideline-directed medical therapies (GDMT). Patients with HFrEF are optimally 
managed by cardiovascular specialty clinics. Typically, patients are referred to cardiology or heart failure (HF) 
clinics from primary care, emergency department, or post-hospitalization clinicians and scheduled into clinic 
grids. These patients may be lost to follow-up, not referred without prior HF hospitalization, or clinicians may 
miss opportunities to optimize GDMT for HFrEF. GDMT includes Class I indicated medications from the following 
classes: beta blockers (BB), angiotensin-converting enzyme inhibitor (ACE), angiotensin II receptor blockers 
(ARB), angiotensin receptor neprilysin inhibitor (ARNI), mineralocorticoid receptor antagonist (MRA), sodium-
glucose cotransporter-2 inhibitor (SGLT2i). 1–3 The intervention is designed around prospective panel 
management clinics led by clinicians using impromptu patient telephone calls or electronic communications 
with existing responsible clinicians. 
 
3 
Study Objectives 
 
The purpose of this study is to measure the effectiveness of proactive panel management clinics to optimize 
GDMT relative to usual care. The study will also evaluate secondary outcomes that signify improved outcomes 
such as reduced hospitalizations and mortality. The study will also evaluate clinician time per intervention 
relative to usual cardiology or HF clinic structure. 
 
4 
Study Methods 
 
4.1 
General Study Design and Plan 
This is a randomized, pragmatic QI study designed to evaluate the effectiveness of proactive panel management 
to close gaps in evidence-based care for patients with HFrEF. We will use the VA’s ADHFD to generate a list of 
actionable patients with HFrEF and left ventricular ejection fraction (LVEF) ≤ 35%. After identifying a cohort of 
HFrEF patients from the ADHFD, we will randomize individual patients on the actionable list to usual VA care or 
a novel proactive panel management clinic. Clinicians will be trained on how to use the dashboard information 
to identify opportunities for optimization based on detailed chart review. The proactive panel management 
intervention will use clinicians to perform an electronic chart review and call patients impromptu at their 
discretion to evaluate HFrEF management and opportunities to optimize GDMT. Each panel management clinic 
is staffed by a single cardiovascular clinician or trainee with cardiology (PI) supervision. All patients will receive 
chart review or telehealth notes brought to the attention of primary care and cardiology clinicians. Patients 
randomized to the intervention will only receive one chart review during a half-day panel management clinic 
with follow-up of any laboratory results or diagnostic tests as required and referral to HF or general cardiology 
clinic as deemed appropriate. The control arm consists of the usual delivery of health services with routine 
scheduled appointments for primary care or cardiology. 
 
Outcomes will be assessed at 6-months from the last patient to receive the intervention. The study is powered 
to detect superiority of the intervention compared to usual care in optimizing GDMT for HFrEF. Treatment 
assignment is based on 1:1 randomization using fixed blocks (size=6) to assure an equivalent number of patients 
randomized to the intervention and usual care. Patients are randomized after a list of 300 actionable patients 

5 
 
are generated from the ADHFD. Study participant numbers will be assigned to the list of patients sorted by 
optimization scores in Excel. The supervising statistician (AA) will generate concealed randomization 
assignments by participant identification numbers. The randomization assignments will be merged with baseline 
study dataset and exported as password protected Excel and PDF documents. Study investigators will divide the 
intervention arm into lists of 10 to 15 per half-day clinic. Patients not receiving chart review or phone call 
attempts will be reassigned to future panel management clinics until all patients receive the intervention. 
Patients that did not answer phone calls will receive chart review notes for primary care and cardiology clinicians 
and not be reassigned to future panel management clinics.  
 
Study participants do not require informed consent as determined by the VA IRB review. Patients will receive 
all accepted standards of care and medications approved by the Food and Drug Administration for HFrEF 
indications. The VA Subcommittee for Research and Safety found an absence of any declared research-
laboratory-based biohazards and granted exemption from continued review. The study will evaluate the 
effectiveness of the QI intervention, telephone/telemedicine panel management clinics, to more rapidly 
implement evidence-based care for patients with HFrEF. Patients in the usual care arm will be unaware they are 
part of the control group for the RCT. Intervention patients nor study staff are blinded to usual care or 
intervention assignments. Patients that receive the intervention will be informed this is a pilot quality 
improvement effort with informal consent before proceeding to the clinical interventions. Intervention patients 
may refuse to participate after being contacted by phone in the intervention. 
 
Study enrollment is based on the inclusion and exclusion criteria used to filter the ADHFD list. A list of actionable 
patients with HFrEF will be exported for randomization. The GDMT optimization score will be automated for 
each patient on the extracted list (Table 1). A sample of 300 patients will be selected with the lowest GDMT 
composite scores. Once the final sample of the study is determined, patients will be randomized to usual care 
or the intervention. Intervention patients will be divided into smaller lists of 10 to 15 patients. These smaller 
lists will be assigned to proactive panel management clinics. Clinicians staffing the intervention clinics will review 
ADHFD data, review the electronic health record (EHR) and decide whether to proceed to evaluate and 
recommend treatment over the phone to patients directly. If clinicians did not have sufficient time to review all 
patients on their clinic list, they will be redistributed to future intervention clinics. Intervention clinics will be 
held until each patient assigned the intervention has a chart review or attempted telephone contact. A failure 
to contact a patient will trigger a letter to a patient or electronic communication to their primary care or 
cardiology clinician. 
 
Prior to each ADHFD telehealth clinic (half-day clinic lasting 4 to 4.5 hours), clinicians will be sent a secure email 
that will include a password-protected Excel document of 15 patients with exported clinical summary data from 
the ADHFD. Clinicians will be instructed to chart-review patients and decide if an opportunity exists to further 
optimize the receipt of GDMT. Clinicians will also be given a document providing guidance on the sequence of 
GDMT optimization based on latest guidelines and VA policies (Supplement S1 GDMT Guidance Document). If a 
patient does not qualify for further optimization (i.e. chart documentation of prior intolerance, patient 
preference), a short note in the electronic health record (EHR) will document the chart review and inform the 
primary care clinician that based on chart review, no opportunity currently exists but they may consider further 
GDMT titration in the future. If a patient appears to have an opportunity for further titration, the clinician is 
encouraged to call the patient to see if they are available to discuss their HF care. If the patient agrees, a 
telehealth visit will take place over phone or switch to video. A formal telehealth cardiology visit will occur at 
the time of care. If the patient is interested but does not have time for a visit, a brief telephone note will be 
placed and a request for a future cardiology clinic visit will be requested. If a formal telehealth visit occurs, 
clinicians will be asked to inquire about key details around medication titration (Supplement S2 Interview 

6 
 
Guide). The data from chart review and interviews will be documented on a password-protected Excel 
document (Supplement S3 Clinician Documentation Form). Any medication addition or titration will have 
indicated laboratory labs ordered per usual care. Lastly, clinicians will also be asked to administer a short survey 
with each participant based on a template at the end of the call proactive phone call (Supplement S2 Interview 
guide). Primary care and regular cardiology clinicians will be notified of any changes in medication management 
in the EHR. The study’s lead (BZ, AV) will be available by phone to answer questions or problems that arise 
during the clinic. Supervision of patient encounters by clinical pharmacists, medical trainees, or advanced 
practice nurse practitioners and study protocols will be BZ as the licensed and boarded general cardiologist. 
 
4.2 
Inclusion-Exclusion Criteria and General Study Population 
This quality improvement (QI) initiative involves patients with heart failure with reduced ejection fraction 
(HFrEF) receiving care in the VA West Los Angeles (WLA). The criteria for eligible patients are:  
 
Inclusion criteria:  
● Facility: Greater Los Angeles, CA 
● Division: All divisions within Greater Los Angeles 
● Patient is eighteen years of age or older  
● Patients has a primary diagnosis of HFrEF (last documented LVEF ≤35% per ADHFD algorithms) 
● Patient has an estimated GFR greater than or equal to 30 mL/min 
● Patient lacks at least one active prescription of a beta-blocker, ACE/ARB/ARNI, MRA, or SGLT2i 
● There are no cardiology appointments in the upcoming 2 weeks.  
Exclusion criteria:  
● Patient is currently hospitalized at WLA 
 
4.3 
Randomization and Blinding 
Patients will be randomized 1:1 to intervention and usual care groups with all patients randomized at one time; 
given the target sample size of n=300 total patients, the sequence will be generated using permuted blocks of 
size 6 to ensure that an equal number of patients are randomized to panel management and usual care, 
maximizing efficiency (power). The randomization sequence will be concealed from the clinicians until after 
randomization has already been complete. Post-randomization, study staff will not be blinded to allocation. GLA 
IRB exemption was granted for consent of the low risk, non-experimental intervention.  The intervention does 
not allow for blinding of participants in the intervention arm.  
 
 
 

7 
 
Figure 1: CONSORT Study Flow Diagram Template 
 
 
5 
Safety  
Clinicians involved with the intervention will report acute kidney injury (AKI) defined as 25% decrease in GFR 
from baseline on follow-up labs (1-week for MRA and 1-2 weeks for ACE/ARB/ARNI) after a successful 
medication titration within the intervention group. Laboratory alerts will be followed by pilot study clinicians. 
Hospitalization related to adverse medication event (e.g. symptomatic hypotension, AKI, hyperkalemia) related 
to the intervention. Difference in mortality between intervention and usual care. 
 
6 
Adverse Events 
Specific adverse events of interest include symptomatic hypotension documented in the EHR. Hospitalizations 
related to heart failure will be captured during the study end using the ADHFD.  If patients were removed from 
the dashboard at 6 months, a chart review will be performed to abstract missing data. 
 
 
 

8 
 
7 
References 
 
1.  
McMurray JJV, Solomon SD, Inzucchi SE, et al. Dapagliflozin in Patients with Heart Failure and Reduced 
Ejection Fraction. N Engl J Med. 2019;381(21):1995-2008. doi:10.1056/nejmoa1911303 
2.  
Packer M, Anker SD, Butler J, et al. Cardiovascular and Renal Outcomes with Empagliflozin in Heart 
Failure. N Engl J Med. 2020;383(15):1413-1424. doi:10.1056/nejmoa2022190 
3.  
Maddox TM, Januzzi JL, Allen LA, et al. 2021 Update to the 2017 ACC Expert Consensus Decision 
Pathway for Optimization of Heart Failure Treatment: Answers to 10 Pivotal Issues About Heart Failure With 
Reduced Ejection Fraction: A Report of the American College of Cardiology Solution Set Oversig. J Am Coll 
Cardiol. 2021;77(6):772-810. doi:10.1016/j.jacc.2020.11.022 
 
 

9 
 
8 
Listing of Tables, Listings, and Figures 
 
Figure 1: CONSORT Study Flow Diagram Template  
 
 
 
 
8 
 
 

10 
 
9 
Supplemental Material 
 
S1: GDMT Guidance Document for LVEF ≤35% 
I. 
Make a recommendation 
Step 1: patient not at target ACE/ARB or beta-blocker 
Initiate/titrate up ACE/ARB and/or beta blocker 
- 
If signs of volume overload or HR<70 → ACE/ARB 
- 
If signs of euvolemia, HR>70, atrial fibrillation history, ventricular ectopy → Beta-blocker 
- 
Age < 75, systolic BP>120 mm Hg, HR >70, normal renal function → Start both  
Tailored based on patient’s profile and history. 
Step 2a: Transition ACE/ARB to ARNI 
- 
Initiate ARNI once patient is taking equivalent dosing to lisinopril 20 mg daily  
Step 2b: Initiate and titrate up aldosterone antagonist  
- 
If K < 5 (helpful for hypokalemia) 
- 
Well tolerated in low BP patients 
- 
Check labs 3-7 days within initiation. Repeat labs monthly for the first 3 months.  
 
Step 2c:  
Initiate SGLT2i – empagliflozin 10mg daily 
- 
Initiate earlier if A1C ≥7% or GFR 25-60 mL/min/1.73m2 refer nephrology for SGLT2i 
- 
Otherwise, add to cornerstone beta-blocker and RAAS inhibitor, ideally when dosing is stable. 
 
II. 
Discuss instructions and precautions  
Symptomatic hypotension, genital yeast infections (SGLT2i) 
 
III. 
Recommended follow-up 
 
Labs, diagnostic imaging or studies, new consults, follow-up appointments 
 
Strategies for intolerance/symptomatic hypotension 
• 
Reduce non-GDMT antihypertensives, half diuretic dose with initiation of RAAS inhibitor or SGLT2i.  
• 
Consider insulin reduction for history hypoglycemic events with SGLT2i. 
• 
Space out administration times for medications 
• 
Move RAAS inhibitors to evening to peak during sleep 
• 
Lower morning doses relative to evening doses 
 
 
 
 

11 
 
S2: Interview Guide 
 
Introduction 
Hello, I am Dr. ______ calling from the West LA VA Cardiology. We are piloting an effort to proactively reach 
out to Veterans with heart disease to see how they are doing and improve their medical therapies for heart 
failure. Is now a convenient time to discuss your heart medications?  
- Yes: Thank you. Do you have access to a smartphone or computer? May we convert this visit to video?  
- No: May we request a follow-up phone, video, or in-person visit with our heart failure clinic? 
 
Yes: Thank you. [RTC WLA-Cardiomyopathy Clinic] 
No: Thank you for your time. [Chart review note for PMD and last cardiology fellow/attending 
highlighting potential opportunity for further medication optimization] 
 
Obtain history and assess functional NYHA class 
1. How have you been feeling? Any change in [dyspnea/orthopnea/edema]?  
2. What type of physical activities do you do regularly [walking, exercise, stairs]? 
3. Do you know what medications you take for heart failure and how do manage your medications? 
4. Have you had issues with any of heart failure medications in the past? 
5. Do you check your home blood pressure and weights regularly? What are they? 
6. Do you have issues with lightheadedness/dizziness or passing out? 
 
Make recommendation 
Optimization: I see that you might benefit from an increase in you _____ / I see that you might benefit from an 
additional medication ______/I see you may benefit from stopping one of your non-heart failure blood 
pressure medications. May we start that today and you can receive the medication in the mail or pick-up from 
your local VA clinic? 
 
Hypervolemia: Increase diuretic regimen and refer for face to face visit within 1 week. 
 
Discuss appropriate precautions with optimization 
Dizziness, orthostasis, follow-up blood tests.  
SGLT2i [genital yeast infections/hypoglycemia for IDDM] 
 
Next steps 
- Order medications 
- Follow-up appointment 
- Required labs 
- BMP in one week (MRA), 1-2 weeks (ACE/ARB/ARNI) 
 
Questions 
Do you have any concerns related to medication change? Other questions? 
 
Feedback 
Thank you for your time. This was a call part of our pilot telephone heart clinic program. How would you rate 
your experience with the heart failure outreach today on a scale 1 to 10 (10 being very appreciated)? Any 
suggestions to improve the program? 
 
 
 

12 
 
S3: Clinician Documentation Form  
 
Documentation survey which will guide clinician’s chart review and patient conversation. The form will be 
password-protected and utilize checkbox and short answers for clinician ease.  
 
Clinic 
Date 
Clinician 
Start 
Time 
Homeless 
Active 
Substance Use 
Female 
Last 
EF 
Last cards 
appt 
Last PCP appt 
1/1/21 
Ziaeian, 
Boback 
13:55 
x 
x 
x 
35-
40% 
1/1/21 
1/1/21 
 
Phone Call Time 
NYHA Class 
No Response 
9 minutes 
III 
x 
 
Reasons for no GDMT titration 
Prior intolerance 
Prior adverse event 
Patient declined 
Patient concerned of side effects 
Other 
x 
x 
x 
x 
Cost 
 
 
Actions Performed 
Number of Rx 
adjusted 
Med 
adjustment 
Labs 
ordered 
Imaging / 
diagnostic tests 
RTC 
Patient Letter 
Consults 
3 
Amlodipine 
stopped 
x 
x 
x 
x 
x 
 
Feedback 
End Time 
Comments 
9 
1415 
Straight to voicemail 
 
 
 

13 
 
 
Clinician Documentation form definitions 
Clinic date 
Date today, (mm/dd/yy) 
Clinician 
Name of clinician (Last, First) 
Start Time 
Military time at onset of pre-chart 
Homeless 
Is the veteran currently experiencing homelessness?  
Active substance use 
Is the veteran actively using substances? 
Female 
Sex as categorized in EHR 
Last EF  
Most recent left ventricular ejection fraction on transthoracic echocardiogram, % 
Last cards appt 
Date of last cardiology clinic visit, (mm/dd/yy) 
Last PCP appt 
Date of last PCP visit, (mm/dd/yy) 
Phone Call Time 
Duration of successful phone or video visit 
NYHA Class 
Based on patient's symptoms and chart review, (1-3) 
No response 
Indication if no response after 2 attempts 
Patient requests later 
appointment 
Indication if patient is interested in further discussion, but busy at this time. Check and 
order RTC cardiology 
Reasons for no GDMT 
 
Prior intolerance 
History of symptomatic bradycardia or hypotension on GDMT 
Prior adverse event 
History of hospitalization or angioedema related to GDMT titration. History of yeast 
infection while taking an SGLT2i inhibitor 
Patient declined 
Patient declined additional or higher doses of medications in the past  
Patient concerned of side 
effects 
Patient is concerned of side effects of GDMT 
Other  
Other reasons cited by patients or on chart review in the comments 
Actions Performed 
 
# medication adjustments Number of medications adjusted after this visit 
Medication adjustment 
detail 
Description of medication adjustment 
Labs ordered 
If laboratory tests ordered as part of today’s plan 
Imaging / diagnostic tests 
ordered 
If imaging or diagnostic tests ordered as part of today’s plan 
RTC 
If "return to clinic" order placed to patient's cardiology clinic  
Patient Letter 
Letter mailed to patient regarding following up with primary care or cardiology regarding 
heart failure. 
New consults 
If new consults placed as part of today’s plan 
Patient feedback  
Self-reported experience of conversation and heart failure plan, on a scale of 1 to 10, 
where 1 means an awful experience and 10 means an exceptional experience 
Time (end call)  
Military time on completion of phone call  
Comments 
Noteworthy general observations not contained in fields regarding chart review or patient 
experience