Clinical trial NCT05001165: Dashboard Activated Services and Tele-Health for Heart Failure
Official title: Dashboard Activated Services and Tele-Health for Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure With Reduced Ejection Fraction
Keywords: heart failure
proactive outpatient management
learning health system
panel management
medical optimization
Lead sponsor: VA Greater Los Angeles Healthcare System
Sponsor class: FED
First posted: 2021-08-11
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The Dashboard Activated Services and tele-Health for Heart Failure (DASH-HF) 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 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). The intervention is designed around a novel prospective panel management clinic led by clinicians or clinical pharmacists using impromptu patient telephone calls or electronic communications with existing responsible clinicians.

Detailed description: 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. The investigators 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, the investigators 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 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 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.

Eligibility criteria: Inclusion Criteria:

* Facility: Greater Los Angeles, CA
* Division: West LA VAMC
* 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 has a last documented potassium less than 5
* Patient has a last documented systolic blood pressure over 90 mm Hg
* Patient lacks at least one active prescription of a beta-blocker, ACE/ARB/ARNI, MRA, or SGLT2i
* There are no upcoming heart failure or primary care appointments in the upcoming 2 weeks.

Exclusion Criteria:

● Patient is currently hospitalized at WLA

Primary outcomes:
measure: Optimization Potential Score
timeFrame: 6-months after all patients receive the intervention
Secondary outcomes:
measure: Change in Number of Patient Receiving ACE/ARB/ARNI
timeFrame: 6-months after all patients receive the intervention
measure: Change in the Number of Patients Receiving Beta-blockers
timeFrame: 6-months after all patients receive the intervention
measure: Change in the Number of Patients Receiving MRA
timeFrame: 6-months after all patients receive the intervention
measure: Change in Number of Patients Receiving ARNI
timeFrame: 6-months after all patients receive the intervention
measure: Change in Number of Patients Receiving SGLT2i
timeFrame: 6-months after all patients receive the intervention
measure: Total Number of Hospitalizations
timeFrame: 6-months
measure: Change in Total Deaths
timeFrame: 6-months
Other outcomes:
measure: Qualitative Analysis of Patient Satisfaction
timeFrame: At the end of the successful telehealth intervention. On average within one month of randomization.
measure: Average Number of Patients Contacted Per Half-day Clinic
timeFrame: After intervention is delivered (post-baseline) - on average within 1 month of randomization.
measure: Clinician Time Per Patient
timeFrame: After intervention delivery (post-baseline). Within 1 month of the intervention on average.
measure: Average Number of Orders Placed Per Clinic
timeFrame: After intervention clinic delivered - on average within one month of randomization.
Locations:
city: Los Angeles
country: United States
facility: VA West Los Angeles
state: California
Study officials:
affiliation: VA Greater Los Angeles Healthcare System
name: Boback Ziaeian, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Verma A, Fonarow GC, Hsu JJ, Jackevicius CA, Mody FV, Amidi O, Goldberg S, Upparapalli D, Theodoropoulos K, Gregorio S, Chang DS, Bostrom K, Althouse AD, Ziaeian B. The design of the Dashboard Activated Services and Telehealth for Heart Failure (DASH-HF) study: A pragmatic quality improvement randomized implementation trial for patients with heart failure with reduced ejection fraction. Contemp Clin Trials. 2022 Sep;120:106895. doi: 10.1016/j.cct.2022.106895. Epub 2022 Aug 24.