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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Patients with perceived gaps in performance measures for guideline-directed medical therapies for heart failure with reduced ejection fraction will be chart-reviewed and called impromptu to receive point of care medication titration or reintegration into routine heart failure clinic. Patients lost to follow-up may be better identified using the HFrEF panel management tools. |
|
| Usual Care | No Intervention | A control group of patients with HFrEF will receive routine primary and cardiology care as currently indicated in routine scheduled clinic grids. Patients are at the discretion of their primary care and cardiology clinicians regarding whether further HFrEF optimization is warranted. While panel management data is available to all clinicians, clinical workflows and responsibilities do not encourage the use of panel data or response to performance measurement for HFrEF. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proactive Panel Management Clinics for HFrEF | Other | Novel clinic based on review of panel HFrEF data and impromptu telephone or video patient contacts/visits. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Optimization Potential Score | Change in composite score created for reaching target doses of guideline-directed medical therapies for HFrEF compared between treatment arms at the end of the study. Optimization Potential Scores ranges from 0 (least optimized) to 10 (full-optimized). | 6-months after all patients receive the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Number of Patient Receiving ACE/ARB/ARNI | Number of patients that receive an active prescription for angiotensin-converting enzyme inhibitor (ACE), angiotensin II receptor blockers (ARB), or angiotensin receptor neprilysin inhibitor (ARNI) compared between treatment arms at the end of the study. | 6-months after all patients receive the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Qualitative Analysis of Patient Satisfaction | For only patients that received the intervention, we perform an informal survey of patient feelings about the telehealth intervention scaled from a range of 0 to 10 for satisfaction at the end of the visit. Zero represents no satisfaction with the intervention and 10 being complete satisfaction with the intervention. Control patients do not receive a survey question, since they did not receive the intervention. |
Inclusion Criteria:
Exclusion Criteria:
● Patient is currently hospitalized at WLA
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| Name | Affiliation | Role |
|---|---|---|
| Boback Ziaeian, MD PhD | VA Greater Los Angeles Healthcare System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA West Los Angeles | Los Angeles | California | 90048 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37494051 | Derived | Verma A, Fonarow GC, Hsu JJ, Jackevicius CA, Vaghaiwalla Mody F, Nguyen A, Amidi O, Goldberg S, Vetrivel R, Upparapalli D, Theodoropoulos K, Gregorio S, Chang DS, Bostrom K, Althouse AD, Ziaeian B. DASH-HF Study: A Pragmatic Quality Improvement Randomized Implementation Trial for Patients With Heart Failure With Reduced Ejection Fraction. Circ Heart Fail. 2023 Sep;16(9):e010278. doi: 10.1161/CIRCHEARTFAILURE.122.010278. Epub 2023 Jul 26. | |
| 36028192 |
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Included patients were those over the age of 18 years, with a primary diagnosis of HFrEF with a last documented left ventricular ejection fraction ≤35%, an estimated eGFR ≥30 mL/minuter, and optimization potential score (OPS) of less than or equal to 5 out of 10, and no general cardiology or HF appointments in the upcoming 2 weeks. Exclusion criteria included if the dashboard indicated that the patient was currently hospitalized at the GLA VA.
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| ID | Title | Description |
|---|---|---|
| FG000 | Proactive Telehealth-based Clinics | The intervention included telehealth-based clinics, or DASH-HF clinics, for the target population. The clinics were led by clinicians (board-certified cardiologist, advanced HF cardiologist, nurse practitioner, cardiology fellow, advanced HF fellows [2], internal medicine resident and clinical pharmacists [2]). Clinicians staffing the clinic were provided a list of 10 to 15 intervention patients and worked at their own pace. The clinicians reviewed dashboard data and EHR and decided whether to proceed with a telehealth encounter. If the clinician did not have sufficient time to review all patients assigned to that day's clinic, the remaining patients were redistributed to future clinics. Patients who did not answer phone calls received mailed patient letters to encourage cardiology follow-up. Patients that were not able to be contacted were not reassigned to future panel management clinics. DASH-HF clinics were held until all subjects assigned to the intervention group had a chart review or attempted telephone contact. |
| FG001 | Usual Care | Patients with the VA Greater Los Angeles that received primary care or cardiovascular care as routinely scheduled. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Proactive Telehealth-based Clinics | The intervention included telehealth-based clinics, or DASH-HF clinics, for the target population. The clinics were led by clinicians (board-certified cardiologist, advanced HF cardiologist, nurse practitioner, cardiology fellow, advanced HF fellows [2], internal medicine resident and clinical pharmacists [2]). Clinicians staffing the clinic were provided a list of 10 to 15 intervention patients and worked at their own pace. The clinicians reviewed dashboard data and EHR and decided whether to proceed with a telehealth encounter. If the clinician did not have sufficient time to review all patients assigned to that day's clinic, the remaining patients were redistributed to future clinics. Patients who did not answer phone calls received mailed patient letters to encourage cardiology follow-up. Patients that were not able to be contacted were not reassigned to future panel management clinics. DASH-HF clinics were held until all subjects assigned to the intervention group had a chart review or attempted telephone contact. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Optimization Potential Score | Change in composite score created for reaching target doses of guideline-directed medical therapies for HFrEF compared between treatment arms at the end of the study. Optimization Potential Scores ranges from 0 (least optimized) to 10 (full-optimized). | Posted | Mean | Standard Deviation | score on a scale | 6-months after all patients receive the intervention |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Proactive Telehealth-based Clinics | The intervention included telehealth-based clinics, or DASH-HF clinics, for the target population. The clinics were led by clinicians (board-certified cardiologist, advanced HF cardiologist, nurse practitioner, cardiology fellow, advanced HF fellows [2], internal medicine resident and clinical pharmacists [2]). Clinicians staffing the clinic were provided a list of 10 to 15 intervention patients and worked at their own pace. The clinicians reviewed dashboard data and EHR and decided whether to proceed with a telehealth encounter. If the clinician did not have sufficient time to review all patients assigned to that day's clinic, the remaining patients were redistributed to future clinics. Patients who did not answer phone calls received mailed patient letters to encourage cardiology follow-up. Patients that were not able to be contacted were not reassigned to future panel management clinics. DASH-HF clinics were held until all subjects assigned to the intervention group had a chart review or attempted telephone contact. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalizations | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boback Ziaeian | VA Greater Los Angeles | 310-478-3711 | boback.ziaeian@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 20, 2021 | Aug 5, 2024 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 20, 2021 | Jul 20, 2021 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Change in the Number of Patients Receiving Beta-blockers | Number of patients that receive an active prescription for beta-blockers compared between treatment arms at the end of the study. | 6-months after all patients receive the intervention |
| Change in the Number of Patients Receiving MRA | Number of patients that receive an active prescription for mineralocorticoid receptor antagonist (MRA) compared between treatment arms at the end of the study. | 6-months after all patients receive the intervention |
| Change in Number of Patients Receiving ARNI | Number of patients that receive an active prescription for angiotensin receptor neprilysin inhibitor (ARNI) compared between treatment arms at the end of the study. . | 6-months after all patients receive the intervention |
| Change in Number of Patients Receiving SGLT2i | Number of patients that receive an active prescription for sodium-glucose cotransporter-2 inhibitor (SGLT2i) compared between treatment arms at the end of the study. . | 6-months after all patients receive the intervention |
| Total Number of Hospitalizations | Total number of any cause hospitalizations compared between treatment arms at the end of the study. | 6-months |
| Change in Total Deaths | Total number of all-cause deaths compared between treatment arms at the end of the study. | 6-months |
| At the end of the successful telehealth intervention. On average within one month of randomization. |
| Average Number of Patients Contacted Per Half-day Clinic | Average number of patients reviewed or contacted per half-day clinic to understand health services efficiency | After intervention is delivered (post-baseline) - on average within 1 month of randomization. |
| Clinician Time Per Patient | This is estimated only for the intervention arm. Control patients did not receive the intervention so no time was spent per patient to compare. Clinician time spent per patient from opening chart to end of patient-specific intervention and documentation. | After intervention delivery (post-baseline). Within 1 month of the intervention on average. |
| Average Number of Orders Placed Per Clinic |
| After intervention clinic delivered - on average within one month of randomization. |
| Derived |
| 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. |
| BG001 | Usual Care | Patients with the VA Greater Los Angeles that received primary care or cardiovascular care as routinely scheduled. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Usual Care | Patients with the VA Greater Los Angeles that received primary care or cardiovascular care as routinely scheduled. |
|
|
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| Secondary | Change in Number of Patient Receiving ACE/ARB/ARNI | Number of patients that receive an active prescription for angiotensin-converting enzyme inhibitor (ACE), angiotensin II receptor blockers (ARB), or angiotensin receptor neprilysin inhibitor (ARNI) compared between treatment arms at the end of the study. | Posted | Count of Participants | Participants | 6-months after all patients receive the intervention |
|
|
|
|
| Secondary | Change in the Number of Patients Receiving Beta-blockers | Number of patients that receive an active prescription for beta-blockers compared between treatment arms at the end of the study. | Entire study population | Posted | Count of Participants | Participants | 6-months after all patients receive the intervention |
|
|
|
|
| Secondary | Change in the Number of Patients Receiving MRA | Number of patients that receive an active prescription for mineralocorticoid receptor antagonist (MRA) compared between treatment arms at the end of the study. | Posted | Count of Participants | Participants | 6-months after all patients receive the intervention |
|
|
|
|
| Secondary | Change in Number of Patients Receiving ARNI | Number of patients that receive an active prescription for angiotensin receptor neprilysin inhibitor (ARNI) compared between treatment arms at the end of the study. . | Posted | Count of Participants | Participants | 6-months after all patients receive the intervention |
|
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|
|
| Secondary | Change in Number of Patients Receiving SGLT2i | Number of patients that receive an active prescription for sodium-glucose cotransporter-2 inhibitor (SGLT2i) compared between treatment arms at the end of the study. . | Posted | Count of Participants | Participants | 6-months after all patients receive the intervention |
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| Secondary | Total Number of Hospitalizations | Total number of any cause hospitalizations compared between treatment arms at the end of the study. | Posted | Number | hospitalizations | 6-months |
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| Secondary | Change in Total Deaths | Total number of all-cause deaths compared between treatment arms at the end of the study. | Posted | Count of Participants | Participants | 6-months |
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| Other Pre-specified | Qualitative Analysis of Patient Satisfaction | For only patients that received the intervention, we perform an informal survey of patient feelings about the telehealth intervention scaled from a range of 0 to 10 for satisfaction at the end of the visit. Zero represents no satisfaction with the intervention and 10 being complete satisfaction with the intervention. Control patients do not receive a survey question, since they did not receive the intervention. | Patients Contacted | Posted | Mean | Standard Deviation | Satisification Score (0-10) | At the end of the successful telehealth intervention. On average within one month of randomization. |
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| Other Pre-specified | Average Number of Patients Contacted Per Half-day Clinic | Average number of patients reviewed or contacted per half-day clinic to understand health services efficiency | Half-day clinics | Posted | Mean | Standard Deviation | number of participants | After intervention is delivered (post-baseline) - on average within 1 month of randomization. | Clinics | Clinics |
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| Other Pre-specified | Clinician Time Per Patient | This is estimated only for the intervention arm. Control patients did not receive the intervention so no time was spent per patient to compare. Clinician time spent per patient from opening chart to end of patient-specific intervention and documentation. | Patients chart reviewed | Posted | Mean | Standard Deviation | Minutes spent per patient | After intervention delivery (post-baseline). Within 1 month of the intervention on average. |
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| Other Pre-specified | Average Number of Orders Placed Per Clinic |
| Intervention group | Posted | Mean | Standard Deviation | Number of orders | After intervention clinic delivered - on average within one month of randomization. | Clinics | Clinics |
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| 17 |
| 150 |
| 43 |
| 150 |
| 0 |
| 150 |
| EG001 | Usual Care | Patients with the VA Greater Los Angeles that received primary care or cardiovascular care as routinely scheduled. | 24 | 150 | 38 | 150 | 0 | 150 |
| Mortality | General disorders | Non-systematic Assessment |
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| Title | Measurements |
|---|---|
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| Referral for consult/device therapy orders |
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