Dashboard Activated Services and Tele-Health for Heart Failure

NCT05001165 | Completed Results

• 1 other identifier: 2020-000311
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure With Reduced Ejection Fraction

Keywords

heart failure; proactive outpatient management; learning health system; panel management; medical optimization

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Change in Number of Patient Receiving ACE/ARB/ARNI

  6-months after all patients receive the intervention

• Change in the Number of Patients Receiving Beta-blockers

  6-months after all patients receive the intervention

• Change in the Number of Patients Receiving MRA

  6-months after all patients receive the intervention

• Change in Number of Patients Receiving ARNI

  6-months after all patients receive the intervention

• Change in Number of Patients Receiving SGLT2i

  6-months after all patients receive the intervention

Other Outcomes (4)

• Qualitative Analysis of Patient Satisfaction

  At the end of the successful telehealth intervention. On average within one month of randomization.

• Average Number of Patients Contacted Per Half-day Clinic

  After intervention is delivered (post-baseline) - on average within 1 month of randomization.

• Clinician Time Per Patient

  After intervention delivery (post-baseline). Within 1 month of the intervention on average.

Study Arms (2)

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.

Other: Proactive Panel Management Clinics for HFrEF

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.

Interventions

Proactive Panel Management Clinics for HFrEF OTHER

Novel clinic based on review of panel HFrEF data and impromptu telephone or video patient contacts/visits.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• ● Patient is currently hospitalized at WLA

Sponsors & Collaborators

• VA Greater Los Angeles Healthcare System: lead

Study Sites (1)

VA West Los Angeles

Los Angeles, California, 90048, United States

Location

Related Publications (2)

• 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.

  PMID: 37494051 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.

  PMID: 36028192 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Boback Ziaeian
• Organization: VA Greater Los Angeles

boback.ziaeian@va.gov

310-478-3711

Study Officials

• Boback Ziaeian, MD PhD

  VA Greater Los Angeles Healthcare System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Cardiologist

Study Record Dates

• First Submitted: June 30, 2021
• First Posted: August 11, 2021
• Study Start: September 17, 2021
• Primary Completion: June 16, 2022
• Study Completion: June 16, 2022
• Last Updated: November 14, 2024
• Results First Posted: November 14, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)