Trial Outcomes & Findings for Dashboard Activated Services and Tele-Health for Heart Failure (NCT NCT05001165)

NCT ID: NCT05001165

Last Updated: 2024-11-14

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 300 participants
• Primary outcome timeframe: 6-months after all patients receive the intervention
• Results posted on: 2024-11-14

Participant Flow

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.

Participant milestones

Measure	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.	Usual Care Patients with the VA Greater Los Angeles that received primary care or cardiovascular care as routinely scheduled.
Overall Study STARTED	150	150
Overall Study COMPLETED	150	150
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Dashboard Activated Services and Tele-Health for Heart Failure

Baseline characteristics by cohort

Measure	Proactive Telehealth-based Clinics n=150 Participants 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.	Usual Care n=150 Participants Patients with the VA Greater Los Angeles that received primary care or cardiovascular care as routinely scheduled.	Total n=300 Participants Total of all reporting groups
Age, Continuous	71.1 Years STANDARD_DEVIATION 11.5 • n=5 Participants	72.1 Years STANDARD_DEVIATION 10.6 • n=7 Participants	71.6 Years STANDARD_DEVIATION 11.1 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	148 Participants n=5 Participants	148 Participants n=7 Participants	296 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Black or African American	49 Participants n=5 Participants	43 Participants n=7 Participants	92 Participants n=5 Participants
Race (NIH/OMB) White	74 Participants n=5 Participants	82 Participants n=7 Participants	156 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6-months after all patients receive the intervention

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).

Outcome measures

Measure	Proactive Telehealth-based Clinics n=150 Participants 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.	Usual Care n=150 Participants Patients with the VA Greater Los Angeles that received primary care or cardiovascular care as routinely scheduled.
Optimization Potential Score	2.9 score on a scale Standard Deviation 2.1	2.6 score on a scale Standard Deviation 2.1

SECONDARY outcome

Timeframe: 6-months after all patients receive the intervention

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.

Outcome measures

Measure	Proactive Telehealth-based Clinics n=150 Participants 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.	Usual Care n=150 Participants Patients with the VA Greater Los Angeles that received primary care or cardiovascular care as routinely scheduled.
Change in Number of Patient Receiving ACE/ARB/ARNI	97 Participants	86 Participants

SECONDARY outcome

Timeframe: 6-months after all patients receive the intervention

Population: Entire study population

Number of patients that receive an active prescription for beta-blockers compared between treatment arms at the end of the study.

Outcome measures

Measure	Proactive Telehealth-based Clinics n=150 Participants 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.	Usual Care n=150 Participants Patients with the VA Greater Los Angeles that received primary care or cardiovascular care as routinely scheduled.
Change in the Number of Patients Receiving Beta-blockers	109 Participants	107 Participants

SECONDARY outcome

Timeframe: 6-months after all patients receive the intervention

Number of patients that receive an active prescription for mineralocorticoid receptor antagonist (MRA) compared between treatment arms at the end of the study.

Outcome measures

Measure	Proactive Telehealth-based Clinics n=150 Participants 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.	Usual Care n=150 Participants Patients with the VA Greater Los Angeles that received primary care or cardiovascular care as routinely scheduled.
Change in the Number of Patients Receiving MRA	53 Participants	47 Participants

SECONDARY outcome

Timeframe: 6-months after all patients receive the intervention

Number of patients that receive an active prescription for angiotensin receptor neprilysin inhibitor (ARNI) compared between treatment arms at the end of the study. .

Outcome measures

Measure	Proactive Telehealth-based Clinics n=150 Participants 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.	Usual Care n=150 Participants Patients with the VA Greater Los Angeles that received primary care or cardiovascular care as routinely scheduled.
Change in Number of Patients Receiving ARNI	35 Participants	31 Participants

SECONDARY outcome

Timeframe: 6-months after all patients receive the intervention

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. .

Outcome measures

Measure	Proactive Telehealth-based Clinics n=150 Participants 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.	Usual Care n=150 Participants Patients with the VA Greater Los Angeles that received primary care or cardiovascular care as routinely scheduled.
Change in Number of Patients Receiving SGLT2i	44 Participants	33 Participants

SECONDARY outcome

Timeframe: 6-months

Total number of any cause hospitalizations compared between treatment arms at the end of the study.

Outcome measures

Measure	Proactive Telehealth-based Clinics n=150 Participants 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.	Usual Care n=150 Participants Patients with the VA Greater Los Angeles that received primary care or cardiovascular care as routinely scheduled.
Total Number of Hospitalizations	29 hospitalizations	17 hospitalizations

SECONDARY outcome

Timeframe: 6-months

Total number of all-cause deaths compared between treatment arms at the end of the study.

Outcome measures

Measure	Proactive Telehealth-based Clinics n=150 Participants 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.	Usual Care n=150 Participants Patients with the VA Greater Los Angeles that received primary care or cardiovascular care as routinely scheduled.
Change in Total Deaths	17 Participants	24 Participants

OTHER_PRE_SPECIFIED outcome

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

Population: Patients Contacted

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.

Outcome measures

Measure	Proactive Telehealth-based Clinics n=40 Participants 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.	Usual Care Patients with the VA Greater Los Angeles that received primary care or cardiovascular care as routinely scheduled.
Qualitative Analysis of Patient Satisfaction	9.3 Satisification Score (0-10) Standard Deviation 2.22	—

OTHER_PRE_SPECIFIED outcome

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

Population: Half-day clinics

Average number of patients reviewed or contacted per half-day clinic to understand health services efficiency

Outcome measures

Measure	Proactive Telehealth-based Clinics n=21 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.	Usual Care Patients with the VA Greater Los Angeles that received primary care or cardiovascular care as routinely scheduled.
Average Number of Patients Contacted Per Half-day Clinic	7.14 number of participants Standard Deviation 2.46	—

OTHER_PRE_SPECIFIED outcome

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

Population: Patients chart reviewed

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.

Outcome measures

Measure	Proactive Telehealth-based Clinics n=150 Participants 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.	Usual Care Patients with the VA Greater Los Angeles that received primary care or cardiovascular care as routinely scheduled.
Clinician Time Per Patient	33.72 Minutes spent per patient Standard Deviation 14.59	—

OTHER_PRE_SPECIFIED outcome

Timeframe: After intervention clinic delivered - on average within one month of randomization.

Population: Intervention group

1. Average medication adjustments (stop, start, titration) per half-day clinic

2. Average laboratory tests ordered per half-day clinic

3. Average imaging/diagnostic procedures ordered per half-day clinic

4. Average of referrals for consults/device therapy per half-day clinic

Outcome measures

Measure	Proactive Telehealth-based Clinics n=21 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.	Usual Care Patients with the VA Greater Los Angeles that received primary care or cardiovascular care as routinely scheduled.
Average Number of Orders Placed Per Clinic Medication orders	0.62 Number of orders Standard Deviation 1.07	—
Average Number of Orders Placed Per Clinic Laboratory test orders	0.81 Number of orders Standard Deviation 1.12	—
Average Number of Orders Placed Per Clinic Imaging/diagnostic procedure orders	0.57 Number of orders Standard Deviation 0.87	—
Average Number of Orders Placed Per Clinic Referral for consult/device therapy orders	0.76 Number of orders Standard Deviation 0.94	—

Adverse Events

Proactive Telehealth-based Clinics

Serious events: 43 serious events

Other events: 0 other events

Deaths: 17 deaths

Usual Care

Serious events: 38 serious events

Other events: 0 other events

Deaths: 24 deaths

Serious adverse events

Measure	Proactive Telehealth-based Clinics n=150 participants at risk 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.	Usual Care n=150 participants at risk Patients with the VA Greater Los Angeles that received primary care or cardiovascular care as routinely scheduled.
General disorders Hospitalizations	19.3% 29/150 • Number of events 29 • 6 months	11.3% 17/150 • Number of events 17 • 6 months
General disorders Mortality	11.3% 17/150 • Number of events 17 • 6 months	16.0% 24/150 • Number of events 24 • 6 months

Other adverse events

Adverse event data not reported

Additional Information

Boback Ziaeian

VA Greater Los Angeles

Phone: 310-478-3711

Email: boback.ziaeian@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place