Prescribing Improvement Strategies for Heart Failure

(Nudge Trial)

Overseen By Eric E Glenn

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: In training status

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve care for Veterans with heart failure by encouraging doctors to use specific medications that can save lives and reduce hospital visits. The study will test different methods of sending reminders and comparison reports to doctors to determine if these can help more Veterans receive recommended treatments, including medications like Dapagliflozin, Empagliflozin, Canagliflozin, and Ertugliflozin (known by brand names such as Farxiga, Jardiance, Invokana, and Steglatro). Primary care or cardiology doctors working at the Southern AZ VA Health Care System might be a good fit for this study. As an unphased trial, the study aims to enhance treatment strategies, offering Veterans a chance to benefit from improved care practices.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that these informational nudges are safe for improving heart failure care?

Research has shown that informational nudges safely improve heart failure care. These nudges, which are reminders or suggestions sent to doctors, help them make better decisions without causing harm. For example, one study found that these nudges can influence how doctors prescribe medicines by highlighting important information such as patient risks.

No reports indicate that these nudges cause direct harm, as they are purely informational prompts. They do not involve administering drugs or performing procedures. Instead, they assist doctors in making better decisions, making them a well-accepted method for enhancing patient care in heart failure. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to improve prescribing practices for heart failure. Unlike traditional treatments that focus solely on medications, this trial investigates the impact of informational nudges on clinicians' behavior. The trial's unique approach includes sending peer comparison reports and timely alerts before patient appointments. These strategies aim to enhance the use of effective medications like SGLT2 inhibitors and MRAs by encouraging clinicians to reflect on their prescribing habits. This could lead to more effective management of heart failure, potentially improving patient outcomes without introducing new drugs.

What evidence suggests that this trial's treatments could be effective for heart failure?

Research has shown that simple reminders can help doctors prescribe the right medications for heart failure. In this trial, some clinicians will receive reports comparing their prescribing habits to those of their peers, while others will receive alerts to prescribe important drugs like SGLT2 inhibitors (a diabetes medication also helpful for heart failure) and MRAs (which help lower blood pressure). Additionally, some clinicians will receive both interventions. These reminders use social norms and prompts to encourage better prescribing practices. Studies have found that these strategies improve heart failure care, leading to better patient outcomes. By making it easier for doctors to choose the right medications, these reminders can save lives and reduce hospital visits. ^{1 4 6 7 8}

Who Is on the Research Team?

Sandesh Dev, MD

Principal Investigator

Southern Arizona VA Health Care System, Tucson, AZ

Are You a Good Fit for This Trial?

This trial is for primary care and cardiology clinicians at the Southern AZ VA Health Care System who work in outpatient clinics. Clinicians still in training, like residents or fellows, cannot participate.

Inclusion Criteria

This criterion includes primary care and cardiology clinicians who work in the outpatient clinic setting at the Southern AZ VA Health Care System.

Exclusion Criteria

Clinicians who are in training status (resident, fellow) will be excluded.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Clinicians receive informational alerts and peer comparison feedback to improve prescribing of SGLT2 and MRA therapies for heart failure patients

6 months

Ongoing clinician interactions via secure email and alerts

Follow-up

Participants are monitored for safety and effectiveness after intervention

30 days

What Are the Treatments Tested in This Trial?

Interventions

• Informational Nudge

Trial Overview

The study tests two methods to encourage better prescription practices for heart failure: a peer comparison report and an alert system. It aims to see if these 'nudges' can improve the health of Veterans by increasing the use of life-saving SGLT2 and MRA therapies.

How Is the Trial Designed?

Group I: Control Active Control 1 Intervention

No alert or peer comparison

Group II: Peer Comparison Report Active Control 1 Intervention

Clinicians assigned to peer comparison, will receive messages by secure email every two weeks regarding their SGLT2i and MRA prescribing performance.

Group III: Alert Active Control 1 Intervention

Clinicians in the alert arm will receive an alert two business days prior to a patient's upcoming appointment. Clinicians will receive approximately two alerts per week.

Group IV: Alert and Peer Comparison Active Control 2 Interventions

The combined alert and peer comparison arm will receive both interventions.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Arizona State University

Collaborator

Trials

311

Recruited

109,000+

Published Research Related to This Trial

A meta-analysis of 10 randomized controlled trials involving 15,373 heart failure patients found no significant differences in clinical outcomes among the SGLT2 inhibitors empagliflozin, dapagliflozin, canagliflozin, and ertugliflozin regarding heart failure hospitalizations, cardiovascular deaths, and all-cause mortality.

Despite the lack of differences in treatment effects, the analysis highlighted the need for further research due to the variability in study results and the wide confidence intervals observed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing the clinical outcomes across different sodium/glucose cotransporter 2 (SGLT2) inhibitors in heart failure patients: a systematic review and network meta-analysis of randomized controlled trials. Teo, YH., Yoong, CSY., Syn, NL., et al.[2022]

Dapagliflozin, when added to usual care for patients with heart failure and mildly reduced or preserved ejection fraction, significantly improves quality-adjusted life years (QALYs) and life expectancy, with increases of 0.231 QALYs and 0.354 life-years in the UK.

The treatment is projected to be cost-effective across the UK, Germany, and Spain, with high probabilities (91% in the UK, 89% in Germany, and 92% in Spain) of being within acceptable cost-effectiveness thresholds, making it a viable option for healthcare systems in these countries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The cost-effectiveness of dapagliflozin in heart failure with preserved or mildly reduced ejection fraction: A European health-economic analysis of the DELIVER trial. Booth, D., Davis, JA., McEwan, P., et al.[2023]

Empagliflozin, when added to standard care for heart failure patients, significantly improves quality-adjusted life expectancy by 0.15 QALYs at an additional cost of 1,594 euros, making it a cost-effective treatment option.

The probability of empagliflozin being cost-effective compared to standard care alone is high, at 77.6% for a willingness-to-pay threshold of 35,000 euros per QALY, indicating strong economic viability in the Finnish healthcare system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-Effectiveness of Empagliflozin in Combination with Standard Care versus Standard Care Only in the Treatment of Heart Failure Patients in Finland. Hallinen, T., Kivelä, S., Soini, E., et al.[2023]

In a study of 441 outpatients with heart failure with reduced ejection fraction (HFrEF), 45% were eligible for both dapagliflozin and empagliflozin, indicating a significant potential for these SGLT2 inhibitors to be used in real-world clinical practice.

When excluding the NT-proBNP threshold from eligibility criteria, the proportion of patients eligible for dapagliflozin increased to 86%, suggesting that broader application of these medications could further reduce morbidity and mortality in HFrEF patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sodium-glucose co-transporter-2 inhibitors eligibility in patients with heart failure with reduced ejection fraction. Monzo, L., Ferrari, I., Cicogna, F., et al.[2021]

Immediate initiation of dapagliflozin treatment in patients with a history of hospitalization for heart failure significantly reduces heart failure events and cardiovascular mortality compared to standard therapy, demonstrating its efficacy in improving patient outcomes.

Both immediate and delayed initiation of dapagliflozin are cost-effective options, but immediate initiation offers greater clinical benefits, yielding nearly 10% more quality-adjusted life years (QALYs), making it the preferred standard of care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-effectiveness of immediate initiation of dapagliflozin in patients with a history of heart failure. Miller, RJH., Chew, DS., Qin, L., et al.[2023]

SGLT2 inhibitors (SGLT2i) significantly reduce all-cause mortality (hazard ratio 0.85) and major adverse cardiovascular events (MACE) (hazard ratio 0.91) in patients with type 2 diabetes and cardiovascular disease, based on a meta-analysis of 46,969 patients across six trials.

Among the SGLT2i, empagliflozin was found to be the most effective in preventing cardiorenal events and mortality, while ertugliflozin was less effective compared to other SGLT2i, indicating that treatment choice can impact patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of SGLT2 Inhibitors: A Multiple-Treatment Meta-Analysis of Clinical Decision Indicators. Martínez-Vizcaíno, V., Díez-Fernández, A., Álvarez-Bueno, C., et al.[2021]

Dapagliflozin, when added to standard treatment for heart failure with reduced ejection fraction (HFrEF), significantly improves patient outcomes, increasing quality-adjusted life years (QALYs) from 6.33 to 6.92, while the cost of treatment rises from approximately 559 USD to 1745 USD.

The cost-effectiveness analysis shows that dapagliflozin is a cost-effective option for HFrEF patients, with an incremental cost-effectiveness ratio (ICER) of 1991 USD/QALY, and it remains cost-effective for 87% of scenarios at a willingness to pay threshold of 5131 USD/QALY.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-utility analysis of add-on dapagliflozin treatment in heart failure with reduced ejection fraction. Krittayaphong, R., Permsuwan, U.[2021]

Empagliflozin has been shown to be effective in improving outcomes for patients with heart failure, regardless of their kidney function status, indicating its broad applicability in this patient population.

The study included a diverse group of patients with varying levels of kidney risk, which supports the safety and efficacy of empagliflozin across different kidney health categories.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In chronic HF, empagliflozin reduced a composite of CV death or HF hospitalization across kidney risk categories. Ziaolhagh, A., Molony, DA.[2023]

Dapagliflozin, when added to standard therapy for heart failure with reduced ejection fraction (HFrEF), significantly improves patient outcomes, increasing life-years from 5.62 to 6.20 and quality-adjusted life-years (QALYs) from 4.13 to 4.61, while also reducing hospitalizations for heart failure.

The treatment is considered cost-effective across the UK, Germany, and Spain, with incremental cost-effectiveness ratios well below the commonly accepted thresholds, indicating that it provides good value for the healthcare systems in these countries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-effectiveness of dapagliflozin as a treatment for heart failure with reduced ejection fraction: a multinational health-economic analysis of DAPA-HF. McEwan, P., Darlington, O., McMurray, JJV., et al.[2021]

Dapagliflozin is more cost-effective than empagliflozin for preventing cardiovascular death in heart failure patients, with a cost needed to treat (CNT) of $528,770 compared to $1,018,368 for empagliflozin, based on data from major clinical trials.

The annualized number needed to treat (aNNT) to prevent one cardiovascular death was significantly lower for dapagliflozin (110) than for empagliflozin (204), indicating that dapagliflozin may provide better clinical outcomes for the cost in heart failure management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Dapagliflozin Versus Empagliflozin on Cardiovascular Death in Patients with Heart Failure Across the Spectrum of Ejection Fraction: Cost per Outcome Analysis. Alnsasra, H., Tsaban, G., Solomon, A., et al.[2023]

In the EMPEROR-Reduced study involving over 3700 participants with chronic heart failure and reduced ejection fraction, empagliflozin significantly reduced the risk of hospitalization for heart failure complications (13.2% vs. 18.3% for placebo) over an average of 16 months.

Empagliflozin also showed a lower incidence of serious kidney problems (1.6% vs. 3.1% for placebo), indicating its potential safety and efficacy in managing heart failure, although it was associated with a higher rate of genital tract infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug treatment with empagliflozin lowered risk for hospitalization in people with heart failure with reduced ejection fraction: plain language summary of the EMPEROR-Reduced study. Zannad, F., Macari, S.[2023]

Citations

1.

sciencedirect.com

sciencedirect.com/science/article/pii/S1071916424007607

Closing The Gap In Heart Failure Care Using Nudge ...

This study introduces the use of nudge interventions for clinicians to enhance medication use, with the idea that these interventions can be crucial to ...

2.

centerwatch.com

centerwatch.com/clinical-trials/listings/NCT05986695/informational-nudge-to-improve-heart-failure-prescribing

Informational Nudge to Improve Heart Failure Prescribing

This study addresses a critical gap in quality of care for Veterans with heart failure (HF). Only 1/3 or fewer eligible Veterans are receiving ...

3.

casi.asu.edu

casi.asu.edu/wp-content/uploads/sites/32/2023/05/Dev-S.-Research-Day-Data-Blitz_-UofA-College-of-Medicine_3.29.2023.pdf

Effect of Clinician 'Nudges' on Heart Failure Prescribing

Informational alerts exert effects through salience, cold-state priming, active choice whereas peer comparison acts through social norms. Study design. Peer ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9908072/

Nudging to Improve Cardiovascular Care-Clinicians ...

This nudge included 2 components: an active choice prompt embedded in the EHR ordering section and a monthly peer comparison report received in the clinician ...

5.

reporter.nih.gov

reporter.nih.gov/search/lpri8RdgdUS-3-aZVacwOg/project-details/11300928

Project Details - NIH RePORTER

In this proposed study, we will evaluate two nudge interventions, alerts and peer comparison feedback, that exploit several biases which constitute the ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8971005/

Nudging within learning health systems: next generation ...

The nudge intervention consisted of changing the choice architecture of the EHR to display a 1-year mortality risk for patients admitted with ...

7.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1071916424007607

Closing The Gap In Heart Failure Care Using Nudge ...

Data collection includes demographics, vitals, comorbidity index, and implementation measures, contributing to closing the HF treatment gap, enhancing ...

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11930280/

Nudging Health Behavior Change Among Home-Based ...

This study aimed to identify nudging interventions to promote health behavior change among patients undergoing home-based cardiac rehabilitation.