Table 1.
Notable recent trials in heart failure quality improvement
| Trial | Format | N | Primary findings | Strengths | Limitations | Implications | |
|---|---|---|---|---|---|---|---|
| Multidisciplinary | STRONG-HF [11••] | Multinational, randomized, parallel group implementation trial | 1078 | Rapid up-titration of GDMT after HF admission significant reduced all-cause death or HF readmission at 180 days | Specific targets and timeline of intervention; similar rates of serious adverse events with usual care | Unblinded; causes of readmission were not adjudicated; SGLT2i not included | 4 clinic visits within 2 weeks post-discharge in the intensive treatment arm requires significant patient, provider, and system commitment. Follow-up performed by HF experts |
| CONNECT-HF [10] | Cluster-randomized, multicenter, implementation, post-discharge QI | 5647 | No difference in composite of mortality or HF readmission; Hospitals randomized to receive extensive HF-related education | Large, multicenter | Did not provide recommendations or automate orders/referrals | No difference in outcomes detected with hospitals who were provided HF education and quality initiative information; Limits buy-in from health systems | |
| PACT-HF [26] | Stepped-wedge cluster randomized; single-center | 2494 | No difference in all-cause readmission, ED visit, or death at 3 months; Patient-centered transitional care model vs usual care | Significant resource commitment with transitional care; patients, providers, and policy-makers involved | Single healthcare system; did not assess adherence to discharge (DC) recommendations | No difference in primary outcome(s) with transitional care model which included nurse-led self-care education, DC summary, close follow-up, ± home-care visits | |
| Remote Optimization. Desai et al. [32] | Case–control study for algorithmic, multidisciplinary GDMT optimization | 1028 (19% in optimization group) | Significant increase in dose or use of BB and RAAS antagonists (but not MRA) with navigator driven remote medication optimization vs usual care | Clinical navigator driven algorithmic intervention; remote-care; multidisciplinary approach | Non-randomized; short-term follow-up; single-center | Potentially scalable; would require dedicated navigator, pharmacist, and HF cardiologist efforts | |
| EHR-based | PROMPT-HF [22•] | Single-center, randomized, pragmatic, EHR-based; outpatient | 100 providers; 1310 patients | Increase in GDMT prescriptions (primarily with BB) at 30 days. Providers randomized to receive targeted prompts vs usual care | Provides framework for rapid, lower cost EHR-based, pragmatic randomized trials | Single-system; Detected changes quite modest (mostly beta-blocker) | Relatively low-cost and scalable; requires integrated EHR; Average of 14 prompts per provider to prescribe 1 additional class of GDMT |
| REVEAL-HF [25] | Single-center, randomized, pragmatic, EHR-based | 3124 | No difference in composite of all-cause mortality at 1 yr and HFH within 30 days; Providers randomized to receive prognostic information vs usual care | Easy to integrate within existing EHR | Did not provide recommendations or automate orders/referrals | No benefit detected to providing 1 year mortality estimates | |
| IMPLEMENT-HF pilot study [44] | Prospective pilot study; EHR-based | 118 | Increase in prescriptions at time of discharge for BB, ARNI, and MRA; Primary team provided with algorithmic recommendations from pharmacist–physician GDMT Team | Increase in GDMT score in the intervention arm; proof-of-concept | Small, single-center pilot quality study | Requires dedicated HF Cardiologist and Pharmacist effort | |
| EPIC-HF [9] | Single-center; randomized; patient-centered | 306 | Increase in GDMT intensification at 30 days; 3-min video and 1 page checklist provided electronically to patients prior to clinic visit | Patient-engagement, readily scalable at centers with integrated EHR and patient messaging capability | Single system. Patients already scheduled with Cardiology were enrolled | Relatively low cost and scalable for patients with technology literacy | |
| Virtual RCT | CHIEF-HF [62] | Completely remote, patient-centered | 476 | Canagliflozin use improved KCCQ symptom score at 12 weeks | Similar QOL improvement with both HFrEF and HFpEF; all-remote trial with no in-person interaction | Subjective symptom assessment and QOL measures | Virtual implementation of GDMT shown to be safe and effective, trial design efficient/cost-effective. Fitbit devices to monitor activity level |
| Remote monitoring | CHAMPION [42] | Single-blind, randomized trial with CardioMEMS device | 550 | Reduction in HF hospitalization at 6 months with the addition of ambulatory PA pressure monitoring | Success with remote monitoring device | Single-blinded; industry-funded | Scalability has some limitations given invasive procedure that requires dedicated resources to receive and act on hemodynamic data but likely underutilized for eligible patients |