Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Review
. 2023 Aug 8;82(6):544-558.
doi: 10.1016/j.jacc.2023.05.050.

Bridging Treatment Implementation Gaps in Patients With Heart Failure: JACC Focus Seminar 2/3

Mohamed B Jalloh  1 , Tauben Averbuch  2 , Prashanth Kulkarni  1 , Christopher B Granger  3 , James L Januzzi  4 , Faiez Zannad  5 , Robert W Yeh  6 , Clyde W Yancy  7 , Gregg C Fonarow  8 , Khadijah Breathett  9 , C Michael Gibson  10 , Harriette G C Van Spall  11
Affiliations
Review

Bridging Treatment Implementation Gaps in Patients With Heart Failure: JACC Focus Seminar 2/3

Mohamed B Jalloh et al. J Am Coll Cardiol. .

Abstract

Heart failure (HF) is a leading cause of death and disability in older adults. Despite decades of high-quality evidence to support their use, guideline-directed medical therapies (GDMTs) that reduce death and disease burden in HF have been suboptimally implemented. Approaches to closing care gaps have focused largely on strategies proven to be ineffective, whilst effective interventions shown to improve GDMT uptake have not been instituted. This review synthesizes implementation interventions that increase the uptake of GDMT, discusses barriers and facilitators of implementation, summarizes conceptual frameworks in implementation science that could improve knowledge uptake, and offers suggestions for trial design that could better facilitate end-of-trial implementation. We propose an evidence-to-care conceptual model that could foster the simultaneous generation of evidence and long-term implementation. By adopting principles of implementation science, policymakers, researchers, and clinicians can help reduce the burden of HF on patients and health care systems worldwide.

Keywords: clinical trials; conceptual frameworks; guideline-directed medical therapies; heart failure; implementation science.

PubMed Disclaimer

Conflict of interest statement

Funding Support and Author Disclosures Dr Breathett was supported by research grant funding from the National Heart, Lung, and Blood Institute (K01HL142848, R01HL159216, R01HL16074) and the Health Resources and Services Administration of the U.S. Department of Health and Human Services. Dr Granger has received consulting fees from AbbVie, Abiomed, Alnylam Pharmaceuticals, Anthos, Bayer Corporation, Boehringer Ingelheim, Boston Scientific Corporation, Bristol Myers Squibb, Cardionomics, CeleCor Therapeutics, Janssen Pharmaceutical, Merck, Novo Nordisk, Novartis Pharmaceutical Company, Pfizer, Philips, REATA, and NephroSynergy; has salary funded by Duke grants sponsored by Boehringer Ingelheim, Bristol Myers Squibb, Daiichi-Sankyo, the U.S. Food and Drug Administration, Janssen Pharmaceuticals, Novartis Pharmaceutical Company, Pfizer, and Philips; and owns equity in Tenac.io. Dr Januzzi is a Trustee of the American College of Cardiology; has served as a board member for Imbria Pharmaceuticals and director at Jana Care; has received grant support from Abbott Diagnostics, Applied Therapeutics, Innolife, Novartis Pharmaceuticals, and Roche Diagnostics; has received consulting income from Abbott, Abiomed, Beckman Coulter, Janssen, Merck, Novartis, Prevencio, and Roche Diagnostics; and has served on clinical endpoint committees/data safety monitoring boards for Abbott, AbbVie, Bayer, CVRx, Janssen, Pfizer, and Takeda. Dr Zannad has received personal fees from 89Bio, Applied Therapeutics, Bayer, Boehringer, Bristol Myers Squibb, CVRx, Cardior, Cereno Pharmaceutical, CellProthera, CEVA, KPB, Merck, Novartis, Novo Nordisk, Owkin, Pfizer, Otsuka, Roche Diagnostics, Servier, and US2.2; owns stock options at G3Pharmaceutical and equities at Cereno pharmaceutical, Cardiorenal, and Eshmoun Clinical Research; and is founder of Cardiovascular Clinical Trialists. Dr Yeh has served as a consultant for Abbott Vascular, Boston Scientific, Elixir Medical, Medtronic, Shockwave, and Zoll; and has received research funding from Abbott Vascular, BD Bard, Boston Scientific, Cook Medical, Medtronic, and Philips. Dr Yancy has served on various National Institutes of Health– and National Heart, Lung, and Blood Institute–sponsored clinical trial and clinical research network oversight committees; has served as President (past) of the American Heart Association; and has a spouse who was previously employed by Abbott Labs, Inc. Dr Fonarow has served as a consultant for Abbott, Amgen, AstraZeneca, Bayer, Cytokinetics, Eli Lilly, Janssen, Medtronic, Merck, Novartis, and Pfizer. Dr Gibson has received funding from CSL Behring, Janssen Pharmaceuticals, Johnson & Johnson Corporation, and SCAD Alliance; has served as a consultant for Angel Medical Corporation, AstraZeneca, Bayer Corporation, Bioclinica, Boston Clinical Research Institute, Boston Scientific, Bristol Myers Squibb, Caladrius Biosciences, Cardiovascular Research Foundation, CeleCor Therapeutics, CSL Behring, Cytokinetics, Daiichi-Sankyo, the Duke Clinical Research Institute, EXCITE International ($0 received), Fortress Biotech, Gilead Sciences, Inari, Janssen Pharmaceuticals, Johnson & Johnson Corporation, MashUp MD, MD Magazine, MedImmune, Medtelligence, Merck, Microport, Micodrop, Miracor, MJ Health, Novartis, Novo Nordisk, Paratek, PERT Consortium, Pfizer, PhaseBio, the Population Health Research Institute, PLxPharma, Revance Therapeutics, the Society for Cardiovascular Angiography and Interventions, Solstic Health/New Amsterdam Pharma, Somahlution/Marizyme, Vectura, Web MD, and Woman As One; owns equity in Absolutys, nference, Dyad Medical, and Fortress Biotech; and has received royalties as a contributor to UpToDate in Cardiovascular Medicine. Dr Van Spall has received research support from the Canadian Institutes of Health Research and Heart and Stroke Foundation of Canada; and has received educational program grants from Novartis and Boehringer Ingelheim. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Figures

Figure 1.
Figure 1.. Barriers to implementation of evidence-based interventions in healthcare settings.
Barriers include misalignment with policy or healthcare system priorities, high cost or complexity, inadequate infrastructure or personnel to deliver the intervention, and regional disparities in resources.
Figure 2.
Figure 2.. Considerations in the planning and design of implementation trials.
Once a clinically relevant evidence-care gap is identified, an implementation strategy should be designed with input from relevant stakeholders and consideration of health equity, sustainability, and scalability of the intervention. Site selection should consider operational culture and resources. The effect of the implementation should be tested using a robust design and relevant, valid outcomes.
Figure 3.
Figure 3.. Steps to enhance implementation during and following a clinical trial.
High quality evidence can be implemented through the design of an intervention that is tailored to local context. A pilot phase can be used to assess feasibility and improve implementation processes during the trial. Knowledge generated from the full-scale trial can be used to drive further implementation efforts. This approach can also be used to improve implementation in clinical settings.
Figure 4.
Figure 4.. Factors that facilitate embedding of implementation trials in healthcare systems.
Effective embedding of trials in the healthcare system can facilitate long-term implementation, but require alignment of several important factors.
Figure 5.
Figure 5.. Randomization schemes in cluster trials.
Clusters are assigned to intervention (I) or control (C). A. Parallel group cluster design. Clusters receive their allocated treatment through to the end of the intervention period. B. Cluster crossover design for a trial with four clusters and four periods. Each row represents a treatment sequence. Cluster cross over between allocated treatments in each period. C. Stepped wedge design. In step 1, all clusters receive the control. At each subsequent step, a cluster crosses over to receive the intervention. The sequence of crossover is randomized.
Central illustration.
Central illustration.. Evidence-to-Care Conceptual Framework for Research and Clinical Implementation.
This framework is grounded in four pillars: high-quality evidence to support the therapy being implemented; an equitable, sustainable, and scalable implementation strategy; a robust trial design to test the effect of the implementation strategy; and measurement of relevant outcomes to guide scale-up of the implementation strategy. The four pillars are anchored in the healthcare system, with engagement of multi-level stakeholders and adaptation of the strategy to regional and local context.
See this image and copyright information in PMC

References

    1. Wei S, Miranda JJ, Mamas MA, et al. Sex differences in the etiology and burden of heart failure across country income level: analysis of 204 countries and territories 1990–2019. Eur Hear J - Qual Care Clin Outcomes 2022;0:1–11. - PMC - PubMed
    1. Greene SJ, Fonarow GC, DeVore AD, et al. Titration of Medical Therapy for Heart Failure With Reduced Ejection Fraction. J Am Coll Cardiol 2019;73:2365–2383. - PMC - PubMed
    1. Van Spall HGC, Fonarow GC, Mamas MA Under-utilization of Guideline-Directed Medical Therapy in Heart Failure: Can Digital Health Technologies PROMPT Change? J Am Coll Cardiol 2022. - PubMed
    1. Shanbhag D, Graham ID, Harlos K, et al. Effectiveness of implementation interventions in improving physician adherence to guideline recommendations in heart failure: a systematic review. BMJ Open 2018;8:e017765. - PMC - PubMed
    1. Sullivan K, Doumouras BS, Santema BT, et al. Sex-Specific Differences in Heart Failure: Pathophysiology, Risk Factors, Management, and Outcomes. Can J Cardiol 2021;37:560–571. - PubMed

Publication types