Clinical Trials Logo

Clinical Trial Summary

The purpose of this pilot feasibility study is to test a pharmacist-facing clinical decision support tool designed to increase adherence to guideline-directed medical therapy and evaluate the tool using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) evaluation framework.


Clinical Trial Description

Heart failure (HF) is a common, morbid, and costly condition with an enormous toll on health and the health care system in the US. Unlike other HF types, for patients with HFrEF decades of high quality, randomized controlled trials have demonstrated numerous interventions-including medications, devices, and cardiac rehabilitation-that improve quality of life, lengthen survival, and reduce hospitalizations. Despite the substantial evidence, many patients with HFrEF do not receive optimal guideline-directed medical therapy (GDMT) as shown by several US quality registries dating back to 2009. Contributors to gaps in care quality have been shown to include patient-level (i.e., illness severity, race/ethnicity, socio-economic status), clinician-level (i.e., lack of knowledge, clinical inertia), and health system-level (i.e., lack of care coordination) factors. Pharmacist-led clinics in several health systems and studies have been shown to lead to high rates of GDMT intensification. This finding is consistent with decades of research in HF and other conditions in which more resources allocated to disease management can improve quality of care. Yet, little data exist on adherence to optimal GDMT after completion of an intensive disease management program. Northwestern Medicine is a large, integrated system that operates multiple pharmacist-led clinics to optimize GDMT in patients with HFrEF. Once patients reach the maximum level of intensification, they complete the program and are no longer actively followed by the pharmacist team. The adoption of electronic health records (EHRs) and integration of novel data sources, such as prescription fill data from third-party vendors, create the opportunity to implement strategies to monitor adherence over time and intervene when adherence declines. Clinical decision support nudges in the EHR are inexpensive strategies that have been shown in clinical areas outside of HF to increase adherence to evidence-based therapies. Studies that use pharmacy fill data to monitor adherence to evidence-based care are rare given some of the technical challenges of accessing these data and using them for clinical decision support tools. In this pilot feasibility study, we aim to develop and test a pharmacist-facing clinical decision support tool designed to increase adherence to GDMT and evaluate the tool using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) evaluation framework. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06103565
Study type Interventional
Source Northwestern University
Contact Lacey Gleason, MSPH
Phone 312-503-7221
Email lacey.gleason@northwestern.edu
Status Not yet recruiting
Phase N/A
Start date July 2024
Completion date July 2025

See also
  Status Clinical Trial Phase
Completed NCT05077293 - Building Electronic Tools To Enhance and Reinforce Cardiovascular Recommendations - Heart Failure
Completed NCT03614169 - Direct HIS-pacing as an Alternative to BiV-pacing in Symptomatic HFrEF Patients With True LBBB N/A
Recruiting NCT05278962 - HF Patients With LVADs Being Treated With SGLT2i Phase 4
Completed NCT04210375 - Study of JK07 in Subjects With Heart Failure With Reduced Ejection Fraction (HFrEF) Phase 1
Not yet recruiting NCT06433687 - Evaluation of the HekaHeart Platform in Medication Management for Heart Failure Patients
Completed NCT05001165 - Dashboard Activated Services and Tele-Health for Heart Failure N/A
Active, not recruiting NCT03701880 - Early Use of Ivabradine in Heart Failure N/A
Recruiting NCT05650658 - Left vs Left Randomized Clinical Trial N/A
Not yet recruiting NCT06299436 - Hemodynamic Assessment of underLying myocyTe Function in Right Heart Failure
Recruiting NCT05992116 - Iron Deficiency in Patients With Heart Failure and Reduced and Mildly Reduced Ejection Fraction
Recruiting NCT05365568 - Left Bundle Branch Area Pacing for Cardiac Resynchronization Therapy: A Randomized Study N/A
Active, not recruiting NCT05204238 - Follow Up of acuTe Heart failUre: a pRospective Echocardiographic and Clinical Study (FUTURE)
Not yet recruiting NCT04420065 - Effects of Preferential Left Ventricular Pacing on Ventriculoarterial Coupling and Clinical Course of Heart Failure N/A
Terminated NCT03479424 - Home Outpatient Monitoring and Engagement to Predict HF Exacerbation
Completed NCT02113033 - VAgal Nerve Stimulation: safeGUARDing Heart Failure Patients Phase 2
Recruiting NCT03209180 - Immediate Release Versus Slow Release Carvedilol in Heart Failure Phase 4
Recruiting NCT05299879 - Screening for Advanced Heart Failure IN Stable ouTpatientS - The SAINTS Study
Recruiting NCT05637853 - Telemonitored Fast Track Medical Sequencing for Heart Failure With Reduced Ejection Fraction
Completed NCT03870074 - CPET Predicts Long-term Survival and Positive Response to CRT
Recruiting NCT04590001 - Effect of the MobiusHD® in Patients With Heart Failure N/A