Viewing Study NCT06103565



Ignite Creation Date: 2024-05-06 @ 7:42 PM
Last Modification Date: 2024-10-26 @ 3:12 PM
Study NCT ID: NCT06103565
Status: NOT_YET_RECRUITING
Last Update Posted: 2024-06-11
First Post: 2023-10-23

Brief Title: EHR Nudges to Improve Quality of Care in HF
Sponsor: Northwestern University
Organization: Northwestern University

Study Overview

Official Title: Electronic Health Record Nudges to Improve Quality of Care in Heart Failure
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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
Detailed 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 ie illness severity raceethnicity socio-economic status clinician-level ie lack of knowledge clinical inertia and health system-level ie 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None