EHR Nudges to Improve Quality of Care in HF

Sponsor
Northwestern University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06103565
Collaborator
(none)
5
1
1
14
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Clinical Decision Support Tool
N/A

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 (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

Study Type:
Interventional
Anticipated Enrollment :
5 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Electronic Health Record Nudges to Improve Quality of Care in Heart Failure
Anticipated Study Start Date :
May 1, 2024
Anticipated Primary Completion Date :
Feb 1, 2025
Anticipated Study Completion Date :
Jul 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Other: Active clinical decision support tool for pharmacists

In this single arm, pilot feasibility study, pharmacists with be exposed to a clinical decision support tool to facilitate monitoring adherence to GDMT for patients with heart failure with reduced ejection fraction

Other: Clinical Decision Support Tool
Clinical decision support tool to enable pharmacists to monitor adherence to guideline-directed medical therapy for patients with heart failure with reduced ejection fraction

Outcome Measures

Primary Outcome Measures

  1. Reach [6-months]

    Percentage of alerts in which the pharmacist contacts the patient to discuss the low medication adherence rate

Secondary Outcome Measures

  1. Adoption [6-months]

    Percentage of pharmacists who contact at least 50% of eligible patients

  2. Implementation [After the end of the 6-month intervention period]

    Qualitative interviews will be conducted to evaluate acceptability, appropiateness, and feasibility

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Pharmacist at Northwestern Medicine participating in the Medication Adjusted to Target (MAT) Clinic
Exclusion Criteria:
  • None

Contacts and Locations

Locations

Site City State Country Postal Code
1 Northwestern University Feinberg School of Medicine Chicago Illinois United States 60611

Sponsors and Collaborators

  • Northwestern University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Faraz Ahmad, Assistant Professor, Northwestern University
ClinicalTrials.gov Identifier:
NCT06103565
Other Study ID Numbers:
  • STU00214805
First Posted:
Oct 27, 2023
Last Update Posted:
Oct 27, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Faraz Ahmad, Assistant Professor, Northwestern University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 27, 2023