Clinical Decision Support Tool for Heart Failure
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Northwestern University
No Placebo Group
Trial Summary
What is the purpose of this trial?
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.
Do I need to stop my current medications for this trial?
The trial information does not specify whether participants need to stop taking their current medications.
What data supports the effectiveness of the Clinical Decision Support Tool treatment for heart failure?
Patient-reported outcomes (PROs) are valuable in heart failure care because they help healthcare providers understand how patients feel and function, leading to more patient-centered care and improved quality of life. PROs have shown precision in evaluating disease status and are associated with better prognosis, suggesting that tools incorporating PROs could enhance heart failure management.12345
Is the Clinical Decision Support Tool for Heart Failure safe for humans?
How does the Clinical Decision Support Tool for Heart Failure differ from other treatments?
The Clinical Decision Support Tool for Heart Failure is unique because it uses technology to help doctors make better treatment decisions by integrating expert advice and guidelines, optimizing medication doses, and predicting hospital readmissions. Unlike traditional treatments, it leverages electronic health records and telemonitoring to improve patient care and reduce hospital visits.611121314
Eligibility Criteria
This trial is for pharmacists working at Northwestern Medicine in the Medication Adjusted to Target (MAT) Clinic. There are no specific exclusion criteria, so all pharmacists in this setting are eligible to participate.Inclusion Criteria
I am a pharmacist at Northwestern Medicine involved in the MAT Clinic.
Exclusion Criteria
N/A
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Intervention
Pharmacists are exposed to a clinical decision support tool to facilitate monitoring adherence to GDMT for patients with heart failure with reduced ejection fraction
6 months
Ongoing monitoring through EHR
Implementation Evaluation
Qualitative interviews conducted to evaluate acceptability, appropriateness, and feasibility of the intervention
After the 6-month intervention period
Follow-up
Participants are monitored for adherence to GDMT and effectiveness of the intervention
4-8 weeks
Treatment Details
Interventions
- Clinical Decision Support Tool (Behavioural Intervention)
Trial OverviewThe study is testing a new tool that helps pharmacists improve treatment adherence in heart failure patients by following medical guidelines more closely. The success of the tool will be measured using the RE-AIM framework.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Active clinical decision support tool for pharmacistsExperimental Treatment1 Intervention
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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Northwestern University Feinberg School of MedicineChicago, IL
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Who Is Running the Clinical Trial?
Northwestern UniversityLead Sponsor
References
Utility of Patient-Reported Outcome Instruments in Heart Failure. [2016]Patient-reported outcomes (PRO) are defined as reports coming directly from patients about how they feel or function in relation to a health condition and its therapy. Although there are numerous compelling reasons why PRO could be an important help in clinical care, they have not evolved into clinical tools integrated into care. The purpose of this review is to assess existing PRO instruments for heart failure with respect to their psychometric properties and potential for use in clinical care. We performed a systematic search of articles published between July 2008 and January 2015 within the MEDLINE, PROMIS, PROQOLID, and Cochrane Library databases. Included instruments had to be developed and tested for heart failure and have had their development processes and psychometric properties described. A total of 31 instruments were identified, 9 of which met all inclusion criteria. After evaluating each remaining instrument in terms of psychometric and clinical criteria and symptom coverage, only 2 instruments-Minnesota Living with Heart Failure and Kansas City Cardiomyopathy questionnaire-met all evaluation criteria. Although clinically useful PRO instruments exist, increasing education to providers on the value and interpretability of PRO instruments, as well as a more streamlined approach to their implementation in the clinical setting is necessary. A clinical trial comparing the routine use of disease-specific PRO with clinical care could further support their incorporation into practice.
Outcome assessment: functional status measures as therapeutic endpoints for heart failure. [2019]The role of measures of patients' functional status during chronic heart failure is to bridge the outcome information gap between physiologic assessments and the goal of medical care, which is to prolong the patient's life with minimal disability due to the syndrome and subsequent health care. The methods of rigorously developing and applying patient questionnaires as outcome measures will be unfamiliar to many health care providers. Many health care providers trained with different perspectives probably have an incredulous view of patient evaluations. What have we accomplished, though, if patients cannot perceive a net benefit from our services? In the final analysis, the patients' outcome assessments, collected in a systematic and unbiased manner, rather than the proxy measures used by health care providers, are the bottom line.
Patient-reported outcomes in heart failure: existing measures and future uses. [2022]Patient-reported outcomes (PROs) are any report obtained directly from a patient about how they feel or function in relation to their health condition and its therapies. Strong support for PROs exists at multiple levels of the health-care community from regulatory boards to clinical researchers. PROs are particularly important in heart failure because it is a common chronic illness marked with acute exacerbations, often requiring hospitalization, and significant symptom burden. Use of PROs to understand patient perspectives will help providers deliver more patient-centered care, and thus improve the quality of care. This review provides a contemporary overview of the current state of PROs in heart failure and suggests future directions and opportunities to advance PRO use to provide more comprehensive care. Advancing PRO measurement along with incorporating longitudinal measures in national databases and local electronic health records will serve to improve patient-centered care for patients with heart failure.
Use of patient-reported outcomes in heart failure: from clinical trials to routine practice. [2023]Heart failure (HF) is a complex syndrome that affects mortality/morbidity and acts at different levels in the patient's life, resulting in a drastic impairment in multiple aspects of daily activities (e.g. physical, mental/emotional, and social) and leading to a reduction in quality of life. The definition of disease status and symptom severity has been traditionally based on the physician assessment, while the patient's experience of disease has been long overlooked. The active participation of patients in their own care is necessary to better understand the perception of disease and the multiple aspects of life affected, and to improve adherence to treatments. Patient-reported outcomes (PROs) aim to switch traditional care to a more patient-centred approach. Although PROs demonstrated precision in the evaluation of disease status and have a good association with prognosis in several randomized controlled trials, their implementation into clinical practice is limited. This review discusses the modalities of use of PROs in HF, summarizes the most largely adopted PROs in HF care, and provides an overview on the application of PROs in trials and the potential for their transition to clinical practice. By discussing the advantages and the disadvantages of their use, the reasons limiting their application in daily clinical routine, and the strategies that may promote their implementation, this review aims to foster the systematic integration of the patient's standpoint in HF care.
Validity and responsiveness of the pediatric quality of life inventory (PedsQL) 4.0 generic core scales in the pediatric inpatient setting. [2022]Validated patient-reported outcomes responsive to clinical change are needed to evaluate the effectiveness of quality improvement interventions.
Adverse event prediction in patients with left ventricular assist devices. [2020]This work presents the Treatment Tool, which is a component of the Specialist's Decision Support Framework (SDSS) of the SensorART platform. The SensorART platform focuses on the management of heart failure (HF) patients, which are treated with implantable, left ventricular assist devices (LVADs). SDSS supports the specialists on various decisions regarding patients with LVADs including decisions on the best treatment strategy, suggestion of the most appropriate candidates for LVAD weaning, configuration of the pump speed settings, while also provides data analysis tools for new knowledge extraction. The Treatment Tool is a web-based component and its functionality includes the calculation of several acknowledged risk scores along with the adverse events appearance prediction for treatment assessment.
Perceived adverse drug events in heart failure: patients' perception and related factors. [2011]Patients with heart failure (HF) often perceive adverse drug events (ADEs), affecting quality of life. For weighing the benefits and burden of medication in HF care, knowledge on patients' perception of ADEs is needed. Our aim was to assess these ADE perceptions and to identify factors related to these perceptions.
A Comparative Safety Analysis of Medicines Based on the UK Pharmacovigilance and General Practice Prescribing Data in England. [2022]Adverse drug reactions (ADRs) represent a major concern leading to significant increases in both morbidity and mortality globally. Providing healthcare professionals (HCPs) and patients with real-world data on drug safety is imperative to facilitate informed decision-making. The study aimed to determine the feasibility of creating comparative safety charts for medicines by mapping ADR reporting onto prescribing data.
The impact of perceived adverse effects on medication changes in heart failure patients. [2013]Given the importance of patient safety and well-being, we quantified the likelihood and type of medication changes observed after 5 possible adverse effects (AE) perceived by heart failure (HF) patients.
Improving patient safety in the inpatient setting through risk assessment and mitigation. [2016]This article describes a working tool for clinicians in an inpatient oncology unit, aimed at preventing adverse events and increasing the clinical safety of patients with cancer. With the development of a catalog of adverse events and a risk map, healthcare providers are able to implement safe, best practices in daily activities.
Clinical decision support software for chronic heart failure. [2007]Critical care pathways, protocols, and guidelines have become an everyday feature of clinical practice and represent a distillation of the best available evidence. Chronic heart failure guidelines can be complex, and it is acknowledged that a combination of knowledge and expert advice, in addition to guidelines, is required to optimally treat these patients. This current article describes the potential value of clinical decision support software (CDSS) in the treatment of patients with chronic heart failure and practical aspects of using such a tool. Barriers to implementation of our tool included relatively low computer skills among family physicians and a lack of complexity within CDSS in addressing the wider nonmedical needs of patients. Improving computer skills, integrating CDSS into referral pathways, and requests for investigation may be ways of enhancing the use of this technology.
Heart Failure Management Innovation Enabled by Electronic Health Records. [2021]Patients with congestive heart failure (CHF) require complex medical management across the continuum of care. Electronic health records (EHR) are currently used for traditional tasks of documentation, reviewing and managing test results, computerized order entry, and billing. Unfortunately many clinicians view EHR as merely digitized versions of paper charts, which create additional work and cognitive burden without improving quality or efficiency of care. In fact, EHR are revolutionizing the care of chronic diseases such as CHF. This review describes how appropriate use of technologies offered by EHR can help standardize CHF care, promote adherence to evidence-based guidelines, optimize workflow efficiency, improve performance metrics, and facilitate patient engagement. This review discusses a number of tools including documentation templates, telehealth and telemedicine, health information exchange, order sets, clinical decision support, registries, and analytics. Where available, evidence of their potential utility in management of CHF is presented. Together these EHR tools can also be used to enhance quality improvement, patient management, and clinical research as part of a learning health care system model. This review describes how existing EHR tools can support patients, cardiologists, and care teams to deliver consistent, high-quality, coordinated, patient-centered, and guideline-concordant care of CHF.
Interdisciplinary Human-Centered AI for Hospital Readmission Prediction of Heart Failure Patients. [2023]The evolution of clinical decision support (CDS) tools has been improved by usage of new technologies, yet there is an increased need to develop user-friendly, evidence-based, and expert-curated CDS solutions. In this paper, we show with a use-case how interdisciplinary expertise can be combined to develop CDS tool for hospital readmission prediction of heart failure patients. We also discuss how to make the tool integrated in clinical workflow by understanding end-user needs and have clinicians-in-the-loop during the different development stages.
Telemonitoring in heart failure patients with clinical decision support to optimize medication doses based on guidelines. [2020]The European Society of Cardiology guidelines for heart failure management are based on strong evidence that adherence to optimal medication is beneficial for heart failure patients. Telemonitoring with integrated clinical decision support enables physicians to adapt medication dose based on up to date vital parameters and reduces the number of hospital visits needed solely for up-titration of heart failure medication. Although keeping track of weight and blood pressure changes is recommended during unstable phases, e.g. post-discharge and during up-titration of medication, guidelines are rather vague regarding telehealth aspects. In this paper, we focus on the evaluation of a clinical decision support system for adaption of heart failure medication and for detecting early deteriorations through monitoring of blood pressure, heart rate and weight changes. This clinical decision support system is currently used in INTENSE-HF, a large scale telemonitoring trial with heart failure patients. The aim of this paper was to apply the decision support algorithm to an existing telemonitoring dataset, to assess the ability of the decision support concept to adhere to the guidelines and to discuss its limitations and potential improvements.