- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03804606
Risk and Benefit Informed MTM Pharmacist Intervention in Heart Failure
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Heart failure is a highly prevalent, complex disease associated with significant morbidity and cost. For example, Geisinger manages over 900 heart failure admissions per year, with each admission costing an estimated $10,000-$12,000. As payment models continue to shift from fee-for-service to value-based, significant investments are occurring in care team resources to help manage populations of patients with heart failure. These care team resources have demonstrated effectiveness. For example, internal Geisinger metrics indicate that interventions led by clinical pharmacists aimed at poorly controlled type II diabetics have resulted in a sustained median 1% (absolute) drop in hemoglobin hemoglobin a1C (glycated hemoglobin). In this new environment, intelligent deployment of limited resources is critical to drive quality and contain costs.
In heart failure, current risk prediction have demonstrated poor prognostic abilities and present a barrier to "precision delivery" of care team resources. Currently approaches are limited due to not fully utilizing rich, highly granular objective data such as imaging, laboratory values, and vital signs, and therefore are not optimized to accurately predict outcomes. The investigators have generated a machine learning model to predict both 1-year survival and heart failure hospitalization within 6 months of echocardiography. This model utilized 169 input variables including clinical data, imaging measures, and 18 care gap variables. Our results showed not only that the machine learning model had far superior accuracy to predict the morbidity endpoints compared to current approaches utilizing billing code data, but also that care gap variables were important for predicting 1-year survival. Moreover, the investigators showed that closing four of the care gap variables (flu vaccination, evidence-based beta blocker treatment, ACE (angiotensin-converting-enzyme) inhibitor/ARB (angiotensin receptor blockers) treatment, and control of diabetic a1C (i.e., values "in goal)) resulted in a predicted improvement in 1-year survival of ~1200 (out of ~11,000) patients. This study therefore aims to apply this machine learning approach to direct care team resources in a clinical setting to evaluate its impact on patient survival and healthcare utilization.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Pennsylvania
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Danville, Pennsylvania, United States, 17822
- Geisinger Health System
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- All adult Geisinger patients with heart failure, as identified by a validated EHR (Electonic Health Record)-based phenotype algorithm,
- Patients with a Geisinger primary care provider (PCP)
- Patients who follow with Geisinger Cardiology (at least 1 visit in past two years).
- Fulfills the specifications for arm assignment based on the results of the care gap benefit model.
Exclusion Criteria:
- Patients with a Geisinger PCP or Cardiologist in the South Central Region (part of the Geisinger Holy Spirit footprint) as MTM availability is limited in this service area.
- Patients who have indicated they do not wish to participate in research studies
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: High benefit, MTM
This arm will comprise patients with heart failure who are predicted to receive high benefit (reduction in mortality risk) by addressing open care gaps.
Following randomization, they will be referred to MTM pharmacy for review of treatments in an attempt to close appropriate care gaps.
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Patients will be referred for an encounter with a medication therapy management pharmacist.
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No Intervention: High benefit, no MTM
This arm will comprise patients with heart failure who are predicted to receive high benefit (reduction in mortality risk) by addressing open care gaps.
Following randomization, they will continue to receive clinical standard-of-care: regular follow-ups with Community Medicine (every 3 months) and Cardiology (every six months).
Importantly, these individuals are eligible for referral to MTM at the discretion of their physicians.
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Active Comparator: Low benefit, MTM
This arm will comprise patients with heart failure who are predicted to receive low benefit (reduction in mortality risk) by addressing open care gaps.
They will be selected based on age, sex, and risk-matching to the High benefit, MTM arm.
They will be referred to MTM pharmacy for review of treatments in an attempt to close appropriate care gaps.
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Patients will be referred for an encounter with a medication therapy management pharmacist.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
All-cause mortality
Time Frame: 1 year
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Death following randomization
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1 year
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Hospital admission
Time Frame: 1 year
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Number of admissions to the hospital
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1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Healthcare utilization - Total cost of care
Time Frame: 1 year
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Total cost of care (co-pays, claims paid, co-insurance, out-of-pocket costs) for the subset of patients in the study covered by the Geisinger Health Plan
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1 year
|
Incidence of flu vaccine care gap closure; relationship to mortality
Time Frame: 1 year
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The investigators will compare rates of closure for the flu vaccine care gap among arms and compare predicted versus actual mortality as a function of the observed care gap closure.
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1 year
|
Incidence of evidence-based beta blocker care gap closure; relationship to mortality
Time Frame: 1 year
|
The investigators will compare rates of closure for the evidence-based beta blocker care gap among arms and compare predicted versus actual hospitalization as a function of the observed care gap closure.
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1 year
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Incidence of ACE inhibitor/ARB care gap closure; relationship to mortality
Time Frame: 1 year
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The investigators will compare rates of closure for the ACE inhibitor/ARB care gap among arms and compare predicted versus actual hospitalization as a function of the observed care gap closure.
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1 year
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Incidence of diabetic a1C "in goal" care gap closure; relationship to mortality
Time Frame: 1 year
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The investigators will compare rates of closure for the diabetic a1C "in goal" care gap among arms and compare predicted versus actual hospitalization as a function of the observed care gap closure.
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1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Christopher M Haggerty, PhD, Geisinger Clinic
- Principal Investigator: Brandon K Fornwalt, MD, PhD, Geisinger Clinic
Publications and helpful links
General Publications
- Mortazavi BJ, Downing NS, Bucholz EM, Dharmarajan K, Manhapra A, Li SX, Negahban SN, Krumholz HM. Analysis of Machine Learning Techniques for Heart Failure Readmissions. Circ Cardiovasc Qual Outcomes. 2016 Nov;9(6):629-640. doi: 10.1161/CIRCOUTCOMES.116.003039. Epub 2016 Nov 8.
- Bhavnani SP, Parakh K, Atreja A, Druz R, Graham GN, Hayek SS, Krumholz HM, Maddox TM, Majmudar MD, Rumsfeld JS, Shah BR. 2017 Roadmap for Innovation-ACC Health Policy Statement on Healthcare Transformation in the Era of Digital Health, Big Data, and Precision Health: A Report of the American College of Cardiology Task Force on Health Policy Statements and Systems of Care. J Am Coll Cardiol. 2017 Nov 28;70(21):2696-2718. doi: 10.1016/j.jacc.2017.10.018. No abstract available.
- Haga K, Murray S, Reid J, Ness A, O'Donnell M, Yellowlees D, Denvir MA. Identifying community based chronic heart failure patients in the last year of life: a comparison of the Gold Standards Framework Prognostic Indicator Guide and the Seattle Heart Failure Model. Heart. 2012 Apr;98(7):579-83. doi: 10.1136/heartjnl-2011-301021.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-0735
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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