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| Name | Class |
|---|---|
| Washington University, Barns Jewish Hospital, St. Louis, MO | UNKNOWN |
| Henry Ford Hospital, Detroit, MI | UNKNOWN |
| Emory University, Grady Hospital, Atlanta, GA | UNKNOWN |
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The SmartHF study is a 12-week prospective randomized controlled multicenter clinical trial. This study will investigate the efficacy of an adaptive web application to facilitate guideline-directed medical therapy (GDMT) optimization in HFrEF patients. Eligible participants will be randomized to the web application intervention or control in a 1:1 manner, stratified by site.
The intervention is an adaptive medication optimization web application that extracts and analyzes the EHR data with a computable medication optimization algorithm. The algorithm provides a medication quality score and outputs medication optimization recommendations written in a patient -friendly manner.
The investigators have developed an adaptive medication optimization web application, named SmartHF, that provides patients with tailored information about potential HFrEF GDMT optimization. SmartHF guides patients to share the GDMT optimization recommendations with their provider during a clinic visit.
Participants will be randomized to receive the web application intervention or control up to 30 days before a clinic visit in a 1:1 manner and followed for 12 weeks after the clinic visit. This trial will determine the efficacy of SmartHF in prescribing GDMT in HFrEF patients compared to controls.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SmartHF application | Experimental | The web application-based study intervention provides adaptive medication recommendations that can be shared with their HF provider. |
|
| Control - Patients Standard Medication(s) | Active Comparator | No change to current medication(s) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SmartHF application | Other | Adaptive medication recommendations that can be shared with the participants HF provider. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Endpoint: Change in GDMT medication score | Change in GDMT medication score generated by the computable algorithm from baseline to Week 12 | Baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Endpoint: Level of agreement between the medication optimization algorithm recommendations and actual GDMT prescribed | The level of agreement between the medication optimization algorithm recommendations (Yes/No) and actual GDMT prescribed (Yes/No) | Over 12 Weeks |
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Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University, Grady Hospital | Atlanta | Georgia | 30303 | United States | ||
| University of Michigan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38939592 | Background | Dorsch MP, Sifuentes A, Cordwin DJ, Kuo R, Rowell BE, Arzac JJ, DeBacker K, Guidi JL, Hummel SL, Koelling TM. A Computable Algorithm for Medication Optimization in Heart Failure With Reduced Ejection Fraction. JACC Adv. 2023 Apr 12;2(3):100289. doi: 10.1016/j.jacadv.2023.100289. eCollection 2023 May. |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Ann Arbor |
| Michigan |
| 48109 |
| United States |
| Henry Ford Hospital and Health System | Detroit | Michigan | 48202 | United States |
| Trinity Healthcare St. Joseph Mercy Ann Arbor | Ypsilanti | Michigan | 48197 | United States |
| Washington University, Barns Jewish Hospital | St Louis | Missouri | 63110 | United States |