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| Name | Class |
|---|---|
| University of Colorado, Denver | OTHER |
| Lancaster General Hospital | OTHER |
| University of North Carolina, Greensboro | OTHER |
| Abbott |
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Heart failure (HF) is a major public health problem. The New York Heart Association (NYHA) Functional Classification by a HF provider helps to guide their decisions in patient treatment. The purpose of this study is to further examine the NYHA Classification Guide that is designed to assist healthcare providers. The investigators will conduct the study in the outpatient clinic setting where adult patients with chronic heart failure are treated. HF providers will be asked to complete the NYHA classification Guide and then participants will complete a standardized 6-minute walk test which is considered as the gold standard. Participant results will be compared between providers' assigned class and the results from the 6-minute walk test. The subsequent phase of the study will be incorporation of the NYHA Classification Guide into clinical practice. HF providers will use the NYHA Classification Guide for 30 days in the clinic setting and will report their perceptions.
As a continuation of prior work, the purpose of this study is to further examine the reliability and validity of the New York Heart Association (NYHA) Classification Guide and application into practice. The investigators will conduct a prospective cross-sectional study in the ambulatory care settings that manages adult patients with chronic heart failure (both heart failure with reduced ejection fraction [HFrEF] and heart failure with preserved ejection fraction [HFpEF]). HF providers will be asked to complete the NYHA classification Guide and assign one of 4 functional classes: Class I, Class II, Class III, or Class IV. Participants will then complete a standardized 6-minute walk test (6MWT), considered as the gold standard. Participant results will be compared between providers' assigned class and the results from the 6-minute walk test. The subsequent phase of the study will be incorporation of the NYHA Classification Guide into clinical practice. Clinicians will utilize the NYHA Classification Guide for 30 days and will report perceived barriers and facilitators. Data reporting NYHA Class and HF Stage will be obtained from 30 days prior implementation and compared to during implementation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Intervention Study Arm | Experimental | All participants with HF will be evaluated by their HF providers who will use the NYHA Classification Guide to assist with assignment of HF class. The participant will then complete a 6-minute walk test. Subsequently participating providers will utilize the guide to assess and assign the class of their HF patients in practice. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| New York Heart Association Classification Guide | Other | The New York Heart Association Classification Guide is a questionnaire that assists in guiding the provider in selection of the patient's class |
| Measure | Description | Time Frame |
|---|---|---|
| Reliability of the New York Heart Association (NYHA) Classification Guide | Experts will assign NYHA class using the guide in 30 selected clinical records. The assigned class results will be compared to determine reliability. | 12 weeks |
| Validity of the New York Heart Association (NYHA) Classification Guide | Providers will assign NYHA class using the guide to assess participants with HF who will then perform a 6-minute walk test. | 1 year |
| Barriers to implementation of the New York Heart Association (NYHA) Classification Guide | Providers will be surveyed following 30-days of using the NYHA Classification Guide in the clinical setting regarding perceived barriers to implementation into practice. | 30-days |
| Facilitators to implementation of the New York Heart Association (NYHA) Classification Guide | Providers will be surveyed following 30-days of using the NYHA Classification Guide in the clinical setting regarding perceived facilitators to implementation into practice. | 30-days |
| Documentation after Implementation of the New York Heart Association (NYHA) Classification Guide | 30-days prior and 30-days during implementation of the NYHA Classification Guide in clinical practice, the provider clinic notes from the patient visit will be assessed for documentation of NYHA class (I-IV) and HF stage (A-D). | 60-days |
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Participant Inclusion Criteria:
Participant Exclusion Criteria:
Provider Inclusion Criteria:
• Licensed healthcare providers (Physicians and Advance Practice Providers) in HF ambulatory clinical sites who care for adult patients with HF.
Providers Exclusion Criteria:
• Providers who do not actively manage adult patients with HF.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marilyn A. Prasun, PhD | Contact | 217-433-2316 | maprasu@ilstu.edu | |
| Kelly D. Stamp, PhD | Contact | 303-724-8398 | Kelly.Stamp@CUAnschutz.edu |
| Name | Affiliation | Role |
|---|---|---|
| Marilyn A. Prasun, PhD | Board of Trustees of Illinois State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Medical Center | Not yet recruiting | Aurora | Colorado | 80045 | United States |
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| Label | URL |
|---|---|
| Providers' Accuracy in Decision-Making with Assessing NYHA Functional Class of Patients with Heart Failure after use of a Classification Guide | View source |
| Providers' assignment of NYHA functional class in patients with heart failure: A vignette study | View source |
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Aggregate data will be published.
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| INDUSTRY |
A prospective cross-sectional study in the ambulatory care settings that manages adult patients with chronic heart failure (both heart failure with reduced ejection fraction [HFrEF] and heart failure with preserved ejection fraction [HFpEF]).
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For the 6-minute walk test the technician performing the test is masked. The remainder of the data is not masked.
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| Carle BroMenn Medical Center | Recruiting | Normal | Illinois | 61761 | United States |
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| Lancaster General Health/Penn Medicine | Not yet recruiting | Lancaster | Pennsylvania | 17602 | United States |
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