Examining the Reliability and Validity of the New York Heart Association Classification Guide to Assign Class for Patients With Heart Failure and Application Into Practice
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 104
- Locations
- 3
- Primary Endpoint
- Reliability of the New York Heart Association (NYHA) Classification Guide
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Masking Description
For the 6-minute walk test the technician performing the test is masked. The remainder of the data is not masked.
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Participant Inclusion Criteria:
- •A documented confirmed diagnosis of Heart Failure (HF)
- •Under the care of a Cardiologist and/or Advanced Practice Provider working in Cardiology
- •18 years of age or older and less than 90 years of age
- •Alert and oriented to person, place, and time
- •Ability to walk without assistance
- •Able to read and speak English
- •Participant
Exclusion Criteria
- •Diagnosed with myocardial infarction, coronary artery bypass graft (CABG), angioplasty or stent in the previous 30-days
- •Unstable angina in the previous 30 days
- •Active endocarditis
- •Acute myocarditis or pericarditis
- •Symptomatic severe aortic stenosis
- •Uncontrolled hypertension with systolic blood pressure readings > 180 mmHg or diastolic pressure readings > 100 mmHg
- •Uncontrolled atrial dysrhythmia or 3rd degree heart block
- •Active ventricular arrhythmias resulting in 1 or more shocks in the past month
- •Acute pulmonary embolus or pulmonary infection
- •Thrombosis of the lower extremities
- •Suspected dissecting aneurysm
- •Uncontrolled asthma
- •Pulmonary edema
- •Room air oxygen saturation (SPO2) at rest less than 90%
- •Acute respiratory failure
- •Acute noncardiopulmonary disorder that may affect exercise performance or be aggravated by exercise such as, infection, thyrotoxicosis
- •Left ventricular assist device
- •Mental impairment leading to inability to cooperate
- •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.
Arms & Interventions
Single Intervention Study Arm
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.
Intervention: New York Heart Association Classification Guide (Other)
Outcomes
Primary Outcomes
Reliability of the New York Heart Association (NYHA) Classification Guide
Time Frame: 12 weeks
Experts will assign NYHA class using the guide in 30 selected clinical records. The assigned class results will be compared to determine reliability.
Validity of the New York Heart Association (NYHA) Classification Guide
Time Frame: 1 year
Providers will assign NYHA class using the guide to assess participants with HF who will then perform a 6-minute walk test.
Documentation after Implementation of the New York Heart Association (NYHA) Classification Guide
Time Frame: 60-days
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).
Barriers to implementation of the New York Heart Association (NYHA) Classification Guide
Time Frame: 30-days
Providers will be surveyed following 30-days of using the NYHA Classification Guide in the clinical setting regarding perceived barriers to implementation into practice.
Facilitators to implementation of the New York Heart Association (NYHA) Classification Guide
Time Frame: 30-days
Providers will be surveyed following 30-days of using the NYHA Classification Guide in the clinical setting regarding perceived facilitators to implementation into practice.
Secondary Outcomes
No secondary outcomes reported
Investigators
Marilyn Prasun
Professor, Carle BroMenn Medical Center Endowed Professor
Board of Trustees of Illinois State University