Effectiveness of advanced practice nurse-led heart failure clinics on all-cause mortality: a systematic review of quantitative evidence protocol
Authors: Danna Denise , Garbee Deborah , Kensler Paula 
Published: December 2014

Review objectives/question
The objective of this systematic review is to synthesize the best available evidence regarding the effectiveness of interventions delivered in advance practice nurse-led clinics on mortality in adult (19 years of age and older) patients with heart failure.
The review question is: in adult patients,19 years of age and older, diagnosed with heart failure, what is the effectiveness of the interventions provided in advanced practice nurse-led heart failure clinics on all-cause mortality rates compared to usual care?

Background
The American College of Cardiology Foundation (ACCF)/American Heart Association (AHA) Task Force on Practice1 describes heart failure (HF) as "a complex clinical syndrome that results from any structural or functional impairment of ventricular filling or ejection of blood".1
(p.12) The World Health Organization (WHO) categorizes HF as a non-communicable disease (NCD) and is included with cardiovascular diseases, diabetes, cancer and chronic respiratory diseases.2 The causes of NCD include risky behaviors of tobacco use, insufficient physical activity, harmful use of alcohol, and unhealthy diet.2 These behaviors lead to elevated blood pressure, raised blood glucose and cholesterol levels, and excess body weight.2 HF is characterized by shortness of breath, fatigue, exercise tolerance limitations, and fluid retention, which may lead to pulmonary, visceral and peripheral edema.1 Pathologies that may be comorbid with or lead to the development of HF include hypertension, cardiovascular disease, diabetes mellitus, obesity, atrial fibrillation, and hyperlipidemia.1

The 2013 ACCF/AHA Guideline for the Management of Heart Failure report1 stated that the lifetime risk of developing HF is 20% for Americans 40 years of age or older. To illustrate the magnitude of the problem, the report states that: 1) approximately 5.1 million persons in the United States (US) suffer from HF today (2.4% of the population); 2) the absolute mortality rates for patients with HF remain at about 50% within five years of diagnosis; and 3) total costs for HF care exceed US$40 billion annually, with over half of the cost going toward hospitalizations.1,3 Centers of Medicare and Medicaid (CMS) report HF is the leading cause of hospitalization among adults 65 years of age and older, and patients admitted to the hospital for HF have the highest all-cause 30 day readmission rate.4 An estimated 1 to 2% of the population in European countries lives with HF and the prevalence of HF increases to greater than 10% in those aged 70 years and older.5 Globally, it is estimated that 1 to 2% of the population in developed countries suffers from HF, with the incidence of HF approaching five to10 per 1000 persons per year.5 Estimates in most developing countries are not available.5

The World Health Organization describes HF as a NCD. Non-communicable diseases are the leading cause of death worldwide, causing the deaths of 36 million people, or contributing to 63% of all deaths in 2008.2 Age-specific death rates due to NCDs are generally higher in countries with low-income levels, with almost half of deaths caused by NCDs in low- and middle-income countries occurring under the age of 70, and almost 30% below the age of 60.2 Many countries around the world, including countries of the European Union, the Americas, Asia, Australia, New Zealand and Japan, have experienced a decrease in mortality from cardiovascular diseases including acute myocardial infarction and cerebral vascular accident.6,7,8 This is the result of healthier lifestyle behaviors that include a healthy diet and exercise, decreased alcohol consumption and tobacco use, and preventive healthcare including control of hypertension and hyperlipidemia. People are living longer, however due to aging and the presence of chronic disease, many people will develop HF.8 Globally, acute myocardial infarction incidence and angina prevalence have decreased, and ischemic HF prevalence has increased since 1990.8 The challenge of providing healthcare to older patients with HF in the US and countries around the world is increasing substantially.1-9 Patients' ease of access to primary care providers using current evidence-based standards of care are essential to improving quality of life and mortality rates in this population of patients.
Worldwide, populations are growing and aging; and in the US, recent health care reforms have created an even greater demand for primary care providers.10 Yet, there is a downward trend in the number of primary care providers available to meet this need, with estimates that the shortage of adult primary care providers in the US could be as much as 35,000 to 44,000 by 2025.10,11 Physicians make up a significant proportion of primary care providers with more than 25% of physicians in the US being international medical school graduates.10,12 The downward trend of the ratio of physicians to population is being observed worldwide due to many of the same reasons seen in the US including: increasing older populations, retiring physician cohorts, and conservative forecasting of physician supply and demand.12-16

The HF patient's plan of care should include attention to the following elements: 1) adhering to prescribed medications; 2) monitoring daily weight; 3) following a low sodium diet; and 4) recognizing and timely reporting of heart failure symptoms. The AHA1 and the European Society of Cardiology17 (ESC) are two of a number of organizations worldwide that provide healthcare providers with up to date evidence-based practice guidelines for the prevention and treatment of HF.3,18,19 The AHA's Get with the Guidelines®- Heart Failure and Heart 360, and ESC's Guidelines for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2012 and ESC Mobile Pocket Guidelines are examples of materials that assist healthcare providers in using the latest strategies to treat their patients and assist with monitoring of the patient's ongoing health status. Current healthcare delivery structures are not meeting the increasing complexity and demand for healthcare that patients with HF need to maintain their optimal health.9

The Institute of Medicine (IOM)20 stated in their 2010 report, The Future of Nursing - Leading Change, Advancing Health:
Advanced practice nurses (APNs) have the knowledge and skills to improve the population's access to quality healthcare and are ready to meet this escalating need. There are a number of studies beginning in the 1970s21-28 that demonstrate that APNs provide quality care, with patient outcomes being similar to those of physicians. More recently, several studies focusing specifically on APN-led HF clinics have demonstrated their ability to provide evidenced-based care to patients with HF in the US and countries around the world.29-35

All-cause mortality rate is an overarching outcome. Using this outcome measure, patients who are 19 years of age and older, diagnosed with HF and cared for in APN-led heart failure clinics compared with other models of care such as the primary care physician, will be evaluated in this review. All-cause mortality rate as defined by the Centers for Disease Control and Prevention (CDC) as the total number of deaths in a defined population over a set period of time.36 In conjunction with all-cause mortality rate, a classification of the severity of the patient's HF will be used. Examples of these standardized tools are the New York Heart Association (NYHA) Functional Classification37 and the AHA Stages of Heart Failure.19 The ESC uses the NYHA Functional Classification in their guidelines. The severity of HF classification assists with understanding what the realistic outcomes are for the patient and the best strategy for delivery of the healthcare needed.
A quantitative systemic review to assess the effectiveness of APN-led HF clinics on all-cause mortality rates is proposed. In the forward of the IOM report,20 The Future of Nursing - Leading Change, Advancing Health; Harvey V Fineberg, MD, PhD, President of IOM, emphasizes the critical role that nursing plays in building a successful healthcare system going forward. The population of patients with HF is increasing2,8 and the number of primary care physicians is decreasing.12-17 The patient with HF needs frequent access to quality care to maintain optimal health. Advanced practice nurses have demonstrated their ability to provide quality healthcare and make a positive difference in the lives of patients with HF.
A preliminary search of PubMed/ MEDLINE, CINAHL, Cochrane Database of Systematic Reviews (CDSR), ProQuest, PROSPERO, and the JBI Database of Systematic Reviews and Implementation Reports was performed and no existing or ongoing systematic reviews on this topic were identified. This systematic review will provide specific information about the quality of care, using all-cause mortality rate, that the APN can provide to the patient with HF compared to usual care.