Authors
- Danna, Denise DNS, RN, NEA-BC, CNE, FACHE
- Garbee, Deborah PhD, APRN, ACNS-BC
- Kensler, Paula RN, MSN, MBA
Abstract
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(R)- 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:
"Nurses[horizontal ellipsis] are poised to help bridge the gap between coverage and access, to coordinate increasing complex care for a wide range of patients, to fulfill their potential as primary care providers to the full extent of their education and training, and to enable the full economic value of their contributions across practice settings to be realized."20(p.13)
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.
Article Content
Inclusion criteria
Types of participants
The review will consider studies that include patients who are 19 years of age or older, diagnosed with HF, regardless of gender, ethnicity, other co-existing health conditions, level of education, income or health insurance. Participants must have been assessed using an established classification or categorization system by a primary care provider (i.e. APN, physician or cardiologist) at the beginning of the research study to determine their severity of symptoms or physical activity limitations. The NYHA Functional Classification37 and the AHA Stages of Heart Failure19 are two of the most widely used instruments.
Types of intervention(s)
The review will consider studies that evaluated evidence-based interventions delivered in APN-led HF clinics compared to usual care. Usual care refers to all non-APN-led HF clinics, care approaches including care provided by primary care physicians, or cardiology clinics and physician-led HF clinics.
APN-led HF clinics are defined as outpatient HF clinics where a nurse with advanced practice education and skills is the primary care provider for the patient. The types of interventions that will be included in the review are symptom management, optimization of medication therapy, patient and caregiver education, and psychosocial support. The APN with specialized training in HF collaborates and consults with physicians, but is not dependent on physicians to provide the healthcare described above.
Types of outcomes
The outcome measure to be evaluated is all-cause mortality rate. The CDC defines all-cause mortality rate as the total number of deaths in a defined population over a set period of time.36 HF is a progressive disease where the patient often has several comorbid conditions making the plan of care more complex and an exact cause of death difficult to determine.1 The WHO uses mortality to discuss severity and quality of care in NCD.2 All-cause mortality rate is a significant outcome potentially related to quality of care and is an outcome measure that is trended by healthcare providers and payers including hospitals and CMS.41 The CMS 30-day mortality measures are required by the Deficit Reduction Act (DRA) of 2005 and are publicly reported.41
Types of studies
Both experimental and epidemiological study designs including randomized controlled trials, non-randomized controlled trials, quasi-experimental studies, before and after studies, prospective and retrospective cohort studies, case control studies and analytical cross sectional studies will be included. The review will also consider descriptive epidemiological study designs including case series, individual case reports and descriptive cross sectional studies for inclusion.
Search strategy
The search strategy aims to find both published and unpublished studies. A three-step search strategy will be utilized in this review. An initial limited search of MEDLINE and CINAHL will be undertaken followed by analysis of the text words contained in the title and abstract, and of the index terms used to describe article. A second search using all identified keywords and index terms will then be undertaken across all included databases. Thirdly, the reference lists of all identified reports and articles will be searched for additional studies. Only studies published in English or available in English translation will be considered for inclusion in this review. The nurse practitioner role emerged in the US in the mid-1960s42 and the United Kingdom in the 1980s.43 Other countries followed in the 1990s.43 In order to be inclusive of any possibility of an APN-led HF clinic study, the search is inclusive of 1970 through August 2014.
The databases to be searched include:
Cochrane Central Register of Controlled Trials (CENTRAL)
PROSPERO
Medline/Ovid
CINAHL
Embase
Web of Science
PsycINFO
Google Scholar
The search for unpublished studies and Grey literature will include:
Mednar
Agency for Healthcare Research and Quality (AHRQ)
ProQuest Dissertations and Theses
Initial keywords to be used will be:
Advanced Practice Nurse/APN
Nurse Practitioner/NP
Heart failure nurse specialist
Nurse-led heart failure clinic
Advanced practice nurse-led clinic
Nurse managed heart failure clinic
Heart failure
Congestive heart failure
All-cause mortality rate
Heart failure patient
Cardiology clinics
Primary care physicians
Assessment of methodological quality
Quantitative research papers selected for retrieval will be assessed by two independent reviewers for methodological validity prior to inclusion in the review using standardized critical appraisal instruments from the Joanna Briggs Institute Meta-Analysis of Statistics Assessment and Review Instrument (JBI-MAStARI) (Appendix I ). Any disagreements that arise between the reviewers will be resolved through discussion, or with a third reviewer.
Data collection
Quantitative data will be extracted from papers included in the review using the standardized data extraction tool from JBI-MAStARI (Appendix II ). The data extracted will include specific details about the interventions, populations, study methods and outcomes of significance to the review question and specific objectives. Authors of primary studies will be contacted for missing information or to clarify unclear data.
Data synthesis
Quantitative research results will, where possible be pooled in statistical meta-analysis using JBI-MAStARI software. All results will be subject to double data entry. Effect sizes expressed as odds ratio (for categorical data) and weighted mean differences (for continuous data) and their 95% confidence intervals will be calculated for analysis. Heterogeneity will be assessed statistically using the standard Chi-square and also explored using subgroup analyses based on the different quantitative study designs included in this review. Where statistical pooling is not possible the findings will be presented in narrative form including tables and figures to aid in data presentation where appropriate.
Conflicts of interest
No conflict of interest.
Acknowledgements
This review will partially fulfill degree requirements for successful completion of the Doctor of Nursing Practice Program at Louisiana State University Health Sciences Center, School of Nursing for Paula Kensler.
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Appendix I: Appraisal instruments
MAStARI appraisal instrument[Context Link]
Appendix II: Data extraction tools[Context Link]
Keywords: Advanced Practice Nurse; Nurse Practitioner; Heart failure; nurse specialist; Nurse-led heart failure clinic; Advanced practice nurse-led clinic; Nurse managed heart failure clinic; Heart failure; Congestive heart failure; All-cause mortality rate; Quality