In patients with chronic systolic heart failure, does the use of Entresto lead to fewer hospitalizations than the use of Enalapril?

Nursing Research EBP Project
Step 1: What is the clinical question that guided the project?
In patients with chronic systolic heart failure, does the use of Entresto lead to fewer hospitalizations than the use of Enalapril?
What is the clinical question in PICO(T) format?
P: Patients with systolic heart failure (HFrEF)I: EntrestoC: EnalaprilO: fewer hospitalizations
What is the relevance of the clinical question to nursing practice?
This topic is relevant to nursing practice because of the prevalence of heart failure patients that are hospitalized in the U.S. It is important for this chronic condition to be managed to help benefit the patient to keep them out of the hospital for acute heart failure and live longer with the condition. It is important to help them with more advanced treatment options.
Step 2: Which search engines were used?
The search engines that were used were the National Institute for Health and Care Excellence (nice.org.uk), PubMed, Medline, and National Guideline Clearinghouse.
What were the keywords used in the search?
“Entresto” “Hospitalizations” “heart failure guidelines”
How many results were obtained from each search engine?
None from National Guideline Clearinghouse, PubMed had 320 with “Entresto” and 72 with “Entresto” and “hospitalizations”, Medline had none to do with hospitalizations, NICE had one article.
What was done to get the search results to a manageable number? How were the final five articles chosen?
I attempted to find guidelines regarding heart failure and Entresto using National Guideline Clearinghouse, but no search results were found when I entered “Entresto”. When I entered “heart failure”, there were a few topics, but none that related to Entresto. I knew that there were ACC/AHA/HFSA guidelines that mention Entresto. So, I did a google search for “heart failure guidelines”. The JACC article regarding the guidelines was the first option. After I found the guidelines, I searched PubMed with the keyword “Entresto” and 320 articles were shown. I then entered the keywords “Entresto” and “hospitalizations” and 72 articles were shown. I started at the top and found an article regarding the 30-day readmission rate as in regard to Entresto’s influence. At the bottom of this article there was a link to another article called, “Can 2 Pills a Day Keep Readmission Away?: Sacubitril/Valsartan to Reduce 30-Day Heart Failure Readmissions.” I then returned to PubMed and under the list of 72 articles, I found another article called, “Sacubitril/valsartan in cardiovascular disease: evidence to date and place in therapy.” I then searched NICE website with the keyword “Entresto” and the article regarding guidelines in the U.K. was shown along with the evidence mentioning the PARADIGM-HF trial. This trial was a randomized, double-blind, controlled, phase III trial that compared sacubitril/valsartan (Entresto) to enalapril. (nice.org.uk, 2018) I searched Medline, as well, but only got information regarding the medication and without mention of hospitalizations. One of the articles that I will be using is the 2017 ACC/AHA/HFSA guidelines about the treatment of heart failure. The guidelines are very specific to the recommendation of Entresto over ACE inhibitors for the decrease in heart failure hospitalizations. (Yancy, et al., 2017) The other article that I will be using is “Can 2 Pills a Day Keep Readmission Away?: Sacubitril/Valsartan to reduce 30-Day Heart Failure Readmissions.” This article is specific to how Entresto can help reduce heart failure admissions, but also heart failure readmissions. (Mentz & O’Brien, 2016) It shows cost-effectiveness because Medicare charges penalties to hospitals with high readmission rates for heart failure within 30 days.
Of the five articles chosen, how many were qualitative studies? How many were quantitative studies? What other types of articles were included?
None were qualitative studies. The primary study was a quantitative study. PARADIGM-HF study was a randomized, double-blind, prospective comparison of Entresto with enalapril in patients with chronic heart failure. The other articles that were included were the heart failure guidelines and articles that discuss and critique the PARADIGM-HF study.
Which ONE article do you felt best represented the clinical question and why?
“Can 2 Pills a Day Keep Readmission Away?: Sacubitril/Valsartan to Reduce 30-Day Heart Failure Readmissions” This article is about 30-day readmission rates with patients that have heart failure. The study showed a 38% reduction in HF readmission rates for those patients taking Entresto compared to enalapril. This article specifically discussed the hospitalization aspect of the PARADIGM-HF study.
Step 4: What were the identified patient barriers or values that might impact the implementation of the EBP project?
Two patient preferences or values that might come into when looking at my clinical question are: 1) the costs of new medications and 2) not wanting to change or add new medications to their heart failure treatment. I feel that these are relevant preferences because patients can prefer to not change medications because they feel like what they are taking is working for them. Also, costs of medications can drive the patient’s preferences of which medications are available for them.
What measures could be taken to address the identified patient barriers?
The identified barriers related to patient values or preferences that might come up when implementing the evidence is the cost of the medication if the patient doesn’t have prescription drug insurance, if the insurance covers the medication, if the cost of the copay is affordable, and if the patient is open to change medications. Ideas for addressing these barriers include giving information regarding insurance coverage, copay amounts, patient assistance information, and drug-company sponsored free month supply. This way the patient can try the medication and see how they do with it, before having to pay anything. Also, tackling the cost and insurance coverage first thing encourages the patient to not worry about the cost up front. Also, providing the rationale for the change of medication given the evidence is also important so that the patient understands why there is a change in medication.
Was a guideline located that provided support for the clinical question? If yes, briefly summarize the guideline and provide a rationale as to why it is applicable to the chosen clinical question. If no, briefly summarize why a guideline could not be located.
The JACC article “2017 ACC/AHA/HFSA Focused Update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure” included a guideline that recommends Entresto due to the decrease in HF hospitalizations. The guidelines recommend Entresto for those patients that are already tolerating an ACE or ARB for heart failure. These specific guidelines are the answer to my clinical question.
What is the recommended practice change, based on the clinical question, and the evidence located in the literature search? Include a specific rationale from any articles or guidelines located.
The recommendation for change that I am making, based on my clinical question, the literature search results, patient preferences and values, and guidelines is to implement a program that would help hospitals decrease heart failure readmissions by encouraging the providers to prescribe Entresto over an ACE inhibitor like enalapril. The research articles that I researched showed that the PARADIGM-HF study showed a decrease in 38% reduction in heart failure readmissions. (Mentz & O’Brien, 2016) The 2017 ACC/AHA/HFSA Guidelines for the Management of Heart Failure recommends that with patients that have chronic heart failure with ejection fraction of 35% or less, currently NYHA class II to III, who can already tolerate an ACE inhibitor or ARB, should be switched to Entresto to further reduce morbidity and mortality. (Yancy, et al., 2017) To incorporate patient preferences and values, it would be important to educate case management or physician office staff to assist the patient with co-pay cards, free trial offers, patient assistance, and/or assistance with the pharmacy filling the medication. It would also be important for follow up visits to be arranged for the patient after they are discharged to monitor them, make medication adjustments, and recheck labs. If the hospital has a high readmission rate and is currently paying penalties to Medicare, this program can save the hospital money and help patients remain out of the hospital with decreases their quality of life.
The Model for Evidence-Based Practice Change could be used to implement this project. Steps 1 through 3 have been completed. Step 4 is to design practice change. Step 5 is to implement and evaluate a change in practice.
Key actions in Step 4 are:
Define the proposed change: In this project, the proposed change is to create a program to decrease heart failure readmissions by encouraging the patients being discharged are taking Entresto instead of ACE/ARB. This program would offer to follow up, financial assistance, and medication management.Identifying needed resources: Assigning an APRN to prescribe Entresto and manage these heart failure patients before and after discharge from the hospital. The APRN would need to see the patients after discharge in a clinic setting and can then communicate with the patient’s primary cardiologist to turn over care to them after 30 days. The APRN would need to be aware of the different financial avenues to assist the patient to afford the medication.Designing and evaluating the pilot plan: The pilot project will be designed by the hospital executive committee. The pilot plan will be implemented at Oklahoma Heart Hospital Heart Failure Clinic. Evaluation will be done after 3 months by the Executive Committee.Designing the implementation plan will be completed after the pilot project is completed.
Key actions in step 5 are:
Implementation of a pilot study – The pilot study will be implemented at Oklahoma Heart Hospital Heart Failure Clinic, beginning October 1, 2018, and ending January 1, 2018.Evaluation of the processes – The processes will be evaluated by the executive committee, including staff from the heart failure clinic.Outcomes – Outcomes will be reviewed as part of the evaluation process.Costs related to the practice change – The anticipated costs related to the practice change will be minimal if the readmission rates are decreased. The cost offsets the penalties being paid by the hospital for heart failure readmissions.Development of the conclusions and recommendations – This will occur once the final project is ready to be implemented.
Key staff and stakeholders important to the implementation of the recommendation are the providers at the clinic, the nursing staff who work directly with the patients, the administrators of the hospitals, and anyone else identified as being part of the education process.
Step 5: What are the identified leadership roles that would be necessary for proper evaluation of the recommended practice change?
Four individuals that would serve well in the EBP leadership role to incorporate this practice change would be the CNO-chief nursing officer would have the data on admissions/readmissions; the physician in charge of Heart Failure Clinic, APRN that works in the HF clinic, and the provider seeing the pilot study HF patients, and an APRN that works in the HF clinic who speaks with the patients over the phone regarding symptoms and changes in treatment recommended by the HF physician and APRN. This RN can be trained in helping the patients afford Entresto by being educated about the different financial assistance programs available.
Step 6: Provide examples and explanations of three dissemination activities that would be appropriate for this type of a practice change recommendation.
The first type of dissemination activity I would choose for my clinical question would be a panel presentation. Panel presentations are good for presenting information to have groups of colleagues from different clinical settings. (Melnyk, 2015) There is a moderator that asks questions of the panel members, and the audience members ask questions. It would be beneficial to have participation and questions being asked about my clinical question to help guide other hospitals to lower readmission rates for heart failure. Also, it would be important for colleagues from different clinical settings to hear about the change in practice due to the heart failure guidelines. It is important to keep all different specialties of professionals familiar with new medications and treatment options for heart failure.
The second type of dissemination activity would be to attend hospital/organizational and professional committee meetings. This group would be a group of fellow professionals. Ideally, this would be at a heart failure conference or meeting of cardiologists. To present the data of lowering hospital readmissions when using Entresto along with follow-up with an APRN after discharge, will allow other hospital organizations, cardiologists, and other heart failure professionals to hear the evidence and decide to utilize a similar approach to lowering HF readmissions.The third type of dissemination activity would be to do a poster presentation. The poster provides a visual representation of the evidence related to the practice change where the participants can read the information provided, and the presenter stands next to the poster. It would be helpful to list all of the statistics available from the PARADIGM-HF study and list the highlights so that it catches their attention. Afterwards, the presenter can answer questions and provide additional information about how hospitalizations can be reduced using Entresto instead of enalapril for chronic systolic heart failure patients.References
Desai, A. S., Claggett, B. L., Packer, M., Zile, M. R., Rouleau, J. L., Swedberg, K., . . . Solomon, S. D. (2016). Influence of Sacubitril/Valsartan (LCZ696) on 30-Day Readmission After Heart Failure Hospitalization. Journal of the American College of Cardiology,68(3), 241-248. doi:10.1016/j.jacc.2016.04.047Mentz, R. J., & O’Brien, E. C. (2016). Can 2 Pills a Day Keep Readmission Away? Journal of the American College of Cardiology,68(3), 249-251. doi:10.1016/j.jacc.2016.05.013Sacubitril valsartan for treating symptomatic chronic heart failure with reduced ejection fraction. (n.d.). Retrieved from https://www.nice.org.uk/guidance/ta388/chapter/3-EvidenceYancy, C. W., Jessup, M., Bozkurt, B., Butler, J., Casey, D. E., Colvin, M. M., . . . Westlake, C. (2017, April 28). 2017 ACC/AHA/HFSA Focused Update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure. Retrieved from http://www.onlinejacc.org/content/early/2017/04/20/j.jacc.2017.04.025?_ga=2.107384258.1380552397.1535631050-490089232.1523999777Yandrapalli, S., Khan, M. H., Rochlani, Y., & Aronow, W. S. (2018). Sacubitril/valsartan in cardiovascular disease: Evidence to date and place in therapy. Therapeutic Advances in Cardiovascular Disease,12(8), 217-231. doi:10.1177/1753944718784536

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