An Article Critique on



The Primary Research of the Efficacy and Safety of Dupilumab in Severe Asthma Cases

Effectiveness of Dupilumab in Treating Glucocorticoid-Dependent Severe Asthma

Asthma is a complex, chronic disorder that can cause debility in the young, as well as in the older adult populations. Asthma is categorized as an inflammatory disorder of the airways in which many cells and cellular elements play a role: Mast cells, eosinophils, neutrophils, T-lymphocytes, macrophages, and epithelial cells all take a part of the response that can cause a sudden onset of symptoms and can cause fatal exacerbations (Guidelines for the Diagnoses and Management of Asthma, 2007).

Asthma symptoms are recurring and variable in nature; as symptoms stem from airflow obstruction, bronchial hyperresponsiveness, and underlying inflammation (Guidelines for the Diagnoses and Management of Asthma, 2007). The goal of asthma treatment is asthma control (Guidelines for the Diagnoses and Management of Asthma, 2007), and in severe, persistent cases of asthma, systemic corticosteroids are used. Corticosteroids are used in short-term therapy and as long-term therapy interventions to help control those symptoms (Guidelines for the Diagnoses and Management of Asthma, 2007). The concern is the effects that systemic corticosteroids have on body systems, so a medication that providers can prescribe to help reduce the use of oral glucocorticoids is needed.

Overview of Current Therapy

Once diagnosed with asthma, the next steps are to assess the impairment and risk then to determine the initial treatment (Guidelines for the Diagnoses and Management of Asthma, 2007). Lung function measures by spirometry must be obtained in order to develop a baseline (Guidelines for the Diagnoses and Management of Asthma, 2007).  Spirometry readings should be attained at least every 1–2 years, as indicated and more frequently for not-well-controlled asthma (Guidelines for the Diagnoses and Management of Asthma, 2007).

Nonpharmacological care for the patient with asthma includes self-monitoring in order to self-assess the level of asthma control and to be able to find signs of worsening asthma (Guidelines for the Diagnoses and Management of Asthma, 2007). Peak flow monitoring is particularly helpful for patients who have difficulty perceiving symptoms (Guidelines for the Diagnoses and Management of Asthma, 2007). Providers should help the patient to use written asthma action plans that help the patient to know the differences between long-term control medications and the quick-relief medication usage, and how to take medications correctly (Guidelines for the Diagnoses and Management of Asthma, 2007). The patients are also educated to avoid environmental factors that may worsen their asthma symptoms (Guidelines for the Diagnoses and Management of Asthma, 2007).

Monitoring is also a part of the care of a patient with asthma, as it is a condition in which the symptoms are highly variable (Guidelines for the Diagnoses and Management of Asthma, 2007). A patient with asthma should be seen at 2- to 6-week intervals while gaining control (Guidelines for the Diagnoses and Management of Asthma, 2007).  A patient within the step of care treatments should be seen between one- and six-month intervals (Guidelines for the Diagnoses and Management of Asthma, 2007).

Initial pharmacological therapy involves the stepwise approach that expands into six steps (Guidelines for the Diagnoses and Management of Asthma, 2007).  Medications are set within the six steps of care (Guidelines for the Diagnoses and Management of Asthma, 2007). Inhaled corticosteroids (ICSs) continue as preferred long-term control therapy for all ages, a combination of long-acting beta2-agonist (LABA) and ICS is another option, and Omalizumab is recommended for adults who require step 5 or 6 care which is severe asthma (Guidelines for the Diagnoses and Management of Asthma, 2007).

Treatment for long-term control of severe-persistent asthma symptoms with glucocorticoids has been used to control a further decrease in peak flow, cough, breathlessness, wheezing and chest tightness (Edmunds & Mayhew, 2014). The use of systemic glucocorticoids, although helpful, can also harm multiple body systems (Edmunds & Mayhew, 2014). Some of those concerns are hypertension; thrombophlebitis; thromboembolic events; loss of muscle mass; necrosis of femoral and humeral heads; spontaneous fractures; paresthesia; sodium and fluid retention; glaucoma and posterior subcapsular cataracts, to name a few (Edmunds & Mayhew, 2014).

To help reduce the use of systemic glucocorticoids for control of persistent, severe asthma, current research is focused on finding the efficacy and effectiveness of a new medication: dupilumab. Dupilumab (Dupixent) is an interleukin antagonist that reduces inflammation and alters the immune response (Epocrates, 2019). It comes in an injectable form: a pre-filled syringe of a dose of 200 mg per 1.14 mL and a pre-filled syringe dose of 300 mg per 2 mL (Epocrates, 2019). Indications for use are for moderate to severe asthma (adjunct treatment) and with PO corticosteroid-dependent asthma patients.

One study, in an effort to analyze a new treatment for asthma, looked at 210 patients with oral glucocorticoid -treated asthma.

That study is the subject of this paper. The clinical trial was used to discover if the addition of dupilumab to the participant’s medication regime for the control of severe asthma, helped to reduce the use of their oral glucocorticoids. The study also was aimed at discovering if dupilumab use helped to reduce exacerbations of their asthma symptoms.

Analysis

The research study:

Efficacy and Safety of Dupilumab in Glucocorticoid-Dependent Severe Asthma

, was conducted as an international, randomized, double-blind, placebo-controlled, phase 3 trial that utilized 210 patients with the trial ending after 24 weeks (Rabe et al., 2018).  The participants were dependent upon oral glucocorticoid–treatment for control of their asthma symptoms (Rabe et al., 2018).  The participants were chosen randomly: some receiving the add-on medication dupilumab while others did not (Rabe et al., 2018). Dupilumab 300 mg every two weeks for 24 weeks was administered to one group, while the second group received a placebo every 2 weeks for 24 weeks (Rabe et al., 2018). Adjustment periods of the glucocorticoid doses (a downward adjustment) were conducted in order to monitor the effectiveness of dupilumab (Rabe et al., 2018). The oral glucocorticoid dose-adjustment period lasted three to up to ten weeks and then was followed by a 1:1 randomization to receive dupilumab or a placebo for a 24-week period (Rabe et al., 2018). The goal of the study was to find the percentage reduction in the glucocorticoid dose at week 24 (Rabe et al., 2018). The intervention period consisted of a 4-week induction period, and during this time, the adjusted oral glucocorticoid dose was continued (Rabe et al., 2018).  The second step, weeks 4 to 20, used a 16-week period of reduction in oral glucocorticoid use (Rabe et al., 2018). The 16-week period consisted of glucocorticoid dose adjustments that staggered every 4 weeks according to their protocol-prespecified algorithm (Rabe et al., 2018). The next step in the research was a 4-week maintenance period (Rabe et al., 2018). This maintenance period had the participants continue the glucocorticoid dose that was established at week 20 (Rabe et al., 2018). After the intervention period was conducted, a 12-week evaluation period ensued (Rabe et al., 2018).

Criteria for participants included: ages 12 years of age or older who had been diagnosed with asthma by a physician, for 1 year or more, and who had been receiving treatment with regular systemic glucocorticoids in the previous 6 months (Rabe et al., 2018). Other criteria included were: during the 4 weeks before screening, the participant’s treatment had to include a high-dose inhaled glucocorticoid use that was in combination with up to two controllers for at least 3 months, a forced expiratory volume in 1 second before bronchodilator use of 80% or less of the predicted normal value, and/or a hyperresponsiveness episode documented in the last 12 months before the screening visit (Rabe et al., 2018). Participants were excluded if they were less than 12 years of age, if they had a diagnosis of obstructive pulmonary disease or a lung disease that would impair lung function, patients who required 12 puffs or more of their rescue inhalers, and patients with a smoking history or current smoking status (Rabe et al., 2018).

Efficacy is the strength of the research. The effectiveness, or efficacy, of this trial, was shown by basing and comparing the percentage of the reduction of the oral glucocorticoid doses compared to the baseline up to week 24 and that the participant’s asthma symptoms were controlled (Rabe et al., 2018). The researchers also have shown effectiveness by secondary end points such as the assessment of asthma control with a reduction from their baseline use of an oral glucocorticoid of 50% (Rabe et al., 2018). End-point efficacy included rates of severe exacerbation of symptoms, a hospitalization, or an emergency department visit, or an absolute change in their baseline spirometry readings (Rabe et al., 2018).  In regards to statistical methods, “The primary efficacy endpoint was analyzed using an analysis of covariance (ANCOVA) model. The model included the percentage reduction of oral glucocorticoid dose at Week 24 as the response variable, and treatment groups, optimized glucocorticoid dose at baseline, regions (pooled countries), and baseline eosinophil level subgroups (≥150 cells/µL, <150 cells/µL,) as covariates” (Rabe et al., 2018, para 4).

Strengths of this research trial are many, as all aspects of a scholarly experiment are present. This trial was conducted as an international, randomized, double-blind, placebo-controlled, phase 3 trial that utilized 210 patients with the trial ending after 24 weeks (Rabe et al., 2018).  In relation to the international aspect; Argentina, Belgium, Brazil, Canada, Chile, Italy, and the United States are some example areas that were involved (Rave et al., 2018). The trial was randomized meaning that “each individual has an equal probability of being selected from the population, ensuring that the sample will be representative of the population” (Creswell & Creswell, 2018, p. 250). A double-blind trial is an experimental procedure in which neither the subjects of the experiment nor the persons administering the experiment know the critical aspects of the experiment (thefreedictionary.com, 2019). Placebo-controlled experiment “is a comparative experiment where the comparator treatment is a placebo treatment and is given to a placebo-controlled group member” (Mellis, n.d., para 1). A phase-3 trial is a clinical trial that is “designed to demonstrate the potential advantages of the new therapy over other therapies already on the market; safety and efficacy of the new therapy are studied over a longer period of time” (thefreedictionary.com, n.d., para 1).  Lastly, the number of participants in the study shown to be a large random sampling.

This research study used three phases. The first phase, after the screening, participants were randomly assigned to receive the dupilumab injection while others received the placebo (Rabe et al., 2018). The second phase trialed the doses that were effective and safe in controlling asthma symptoms; with the lower the dose, the better (Rabe et al., 2018). The third phase went into an extensive study so that the researchers could define any adverse side effects and long-term therapeutic effects (Rabe et al., 2018).

In comparison to the group of participants who received the placebo, the group that received the dupilumab injection shown a reduction in the need for oral glucocorticoids- 70.1%, as compared to the placebo group of 41.9% who still used such (Rabe et al., 2018). In relation to adverse side effects, the dupilumab group shown more transient blood eosinophilia concerns as compared to the placebo group, along with higher injection site reactions as well (Rabe et al., 2018).

Study Results

The study results show that use of dupilumab in a patient population greater than 12 years of age who are steroid dependent for control of asthma symptoms could benefit from its use. The clinical trial showed that even though participants had major glucocorticoid-dose reductions, the overall population of

dupilumab

treated patients shown a severe exacerbation rate that was 59% lower than that in the placebo group (Rabe et al., 2018). The spirometry results also shown higher results as compared to the placebo group (Rabe et al., 2018).

Case Study

Workshop two in Advanced Pharmacology, we focused on the management of asthma.

Our discussions focused on respiratory pharmacology, class respiratory case studies, and an individual case study/dropbox assignment related to an asthma case study. My case study was a 19-year-old female with a diagnosis of moderate-persistent asthma of 12 years who complained of her asthma acting up. She also felt that she has missed too much school due to asthma concerns. Her medications included: Proventil HFA MDI 2 puffs prn; Flovent 44mcg one puff BID and Albuterol nebulization 2.5mg in 3ml NS prn. In contrast to this study, she was not in the severe stages of asthma and had not needed an oral glucocorticoid before that point in time.

In order for my patient in the case study above to be able to take dupilumab, she would have to be dependent upon an oral glucocorticoid for management of her asthma symptoms. A case study based upon Workshop Two in Advanced Pharmacology will be used as a base for a created case study that utilizes dupilumab. I would be comfortable administering this medication, but I would have to monitor her very closely. I would encourage her to communicate any changes in her health status during this period of adjustment, so a therapeutic, open relationship must be developed.

Case Study

CC:  “My feet have been swelling a lot since I was prescribed prednisone. I’ve been on Prednisone for years, but my swelling is getting worse”.

HPI:  AW is a 53 yof who presents to the health clinic complaining of worsening pedal edema.

PMH:

Severe persistent asthma for 12 years-oral glucocorticoid dependent.

FH:  One sibling age 48 in good health. Mother passed away 15 years ago from a MVA. Father passed away last year from CHF complications.

SH:  No alcohol or tobacco use.  The patient is a cashier, lives in her own home alone.

Medications:

Proventil HFA MDI 2 puffs prn

Flovent 44mcg one puff BID

Albuterol nebulization 2.5mg in 3ml NS prn

Prednisone 60 mg daily

Allergies:

Aspirin (urticaria)

ROS:  Unremarkable except for 3+ pedal edema.

Physical Exam:

GEN:  Worried-appearing Caucasian female in no distress. Skin

VS:  BP 138/82, HR 82, RR 20, T 98.6, wt 140 lb

CHEST:  CTA

CV:   regular rhythm; NMRG

Peak Flow: 340 L/min; her baseline, oxygen saturation 94% RA.

LABS: All WNL

Conclusion

In conclusion, the study found that use of dupilumab was both effective and safe. The study results can change current therapy by allowing a decrease in oral glucocorticoid usage. The prescriber must be aware to closely monitor the patient for exacerbations, and emergency room visits related to severe asthma exacerbation symptoms. The provider must also monitor adverse side effects such as irritation at injection sites and an increase in eosinophils.

Dupilumab therapy was effective, as proven by reducing the use of oral glucocorticoids in the participants (Rabe et al., 2018). Dupilumab was found safe, as the only side effects noted were irritation at the injection site and chances of elevated eosinophils (Rabe et al., 2018). The long-term study phase also showed no severe adverse side effects that were at a high degree to where it should not be marketed (Rabe et al., 2018).  Dupilumab can be an effective and safe medication to help reduce glucocorticoid usage that can harm multiple body systems.

References

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Throughout our life, there are many fears; the fear of life, the fear of death, the fear of failure. All are realistic fears that sit in the back of our head whispering to us through our lives. However, it is only when an incident brings to light the reality of how real these fears really are. One of the easiest fears to be reminded of the fear of health and dying. So easily can the complex system that is our body make a tiny mistake that can severely mess up the way we function. One of the most common medical heart issues among people is Congestive Heart Failure which effects more than five million Americans. (“Congestive Heart Failure” 1)

So as everyone knows, blood is necessary for every human’s survival and understanding that the heart controls all of the blood regulation that means that it would be extraordinarily bad if something were to happen to it. In this the case of congestive heart failure (CHF), it simply means that the heart for some reason is unable to sufficiently pump blood the way it is needed to. The two know types of CHF are when the heart muscle is weak and therefore struggles to pump enough blood to the rest of the body or the other is when the heart cannot pump enough blood through the body even though the heart is squeezing normally. (“Congestive Heart Failure” 1)

Congestive heart failure can be caused by many things including genetics, weight, age, sex, and preexisting conditions. People who are sixty-five years or older have a higher rate of developing CHF. Also, African Americans are more likely to get it genetically than other ethnicities as well as people who are overweight. Men also have been found to have a higher rate of CHF than women. (“Congestive Heart Failure | Heart Failure | CHF.” 23) Many pre-existing conditions can contribute to congestive heart failure including cardiac

arrhythmia, cardiomyopathy, congenital defects, heart valve disease, high blood pressure, coronary artery disease, diabetes, and people who have had a heart attack. (“Congestive Heart Failure” 1)

So to predict this major health issue, many signs and symptom have been recorded for the benefit of the public. The signs of congestive heart failure include having shortness of breath, an ongoing cough or wheezing, an irregular or increased heart rate, and a buildup of excess fluids in the tissue which can lead to swelling of the legs, feet, and abdomen. The symptoms of congestive heart failure include fatigue, chest pain, lack of appetite or nausea, and confusion or impaired thinking. It is also important to note that in the case of more severe heart failure, these symptoms can continue even when the person is asleep. (“Warning Signs of Heart Failure.” 1) Some tests can be done to help medical professionals better diagnose CHF. These test can include intravascular ultrasounds (IVUS), Cardiac Angiograph, Electrocardiogram (EKG), Cardiac MRI, Cardiac Computed Tomography, and Cardiac Echocardiogram (ECHO). Some more invasive techniques to get a better look at what is happening with the heart includes heart biopsies and cardiac catheterization. (“Diagnostic Procedures.” 1)

Doctors are human too and on many occasions will get it wrong when attempting to diagnose an illness. It can be common to have multiple diseases with the same signs and symptoms. In this case, some of the signs of CHF like wheezing, coughing, and shortness of breath overlap with the signs of cardiac asthma. (“What Is Cardiac Asthma?” 1) Another disease with similar signs to CHF is a pulmonary edema. It has signs of difficulty breathing, persistent coughing and wheezing, and leg or abdominal swelling. (“Pulmonary Edema.” 1) Even cancer has certain symptoms that are the same as in CHF like fatigue, nausea, and chest pain. (“Signs and Symptoms of Cancer | Do I Have Cancer?” 1)

Depending on what type of heart failure you have and what some of the causes of it where, there are various ways including medication, device therapy, lifestyle changes, and surgery to help treat CHF. Once diagnosed with CHF, it is highly suggested that the patient changes their lifestyle to ensure the best results from whatever treatment that they are receiving. They are advised to always take the medications that have been prescribed, change to a low sodium diet, keep active, and make sure to track the symptoms. (“Living with Heart Failure.” 1)

It is important to note that for medication, it will not cure a person’s heart failure, however, it can help to improve your symptoms and prevent your condition from becoming worse. Medications that are angiotensin receptor blockers (ARB), Isosorbide Dinitrates, Hydralazines and angiotensin-converting enzyme inhibitors (ACE-I) can help to improve the pumping of your heart over time by dilating the blood vessels to help allow more blood flow to the rest of the body. Beta-blocker medications are used to also improve heart function over time by controlling blood pressure and helping the heart to keep a more normal rhythm. Diuretic medications can be used to help pump your heart more easily and can help decrease swelling in the feet, legs, and abdomen by allowing the kidneys to remove extra fluids. Aldosterone Antagonists can help to regulate stress hormones so it does not worsen the heart failure and it can help to increase the potassium levels in the blood. Digoxins and Ivabradine can help to slow the heart rate and allow for a more regular heartbeat. (“Heart Failure Medications.” 1)

Devices that can be used to help the congestive heart failure include an implantable cardiac defibrillator, cardiac resynchronization therapy (biventricular pacing), and ventricular assist devices (VADs) that all are used to help keep more regular pump action within the heart. (“Cardiac Devices for Patients with Heart Failure.” 1) Of course, when the medications, therapy, and lifestyle changes are not enough to resolve the issue, surgery is the last resort. Surgeries to help fix heart failure depending on the issue include coronary artery bypass graft (CABG) surgery, valve surgery, aneurysm repair surgery, and if all else fails, a heart transplant. (“Heart Failure Surgery.” 1)

Patients with a class I (no limitations on life and no apparent symptoms) or class II (few limitations on life and mild symptoms) congestive heart failure have a significantly high survival rate. However, patients with class III (many limitations on life and significant symptoms) or class IV (severe limitations on life and crippling symptoms) congestive heart failure have a significantly low survival rate. In an overall study of the survival rate of people with varying classes of CHF, it was reported that in the first year the survival rate was 78.5%, the third year survival rate was 59.8%, the fifth year survival rate was 50.4%, and the tenth year survival rate was 14.7%. If left untreated, a person with congestive heart failure will die. (Matoba 1)

Having congestive heart failure is not cheap. With just the cost of doctors and hospital appointments averaging $62,509 and medications averaging $942. That’s not even considering the cost of surgery which can range anywhere from 30,000 to 200,000 dollars depending on the type of heart surgery, where it is done at, and who was performing the operation. Not to mention that not everyone is privy to the same medical help as others. A person could require a heart transplant but live in a small town far from a facility authorized to do that procedure. After all of that expense, there still is a 2.94% chance of death after the surgery which might not seem that high but there is little guarantee that the patient will fully recover. It is even harder when the patient has to provide for themselves or the family but is unable to for the duration of the surgery and recovery time. (Xuan 1)

When all is said and done, health is usually the number one priority for most people. It is important to take care of our bodies and make sure everything in our bodies is working properly. If a person was to find out that something was wrong with the way their body was functioning, they should do everything in their power to fix that problem. Unfortunately, not everyone is able to get better after developing congestive heart failure but there are many solutions including medication, therapy, lifestyle changes, and surgeries to help solve the problem. And with more and more solutions being developed every year, we should be hopeful that if any one of us were unfortunate enough to develop CHF, we too could hopefully recover from it and continue to productively live our lives.

Works Cited:

• “Cardiac Devices for Patients with Heart Failure.”
  
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  , my.clevelandclinic.org/health/treatments/16835-cardiac-devices-for-patients-with-heart-failure.
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  MedStar Heart & Vascular Institute
  
  , www.medstarheartinstitute.org/conditions/congestive-heart-failure/.
• “Congestive Heart Failure | Heart Failure | CHF.”
  
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  , U.S. National Library of Medicine, 6 Sept. 2018, medlineplus.gov/heartfailure.html.
• “Diagnostic Procedures.”
  
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  , www.medstarheartinstitute.org/treatments/diagnosis/diagnostic-procedures/#q={}.
• “Heart Failure Medications.”
  
  Cleveland Clinic
  
  , my.clevelandclinic.org/departments/heart/patient-education/recovery-care/heart-failure/medications#medications-tab.
• “Heart Failure Surgery.”
  
  Cleveland Clinic
  
  , my.clevelandclinic.org/health/treatments/12905-heart-failure-surgery.
• “Living with Heart Failure.”
  
  Cleveland Clinic
  
  , my.clevelandclinic.org/health/diseases/17181-heart-failure-living-with-heart-failure.
• Matoba, M, et al. “Long-Term Prognosis of Patients with Congestive Heart Failure.” Current Neurology and Neuroscience Reports., U.S. National Library of Medicine, Jan. 1990, www.ncbi.nlm.nih.gov/pubmed/2332933.
• “Pulmonary Edema.”
  
  University of Maryland Medical Center
  
  , www.umms.org/ummc/patients-visitors/health-library/medical-encyclopedia/articles/pulmonary-edema.
• “Signs and Symptoms of Cancer | Do I Have Cancer?”
  
  American Cancer Society
  
  , www.cancer.org/cancer/cancer-basics/signs-and-symptoms-of-cancer.html.
• “Warning Signs of Heart Failure.”
  
  About Heart Attacks
  
  , 31 May 2017,
  
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  .
• “What Is Cardiac Asthma?” Ice Packs vs. Warm Compresses For Pain – Health Encyclopedia – University of Rochester Medical Center, www.urmc.rochester.edu/encyclopedia/content.aspx?ContentTypeID=56&ContentID=DM164.
• Xuan, J, et al. “The Economic Burden of Congestive Heart Failure in a Managed Care Population.”
  
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  , U.S. National Library of Medicine, June 2000, www.ncbi.nlm.nih.gov/pubmed/10977478.

Enhancing Learning in a Specialist Environment: Development of a Tool for Nursing Students

I am a qualified nurse, qualified to care for Paediatric Patients and have been qualified since 2017, I have been in my current role since qualification and plan to extend my role to further support students within the settings, who are aiming to complete a nursing degree to become registered practitioners. Whilst mentoring students, I plan to encourage and assist them in forming an understanding of the role of nurses in the United Kingdom (UK) such that they understand and gain competencies, which will aim to lead them to registered qualification. The role of a nurse is described and regulated by a professional body, the Nursing and Midwifery Council (hereafter referred to as “NMC”) and contains specific standards within “The Code” of conduct that express the roles and responsibilities of a nurse (NMC, 2018a). The

NMC

and the representing body the Royal College Of Nurses (hereafter referred to as “RCN”) depict throughout their literature (such as the Code) that a nurse must continue to expand upon his/her professional development (NMC, 2018b, RCN, 2019a). As part of professional development for qualified nurses, the NMC states that nurses have a responsibility to complete a training course that enables the extension of their role from “registered to practice in this country” to being “registered to mentor” and educate students on the Nursing course (during practice placements, in the working environment), through completion of the “Standards to Support Learning and Assessment in Practice” Course, or SLAiP (NMC, 2008).

As a qualified nurse, I wish to complete this course as part of my continuing professional development to permit me to educate (within my scope of practice) and assess student nurses in practice prior to their qualification. The requirement to achieve this responsibility has come from the NMC (2008) which states “registered nurses must attend a post-registration course that follows a framework set out by the NMC”. The domains that make up the NMC framework are applicable within the context of learning and development, and subsequently provide opportunities for nurses and midwives to develop other roles within healthcare, including supporting student practitioners (NMC, 2008).

This assignment will critically analyse a resource formulated to assist students on a specialist high dependency unit in an inpatient paediatric setting. The resource developed is a shift planner aimed to support and facilitate Domain 1 and Domain 2 of the assignment brief (Establish Effective Working Relationships and Faciliation Of Learning), in relation to the current student assessment book, as depicted by the Nursing and Midwifery Council (NMC). I have developed this resource to help integrate students into the practice area by giving them knowledge of their caseload, offering prompts for cares needed by the patients allocated to myself (a mentor) and the student working with me, it will assist me in assessing the student in knowing that they are able to “plan care”. The planning checklist and handover permits the student to have patient details that they otherwise would not have access to, as students are not permitted to have full handover sheets in my place of work. The assignment will begin with an explanation of the tool and how I intend it to be used, it will then go on to critically analyse the tool by addressing the competing influences that may impact on its’ use. Following this, I will consider how this will affect me as a mentor, how I am able to teach and assess and will then compare the above to analyse if my tool will benefit the students who have access to it. I aim to be able to integrate the opinions of students, comparing learning theory and using current evidence base to finally conclude points to summarise.

The resource (Appendix 1) has been developed as a means of documenting and as an observation tool to be used in place of a handover sheet with a care planning aspect to support student learning. It has been developed for students to use on a daily basis, to support them in nursing skills and developing autonomy. It has been suggested by Seifert and Sutton (2009) that students benefit in a new environment when they have access to an environment specific resource, relevant to the working environment alongside support from a mentor with specific knowledge, which this resource aims to do to facilitate learning (applicable to appropriate nursing domains).

This resource is a planning checklist to be utilised by students in place of a handover sheet, I feel that there is a specific need for the ward setting to have this type resource for students that they are permitted to use to store information on. The resource aims to allow students to develop an understanding of the child’s care needs, by detailing key pieces of information about the child and their needs. Having a comprehensive understanding of patient need is described as an essential part of care by the NMC who discuss that nurses (including student nurses) must offer time to patients to develop this to promote patient care (NMC, 2018). Stated by Hemingway et al. (2018) “nurses need to engage with individuals and ensure that they focus their practice on the health needs of the groups they serve” and this is relevant to students and nursing mentors having an understanding of need.

Information understanding and sharing (for the purpose of discussion this is referred to in relation to students, but is applicable to all nurses and the wider multidisciplinary team) is described as essential by nursing bodies, namely the NMC (section 5.4 of the Code) and RCN, such that it is done in a safe manner (NMC, 2018c, RCN, 2019b). The sharing of information is necessary to protect patients and their needs, discussed by Dyer (2009) who stated that care delivery “may be hindered and patient outcomes affected if information is not shared appropriately”, this is extended to the students in a placement area. In addition to this, it is essential to consider that information is shared in a professional way, only to be shared when it is necessary; this is to ensure that nurses and allied health professionals are not in breach of the setting’s confidentiality policy. As discussed earlier, professional nursing bodies, the NMC and RCN detail that it is imperative that confidentiality standards are not breached, to protect patients and their personal information. The aforementioned bodies express that is essential that students (not just their mentors or registered colleagues) have a good understanding of patients’ medical needs, histories and current concerns that has lead to the inpatient stay, such that they are able to partake in providing safe patient care (Lewis and Kelly, 2018). However, it is entirely necessary this information must only be shared in a relevant and professional manner so that the patient and their details are protected (HM Government, 2018).

Ervin’s (2008) research regarding understanding key information suggests that having visual aids may benefit students in effective management of a caseload (alongside a qualified nurse, a mentor). Although this reference is dated, it is supported by (Alvarez, 2014) who agrees with Ervin in stating that aid sheets and other supporting documents/visual tools, which include direction are necessary to help facilitate learning and planning, particularly where individuals may not have prior experience in a particular setting. Contrary to this, it may be suggested that having such a tool does not prompt a student to use his or her intuition to consider patient need and plan cares (National Research Council, 2000), and may mean that the student may become reliant on the produced tool, this may affect their developing autonomy. The sheet has twelve depicted sections for up to four children on one nurse’s caseload (in this case, the nurse is acting as the student’s mentor), such that they are able to document clearly for each patient in a structured format with an additional section for other notes relating to history and current issues. Williams (2001) states that students are likely to find this formal structure useful and refers to constructive and problem-based learning theory models which state that structured support “facilitates the development of nursing students’ abilities to become self-directed in learning “, this is supported by Spooner et al (2018) who explored the use of supplementary handover tools and found that by using a tool to record information, more information was able to be retained. I believe that the tool will be useful for students to ensure that they have more familiarity with the new ward environment that they may not have been to before, it is important that students are further understanding as we are a specialist unit with highly dependent children.

The columns are blank so that it can be adapted to different patients; as it is intended for single day/use and states that it must be discarded following the completion of a shift, this is to remain in consideration of confidentiality policy, supported by the NMC. The resource is required within my setting as students are not permitted to have full handover sheets due to a previous breach of data protection and it is imperative that we strive to protect patients at all time (NMC Code), it is also to be used as a “tick sheet” style resource to ensure that essential care needs are complete. Due to the nature of the area of practice and as students are not allowed full handover sheets, their understanding and knowledge may be limited in relation to how they are able to plan care as they do not immediate access to all the information. As above, Lewis and Kelly (2018), the NMC and the RCN state that patient details are essential to providing patient centred care, as it may be that students in our area are disadvantage by not having this information. The resource is reliant on the mentor to inform the mentee with details about the patient; as the information is not available to them via the handover sheet medium. The resource aims to eradicate this barrier to care planning by allowing the student to form understanding of the caseload and subsequently plan patient care using the checklist under the direct supervision of a mentor.

The resource, as depicted above, aims to not only store information, but to also ensure that essential care factors are noted and considered by the student, by giving a prompted list of factors that should be considered by the nurse and student when organising care. As the student will be recording the information independently, it should be written within their scope of understanding and it is hoped that this will challenge the student to ask about areas of where understanding is lacking (in this case, where they may have blank boxes on the tool sheet). When the student has been within the setting for a prolonged period it may be that they may develop an unconscious understanding and start referring to the resource less as their knowledge of care needs develops, moving through the four stages of competence (Kuldas et al, 2013). The need for such a resource is supported by previously mentioned Lewis and Kelly  (2018) and further by Jamshidi et al (2016) who state that students may feel overwhelmed with complex patient care and may benefit from prompting tools as the of the ward may be overwhelming.

Learning theories have been considered in relation to how this tool is able to be applicable to students with different learning styles. Pioneer in behaviourist learning theory, John Watson (1913) (researched by McLeod, 2017) suggested that by “explaining at the outset what it is that people will learn will encourage them to achieve” based on a stimulus response, in this instance the “stimulus” is completing a successful placement and achieving set criteria as depicted in student’s placement book (within the domains). The tool developed aims to help develop skills which will facilitate the achievement of a successful placement. Insight theory was also considered, as if students are given the tool to be able to facilitate development of understanding, by being given insight, then they are more likely to achieve (Barber, 2002).

Following review, the resource has been found to be best suited for students who are “activists” (who learn best from activities where they can be engrossed in immediate events) and “reflector” (people who collect data and review in summary) styles as the way in which a student is able to document information and relay this onto the necessary nursing care. Consequently, this may mean that it is likely to be less effective for those who consider themselves “theorists” or “pragmatists”. Learning theories, methods and subsequent student needs have been applied and taken into consideration when developing the tool. It is understood that students are not likely to all share the same learning style (Advanology, 2019) and that is where I think there may be a problem in developing a tool as it is hard to facilitate all kinds of learners. Regardless of learning style, it is hoped that the use of direction and prompt will be beneficial for all students in practice. Studies show that it is likely that teaching styles delivered by mentors will need to be reviewed for each student, such that they become best adapted to a particular student, is likely to be needed, as is possible for students can change learning styles as they progress through a course/over time, this is known as multimodal learning teaching will be adjusted to suit what is required (Leve, E, KL, 2015). The benefits to this include being able to refer back to the resource to assess development and understanding, to see if a student is progressing, this also related back to the stages of competence as discussed earlier.

When developing this resource, I was mindful to consider the specific needs of the patients cared for the ward. I offered the resource to some students who used and evaluated the resource after using it for one thirteen hour shift. Two students used the resource, which is a small sample size, but I feel that the response from them is important I assessing the usefulness of my resource. Student A (a third year student) suggested that the resource may not be comprehensive enough and felt making her own notes would be more beneficial than the formal structure as she felt there wasn’t enough space for the information to be documented And that the sections were too stringent and didn’t leave scope for variation. Student B was a first year student and she said that she appreciated the prompts that the tool offered as she was unfamiliar with the ward and hadn’t worked in a placement setting before. She said that she would benefit from the tool, as long as she had time to fill it in and if she was given a full handover, alongside a mentor, otherwise she was worried that she may miss vital information. She also said that she worried about the understanding of the mentor in comparison to herself, as her “knowledge of different conditions or medications” will differ greatly from the mentor’s.

My concern with assessing this tool is that I do not feel that I have been able to gather a comprehensive review of the tool as the students I approached did not used it for a prolonged period. I feel that as a mentor assessing the tool’s effect, whether positive or not, I would need to observe over a longer period of time and observe use in the clinical area. It would also be beneficial to review it again in a few weeks, when the students have become accustomed to and are competent in using it. In doing this I could follow up the observation by tackling any concerns that arise and further adapt the tool to suit. I also feel that there may be a barrier to implementation as I was only able to ask two students to review it and it may be that additional barriers are encountered in communicating the change (RCN, 2019c). I feel that with further expansion and roll out of the tool, it would be better evaluated.

This resource will enhance teaching by prompting students to follow a plan of care and by encouraging them to consider important parts of care specific to the children in the ward setting. By the end of the placement on the Ward it is hoped that a student will be more able than they were and will be more likely to use their own intuition to plan care, therefore less reliant on formal checklist. Historic information may not be recorded on the sheet, as there is limited capacity for space, this may meant that students remain inhibited in not having a handover as they will not have all the information. However, it will remain available as a prompt to ensure care needs are fulfilled. This method of teaching has been theorised by Engelmann (1991) and reviewed with Carnine (2016) who refer to educating via direction and instruction where a student is guided and educated, that I hope the tool offers to students. The tool facilitates the cording of information, but does not tell how to obtain that information, that would involve additional basic training to be taught by the mentor to the student, however, it is also hoped that the student would enter the placement setting with some understanding of how to obtain information such as PEWS, height and weight that should have been taught at the university prior to the placement commencing.

I feel that this resource is best suited for first and second year students as it is expected that third year the students should have more understanding and therefore be more autonomous within their work in a placement setting. However, it may be a resource that the third year student uses when getting used to the ward, if it isn’t an area they’ve been to before, and such have limited understanding.

The resource has been developed in using a pedagogic approach, with some direction given by means of prompt (the headings provided). It encourages the student to fulfil cares in a timely manner, by prompting the student to document different items on which to form the basis of care. The resource is a planning list which will be used by students, it has previously been stated which will challenge students to ask questions about the care provided and will prompt in place of a paper handover. Paper handovers do support understanding of patient need, instead they show history and may include some current cares, this was discussed above, in regard. Following review of the resource it has demonstrated that it is not entirely comprehensive and is largely reliant on a student’s individual ability and will to record information during handover. If a student is reluctant to use the tool, or has a disability that affect their ability to record information, it may be that reasonable, adjustments may be needed to facilitate these needs.

Without the resource, it is generally assumed that students do still learn to take notes regarding patient care, but it is hoped that with a structured planner, this information is stored in a safer, more organised way. T is hoped that mentors with go over the information recorded by the student on the resource sheet bad that information will be shared with the student but this is dependent on the mentor.

Following the responses of the students I would further like to develop the tool to suit their needs, but certainly feel that further research into additional theories would help me in adapting it to support one target audience, a first year student, as opposed to trying to make it suitable for all; response showed that it doesn’t suit that due to the varying capabilities of individual students. I had previously had concern with my resource in choosing the more necessary parts of care to put onto the sheet, knowing that I would have very limited space, it may be better to develop the tool into a prompt rather than somewhere to store historic information.

I believe that the resource will be useful within my area of practice and will be relevant to all patients we encounter. The mentor role in promoting development can be benefitted by relating back to the tool to ensure that the student’s developing understanding and skill is improving. It also boasts the ability to offer direction where there may be concern, which may be a difficult conversation to have, but I feel that between the student documentation book and the tool, it will be possible to assist in the assessment of the student hoping to qualify. The NMC state that “As mentors you have the privilege and professional responsibility of helping students translate theory into practice, supporting the conversion of learning in the classroom into effective and safe practice in line with the Nursing and Midwifery Council’s Code (2015)” and I feel that the tool, with adaptation made as suggested will help to facilitate this.

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