Significance of the Study
Question:
How Effective the self management manual was in terms of admission/readmission of patients?
There are more than 26 million people and families that are living with heart failure across the globe (Bui, Horwich,& Fonarow, et al., 2011). The total healthcare expenditure in Latin America, North America, and Western Europe is estimated at 1–3 % with hospitalizations constituting the main driver of the total costs (Ponikowsk, Anker, & al Habib,, et al., 2014).
For patients to effectively manage heart failure, they need to engage in several self care behaviours such as adhering to medications, symptoms monitoring, seeking medical assistance when needed, managing depression, exercising, and healthy eating and drinking (McMurray, Adamopoulos, & Anker et al., 2012; NIHCE, 2010; Tu, Zeng, & Zhong et al., 2014). In addition, patients may need to adapt and abstain from certain behaviours such as restrict their fluid, cholesterol, and sodium intake and cease from smoking. Nurses assist heart failure patients through educating them and their families about lifestyle changes(Muus, Knudson, and Klug, et al., 2010)
In this paper, the study by Cockayne, Pattenden, Worthy, Richardson, and Lewin (2014):Nurse facilitated Self-management support for people with heart failure and their family carers (SEMAPHFOR): a randomized controlled trial will be critically analyzed
Significance of the Study
The study is significant as it illuminates the effectiveness of a cognitive behavioral self management manual that the researchers had interest in and was a newly developed one. The effectiveness was determined by the number of admissions/readmissions(Fonarow , Abraham, and Albert et al., 2008).
Aim
The aim was to determine how effective the self management manual was in terms of admission/readmission of patients who were guided by specialist nurses and those who opted to use the manual by themselves (Ditewig, Blok, Havers, et al., 2010)
Design
A randomized control trial was used. In an RCT, participants are assigned to specific groups referred to as treatment conditions or study arms in a random manner (they have a probability that is equal at being assigned at any one particular group)(Kabisch, Ruckes, and Seibert et al., 2011).
Appropriateness
RCT was appropriate as it tested between two groups that were using the same self management manual but under different conditions. The first group was assessed by specialist nurses while the second group was self managed.
Sampling
Participants:
The participants included 260 patients who had been diagnosed with symptomatic heart failure defined LVSD by ECHO, coronary angiography, or clinical diagnosis.
Inclusion/exclusion
Male and female participants aged 18 years with definite symptomatic heart failure diagnosis LVSD were included. The LVSD condition was determined through a coronary angiography or clinical diagnosis. Particiants with a written cognitive deficits case records were excluded and so too were those unable to read English, make their personal care decisions, lived in nursing homes, or had existing concomitant life threatening condition.
Why the inclusion/exclusion criteria was important
The study involved two groups one of which was required to follow the manual without any nursing assistance. For the participant to adhere to this condition, they needed to be capable of achieving the goal of the study and hence had to know how to read English, be able to make their own personal decisions, and have a level of independence.
Aim
Sampling Technique:
The eligible persons were randomized via a computer using a remote, secure, telephone randomization service. This was done by an independent person who did not have prior knowledge of the participants. The randomization was initially done at 1:1 then later switched to 2:1 in favor of the control group. This was stratified by NYHA and center class in the first randomization but was excluded in the second randomization.
Appropriateness
This was appropriate as it increased the number of participants and also offered a clearer distinction between the self managed group and the intervention group with regard to possible results of the study
Intervention and control groups
The patients in the intervention group received a Heart Failure Plan which was a self management program that was nurse facilitated. They also received a DVD, exercises that they did in and around a chair, relaxation tape, regular signs and symptoms monitoring, clinical assessments, blood tests, as well as referrals. The participants received six sessions that were nurse assisted.
The control group was also given the manual, the usual monitoring of symptoms and signs, clinical assessments, blood tests, and referrals such as rehabilitation where it could be availed. The group was expected to follow the manual as much as possible without the intervention of nurses.
Participant Allocation
As this was a Random Controlled Test, the randomization was initially done at 1:1 then later switched to 2:1 in favor of the control group. This was stratified by NYHA and center class in the first randomization but was excluded in the second randomization. The participants had an equal chance of being allocated to either group based on the inclusion criteria
Appropriateness
This was not appropriate as the participants should have been given equal chances such that the study should have been in two phases. In the first phase, the current allocation would have sufficed. In the second phase, the participants would have switched with those in the control group becoming the intervention group and vice versa. The results from the two phases would have offered a more in-depth analysis and conclusion.
Data Collection
Independent/dependent variables
The primary outcome included hospital admission within a 12 month period after the randomization. The information was collected on months 3, 6, and 12 after patient and nurse randomization. The secondary outcomes included: quality of life in relation to health measured by the Anxiety and Depression Scale (HAD), EQ5D; Minnesota Living with Heart Failure (MLHF), the Hospital, and European heart-failure self-care behavior scale.
Data Collection
Data was collected over a 12month period at months 3, 6 and 12 with regard to hospital admission after patient and nurse randomization. Checks on achievement of targets were done on the second meeting, and 1, 3 and 6 weeks later.
Appropriateness
This method of data collection was appropriate as it allowed for regular monitoring and for the creation of interventions that would ensure the patients stayed on track. By collecting the data at the said intervals, the patients’ progress was recorded and any issues that arose were addressed promptly.
Design
Reliability and Validity
Reliability is the variability proportion in a measured score due to a true score variability (Leung, 2015).
Validity of a research is categorized as external or internal. External validity involves application of the study to people and situations and considers that the conditions in which the research is done represents time and situations where the results are applicable (Sullivan, 2011).
Internal validity addresses study outcome reasons and helps in reducing other unanticipated reasons that would affect the outcome. Internal validity is assessed based on construct, criterion, and content.
How reliability and validity have been used
Identification of potential participants was done by heart failure nurses, special interest GPs, research consultants and coordinators form heart failure open access diagnostic clinics, medical, and acute wards, following hospital discharge or form General Practitioners registers in 7 centers located in Darlington and Birmingham between 2006-2008. Eligible participants who signed consent forms were randomized by an external person who had no previous knowledge of them.
How Data was analyzed
Analyses was done using SAS version 9.1. The analysis utilized the 2- sided significance tests at the significance level of 5%. Intention to treat was the basis of analysis for each group. The primary analysis of patient admission/readmission within 12 months and which the nurse recorded was compared between the groups by using a chi-square test. Patient age, NYHA, and center, were adjusted using a logistic regression model. Follow up patients who were lost prior to 12 months were considered as being admitted and also if it had been recorded in an assessment done earlier. Failure to record an admission by the patient or nurse was assumed as being a non-admission.
Appropriateness
This was appropriate as the occurrence of admissions/readmissions is what was being studied with regard to the two participant groups.
Differences in outcomes
The study showed no evidence of admission/readmission of participants in the two groups. The results remained the same for adjusted analysis. Secondary outcomes showed no evidence in treatment groups’ differences.
Significance of the Results
The results were not significant. Hospital readmission among the patients that were allocated a nurse was less than those of the self management group. However the difference was too small to be of any significance.
Generalization of Results
The results can be generalized as the study population was randomly selected and represented a significantly large population area namely: Darlington and Birmingham.
Evidence utilization
The findings of this study cannot be used in clinical practice. Utilization of the care management program was successful with or without the supervision of a nurse. Hospitals should not invest in assign nurse specialists to monitor care programs that patients can follow with minimal assistance. Re-admission was not reduced to significant numbers to warrant the implementation of the (Kennedy et al., 2013).
References
Bui AL, Horwich TB, Fonarow GC. (2011). Epidemiology and risk profile of heart failure. Nat Rev Cardiol. 8(1):30–41
Cockayne, Pattenden, Worthy, Richardson, and Lewin (2014). Nurse facilitated Self-management support for people with heart failure and their family carers (SEMAPHFOR): a randomized controlled trial. International Journal of Nursing Studies (51)1207–1213
Ditewig, J.B., Blok, H., Havers, J., et al., 2010. Effectiveness of self-management interventions on mortality, hospital readmissions, chronic heart failure hospitalization rate and quality of life in patients with chronic heart failure: a systematic review. Patient Educ. Couns. 78 (3) 297– 315.
Fonarow GC, Abraham WT, Albert NM, et al. Factors identified as precipitating hospital admissions for heart failure and clinical outcomes: findings from OPTIMIZE-HF. Arch Intern Med. 2008;168:847–854
Kabisch, M., Ruckes, C., Seibert-Grafe, M., & Blettner, M. (2011). Randomized Controlled Trials: Part 17 of a Series on Evaluation of Scientific Publications. Deutsches Ärzteblatt International, 108(39), 663–668. https://doi.org/10.3238/arztebl.2011.0663
Kennedy, A., Bower, P., Reeves, D., et al., 2013. Implementation of self management support for long term conditions in routine primary care settings: cluster randomised controlled trial implementation of self management support for long term conditions in routine primary care settings: cluster randomised controlled trial. BMJ 346, f2882.
Leung, L. (2015). Validity, reliability, and generalizability in qualitative research. Journal of Family Medicine and Primary Care, 4(3), 324–327. https://doi.org/10.4103/2249-4863.161306
McMurray JJ, Adamopoulos S, Anker SD, et al.(2012). ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2012: The Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2012 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association (HFA) of the ESC. Eur Heart J. 33(14):1787–847.
Muus KJ, Knudson A, Klug MG, et al. Effect of post-discharge follow-up care on re-admissions among US veterans with congestive heart failure: a rural-urban comparison. Rural Remote Health. 2010;10:1447.
NIHCE (2010). National Institute for Health and Clinical Excellence. Chronic Heart Failure. Management of chronic heart failure in adults in primary and secondary care. NICE Clinical Guideline CG108 https://www.nice.org.uk/guidance/Cg108
Ponikowski P, Anker SD, al Habib KF, et al. (2014). Heart failure: preventing disease and death worldwide. ESC Heart Failure. 1:4–25.
Sullivan, G. M. (2011). A Primer on the Validity of Assessment Instruments. Journal of Graduate Medical Education, 3(2), 119–120. https://doi.org/10.4300/JGME-D-11-00075.1
Tu RH, Zeng ZY, Zhong GQ, et al.(2014). Effects of exercise training on depression in patients with heart failure: a systematic review and meta-analysis of randomized controlled trials. Eur J Heart Fail.16(7):749–57.
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