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Difference between Readmission Rate to Psychiatric Services in Patients with Schizophrenia

Schizophrenia, a chronic mental disorder affects approximately 1 % of the United States population and costs taxpayers about $33 billion per year (Cloutier et al., 2016; Olfson, Gerhard, Huang, Crystal, & Stroup, 2015). The lifetime prevalence of the disease is from 0.4 to 1.4 while suicide rates among patients with Schizophrenia are estimated to be about 10% (Cloutier et al., 2016; Olfson et al., 2015). Also, fewer patients with the condition are employed at various workplaces due to the incapacitating condition imposed by the disease. The chronic form of the disease results in different outcomes as some patients experience frequent relapses associated with increased incidences of rehospitalization or readmission. In other cases, patients fully recover from the disease though they are maintained with appropriate antipsychotic drugs. Treatment using antipsychotic drugs has been proved to decrease relapse rates (Cloutier et al., 2016). Nonetheless, poor maintenance therapy commonly results in successive relapse cases, reducing the quality of patients functioning and increasing refractoriness to future treatments (Baker, & Abei, 2017). In recent years, Clozapine, a psychotic drug has been considered to be the most efficacious drug for the treatment of schizophrenia. The drug showed lower refractoriness compared to the standard drugs. Studies also demonstrate that the drug normally reduces some of the common positive symptoms associated with the disease such as delusions and hallucinations (Baker, & Abei, 2017). Nonetheless, the efficacy of the drug is quite unclear when it comes to dealing with other negative conditions such as social functioning, lack of motivation, and blunted effect. The drug is also associated with low incidences of extrapyramidal effects. Unfortunately, the drug also has negative effects such as fatal agranulocytosis in approximately 1 percent of the patients. Therefore, patients prescribed to use Clozapine should be monitored regularly using white cell testing. Although the benefits of Clozapine have been mentioned above, the drug is eleven times more expensive than the conventional drugs used in the management of schizophrenia. One of the most commonly used conventional drugs is haloperidol. The type of drug used in the management of different patients with Schizophrenia serves to provide information or clues on the readmission rates of the patients. In most cases, effective drugs tend to reduce the chances of readmission to clinical settings while non-effective drugs serve to increase the readmission rates after a short period of time. Readmission rates, which act as a measure or indication of quality, serve to provide information on the specific drugs to be used in the management of Schizophrenia. The chart below indicates hospital readmission rates for patients with Schizophrenia adapted from (Heslin, Kevin C.; Weiss, 2015)

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Review of Literature

Numerous studies have been conducted by various scholars with the key aim being to show the interrelation between the use of specific drugs and the hospital readmission rates. Baker and Abei (2017) reviewed recidivism rates of various antipsychotic drugs to be used by the oral mono-therapy inpatient population in an Oregon hospital. The charts used showed patients discharged from 2011 to 2015 that had been diagnosed with disease conditions such as Schizophrenia or Schizoaffective based disorders. Discharge antipsychotics were compared to oral monotherapy for the average number of days till the readmission of the patient in a clinical setting. The results of the study revealed that the average number of days of readmission was directly associated with long-acting injections and oral monotherapy although long-acting injections readmission days were averaged to be 78 compared to 85 days of oral monotherapy. Clozapine monotherapy was associated with the highest level of patients who were not readmitted and currently stood at 46%. These results indicated that Clozapine was one of the drugs associated with lower readmission rates in clinical settings for the management of Schizophrenia and other associated disorders.

Valevski, Gilat, Olfson, Benaroya-Milshtein, & Weizman (2012) investigated the interrelationship between hospital discharge, readmission, and different pharmacological treatments in the management of Schizophrenia patients. The rate of readmission was analyzed based on a 12-month treatment by specific pharmacological medicines. The results of the study revealed no significant differences between the risk of readmission among patients treated with second-generation antipsychotic drugs and first-generation antipsychotic drugs. Also, neither did the adjuvant psychotropic medications attenuate the readmission rates. The readmission rates in individuals treated with Clozapine were significantly lower compared to the individuals who used first-generation antipsychotic drugs. Clozapine as a second-generation drug was found to reduce the risk of readmission more than the first-generation antipsychotic drugs.

Krivoy, Fischel, Yosef, Weizman, & Valevski (2012) notes that Clozapine had superior effectiveness in treating patients with Schizophrenia compared to the other drugs. The discontinuation of this form of treatment was shown to have detrimental consequences in the management of patients' conditions. A retrospective study was conducted to examine the effects of clozapine discontinuation in patients diagnosed with Schizophrenia by investigating data on patients from 2002 to 2008. Clinical and demographic variables were compared and examined among patients who were sustained with Clozapine treatment and those who suspended clozapine treatment after a follow-up period of about 8 years. Discontinuation of the drug was based on the side effects of the drug. Thirty-three patients stopped taking the drug after the first year of their treatment, and this directly correlates to the high readmission rates. Also, the reduction in the total number of suicide attempts was noted among patients who choose to continue with clozapine treatment compared to those who were willing to suspend. Predictors of drug discontinuation included substance abuse and old age. The results indicate that patients with Schizophrenia may need special incentives to reduce discontinuation of clozapine. Discontinuation of Clozapine should therefore be minimized due to the overall effects of the disease.

Machielsen, Veltman, van den Brink, & de Haan (2014) examined the effects of the two drugs on brain activity and other activities such as cravings. Patients were randomized in the study groups with both drugs and after four weeks of using different medications, the regional brain activity was measured through the use of magnetic resonance imaging. Individuals treated with Clozapine were shown to have abridged longing desires and stimulation in the insula after the introduction of the cannabis word Stroop. Risperidone patients were proved to show a superior decline in brain activation. The results suggest that the use of Clozapine is essential in the management of patients with Schizophrenia.

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Nakajima et al., (2015) compared the effects of different anti-depressive drugs in the treatment of Schizophrenia. The different drugs in question included quetiapine, ziprasidone or Risperidone, and Clozapine. Antidepressant effects of Clozapine were compared to the atypical antipsychotics mentioned above. The results indicated the different antidepressant effects compared to the atypical antidepressants. Clozapine was effective against quetiapine in the management of chronic Schizophrenia. These results were similar to the other drugs including olanzapine and Risperidone. The findings suggest that Clozapine had superior antidepressant capabilities compared to the effects of atypical antipsychotics. The results show that Clozapine is more effective in the management of patients with Schizophrenia compared to the atypical psychotic drugs.

The above information provides evidence on the specific attributes of Clozapine and its effect on the management of Schizophrenia patients. A comparison of Clozapine and other antipsychotic drugs may serve to provide information on the effectiveness of the disease management and to confirm some of the results indicated in the above study. A comparison of the effectiveness of clozapine and haloperidol has not yet been conducted, and therefore there is insufficient data on the two drugs. Incorporating the effects of readmission rates serves to provide information regarding which drug is considered to be more effective in the management of patients with Schizophrenia.

Purpose Statement

The management of Schizophrenia has largely revolved around the use of different drugs. The effectiveness of these drugs has recently come into question due to the high relapse rates, which increase the chances of refractoriness to the disease condition. First and second-line generation drugs have been indicated to have different rates of effectiveness, but are associated with high relapse cases and increased readmission rates in the clinical setting. There is a need to have a drug that can reduce the readmission rates in the current clinical setting. Readmission rates serve as an indicator of the quality of specific clinical practices. High readmission rates due to the use of specific drugs indicate that the drug being used is less effective than desired. Clozapine has been associated with significant benefits, which distinguish it from conventional drugs. Comparing the readmission rates of the disease serves to provide further information on the quality of the drug.

Research Questions

1. Does the average readmission time change after the treatment of patients with haloperidol and clozapine?

2. Of haloperidol and clozapine which is more effective in the treatment of Schizophrenia?

Methodology

Research Design

A retrospective study will be carried out in one of the clinical psychiatric hospitals. The study will be based on data collected in the clinical setting between the years 2000 to 2010. The data will be limited to patients who had been treated with haloperidol and clozapine between the specific periods of time mentioned above. Readmission will be defined as any form of re-hospitalization to the clinical setting after being discharged. Readmission will also be associated with the presence of the diagnosed symptoms associated with Schizophrenia. It will define the number of days after discharge of the patient in the clinical setting and record several days. The risk factors related to high readmission rates will be investigated.

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Participants

All patients recruited for the study must be diagnosed with Schizophrenia. The study targets males and females between 18-40 years diagnosed with Schizophrenia. The clinical eligibility criteria will be based on the diagnosis as defined by the Diagnostic and Statistical Manual of Mental Disorders. The study will exclude patients who failed to provide consent or had been treated with any of the two drugs in the past. Also, patients who are pregnant or had incidences of substance abuse in the past will not be included in the study. The study will seek to ensure that it includes the majority of patients diagnosed with Schizophrenia.

Sampling techniques

The patients will be randomly placed in specific groups and then assigned to different centers for the application of either form of treatment. 100mg to 900mg of clozapine will be provided to the patients in one group, while 5 to 30 m of haloperidol will be provided to the patients in the other group. All the doses will be clinically fixed to a total number of 12 doses. Patients receiving haloperidol were provided with benztropine mesylate for side effects while those provided with clozapine were given benztropine placebos. To maintain the blinding effects of the drugs on the patients, the patients who received haloperidol will be given weekly blood counts which are commonly required for individuals being treated with clozapine.

The G power analysis will be based on using a sample population of 1000 where 50 participants will be classified into separate categories. The power value to be used will be 0.8 or 80% while the alpha value will be the 95% confidence interval. The G power analysis reveals the following plot

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Operationalization of Variables

The independent variable to be measured will be the type of drug given to the patients while the dependent variable will be the number of days it takes for the patient to be readmitted in the clinical setting after being discharged. These variables have been used in most of the literature sections. For example, Baker, and Abei (2017) used the different types of drugs as the independent variable, while the readmission rates of the patients across different periods of the year were considered as the dependent variable. Similarly, Valevski et al., (2012) used different treatment regimens as the independent variable and hospital readmission and discharge rates were used as dependent variables. The dependent variable was measured as the average number of days after which a patient was readmitted to the clinical setting after being discharged while the independent variable was measured as the average dose of the specific drug given to the patients in the course of their treatment.

Data Collection

Data will be collected from the clinical setting database. The information to be collected will largely include demographic information depending on several variables. The gender, race, and ethnic and marital status of the patient will be collected. Also, the education level, source of income, and any insurance policy related to the condition will also be collected. The age at the onset of Schizophrenia and the quality of life of the patient will be assessed using the standard tests. Also, the number of times patients have been hospitalized in the past years is also expected to be estimated in the study.

Ethical and Legal Considerations

First, ethical approval will be sought for the above study to limit unethical behavior. The study may be associated with some conflicts as the patients expect to recover from the disease and may engage in practices that may serve to provide deviating results to the study. Nonetheless, such a conflict will be addressed by using some of the key ethical principles. Beneficence requires the researchers to only engage in good acts that will see the recovery of the patient. The study is formulated on a structure based on treating patients with different drugs with the ultimate effect of reducing the rates of readmission of patients with Schizophrenia to ensure their recovery. The study will also seek to apply the principles of justice and autonomy in the study. The patients will be selected randomly to minimize any effects of bias. Also, any patient who fits the inclusion criteria of the study will be allowed to engage in the study. Autonomy requires the subjects to indicate whether they are willing to participate in the study or not. Participation will largely be voluntary and any patients who wish to get excluded from the study at any particular time will be allowed to do so without any restrictions.

Statistical Plan

Repeated measures ANOVA will be the key method used to analyze data. The changes in the readmission means will be assessed over a period of every three months for the entire period of the study. Confounding variables will be eliminated from the study by stratification of the data and by blocking all the factors that may at specific points affect the dependent and independent variables. Matching and stratification will be the two commonly used methods used to control the confounding variables in the study.

Interpretation

Descriptive statistics will be used to present the mean and standard deviation of some of the demographic variables. This information will be presented in tables. Scatterplots will be used to show the association between a specific drug and the readmission rate across the different time periods. Any other information contained in the study will be presented in the form of figures with a legend providing information about the data.

Implications for Practice

The current study seeks to compare the effectiveness of two drugs in the management of one of the chronic mental conditions. At the end of the study, the researcher will provide critical information on which drug is more effective in reducing the readmission rates in a clinical setting. For future studies, it will be critical to investigate the combined effects of several drugs used in the management of Schizophrenia as the results may indicate either an antagonistic or a synergistic effect.

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