Quantitative Analysis of Compliance Rates: Oral Versus Long-acting Injectable Medication


Background

Medication compliance is an issue that revolves around many disciplines and specialties in healthcare. A great public concern in the community is the consequences of medication noncompliance in psychiatric patients where accompanying symptoms and behaviors of psychosis pose unique risks and challenges. While limited infrastructure and community resources remains a large issue with policymakers, medication noncompliance is an underlying and overlooked issue that must be addressed. The first step in management is to investigate, through quantitative research, factors affecting adherence particularly in patients diagnosed with psychiatric disorders.


Definitions and Measurement

Quantitative research is utilized to determine and analyze the relationship between an independent variable and an outcome variable within a population. This method emphasizes objective measurement and the statistical, mathematical, or numerical analysis of data (Babbie, 2010). There are many advantages to utilizing quantitative research methods as it allows statistical analysis for greater objectivity. The obtained numerical data can be displayed as graphs, charts, tables, and other formats to enhance interpretation (“Research Guides: Organizing Your Social Sciences Research Paper: Quantitative Methods”, 2012). Additionally, numerical quantitative data may be viewed with greater credibility.


Application of Quantitative Method

The methodology is applied to this study in the form of the survey questionnaire in Appendix A, which patients fill out. From this raw data, patient opinion is translated into numbers via a Compliance Rating Scale by focusing of contributing factors for patient non-compliance including: remembering medication administration, reasons for forgetting administration times, reasons for not taking medications, the ability to list personalized regimens, and having general understanding of medications they currently take. This rating system is seen in Table 1.

Trouble Remembering

Never +3

Rarely +2

Sometimes +1

Always +0

Number of Reasons for not Remembering

None +3

1 +2

2 +1

>3 +0

Reasons for Not Taking Medications

0 +3

1 +2

2 +1

>3 +0

Ability to List Medications

All +3

Most +2

Some +1

None +0

Medication Understanding

Yes +3

Kind of +2

MD not explaining +1

None +0

Table 1. Compliance Rating Scale. Scores are based on a point system with 15 out of 15 representing the best possible chance for compliance towards medications.

This paper will analyze the quantitative findings of the study through statistical analysis, interpret and describe the comparison and relationships among variables, and discuss implications and summary of findings.


Research Topics

The topic of this survey was centered around the issue of medication compliance in such a vulnerable patient population. For this study, the population surveyed were patients who were admitted into an acute inpatient psychiatric hospital and those who were being prescribed psychotropic medication. The patient population survey included male and female patients of varying ages who were admitted with a variety of primary psychiatric diagnosis including bipolar disorder and schizophrenia. However, all the patients surveyed were currently prescribed and taking antipsychotics. In psychiatric patients, it is important to mention that although consent is required for administration of psychotropics, patients still have the right to refuse medications. The only exception would be unique situations that include permanent conservatorship, Riese status (legal incapacity to consent), or emergency situations all of which were excluded in this survey.

The questionnaire included in Appendix A provided basic patient demographics while also preserving their privacy. Additionally, it surveyed a basic comprehension of the patient’s current medication regimen. The patients were also questioned regarding their compliance or lack thereof and reasoning.  The goal of the survey was to compare and determine if offering an injectable medication in lieu of oral antipsychotics would increase medication compliance in this specific

patient population.


Hypothesis Based on Analysis

Null Hypothesis:

There is no significant difference in compliance rates between different formulations of medications.

Alternative Hypothesis:

There are significant differences in compliance rates between different formulations of medications.


Goals of Research

Beyond the evaluation of this research study, another invaluable aspect worth learning would be patient perspective. The population surveyed were patients diagnosed and affected by psychiatric disorders in which thought or mood dysregulation was more likely present. The question then would be how the current cognitive or behavioral state could affect the comprehension and interpretation of the results. The patient’s perspective would be worth investigating in the hopes that it would reveal more than compliance issues. Other intriguing goals of this study include determining other variables that might affect compliance such as logistical, geographical, or insurance issues. Regardless of the patient’s comprehension of medications and willingness to take an injectable medication, other variables might adversely affect the likelihood

of compliance as the unintended result.


Interpretation of Results

After applying a linear regression analysis, it is obvious that the research does not support the alternative hypothesis of there being a significant difference in compliance rates between different formulations of medications. This is proven via P value testing as calculated in Appendix B. Here, the P value is calculated to be 0.3466 for an unpaired T-test using a 0.05 or 5% significance interval. As the P value is greater than the significance interval, it proves the results are statistically insignificant and we can reject the alternative hypothesis.  Thus, the null hypothesis of no meaningful connection between medication formulation and compliance outcomes is a possibility.

As shown in Figure 1, we see the comparison with standard deviation of the two populations, and although at first glance it would appear that oral medications are more favorable in terms of compliance, with such a large standard deviation, the compliance rating of both medication administration methods is approximately 8 out of 15.

As the maximum score is 15 out of 15, with an average compliance across both medication formulations being 8 out of 15 this is consistent with current data that patients traditionally are non-compliant with antipsychotic medication.

Figure 1. Graphical Representation of Injectable and Oral Medication Compliance Rates with Standard Deviation.


Relevant Studies

Few studies have thoroughly compared long-acting injectable antipsychotics to its oral counterparts. Long-acting formulations were manufactured to combat the issue of medication noncompliance in psychiatric patients deemed at risk. Although long-acting injectable medications are a powerful tool to assure compliance or signal noncompliance, recent results from randomized controlled trials failed to show superiority compared to oral antipsychotics (Kane, J. M., Kishimoto, T., & Correll, C. U., 2013). This further suggests that there is not a non-adherent personality observed among this patient population that is valid nor reliable in predicting medication compliance. It is also significant to note that medication noncompliance, especially in psychiatric patients, can be influenced by the level of knowledge or insight and attitude towards their psychiatric disorder and the resulting treatment regimen. The patient’s perceived risks and benefits of medication and treatment of their disorder greatly influences the likelihood of compliance.


Application to Healthcare

The issue of medication compliance is an issue in healthcare that would be invaluable to research. A concept learned in this course that was relevant in this process of this survey and analysis is utilizing tools for data organization, analysis, and presentation.  Data analytics is a critical aspect in the healthcare field. This course emphasized establishing standards to enhance data quality. it is important as it provides guidelines and a general direction in the process of collecting data. Also, establishing a numbering or tracking system as it is demonstrated in Appendix B. A unique numbering system helps to develop and identify all organizational forms so that as research is continued, the process of data collection, measurement, and results could be

repeated (Sayles, N.B., 2016).


Limitations of Research

The findings of the survey yield a quantitative result that suggests the preparation or formulation in which antipsychotic medication is administered did not improve or increase the likelihood of adherence to prescribed medication. A limitation to this study is the size of subjects completing the questionnaire as only ten patients were surveyed. Also, the specific population that was surveyed is unique in which there may be symptomology present related to their psychiatric illness which could be considered a limitation to the questioning in this study.  The risk being the inability or lack of insight to comprehend the study and the subjective bias this may entail. This also influences the results as any potential thought dysregulation may dictate if medication compliance is possible. Another limitation to consider is this patient population may exhibit symptoms such as paranoia secondary to their primary diagnosis in which administration of injectable medication may further exacerbate their acute condition. These alone did not inhibit effective interpretation of the results as the compliance rate system used for statistical analysis scored patients appropriately based on numerous factors that would predict the likelihood of compliance.


Summary of Findings, Recommendations and Future Research

Prior to the study, one could occupy the assumption that offering an alternative to oral medication such as a long-acting injectable medication would increase medication compliance. The findings of this research study invalidate the concept that there is no significant difference in compliance rates between different formulations of medications offered to psychiatric patients.  The results may help illustrate one of the issues relating to the public community. Noncompliance can have negative consequences and an increase in medication adherence would decrease the incidence of decompensations that result in institutionalization or incarceration. It would be imperative to intervene in the early phase and manage patient compliance to help prompt providers, healthcare administrators, and policymakers realize the gravity of the issue. There is a need for continued research and insight relating to the factors that influence medication noncompliance and further investigation is warranted to bridge the gap between medications and

patient compliance.


References


  • Babbie, Earl R.

    The Practice of Social Research

    . 12th ed. Belmont, CA: Wadsworth Cengage, 2010; Muijs, Daniel.

    Doing Quantitative Research in Education with SPSS

    . 2nd edition. London: SAGE Publications, 2010.
  • Fenton, S.H., Biedermann, S. (2017).

    Introduction to Healthcare Informatics

    (2

    nd

    ed

    .)

    . Chicago, IL: AHIMA.

    Kane, J. M., Kishimoto, T., & Correll, C. U. (2013). Non-adherence to medication in patients with psychotic disorders: epidemiology, contributing factors and management strategies.

    World psychiatry : official journal of the World Psychiatric Association (WPA)

    ,

    12

    (3), 216-26.

  • Research Guides: Organizing Your Social Sciences Research Paper: Quantitative Methods. (n.d.). Retrieved from http://libguides.usc.edu/writingguide/quantitative
  • Sayles, N. B. (2016).

    Health Information Management Technology: An Applied Approach

    (5

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    ed.). Chicago, IL: AHIMA


Appendix A

The following survey/questions do not require you to disclose your name/identification.

Please answer the following questions to the best of your ability and to what you feel you are comfortable in answering. Please stop and ask for clarification when necessary.

▢ Male ▢ Female     Age: _______

Primary Diagnosis (if possible): __________________________________________


1. What route/forms/preparations of medications are you familiar with?

▢Pills (tablets/capsules) ▢oral suspension/liquid(syrup) ▢Injection ▢Intravenous (IV)


2. What route/forms/preparations of medications do you



currently take



?

▢Pills (tablets/capsules) ▢oral suspension/liquid(syrup) ▢Injection ▢Intravenous (IV)


3. Do you have trouble remembering to take the medication prescribed by your psychiatrist daily?

▢ Never ▢Sometimes ▢ Rarely ▢ I never forget


4. What are the reasons you forget or have trouble taking medication(s)? *Please explain (i.e, work schedule, travel, appointments, access)

_________________________________________________________________________________________________________


5. Please list some of the reasons why you



do not like



to take the medication(s) prescribed by your psychiatrist:

▢ Side effects ▢ Taste ▢ Lab/blood work for therapeutic levels ▢ Amount of medication ▢ difficulty keeping follow-up appointments ▢ Cost/Copays ▢ Transportation issues ▢ Effectiveness ▢ This doesn’t apply to me ▢ Other:____________________


6. Please list the medications (If you can) that you are being prescribed by your



psychiatrist



:

_________________________________________________________________________________________________________


7. Do you have a general understanding of these medications? (What they are for? What do you need to look out for or monitor?

)▢ Yes ▢No ▢ I kind of understand ▢ My physician hasn’t explained them to me * If yes, please explain:

_________________________________________________________________________________________________________


8. Would you be willing to take a long-acting injectable medication in place of the oral medication taken every day prescribed by the psychiatrist? The injection would/could be ONCE every 1 or 3 months

.

▢ Yes ▢ No * If NO, please explain why: ______________________________________________________________________


9. Would offering you a long-acting injection once a month help you to be compliant with your medication?

▢ Yes ▢ No * If NO, please explain why: ______________________________________________________________________


10. Please list any other questions or comments regarding taking a long-acting injectable medication?

__________________________________________________________________________________________________________________________________________________________________________________________________________________


Thank you for participating in this survey/questionnaire. Your feedback is greatly appreciated!

Appendix B


Injectable

Patient 3 37 Bipolar affective disorder

5

Patient 4 64 Bipolar affective disorder

3

Patient 5 29 Schizophrenia

4

Patient 8 57 SAD

8

Patient 9 24 Bipolar disorder

7


Oral

Patient 1 25 schizophrenia

5

Patient 2 57 SAD

6

Patient 6 23 Bipolar affective disorder

7

Patient 7 27 Schizophrenia

5

Patient 10 55 Bipolar Affective disorder

12

Oral Population Total: 5

Injectable Population Total: 5

Stdev (oral): 2.915475947

Stdev (long acting): 2.073644135

Confidence Interval 0.05

Unpaired T-test results: P value = 0.3466

As the P value > 0.05 the results are not statistically significant for any difference in any of the variables. We cannot reject the null hypothesis at this time; there may be no significant impact on medication compliance with change of medication formulation.

Tables

Table 1

Compliance Rate System

Trouble Remembering

Never +3

Rarely +2

Sometimes +1

Always +0

Number of Reasons for not Remembering

None +3

1 +2

2 +1

>3 +0

Reasons for Not Taking Medications

0 +3

1 +2

2 +1

>3 +0

Ability to List Medications

All +3

Most +2

Some +1

None +0

Medication Understanding

Yes +3

Kind of +2

MD not explaining +1

None +0

Note:  Compliance Rating Scale. Scores are based on a point system with 15 out of 15 representing the best possible chance for compliance towards medications.

Figures

Figure 1

Comparison of Injectable Vs Oral Medication Compliance Rating

Figure 1. Graphical Representation of Injectable and Oral Medication Compliance Rates with Standard Deviation.

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