Post-Intervention Phase
3.4 Study Populations and Samples
For the two areas of the study different populations were used, with samples being drawn from these total populations.
3.4.1 Exclusion criteria.
In order to obtain samples from the total populations for each area of the study, criteria were needed to exclude participants who would not be suitable.
3.4.1.1 Clinical audit study.
Patients were excluded from the clinical audit study in both pre- and post- intervention phases if they were below 18 years of age, or were not prescribed an antipsychotic drug during their admission.
3.4.1.2 Questionnaire of healthcare
professionals study.
Healthcare professionals were excluded from the questionnaire study if they were not involved in the process of documentation of ADRs, or if they did not have a presence in the wards (e.g. the staff nurse; the matron in charge of nurses). Furthermore the clinical head, a practicing psychiatrist, was excluded from the
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questionnaire study to preserve the relevance of the research. This is due to the fact that he was closely involved in the organising of the research and the development of the questionnaire.
3.4.2 Sampling methods.
For the purpose of the clinical audit study convenience sampling was used. Patient files were chosen if they did not meet any of the exclusion criteria. Total sampling was used for the healthcare professional questionnaire study. This was because the overall population of healthcare professionals involved in the documentation of ADR was relatively small, and the exclusion of any willing participants would have impacted negatively on the sample size.
3.4.3 Clinical audit population and samples.
The population for the pre-intervention clinical audit included all patients who were admitted to the study site between the periods of 13 August 2013 to 20 September 2013. This population consisted of 193 members before inclusion and exclusion criteria were applied.The required sample size for the clinical audit in the pre-intervention phase was between 50 and 150 medical files of patients at the study site. The actual sample size was 102 patient medical files. As previously mentioned the maximum bed space for the site of study was 163 beds. However not all patients met the inclusion criteria for the study, i.e. there were patients at the site of study who were under the age of 18, and others who did not receive treatment with antipsychotic medication.
The population for the post-intervention clinical audit included all patients currently admitted to the study site between the periods of 18 March 2014 to 29 May 2014. Similarly to the pre-intervention population, this population had a maximum size of 193 members before exclusion criteria were applied.
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The post-intervention phase sample was again expected to consist of between 50 and 150 patient medical files, drawn from all wards at the site of study. The actual sample size for the post-intervention phase clinical audit was 102 patient medical files. This sample differed from the pre-intervention sample in that the same patients were not used. This was a result of the rapid turnover of patients at the study site.
3.4.4 Questionnaire of healthcare professionals
population and samples.
The population for the pre-intervention questionnaire included all professional nurses and medical doctors who were employed at the study site. This population was identified as including 71 professional nurses and 11 medical doctors.
The maximum sample size of the sample for the questionnaire of healthcare professionals for the pre-intervention phase was 82healthcare professionals (comprising of 11 medical doctors and 71 professional nurses). The actual sample size for the pre-intervention questionnaire was 65 professionals, of whom 10 were medical doctors and 55 were professional nurses. The pre-intervention response rate therefore was 79.27% for all healthcare professionals, 90.91% for doctors only and 77.46% for nurses only.
The population for the post-intervention questionnaire included 68 professional nurses and 8 medical doctors. Two medical doctors and two professional nurses had left the study site between the end of the pre-intervention phase and the beginning of the intervention phase and their replacements had not arrived at the study site before the beginning of the intervention phase, while a further one medical doctor left the site of study and was not been replaced at all. One further professional nurse passed away before the beginning of the post-intervention phase. Therefore, the maximum sample size for the questionnaire of healthcare
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professionals in the post-intervention phase was 76healthcare professionals. The actual sample size for the post-intervention questionnaire was 43 individuals, of whom 5 were medical doctors and 38 were professional nurses. The post- intervention response rate was therefore 56.58% for all healthcare professionals, 62.5% for doctors only and 55.88% for nurses only.
3.5 Ethical Considerations
As the study involved the records of mental health patients, the medical records were deemed to be sensitive information. Therefore the ethical implications of using such information needed to be taken into consideration. For this purpose both the Belmont Report (1986) and the Declaration of Helsinki (World Medical Association, 2008) were consulted to determine the appropriate steps to be taken during the research. All ethical considerations relating to the study were addressed prior to the approval of the study. The study was approved by the NMMU Research Ethics Committee - Human Ethics as being safe and ethical, and a letter of approval provided (Appendix 3). The study was then approved by the Ethics committee at the Eastern Cape Department of Health offices in Bisho (Appendix 4). No names or identifying information of patients were recorded. Patients included in the sample were distinguished only by their patient file numbers. Intra-institutional permission was obtained prior to the initiation of the pilot studies (Section 3.5.2) from the acting Medical Superintendent at the study site (Appendix 6).
Written informed consent (Appendix 5) was obtained from the healthcare professionals prior to the administration of the questionnaire, and all questionnaires were separated from the consent forms prior to data capture. To this end no questionnaires could be linked to the professional who completed them, ensuring personnel anonymity. Prior to the completion of the questionnaire the
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study was explained to the professionals in detail both verbally and in writing, and all risks and benefits were made known to them. In no way was the study tied to the performance of the professional in his or her work, and in no way did it affect the stability of their employment.