Chapter Two Literature Review
2.5 Educational Interventions Based on Improving Documentation
The term 'intervention' can be interpreted in a variety of ways depending upon the setting in which it is used. At the basic level the term can be defined as "a planned modification of the environment for the purpose of altering behaviour in a prespecified way" (Riley-Tillman & Burns, 2010). Interventions in a clinical setting will often refer to the use of a treatment or a type of surgery in improving patient
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outcomes. Interventions in a research setting will often focus on less physical outcomes such as improving attitudes or modifying the incidence of one or other variable. Interventions taking various approaches have been attempted, whether they are psycho-social (Liebman et al., 2014), activity-based (Botts, Losardo, Tillery, & Werts, 2014) or otherwise. The only common factor between different interventions in different settings is that there is a comparison of the state of the object of study before and after the intervention. In the more specific setting of healthcare the choice of interventions is still broad. Interventions relating to healthcare are often termed 'complex interventions' as they have multiple components. Healthcare interventions might involve the implementation of guidelines, community based programmes, new units in a hospital setting, behavioural change strategies or health promotion, among others. This broadness produces difficulty in the achievement of a given outcome with many possible paths leading to an end, as well as in the reproducibility of interventions as the steps taken in healthcare interventions are often poorly defined (Campbell et al., 2000). In 2000 the Medical Research Council (MRC) based in the United Kingdom (UK) released a document titled "Framework for the Development and Evaluation of RCTs for Complex Interventions to Improve Health", with an accompanying article. This framework addresses some issues experienced with the delivery of health- based interventions, such as development, piloting and evaluation. Although the document mostly addresses randomised control trials (RCT), the basic tenets laid out apply to all interventions of a healthcare related nature.
The form which the intervention takes is often deemed less important than its effect on the outcomes. However, overlooking the best way to perform a desired intervention may in turn reduce its overall effectiveness. When one refers specifically to the view and management of ADR this is equally true. An intervention focused on improving documentation as is the case in this study could take several
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forms, and any one of those forms could have a different overall effect. In fact various types of interventions have been attempted in multiple settings, albeit mostly focusing on reporting of ADR as opposed to documentation (Sullivan & Spooner, 2008). Particular emphasis has been placed on interventions including, and excluding, education in conjunction with an altered tool for reporting or documenting (Gonzalez-Gonzalez, Lopez-Gonzalez, Herdeiro, & Figueiras, 2013). Education would typically involve an initial session, which may or may not be followed by repeat or follow-up sessions. Altered tools for documentation included ADR documentation forms, ADR report forms, or electronic databases for ADR documentation.
Education as a tool for intervention has seen use in a number of ways. An article by DeGeeter et al published in 2014 describes the effect of education on pharmacy students' ability to identify plagiarism (DeGeeter et al., 2014). Students were given scenarios which may or may not have involved plagiarism and were asked to identify the cases of plagiarism. Education was then presented to these students in the form of a seminar and the same assessment cases were used in randomised order for post-intervention assessment. This educational approach resulted in a significant improvement in ability to identify cases of plagiarism (DeGeeter et al., 2014). In general educational interventions have seen positive results on their desired outcomes whether those out comes involve: reducing errors on death certificates (Azim et al., 2014); reducing stigma and increasing awareness around mental illness (Yamaguchi, Mino, & Uddin, 2011); or reducing errors in prescribing by medical students and junior doctors (Ross & Loke, 2009). Thus educational interventions have been proven to have benefit in multiple settings.
The usefulness of an educational intervention can be applied to management of ADR through documentation and reporting. Most interventions which aim to improve either documentation or reporting of ADR by healthcare professionals
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have used an educational approach in addition to the implementation of an intervention tool.
A meta-analysis by Gonzalez-Gonzalez et al in 2013 summarised a number of studies which involved educational interventions. A total of 36 interventions were implemented in a single setting, similarly to the study detailed in this document. Professions ranging from doctors, nurses and pharmacists to students of the aforementioned were included in these interventions. As this study focused on doctors and professional nurses (but included intern and community service doctors), studies not involving these professions can be excluded. This leaves 31 studies of interest, 23 of which employed a pre-post experimental design (similar to the quasi-experimental before-and-after design used for this study).
One such study, performed by Miwa and Randall in 1986 introduced an educational session in conjunction with a modified form. This was a pre post experimental study, which is similar at a basic level to a before-and-after study given that it compares a variable before and after an event, not necessarily an intervention. The study targeted pharmacists and nurses, focusing on the use of an educational training session with a follow-up reminder in addition to a modified reporting form and protocol. Nurses and pharmacists were requested to fill out an ADR report form whenever a change in the patient's condition or a particular medicine order (such as one for a medicine typically used in the treatment of an ADR) raised suspicion of a possible ADR. The method followed produced a 26.5 fold increase in pharmacovigilance activities focusing on ADR (Miwa and Randall, 1986).
Several years later Gilroy et al (1990) implemented an intensive intervention aimed at physicians. The intervention included: an education session; follow up education; assistance with pharmacovigilance from a pharmacist; a modified procedure for reporting; a financial incentive for reporters; and feedback. This intervention produced a 43.8 fold increase in pharmacovigilance activities. A more
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recent study by Lee et al (2004) targeted doctors and nurses. The intervention used for this study included: an education session; follow up education; a modified pharmacovigilance procedure; and an incentive for professionals. This produced a 4.3 fold increase in pharmacovigilance, a modest increase in comparison to those mentioned previously. Another study performed in 1990 by Scott et al, introduced an intervention to a hospital setting and a primary care setting in Rhode Island, USA, focused instead on physicians over a longer period of 36 months. The format of the educational intervention was similar to that of Miwa and Randall, including both a training session and a follow-up reminder. However, the modifications to reporting included deeper involvement, consisting of a modified form, a modified procedure and active feedback to physicians. This state-wide study increased incidence of ADR reporting 17 fold, along with a parallel increase in the number of significant ADR reported after the study (Scott et al., 1990).
Yee, Norton and Catania's 1995 study introduced an intervention which followed the same broad processes as that of Scott's: an education session with accompanying follow-up, as well as modifications to the form and procedure used for reporting of ADR. This was introduced in a hospital setting to doctors, nurses and pharmacists over a period of 15 months. The result was a comparatively low 2.5 fold increase in reporting of ADR at the study site (Yee, Norton and Catania, 1995).
A study performed by Valente et al (2010) employed an intervention which was closest in construction to that presented in this research. An education session with follow up education was presented to nurses, with no incentive to report. This resulted in a 2.5 fold increase in documentation. Of the studies included in this meta-analysis, one featuring an intervention closest to that of the study featured herein was that performed by Saltiel et al (1995). This USA based study targeted medical doctors in a hospital setting (similar in part to the population used for this
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methodology). The intervention employed by these researchers included an education session, and a modified form for reporting. The end result of this study was a 2 fold increase in pharmacovigilance at the study site.
While these studies have employed moderately different interventions with an accompanying wide variation in results, they have all been localised to the United States of America. Focus can thus be shifted to studies performed elsewhere. A study by Tabali et al (2009) in Germany introduced an intervention to physicians consisting of the following: an education session; follow up education; assistance with pharmacovigilance; and an incentive system for physicians. This study resulted in a 2.5 fold increase in pharmacovigilance activities. Finally, a study by Yen et al (2010) in Taiwan introduced an altered procedure for the reporting of ADR. This intervention was conducted without any accompanying education or incentive. The result of this intervention was a 3.6 fold increase in pharmacovigilance activities.
With success rates ranging from 2 to 43.8 fold increases in pharmacovigilance, it is plain to see that educational interventions have varying degrees of success (albeit largely positive), depending on the elements of the intervention. Inclusion of a financial incentive generally appears to improve pharmacovigilance to a more profound degree.
Although the aforementioned results, when compiled into the systematic analysis, were promising at face value, they were identified by Gonzalez-Gonzalez et al as having a high risk of bias. This may be due to the nature of the research design employed for these studies being un-randomised, and un-controlled. To emphasise this point, the studies considered to be of low bias in the systematic review were either randomised controlled experimental studies or cluster- randomised controlled experimental studies.
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One study not included in the aforementioned meta-analysis was one by Szymusiak-Mutnick and Ross in 1995. This study followed a similar methodology of including an altered tool for ADR documentation. Wall-mounted ADR report forms were adapted from the existing ADR reporting form and were introduced to the wards(Szymusiak-Mutnick & Ross, 1995). These forms employed a 'tear-off' design, meaning that a documenting professional could easily access one of the forms simply by removing the topmost page from the wall-mounted pad. While less emphasis was placed on education throughout this study, the altered tool was presented to healthcare professionals in a manner that was similar to most educational sessions as laid out in the previously mentioned studies. The end result of the study was an increase from six total instances of ADR being reported in 1993 to 34 instances in 1994 (1994 being the first year following introduction of the newly altered tool).
Therefore, literature focusing on the use of education in combination with an additional tool shows positive results. Given the similarity between documentation and reporting of ADR, and considering that documentation provides arguably less extra work for healthcare professionals (since the process is in-house and focuses on patient medical notes), it stands to reason that the same method used to improve reporting could also improve documenting.