Abstract
Antipsychotic medications continue to be an enduring treatment in the management of schizophrenia and other psychotic disorders [1]. The role of antipsychotic medications in producing better outcomes for people with psychotic illness has been clearly demonstrated [1,2]. However, antipsychotic medications can also produce a range of adverse effects, which impact on the patient's quality of life [3] and may cause even greater levels of distress than the symptoms of the illness [4]. These side-effects can intrude upon on the patients' sociability and relationships [5]. Some side-effects, such as postural hypotension, can cause serious injury through falls, especially in elderly patients. The majority are unpleasant, physically and/or socially disfiguring, frightening and emotionally damaging [6]. Other side-effects, such as weight gain, may be underestimated as a cause of emotional distress [7].
Neuroleptic side-effects have also been identified as a major determinant of non-compliance in many studies [8–12]. Non-compliance may occur in 50% of patients with schizophrenia on neuroleptics and even more frequently in younger people [13]. It was claimed that non-compliance with medication was a critical factor in 92% of multiple admissions [14]. However, it has been suggested that non-compliance may be seen as a very rational action from the patient's viewpoint [15]. This is especially true if side-effects seriously undermine the patient's ability to function effectively in a social context. Home summarised the situation: ‘… most patients with chronic illness are faced with the need to take regular medication. However, many fail to do this and non-adherence to medication is a major concern for health practitioners’ [16, p. 155].
The successful management of side-effects is an important factor in ensuring that patients adhere to prescribed treatment regimens. One of the first steps in the management process is assessment. However, the literature on the assessment of side-effects offers little guidance to the clinician. The few published studies that are available indicate that nurses did not assess patients in a systematic manner and they typically identified only three or four side-effects per patient [17]. While community nurses claimed to be monitoring neuroleptic side-effects, their knowledge about side-effects was poor and they lacked a systematic approach to the assessment of side-effects [18,19]. These deficiencies are in stark contrast to the principles of case management suggesting that the assessment and management of medication is a critical component of a patient's package of care [20].
The difficulty of arriving at an objective assessment of the presence of neuroleptic side-effects must be acknowledged [21,22]. It may not be possible to discriminate between some side-effects (e.g. restlessness) and symptoms of the illness. This issue signifies the need to take a careful note of a ‘symptom baseline’ prior to administering medication and reduce the risk that ‘the clinician may be easily misled and the wrong diagnosis can lead to an increase rather than a decrease in neuroleptic medication’ [23, p. 11]. The difficulty of undertaking side-effect assessments is further complicated by the fact that many staff do not appear to have the time, nor the tools, to perform comprehensive assessments.
While acknowledging the difficulties associated with accurately identifying side-effects, the use of standardised rating scales for the assessment and monitoring of medication side-effects may be important in providing an effective, customised service to patients [5,18,19,24]. Assessment schedules may increase staff awareness of the problems, provide a structured format for assessments and elicit data that may be used as an adjunct to clinical judgements.
Another major factor that may negatively influence the assessment process is the attitude of multi-disciplinary staff who deal with patients on a regular basis. Many may see the side-effects of medication as the inevitable ‘cost’ of treatment which results in improvements in patients' mental health and feel powerless to do much about them. It has even been suggested that the widespread use of medication over the last 30 years has ‘desensitised’ psychiatrists to the side-effects which patients may experience [22] and results in a lack of empathy which may border on callousness [25, p. 37]:
The most common complaint of people with psychiatric disabilities was that too often their concerns were not taken seriously (often being dismissed as part of their illness) or were seen as secondary to the objective of treating their mental illness. It was argued that the way in which medicines were sometimes used among those with psychiatric disabilities compromised their civil rights.
While it is likely that these problems have been recognised privately for many years, it is only recently that the social climate has made it possible, to voice them publicly.
Accompanying this attitudinal shift, and intertwined with it, has been a discernible change in the role of nurses within the health care system. Napthine reinforced the idea of a ‘therapeutic alliance between nurses and consumers’ (cited in [25] p. 23). This role is generally defined in terms of a closer relationship with the patient and takes account of initiatives which ‘inform nursing with users’ perspectives and experiences… to provide the necessary balance in services which are increasingly controlling' [26, p. 389]. However, the ideal of a therapeutic alliance as described by Napthine is one which all committed mental health professionals aspire to.
Any attempt to enhance the assessment of side-effects must include these attitudinal components since they reflect the current realities of mental health case management practice and embrace some of the aims and aspirations of patients and case managers.
In this component of the study we developed an educational intervention designed to explore attitudes and improve case managers' assessment and management skills. Other aspects of the study explored the extent and impact of neuroleptic side-effects experienced by mentally ill people and how assessments of side-effects are currently undertaken by case managers [27].
Method
Sample
A stipulation for Ethical Committee approval was that case managers select suitable patients from their caseloads to take part in the study and provide contact details to the research team who then invited patients to participate. Each case manager was told about the purpose of the study through staff meetings and personal communication and asked to identify two patients from their caseload who were taking antipsychotic medication. We also asked case managers to select male and female patients and patients from different age groups. Case managers also filtered the patient sample to ensure that patients who were acutely disturbed were not approached. Thus case managers played a critical role in determining which patients were selected and omitted.
Initially, 48 case managers from two geographically distinct health districts (referred to as ‘comparison’ and ‘intervention’ areas) in the Brisbane area volunteered to take part in the study. Case managers did not know if they would be in the comparison or intervention groups when they selected patients initially. The case managers were drawn from a range of professional disciplines (general and psychiatric nursing, social work, occupational therapy and psychology).
Most of the case managers (68.7%) were from nursing and 45.8% held psychiatric nurse qualifications. The mean length of time as a case manager was 48.5 months. Some case managers did not provide patients for the study and the reasons for this were unclear. Case managers in the comparison and intervention areas were very similar with respect to professional discipline, length of time as a case manager and the frequency with which medication reviews were completed.
A total of 44 patients consented to take part in the study (20 from the comparison area and 24 in the intervention area). A majority of the patients selected were diagnosed with some form of psychotic disorder, the term most frequently used by case managers was ‘schizophrenia’. A smaller number were reported to have a diagnosis of ‘bi-polar disorder’ or ‘psychotic depression’. They ranged in age from 17 to 70 years (mean = 38.5 years) and 27 were male.
The majority of patients (60%) were receiving conventional antipsychotic medication that was taken orally or by depot injection. The remainder (40%) were prescribed ‘atypical’ antipsychotics. The patients had been receiving antipsychotic medication for periods of between 4 months to 20 years. Twelve patients (27%) were receiving antipsychotic medication only, 9 (20%) were receiving antipsychotic and anticholinergic medication, 10 (23%) were receiving antipsychotic and either antidepressant or antianxiety agents, and 13 (30%) were receiving antipsychotic medication and some other medication (e.g. contraceptive pill, antacids).
Data collection
The Liverpool University Neuroleptic Side-effect Rating Scale (LUNSERS) is a 41-item, self-rating scale which requires respondents to indicate how much they experienced each of the side-effects listed in the last month. The LUNSERS has established reliability and validity [28,29]. Responses are scored on a five-point scale from 0 (not at all) to 4 (very much). The scale may be completed comfortably within 5–20 min, even by acutely disturbed patients, and that it ‘may be a useful tool for systematically eliciting side-effect information from patients, and as a brief and cost-effective measure of side-effects in research studies’ [28, p. 653].
In contrast to other scales designed to assess side-effects, the LUNSERS enables patients to report their experiences of side-effects. It is also in keeping with approaches to care which give credence to subjective patient responses [30]. In addition, in order to estimate the level of distress associated with each side-effect we superimposed a ‘distress’ scale on the questionnaire during the second LUNSERS survey. A very similar distress scale was also used by the authors of the LUNSERS [29].
Procedure
The majority of patients were seen at home, and a few were seen in their community mental health clinic or hospital. All participants were asked if they would like another person to be present when they completed the LUNSERS. With only a few exceptions, patients nominated to be on their own. Case managers were present on five occasions and in six instances, relatives were present. On every occasion, verbal directions about how to complete the scale (e.g. ‘place a tick in the appropriate box beside each question’), and reassurance that it was the patient's perception of how often each side-effect had occurred, were given by the researcher. Most patients completed the scale in 10 min. Seven patients asked the research assistant (a qualified psychiatric nurse) to complete the scale for them because of poor eyesight, impaired concentration or a sense of feeling ‘overwhelmed by the task’. Administration of the LUNSERS took place 2 months prior to the intervention training program and 2 months following.
Training program for case managers
The intervention consisted of two half-day experiential workshops. These were firmly grounded in the earlier phases of the study, which explored the experiences of case managers and patients. We were also acutely aware of the lack of assessment schedules that could be readily used by patients and case managers, the attitudes of professionals and the carer-patient relationship as potential restrictive factors in the assessment process. We elicited the help of a senior pharmacist, members of the Schizophrenia Fellowship and Association of Relatives and Friends of the Mentally Ill. A deliberate attempt to evoke attitudinal and behavioural change in case managers in a supportive, non-confrontational and participative manner was made. The main content areas and resources used are outlined in Table 1.
Summary of content and resources used in the training program
During the first day we focused on raising case managers' awareness of the problems associated with side-effects and the impact of these on patients' lives by drawing on the research literature and using research findings as a basis for group discussion. The session was also designed to enhance participants' understanding of the pharmacology of antipsychotic medications. We asked case managers about their current practice in relation to assessing for side-effects. Finally we reported findings from interviews we completed in an earlier component of the study with samples of patients (n = 10) and case managers (n = 9).
During the second day we introduced the LUNSERS and presented the findings from our first LUNSERS survey, which included the patients they provided for the study. Each case manager was given a copy of the LUNSERS and encouraged to use it in their practice. In addition, members of the Schizophrenia Fellowship and Association of Relatives and Friends of the Mentally Ill took part in a discussion group with case managers.
Finally, we provided participants with a list of all the side-effects described in the LUNSERS and used this to elicit potential strategies for managing each side-effect more effectively. A wide range of strategies was assembled. For example, ‘difficulty concentrating’ could be managed by some of the following: developing a structured routine; using a diary or notepad; telling others about the problem; breaking down tasks into smaller steps; using memory aides, cue cards and lists; choosing stimulating activities. While ‘tension’ could be managed through: the use of relaxation tapes, exercise, yoga, massage, hot baths, essential oils, avoiding stressful situations, and psychotherapeutic techniques. The complete array of potential strategies will be described fully in a future paper.
Our aim was to encourage case managers to apply the knowledge, skills and perspectives they were exposed to during the training program to their practice when dealing with patients experiencing neuroleptic side-effects. This was evaluated by collecting LUNSERS data from the patients in their care on two separate occasions (intervention group). In addition, we compared the results with LUNSERS data collected from patients whose case managers did not receive the educational intervention (comparison group).
Participants
Although only 24 case mangers were allocated to the intervention group, a total of 30 took part in the training program including 18 nurses, 8 social workers and 2 psychologists and 2 occupational therapists. Twenty-two individuals attended both sessions, another six attended the first, and two others were present for the second. Five of the eight who participated in a single workshop had not been formally recruited into the study and attended because of personal interest. Of the 22 who attended both parts of the training program, 13 (59%) had a nursing background. The remaining nine (41%) were from psychology, social work and occupational therapy. Of the 24 case managers who agreed to take part in the intervention program, 14 supplied 24 patients for the study. Ten of the case managers provided two patients each, the remaining four case managers provided one patient each from their respective caseloads.
Results
A comparison of side-effect prevalence between the intervention and comparison groups at pre- and postintervention is displayed in Table 2. The pattern in both groups is a positive one. The general trend observed in both groups over the first and second LUNSERS surveys was a reduction in the overall prevalence of side-effects. No statistical difference in total side-effect scores between the two groups was observed at the pre- and postintervention assessments. However, the patients attached to case managers who underwent training, reported a significant reduction in mean side-effect scores between the first and second LUNSERS surveys (Wilcoxon Matched Pairs Signed-ranks Test, z = −2.8411, two-tailed, p < 0.01).
Percentage prevalence of neuroleptic side-effects in comparison and intervention groups
In the postintervention assessments the prevalence of side-effects was reduced on 66% (27/41) of the LUNSERS items in the comparison group and 81% (33/41) in the intervention group. Increases occurred on 34% (14/41) and 12% (5/41) of the LUNSERS items in the respective groups.
Total distress scores were also calculated for each of the LUNSERS items. Not surprisingly, a highly significant correlation was found between the total side-effect score and total distress scores for the combined groups (Spearman's r = 0.905, p < 0.01).
After completing the second LUNSERS survey all patients were asked if case managers had suggested ways of dealing with side-effects since the completion of the first survey. There was a noticeable difference in responses to this question. In the comparison group, one patient replied that the case manager suggested that he ‘may need Valium’, while another case manager ‘referred the patient to the doctor’. No other positive strategies were elicited from the patients in this group.
In the intervention group, eight patients provided a range of potential strategies which they received from their case managers including: attending gym to combat weight gain; group discussion of side-effects; referral to a dietitian; deep breathing and relaxation tapes; referral to a psychologist to learn positive self-talk; diet change to reduce constipation; talked about excessive salivation; powder for itchy skin; case manager recommended Valium or Cogentin; imagery and relaxation; watching TV for distraction; gardening; rest periods in the day; and a referral to the doctor because of concerns about tongue movements. A number of these, such as references to changes in diet, exercise and relaxation were mentioned by several patients. The strategies were elicited from eight different patients distributed across six of the 12 case managers who took part in the training program and who provided patients for the study.
Discussion
It is clear that side-effects were prevalent across the two groups of patients in our sample and that these side-effects were distressing for patients. The literature indicates that case managers must attend to this problem area to improve the quality of life for patients and facilitate adherence to prescribed medication for those who need it. This small study indicates that it is possible to heighten case managers' awareness of the problem and enhance their assessment and management skills.
The overall reduction in side-effect prevalence across both groups is a positive result. The process of getting case managers and patients involved in the study may have heightened their awareness of the problem and the need to consider this area more carefully. Moreover, all patients may have developed a more positive disposition over the duration of the study because of the fact that ‘researchers’ were cognisant of the side-effect problem and were attempting to do something about it. This may provide patients with a sense of ‘hope’ for the future.
While these explanations may help to account for the general trend, they cannot fully explain the significant reduction in side-effects found in patients whose case managers attended the training program. The program also explored ways of managing side-effects more effectively and this may provide a rationale for the significant reduction in side-effects found in the intervention group. During the program, participants were asked to generate possible management strategies using the 41 side-effects described in the LUNSERS. This meant that those case managers who attended the training program had exposure: to people and issues which might elicit a more empathic attitude to patients with side-effects; an opportunity to review their own practice and personal limitations in this area; a practical tool for assessing side-effects which could be easily administered and used to monitor changes in side-effects; and positive strategies for managing side-effects.
The link between case managers' approaches to side-effects and prescribing patterns of the psychiatrists also need to be considered. An awareness of side-effects and better assessment techniques provide case managers with important clinical information which could be fed back to the psychiatrists who prescribe. This is a link in the approach to care and a long-term goal of training programs. The reduction in side-effects could have resulted from changes in the medication during the study. A small number of prescription changes were noted in both groups.
All antipsychotics were converted into chlorpromazine equivalents [31,32,33]. The profile of chlorpromazine equivalents at the first LUNSERS survey was 347.84 mg/day (SD, 230.47); the doses ranged from 30 to 800 mg/day with 53.5% of the sample prescribed < 300 mg. No significant differences were found between the first and second surveys.
The results from the intervention group, together with the qualitative reports on positive management strategies which emerged during the second LUNSERS survey, suggest that some case managers had begun to address the side-effect problem. This led to noticeable and positive changes in the side-effect profiles of patients.
The interest in the program and the feedback indicate that this model may suit busy practitioners. The focus on ‘real’ problems, provision of assessment and management strategies and participation of professionals, patients and carers in the program were all perceived positively.
Limitations
Selection was problematic because it depended on case managers, with limited time for research, to elicit interest in the patients. This meant that our sample was non-random and small (n = 44). The study was also limited to two health districts.
It was not possible to select patients receiving antipsychotics only. Many patients were already receiving other medications to counteract side-effects or to manage other medical or psychological problems and these too may have side-effects. This highlights problems patients face daily and presents a dilemma for researchers. No systematic differences in the class of medications used were observed between the two groups. However, the pattern of medications used by patients was similar to that reported in a large Australian study [34].
Limited resources did not allow us to complete a third LUNSERS survey to establish if improvements were maintained.
Conclusion
All case managers must assess and manage side-effects. Practically oriented, skills-based and short-term training programs, can be used by busy case managers to enhance practice and reduce prevalence of antipsychotic side-effects. The ability to deal with side-effects is a vital aspect of patient and carer education [35,36].
Footnotes
Acknowledgements
We thank the patients and staff who took part in or supported the study which was funded by the Pharmaceutical Education Program, Commonwealth Department of Health and Family Services (PEP Grant 172). We also thank Gayle Lawrence who collected the data.