Health Services Research Department, Institute of Psychiatry, De Crespigny Park, London
Health Services Research Department, Institute of Psychiatry, De Crespigny Park, London
Correspondence: Dr Richard Gray, PO 30, Health Services Research Department, Institute of Psychiatry, De Crespigny Park, London SE5 8AF. Tel: +44 (0)20 7848 0139; e-mail: R.Gray{at}iop.kcl.ac.uk
Declaration of interest The South London and Maudsley NHS Trust provided financial support.
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ABSTRACT |
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Aims To assess the effectiveness of a medication management training package for community mental health nurses (CMHNs) in improving compliance and clinical outcomes in patients with schizophrenia.
Method Pragmatic randomised controlled trial. Sixty CMHNs in geographical clusters were assigned randomly to medication management training or treatment as usual. Each CMHN identified two patients on their case-load who were assessed at baseline and again after 6 months by a research worker. The primary efficacy outcome of interest was psychopathology, measured using the Positive and Negative Syndrome Scale (PANSS).
Results Nurses who had received medication management training produced a significantly greater reduction in patients'overall psychopathology compared with treatment as usual at the end of the 6-month study period (change in PANSS total scores: medication management -16.62, treatment as usual 1.17; difference -17.79; 95% CI -24.12 to -11.45; P<0.001).
Conclusions Medication management training for CMHNs is effective in improving clinical outcomes in patients with schizophrenia.
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INTRODUCTION |
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METHOD |
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Community mental health nurses
We sent written invitations to CMHNs working in two mental health care
providers in London, inviting them to participate. The CMHNs were accepted
into the trial if they were registered nurses and had at least 12 months of
post-registration experience. Once accepted into the trial each CMHN
identified two patients on their case-load who satisfied the
inclusion/exclusion criteria. The CMHNs were aware of which group they had
been allocated to when identifying appropriate patients.
Patients
Patients who were prescribed antipsychotic medication with a recorded
ICD-10 diagnosis of schizophrenia or schizoaffective disorder
(World Health Organization,
1992) were invited to participate in the study if they were over
18 years of age with known or suspected poor treatment compliance (reported by
the CMHN) or who had, within the previous 12 months, at least one admission or
relapse. Patients were excluded at screening if they had a diagnosis of
moderate or severe learning disabilities or organic brain disorders concurrent
with schizophrenia, were being treated by forensic psychiatric services (or
posed a current or serious risk of suicide or homicide) or were in-patients at
the start of the trial. Other exclusion criteria included pregnancy (or a
likelihood of becoming pregnant), lactation and alcohol/substance dependence.
Local ethics committees approved the study and patients gave oral and written
informed consent to participate.
Study design
This was a pragmatic 26-week, randomised, single-blind controlled study
conducted in London, UK. The CMHNs were organised into 12 clusters (five CMHNs
per cluster) based on the geographical location of the community mental health
team or general practitioner surgery where they were based. The trial was
staggered over three phases with 20 CMHNs (four clusters) in each phase.
Randomisation sequences were prepared prior to the start of the trial and kept
in opaque sealed envelopes. Clusters were randomised, at the start of each of
the three phases of the trial, to receive 80 h of medication management
training or to continue with treatment as usual. Patients completed a battery
of self-report and research-worker-rated outcome measures at baseline and
again after 26 weeks (Fig. 1).
The research workers were masked to whether the nurse was in the training or
treatment as usual group. Nurses were told not to discuss any aspect of their
training allocation with the rater. All patients were seen either in their own
home or in an out-patient clinic.
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Training and fidelity
Medication management training consisted of 80 h of teaching delivered on a
day-release basis over 10 weeks. Training focused on teaching CMHNs the
compliance therapy approach detailed in a treatment manual
(Kemp et al, 1997).
Additionally, the programme included training in the use of a range of
standardised measures to assess the side-effects of medication and patients'
beliefs and feelings about treatments, and a psychopharmacology component that
considered effective treatment strategies for schizophrenia and the management
of common side-effects. A multidisciplinary team that included clinical nurse
specialists, psychologists and psychiatric pharmacists provided the training.
The cost of training each CMHN was estimated at £1474. A detailed
training manual is available from the authors upon request.
We have reported elsewhere (Gray et al, 2003) that training resulted in significant improvements in clinical skills. Performance on a role-play task was rated independently using the Cognitive Therapy Scale (CTS; Vallis et al, 1986) both pre- and post-training. A score of 30 indicates satisfactory clinical skills. The mean pre-training score was 13.9. Following training CTS total scores improved significantly (mean 30.6, P<0.01). Nurses who attended training also reported a high degree of satisfaction and clinical applicability.
Outcome measures
All patient interviews were performed by one of two research workers (R.G.
and Sara Dickson, see Acknowledgements) masked to the training condition. Both
researchers attended a 1-day training workshop in administering and reliably
rating the Positive and Negative Syndrome Scale (PANSS;
Kay et al, 1989) and
obtained a satisfactory level of interrater reliability.
Primary outcome measure
Positive and Negative Syndrome Scale
The PANSS is a widely used measure for evaluating the symptoms of
schizophrenia in clinical trials of both pharmacological and psychological
interventions. Thirty items are rated on a seven-point scale following the
general format of the Brief Psychiatric Rating Scale
(Overall & Gorham, 1962).
The PANSS has strict operational criteria for conducting a 30-40 min patient
interview, thorough definitions for all 30 items and detailed rating criteria
for each level of psychopathology (Kay
et al, 1989). The measure has established interrater,
test-retest and internal reliability, and internal, external and construct
validity (Kay et al,
1989). A ten-point reduction in PANSS total scores would represent
a clinically important training effect.
Secondary outcome measures
Three further scales were used to assess efficacy; the Hogan Drug Attitude
Inventory (DAI-30; Hogan et al,
1983), the Clinician Rating of Compliance Scale
(Kemp et al, 1998)
and the Liverpool University Neuroleptic Side Effect Rating Scale (LUNSERS;
Day et al, 1995). The
DAI-30 is a 30-item self-report measure predictive of compliance in people
with schizophrenia. Each item is rated by the patient as being true or false
and produces a total score ranging from +30 to -30. A positive score is
predictive of compliance and a negative score is predictive of non-compliance.
The Clinician Rating of Compliance Scale is an observer rating of compliance
on a seven-point scale ranging from 1 (complete refusal) to 7 (active
participation in treatment). The LUNSERS is a self-report measure of the
side-effects of antipsychotic medication. Forty-one items cover psychological,
neurological, autonomic, hormonal and miscellaneous side-effects. Each item is
rated on a five-point scale ranging from not at all to
very much, based on how frequently the patient has experienced
the side-effect in the preceding month.
Additional patient information
Patients' age, gender, ethnicity, diagnosis and duration of illness were
collected from the patients' medical notes at the baseline assessment and
confirmed with the patient at interview. All the medication that patients were
prescribed on the day of assessment was recorded. The dose of antipsychotic
medication was converted to chlorpromazine equivalents using the World Health
Organization's Anatomical Therapeutic Chemical Classification
(World Health Organization,
1993). We also observed for any serious or unexpected adverse
events throughout the trial, including death or attempted suicide.
Nurse information
Nurses completed a brief questionnaire detailing their age, gender,
ethnicity, clinical and academic experience, grade and case-load.
Statistical analyses
A sample size of 120 patients (and therefore 60 CMHNs) was chosen to
determine the effect of medication management training on the clinical outcome
of patients with schizophrenia. Power calculations suggested that to detect a
ten-point difference in PANSS total scores, assuming a standard deviation of
12.4 (Gray, 2001), 120 patients
should be recruited to give an 80% power at a significance level of 5%,
allowing for drop-out of 20%. Our power analysis did not allow for clustering
of patients. Retrospectively it would have been preferable in principle to
have allowed for this through the variance inflation factor. In fact, the
observed intraclass correlation within clusters was very low and therefore any
underestimate of power would have been negligible.
Data were analysed initially using the Statistical Package for the Social Sciences Version 11 for Windows to compare the randomised groups of nurses and patients at baseline. The distributions of the outcome variables were approximately normal at baseline. Differences between the two groups at baseline and after intervention are reported with confidence intervals (but not the estimate of the intervention effect) adjusted for the effect of clustering. This is achieved by applying the variance inflation factor based on the intraclass correlation to the within-group standard errors (Donner & Klar, 2000). This also allows a simple adjustment to the standard t-test and is implemented in the clttest routine in Stata version 7 for Windows. The effects of the intervention are reported as change scores. Sensitivity checks were performed on all significant findings by performing a mixed effect regression (using the xtreg-mle procedure), controlling for baseline level, age, gender and ethnic group and allowing for clustering at geographical and CMHN cluster level separately.
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RESULTS |
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Sample of patients
The CMHNs identified 89 patients to take part in the study
(Fig. 1). At trial entry, seven
were excluded because they did not satisfy the inclusion/exclusion criteria:
five were not diagnosed with schizophrenia or schizoaffective disorder and two
were not on the case-load of the CMHN who referred them. Of the 82 who were
eligible to take part, three refused to participate, two withdrew their
consent and five did not complete the baseline assessment. Seventy-two
patients gave written consent and entered the study, which is a mean of 1.4
per CMHN. The patients who entered the trial
(Table 2) were similar to
populations of patients with schizophrenia in other trials of compliance
interventions (Kemp et al,
1998). The two groups were comparable in terms of demographic
features, duration of illness, age at illness and number of admissions.
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Follow-up assessment
All CMHNs who entered the trial completed training (i.e. attended >80%
of the course). Of the 72 patients who entered the trial 53 (74%; 29 in the
training group and 24 in the treatment-as-usual groups;
Fig. 1) were assessed on the
primary outcome measure (PANSS total) at the trial end-point. Eleven refused
to be interviewed but did not withdraw consent, five were not available for
interview, two had moved away and one could not be traced. There was no
evidence for differential drop-out. For those who were missing at follow-up,
the PANSS total baseline score was similar in both groups (training=68.5
v. treatment as usual=67.7).
Medication dosage
The dose of antipsychotic medication prescribed for the duration of the
trial was stable in both groups. At baseline there was no significant
difference between the two groups in the mean dose of antipsychotic medication
(in chlorpromazine equivalents) prescribed (training=400 mg/day v.
treatment as usual=469 mg/day). There was also no evidence for a difference in
the proportion of patients prescribed atypical antipsychotics (training
n=6 v. treatment as usual n=8). At the trial
end-point there had been no significant changes between the groups in the dose
of antipsychotic medication prescribed (training=307 mg/day v.
treatment as usual=379 mg/day) or the proportion prescribed atypicals
(training n=3 v. treatment as usual n=6).
Efficacy outcomes
Baseline scores (Table 2)
were indicative of moderate levels of schizophrenic symptoms, and ambivalence
about the need for taking-medication. The LUNSERS scores suggested that
patients were experiencing a moderate number of side-effects from
antipsychotic medication. Although patients in the intervention group tended
to have more symptoms, lower compliance and more side-effects than those in
the treatment-as-usual group, the differences were not statistically
significant.
Statistically significant improvements were seen in the medication management training group compared with the treatment-as-usual group (Table 3) in overall psychopathology (PANSS total), attitudes towards antipsychotic medication (DAI-30) and compliance. No significant differences between the groups were seen in patients' antipsychotic side-effects. The sensitivity analyses adjusting for both cluster effects and confounders showed very similar results, with a slight attenuation of the effect for the PANSS total score (mean difference=16.1). Clinically significant improvements in psychopathology (defined as an improvement of at least 30%) were seen in 6 of the 29 patients in the medication management group but in none of the 24 in the treatment-as-usual group.
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Safety assessments
Relapse was defined as a 30% or more increase in PANSS total scores. None
of the patients in the training group and one in the treatment-as-usual group
experienced a relapse during the trial. There were no patient deaths during
the trial and no attempted suicides.
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DISCUSSION |
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Community mental health nurses
The CMHNs provide much of the day-to-day care for people with schizophrenia
and they are ideally placed to deliver compliance therapy. In this trial the
demographic characteristics of CMHNs were comparable with those in the
national census, suggesting that they were representative of those currently
practising in the UK. The only important difference was that CMHNs were from a
more diverse ethnic background. However, this would be anticipated, given that
the study was carried out in south London where the population is more
ethnically diverse. The training and treatment-as-usual groups were generally
well matched.
Patient population
People with schizophrenia are often non-compliant with antipsychotic
medication, resulting in increased levels of psychopathology or relapse. The
baseline demographic and clinical data from this study underscore this
observation. In an apparently stable population prescribed fairly high doses
of antipsychotic medication, patients were experiencing moderately severe
levels of psychopathology. Scores on the DAI-30 suggested that patients were
ambivalent about taking medication and ratings on the clinician rating of
compliance indicated that they questioned the need to take medication.
Participants in this trial were representative of patients living in the
community managed by CMHNs.
Medication management training efficacy and safety
This study demonstrated that medication management training for CMHNs is
effective in improving clinical outcomes in people with schizophrenia over a
26-week period. The primary efficacy measure (PANSS total) showed
statistically significant improvements compared with treatment as usual at the
week 26 assessment. Significant improvements were observed also in patients'
attitudes towards treatment (DAI-30) and compliance (clinician rating)
compared with treatment as usual. However, there were no improvements in
medication side-effects (LUNSERS total). The improvements in patients'
attitudes towards treatment and compliance are consistent with the original
compliance therapy trial (Kemp et
al, 1998) and suggest that medication management training
equips CMHNs with the skills that they need to be effective in delivering
compliance therapy. However, anticipated improvements in antipsychotic
side-effects were not realised. Medication management training was acceptable
to patients and did not result in any unexpected findings with regard to
safety.
Methodological considerations
The proportion of patients for whom complete data were not available was
high (26%) but below the average rate of 33% reported in a systematic review
of dropout in published randomised trials with this patient population
(Wahlbeck et al,
2001). The large number of patients dropping out of the trial may
be explained by the nature of the disorder: patients are chaotic, they miss
appointments and are often distrustful of strangers. The study may have
benefitted from a comparison with an inert training intervention that would
allow for training time to be controlled. However, it would be unethical and
expensive to provide training that was of no real benefit to CMHNs. In this
study we used self-report (DAI-30) and clinician ratings of compliance. These
measures have been criticised because they may introduce observer bias.
However, direct methods such as electronic monitoring were impractical and
costly and, in any case, also can be subject to bias. Patients were followed
up for a relatively short (6-month) period. It would be important to examine
whether the improvements observed are maintained over a longer period of time
or whether the effects of training begin to degrade. Allowing CMHNs to
identify patients for inclusion in the trial after randomisation may have
introduced the potential for selection bias. This is suggested by the baseline
differences, even though they are non-significant. Recruiting patients who
satisfied the inclusion/exclusion criteria randomly from CMHNs case-loads
could have addressed this.
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Clinical Implications and Limitations |
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LIMITATIONS
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ACKNOWLEDGMENTS |
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REFERENCES |
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Received for publication September 16, 2003. Revision received January 29, 2004. Accepted for publication February 14, 2004.
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