Latrobe Regional Hospital, Traralgon Victoria, Australia
London School of Hygiene and Tropical Medicine, London, UK
Department of Human Services, Morwell, Victoria, Australia
London School of Hygiene and Tropical Medicine, London, UK
Correspondence: Dr Vikram Patel, Sangath Centre, 841/1 Alto Porvorim, Goa 403521, India. Fax: +91832 415244; E-mail: vikpat{at}goatelecom.com
Funding detailed in Acknowledgements.
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ABSTRACT |
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Aims To compare CBR with out-patient care (OPC) for schizophrenia in a resource-poor setting in India.
Method A longitudinal study of outcome in patients with chronic schizophrenia contrasted CBR with OPC. Outcome measures were assessed using the Positive and Negative Symptom Scale and the modified WHO Disability Assessment Schedule at 12 months.
Results Altogether, 207 participants entered the study, 127 in the CBR group and 80 in the OPC group. Among the 117 fully compliant participants the CBR model was more effective in reducing disability, especially in men. Within the CBR group, compliant participants had significantly better outcomes compared with partially compliant or non-complaint participants (P<0.001). Although the subjects in the CBR group were more socially disadvantaged, they had significantly better retention in treatment.
Conclusions The CBR model is a feasible model of care for chronic schizophrenia in resource-poor settings.
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INTRODUCTION |
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The mental health programme described here was initiated in partnership with Ashagram (village of hope), a non-governmental organisation working towards the rehabilitation of people affected by leprosy. Ashagram's facilities included a 30-bed general hospital, and physiotherapy, prosthetics and income-generation units. The initial focus of the mental health programme was on establishing out-patient facilities at Ashagram; however, preliminary analysis of service utilisation profiles suggested that out-patient care did not reach the most vulnerable sections of the population (Chatterjee & Chatterjee, 1999). To redress these limitations, an attempt was made to adapt the CBR model for use by people with chronic schizophrenia. The content of the intervention was shaped by consultation with patients, families and key persons in the community (further details available from the author upon request). The objective of the study was to compare the effectiveness of CBR with that of out-patient care in the treatment of people with chronic schizophrenia, and to test the hypothesis that CBR would produce superior clinical and disability outcomes compared with standard out-patient care.
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METHOD |
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Study design
A prospective study design was used which compared CBR and out-patient care
for a consecutive series of patients suffering from chronic schizophrenia.
Sample and measures
The recruitment period was from December 1997 to December 1998. The
inclusion criterion was a first presentation to the services with a diagnosis
of chronic schizophrenia. This diagnosis was established in both groups by a
psychiatrist (S.C.) after a clinical interview with the patient and family,
using the ICD10 criteria (World
Health Organization, 1992). Chronicity was defined as having
suffered from symptoms for at least 2 years prior to recruitment. The CBR
group comprised patients living in the designated programme area: this
consisted of 66 villages within the Barwani block, with an approximate
population of 98000. The out-patient care group consisted of patients living
outside the designated area. The purpose of the study was explained to
patients and their families and written informed consent for participation was
obtained. For those without reading skills, verbal informed consent was
obtained. The Positive and Negative Syndrome Scale (PANSS) for schizophrenia
(Kay et al, 1987),
which has been used in Indian settings (e.g.
McCreadie et al,
1996), was used as a measure of clinical symptoms. The World
Health Organization Disability Assessment Schedule (DAS), validated for use in
Indian settings (Thara et al,
1988), was used to assess social, occupational and behavioural
disabilities.
Intervention
The out-patient care model consisted of clinical services provided
exclusively at the clinic in Ashagram. After the initial assessment, patients
and families were usually seen once a month for follow-up. During these
sessions, ongoing drug treatment was reviewed and families were educated about
the illness, compliance and recognition of side-effects. Additionally,
rehabilitation strategies to enhance the patients' social and occupational
functioning were discussed. The CBR model used a three-tiered service-delivery
system. At the top was the out-patient care. The second tier employed mental
health workers drawn from the local community. After a 60-day training
programme they worked with patients, families and the local community in
providing services. Each of the mental health workers serviced five or six
contiguous villages and carried a case-load of 25-30 patients, including some
of the study participants. The third tier consisted of family members and key
people in the community who formed the local village health groups
(samitis). These groups were a forum for the members to plan relevant
rehabilitation measures and reduce social exclusion. Important differences
between the two models of care are summarised in
Table 1. All patients were
initially given antipsychotic medication, which in most instances was
risperidone (dosage range 2-8 mg); where the risk of non-compliance was
significant, depot anti-psychotic formulations were used. In addition, during
the ongoing reviews with the psychiatrist, adjunctive psychotropic agents were
prescribed according to clinical requirements.
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Outcomes
Outcomes were assessed at 12 months for all participants, except those in
the out-patient care group who had dropped out of care. Since members of their
group lived relatively further from Ashagram, it was not feasible to complete
these assessments. The primary outcome measures were the changes in PANSS and
DAS scores over 12 months; in both measures higher scores indicate increasing
clinical severity. Both sets of ratings (baseline and end-point) were
completed by an experienced psychiatrist (S.C.), who was not blind to the
allocation of participants to the intervention groups.
Analyses
Compliance was assessed as a summary measure based on an interview with the
patient and the patient's family at the 12-month review. Patients who had
taken their medication for the full 12 months were considered fully compliant;
those who had taken it for at least 9 months were considered partially
compliant and the remainder were non-compliant. Chi-squared tests for
difference in proportions were used to compare the distribution of baseline
variables between the CBR and out-patient care groups. Continuous variables
were assessed with either the t-test (age) or Wilcoxon rank sum test
(duration of illness). The effect of intervention group on change in score was
assessed by multiple linear regression, including factors that were
significantly different at baseline, and baseline value of the score, in the
model. Analyses were also stratified by gender. Statistical interaction
between gender and intervention group was assessed by including an interaction
term for these two variables in the linear regression model.
Intention-to-treat and treatment completer analyses were carried out. For the
treatment completer analysis two methods were used to estimate the score in
non-complaint patients in the out-patient care group. The first method (the
conservative scoring method) estimated the final score among non-compliant
patients to be the average score in partially compliant out-patient care
participants. The second method assumed that there was no change in score
among the non-compliant patients. This method is referred to as the
last observation carried forward (LOCF) approach
(Streiner, 2002). Finally,
outcomes for the compliant and partially or non-compliant participants were
compared in the CBR group.
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RESULTS |
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Comparison of outcomes
Group difference
Compliance was significantly better in the CBR group, where 80 patients
(63%) were fully compliant, compared with 37 (46%) in the out-patient care
group (P=0.02). The intention-to-treat comparison of outcomes using
the conservative scoring approach did not reach statistical significance after
adjustment for other confounders (Table
3). However, intention-to-treat analyses using the LOCF approach
showed significantly superior changes in score for each outcome among the CBR
group (P < 0.03; Table
3). Treatment completer analyses showed that clinical and
disability outcomes were superior for the CBR group; these differences reached
statistical significance for disability
(Table 4). The differences were
greater for men than for women, and there was evidence of a statistically
significant interaction with gender for PANSS positive scores
(P=0.03) and PANSS general scores (P=0.07).
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Compliance
There was no significant difference in age, economic status or gender
between the compliant and non-compliant participants in the CBR group;
clinical and disability measures at recruitment were also similar, except that
compliant patients had significantly lower PANSS general scores
(P=0.04). Compliant patients had significantly greater changes on all
measures, and this was true for both men and women
(Table 5).
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DISCUSSION |
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Limitations
This study was not a randomised controlled trial, but was the most feasible
design in the setting of an actual health service innovation in a remote
region. As a consequence, methodological problems such as the potential for
observer bias in the ratings could confound the interpretations made. Second,
there was no outcome evaluation for the non-compliant out- patient group owing
to logistic difficulties. For the intention-to-treat analysis comparing the
two interventions, we have used two ways of estimating the outcomes of the
missing participants: the LOCF and the conservative assumption that the
average end-point scores were the same as those of the partially compliant
group in out-patient care. The effect of the latter assumption is likely to
overestimate the true effect of the out-patient intervention, as partially
compliant patients are likely to have better outcomes than non-compliant
patients. The outcome measures used in the study were focused on clinical and
disability measures and did not measure changes in important social processes
such as social inclusion and stigma, nor other indicators such as violence and
self-harm. Finally, there is no estimation of the costs of each model of care.
Thus, the study is unable to answer the crucial question of the
cost-effectiveness of these two models, which is especially relevant in the
light of the fact that CBR is more resource-intensive.
Therapeutic strengths of CBR
The CBR method was more efficient in overcoming the economic, cultural and
geographical barriers and was more effective in retaining patients and their
families in the programme, as reflected in the significantly better compliance
rates. It is plausible to speculate that the mental health workers made a
significant contribution by providing a range of services at home. Being
members of the local community, they communicated effectively with patients
and families, using shared cultural idioms and thus promoting greater
adherence to treatment. The mental health workers worked closely with the
families and supported them in coping with the appropriate management of the
illness. Community-based rehabilitation relies on the engagement of
communities in the management of disability. Patients and their families were
empowered to become informed partners in the planning and implementation of
rehabilitation strategies that were ecologically feasible. The village
samitis provided broad-based local community support for the
programme and made a significant impact by generating a positive social milieu
that facilitated recovery. Compliance with prescribed medication and male
gender clearly emerged as important variables influencing outcome. Whereas the
former factor clearly points to the importance of the role of medication in
influencing outcomes, we can only speculate that gender-related social and
cultural factors could differentially influence the recovery process in men
and women. In addition, other ingredients of CBR such as the frequent review
process might have influenced the outcome.
Implications for service provision and research
This study has provided preliminary evidence that CBR is a feasible model
of rehabilitation for people with schizophrenia even in economically deprived
settings, and that outcomes are better, at least for those who are treatment
compliant. Since a lack of professional resources is the reality in rural
settings in India and other developing countries, the CBR method offers a
model which involves active local community participation and low levels of
technical expertise to deliver services. Mental health professionals can
contribute to enlarging the capacity of existing non-governmental
organisations that already operate in such areas to initiate services that
draw upon the resources of the community. Emphasising compliance with
medication may be a core element of the intervention strategy. In recognition
of the limitations of the study reported here, we would recommend a systematic
randomised controlled trial, in which communities are randomised into those
that receive CBR and those that do not, to study the critical therapeutic
ingredients and cost-effectiveness of the CBR model.
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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 April 19, 2002. Revision received August 29, 2002. Accepted for publication August 30, 2002.