Abstract
BackgroundStrict compliance with prescribed medication is the key to reducing relapses in schizophrenia. As villagers in China lack regular access to psychiatrists to supervise compliance, we propose to train village ‘doctors’ (i.e., villagers with basic medical training and currently operating in villages across China delivering basic clinical and preventive care) to manage rural patients with schizophrenia with respect to compliance and monitoring symptoms. We hypothesize that with the necessary training and proper oversight, village doctors can significantly improve drug compliance of villagers with schizophrenia.Methods/designWe will conduct a cluster randomized controlled trial in 40 villages in Liuyang, Hunan Province, China, home to approximately 400 patients with schizophrenia. Half of the villages will be randomized into the treatment group (village doctor, or VD model) wherein village doctors who have received training in a schizophrenia case management protocol will manage case records, supervise drug taking, educate patients and families on schizophrenia and its treatment, and monitor patients for signs of relapse in order to arrange prompt referral. The other 20 villages will be assigned to the control group (case as usual, or CAU model) wherein patients will be visited by psychiatrists every two months and receive free antipsychotic medications under an on-going government program, Project 686. These control patients will receive no other management or follow up from health workers. A baseline survey will be conducted before the intervention to gather data on patient’s socio-economic status, drug compliance history, and clinical and health outcome measures. Data will be re-collected 6 and 12 months into the intervention. A difference-in-difference regression model will be used to detect the program effect on drug compliance and other outcome measures. A cost-effectiveness analysis will also be conducted to compare the value of the VD model to that of the CAU group.Discussion/implicationsLack of specialists is a common problem in resource-scarce areas in China and other developing countries. The results of this experiment will provide high level evidence on the role of health workers with relatively limited medical training in managing severe psychiatric disease and other chronic conditions in developing countries.Trial registrationChiCTR-TRC-13003263.
Highlights
Strict compliance with prescribed medication is the key to reducing relapses in schizophrenia
Schizophrenia affects approximately 0.3% to 0.7% of people at some point in their lives [1], or 24 million people worldwide [2], accounting for an estimated 1.1% of global Disability-adjusted life year (DALY) and 2.8% of global Years lived with disability (YLD) [3]
Drug compliance Since chlorpromazine was introduced in 1952, antipsychotics have become the principal element of schizophrenia treatment, and compliance is key to reducing relapse
Summary
Schizophrenia affects approximately 0.3% to 0.7% of people at some point in their lives [1], or 24 million people worldwide [2], accounting for an estimated 1.1% of global DALYs (disability-adjusted life years) and 2.8% of global YLDs (years lived with disability) [3]. Case management and village doctors Community support services commonly available to psychiatric patients in developed countries include drop-in centers, visits by a community mental health team, facilitated employment [9] and support groups. VDs will receive antipsychotics from psychiatrists every two months, store the medications, manage schizophrenia cases by dispensing medications to patients and their family members every week or every day (both intervention strategies will be tested), counsel patients and family members about the importance of compliance, address concerns raised by patients and family members, and monitor patients for signs of disease and indications of non-compliance. The proposed study has important implications for improving the management of schizophrenia patients in over 100 communities enrolled in Project 686 in China, and will generate findings as to the effectiveness of involving low level health workers and family members in managing mental disorders common in rural China. Management: maintaining patient files; accompanying patients to bimonthly psychiatrist visits; storing and distributing antipsychotics; monitoring drug-taking; and monitoring patients for symptoms
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