| AimsTo provide integrated community-based mental health care for patients with schizophrenia,China launched the Community-based Program of Management and Treatment for Serious Mental Illness,known as the Community Management Service.Service receivers are mainly schizophrenic patients.According to the registration status,patients are divided into registered patients and unregistered patients.Among registered patients,patients are divided into registered patients receiving management,and registered patients without management based on whether receiving the management service or not.Efficacy evaluation is crucial for future comprehensive evaluation of the Program.However,though the community service has been implemented for more than ten years and has covered the whole the mainland of China,the effects of Community Management Service on patient-level outcomes remain unknown.The aims of the study were to(1)describe the prevalence of registration among patients with schizophrenia and the prevalence of management among registered patients,and to analyses factors associated with registration and management;(2)analyses the associations of Community Management Service with outcomes of schizophrenia patients,including symptoms,relapse,readmission,social function,employment status,quality of life,outpatient service utilization,medication compliance,stigma,and violent behavior,and to estimate potential effects of the Community Management Service on patient-level outcomes.Methods(1)A cross-sectional study design was used to describe the prevalence of registration and management,and analyses associated factors.Eligible participants were patients hospitalized with schizophrenia at the year of2019 in psychiatric specialty hospitals Guangzhou,Tianjin,and Hangzhou.Sociodemographic information,symptoms,severity of illness,onset of age,duration of illness,numbers of hospitalizations due to schizophrenia,violence,medical history,registration,and management status of the eligible patients were collected retrospectively from clinical records and System of Community Management Program.Registration was defined as being registered in the Program.Management was defined as receiving at least one service according to the records of the Program system.Descriptive analyses were employed to characterize participants.Mixed-effects logistic regression models,with a random effect for the city,were used to assess associations between factors above and registration and management.(2)A single-blind,multi-centered,mixed retrospective and prospective cohort study was used to evaluate the outcomes of patients receiving the Community Management Services.Affected by the COVID-19 epidemics last year,our research sites were only in Hangzhou and Guangzhou.The exposed group was registered patients who received Community Management Services.Patients who self-reported receiving at least one service during follow-up were classified as receiving Services.In theory,unregistered patients and registered patients without management composed the control group.But there were very few registered patients without management.Thus,unregistered patients were deemed as controls in the analyses.Considering the increasing registration rate by year,the number of unregistered patients continues to decrease.Thus,we decided to recruit unregistered patients first.Then,we matched one unregistered patient with two patients receiving management according to city,gender,and age(±3 years).203 unregistered patients who met inclusion and exclusion criteria were identified fr1096 unregistered patients at baseline.Then,research assistants invited them to participate in face-to-face interviews through telephone recruitment and recruitment from outpatient psychiatrists.93 patients agreed to participate in.There was no significant difference in the baseline characteristics between unregistered patients who completed the interview and unregistered patients who declined.Baseline data were from patients’ medical records in 2019.Sociodemographic information,age of onset,duration of untreated psychiatric illness(DUP),and outcomes including symptoms,relapse,readmission,social function,employment status,quality of life,outpatient visits,medication compliance,stigma,and violent behavior were collected via face-to-face interviews.The primary outcome was symptom,assessed using the Positive and Negative Syndrome Scale(PANSS),with higher scores indicating severer symptoms.The internal consistency of PANSS was satisfactory(Cronbach’s α= 0.80).Ten trained interviewers were blinded to the management status of patients.All patients were interviewed from March 2022 to January 2023,with a median follow-up period of 36.0months.Descriptive analyses including two-sample t-test,Wilcoxon rank-sum test,chi-square test,and Fisher’s exact test were employed to compare characteristics and outcomes of patients receiving management with patients without management.Multivariate regression models were used to estimate the potential effects of the Community Management Services on patients’ outcomes.Potential confounding variables were adjusted according to previous knowledge and univariate regression.Regression models were selected according to the specific data distribution of each outcome.Logarithmic transformations were used for PANSS and stigma with skewed distributions.For PANSS,social function,quality of life,and stigma,linear regression models were used.Logistic regression models were used for dichotomous variables,including employment status,relapse,readmission,and violent behavior.For count variables,including the number of outpatient visits,number of hospitalizations,number of relapses,and adherence,Poisson regression or negative binomial regression models were used.The statistical significance of possible effect modification was tested by adding a cross product interaction term to each regression model.Propensity score matching,propensity score adjustment,and regression excluding inpatients at the time of interview were performed as sensitivity analysis.Analyses were conducted using Stata statistical software version 17.0(Stata Corp)and SAS version 9.4,with statistical significance set at 0.05.Results(1)3993 patients hospitalized with schizophrenia were included in the analysis.The mean age was 38.8±14.8 years,and 53.7% were females.Among all patients,29.1% were from Hangzhou,29.3% from Tianjin,and41.6% from Guangzhou.1)The registration rate was 67.2%.Based on multivariable regression,male,unemployment,lower education,local hukou,longer duration of illness,violent behavior,more previous hospitalizations,and family history of suicide were associated with significantly higher odds of being registered.2)The prevalence of receiving management among 1935 registered patients were 88.9%.Males,unemployment,lower educational level,longer duration of illness,and more hospitalizations were associated with significantly higher odds of receiving management.(2)A total of 259 patients were included in the cohort study,including93 unregistered patients and 166 patients receiving management.There were no significant differences in gender,age,education level,marital status,family income,living situation,DUP,baseline symptoms,insights,severity of illness,family history,and antipsychotic medication at baseline.However,patients receiving management were less likely to be employed,with local Hukou,worse global improvement,more hospitalizations,more likely to have violent behaviors,earlier onset age,and longer duration of illness.1)Analysis of the primary outcome showed that median PANSS score in patients receiving management was significantly higher(58.0(45.0,70.0)vs.49.5(38.5,64.0),Z =2.910,P= 0.004).Adjusted for city,age,education,employment status at baseline,family income,Hukou,DUP,duration of illness,baseline symptoms,insights,severity of illness,and number of hospitalizations,result of the multivariate linear regression model showed no statistically significant difference in PANSS between patients receiving management or not(b=0.015,95%CI=-0.076,0.106,P=0.751).The results of sensitivity analysis using propensity score matching(b = 0.026,95%CI=-0.061,0.112,P=0.561),propensity score regression adjustment(b=0.023,95%CI=-0.077,0.122,P=0.655),and regression excluding inpatients at the time of interview were(b = 0.012,95%CI =-0.078,0.102,P=0.794)in agreement with the main analysis findings.However,among patients with primary school or below educational level,those receiving Community Management Services was observed to have lower PANSS(b=-0.401,95%CI=-0.710,-0.092,P=0.011).2)Analysis of the secondary outcome showed that patients receiving Management had more outpatient visits(IRR=1.140,95%CI=1.005,1.293,P=0.041),and higher odds of regular outpatient visits(OR=1.972,95%CI=1.096,3.551,P=0.024).Multivariate regression analysis showed that score of social function deficits was higher in patients receiving management(b=1.234,95%CI=0.001,2.466,P=0.050).But among patients with primary school or below educational level,those receiving Management tended to have less social function deficits.There were no significant associations between Management Service and relapse,readmission,employment,quality of life,medication compliance,violent behaviors,and internalized stigma.Conclusions(1)Albeit all inpatients with schizophrenia are required to be registered,we found that only approximately two-thirds of patients were registered in urban city.Male,patients with older age,and longer duration,patients with low socioeconomic status including being unemployed and less educated,and patients with violent behavior were more likely to be registered.Mental health services utilization will increase the probability of registration.However,patients without local hukou are less likely to be registered.Symptoms and severity of illness do not affect the registration.Most(88.9%)registered patients receiving Management.Male,patients with longer duration,being unemployment,with lower educational level were more likely to receiving Management.Mental health services utilization increases the possibility of management.The above findings suggested a gap between the current registration situation and the Program’s requirement.Therefore,in the future,standardization of the registration of patients should be strengthened,and the prioritization of patients with non-local hukou in cities should be considered.(2)The results of the study found that Community Management Service improved patients’ outpatient services utilization.However,we did not find evidence to support that the Service could improve symptoms,social function,or quality of life,prevent relapse or readmission,or reduce violent behavior among patients with schizophrenia in urban China.We also did not find that the Service could elevate internalized stigma.Although Community Management Service have established China’s first community-based mental health system,our findings suggested limited improvement in patient-level outcomes.Therefore,in the future,intensive intervention services,such as psychosocial intervention and intervention targeting medication adherence,should be considered based on existing services.(3)The results of the study found that patients receiving Community Management Services with lower educational level had less symptoms and better social functions,suggesting that Service may improve outcomes for patients with certain characteristics.Given the limited resources of community mental health services,future research should further identify patients who are more sensitive to Community Management Services to promote the rational allocation and utilization of resources and promote the optimization and improvement of the Program. |