Outcomes During and After Early Intervention Services for First-Episode Psychosis: Results Over 5 Years From the RAISE-ETP Site-Randomized Trial.

To examine long-term effects of early intervention services (EIS) for first-episode psychosis, we compared Heinrichs-Carpenter Quality of Life (QLS) and Positive and Negative Syndrome Scale (PANSS) scores and inpatient hospitalization days over 5 years with data from the site-randomized RAISE-ETP trial that compared the EIS NAVIGATE (17 sites; 223 participants) and community care (CC) (17 sites; 181 participants). Inclusion criteria were: age 15-40 years; DSM-IV diagnoses of schizophrenia, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, or psychotic disorder not otherwise specified; first psychotic episode; antipsychotic medication taken for ≤6 months. NAVIGATE-randomized participants could receive NAVIGATE from their study entry date until NAVIGATE ended when the last-enrolled NAVIGATE participant completed 2 years of treatment. Assessments occurred every 6 months. 61% of participants had assessments conducted ≥2 years; 31% at 5 years. Median follow-up length was CC 30 months and NAVIGATE 38 months. Primary analyses assumed data were not-missing-at-random (NMAR); sensitivity analyses assumed data were missing-at-random (MAR). MAR analyses found no significant treatment-by-time interactions for QLS or PANSS. NMAR analyses revealed that NAVIGATE was associated with a 13.14 (95%CI:6.92,19.37) unit QLS and 7.73 (95%CI:2.98,12.47) unit PANSS better improvement and 2.53 (95%CI:0.59,4.47) fewer inpatient days than CC (all comparisons significant). QLS and PANSS effect sizes were 0.856 and 0.70. NAVIGATE opportunity length (mean 33.8 (SD = 5.1) months) was not associated (P = .72) with QLS outcome; duration of untreated psychosis did not moderate (P = .32) differential QLS outcome. While conclusions are limited by the low rate of five-year follow-up, the data support long-term benefit of NAVIGATE compared to community care.

Psychopharmacological Treatment in the RAISE-ETP Study: Outcomes of a Manual and Computer Decision Support System Based Intervention.

OBJECTIVE: The Recovery After an Initial Schizophrenia Episode-Early Treatment Program compared NAVIGATE, a comprehensive program for first-episode psychosis, to clinician-choice community care over 2 years. Quality of life and psychotic and depressive symptom outcomes were found to be better with NAVIGATE. Compared with previous comprehensive first-episode psychosis interventions, NAVIGATE medication treatment included unique elements of detailed first-episode-specific psychotropic medication guidelines and a computerized decision support system to facilitate shared decision making regarding prescriptions. In the present study, the authors compared NAVIGATE and community care on the psychotropic medications prescribed, side effects experienced, metabolic outcomes, and scores on the Adherence Estimator scale, which assesses beliefs related to nonadherence. METHOD: Prescription data were obtained monthly. At baseline and at 3, 6, 12, 18, and 24 months, participants reported whether they were experiencing any of 21 common antipsychotic side effects, vital signs were obtained, fasting blood samples were collected, and the Adherence Estimator scale was completed. RESULTS: Over the 2-year study period, compared with the 181 community care participants, the 223 NAVIGATE participants had more medication visits, were more likely to receive a prescription for an antipsychotic and more likely to receive one conforming to NAVIGATE prescribing principles, and were less likely to receive a prescription for an antidepressant. NAVIGATE participants experienced fewer side effects and gained less weight; other vital signs and cardiometabolic laboratory findings did not differ between groups. Adherence Estimator scores improved in the NAVIGATE group but not in the community care group. CONCLUSIONS: As part of comprehensive care services, medication prescription can be optimized for first-episode psychosis, contributing to better outcomes with a lower side effect burden than standard care.

Hospitalization Risk Before and After Employment Among Adults With Schizophrenia, Bipolar Disorder, or Major Depression.

OBJECTIVE: The influence of employment on subsequent psychiatric hospitalization for people with serious mental illness is unclear. This study examined whether unemployed people with serious mental illness were more or less likely to experience psychiatric hospitalization after gaining employment. METHODS: A secondary analysis was conducted of data from the Mental Health Treatment Study. Two years of prospective employment and psychiatric hospital outcomes were examined for 2,055 adults with schizophrenia, bipolar disorder, or major depression. The analyses examined associations between employment and psychiatric hospitalization via multilevel regression by using time-lagged modeling. RESULTS: Employment was associated with a lower subsequent three-month risk of psychiatric hospitalization (odds ratio=.65, 95% confidence interval=.50-.84) after the analysis adjusted for baseline characteristics, including previous psychiatric hospitalizations and self-reported physical health. CONCLUSIONS: Unemployed outpatients with serious mental illness were less likely to experience psychiatric hospitalization after gaining employment.

Comprehensive Versus Usual Community Care for First-Episode Psychosis: 2-Year Outcomes From the NIMH RAISE Early Treatment Program.

OBJECTIVE: The primary aim of this study was to compare the impact of NAVIGATE, a comprehensive, multidisciplinary, team-based treatment approach for first-episode psychosis designed for implementation in the U.S. health care system, with community care on quality of life. METHOD: Thirty-four clinics in 21 states were randomly assigned to NAVIGATE or community care. Diagnosis, duration of untreated psychosis, and clinical outcomes were assessed via live, two-way video by remote, centralized raters masked to study design and treatment. Participants (mean age, 23) with schizophrenia and related disorders and ≤6 months of antipsychotic treatment (N=404) were enrolled and followed for ≥2 years. The primary outcome was the total score of the Heinrichs-Carpenter Quality of Life Scale, a measure that includes sense of purpose, motivation, emotional and social interactions, role functioning, and engagement in regular activities. RESULTS: The 223 recipients of NAVIGATE remained in treatment longer, experienced greater improvement in quality of life and psychopathology, and experienced greater involvement in work and school compared with 181 participants in community care. The median duration of untreated psychosis was 74 weeks. NAVIGATE participants with duration of untreated psychosis of <74 weeks had greater improvement in quality of life and psychopathology compared with those with longer duration of untreated psychosis and those in community care. Rates of hospitalization were relatively low compared with other first-episode psychosis clinical trials and did not differ between groups. CONCLUSIONS: Comprehensive care for first-episode psychosis can be implemented in U.S. community clinics and improves functional and clinical outcomes. Effects are more pronounced for those with shorter duration of untreated psychosis.

Comparison of outcomes for African Americans, Hispanics, and Non-Hispanic Whites in the CATIE study.

OBJECTIVE: Medication outcome literature in schizophrenia across racial-ethnic groups is sparse, with inconsistent findings. The Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) study provided an opportunity for exploratory analyses of racial-ethnic outcomes. The study objective was to examine race-ethnicity outcomes for CATIE's main outcome (study discontinuation) and secondary outcomes. METHODS: CATIE participants included whites (non-Hispanic) (N=722), African Americans (N=506), and Hispanics (N=170). Survival analyses and mixed-effects regression modeling were conducted, with adjustment for baseline sociodemographic differences and baseline scores of the secondary outcomes. RESULTS: Racial-ethnic groups had unique patterns of outcomes. Hispanics were much more likely to discontinue for lack of efficacy from perphenazine (64% versus 42% non-Hispanic whites and 24% African Americans) and ziprasidone (71% versus 40% non-Hispanic whites and 24% African Americans); Hispanics' quality of life also declined on these medications. Non-Hispanic whites were more likely to discontinue for lack of efficacy in general (averaging olanzapine, quetiapine, and risperidone discontinuation rates). African Americans were less likely to continue after the first phase (32% continuing versus 40% for non-Hispanic whites and 41% Hispanics). Discontinuations were driven by research burden, personal issues, and unspecified loss to follow-up. Non-Hispanic whites had higher depression scores during the follow-up period. African Americans had fewer side effects. CONCLUSIONS: CATIE results did not show disparities favoring non-Hispanic whites. CATIE may have provided state-of-the-art treatment and thus reduced disparate treatments observed in community clinics. African Americans discontinued even after consideration of socioeconomic differences. Why perphenazine and ziprasidone may be less effective with Hispanics should be explored.

A case control study of the implementation of change model versus passive dissemination of practice guidelines for compliance in monitoring for metabolic syndrome.

We developed an intervention to improve compliance with guidelines for monitoring metabolic syndrome and compared compliance prior to intervention and three times post-intervention at three community mental health clinics in Texas. One test clinic received intervention and two other clinics served as controls. Fifty random charts were reviewed from each clinic for three specific, 1-2 weeks periods over the course of 18 months. There were significant improvements in the ordering of labs, the presence of lab results in the chart, and documentation of blood pressure, body mass index and waist circumference in the intervention clinic over time in comparison to the control clinics. Documented evidence of physician action with respect to out of range values remained low. Metabolic monitoring is a multi-step process. Removing barriers, creating specific procedures, and dedicating staff resources can improve compliance with monitoring.

Can medication management coordinators help improve continuity of care after psychiatric hospitalization?

OBJECTIVE: This demonstration project examined whether medication management coordinators enhanced continuity of care from inpatient facilities to an outpatient public mental health clinic. METHODS: From 2004 to 2008, patients (N=325) hospitalized with schizophrenia or schizoaffective or bipolar disorder enrolled in a medication management program before discharge or at their first clinic appointment. Medication management coordinators supplemented existing clinic practices by identifying recently hospitalized patients, providing inpatient and outpatient prescribing clinicians with patients' complete medication history, meeting with patients for six months postdischarge to assess clinical status and provide medication education, and advocating guideline-concordant prescribing. Recently discharged patients (N=345) assigned to a different outpatient clinic within the same agency served as the comparison group. Intent-to-treat, repeated-measures analyses for mixed models compared the groups' number of hospital admissions, hospital days, and medication appointments kept and use of nurse or case manager contact hours and emergency or crisis services during the 12 months before enrollment, the six-month intervention, and the six-month follow-up period. RESULTS: After discharge, individuals enrolled in medication management were more likely than comparison patients to attend outpatient appointments, and they had more medication visits and nurse or case manager treatment hours than the comparison group. Use of hospital and crisis or emergency services by all patients decreased. Almost one-third of patients never attended an outpatient appointment after hospital discharge. CONCLUSIONS: Although this program succeeded in improving continuity of care, additional interventions may be required to reduce rehospitalization and crisis care.

Community mental health agency views of research.

We examined community mental health center staff perceptions of ongoing research within their agency. We interviewed upper management and conducted focus groups with medical staff, non-medical clinicians, and administrative staff. Participants were asked about (1) their attitudes towards research in general, agency research and towards the principal academic institution doing research with clients, (2) their perceptions of the value of research and (3) ideas for improving the collaboration. We identified 5 overarching themes: inter-agency communication, shared goals and equality in research, researchers adding knowledge to the agency, improving attitudes toward research, and agency involvement in research. Under these domains, specific suggestions are made for how to improve the collaboration across all stakeholder groups. Lack of shared values and inadequate communication processes can negatively impact community-based research collaborations. However, clear strategies, and adequate resources have great potential to improve community mental health collaborations.

Interrater reliability of using brief standardized outcome measures in a community mental health setting.

OBJECTIVE: Given psychiatry's need to implement measurement-based care, the study examined whether direct-care staff could reliably administer brief positive and negative symptom instruments to track symptom changes and inform clinical decision making. METHODS: Raters (82 case managers) were assessed at baseline. Training was provided for individuals not meeting reliability criteria. These individuals were reassessed to determine the effect of training. In addition, rater drift was assessed for raters judged to be reliable at baseline. RESULTS: Seventy-seven percent of direct-care staff met criteria for reliability either at baseline or after they received additional training. CONCLUSIONS: A majority of direct-care staff can be trained to reliability on brief scales of positive and negative symptoms that can be used to guide clinical decision making.

Association of clinical symptoms and neurocognitive performance in bipolar disorder: a longitudinal study.

OBJECTIVE: Despite evidence that individuals with bipolar disorder have neurocognitive impairment that persists during euthymia, the impact of changes in affective symptoms on cognitive function has not been well established. Here, we sought to determine whether specific neurocognitive functions are sensitive to mood changes in individuals with bipolar disorder assessed three months apart without changes in treatment regimen. METHODS: A total of 29 individuals with DSM-IV bipolar disorder and 30 healthy controls participated in the study. All participants received a comprehensive neuropsychological assessment and ratings of depressive [Hamilton Depression Rating Scale (HAMD)] and manic [Young Mania Rating Scale (YMRS)] symptoms at baseline and follow-up. Changes in symptoms over time were calculated and were examined in relation to changes in neurocognitive performance. RESULTS: At baseline, clinically stable but symptomatic patients were impaired on measures of speed of processing and attention. Over the three-month follow-up period, HAMD scores changed by 6 points on average [range: -10 to +18] and YMRS scores changed by 5.31 points on average [range -11 to +15]. Changes in depressive symptoms were correlated with poorer verbal fluency, while no relationship between manic symptoms and neuropsychological performance was detected. CONCLUSIONS: Individuals with bipolar disorder showed consistent impairment on speed of processing and attention over time, despite significant changes in mood.

Factors in second-generation antipsychotic switching patterns in a national sample of older veterans with schizophrenia.

OBJECTIVE: A 2004 consensus statement by the American Psychiatric Association and other groups noted that metabolic side effects of second-generation antipsychotics require monitoring. To reduce risk, prescribers may consider factors differentially associated with development of metabolic abnormalities, such as age, gender, and race-ethnicity. As part of a study of older patients with schizophrenia (50-102 years), this study evaluated factors associated with antipsychotic switches and switches that incurred a greater or lesser metabolic risk. METHODS: Administrative data were analyzed for a national cohort of 16,103 Veterans Health Administration patients with schizophrenia receiving second-generation antipsychotics. Multinomial logistic regression predicted the likelihood of switches from 2002 to 2003 and again from 2004 to 2005. RESULTS: At baseline nearly half the patients (45%) had a diagnosis of hypertension, a third (34%) had dyslipidemia, and 15% had a diagnosis of obesity. In both periods diabetes was associated with switches to lower-risk antipsychotics, and older patients were likely to experience neutral or no switches. Women were more likely to experience switches to higher-risk antipsychotics in 2004-2005. CONCLUSIONS: General medical conditions potentially associated with antipsychotic-related metabolic concerns were common; however, half of these patients were prescribed medication that made them liable to developing metabolic problems. Modest evidence suggests that metabolic considerations became a higher priority during the study. Future research should investigate the differential impact of antipsychotics on metabolic dysregulation for women and elderly patients. Findings underscore the need to monitor metabolic parameters of older patients taking antipsychotics.

Medication adherence, ethnicity, and the influence of multiple psychosocial and financial barriers.

Medication adherence is critical for patients with bipolar disorder to avoid symptom exacerbation and diminished quality of life. Most analyses consider adherence barriers individually rather than conjointly, while neglecting potential ethnic differences. 435 patients in the Continuous Improvement for Veterans in Care--Mood Disorders study reported multiple financial and psychosocial factors influencing adherence. Logistic regression modeled adherence as a function of perceived barriers, including cost burden, access, binge drinking, poor therapeutic alliance, and medication beliefs. Nearly half the cohort experienced adherence difficulty, averaging 2.8 barriers, with minority veterans reporting lower adherence than white patients, particularly financial burden and treatment access. Total barriers were significantly associated with worse adherence (OR = 1.24 per barrier), notably poor medication beliefs, binge drinking, and difficulty accessing psychiatric specialists (ORs of 2.41, 1.95 and 1.73, respectively). Veterans with bipolar disorder experience numerous adherence barriers, with certain obstacles proving especially pernicious. Fortunately tailored clinical interventions can improve adherence, particularly by addressing modifiable risk factors.

Prediabetes assessment and follow-up in older veterans with schizophrenia.

OBJECTIVES: Assess glycemic monitoring and follow-up. DESIGN: Retrospective study using administrative data (October 2001-September 2005). SETTING: Veterans Health Administration. PARTICIPANTS: A nationwide sample of 39,226 outpatients aged 50 years or older with schizophrenia. Patients had no diagnosis or medications for diabetes at baseline. MEASUREMENTS: Hemoglobin A1c tests; blood glucose tests with same-day low-density lipoprotein to approximate fasting glucose. Glycemic tests were combined to indicate a) prediabetic dysglycemia (100-125 mg/dL proxy fasting glucose or 5.8%-6.4% hemoglobin A1c) and b) diabetic dysglycemia (≥126 proxy fasting glucose or ≥6.5% A1c). RESULTS: Approximately one-third of patients (32%; 12,587) had proxy fasting blood glucose or A1c tests in 2002; multiple tests were rare. The proportion tested increased to 40% by 2005. Test results suggested prediabetic dysglycemia for 5,345 tested patients (42% of those tested) and diabetic dysglycemia for 1,287 tested patients (10%) at baseline. In multivariate regression models, glycemic testing was associated with dyslipidemia, hypertension, and younger age. Dysglycemia was associated with hypertension, dyslipidemia, and older age. Follow-up treatment/diagnosis of diabetes occurred for 8% of patients (11% of those tested) and was associated with baseline dysglycemia, hypertension, and younger age. Mortality (15% during the 4-year study) was higher among untested and untreated patients. CONCLUSIONS: Dysglycemia was prevalent among older patients with schizophrenia, although monitoring and follow-up were uncommon. Follow-up treatment correlated with survival. Despite evident utility of testing, few at-risk patients with schizophrenia were adequately monitored, diagnosed, or treated for dysglycemia.

Public-academic partnerships: tools for mental health agencies to evaluate research protocols.

Research involving community mental health center clients, resources, or both can affect clinical care, administrative processes, and costs. To help agencies identify and quantify these effects, a stakeholder group examined and discussed a range of protocols and then developed questionnaires and rating scales for agency use. The purpose of these materials is to make explicit the risks, costs, and benefits of a research protocol so an agency can make informed decisions about protocol approval and implementation. The goal of this work was to promote the conduct of appropriate research in community mental health settings while reducing risks to the agency and its clientele.

Prescriber fidelity to a medication management evidence-based practice in the treatment of schizophrenia.

OBJECTIVE: Medication Management Approaches in Psychiatry (MedMAP) is an evidence-based practice developed to guide the management and monitoring of psychotropic medications for individuals with schizophrenia. This article reports prescriber fidelity to MedMAP principles in a public mental health service system. METHODS: This three-year longitudinal intervention study implemented MedMAP in six community mental health centers in Kentucky. Nine psychiatrists and five advanced practice psychiatric nurses with prescriptive authority participated in the study. Prescribers were trained in the use of MedMAP about one month before implementation, and MedMAP principles were reinforced throughout the study. Four posttraining assessments were conducted at each site at approximately four-month intervals over a period of 30 months. An 18-item scale was used to assess baseline and posttraining prescriber fidelity over a period of 30 months in 900 randomly selected medical records. RESULTS: Average fidelity scores improved significantly over baseline at each of the four postimplementation fidelity assessments. Training effects were most evident at the second posttraining fidelity assessment, but effects persisted over the course of the study. There was considerable variability in scores across items both at baseline and subsequently. Posttraining improvement was greatest in patient education, documentation of illness and medication history, and simplification of medication regimen. CONCLUSIONS: Implementation and monitoring of MedMAP were feasible in these community mental health settings. Additional implementation projects are crucial for advancing evidence-based practice in clinical settings.

Patterns of primary care and mortality among patients with schizophrenia or diabetes: a cluster analysis approach to the retrospective study of healthcare utilization.

BACKGROUND: Patients with schizophrenia have difficulty managing their medical healthcare needs, possibly resulting in delayed treatment and poor outcomes. We analyzed whether patients reduced primary care use over time, differentially by diagnosis with schizophrenia, diabetes, or both schizophrenia and diabetes. We also assessed whether such patterns of primary care use were a significant predictor of mortality over a 4-year period. METHODS: The Veterans Healthcare Administration (VA) is the largest integrated healthcare system in the United States. Administrative extracts of the VA's all-electronic medical records were studied. Patients over age 50 and diagnosed with schizophrenia in 2002 were age-matched 1:4 to diabetes patients. All patients were followed through 2005. Cluster analysis explored trajectories of primary care use. Proportional hazards regression modelled the impact of these primary care utilization trajectories on survival, controlling for demographic and clinical covariates. RESULTS: Patients comprised three diagnostic groups: diabetes only (n = 188,332), schizophrenia only (n = 40,109), and schizophrenia with diabetes (Scz-DM, n = 13,025). Cluster analysis revealed four distinct trajectories of primary care use: consistent over time, increasing over time, high and decreasing, low and decreasing. Patients with schizophrenia only were likely to have low-decreasing use (73% schizophrenia-only vs 54% Scz-DM vs 52% diabetes). Increasing use was least common among schizophrenia patients (4% vs 8% Scz-DM vs 7% diabetes) and was associated with improved survival. Low-decreasing primary care, compared to consistent use, was associated with shorter survival controlling for demographics and case-mix. The observational study was limited by reliance on administrative data. CONCLUSION: Regular primary care and high levels of primary care were associated with better survival for patients with chronic illness, whether psychiatric or medical. For schizophrenia patients, with or without comorbid diabetes, primary care offers a survival benefit, suggesting that innovations in treatment retention targeting at-risk groups can offer significant promise of improving outcomes.

The short-term impact of generic versus individualized environmental supports on functional outcomes and target behaviors in schizophrenia.

We examined the short-term efficacy of two treatments using environmental supports (e.g. signs, alarms, pill containers, and checklists) to improve target behaviors in individuals with schizophrenia. 120 participants were randomized into one of the following three treatment groups: 1) Cognitive Adaptation Training (CAT; a manual-driven set of environmental supports customized to individual cognitive impairments and behaviors, and established and maintained in participants' homes on weekly visits; 2) Generic Environmental Supports (GES; a generic set of supports given to patients at a routine clinic visit and replaced on a monthly basis); and 3) treatment as usual (TAU; standard follow-up provided by a community mental health center). Global level of functional outcome and target behaviors, including orientation, grooming and hygiene, and medication adherence, were assessed at baseline and 3 months. Results of an analysis of covariance indicated that patients in both CAT and GES had better scores on global functional outcome at 3 months than those in TAU. Results of Chi Square analyses indicated that patients in CAT were more likely to improve on target behaviors, including orientation, hygiene, and medication adherence, than those in GES. Irrespective of treatment group, individuals who were high utilizers of environmental supports were more likely to improve on target behaviors than individuals who were low utilizers of supports.

Clinical and demographic factors associated with homelessness and incarceration among VA patients with bipolar disorder.

OBJECTIVES: We assessed the association between homelessness and incarceration in Veterans Affairs patients with bipolar disorder. METHODS: We used logistic regression to model each participant's risk of incarceration or homelessness after we controlled for known risk factors. RESULTS: Of 435 participants, 12% reported recent homelessness (within the past month), and 55% reported lifetime homelessness. Recent and lifetime incarceration rates were 2% and 55%, respectively. In multivariate models, current medication adherence (based on a 5-point scale) was independently associated with a lower risk of lifetime homelessness (odds ratio [OR] = 0.80 per point, range 0-4; 95% confidence interval [CI] = 0.66, 0.96), and lifetime incarceration increased the risk of lifetime homelessness (OR = 4.4; 95% CI = 2.8, 6.9). Recent homelessness was associated with recent incarceration (OR = 26.4; 95% CI = 5.2, 133.4). Lifetime incarceration was associated with current substance use (OR = 2.6; 95% CI = 2.7, 6.7) after control for lifetime homelessness (OR = 4.2; 95% CI = 2.7, 6.7). CONCLUSIONS: Recent and lifetime incarceration and homelessness were strongly associated with each other. Potentially avoidable or treatable correlates included current medication nonadherence and substance use. Programs that better coordinate psychiatric and drug treatment with housing programs may reduce the cycle of incarceration, homelessness, and treatment disruption within this vulnerable patient population.

Scales to evaluate quality of medication management: development and psychometric properties.

This paper describes the psychometric properties of two fidelity scales created as part of the Substance Abuse and Mental Health Services Administration (SAMHSA) sponsored medication management toolkit and their metric properties when used in 26 public mental health clinics with 50 prescribers. A 23-item scale, based on chart reviews, was developed to assess whether prescribers are following good medication practices, in conjunction with a 17-item scale to assess organizational support for and evaluation of prescriber adherence to recommended medication-related practices. Fundamental gaps in routine practice, including poor documentation of medication history and infrequent monitoring of symptoms and side effects were found.