Opioid medication use in patients with gastrointestinal diagnoses vs unexplained gastrointestinal symptoms in the US Veterans Health Administration.

BACKGROUND: While opioid prescriptions have increased alarmingly in the United States (US), their use for unexplained chronic gastrointestinal (GI) pain (eg, irritable bowel syndrome) carries an especially high risk for adverse effects and questionable benefit. AIM: To compare opioid use among US veterans with structural GI diagnoses (SGID) and those with unexplained GI symptoms or functional GI diagnoses (FGID), a group for whom opioids have no accepted role. METHODS: Veterans Health Administration (VHA) administrative data from fiscal year 2012 were used to identify veterans with diagnostic codes recorded for SGID and FGID. This cohort study examined VHA pharmacy data to compare groups receiving ≥ 1 opioid prescription during the year and number of prescriptions filled. Bivariate and multiple logistic regression analyses adjusted for potential confounding factors (demographics, medical diagnoses, social factors) and identified potential mediators (service use, psychiatric comorbidity) of opioid use in these groups. RESULTS: A greater proportion of veterans with FGID received an opioid prescription during fiscal year 2012 (36.0% of 272 431) compared to only 28.9% of 1 223 744 in the SGID group (Relative Risk [RR] = 1.25). In multivariate logistic regression, personality disorders and drug abuse (OR 1.23 for each group), recent homelessness (OR 1.22), psychotropic medication fills (OR 1.55) and emergency department encounters (OR 1.21) were independently associated with opioid prescription use. CONCLUSIONS: Despite the potential for adverse consequences, opioids more often are prescribed for veterans with chronic, unexplained GI symptoms compared to those with structural diagnoses. Psychiatric comorbidities and frequent healthcare encounters mediate some of the opioid use risk.

Veteran subjects willingness to participate in schizophrenia clinical trials.

Predictive characteristics of subjects agreeing to be randomized into clinical trials for the treatment of schizophrenia and schizoaffective disorder have been little studied. In this study, we used data from the recruitment phase of a randomized trial that compared long acting injectable (LAI) risperidone to oral antipsychotic medications. Basic socio-demographic and clinical data were gathered from eligible patients and clinicians at the time of screening for trial entry. Bivariate comparisons and multivariate logistic regression were used to compare those who agreed to participate and those who refused. Altogether 446 veterans were eligible on preliminary screening, of these 382 (86 %) agreed to participate and 64 (14 %) declined. Eligible patients who agreed to be randomized were more willing to change medications without regard to their level of satisfaction with their current medication. Subjects reported as currently taking LAI medication and taking risperidone, in particular, were more likely to agree to participate. Factors that did not significantly predict participation included age, years on current medication, reported medication compliance, race, and gender. Veterans with schizophrenia or schizoaffective disorder who were actually more satisfied with their current medications and who were currently taking the experimental agent were more likely to agree to participate in this randomized clinical trial in contrast to expectations that individuals who are unsatisfied with their current treatment would be more likely to enroll in such studies.

Assessing the relationship between health utilities, quality of life, and health care costs in Alzheimer's disease: the CATIE-AD study.

OBJECTIVES: To examine the relationship between multiple measures of health care costs and health utilities, quality of life, and other factors in Alzheimer's Disease (AD). RESEARCH DESIGN: Data were obtained via caregiver proxy at baseline and 3- 6- and 9-months following study entry on 421 patients with AD who participated in the CATIE-AD trial of antipsychotic medication. Spearman rank correlations and mixed models (using logged costs) were used to examine the correlates of health care costs. MEASURES: Health care costs include inpatient hospital, nursing home, residential care, combined institutional, outpatient, ancillary drug, and total costs. Correlates include the AD-Related Quality of Life Scale (ADRQoL) and Health Utilities Index (HUI)-III. RESULTS: Total monthly health care costs averaged $1,205 during the study period. Each .10 increment on the HUI-III (stronger health utilities) was associated with a decrease in institutional, outpatient, and total costs of 9.7%, 6.9%, and 8.2%, respectively. Each one-point increase on the ADRQoL (better quality of life) was associated with an increase in ancillary drug and total costs of 1.7% and 2.1%. Total costs tended to be lower for female patients (beta=-.325) with better physical functioning (beta=-.017) but higher for less cognitively impaired individuals (beta=.038). Older (beta=.025), non-Hispanic Whites (beta=.575) tended have higher outpatient costs, those with better physical functioning lower institutional costs (beta=-.019). Drug costs tended to be lower for females (beta=-.427) and higher for those with greater psychiatric symptoms (beta=.016). CONCLUSION: The HUI-III findings suggest that health utilities could be combined with other known correlates of costs to inform resource allocation cost-effectiveness analyses associated with AD. The ADRQoL findings suggest that better quality of life may make it easier for caregivers to identify problems and/or to access and maintain certain types of health system contacts.

Rethinking antipsychotic formulary policy.

In this commentary, we review recent research suggesting that (a) second-generation antipsychotics (SGAs) may be no more effective than first-generation antipsychotics (FGAs), (b) the reduced risk of EPS and tardive dyskinesia with SGAs is more weakly supported by the research literature than has been appreciated, and (c) benefits may be offset by greater metabolic risks of some SGAs and their substantially greater cost. Bearing in mind, as well, that risperidone, currently the least expensive SGA, will soon be available as an even less expensive generic drug, we propose a new algorithm for maintenance antipsychotic therapy. We further outline a cautious implementation procedure that relies on standardized documentation and feedback, without a restrictive formulary that would limit physician choice. The algorithm outlined here and the process for its implementation are intended as a stimulus for discussion of potential policy responses, not as a finalized proposition.

Evaluating the cost-effectiveness of reduced tardive dyskinesia with second-generation antipsychotics.

BACKGROUND: Second-generation antipsychotics may have few advantages over older, cheaper drugs, except for possibly reduced risk of tardive dyskinesia. AIMS: To evaluate the cost-effectiveness of second-generation antipsychotics with regard to reducing tardive dyskinesia. METHOD: Literature was reviewed on risk of tardive dyskinesia with second-generation antipsychotics; on severity, duration and impairment of tardive dyskinesia; and on the relationship of this disorder to quality of life and quality-adjusted life-years (QALYs). Diverse cost and benefit assumptions and of 1-year and 5-year planning horizons were examined in a deterministic sensitivity analysis. RESULTS: Estimating 0.143 QALYs lost per case of severe tardive dyskinesia, 1-year cost-effectiveness cumulative estimates ranged from pounds 74,000 (dollars 149,000) to pounds 342,000 (dollars 683,000) per QALY, all above the conventional policy threshold of pounds 25,000 (dollars 50,000). CONCLUSIONS: Reduction of tardive dyskinesia with second-generation antipsychotics appears unlikely to meet standards for cost-effectiveness.

Prescribing practices of psychiatrists and primary care physicians caring for children with mental illness.

OBJECTIVE: Although several studies have found that the most effective treatment for both youths and adults diagnosed with mood disorders is the combination of psychotherapy and medications, psychiatrists have been increasingly providing psychotropic medications without psychotherapy to these populations. At the same time, primary care physicians (PCPs) have become increasingly involved in prescribing psychotropic medications. This study compared the prescribing patterns of PCPs and psychiatrists caring for children with mental illness. METHODS: Data were extracted from the MarketScan database, which compiles claims from private health insurance plans nationwide. Of 40,639 children who received mental health services during calendar year 2000 (6.33% of all covered children), we identified 5485 who initiated a new episode of treatment. Multiple regression was use to adjust for differences in patient characteristics. RESULTS: While PCPs were more likely to see young children and psychiatrists saw children with more numerous mental illnesses, there were no significant differences between PCPs and psychiatrists in either the proportion of patients who received psychotropic medication, the frequency of clinical contacts, or the dosages or types of medications prescribed. Patients seen in more actively managed Point of Service plans were more likely to receive medication than those seen in preferred provider or indemnity plans. CONCLUSIONS: This study found no significant differences between psychiatrists and PCPs in psychotropic prescribing practices. In view of the limited availability of child psychiatrists and the decreased availability of psychotherapy in combination with medications, collaborative care models in which non-physician mental health specialists and PCPs work together may increase the availability of effective mental health services for youths.

Premenstrual disorders: bridging research and clinical reality.

INTRODUCTION: As with a number of emotional disorders, premenstrual complaints lie on a continuum dictated by severity, number and type of symptoms experienced. Women with premenstrual dysphoric disorder (PMDD) generally constitute the most symptomatic subgroup among those experiencing premenstrual symptoms. Included in the Diagnostic and Statistical Manual IV (DSM-IV) criteria for PMDD is a requirement for a minimum of 5 symptoms and for confirmation of these symptoms over two months by concurrent symptom ratings. These requirements likely influence critical patient characteristics rendering trial participants and typical patients seeking treatment, very different. METHODS: Women were recruited from 6 primary care obstetric-gynecological practices for participation in an open trial assessing the effectiveness of a serotonin reuptake inhibitor as a treatment for subsyndromal (3-4 symptoms) and syndromal (>4 symptoms) PMDD. Women were screened with the Brief Patient Health Questionnaire and Last Menstrual Period Module. Eligible women were invited to chart symptoms daily for one cycle using the Daily Record of Severity of Problems. Current comorbidity was allowed if women experienced a cyclic change in mood and behavioral symptoms. RESULTS: 47% of 904 women screened in practice settings (n=426) endorsed current PMS symptoms. Of this group, 174 (41%) were not interested in receiving treatment through a research study, 152 (36%) were not eligible to receive treatment (symptoms not severe enough, subsequently declined premenstrual symptom worsening, were already taking a psychotropic or wanted to conceive), 10% were lost to follow-up or had incomplete questionnaires, and 41 (10%) agreed to chart. Of women who charted, 9 (22%) verified symptoms. 93 women (22% of the 426) had comorbid MDD, 23 (5.4%) had minor depressive disorder and 61 (14%) had panic disorder. 24% of women with possible PMDD endorsed suicidal thoughts at any level (several days, more than half the days or every day); 20% endorsed these thoughts for several days. These results are used as a springboard to discuss how treatment results from efficacy trials may differ from treatment results that include women seeking treatment in usual care settings. CONCLUSION: These preliminary findings show that many women in primary care ob-gyn settings endorse serious premenstrual symptoms and have concurrent psychiatric conditions. Despite this, interest in study participation was low. This occurred even though the current study employed procedures that were much less rigorous than those used in the typical efficacy study. More work is needed to explore how the selectivity of patients included in clinical trials may bias estimates of how effective many agents will be in actual clinical practice.

Time-limited assertive community treatment for homeless persons with severe mental illness.

BACKGROUND: The assertive community treatment (ACT) model for people with severe mental illness was originally designed to be provided continuously without termination. This study evaluated postdischarge changes in health status and service use associated with the time-limited provision of ACT to homeless people with severe mental illness. METHODS: Clients in the fourth annual cohort of the Access to Community Care and Effective Services and Supports (ACCESS) program (N = 1617) were assessed at entry into ACT and 3, 12, and 18 months later. Random effects models were used to compare outcomes and service use among clients who terminated ACT and clients who remained in ACT, controlling for potentially confounding factors. RESULTS: Altogether, of clients who participated in follow-up, 8.7% participated for less than 3 months; 40.6%, for 3 to 10 months; 15.3%, for 11-13 months; and 35.3%, for 14 months or more. Controlling for potentially confounding factors, mental health, substance abuse, and housing outcomes did not significantly differ between clients who had been discharged at the time of follow-up as compared with those who had not. Those who had been discharged had worked significantly more days than those who had not (t(1794) = 3.24, P<.001), and they reported significantly less outpatient health service use though there was no decline in hospital days or receipt of public support payments. CONCLUSION: Homeless clients who have severe mental illness can be selectively discharged or transferred from ACT to other services without subsequent loss of gains in mental health status, substance abuse, housing, or employment.

Organizational process: a missing link between research and practice.

Organizational process is an underexamined barrier and a potential bridge for the introduction of innovative treatment models into mental health practice. The author describes key operational characteristics of large, complex organizations and strategies that have been used to facilitate implementation of innovative programs in the Department of Veterans Affairs health care system. He argues that complex organizations of the type in which mental health care is increasingly delivered are characterized by multiple competing goals, uncertain technologies, and fluid involvement of key participants. Interventions shown to be effective in controlled studies are often not easily introduced into such organizations, because research is typically conducted in a buffered organizational niche that is shielded from the complex open systems around it. Key strategies for moving research into practice include constructing decision-making coalitions, linking new initiatives to legitimated goals and values, quantitatively monitoring implementation and ongoing performance, and developing self-sustaining communities of practice as well as learning organizations. The author shows how effective dissemination of new treatment methods requires attention to and effective engagement with organizational processes.

Stigma as a barrier to recovery: Adverse effects of perceived stigma on social adaptation of persons diagnosed with bipolar affective disorder.

OBJECTIVE: The purpose of this study was to evaluate the effect of concerns about stigma on social adaptation among persons with a diagnosis of bipolar affective disorder. METHODS: The sample comprised 264 persons who were consecutively admitted to a psychiatric inpatient or outpatient service at a university-affiliated hospital and who met research diagnostic criteria for bipolar I disorder, bipolar II disorder, or schizoaffective disorder, manic type. Patients were evaluated with use of the Schedule for Affective Disorders and Schizophrenia, Lifetime Version (SADS-L), the Brief Psychiatric Rating Scale (BPRS), and a measure of perceived stigma. Social adjustment was measured at baseline and seven months later with the Social Adjustment Scale (SAS). RESULTS: As predicted, patients who had concerns about stigma showed significantly more impairment at seven months on the social leisure subscale but not on the SAS extended family subscale, after baseline SAS score and symptom level had been controlled for. More refined models using SAS-derived factors as dependent variables indicated that concerns about stigma predicted higher avoidance of social interactions with persons outside the family and psychological isolation at seven-month follow-up, after baseline SAS and BPRS scores had been controlled for. CONCLUSIONS: Concerns about the stigma associated with mental illness reported by patients during an acute phase of bipolar illness predicted poorer social adjustment seven months later with individuals outside the patient's family. Greater attention to patients' concerns about stigma is needed from both researchers and clinicians.

Naltrexone in the treatment of alcohol dependence.

BACKGROUND: Although naltrexone, an opiate-receptor antagonist, has been approved by the Food and Drug Administration for the treatment of alcohol dependence, its efficacy is uncertain. METHODS: We conducted a multicenter, double-blind, placebo-controlled evaluation of naltrexone as an adjunct to standardized psychosocial treatment. We randomly assigned 627 veterans (almost all men) with chronic, severe alcohol dependence to 12 months of naltrexone (50 mg once daily), 3 months of naltrexone followed by 9 months of placebo, or 12 months of placebo. All patients were offered individual counseling and programs to improve their compliance with study medication and were encouraged to attend Alcoholics Anonymous meetings. RESULTS: There were 209 patients in each group; all had been sober for at least five days before randomization. At 13 weeks, we found no significant difference in the number of days to relapse between patients in the two naltrexone groups (mean, 72.3 days) and the placebo group (mean, 62.4 days; 95 percent confidence interval for the difference between groups, -3.0 to 22.8). At 52 weeks, there were no significant differences among the three groups in the percentage of days on which drinking occurred and the number of drinks per drinking day. CONCLUSIONS: Our findings do not support the use of naltrexone for the treatment of men with chronic, severe alcohol dependence.

National Institute of Mental Health Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE): Alzheimer disease trial methodology.

The authors describe the development of the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) protocol for Alzheimer disease (AD), a trial developed in collaboration with the National Institute of Mental Health (NIMH), assessing the effectiveness of atypical antipsychotics for psychosis and agitation occurring in AD outpatients. They provide an overview of the methodology utilized in the trial as well as the clinical-outcomes and effectiveness measures that were implemented.

Cross-system service use among VA mental health patients living in Philadelphia.

There are few published studies of cross-system use of multiple systems of mental health care. This study examines use of VA and non-VA services in Philadelphia County. Results indicated that rates of cross-system use overall are fairly low (16 to 17% of patients across all years), are generally declining over time, and account for a small proportion of total all-system costs (4%). Veterans who used more VA inpatient services also used more non-VA services, and veterans who used fewer VA outpatient services used more non-VA services, indicating that cross-system use may be a quality indicator for the accessibility or acceptability of outpatient care.

Effects of disability compensation on participation in and outcomes of vocational rehabilitation.

OBJECTIVE: The authors sought to determine the relationship between receipt of disability compensation and participants' success in a vocational rehabilitation program. METHODS: Administrative data for 22,515 individuals who participated in the Veterans Health Administration compensated work therapy program between 1993 and 1998 were analyzed. Six dependent variables were compared between participants who were receiving disability compensation and those who were not: duration of participation in compensated work therapy, number of hours worked per week, mean hourly earnings, total income from compensated work therapy, dropout rate, and competitive employment status at discharge. Regression equations were determined for each dependent variable to assess associations with the degree of disability, the amount of disability compensation, and the type of compensation program. RESULTS: Participants who were receiving disability benefits worked fewer hours in compensated work therapy each week, earned less income, had a higher dropout rate, and were less likely to be competitively employed at discharge. The amount of compensation and the type of program were modestly but significantly associated with participation in compensated work therapy and with outcome. CONCLUSIONS: Unintended effects of disability compensation programs discourage full participation in vocational rehabilitation and result in poorer rehabilitation outcomes.

Integrated medical care for patients with serious psychiatric illness: a randomized trial.

BACKGROUND: This randomized trial evaluated an integrated model of primary medical care for a cohort of patients with serious mental disorders. METHODS: A total of 120 individuals enrolled in a Veterans Affairs (VA) mental health clinic were randomized to receive primary medical care through an integrated care initiative located in the mental health clinic (n = 59) or through the VA general medicine clinic (n = 61). Veterans who obtained care in the integrated care clinic received on-site primary care and case management that emphasized preventive medical care, patient education, and close collaboration with mental health providers to improve access to and continuity of care. Analyses compared health process (use of medical services, quality of care, and satisfaction) and outcomes (health and mental health status and costs) between the groups in the year after randomization. RESULTS: Patients treated in the integrated care clinic were significantly more likely to have made a primary care visit and had a greater mean number of primary care visits than those in the usual care group. They were more likely to have received 15 of the 17 preventive measures outlined in clinical practice guidelines. Patients assigned to the integrated care clinic had a significantly greater improvement in health as measured by the physical component summary score of the 36-Item Short-Form Health Survey than patients assigned to the general medicine clinic (4.7 points vs -0.3 points, P<.001). There were no significant differences between the 2 groups in any of the measures of mental health symptoms or in total health care costs. CONCLUSION: On-site, integrated primary care was associated with improved quality and outcomes of medical care.

Use of pharmacy data to assess quality of pharmacotherapy for schizophrenia in a national health care system: individual and facility predictors.

OBJECTIVES: This paper presents a profile of the use of antipsychotic medications in the treatment of schizophrenia in a national health system. METHODS: Prescription drug records written for antipsychotic medications between June 1999 and September 1999 were collected for patients diagnosed with schizophrenia in the Department of Veteran Affairs (VA). Indicators were constructed describing whether patients received multiple antipsychotic medications and whether the total weekly dose was outside of the range specified in the treatment recommendations developed by the schizophrenia Patient Outcomes Research Team (PORT). Generalized estimation equations were used to identify patient and facility characteristics that are associated with adherence to PORT recommendations. RESULTS: Of the 34,925 patients in the final sample, 2,383 (6.8%) received prescriptions for more than one antipsychotic (polypharmacy). A higher number of patients (4,554 or 13.0%) were dosed above the PORT recommendations on an antipsychotic medication and even more (8,148 or 23.3%) were dosed below the recommended PORT dosage. Older patients, minorities, and those with comorbid depression or substance abuse were generally less likely to receive multiple antipsychotics or be dosed above PORT recommendations. Neither academic emphasis (the percentage of the mental health budget spent on research and education) nor fiscal stress was significantly associated with adherence to recommendations. CONCLUSIONS: In the nation's largest mental health system, a relatively small number of patients were prescribed multiple antipsychotic medications, but more than a third were dosed outside of the PORT recommended range.

Vocational outcomes among formerly homeless persons with severe mental illness in the access program.

OBJECTIVE: This study examined the vocational outcomes of 4,778 formerly homeless individuals with severe mental illness who were enrolled in the Access to Community Care and Effective Services and Support (ACCESS) program, a multisite demonstration project designed to provide services to this population. METHODS: Participants were interviewed at the time of enrollment and again three months and 12 months later by trained researchers who were not part of the treatment team to determine their employment status. At 12 months, participants were also asked about the types of services they had received during the past 60 days. Multiple logistic regression analysis was used to predict employment at 12 months. RESULTS: ACCESS participants reported receiving relatively few job-related services. Nonetheless, modest but significant increases occurred between baseline and three months and between three months and 12 months in the total proportion of participants who were employed and who were employed full-time and in hourly earnings and estimated monthly earnings. The number of hours worked per week increased significantly between three months and 12 months. When the analysis controlled for site, study condition (whether the ACCESS site received or did not receive extra funds to improve service integration), minority status, addiction treatment, and mental health treatment, participants who were employed at 12 months were more likely to have received job training and job placement services. CONCLUSIONS: Programs that work with homeless mentally ill persons may better serve their clients by placing as great an emphasis on providing employment services as on providing housing and clinical treatment.

Quality of medical care and excess mortality in older patients with mental disorders.

BACKGROUND: This study investigated whether differences in quality of medical care might explain a portion of the excess mortality associated with mental disorders in the year after myocardial infarction. METHODS: This study examined a national cohort of 88 241 Medicare patients 65 years and older who were hospitalized for clinically confirmed acute myocardial infarction. Proportional hazard models compared the association between mental disorders and mortality before and after adjusting 5 established quality indicators: reperfusion, aspirin, beta-blockers, angiotensin-converting enzyme inhibitors, and smoking cessation counseling. All models adjusted for eligibility for each procedure, demographic characteristics, cardiac risk factors and history, admission characteristics, left ventricular function, hospital characteristics, and regional factors. RESULTS: After adjusting for the potential confounding factors, presence of any mental disorder was associated with a 19% increase in 1-year risk of mortality (hazard ratios [HR], 1.19; 95% confidence interval [CI], 1.04-1.36). After adding the 5 quality measures to the model, the association was no longer significant (HR, 1.10; 95% CI, 0.96-1.26). Similarly, while schizophrenia (HR, 1.34; 95% CI, 1.01-1.67) and major affective disorders (HR, 1.11; 95% CI, 1.02-1.20) were each initially associated with increased mortality, after adding the quality variables, neither schizophrenia (HR, 1.23; 95% CI, 0.86-1.60) nor major affective disorder (HR, 1.05; 95% CI, 0.87-1.23) remained a significant predictor. CONCLUSIONS: Deficits in quality of medical care seemed to explain a substantial portion of the excess mortality experienced by patients with mental disorders after myocardial infarction. The study suggests the potential importance of improving these patients' medical care as a step toward reducing their excess mortality.

Moving assertive community treatment into standard practice.

This article describes the assertive community treatment model of comprehensive community-based psychiatric care for persons with severe mental illness and discusses issues pertaining to implementation of the model. The assertive community treatment model has been the subject of more than 25 randomized controlled trials. Research has shown that this type of program is effective in reducing hospitalization, is no more expensive than traditional care, and is more satisfactory to consumers and their families than standard care. Despite evidence of the efficacy of assertive community treatment, it is not uniformly available to the individuals who might benefit from it.