Influence of cognitive reserve on neuropsychological functioning in bipolar disorder: Findings from a 5-year longitudinal study.

OBJECTIVES: The present study examined the 5-year longitudinal course of cognitive functioning in a large sample of well-characterized patients with bipolar disorder (BP), compared to healthy controls (HCs), and the influence of cognitive reserve factors (e.g., education and IQ) on cognitive change over time. METHODS: Participants included 159 individuals diagnosed with BP and 54 HCs recruited as part of a longitudinal naturalistic study of BP who had completed neuropsychological testing at the time of their enrollment and again 5 years later. RESULTS: The overall relative rate of change did not differ between the BP and HC groups. In total, 46.5% of the BP group and 37% of the HC group showed evidence of decline on at least one measure over time. T-test analyses did not find differences between BP 'decliners' and 'non-decliners' in cognitive reserve variables. However, we found that higher baseline intellectual ability was associated with more stability in cognitive test scores over time for the BP group. Results of linear regression modeling revealed that lower verbal IQ and education were related to increased cognitive decline in specific domains in the BP group. CONCLUSIONS: This study has explored the influence of cognitive reserve on preservation of specific cognitive abilities over time in BP. The BP group did not demonstrate accelerated cognitive decline over 5 years compared to the HC group. Although the trajectory of cognitive change over time was similar between BP patients and HCs, higher overall intellectual ability may be a protective factor against cognitive decline, particularly for BP patients.

Implementing Effective Policy in a National Mental Health Reengagement Program for Veterans.

Policy is a powerful motivator of clinical change, but implementation success can depend on organizational characteristics. This article used validated measures of organizational resources, culture, and climate to predict uptake of a nationwide Veteran's Health Administration (VA) policy aimed at implementing Re-Engage, a brief care management program that reestablishes contact with veterans with serious mental illness lost to care. Patient care databases were used to identify 2738 veterans lost to care. Local recovery coordinators (LRCs) were to update disposition for 2738 veterans at 158 VA facilities and, as appropriate, facilitate a return to care. Multivariable regression was used to assess organizational culture and climate as predictors of early policy compliance (via LRC presence) and uptake at 6 months. Higher composite climate and culture scores were associated with higher odds of having a designated LRC but were not predictive of higher uptake. Sites with LRCs had significantly higher rates of updated documentation than sites without LRCs.

Long-Term Clinical Outcomes from a Randomized Controlled Trial of Two Implementation Strategies to Promote Collaborative Care Attendance in Community Practices.

This randomized controlled implementation study compared the effectiveness of a standard versus enhanced version of the replicating effective programs (REP) implementation strategy to improve the uptake of the life goals-collaborative care model (LG-CC) for bipolar disorder. Seven community-based practices (384 patient participants) were randomized to standard (manual/training) or enhanced REP (customized manual/training/facilitation) to promote LG-CC implementation. Participants from enhanced REP sites had no significant changes in primary outcomes (improved quality of life, reduced functioning or mood symptoms) by 24 months. Further research is needed to determine whether implementation strategies can lead to sustained, improved participant outcomes in addition to program uptake.

Self-efficacy and quality of life among people with bipolar disorder.

People with bipolar disorders report a lower quality of life than the general population does, and few mutable factors associated with health-related quality of life (HRQoL) among people with bipolar disorders have been identified. Using a cross-sectional design, these analyses examined whether self-efficacy was associated with mental and physical HRQoL in a sample of 141 patients with bipolar disorder who completed baseline assessments for two randomized controlled trials. Multiple linear regression analyses indicated that higher levels of self-efficacy were associated with higher mental and physical HRQoL, after controlling for demographic factors and clinical factors (including mood symptoms, comorbid medical conditions, and substance use). Future research should examine whether targeted treatments that aim to improve self-efficacy (such as self-management interventions) lead to improvements in HRQoL among people with bipolar disorder and other serious mental illnesses.

The Association between Sampling and Survival in Patients with Pancreatic Ductal Adenocarcinoma Who Received Neoadjuvant Therapy and Pancreaticoduodenectomy.

Adequate sampling is essential to an accurate pathologic evaluation of pancreatectomy specimens resected for pancreatic ductal adenocarcinoma (PDAC) after neoadjuvant therapy (NAT). However, limited data are available for the association between the sampling and survival in these patients. We examined the association of the entire submission of the tumor (ESOT) and the entire submission of the pancreas (ESOP) with disease-free survival (DFS) and overall survival (OS), as well as their correlations with clinicopathologic features, for 627 patients with PDAC who received NAT and pancreaticoduodenectomy. We demonstrated that both ESOT and ESOP were associated with lower ypT, less frequent perineural invasion, and better tumor response (p < 0.05). ESOP was also associated with a smaller tumor size (p < 0.001), more lymph nodes (p < 0.001), a lower ypN stage (p < 0.001), better differentiation (p = 0.02), and less frequent lymphovascular invasion (p = 0.009). However, since ESOP and ESOT were primarily conducted for cases with no grossly identifiable tumor or minimal residual carcinoma in initial sections, potential bias cannot be excluded. Both ESOT and ESOP were associated with less frequent recurrence/metastasis and better DFS and OS (p < 0.05) in the overall study population. ESOP was associated with better DFS and better OS in patients with ypT0/ypT1 or ypN0 tumors and better OS in patients with complete or near-complete response (p < 0.05). ESOT was associated with better OS in patients with ypT0/ypT1 or ypN0 tumors (p < 0.05). Both ESOT and ESOP were independent prognostic factors for OS according to multivariate survival analyses. Therefore, accurate pathologic evaluation using ESOP and ESOT is associated with the prognosis in PDAC patients with complete or near-complete pathologic response and ypT0/ypT1 tumor after NAT.

Pilot randomized trial of a cross-diagnosis collaborative care program for patients with mood disorders.

OBJECTIVES: Chronic care models improved outcomes for persons with mental disorders but to date have primarily been tested for single diagnoses (e.g. unipolar depression). We report findings from a pilot multisite randomized controlled trial of a cross-diagnosis care model for patients with mood disorders. METHODS: Patients (N = 60) seen in one of four primary care or mental health clinics affiliated with the National Network of Depression Centers were randomized to receive a mood disorder care model, Life Goals Collaborative Care (LGCC, N = 29) or usual care (N = 31). LGCC consisted of five group self-management sessions focused on mood symptom coping and health behavior change strategies followed by monthly patient and provider care management contacts for up to 6 months. Outcomes at 3 and 6 months included mood symptoms (Patient Health Questionnaire-PHQ-9, Internal State Scale-well-being, Generalized Anxiety Disorder scale) and health-related quality of life. RESULTS: Of the 60 enrolled, the mean age was 46.2 (SD = 13.2), 73.3% were female, 16.7% were non-white, and 36.8% had a bipolar disorder diagnosis. LGCC was associated with greater likelihood of depressive symptom remission in 6 months (respectively, 50% versus 19% had a PHQ-9 score ≤9 and 50% reduction in PHQ-9 score, P = .04) and improved well-being (ß = 2.66, P ≤ .01, Cohen's D = 0.43). CONCLUSIONS: LGCC may improve outcomes for patients regardless of mood diagnosis, potentially providing a feasible and generalizable chronic care model for routine practice settings.

Gender differences in health-related quality of life in patients with bipolar disorder.

Health-related quality of life (HRQOL) is a widely accepted measure of illness state that is related to morbidity and mortality. Findings from various populations show that women report lower HRQOL than men. We analyzed baseline HRQOL data for gender differences from a multisite, randomized controlled study for adults with bipolar disorder. HRQOL was assessed using the 12-item Short Form (SF-12) physical component summary (PCS) and mental component summary (MCS) health scales. Multivariate linear and bivariate regression models examined differences in self-reported data on demographics, depressive symptoms (nine-item Patient Health Questionnaire), bipolar disorder symptoms (Internal State Scale), and medical comorbidities. Out of 384 enrolled (mean age = 42 years), 256 were women (66.7 %). After controlling for sociodemographic characteristics and clinical factors, women had lower SF-12 PCS scores than men [ß = -1.78, standard error (SE) = 0.87, p < 0.05], indicating worse physical health, but there were no gender differences in MCS scores. After controlling for patient factors including medical and behavioral comorbidities, the association between gender and PCS score was no longer significant. Of the medical comorbidities, pain was associated with lower PCS scores (ß = -4.90, SE = 0.86, p < 0.0001). Worse physical HRQOL experienced by women with bipolar disorder may be explained by medical comorbidity, particularly pain, suggesting the importance of gender-tailored interventions addressing physical health conditions.

Characteristics of appendicitis after immune checkpoint inhibitor therapy among cancer patients.

PURPOSE: Immune checkpoint inhibitor (ICI) therapy has revolutionized cancer care but is associated with immune-related adverse events (irAEs). Recent case reports raised the concern that acute appendicitis may be an irAE. In this study, we sought to describe the disease course of post-ICI therapy appendicitis and its associated complications. METHODS: Adult patients who had an International Classification of Diseases code for appendicitis within the first 2 years after initiating ICI therapy from January 2010 to April 2021 and who had imaging evidence of appendicitis were studied retrospectively. RESULTS: 13,991 patients were identified who had ICI exposure during the study period, 44 had codes for appendicitis, 10 of whom met the inclusion criteria. Their median age at the time of diagnosis was 59 years. The median time from ICI therapy initiation to appendicitis onset was 188 days. The most common presenting symptoms were abdominal pain (70%) and fever (40%). Abscesses were present in two patients, and a perforation was present in one. All 10 patients received broad-spectrum antibiotics. Five patients needed surgery or interventional radiology drainage. Nine patients had resolution of appendicitis symptoms after treatment. CONCLUSION: Post-ICI therapy appendicitis is rare but presents similarly to and has similar complications rates as conventional appendicitis. Appendectomy remains the mainstay of treatment, but its use can be limited in cancer patients. The decision to continue ICI therapy remains at the discretion of the clinician. Further studies are needed to bring awareness to and advance the understanding of this clinical entity.

Utility of Whole Slide Imaging for Intraoperative Consultation: Experience of a Large Academic Center.

CONTEXT.­: In the United States, review of digital whole slide images (WSIs) using specific systems is approved for primary diagnosis but has not been implemented for intraoperative consultation. OBJECTIVE.­: To evaluate the safety of review of WSIs and compare the efficiency of review of WSIs and glass slides (GSs) for intraoperative consultation. DESIGN.­: Ninety-one cases previously submitted for frozen section evaluation were randomly selected from 8 different anatomic pathology subspecialties. GSs from these cases were scanned on a Leica Aperio AT2 scanner at ×20 magnification (0.25 µm/pixel). The slides were deidentified, and a short relevant clinical history was provided for each slide. Nine board-certified general pathologists who do not routinely establish primary diagnoses using WSIs reviewed the WSIs using Leica Aperio ImageScope viewing software. After a washout period of 2-3 weeks, the pathologists reviewed the corresponding GSs using a light microscope (Olympus BX43). The pathologists recorded the diagnosis and time to reach the diagnosis. Intraobserver concordance, time to diagnosis, and specificity and sensitivity compared to the original diagnosis were evaluated. RESULTS.­: The rate of intraobserver concordance between GS results and WSI results was 93.7%. Mean time to diagnosis was 1.25 minutes for GSs and 1.76 minutes for WSIs (P < .001). Specificity was 91% for GSs and 90% for WSIs; sensitivity was 92% for GSs and 92% for WSIs. CONCLUSIONS.­: Time to diagnosis was longer with WSIs than with GSs, and scanning GSs and uploading the data to whole slide imaging systems takes time. However, review of WSIs appears to be a safe alternative to review of GSs. Use of WSIs allows reporting from a remote site during a public health emergency such as the COVID-19 pandemic and facilitates subspecialty histopathology services.

Prognosticators for Patients with Pancreatic Ductal Adenocarcinoma Who Received Neoadjuvant FOLFIRINOX or Gemcitabine/Nab-Paclitaxel Therapy and Pancreatectomy.

Neoadjuvant FOLFIRINOX and gemcitabine/nab-paclitaxel (GemNP) therapies are increasingly used to treat patients with pancreatic ductal adenocarcinoma (PDAC). However, limited data are available on their clinicopathologic prognosticators. We examined the clinicopathologic factors and survival of 213 PDAC patients who received FOLFIRINOX with 71 patients who received GemNP. The FOLFIRINOX group was younger (p < 0.01) and had a higher rate of radiation (p = 0.049), higher rate of borderline resectable and locally advanced disease (p < 0.001), higher rate of Group 1 response (p = 0.045) and lower ypN stage (p = 0.03) than the GemNP group. Within FOLFIRINOX group, radiation was associated with decreased lymph node metastasis (p = 0.01) and lower ypN stage (p = 0.01). The tumor response group, ypT, ypN, LVI and PNI, correlated significantly with both DFS and OS (p < 0.05). Patients with the ypT0/T1a/T1b tumor had better DFS (p = 0.04) and OS (p = 0.03) than those with ypT1c tumor. In multivariate analysis, the tumor response group and ypN were independently prognostic factors for DFS and OS (p < 0.05). Our study demonstrated that the FOLFIRINOX group was younger and had a better pathologic response than the GemNP group and that the tumor response group, ypN, ypT, LVI and PNI, are significant prognostic factors for survival in these patients. Our results also suggest that the tumor size of 1.0 cm is a better cut off for ypT2. Our study highlights the importance of systemic pathologic examination and the reporting of post-treatment pancreatectomies.

Primary care and behavioral health practice size: the challenge for health care reform.

INTRODUCTION: We investigated the size profile of US primary care and behavioral health physician practices since size may impact the ability to institute care management processes (CMPs) that can enhance care quality. METHOD: We utilized 2009 claims data from a nationwide commercial insurer to estimate practice size by linking providers by tax identification number. We determined the proportion of primary care physicians, psychiatrists, and behavioral health providers practicing in venues of >20 providers per practice (the lower bound for current CMP practice surveys). RESULTS: Among primary care physicians (n=350,350), only 2.1% of practices consisted of >20 providers. Among behavioral health practitioners (n=146,992) and psychiatrists (n=44,449), 1.3% and 1.0% of practices, respectively, had >20 providers. Sensitivity analysis excluding single-physician practices as "secondary" confirmed findings, with primary care and psychiatrist practices of >20 providers comprising, respectively, only 19.4% and 8.8% of practices (difference: P<0.0001). In secondary analyses, bipolar disorder was used as a tracer condition to estimate practice census for a high-complexity, high-cost behavioral health condition; only 1.3-18 patients per practice had claims for this condition. CONCLUSIONS: The tax identification number method for estimating practice size has strengths and limitations that complement those of survey methods. The proportion of practices below the lower bound of prior CMP studies is substantial, and care models and policies will need to address the needs of such practices and their patients. Achieving a critical mass of patients for disorder-specific CMPs will require coordination across multiple small practices.

Role of progenitor cell marker CD133 in supporting diagnosis of collapsing glomerulopathy.

PURPOSE: A previous immunofluorescent study suggests that, in collapsing glomerulopathy, most hyperplastic podocytes that stained positively for a progenitor cell marker CD133 are derived from CD133 + parietal epithelial cells. In pathology practice, not all renal biopsies with collapsing glomerulopathy show the typical morphologic features for this entity, which include florid podocyte hyperplasia, collapsing glomerular capillary loops, and cystic tubular dilation. This study was made to determine if CD133 staining using an immunohistochemical method can be used to confirm hyperplastic podocytes and identify extensive acute tubular injury in collapsing glomerulopathy. METHODS: Twenty-one collapsing glomerulopathy biopsies were stained for CD133 and compared with 15 biopsies with focal segmental glomerulosclerosis, not otherwise specified (FSGS). RESULTS: All patients with collapsing glomerulopathy were of African American descent with prominent renal failure and nephrotic range proteinuria. In contrast, the FSGS group consisted of patients from a variety of ethnic backgrounds with nephrotic range proteinuria but relatively low serum creatinine. The striking finding was that all collapsing glomerulopathy cases showed positive CD133 staining in the clusters of hyperplastic podocytes. There was significantly higher CD133-positive staining rate for hyperplastic podocytes (38%) in the glomeruli of the collapsing glomerulopathy group when compared to small clusters of hyperplastic podocytes in the FSGS group (8%). In addition, when compared to the relatively weak CD133 staining in the proximal tubules of the FSGS group, the proximal tubules of the collapsing glomerulopathy group all showed diffuse and strong CD133 staining as a feature of severe acute tubular injury, which corresponded to the high serum creatinine levels in these patients. CONCLUSION: Our data indicate that the combination of the distinctive mosaic CD133 staining in hyperplastic podocytes and the diffuse tubular CD133 staining is helpful in supporting a diagnosis of collapsing glomerulopathy.

A Novel Method Enables General Pathologists to Create Web Dynamic Forms for Synoptic Tumor Reporting.

CONTEXT.­: Tumor reporting constitutes a significant daily task of pathologists. An efficient tumor-reporting methodology is thus vitally important. The Web dynamic form (WbDF) method offers a multitude of advantages over the prevailing transcription-mediated reporting method based on static-text checklists. However, its adaptation has been severely hampered for 2 decades by its costly needs to maintain a complex back-end system and to change the system for frequent updates of reporting content. OBJECTIVE.­: To overcome these 2 obstacles with a serverless Web platform that enables users to create, customize, use, and download WbDFs as synoptic templates for structured tumor reporting. DESIGN.­: Deploy ReactJS as a Web platform. Create form components in JavaScript Object Notation files. Use JavaScript Object Notation files to make WbDFs on the Web platform. Use the WbDFs to generate final pathology reports. RESULTS.­: Ordinary users (pathologists) can create/customize reporting templates as WbDFs on the Web platform. The WbDF can be used to make a pathology report and stored/shared like ordinary document files. There is no back-end system to change, nor a requirement for computer programming skills. CONCLUSIONS.­: This strategy eliminates the need for a complex back-end system and the associated cost when updating tumor-reporting standards, making it possible to adopt the WbDF method without the technological drawbacks associated with content updates. It also opens a new field of how the tumor-reporting system should be organized, updated, and implemented.

Relationship of vitamin D and parathyroid hormone with obesity and body composition in African Americans.

BACKGROUND: Obesity disproportionately affects African Americans (AA) (especially women), and is linked to depressed 25-hydroxyvitamin D (25-OH D) and elevated parathyroid hormone (PTH). The relationship of 25-OH D and PTH with body composition and size in AA is not well known. OBJECTIVE: To determine the relationship of 25-OH D and PTH levels with body composition and anthropometric measures. DESIGN: A cross-sectional study was conducted in 98 healthy, overweight, adult AA enrolled in an NIH/NIEHS-sponsored weight loss/salt-sensitivity trial. MEASUREMENTS: Multivariable linear regression analyses were used to explore the relationship of 25-OH D and PTH with body composition, determined by dual-energy X-ray absorptiometry, and anthropometric measures. Body composition and size were contrasted across vitamin D/PTH groups using general linear models: (i) normal (25-OH D >50 nmol/l, PTH

Monoclonal Gammopathy of Renal Significance and its Associated Experimental Models.

Monoclonal gammopathy of renal significance (MGRS) is a state of circulating monoclonal immunoglobulin (Ig) and light chains that cause kidney injury without definite evidence of multiple myeloma (MM). Although chemotherapy is used to treat many variants of MGRS and has been recently recommended, relatively limited clinical validation studies are available. A few transgenic models of MM reveal renal deposition of monoclonal Ig and light chains. We have demonstrated that the XBP1s-transgenic mouse model from early plasma cell dyscrasia to MM reveals monoclonal IgG/kappa deposition at the subendothelial spaces of the glomeruli, mimicking proliferative glomerulonephritis with monoclonal immunoglobulin deposits. Inhibition of a key immune-modulator, gp96/grp94, genetically or pharmacologically results in a significant reduction of plasma cells within the bone marrow and reduced renal deposition of monoclonal IgG and kappa light chain. This article will review the emerging role of in vitro and animal models from plasma cell dyscrasia to MM in understanding the renal deposition of monoclonal Ig and light chains, along with its potential treatment strategies.

Kidney injury molecule-1, a sensitive and specific marker for identifying acute proximal tubular injury, can be used to predict renal functional recovery in native renal biopsies.

Kidney injury molecule-1 (KIM-1) staining has been shown to be very useful in identifying acute proximal tubular injury, but its sensitivity, specificity and predicting values for the recovery of renal function after injury in renal biopsies have not been well established. In the first study, we randomly selected 184 renal biopsies from a wide age range of patients (children to elderly) with various renal diseases. KIM-1 staining scores were significantly correlated with serum creatinine (sCr) levels (P < 0.05) in all age groups. Receiver-operating characteristic curve (ROC) was generated to evaluate true-positive rate (sensitivity) and true-negative rate (1-specificity). The area under the curve (AUC) in pediatric cases was 0.74, which demonstrated KIM-1 was a fair index in correlating with sCr. In adults, the AUC was 0.87, indicating that KIM-1 was an even better index in the adult population in correlating to sCr. The second study was to determine whether KIM-1 could be a potential predictor of the recovery of acute kidney injury (AKI), and 51 indicated native biopsies with acute tubular injury were randomly selected for KIM-1 staining and sCr follow-up over a 6-month period. A higher KIM-1/sCr ratio (0.57 ± 0.06) was significantly and positively associated with a better reduction in sCr over 6 months. In summary, our data demonstrated that KIM-1 staining in renal biopsies is a sensitive and specific marker to identify acute tubular injury and KIM-1/sCr ratio is useful for predicting the recovery of renal function after injury, although some patients' sCr levels cannot return to their baseline levels.

Does earlier attainment of blood pressure goal translate into fewer cardiovascular events?

Recently, clinical trial data showed that rapid attainment of goal blood pressure (BP) reduces the risk for cardiovascular disease (CVD) events. It is unknown whether patient characteristics linked to the magnitude of CVD risk influence the speed of BP control. Time to attain goal systolic BP (SBP) in Kaplan-Meier survival curves was contrasted for strata of baseline characteristics and intensity of hypertension treatment. Survival analyses showed that albuminuria, diabetes, increased body mass index, millimeters of mercury above Joint National Committee (JNC) SBP goal, higher Framingham risk score, older age, depressed estimated glomerular filtration rate, and greater intensity of antihypertensive drug treatment all predicted slower JNC SBP goal attainment (P < 0.015); the intensity of antihypertensive drug therapy when goal BP was attained was also greater in all conditions linked to slow goal attainment. Cox proportional hazards model that included the above patient characteristics revealed all characteristics slowed attainment of JNC SBP goals (P < 0.03). Thus, patient characteristics influence speed of BP control and practitioners should avoid therapeutic inertia.

Risk Factors Associated With Antidepressant Exposure and History of Antidepressant-Induced Mania in Bipolar Disorder.

OBJECTIVE: Despite their widespread use in bipolar disorder, there is controversy surrounding the inclusion of antidepressant medications in the disorder's management. We sought to identify which demographic, socioeconomic, and clinical factors are associated with antidepressant exposure in bipolar disorder and which bipolar disorder patients are most likely to report a history of antidepressant-induced mania (AIM) when exposed to antidepressants. METHODS: Our study included subjects with bipolar I disorder (n = 309), bipolar II disorder (n = 66), and bipolar disorder not otherwise specified (n = 27) and schizoaffective disorder, bipolar type (n = 14), from a longitudinal, community-based study. Subjects were evaluated using the Diagnostic Interview for Genetic Studies, modified for DSM-IV criteria. We applied multivariate logistical regression modeling to investigate which factors contribute to antidepressant exposure in bipolar disorder patients. We also used a logistic regression modeling approach to determine which clinical factors in bipolar disorder patients are associated with a history of AIM. Data were gathered from February 2006 through December 2010. RESULTS: Our results suggest that the risk factors most strongly associated with antidepressant exposure are female sex (OR = 2.73, P = .005), older age (OR = 1.03, P = .04), greater chronicity of illness (OR = 2.29, P = .04), and, to a lesser extent, white race (OR = 0.44, P = .051). Factors associated with reduced antidepressant exposure include history of affective psychosis (OR = 0.36, P = .01) and a greater number of previous manic episodes (OR = 0.98, P = .03). In subjects who reported a history of AIM, regression analysis revealed that the only statistically significant factor associated with AIM history was female sex (OR = 3.74, P = .02). CONCLUSIONS: These data suggest that there are certain identifiable factors associated with antidepressant exposure in bipolar disorder patients, and some of these, specifically female sex, are also associated with a history of AIM. These data may be useful in designing prospective trials to identify interventions that can reduce the risk of this adverse outcome.

Improving Physical Health in Patients With Chronic Mental Disorders: Twelve-Month Results From a Randomized Controlled Collaborative Care Trial.

OBJECTIVE: Persons with chronic mental disorders are disproportionately burdened with physical health conditions. We determined whether Life Goals Collaborative Care compared to usual care improves physical health in patients with mental disorders within 12 months. METHODS: This single-blind randomized controlled effectiveness study of a collaborative care model was conducted at a midwestern Veterans Affairs urban outpatient mental health clinic. Patients (N = 293 out of 474 eligible approached) with an ICD-9-CM diagnosis of schizophrenia, bipolar disorder, or major depressive disorder and at least 1 cardiovascular disease risk factor provided informed consent and were randomized (February 24, 2010, to April 29, 2015) to Life Goals (n = 146) or usual care (n = 147). A total of 287 completed baseline assessments, and 245 completed 12-month follow-up assessments. Life Goals included 5 weekly sessions that provided semistructured guidance on managing physical and mental health symptoms through healthy behavior changes, augmented by ongoing care coordination. The primary outcome was change in physical health-related quality of life score (Veterans RAND 12-item Short Form Health Survey [VR-12] physical health component score). Secondary outcomes included control of cardiovascular risk factors from baseline to 12 months (blood pressure, lipids, weight), mental health-related quality of life, and mental health symptoms. RESULTS: Among patients completing baseline and 12-month outcomes assessments (N = 245), the mean age was 55.3 years (SD = 10.8; range, 25-78 years), and 15.4% were female. Intent-to-treat analysis revealed that compared to those in usual care, patients randomized to Life Goals had slightly increased VR-12 physical health scores (coefficient = 3.21; P = .01). CONCLUSIONS: Patients with chronic mental disorders and cardiovascular disease risk who received Life Goals had improved physical health-related quality of life. TRIAL REGISTRATION: ClinicalTrials.gov identifiers: NCT01487668 and NCT01244854.