Attributable Cost of Dementia: Demonstrating Pitfalls of Ignoring Multiple Health Care System Utilization.

OBJECTIVES: To determine dementia prevalence and costs attributable to dementia using Veterans Health Administration (VHA) data with and without Medicare data. DATA SOURCES: VHA inpatient, outpatient, purchased care and other data and Medicare enrollment, claims, and assessments in fiscal year (FY) 2013. STUDY DESIGN: Analyses were conducted with VHA data alone and with combined VHA and Medicare data. Dementia was identified from a VHA sanctioned list of ICD-9 diagnoses. Attributable cost of dementia was estimated using recycled predictions. DATA COLLECTION: Veterans age 65 and older who used VHA and were enrolled in Traditional Medicare in FY 2013 (1.9 million). PRINCIPAL FINDINGS: VHA records indicated the prevalence of dementia in FY 2013 was 4.8 percent while combined VHA and Medicare data indicated the prevalence was 7.4 percent. Attributable cost of dementia to VHA was, on average, $10,950 per veteran per year (pvpy) using VHA alone and $6,662 pvpy using combined VHA and Medicare data. Combined VHA and Medicare attributable cost of dementia was $11,285 pvpy. Utilization attributed to dementia using VHA data alone was lower for long-term institutionalization and higher for supportive care services than indicated in combined VHA and Medicare data. CONCLUSIONS: Better planning for clinical and cost-efficient care requires VHA and Medicare to share data for veterans with dementia and likely more generally.

Reevaluation of a clinical resource for assessment of delirium, dementia, and depression.

There is a perennial need to extend geriatrics knowledge and expertise to primary care providers to meet the unique needs of older patients. Reaching the target population of providers in an effective manner presents challenges for educators and evaluation of education programs. Gaps in a previous dissemination of an Assessment Guide for delirium, dementia, and depression were addressed through a multimodal strategy to reach a greater proportion of the intended audience, primary care clinicians, and to further evaluate the clinical impact of this learning resource. Sixty-five health care providers completed a forced choice online questionnaire. The majority of respondents were primary care providers (62.5%) who used the Assessment Guide in clinical activities such as patient assessment and patient education. Semistructured interviews with selected key informants (N = 16) provided examples of clinical impact such as improved diagnosis and changes in medication.

Early and multiple PSA bounces can occur following high-dose prostate stereotactic body radiation therapy: Subset analysis of a phase 1/2 trial.

PURPOSE: We hypothesized that high-dose stereotactic body radiation therapy (SBRT) would lead to faster time to nadir and lower nadir values compared with conventional radiation therapy experiences. We now report prostate-specific antigen (PSA) kinetics following high-dose SBRT in patients treated with radiation alone. METHODS AND MATERIALS: Ninety-one patients were enrolled on the phase 1/2 dose escalation study of SBRT for localized prostate cancer. All patients with at least 36 months of follow-up and without hormone therapy were included in this analysis (n = 47). Treatment response parameters evaluated include time to nadir, nadir value, occurrence of PSA bounces (rise of ≥0.2 ng/mL followed by a subsequent fall), magnitude of bounces, duration of bounces, and correlation of bounces with clinical outcomes. RESULTS: Median follow-up was 42 months (range, 36-78 months). Treatment dose levels were 45 Gy (n = 10), 47.5 Gy (n = 8), and 50 Gy (n = 29) in 5 fractions. Biochemical control rate was 98%. Median PSA at follow-up was 0.10 ± 0.20 ng/mL. Median time to nadir was 36 ± 11 months. A total of 24/47 (51.1%) patients had ≥1 PSA bounce. Median magnitude of PSA rise during bounce was 0.50 ± 1.2 ng/mL. Median time to first bounce was 9 ± 7.0 months. Median bounce duration was 3 ± 2.3 months for the first bounce and 6 ± 5.2 months for subsequent bounces. Prostate volumes <30 mL were associated with a decreased likelihood of bounce (P = .0202), and increasing prostate volume correlated with increasingly likelihood of having ≥2 bounces (P = .027). Patients reaching PSA nadir of ≤0.1 ng/mL were less likely to experience any bounce (P = .0044). CONCLUSIONS: Compared with other SBRT experiences, our study demonstrated a higher PSA bounce rate, a similar or shorter median time to bounce, and a very low nadir. Prostate volume appears correlated with bounce.

A Phase I/II Study of Nab-Paclitaxel, Cisplatin, and Cetuximab With Concurrent Radiation Therapy for Locally Advanced Squamous Cell Cancer of the Head and Neck.

Nab-paclitaxel might impact efficacy of radiation for head and neck (H&N) cancer. Nab-paclitaxel, cisplatin, cetuximab, and radiation were evaluated in patients with locally advanced head and neck cancer in this phase I/II trial. Median follow-up was 24 months for 34 patients. The maximum tolerated dose of nab-paclitaxel was 20 mg/m2 with 20 mg/m2 cisplatin and 250 mg/m2 cetuximab. The 2-year progression-free survival (PFS) was 60% (95% confidence interval (CI) 0.42, 0.78), local control 71% (95% CI 0.55, 0.87), and overall survival 68% (95% CI 0.50, 0.86). This is the first study evaluating these agents with radiation in humans, with similar 2-year PFS as historic control.

Stereotactic body radiation therapy for low and intermediate risk prostate cancer-Results from a multi-institutional clinical trial.

BACKGROUND: We report the outcome of a phase I/II clinical trial of stereotactic body radiation therapy (SBRT) for low (LR) and select intermediate risk (IR) prostate cancer (PCa) patients. PATIENTS AND METHODS: Eligible patients included men with prostate adenocarcinoma with Gleason score 6 with PSA ≤ 20 or Gleason 7 with PSA ≤ 15 and clinical stage ≤ T2b. For the phase I portion of the study patients in cohorts of 15 received 45, 47.5, or 50 Gray (Gy) in five fractions. Since the maximally tolerated dose was not met in the phase I study, an additional 47 patients received 50 Gy in five fractions in the phase II study. Toxicity using Common Toxicity Criteria for Adverse Events v. 3.0, quality of life, and outcome data was collected. RESULTS: A total of 91 patients are included for analysis; 63.7% had NCCN IR and 36.3% had LR PCa. At a median follow up of 54 months the actuarial freedom from biochemical failure was 100% at 3 years and 98.6% at 5 years. Actuarial distant metastasis free survival was 100% at 3 and 5 years. Overall survival was 94% at 3 years and 89.7% at 5 years with no deaths attributed to PCa. Acute and late urinary grade ≥ III toxicity occurred in 0% and 5.5% of patients, respectively. Gastrointestinal (GI) acute and late toxicity of grade ≥ III occurred in 2% and 7% of patients, respectively. A total of four men experienced grade IV toxicity (three GI, one genitourinary). CONCLUSION: SBRT treatment results in excellent biochemical control rates at 5 years for LR and IR PCa patients although doses greater than 47.5 Gy in five fractions led to increased severe late toxicity.

Predictors of rectal tolerance observed in a dose-escalated phase 1-2 trial of stereotactic body radiation therapy for prostate cancer.

PURPOSE: To convey the occurrence of isolated cases of severe rectal toxicity at the highest dose level tested in 5-fraction stereotactic body radiation therapy (SBRT) for localized prostate cancer; and to rationally test potential causal mechanisms to guide future studies and experiments to aid in mitigating or altogether avoiding such severe bowel injury. METHODS AND MATERIALS: Clinical and treatment planning data were analyzed from 91 patients enrolled from 2006 to 2011 on a dose-escalation (45, 47.5, and 50 Gy in 5 fractions) phase 1/2 clinical study of SBRT for localized prostate cancer. RESULTS: At the highest dose level, 6.6% of patients treated (6 of 91) developed high-grade rectal toxicity, 5 of whom required colostomy. Grade 3+ delayed rectal toxicity was strongly correlated with volume of rectal wall receiving 50 Gy >3 cm(3) (P<.0001), and treatment of >35% circumference of rectal wall to 39 Gy (P=.003). Grade 2+ acute rectal toxicity was significantly correlated with treatment of >50% circumference of rectal wall to 24 Gy (P=.010). CONCLUSION: Caution is advised when considering high-dose SBRT for treatment of tumors near bowel structures, including prostate cancer. Threshold dose constraints developed from physiologic principles are defined, and if respected can minimize risk of severe rectal toxicity.

Phase I dose-escalation study of stereotactic body radiation therapy for low- and intermediate-risk prostate cancer.

PURPOSE: To evaluate the tolerability of escalating doses of stereotactic body radiation therapy in the treatment of localized prostate cancer. PATIENTS AND METHODS: Eligible patients included those with Gleason score 2 to 6 with prostate-specific antigen (PSA) ≤ 20, Gleason score 7 with PSA ≤ 15, ≤ T2b, prostate size ≤ 60 cm(3), and American Urological Association (AUA) score ≤ 15. Pretreatment preparation required an enema and placement of a rectal balloon. Dose-limiting toxicity (DLT) was defined as grade 3 or worse GI/genitourinary (GU) toxicity by Common Terminology Criteria of Adverse Events (version 3). Patients completed quality-of-life questionnaires at defined intervals. RESULTS: Groups of 15 patients received 45 Gy, 47.5 Gy, and 50 Gy in five fractions (45 total patients). The median follow-up is 30 months (range, 3 to 36 months), 18 months (range, 0 to 30 months), and 12 months (range, 3 to 18 months) for the 45 Gy, 47.5 Gy, and 50 Gy groups, respectively. For all patients, GI grade ≥ 2 and grade ≥ 3 toxicity occurred in 18% and 2%, respectively, and GU grade ≥ 2 and grade ≥ 3 toxicity occurred in 31% and 4%, respectively. Mean AUA scores increased significantly from baseline in the 47.5-Gy dose level (P = .002) as compared with the other dose levels, where mean values returned to baseline. Rectal quality-of-life scores (Expanded Prostate Cancer Index Composite) fell from baseline up to 12 months but trended back at 18 months. In all patients, PSA control is 100% by the nadir + 2 ng/mL failure definition. CONCLUSION: Dose escalation to 50 Gy has been completed without DLT. A multicenter phase II trial is underway treating patients to 50 Gy in five fractions to further evaluate this experimental therapy.

Dissemination strategies: the evolution of learning resources on the evaluation of delirium, dementia, and depression.

Clinicians experience great pressures to provide timely, effective, and evidence-based medical care. Educators can aid these clinicians through the development of new tools that can facilitate timely completion of clinical tasks. These tools should summarize evidence-based information in a convenient format that allows easy use. This article describes one process in which a group of Geriatric Research, Education, and Clinical Center educators identified an area where important new information accrued, their development of a new clinical and teaching tool for imparting the new information, the initial dissemination of the tool to a preliminary target audience, and the initial evaluation of the new tool to determine how to improve its distribution and use beyond the original target audience.

Cognitive enhancement therapy for early-course schizophrenia: effects of a two-year randomized controlled trial.

OBJECTIVE: The early application of cognitive rehabilitation may afford long-term functional benefits to patients with schizophrenia. This study examined the two-year effects of an integrated neurocognitive and social-cognitive rehabilitation program, cognitive enhancement therapy (CET), on cognitive and functional outcomes in early-course schizophrenia. METHODS: Early-course outpatients (mean+/-SD illness duration=3.19+/-2.24 years) with schizophrenia or schizoaffective disorder were randomly assigned to CET (N=31) or enriched supportive therapy (EST) (N=27), an illness management intervention utilizing psychoeducation and applied coping strategies, and treated for two years. Multivariate composite indexes of cognitive, social adjustment, and symptom domains were derived from assessment batteries administered annually by computer-based tests and raters not blind to treatment assignment. RESULTS: Of the 58 participants who were randomly assigned and treated, 49 and 46 completed one year and two years of treatment, respectively. Intent-to-treat analyses showed significant differential effects favoring CET on social cognition, cognitive style, social adjustment, and symptomatology composites during the first year of treatment. After two years, moderate effects (d=.46) were observed favoring CET for enhancing neurocognitive function. Strong differential effects (d>1.00) on social cognition, cognitive style, and social adjustment composites remained at year 2 and also extended to measures of symptomatology, particularly negative symptoms. CONCLUSIONS: CET appears to be an effective approach to the remediation of cognitive deficits in early schizophrenia that may help reduce disability in this population. The remediation of such deficits should be an integral component of early intervention programs treating psychiatrically stable schizophrenia outpatients.

Service delivery in older patients with bipolar disorder: a review and development of a medical care model.

OBJECTIVES: Medical comorbidities, especially cardiovascular disease (CVD), occur disproportionately in older patients with bipolar disorder. We describe the development, implementation, and feasibility/tolerability results of a manual-based medical care model (BCM) designed to improve medical outcomes in older patients with bipolar disorder. METHODS: The BCM consisted of (i) self-management sessions focused on bipolar disorder symptom control, healthy habits, and provider engagement, (ii) telephone care management to coordinate care and reinforce self-management goals, and (iii) guideline dissemination focused on medical issues in bipolar disorder. Older patients with bipolar disorder and a CVD-related risk factor (n = 58) were consented, enrolled, and randomized to receive BCM or usual care. RESULTS: Baseline assessment (mean age = 55, 9% female, 9% African American) revealed a vulnerable population: 21% were substance users, 31% relied on public transportation, and 22% reported problems accessing medical care. Evaluation of BCM feasibility revealed high overall patient satisfaction with the intervention, high fidelity (e.g., majority of self-management sessions and follow-up contacts completed), and good tolerability (dropout rate <5%). Use of telephone contacts may have mitigated barriers to medical care (e.g., transportation). CONCLUSIONS: The BCM is a feasible model for older, medically ill patients with bipolar disorder, and could be an alternative to more costly treatment models that involve co-location and/or additional hiring of medical providers in mental health clinics. Future research directions pertinent to the development of the BCM and other medical care models for older patients with bipolar disorder include assessment of their long-term effects on physical health and their cost-effectiveness across different treatment settings.

Improving medical and psychiatric outcomes among individuals with bipolar disorder: a randomized controlled trial.

OBJECTIVES: Comorbid medical conditions, notably cardiovascular disease, occur disproportionately among persons with bipolar disorder; yet the quality and outcomes of medical care for these individuals are suboptimal. This pilot study examined a bipolar disorder medical care model (BCM) and determined whether, compared with usual care, individuals randomly assigned to receive BCM care had improved medical and psychiatric outcomes. METHODS: Persons with bipolar disorder and cardiovascular disease-related risk factors were recruited from a large Department of Veterans Affairs mental health facility and randomly assigned to receive BCM or usual care. BCM care consisted of four self-management sessions on bipolar disorder symptom control strategies, education and behavioral change related to cardiovascular disease risk factors, and promotion of provider engagement. Primary outcomes were physical and mental health-related quality of life; secondary outcomes included functioning and bipolar symptoms. RESULTS: Fifty-eight persons participated. Twenty-seven received BCM care, and 31 received usual care. The mean+/-SD age was 55+/-8 years, 9% were female, 90% were white, and 10% were African American. Repeated-measures analysis was used, and significant differences were observed between the two groups in change in scores from baseline to six months for the 12-Item Short-Form Health Survey (SF-12) subscale for physical health (t=2.01, df=173, p=.04), indicating that the usual care group experienced a decline in physical health over the study period. Change in SF-12 scores also indicated that compared with the usual care group, the BCM group showed improvements in mental health-related quality of life over the six-month study period; however, this finding was not significant. CONCLUSIONS: Compared with usual care, BCM care may have slowed the decline in physical health-related quality of life. Further studies are needed to determine whether BCM care leads to long-term positive changes in physical and mental health-related quality of life and reduced risk of cardiovascular disease among persons with bipolar disorder.

The continuous improvement for veterans in care: Mood Disorders (civic-md) Study, a VA-academic partnership.

The Department of Veterans Affairs (VA) provides an ideal opportunity to conduct mental health services research among vulnerable populations, given its extensive data sources, disproportionate number of vulnerable patients (older, often with comorbidities), and quality improvement mission. Although VA facilities are often affiliated with universities, successful VA-academic research partnerships are sometimes elusive. The Continuous Improvement for Veterans in Care: Mood Disorders (CIVIC-MD) study was a partnership with a VA facility that had not been engaged in mood disorders research. This column describes how the partnership formed, key elements of its success, and challenges and opportunities to inform future research partnerships.

Longitudinal course of substance treatment benefits in older male veteran at-risk drinkers.

BACKGROUND: This investigation aims to determine the 12-month drinking trajectory of older at-risk drinkers in treatment. Furthermore, the drinking trajectory between at-risk drinkers who had met the threshold suggestive of alcohol dependence (problem at-risk drinkers) and those who did not meet this threshold (nonproblematic at-risk drinkers) were compared. METHODS: This investigation is a component of the PRISM-E (Primary Care Research in Substance Abuse and Mental Health for the Elderly) Study, a multisite randomized trial comparing service use, outcomes, and cost between Integrated (IC) versus Enhanced Specialty Referral (ESR) care models for older (65+ years) adults with depression, anxiety, and/or at-risk alcohol consumption. This investigation focuses only on at-risk drinkers, generally defined as exceeding recommended drinking limits, which in the case of older adults has been classified as consuming more than one drink per day. Two hundred fifty-eight randomized older at-risk drinkers were examined, of whom 56% were problem drinkers identified through the Short Michigan Alcohol Screening Test-Geriatric version. RESULTS: Over time, all at-risk drinkers showed a significant reduction in drinking. Problem drinkers showed reductions in average weekly consumption and number of occurrences of binge drinking at 3, 6, and 12 months, whereas nonproblematic drinkers showed significant reductions in average weekly consumption at 3, 6, and 12 months and number of occurrences of binge drinking at only 6 months. IC treatment assignment led to higher engagement in treatment, which led to better binge drinking outcomes for problem drinkers. Despite significant reductions in drinking, approximately 29% of participants displayed at-risk drinking at the end of the study. CONCLUSIONS: Results suggest that older at-risk drinkers, both problem and nonproblematic, show a considerable decrease in drinking, with slightly greater improvement evidenced in problem drinkers and higher engagement in treatment seen in those assigned to IC.

Effect of depression treatment on depressive symptoms in older adulthood: the moderating role of pain.

OBJECTIVES: To investigate whether pain severity and interference with normal work activities moderate the effects of depression treatment on changes in depressive symptoms over time in older adults in primary care. DESIGN: Patient-randomized, clinical trial. SETTING: Multisite: three clinics located in Veterans Affairs Medical Centers. PARTICIPANTS: Adults aged 60 and older (n=524) who screened positive for depression and participated in the Primary Care Research in Substance Abuse and Mental Health for the Elderly Study. INTERVENTION: Integrated care versus enhanced specialty referral care. MEASUREMENTS: Pain severity, the degree to which pain interferes with work inside and outside of the home, and depressive symptoms were examined at baseline and 3, 6, and 12 months. RESULTS: Intention-to-treat analyses revealed that both treatment groups showed reduced depressive symptoms over time, although self-reported pain moderated reductions in depressive symptoms. At higher levels of pain severity and interference with work activities, improvements in depressive symptoms were blunted. Furthermore, pain interference appeared to have a greater effect on depressive symptoms than did pain severity; in individuals with major depression, pain interference fully accounted for the moderating effects of pain severity on changes in depressive symptoms over time. CONCLUSION: Pain and its interference with functioning interfere with recovery from depression. Findings highlight the importance of addressing multiple domains of functioning (e.g., physical and social disability) and the degree to which pain and other forms of physical comorbidity may hinder or minimize treatment-related improvements in depressive symptoms.

Cognitive enhancement therapy for schizophrenia: effects of a 2-year randomized trial on cognition and behavior.

BACKGROUND: Deficits in social cognition and neurocognition are believed to underlie schizophrenia disability. Attempts at rehabilitation have had circumscribed effects on cognition, without concurrent improvement in broad aspects of behavior and adjustment. OBJECTIVE: To determine the differential effects of cognitive enhancement therapy (a recovery-phase intervention) on cognition and behavior compared with state-of-the-art enriched supportive therapy. DESIGN: A 2-year, randomized controlled trial with neuropsychological and behavioral assessments completed at baseline and at 12 and 24 months. SETTING: An outpatient research clinic housed in a medical center's comprehensive care service for patients with severe mental illness. PATIENTS: A total of 121 symptomatically stable, non-substance-abusing but cognitively disabled and chronically ill patients with schizophrenia or schizoaffective disorder. INTERVENTIONS: Cognitive enhancement therapy is a multidimensional, developmental approach that integrates computer-assisted training in neurocognition with social cognitive group exercises. Enriched supportive therapy fosters illness management through applied coping strategies and education. MAIN OUTCOME MEASURES: Six highly reliable summary measures--Processing Speed, Neurocognition, Cognitive Style, Social Cognition, Social Adjustment and Symptoms--were tested using analysis of covariance and linear trend analysis. RESULTS: At 12 months, robust cognitive enhancement therapy effects were observed on the Neurocognition and Processing Speed composites (P<.003), with marginal effects observed on the behavioral composites. By 24 months, differential cognitive enhancement therapy effects were again observed for the 2 neuropsychological composites and for Cognitive Style (P=.001), Social Cognition (P=.001), and Social Adjustment (P=.01). As expected, no differences were observed on the residual Symptoms composite. Effects were unrelated to the type of antipsychotic medication received. Enriched supportive therapy also demonstrated statistically significant within-group effect sizes, suggesting that supportive psychotherapy can also have positive, although more modest, effects on cognitive deficits. CONCLUSION: Many cognitive deficits and related behaviors of patients with stable schizophrenia are improved when sufficient exposure to relevant rehabilitation is provided.

Reach Out and Read: a pediatric clinic-based approach to early literacy promotion.

Approximately 90 million adults in the United States read at a level that limits their ability to function as full members of society or limits their ability to meet their basic needs. Reading success as an adult is related to early literacy experiences. Reading aloud by parents is the single most critical factor in a child's reading success later in life. Children in households where there is little exposure to reading are at risk for reading failure even before entering school. As primary health care providers, pediatric nurse practitioners are in a unique position to affect and encourage parental behaviors that foster early literacy development in children. Literacy should become incorporated as an integral component of health promotion for children. Reach Out and Read is a successful literacy program in the United States that can be easily adopted by pediatric nurse practitioners in primary care settings.