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1.  How context affects electronic health record-based test result follow-up: a mixed-methods evaluation 
BMJ Open  2014;4(11):e005985.
Objectives
Electronic health record (EHR)-based alerts can facilitate transmission of test results to healthcare providers, helping ensure timely and appropriate follow-up. However, failure to follow-up on abnormal test results (missed test results) persists in EHR-enabled healthcare settings. We aimed to identify contextual factors associated with facility-level variation in missed test results within the Veterans Affairs (VA) health system.
Design, setting and participants
Based on a previous survey, we categorised VA facilities according to primary care providers’ (PCPs’) perceptions of low (n=20) versus high (n=20) risk of missed test results. We interviewed facility representatives to collect data on several contextual factors derived from a sociotechnical conceptual model of safe and effective EHR use. We compared these factors between facilities categorised as low and high perceived risk, adjusting for structural characteristics.
Results
Facilities with low perceived risk were significantly more likely to use specific strategies to prevent alerts from being lost to follow-up (p=0.0114). Qualitative analysis identified three high-risk scenarios for missed test results: alerts on tests ordered by trainees, alerts ‘handed off’ to another covering clinician (surrogate clinician), and alerts on patients not assigned in the EHR to a PCP. Test result management policies and procedures to address these high-risk situations varied considerably across facilities.
Conclusions
Our study identified several scenarios that pose a higher risk for missed test results in EHR-based healthcare systems. In addition to implementing provider-level strategies to prevent missed test results, healthcare organisations should consider implementing monitoring systems to track missed test results.
doi:10.1136/bmjopen-2014-005985
PMCID: PMC4244393  PMID: 25387758
Elecronic Health Records; Missed Test Results; Patient Follow-up; Social-Technical Model; Patient Safety; Diagnostic Errors
2.  EFFECTS OF DEPRESSION AND SOCIAL SUPPORT ON COMPREHENSION AND RECALL OF INFORMED CONSENT INFORMATION AMONG PARKINSON DISEASE PATIENTS AND THEIR CAREGIVERS* 
Objective
Relatively little attention has focused on the impact of psychiatric conditions on human subjects’ comprehension of consent information. The purpose of this randomized study was to determine whether depression affects comprehension and recall of informed consent information among persons with Parkinson's disease and their caregivers and to evaluate the effects of support on comprehension and recall during the consent process.
Method
Comprehension and recall of information were assessed using a modified version of the Modified Quality of Informed Consent Questionnaire, taken 1 week and 1 month later, and scored using a consensus-based algorithm. Participants also completed the Center for Epidemiologic Studies Depression Scale. Data analyses were conducted on 129 patients and caregivers (t-tests, Fisher's exact test, and ANCOVAs).
Results
T-tests showed no significant differences in comprehension and recall between depressed and nondepressed participants at 1 week and 1 month. However, ANCOVA showed patients with a support person present had significantly higher comprehension and recall at 1 week but not at 1 month compared with controls. Caregivers present with a patient had lower comprehension/recall than those without a patient present (p = 0.02).
Conclusions
Having a support person present during the informed consent process helps depressed PD patients better retain information in the short term, but effects diminish over the long term. Implications for interventions will be discussed.
PMCID: PMC4147836  PMID: 22641931
informed consent; Parkinson disease; depression
3.  The Peaceful Mind Program: A Pilot Test of a CBT-Based Intervention for Anxious Patients with Dementia 
Objectives
To assess feasibility and to conduct a preliminary evaluation of outcomes following Peaceful Mind, a CBT-based intervention for anxiety in dementia, relative to usual care (UC).
Design
Pilot randomized controlled trial including assessments at baseline, 3 and 6 months
Setting
Houston, TX
Participants
32 outpatients diagnosed with mild (47%) or moderate (53%) dementia receiving care through outpatient clinics at the Veterans Affairs medical center, Baylor College of Medicine, Harris County Hospital District and community day centers for dementia, and their collaterals, who spent at least 8 hours a week with them.
Intervention
Peaceful Mind included up to 12 weekly in-home sessions (mean = 8.7, SD = 2.27) during the initial 3 months and up to eight brief telephone sessions (mean = 5.4, SD = 3.17) during months 3 to 6, involving self-monitoring for anxiety, deep breathing, and optional skills (coping self-statements, behavioral activation and sleep management). Patients learned skills, and collaterals served as coaches. In UC, patients received diagnostic feedback; and providers were informed of inclusion status.
Measurements
Neuropsychiatric Inventory-Anxiety subscale, Rating Anxiety in Dementia scale, Penn State Worry Questionnaire-Abbreviated, Geriatric Anxiety Inventory, Geriatric Depression Scale, Quality of Life in Alzheimer’s disease, Patient Health Questionnaire, Client Satisfaction Questionnaire
Results
Feasibility was demonstrated with regard to recruitment, attrition, and treatment characteristics. At 3 months, clinicians rated patients receiving Peaceful Mind as less anxious, and patients rated themselves as having higher quality of life; collaterals reported less distress related to loved ones’ anxiety. Although significant positive effects were not noted in other outcomes or at 6-month follow-up, the pilot nature of the trial prohibits conclusions about efficacy.
Conclusions
Results support that Peaceful Mind is ready for future comparative clinical trials.
doi:10.1016/j.jagp.2013.01.007
PMCID: PMC3411894  PMID: 23567399
anxiety; dementia; cognitive behavioral therapy; self-ratings; proxy ratings
5.  Behavioral health coaching for rural veterans with diabetes and depression: a patient randomized effectiveness implementation trial 
Background
Depression and diabetes cause significant burden for patients and the healthcare system and, when co-occurring, result in poorer self-care behaviors and worse glycemic control than for either condition alone. However, the clinical management of these comorbid conditions is complicated by a host of patient, provider, and system-level barriers that are especially problematic for patients in rural locations. Patient-centered medical homes provide an opportunity to integrate mental and physical health care to address the multifaceted needs of complex comorbid conditions. Presently, there is a need to not only develop robust clinical interventions for complex medically ill patients but also to find feasible ways to embed these interventions into the frontlines of existing primary care practices.
Methods/design
This randomized controlled trial uses a hybrid effectiveness-implementation design to evaluate the Healthy Outcomes through Patient Empowerment (HOPE) intervention, which seeks to simultaneously address diabetes and depression for rural veterans in Southeast Texas. A total of 242 Veterans with uncontrolled diabetes and comorbid symptoms of depression will be recruited and randomized to either the HOPE intervention or to a usual-care arm. Participants will be evaluated on a host of diabetes and depression-related measures at baseline and 6- and 12-month follow-up. The trial has two primary goals: 1) to examine the effectiveness of the intervention on both physical (diabetes) and emotional health (depression) outcomes and 2) to simultaneously pilot test a multifaceted implementation strategy designed to increase fidelity and utilization of the intervention by coaches interfacing within the primary care setting.
Discussion
This ongoing blended effectiveness-implementation design holds the potential to advance the science and practice of caring for complex medically ill patients within the constraints of a busy patient-centered medical home.
Trial registration
Behavioral Activation Therapy for Rural Veterans with Diabetes and Depression: NCT01572389.
doi:10.1186/1472-6963-14-191
PMCID: PMC4045905  PMID: 24774351
Behavioral medicine; Diabetes mellitus; Depression; Veterans’ health
6.  Information Overload and Missed Test Results in EHR-based Settings 
JAMA internal medicine  2013;173(8):10.1001/2013.jamainternmed.61.
doi:10.1001/2013.jamainternmed.61
PMCID: PMC3822526  PMID: 23460235
diagnostic errors; patient safety; test results; care delays; health information technology; primary care; electronic health records; usability
7.  Peaceful Mind: An Open Trial of Cognitive-Behavioral Therapy for Anxiety in Persons With Dementia 
International psychogeriatrics / IPA  2010;22(6):1012-1021.
Background
Anxiety has a high prevalence among individuals with dementia, and it has a significant negative impact on their functioning; yet intervention studies are lacking. We developed Peaceful Mind, a cognitive-behavioral intervention for persons with dementia. In this article, we describe the intervention and results of an open trial evaluating the feasibility and utility of the intervention and assessment procedures.
Methods
Peaceful Mind is implemented over a period of 3 months in the participant's home with involvement of a caregiver or “collateral.” Dyads are followed for an additional 3 months via telephone. An assortment of simplified skills is offered, including self-awareness, breathing, behavioral activation, calming thoughts, and sleep skills.
Results
Nine participants were enrolled, eight completed the 3-month assessment, and seven completed the 6-month assessment. Overall, participants and collaterals were satisfied with the intervention and reported that they benefited in terms of anxiety, depression, and collateral distress.
Conclusions
A randomized controlled trial would help determine whether this promising new treatment has a statistically significant impact on anxiety in this population.
doi:10.1017/S1041610210000694
PMCID: PMC3071800  PMID: 20550745
CBT; caregiver; intervention; home
8.  Concordance of Self- and Proxy-Rated Worry and Anxiety Symptoms in Older Adults with Dementia 
Journal of anxiety disorders  2012;27(1):125-130.
We compared the psychometric performance of two validated self-report anxiety- symptom measures when rated by people with dementia versus collaterals (as proxies). Forty-one participants with mild-to-moderate dementia and their respective collaterals completed the Geriatric Anxiety Inventory, the Penn State Worry Questionnaire-Abbreviated, and a structured diagnostic interview. We used descriptive and nonparametric statistics to compare scores according to respondent characteristics. Receiver operating characteristic (ROC) curves were calculated to establish the predictive validity of each instrument by rater type against a clinical diagnosis of an anxiety disorder. Participant and collateral ratings performed comparably for both instruments. However, collaterals tended to give more severe symptom ratings, and the best-performing cut-off scores were higher for collaterals. Our findings suggest that people with mild-to-moderate dementia can give reliable self-reports of anxiety symptoms, with validity comparable to reports obtained from collaterals. Scores obtained from multiple informants should be interpreted in context.
doi:10.1016/j.janxdis.2012.11.001
PMCID: PMC3578141  PMID: 23270995
worry; anxiety; elders; dementia; self-ratings; proxy ratings
9.  Utilization and Determinants of Adjuvant Therapy among Older Patients who Receive Curative Surgery for Pancreatic Cancer 
Pancreas  2009;38(1):10.1097/MPA.0b013e318187eb3f.
OBJECTIVE
We conducted a population-based study to describe the utilization, determinants, and survival effects of adjuvant therapies following surgery among older patients with pancreatic cancer.
METHODS
Using SEER-Medicare data, we identified patients >65 years who received surgical resection for pancreatic cancer during 1992–2002. We constructed multiple logistic regression models to examine patient, clinical, and hospital factors associated with receiving adjuvant therapy. Cox proportional hazards models were used to examine the effect of therapy on survival.
RESULTS
Approximately 49% of patients received adjuvant therapy following surgery. Patient factors associated with increased receipt of adjuvant therapy included more recent diagnosis, younger age, stage II disease, higher income, and geographic location. Hospital factors associated with increased receipt of adjuvant therapy included cooperative group membership and larger size. Adjuvant treatments associated with a significant reduction in 2-year mortality (relative to surgery alone) were chemoradiation or radiation alone, but not chemotherapy alone.
CONCLUSIONS
Our findings suggest that adjuvant chemoradiation and to a lesser degree radiation only, are associated with a reduction in the risk of mortality among older patients who undergo surgery for pancreatic cancer. However, receipt of adjuvant therapy varied by time period and geography as well as certain patient and hospital factors.
doi:10.1097/MPA.0b013e318187eb3f
PMCID: PMC3835699  PMID: 18797424
Pancreatic cancer; adjuvant therapy; SEER-Medicare
10.  Identification of Rheumatoid Arthritis Patients Using an Administrative Database: A Veterans Affairs Study 
Arthritis care & research  2012;64(10):1490-1496.
The accuracy of the diagnosis is vital when administrative databases are used for pharmacoepidemiologic and outcome studies. Data pertaining to the utility of databases for rheumatoid arthritis (RA) is sparse and variable. We assessed the utility of various diagnostic algorithms to identify RA patients within the Veterans Health Administration (VHA) databases.
Using the ICD code for RA at two visits, at least six months apart, we identified 1779 patients between 10/1/1998 and 9/30/2009 in our local Veteran Affairs Medical Center administrative database. Disease Modifying Anti Rheumatic Drugs (DMARD) use was ascertained from the pharmacy database. Cases were analyzed based on DMARD therapy and RA codes at clinic visits. 543 patients' medical records selected by stratification and random selection on the basis of their visits were reviewed to ascertain the clinicians' diagnoses and clinical criteria documentation. Positive predictive values (PPV) were calculated for various database case identification algorithms using diagnosis of RA by medical record review as the gold standard.
PPV for identification of RA with two RA codes six months apart was 30.9%. Addition of DMARD therapy increased the PPV to 60.4%. The PPV further increased to 91.4% when having RA code at the last VAMC rheumatology clinic visit criterion was added.
An algorithm using only two administrative RA codes six months apart had a low PPV for correctly identifying patients with RA in the VHA database. Including DMARD therapy and requiring a RA code at the last visit with a rheumatologist increased the performance of the data extraction algorithm.
doi:10.1002/acr.21736
PMCID: PMC3430829  PMID: 22623324
Rheumatoid Arthritis; Health Services Research; Computerized records; Databases; ICD codes
11.  Older Patients’ Enthusiasm to Use Electronic Mail to Communicate With Their Physicians: Cross-Sectional Survey 
Background
Recent evidence indicates increased access to and use of Internet and non-healthcare-related email by older patients. Because email adoption could potentially reduce some of the disparities faced by this age group, there is a need to understand factors determining older patients’ enthusiasm to use email to communicate with their physicians. Electronic mail (email) represents a means of communication that, coupled with face-to-face communication, could enhance quality of care for older patients.
Objective
Test a model to determine factors associated with older patients’ enthusiasm to use email to communicate with their physicians.
Methods
We conducted a secondary data analysis of survey data collected in 2003 for two large, longitudinal, randomized controlled trials. Logistic-regression models were used to model the dichotomous outcome of patient enthusiasm for using email to communicate with their physicians. Explanatory variables included demographic characteristics, health status, use of email with people other than their physician, characteristics of the physician-patient relationship, and physician enthusiasm to use email with patients.
Results
Participants included a pooled sample of 4059 patients over 65 years of age and their respective physicians (n = 181) from community-based practices in Southern California. Although only 52 (1.3%) patient respondents reported that they communicated with their physician by email, about half (49.3%) expressed enthusiasm about the possibility of using it. Odds of being enthusiastic decreased with increased age (by 0.97 for each year over 66) but were significantly higher in African Americans (OR = 2.1, CI = 1.42 - 3.06), Hispanics (OR = 1.6, CI = 1.26 - 2.14) and men (OR = 1.3, CI = 1.1 - 1.5).
A perception of better communication skills of their physician, lower quality of interaction with physician in traditional face-to-face encounters, and physician enthusiasm to use email with patients were significantly associated with an enthusiasm to use email. Patients who did not use email at all were less enthusiastic compared to those who used email for other reasons. Half of the physician respondents were not enthusiastic about communicating with patients using email.
Conclusions
Despite perceived barriers such as limited access to the Internet, older patients seem to want to use email to communicate with their physicians.
doi:10.2196/jmir.1143
PMCID: PMC2762805  PMID: 19632972
Electronic mail; doctor-patient communication; Internet; doctor-patient relationship
12.  Psychometric Properties of a Structured Interview Guide for the Rating for Anxiety in Dementia (RAID-SI) 
Aging & mental health  2012;16(5):592-602.
OBJECTIVES
The Rating Anxiety in Dementia (RAID; Shankar et al, 1999)is a clinical rating scale developed to evaluate anxiety in persons with dementia. This report explores the psychometric properties and clinical utility of a new structured interview format of the RAID (RAID-SI), developed to standardize administration and scoring based on information obtained from the patient, an identified collateral, and rater observation.
METHOD
The RAID-SI was administered by trained master’s level raters. Participants were 32 persons with dementia who qualified for an anxiety treatment outcome study. Self-report anxiety, depression, and quality of life measures were administered to both the person with dementia and a collateral.
RESULTS
The RAID-SI exhibited adequate internal consistency reliability and inter-rater reliability. There was also some evidence of construct validity as indicated by significant correlations with other measures of patient-reported and collateral-reported anxiety, and non-significant correlations with collateral reports of patient depression and quality of life. Further, RAID-SI scores were significantly higher in persons with an anxiety diagnosis compared to those without an anxiety diagnosis.
CONCLUSION
There is evidence that the RAID-SI exhibits good reliability and validity in older adults with dementia. The advantage of the structured interview format is increased standardization in administration and scoring, which may be particularly important when RAID raters are not experienced clinicians.
doi:10.1080/13607863.2011.644518
PMCID: PMC3371288  PMID: 22372475
dementia; anxiety; clinical interview; assessment; Rating for Anxiety in Dementia
13.  Development and Validation of a Measure for Intention to Adhere to HIV Treatment 
AIDS Patient Care and STDs  2012;26(6):329-334.
Abstract
We present the development and validation of a theory-derived scale measuring patients' behavioral intention to adhere to HIV care. Adherence to HIV care includes attendance at appointments and adherence to highly active antiretroviral therapy (HAART) regimens. These two components have been independently associated with long-term HIV outcomes. Items were chosen to reflect behavioral intention as defined by the Health Action Process Approach to health-seeking behavior. Items reflecting self-reported HIV knowledge were also included after expert panel review. The study took place from October 2009 to April 2010 at two HIV clinics in Houston, Texas. Participants were 287 adults with HIV/AIDS (10.1% female, mean age 50.8); 56.5% were African-American and 17% were Hispanic. Of the total, 87.1% were on HAART at enrollment. Factor analysis of survey items resulted in the retention of two domains, knowledge and intention, based on scree plot analysis of eigenvalues. Questions with factor loadings >0.4 were retained, yielding 4 knowledge questions and 10 intention questions. The survey had good internal consistency for knowledge (Cronbach's α=0.83) and for intention (Cronbach's α=0.81). In multivariate analysis, intention was associated with HIV viral suppression, defined as HIV-1 viral load <400 RNA copies/mL, (odds ratio [OR]=1.75, 95% .confidence interval [CI]=1.00–3.07). Knowledge was also associated with HIV suppression (OR=1.55, 95%, CI=1.09–2.12). The resulting study describes the development and preliminary validation of an HIV treatment-seeking intention measure. Additional studies are needed to validate this instrument in other populations.
doi:10.1089/apc.2011.0318
PMCID: PMC3412581  PMID: 22680281
14.  Implementation of Stroke Dysphagia Screening in the Emergency Department 
Nursing Research and Practice  2013;2013:304190.
Early detection of dysphagia is critical in stroke as it improves health care outcomes. Administering a swallowing screening tool (SST) in the emergency department (ED) appears most logical as it is the first point of patient contact. However, feasibility of an ED nurse-administered SST, particularly one involving trial water swallow administration, is unknown. The aims of this pilot study were to (1) implement an SST with a water swallow component in the ED and track nurses' adherence, (2) identify barriers and facilitators to administering the SST through interviews, and (3) develop and implement a process improvement plan to address barriers. Two hundred seventy-eight individuals with stroke symptoms were screened from October 2009 to June 2010. The percentage of patients screened increased from 22.6 in October 2009 to a high of 80.8 in March 2010, followed by a decrease to 61.9% in June (Cochran-Armitage test z = −5.1042,  P < 0.0001). The odds of being screened were 4.0 times higher after implementation compared to two months before implementation. Results suggest that it is feasible for ED nurses to administer an SST with a water swallow component. Findings should facilitate improved quality of care for patients with suspected stroke and improve multidisciplinary collaboration in swallowing screening.
doi:10.1155/2013/304190
PMCID: PMC3595673  PMID: 23533742
15.  Primary care practitioners’ views on test result management in EHR-enabled health systems: a national survey 
Context
Failure to notify patients of test results is common even when electronic health records (EHRs) are used to report results to practitioners. We sought to understand the broad range of social and technical factors that affect test result management in an integrated EHR-based health system.
Methods
Between June and November 2010, we conducted a cross-sectional, web-based survey of all primary care practitioners (PCPs) within the Department of Veterans Affairs nationwide. Survey development was guided by a socio-technical model describing multiple inter-related dimensions of EHR use.
Findings
Of 5001 PCPs invited, 2590 (51.8%) responded. 55.5% believed that the EHRs did not have convenient features for notifying patients of test results. Over a third (37.9%) reported having staff support needed for notifying patients of test results. Many relied on the patient's next visit to notify them for normal (46.1%) and abnormal results (20.1%). Only 45.7% reported receiving adequate training on using the EHR notification system and 35.1% reported having an assigned contact for technical assistance with the EHR; most received help from colleagues (60.4%). A majority (85.6%) stayed after hours or came in on weekends to address notifications; less than a third reported receiving protected time (30.1%). PCPs strongly endorsed several new features to improve test result management, including better tracking and visualization of result notifications.
Conclusions
Despite an advanced EHR, both social and technical challenges exist in ensuring notification of test results to practitioners and patients. Current EHR technology requires significant improvement in order to avoid similar challenges elsewhere.
doi:10.1136/amiajnl-2012-001267
PMCID: PMC3721157  PMID: 23268489
missed test results; medical errors; diagnostic errors; lack of follow-up; health information technology; electronic health records
16.  Etiology of Thrombocytosis in a General Medicine Population: Analysis of 801 Cases With Emphasis on Infectious Causes 
Background
The clinical importance of an elevated platelet count is often overlooked, particularly as a diagnostic clue to the presence of an underlying infection. We sought to better describe the relationship between thrombocytosis and inflammatory conditions, with a focus on infectious causes.
Methods
We retrospectively reviewed 801 sequential cases of thrombocytosis (platelet count > 500 × 109/L) at a tertiary care hospital.
Results
Essential thrombocythemia was the most common cause of primary thrombocytosis, and these patients were more likely to have extreme (> 800 × 109/L) and prolonged (> 1 month) thrombocytosis. Secondary thrombocytosis was more common than primary, with infectious causes accounting for nearly half the cases. Demographic factors associated with an infectious etiology included inpatient status, quadriplegia/paraplegia, an indwelling prosthesis, dementia and diabetes. Clinical and laboratory characteristics associated with an infectious cause of thrombocytosis included fever, tachycardia, weight loss, hypoalbuminemia, neutrophilia, leukocytosis and anemia. Patients with thrombocytosis secondary to infection had a more rapid normalization of platelet count, but higher risk of dying, than those with secondary, non-infectious causes.
Conclusions
Infection is a common cause of thrombocytosis and should be considered in patients with comorbidities that increase risk of infection and when clinical and/or laboratory data support an infectious etiology. Thrombocytosis may have prognostic implications as a clinical parameter.
doi:10.4021/jocmr1125w
PMCID: PMC3513424  PMID: 23226175
Thrombocytosis; Elevated platelet count; Secondary thrombocytosis; Infection
17.  Characteristics of Generalized Anxiety Disorder in Patients With Dementia 
Background
Overlap of cognitive and anxiety symptoms (i.e., difficulty concentrating, fatigue, restlessness) contributes to inconsistent, complicated assessment of generalized anxiety disorder (GAD)in persons with dementia.
Methods
Anxious dementia patients completed a psychiatric interview, the Penn State Worry Questionnaire-Abbreviated, and the Rating for Anxiety in Dementia scale. Analyses to describe the 43 patients with and without GAD included the Wilcoxon Mann-Whitney two-sample test, Fisher’s exact test. Predictors of GAD diagnosis were identified using logistic regression.
Results
Those with GAD were more likely to be male, have less severe dementia and endorsed more worry, and anxiety compared to patients without GAD. Gender, muscle tension and fatigue differentiated those with GAD from those without GAD.
Conclusions
Although this study is limited by a small sample, it describes clinical characteristics of GAD in dementia, highlighting the importance of muscle tension and fatigue in recognizing GAD in persons with dementia.
doi:10.1177/1533317511426867
PMCID: PMC3252749  PMID: 22062223
Generalized anxiety disorder; dementia; anxiety symptoms; dementia symptoms; differential diagnosis for generalized anxiety disorder/dementia
18.  Brief cognitive behavioral therapy in primary care: a hybrid type 2 patient-randomized effectiveness-implementation design 
Background
Despite the availability of evidence-based psychotherapies for depression and anxiety, they are underused in non-mental health specialty settings such as primary care. Hybrid effectiveness-implementation designs have the potential to evaluate clinical and implementation outcomes of evidence-based psychotherapies to improve their translation into routine clinical care practices.
Methods
This protocol article discusses the study methodology and implementation strategies employed in an ongoing, hybrid, type 2 randomized controlled trial with two primary aims: (1) to determine whether a brief, manualized cognitive behavioral therapy administered by Veterans Affairs Primary Care Mental Health Integration program clinicians is effective in treating depression and anxiety in a sample of medically ill (chronic cardiopulmonary diseases) primary care patients and (2) to examine the acceptability, feasibility, and preliminary outcomes of a focused implementation strategy on improving adoption and fidelity of brief cognitive behavioral therapy at two Primary Care-Mental Health Integration clinics. The study uses a hybrid type 2 effectiveness/implementation design to simultaneously test clinical effectiveness and to collect pilot data on a multifaceted implementation strategy that includes an online training program, audit and feedback of session content, and internal and external facilitation. Additionally, the study engages the participation of an advisory council consisting of stakeholders from Primary Care-Mental Health Integration, as well as regional and national mental health leaders within the Veterans Administration. It targets recruitment of 320 participants randomized to brief cognitive behavioral therapy (n = 200) or usual care (n = 120). Both effectiveness and implementation outcomes are being assessed using mixed methods, including quantitative evaluation (e.g., intent-to-treat analyses across multiple time points) and qualitative methods (e.g., focus interviews and surveys from patients and providers). Patient-effectiveness outcomes include measures of depression, anxiety, and physical health functioning using blinded independent evaluators. Implementation outcomes include patient engagement and adherence and clinician brief cognitive behavioral therapy adoption and fidelity.
Conclusions
Hybrid designs are needed to advance clinical effectiveness and implementation knowledge to improve healthcare practices. The current article describes the rationale and challenges associated with the use of a hybrid design for the study of brief cognitive behavioral therapy in primary care. Although trade-offs exist between scientific control and external validity, hybrid designs are part of an emerging approach that has the potential to rapidly advance both science and practice.
Trial registration
NCT01149772 at http://www.clinicaltrials.gov/ct2/show/NCT01149772
doi:10.1186/1748-5908-7-64
PMCID: PMC3503767  PMID: 22784436
Primary care; Hybrid effectiveness-implementation designs; Cognitive behavioral therapy; Mental health; Veterans; Anxiety; Depression
19.  Comparative Effectiveness of Goal Setting in Diabetes Mellitus Group Clinics:Randomized Clinical Trial 
Archives of internal medicine  2011;171(5):453-459.
Background
Diabetes group clinics can effectively control hypertension, but data to support glycemic control is equivocal. This study evaluated the comparative effectiveness of two diabetes group clinic interventions on glycosolated hemoglobin (HbA1c) levels in primary care.
Methods
Participants (n = 87) were recruited from a diabetes registry of a single regional VA medical center to participate in an open, randomized comparative effectiveness study. Two primary care based diabetes group interventions of three months duration were compared. Empowering Patients in Care (EPIC) was a clinician-led, patient-centered group clinic consisting of four sessions on setting self-management action plans (diet, exercise, home monitoring, medications, etc.) and communicating about progress with action plans. The comparison intervention consisted of group education sessions with a diabetes educator and dietician followed by an additional visit with one’s primary care provider. HbA1c levels were compared post-intervention and at one-year follow-up.
Results
Participants in the EPIC intervention had significantly greater improvements in HbA1c levels immediately following the active intervention (8.86 to 8.04 vs. 8.74 to 8.70, mean [SD] between-group difference 0.67±1.3, P=.03) and these differences persisted at 1 year follow-up (.59±1.4, P=.05). A repeated measures analysis using all study time points found a significant time-by-treatment interaction effect on HbA1c levels favoring the EPIC intervention (F(2,85) =3.55, P= .03). The effect of the time-by-treatment interaction appears to be partially mediated by diabetes self-efficacy (F(1,85) =10.39, P= .002).
Conclusions
Primary care based diabetes group clinics that include structured goal-setting approaches to self-management can significantly improve HbA1c levels post-intervention and maintain improvements for 1-year.
Trial registration
ClinicalTrials.gov Identifier: NCT00481286
doi:10.1001/archinternmed.2011.70
PMCID: PMC3132209  PMID: 21403042
diabetes; group clinics intervention; goal-setting; HbA1c; self-efficacy
20.  Missed Opportunities to Initiate Endoscopic Evaluation for Colorectal Cancer Diagnosis 
Objectives
Delayed diagnosis of colorectal cancer (CRC) is among the most common reasons for ambulatory diagnostic malpractice claims in the United States. Our objective was to describe missed opportunities to diagnose CRC before endoscopic referral, in terms of patient characteristics, nature of clinical clues, and types of diagnostic-process breakdowns involved.
Methods
We conducted a retrospective cohort study of consecutive, newly diagnosed cases of CRC between February 1999 and June 2007 at a tertiary health-care system in Texas. Two reviewers independently evaluated the electronic record of each patient using a standardized pretested data collection instrument. Missed opportunities were defined as care episodes in which endoscopic evaluation was not initiated despite the presence of one or more clues that warrant a diagnostic workup for CRC. Predictors of missed opportunities were evaluated in logistic regression. The types of breakdowns involved in the diagnostic process were also determined and described.
Results
Of the 513 patients with CRC who met the inclusion criteria, both reviewers agreed on the presence of at least one missed opportunity in 161 patients. Among these patients there was a mean of 4.2 missed opportunities and 5.3 clues. The most common clues were suspected or confirmed iron deficiency anemia, positive fecal occult blood test, and hematochezia. The odds of a missed opportunity were increased in patients older than 75 years (odds ratio (OR) = 2.3; 95% confidence interval (CI) 1.3–4.1) or with iron deficiency anemia (OR = 2.2; 95% CI 1.3–3.6), whereas the odds of a missed opportunity were lower in patients with abnormal flexible sigmoidoscopy (OR = 0.06; 95% CI 0.01–0.51), or imaging suspicious for CRC (OR = 0.3; 95% CI 0.1–0.9). Anemia was the clue associated with the longest time to endoscopic referral (median = 393 days). Most process breakdowns occurred in the provider–patient clinical encounter and in the follow-up of patients or abnormal diagnostic test results.
Conclusions
Missed opportunities to initiate workup for CRC are common despite the presence of many clues suggestive of CRC diagnosis. Future interventions are needed to reduce the process breakdowns identified.
doi:10.1038/ajg.2009.324
PMCID: PMC2758321  PMID: 19550418
21.  Day One MODS is Associated with Poor Functional Outcome and Mortality in the Pediatric Intensive Care Unit 
Objective
The epidemiology and outcomes of Multiple Organ Dysfunction Syndrome (MODS) are incompletely characterized in the pediatric population due to small sample size and conflicting diagnoses of organ failure. We sought to describe the epidemiology and outcomes of early MODS in a large clinical database of PICU patients based on consensus definitions of organ failure.
Design
Retrospective analysis of a contemporaneously collected clinical PICU database.
Setting
VPICU Performance System (VPS) database patient admissions from 1/2004-12/2005 for 35 US children’s hospitals.
Patients
We evaluated 63,285 consecutive PICU admissions from 1/2004-12/2005 in the VPS database. We excluded patients <1 month or >18 years of age, and hospitals with >10% missing values for MODS variables. We identified day 1 MODS by International Pediatric Sepsis Consensus Conference (IPSCC) criteria with day 1 laboratory and vital sign values. We evaluated functional status using Pediatric Overall Performance Category (POPC) and Pediatric Cerebral Performance Category (PCPC) scores from PICU admission and discharge.
Interventions
Analysis: Student’s t-test, Χ2, Mann-Whitney rank sum, Kruskal-Wallis, linear and logistic regression.
Measurements and Main Results
We analyzed 44,693 admissions from 28 hospitals meeting inclusion criteria. Overall PICU mortality was 2.8%. We identified day 1 MODS in 18.6% of admissions. Patients with day 1 MODS had higher mortality (10.0% v. 1.2%, p<0.001), longer PICU length of stay (3.6 v. 1.3 days, p<0.001) and larger change from baseline POPC and PCPC scores at time of PICU discharge (p<0.001). Infants had the highest incidence of day 1 MODS (25.2% vs. 16.5%, p<0.001) compared to other age groups.
Conclusions
Using the largest clinical dataset to date and consensus definitions for organ failure, we found that children with MODS present on day one of ICU admission have worse functional outcomes, higher mortality, and longer PICU length of stay than children who do not have MODS on day one. Infants are disproportionally affected by MODS.
doi:10.1097/PCC.0b013e3181a64be1
PMCID: PMC2780005  PMID: 19741445
Multiple organ failure; Pediatric; Intensive care; Critical Care; Outcomes Research; Epidemiology
22.  Burden of COPD in a government health care system: a retrospective observational study using data from the US Veterans Affairs population 
Background
Health care utilization and costs among US veterans with chronic obstructive pulmonary disease (COPD) were compared with those in veterans without COPD.
Methods
A cohort of veterans with COPD was matched for age, sex, race, and index fiscal year to a cohort of veterans without COPD (controls) using data from the Veterans Integrated Service Network (VISN) 16 from 10/1/1997 to 9/30/2004. Annual total and respiratory-related health care service utilization, costs of care, comorbidities, and respiratory medication use at the time of diagnosis were assessed.
Results
A total of 59,906 patients with COPD were identified for a 7-year period prevalence of 8.2%, or 82 per 1000 population. Patients with COPD compared with controls had significantly higher all-cause and respiratory-related inpatient and outpatient health care utilization for every parameter examined including mean numbers of physician encounters, other outpatient encounters, emergency room visits, acute inpatient discharges, total bed days of care, and percentage of patients with any emergency room visits or any acute inpatient discharge. Patients with COPD had statistically significantly higher mean outpatient, inpatient, pharmacy, and total costs than the control group. The mean Charlson comorbidity index in patients with COPD was 1 point higher than in controls (2.85 versus 1.84, P < 0.001). 60% of COPD patients were prescribed medications recommended in treatment guidelines at diagnosis.
Conclusion
Veterans with COPD compared with those without COPD suffer a tremendous disease burden manifested by higher rates of all-cause and respiratory-related health care utilization and costs and a high prevalence of comorbidities. Furthermore, COPD patients do not receive appropriate treatment for their disease on diagnosis.
PMCID: PMC2866562  PMID: 20461144
chronic obstructive pulmonary disease (COPD); veterans; health care utilization; costs; respiratory medicine; VA; economic burden; burden of illness
23.  Prescription Patterns of Psychotropic Medications in Elderly Compared to Younger Participants Who Achieved a “Recovered” Status in the Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD) 
Objectives
This study aims at comparing prescription patterns between young adults and elderly with bipolar disorder who achieved a recovery status during the Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD).
Design
STEP-BD is a multicenter National Institute of Mental Health (NIMH)-funded project designed to evaluate the longitudinal outcome of patients with bipolar disorder. The STEP-BD study involved extensive assessment across multiple domains including demographic data, diagnosis, symptom severity, treatment and clinical status. Patients achieved “recovered” status when they experienced eight consecutive weeks without significant symptoms.
Participants
we analyzed data of all subjects who achieved a recovered status at least once in their participation.
Measurements
We compared treatment regimes and doses between young participants to middle age (n=3,364), 20 to 59 years old, and older participants 60 and above (n=246).
Results
Of the 3,615 STEP-BD participants who had a lifetime diagnosis of bipolar subtypes I or II, 67.6% (n=2442) achieved a recovered status during their participation. 78.5% (n=193) of older patients recovered compared to 66.8% of the younger cohort. On average, participants who reached a recovered status took 2.05 medications with no difference between age groups. Lithium was prescribed to 37.8% of younger patients compared to only 29.5% of older participants. The mean dosages taken by younger and older patients differed significantly only for lithium, valproate and risperidone with elderly individuals prescribed lower daily dosages. Significant reduction in lithium dosing was observed among individuals age 50 and older and among individuals 60 and older for valproate. Although valproate was more often prescribed, 42.1% of recovered bipolar elder achieved recovery with lithium alone compared to only 21.3% of the younger cohort.
Conclusion
This data shows recovery is achievable in the elderly though more than one medication is often needed regardless of age.
doi:10.1097/JGP.0b013e318187135f
PMCID: PMC2630050  PMID: 18978253
Bipolar disorder; elderly; valproate; lithium; recovery
24.  Process of Care and Outcomes in Patients with Peripheral Arterial Disease 
Background
We investigated the association of process of care measures with adverse limb and systemic events in patients with peripheral arterial disease (PAD).
Methods
We conducted a retrospective cohort study of patients with PAD, as defined by an ankle-brachial index (ABI) <0.9. The index date was defined as the date, during 1995 to 1998, when the patient was seen in the Michael E. DeBakey VA Medical Center noninvasive vascular laboratory and found to have PAD. We conducted a chart review for process of care variables starting 3 years before the index date and ending at the time of the first event or the final visit (December 31, 2001), whichever occurred first. We examined the association between PAD process of care measures, including risk factor control, and prescribing of medication, with time of the patient’s first major limb event or death.
Results
Of the 796 patients (mean age, 65 ± 9.9 years), 230 (28.9% experienced an adverse limb event (136 lower-extremity bypass, 94 lower-extremity amputation), and 354 (44.5%) died. Of the patients who died, 247 died without a preceding limb event. Glucose control was protective against death or a limb event with a hazard ratio (HR) of 0.74 (95% confidence limits [CL] 0.60, 0.91, P = 0.004). African Americans were at 2.8 (95% CL 1.7, 4.5) times the risk of Whites or Hispanics for an adverse limb event. However, this risk was no longer significant if their glucose was controlled. For process measures, the dispensing of PAD specific medication (HR 1.4, 95% CL 1.1, 1.7) was associated an increased risk for an adverse outcome.
Conclusions
Our data suggest that glucose control is key to reducing the risk for adverse outcomes, particularly limb events in African Americans. Certain process of care measures, as markers of disease severity and disease management, are associated with poor outcomes in patients with PAD. Further work is needed to determine the role of early disease intervention to reduce poor outcomes in patients with PAD.
doi:10.1007/s11606-007-0203-7
PMCID: PMC2219734  PMID: 17453264
peripheral arterial disease; process of care; glucose control; surgery; atherosclerosis risk factors

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