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Background: Seriously ill patients rely on spiritual and existential beliefs to support coping and approach crucial treatment and healthcare decisions. Yet, we lack gold standard, validated approaches to gathering information on those spiritual beliefs. Therefore, we developed I‐SPIRIT, a spiritual needs and beliefs inventory for those with serious illness (IIR‐10‐050). Methods: In prior work to develop measure content, we interviewed a total of 74 participants: 20 patients (veterans with Stage IV cancer, CHF, COPD, ESRD), 19 caregivers, 14 chaplains, 10 social workers, 12 nurses, and 5 physicians. Using directed content analyses, we identified over 50 attributes of spiritual experience comprising five domains: overall importance of spirituality; affiliations and practices; impact on decisions; spiritual needs; and spiritual resources. We then translated these attributes into individual items with Likert response scales. In the quantitative validation of I‐SPIRIT, we administered the instrument and a battery of comparison measures to 249 seriously ill veterans. The comparison measures captured general spiritual well‐being, religious coping, and emotional functioning. Convergent and discriminant validity was examined with the FACIT‐sp (faith, meaning, and purpose), BMMRS (religious/spirituality), POMS and PHQ‐8 (emotional function), and FACT‐G (quality of life). We administered the I‐SPIRIT a week later, for test–retest reliability. Results: Psychometric analyses yielded a final I‐SPIRIT Tool including 30 items. Results demonstrated reliability and validity and yielded a tool with three main components: Spiritual Beliefs (seven items); Spiritual Needs (nine items); and Spiritual Resources (14 items). The Spiritual Beliefs items include key practices and affiliations, and impact of beliefs on healthcare. Higher levels of Spiritual Needs were associated with higher anxiety and depression. Conclusion: The I‐Spirit measures relevance of spirituality, spiritual needs and spiritual resources and demonstrates validity, reliability, and acceptability for patients with serious illness. [ABSTRACT FROM AUTHOR]

Introduction:Although therapeutic inertia is a known driver of suboptimal type 2 diabetes control, little is known about how to combat this phenomenon. We analyzed randomized trial data to determine whether a comprehensive telehealth intervention was more effective than a less structured telehealth approach (telemonitoring and care coordination) at promoting treatment intensification in poorly controlled diabetes. Methods:Patients with poorly controlled type 2 diabetes were randomized 1:1 to telemonitoring/care coordination or a comprehensive telehealth intervention, which included an active, study provider-guided medication management component. Prospectively collected medication lists were used to determine whether treatment intensification occurred for each patient during 3-month intervals throughout the study period. To examine between-arm differences in treatment intensification over time, we fit a generalized estimation equation model. In each arm, hemoglobin A1c levels at the beginning and end of each 3-month interval were used to distinguish between therapeutic inertia and potentially appropriate nonintensification of treatment. Results:The mean, model-estimated likelihood of treatment intensification during 3-month intervals was 61.3% in the comprehensive telehealth group versus 48.6% for telemonitoring/care coordination (odds ratio 1.7, 95% confidence interval 1.2–2.2; p = 0.0007), with no evidence that treatment effect varied over time (p = 0.54). Treatment intervals with observed therapeutic inertia were more common in the telemonitoring/care coordination arm than the comprehensive telehealth arm (116/300, 39% vs. 57/275, 21%). Conclusions:A comprehensive telehealth approach that integrated protocol-guided medication management increased treatment intensification and reduced therapeutic inertia compared with a less structured telehealth approach. The studied approaches may serve as examples of how systems might use telehealth to combat therapeutic inertia. Clinical Trial Registration: ClinicalTrials.gov NCT03520413. [ABSTRACT FROM AUTHOR]

To assess the true effect of novel therapies for ischaemic stroke, a positive control that can validate the experimental model and design is vital. Hypothermia may be a good candidate for such a positive control, given the convincing body of evidence from animal models of ischaemic stroke. Taking conditions under which substantial efficacy had been seen in a meta-analysis of hypothermia for focal ischaemia in animal models, we undertook three randomised and blinded studies examining the effect of hypothermia induced immediately following the onset of middle cerebral artery occlusion on infarct volume in rats (n=15, 23, 264). Hypothermia to a depth of 33°C and maintained for 130min significantly reduced infarct volume compared to normothermia treatment (by 27-63%) and depended on ischaemic duration (F(3,244)=21.242, p<0.05). However, the protective effect varied across experiments with differences in both the size of the infarct observed in normothermic controls and the time to reach target temperature. Our results highlight the need for sample size and power calculations to take into account variations between individual experiments requiring induction of focal ischaemia. [ABSTRACT FROM AUTHOR]

1. Understand the importance of spiritual screening 2. See evidence of the PC-Spirit internal and external validity 3. Discuss the usefulness of implementing the PC-Spirit in clinical practice Spiritual and existential beliefs, for those religious and not, are associated with improved quality of life, reduced suffering, and preferences for care. Yet tools that systematically assess need; link those needs with intervention, treatment recommendations, and outcomes; and communicate needs with other disciplines are lacking. Our research team developed and validated the first quantifiable spiritual screening tool designed specifically for seriously ill veterans, the PC-Spirit. The objective of the study was to present the results of the quantitative validation of the PC-Spirit We administered the instrument along with a battery of comparison measures to 249 veterans with advanced illness. The comparison measures captured general spiritual well-being, religious coping, and emotional functioning and examined convergent and discriminant validity: FACIT (faith, meaning and purpose), QUAL-E (preparation and completion), R-COPE (religious/spiritual coping), POMS and PHQ-8 (anxiety and depression), and FACT-G (quality of life). We administered the PC-Spirit a week later, for test-retest reliability. Results demonstrated reliability and validity and yielded a screening tool with three main components: spiritual relevance, spiritual needs, and spiritual resources. Spiritual needs (9 items) and resources (14 items) had Cronbach's alphas of.76 and.86, respectively, items evaluating relevance of spirituality (7 items) demonstrated a Cronbach's alpha of.76. Psychometric analyses yielded a final PC-Spirit tool including 30 items. Spiritual resources was strongly positively correlated the FACIT-SP three subscales: meaning (r =.63, p <.0001), peace (r =.59, p <.0001), and faith (r =.71, p <.0001); the GES (measuring spirituality and peace with life) (r =.65, p <.0001); and the social and family well-being subscale of the Fact-G (r =.56, p <.0001), positive coping (.63, p <.0001), and religious intensity (.51, p <.0001). Spiritual needs were strongly positively correlated with depression as measured by the PHQ-8 (r =.54, p <.0001) and anxiety as measured by the POMS (r =.52, p <.0001). We also demonstrate threshold values and their correlation with anxiety and depression. The PC-Spirit demonstrates reliability and validity. PC-Spirit offers a validated tool to screening for spiritual distress. [ABSTRACT FROM AUTHOR]

This study evaluated spouse health behavior outcomes from a randomized controlled trial of a spouse-assisted lifestyle intervention to reduce patient low-density lipoprotein cholesterol and improve patient health behaviors. Participants were 251 spouses of patients from the Durham Veterans Affairs Medical Center randomized to intervention or usual care. The intervention comprised 9 monthly telephone calls to patients and spouses. Outcomes were assessed at baseline, 6 and 11 months. At 11 months, there were no differences in spouse outcomes between intervention and usual care groups for moderate intensity physical activity (i.e., frequency, duration) or dietary intake (i.e., total calories, total fat, percentage of calories from total fat, saturated fat, percentage of calories from saturated fat, cholesterol, fiber). To improve spouse outcomes, couple interventions may need to include spouse behavior change goals and reciprocal support between patients and spouses and consider the need for improvement in spouse outcomes. [ABSTRACT FROM AUTHOR]

Background Hypothermia is a promising experimental treatment for acute ischemic stroke. Human trials are still at an early stage, with the focus now on using hypothermia in awake patients. Pethidine (meperidine) is the principle agent used to control shivering in humans; however, whether it has any modulating effects on the neuroprotective efficacy of hypothermia is unknown. Aim The aim of this study was to determine if pethidine influences the neuroprotective effect of hypothermia in experimental stroke. Methods Seventy-two male spontaneously hypertensive rats were anesthetized with isoflurane and randomly assigned to either normothermia (37·4° C rectal temperature); hypothermia (33° C maintained for 130 mins); normothermia plus pethidine (2·5 mg/kg); or hypothermia plus pethidine. Temporary (90 mins) endovascular occlusion of the middle cerebral artery was induced blinded to treatment allocation and was confirmed with laser Doppler flowmetry. Pethidine and cooling were started immediately after vessel occlusion. Animals in the normothermia group had active temperature management using a heat lamp and fan. Assessments of outcome were carried out 24 after the induction of injury. Results Thirteen animals met our prespecified criteria for exclusion, and data for 59 rats were presented here. Hypothermia was associated with a 63% reduction in infarct size, and pethidine had no significant impact on the efficacy of hypothermia. No effects were observed in neurobehavioral outcome or edema volume across experimental groups. Conclusions The effects of hypothermia in a model of focal ischemia are not affected by administration of pethidine. [ABSTRACT FROM AUTHOR]

Purpose: The Veterans Affairs or VA health care system is in the process of significantly expanding home health care (HHC) nationwide. We describe VA HHC use in 2003 for all VA HHC users from 2002; we examine whether VA utilization across a broad spectrum of services differed for a sample of VA HHC users and their propensity-score-matched controls. We also consider crossover between the VA and Medicare. Design and Methods: This is a retrospective study using propensity score and stratified analysis to control for selection bias on observable characteristics. We examined the full cohort of 2002 VA HHC users (n = 24,169) and a 2:1 sample of age- and race-based nonusers (n = 53,356). Utilization measures included VA and Medicare outpatient, inpatient, nursing home, and hospice use, as well as VA home-based primary care, respite care, and adult day health care. Results: VA HHC users had a higher absolute probability of outpatient use by around 3%, of inpatient use by 12%, and nursing home use by 6% than their propensity-score-matched controls. Implications: Veterans who used HHC services had a higher rate of VA service use in the subsequent year than controls did, even after we adjusted for differences in observed health status, eligibility advantages, and supplemental insurance status. High utilization for VA home health users spilled over into high Medicare utilization. [ABSTRACT FROM AUTHOR]

: ObjectiveThere have been no studies that demonstrate surveillance colonoscopy decreases mortality in patients with a history of colorectal cancer. The purpose of this study was to compare the mortality of patients with colorectal cancer who received at least one colonoscopy after their diagnosis with patients who had no further procedures after adjusting for age, race, chemotherapy, radiation therapy, and comorbidity using the national Veterans Affairs (VA) databases.: MethodsWe studied a cohort of 3546 patients within the VA national databases with a new diagnosis of colorectal cancer during fiscal year 1995–1996. Patients with inflammatory bowel disease, metastatic disease at presentation, or who died within 1 yr of initial diagnosis were excluded. We collected data for demographics, comorbidities, colonoscopies, chemotherapy, and radiation therapy. The primary outcome was adjusted 5-yr mortality.: ResultsIn the adjusted analysis, the risk of death was decreased by 43% (hazard ratio = 0.57, 95% CI = 0.51–0.64) in the group who had at least one follow-up colonoscopy compared with patients who had no follow-up colonoscopies.: ConclusionsThis study strongly supports a mortality benefit for follow-up colonoscopy in patients with a history of nonmetastatic colorectal cancer. [Copyright &y& Elsevier]

OBJECTIVES:Practice guidelines recommend surveillance for Barrett’s esophagus (BE) because of the risk of esophageal cancer. The quality of life of patients undergoing surveillance is unknown. The objectives of this study were to develop a new utility instrument to measure quality of life of patients undergoing BE surveillance and determine if Quality of Life in Reflux and Dyspepsia (QOLRD) scores correlate with utility ratings.METHODS:Fifteen patients were administered 16 scenarios describing possible BE surveillance outcomes. Each scenario was rated from 0 (equivalent to being dead) to 10 (equivalent to being in perfect health). Each patient also completed the QOLRD, a validated instrument. A t test was performed to compare the QOLRD means with published means. The Spearman’s rank correlation coefficient was calculated for the median QOLRD score and the median utility rating.RESULTS:QOLRD means ranged from 5.80 to 6.65 (previously published means 4.3–5.4). Lower scores denoted a worsened quality of life. The difference was significant (p < 0.001). The correlation coefficient of median QOLRD score (6.8) and median utility rating (4.0) was 0.10 (p = 0.71).CONCLUSIONS:This population of BE patients had significantly higher QOLRD scores than a previously published population referred for endoscopy. Quality of life using the utility measure was reduced. The utility measure did not correlate with the disease-specific instrument, suggesting that the concerns of patients undergoing surveillance are distinct from their reflux symptoms. [Copyright &y& Elsevier]

Diabetes distress (DD) is a negative psychosocial response to living with type 2 diabetes mellitus (T2DM). We sought insight into Veterans' experiences with DD in the context of T2DM self-management. The four domains in the Diabetes Distress Scale (i.e. regimen, emotional, interpersonal, healthcare provider) informed the interview guide and analysis (structural coding using thematic analysis). The mean age of the cohort (n = 36) was 59.1 years (SD 10.4); 8.3% of patients were female and 63.9% were Black or Mixed Race; mean A1C was 8.8% (SD 2.0); and mean DDS score was 2.4 (SD 1.1), indicating moderate distress. Veterans described DD and challenges to T2DM self-management across the four domains in the Diabetes Distress Scale. We found that (1) Veterans' challenges with their T2DM self-management routines influenced DD and (2) Veterans experienced DD across a wide range of domains, indicating that clinical interventions should take a "whole-person" approach. Trial Registration: NCT04587336 [ABSTRACT FROM AUTHOR]

Background: Rural patients with type 2 diabetes (T2D) may experience poor glycemic control due to limited access to T2D specialty care and self-management support. Telehealth can facilitate delivery of comprehensive T2D care to rural patients, but implementation in clinical practice is challenging. Objective: To examine the implementation of Advanced Comprehensive Diabetes Care (ACDC), an evidence-based, comprehensive telehealth intervention for clinic-refractory, uncontrolled T2D. ACDC leverages existing Veterans Health Administration (VHA) Home Telehealth (HT) infrastructure, making delivery practical in rural areas. Design: Mixed-methods implementation study. Participants: 230 patients with clinic-refractory, uncontrolled T2D. Intervention: ACDC bundles telemonitoring, self-management support, and specialist-guided medication management, and is delivered over 6 months using existing VHA HT clinical staffing/equipment. Patients may continue in a maintenance protocol after the initial 6-month intervention period. Main Measures: Implementation was evaluated using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. The primary effectiveness outcome was hemoglobin A1c (HbA1c). Key Results: From 2017 to 2020, ACDC was delivered to 230 patients across seven geographically diverse VHA sites; on average, patients were 59 years of age, 95% male, 80% white, and 14% Hispanic/Latinx. Patients completed an average of 10.1 of 12 scheduled encounters during the 6-month intervention period. Model-estimated mean baseline HbA1c was 9.56% and improved to 8.14% at 6 months (− 1.43%, 95% CI: − 1.64, − 1.21; P <.001). Benefits persisted at 12 (− 1.26%, 95% CI: − 1.48, − 1.05; P <.001) and 18 months (− 1.08%, 95% CI − 1.35, − 0.81; P <.001). Patients reported increased engagement in self-management and awareness of glycemic control, while clinicians and HT nurses reported a moderate workload increase. As of this submission, some sites have maintained delivery of ACDC for up to 4 years. Conclusions: When strategically designed to leverage existing infrastructure, comprehensive telehealth interventions can be implemented successfully, even in rural areas. ACDC produced sustained improvements in glycemic control in a previously refractory population. [ABSTRACT FROM AUTHOR]

Presents a letter to the editor about the usefulness of a comparison of colon cancer-specific mortality and all-cause mortality to support the contribution of surveillance colonoscopy to the mortality benefit found.

An abstract of the article "Determinants of quality of life in patients with Barrett's," by Deborah Fisher and colleagues is presented.

Spouse-assisted interventions can improve health behaviors, but mechanisms of action are unknown. This study evaluated mediators of dietary and physical activity outcomes during a spouse-assisted intervention to improve low-density lipoprotein cholesterol. This is a secondary analysis of data from a randomized controlled trial comparing usual care (n = 128) to a spouse-assisted lifestyle change intervention (n = 127) comprising nine monthly goal setting telephone calls to participants and support planning calls to spouses over 11 months. Structural equation modeling was used to examine if the intervention influenced the putative mediators of participant self-efficacy and perceived spousal support at 6 months (i.e. action test); if changes in putative mediators at 6 months were associated with changes in diet and physical activity outcomes at 11 months (i.e. conceptual test); and if treatment condition effects on outcomes at 11 months were mediated by its effects on the 6-month putative mediators (i.e. indirect effects test). Participants were 94.9% male, 64.9% white and were 61.3 years old on average. The action test showed that the intervention increased dietary self-efficacy (p < .001) and perceived spousal support for diet (p < .001) and physical activity (p < .01) at 6 months. The conceptual test showed that increases in participant physical activity self-efficacy at 6 months were associated with increases in physical activity frequency (p = .01) and duration (p = .04) at 11 months; other putative mediators were not associated with changes in outcomes at 11 months. The indirect effects tests did not support a mediating role for self-efficacy or perceived spousal support. Intervention-induced changes in spousal support and dietary self-efficacy did not translate into behavior change. Other mechanisms may be driving behavior change. [ABSTRACT FROM PUBLISHER]

Temporal lobe epilepsy (TLE) is the most common form of drug resistant epilepsy. Current treatment is symptomatic, suppressing seizures, but has no disease modifying effect on epileptogenesis. We examined the effects of Z944, a potent T-type calcium channel antagonist, as an anti-seizure agent and against the progression of kindling in the amygdala kindling model of TLE. The anti-seizure efficacy of Z944 (5mg/kg, 10mg/kg, 30mg/kg and 100mg/kg) was assessed in fully kindled rats (5 class V seizures) as compared to vehicle, ethosuximide (ETX, 100mg/kg) and carbamazepine (30mg/kg). Each animal received the seven treatments in a randomised manner. Seizure class and duration elicited by six post-drug stimulations was determined. To investigate for effects in delaying the progression of kindling, naive animals received Z944 (30mg/kg), ETX (100mg/kg) or vehicle 30-minutes prior to each kindling stimulation up to a maximum of 30 stimulations, with seizure class and duration recorded after each stimulation. At the completion of drug treatment, CaV3.1, CaV3.2 and CaV3.3 mRNA expression levels were assessed in the hippocampus and amygdala using qPCR. Z944 was not effective at suppressing seizures in fully kindled rats compared to vehicle. Animals receiving Z944 required significantly more stimulations to evoke a class III (p<0.05), IV (p<0.01) or V (p<0.0001) seizure, and to reach a fully kindled state (p<0.01), than animals receiving vehicle. There was no significant difference in the mRNA expression of the T-type Ca2+ channels in the hippocampus or amygdala. Our results show that selectively targeting T-type Ca2+ channels with Z944 inhibits the progression of amygdala kindling. This could be a potential for a new therapeutic intervention to mitigate the development and progression of epilepsy. [ABSTRACT FROM AUTHOR]

There is limited understanding of how comorbid health conditions affect osteoarthritis (OA)-related outcomes. This study examined associations of different comorbidity measures with baseline OA-related patient-reported outcomes (PROs) among patients with hip and knee OA. Data were from patients ( N = 300, 9 % female, mean age = 61.1; SD = 9.2) enrolled in a randomized control trial at the Durham Veterans Affairs Medical Center. Separate multivariable regression models, adjusted for demographic and clinical characteristics, examined the association of each comorbidity measure with baseline PROs: pain, physical function, depressive symptoms, fatigue, and insomnia. Comorbidity measures included the Self-Administered Comorbidity Questionnaire (SACQ), conditions reported as activity-limiting (SACQ-AL), and indicators of depression, diabetes, hypertension, and back pain. Mean (SD) numbers of comorbid conditions and activity-limiting conditions were 3.4 (1.8) and 1.6 (1.4), respectively. Comorbidity scores (SACQ overall and SACQ-AL) and individual comorbidity conditions were each associated with worse OA-related PROs adjusting for demographic and clinical factors. Worse SACQ overall and SACQ-AL scores were associated with worse mean scores for pain, depressive symptoms, fatigue, and insomnia ( p values <0.01). Additionally, increasing SACQ-AL scores were associated with worse mean scores for function ( p < 0.01). Depression was associated with worse pain ( p = 0.03), fatigue, and insomnia ( p values <0.01). Diabetes was associated with worse fatigue ( p = 0.01), depressive symptoms ( p = 0.02), and insomnia ( p = 0.03). Back pain was associated with worse pain scores ( p = 0.02). Results provide evidence that comorbidity burden, particularly activity-limiting conditions, is associated with worse OA-related PROs. Interventions for patients with OA need to address comorbid conditions and their impact on key outcomes. [ABSTRACT FROM AUTHOR]

Stroke evolution is a highly dynamic but variable disease which makes clinical decision making difficult. Biomarker discovery programs intended to aid clinical decision making have however largely ignored the rapidity of stroke evolution. We have used gene array technology to determine blood mRNA expression changes over the first day after stroke in rats. Blood samples were collected from 8 male spontaneously hypertensive rats at 0, 1, 2, 3, 6 and 24h post stroke induction by middle cerebral artery occlusion. RNA was extracted from whole blood stabilized in PAXgene tubes and mRNA expression was detected by oligonucleotide Affymetrix microarray. Using a pairwise comparison model, 1932 genes were identified to vary significantly over time (p≤0.5x10-7) within 24h after stroke. Some of the top20 most changed genes are already known to be relevant to the ischemic stroke physiopathology (e.g. Il-1R, Nos2, Prok2). Cluster analysis showed multiple stereotyped and time dependent profiles of gene expression. Direction and rate of change of expression for some profiles varied dramatically during these 24h. Profiles with potential clinical utility including hyper acute or acute transient upregulation (with expression peaking from 2 to 6h after stroke and normalisation by 24h) were identified. We found that blood gene expression varies rapidly and stereotypically after stroke in rats. Previous researchers have often missed the optimum time for biomarker measurement. Temporally overlapping profiles have the potential to provide a biological “stroke clock” able to tell the clinician how far an individual stroke has evolved. [ABSTRACT FROM AUTHOR]

Purpose: Although non-pharmacological interventions have been shown to improve physical functioning in individuals with osteoarthritis (OA), the mechanisms by which this occurs are often unclear. This study assessed whether changes in arthritis self-efficacy, perceived pain control, and pain catastrophizing mediated changes in physical functioning following an osteoarthritis intervention involving weight management, physical activity, and cognitive-behavioral pain management.Method: Three hundred Veteran patients of 30 primary care providers with knee and/or hip OA were cluster randomized to an OA intervention group or usual care. The OA intervention included a 12-month phone-based patient behavioral protocol (weight management, physical activity, and cognitive-behavioral pain management) plus patient-specific OA treatment recommendations delivered to primary care providers.Results: Using linear mixed models adjusted for provider clustering, we observed that baseline to 6-month changes in arthritis self-efficacy and pain control partially mediated baseline to 12-month physical functioning improvements for the intervention group; catastrophizing did not.Conclusion: Findings of a mediating role of arthritis self-efficacy and pain control in intervention-related functional changes are consistent with hypotheses and align with theoretical assertions of the role of cognitions in cognitive and behavioral interventions for chronic pain. However, contrary to hypotheses, catastrophizing was not found to be a mediator of these changes. [ABSTRACT FROM AUTHOR]

Background Health behaviors related to diet, tobacco usage, physical activity, medication adherence, and alcohol use are highly determinative of risk for developing cardiovascular disease. This paper describes a study protocol to evaluate a problem-solving intervention that aims to help patients at risk for developing cardiovascular disease address barriers to adopting positive health behaviors in order to reduce cardiovascular risk. Methods Eligible patients are adults enrolled in Veterans Affairs (VA) health care who have not experienced a cardiovascular event but are at elevated risk based on their Framingham Risk Score (FRS). Participants in this two-site study are randomized to either the intervention or care as usual, with a target of 400 participants. The study intervention, Healthy Living Problem-Solving (HELPS), consists of six group sessions conducted approximately monthly interspersed with individualized coaching calls to help participants apply problem-solving principles. The primary outcome is FRS, analyzed at the beginning and end of the study intervention (6 months). Participants also complete measures of physical activity, caloric intake, self-efficacy, group cohesion, problem-solving capacities, and demographic characteristics. Conclusion Results of this trial will inform behavioral interventions to change health behaviors in those at risk for cardiovascular disease and other health conditions. Trial registration: ClinicalTrials.gov identifier NCT01838226 [ABSTRACT FROM AUTHOR]

Background Rates of glycemic control remain suboptimal nationwide. Medication intensification for diabetes can have undesirable side effects (weight gain, hypoglycemia), which offset the benefits of glycemic control. A Shared Medical Appointment (SMA) intervention for diabetes that emphasizes weight management could improve glycemic outcomes and reduce weight while simultaneously lowering diabetes medication needs, resulting in less hypoglycemia and better quality of life. We describe the rationale and design for a study evaluating a novel SMA intervention for diabetes that primarily emphasizes low-carbohydrate diet-focused weight management. Methods Jump Starting Shared Medical Appointments for Diabetes with Weight Management (Jump Start) is a randomized, controlled trial that is allocating overweight Veterans (body mass index ≥ 27 kg/m 2 ) with type 2 diabetes into two arms: 1) a traditional SMA group focusing on medication management and self-management counseling; or 2) an SMA group that combines low-carbohydrate diet-focused weight management (WM/SMA) with medication management. Hemoglobin A1c reduction at 48 weeks is the primary outcome. Secondary outcomes include hypoglycemic events, diabetes medication use, weight, medication adherence, diabetes-related quality of life, and cost-effectiveness. We hypothesize that WM/SMA will be non-inferior to standard SMA for glycemic control, and will reduce hypoglycemia, diabetes medication use, and weight relative to standard SMA, while also improving quality of life and costs. Conclusions Jump Start targets two common problems that are closely related but infrequently managed together: diabetes and obesity. By focusing on diet and weight loss as the primary means to control diabetes, this intervention may improve several meaningful patient-centered outcomes related to diabetes. [ABSTRACT FROM AUTHOR]

Introduction: This clinical demonstration trial compared the effectiveness of the Veterans Affairs Diabetes Prevention Program (VA-DPP) with an evidence-based usual care weight management program (MOVE!®) in the Veterans Health Administration health system.Design: Prospective, pragmatic, non-randomized comparative effectiveness study of two behavioral weight management interventions.Setting/participants: Obese/overweight Veterans with prediabetes were recruited from three geographically diverse VA sites between 2012 and 2014.Intervention: VA-DPP included 22 group-based intensive lifestyle change sessions.Main Outcome Measures: Weight change at 6 and 12 months, hemoglobin A1c (HbA1c) at 12 months, and VA health expenditure changes at 15 months were assessed using VA electronic health record and claims data. Between- and within-group comparisons for weight and HbA1c were done using linear mixed-effects models controlling for age, gender, race/ethnicity, baseline outcome values, and site. Analyses were conducted in 2015-2016.Results: A total of 387 participants enrolled (273 VA-DPP, 114 MOVE!). More VA-DPP participants completed at least one (73.3% VA-DPP vs 57.5% MOVE! p=0.002); four (57.5% VA-DPP vs 42.5% MOVE!, p=0.007); and eight or more sessions (42.5% VA-DPP vs 31% MOVE!, p=0.035). Weight loss from baseline was significant at both 6 (p<0.001) and 12 months (p<0.001) for VA-DPP participants, but only significant at 6 months for MOVE! participants (p=0.004). Between groups, there were significant differences in 6-month weight loss (-4.1 kg VA-DPP vs -1.9 kg MOVE!, p<0.001), but not 12-month weight loss (-3.4 kg VA-DPP vs -2.0 kg MOVE!, p=0.16). There were no significant differences in HbA1c change or outpatient, inpatient, and total VA expenditures.Conclusions: VA-DPP participants had higher participation rates and weight loss at 6 months, but similar weight, HbA1c, and health expenditures at 12 months compared to MOVE!Participants: Features of VA-DPP may help enhance the capability of MOVE! to reach a larger proportion of the served population and promote individual-level weight maintenance. [ABSTRACT FROM AUTHOR]

Background: A single-site study showed that a combined patient and provider intervention improved outcomes for patients with knee osteoarthritis, but it did not assess separate effects of the interventions. Objective: To examine whether patient-based, provider-based, and patient–provider interventions improve osteoarthritis outcomes. Design: Cluster randomized trial with assignment to patient, provider, and patient–provider interventions or usual care. (ClinicalTrials.gov: NCT01435109) Setting: 10 Duke University Health System community-based primary care clinics. Participants: 537 outpatients with symptomatic hip or knee osteoarthritis. Intervention: The telephone-based patient intervention focused on weight management, physical activity, and cognitive behavioral pain management. The provider intervention involved electronic delivery of patient-specific osteoarthritis treatment recommendations to providers. Measurements: The primary outcome was the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score at 12 months. Secondary outcomes were objective physical function (Short Physical Performance Battery) and depressive symptoms (Patient Health Questionnaire). Linear mixed models assessed the difference in improvement among groups. Results: No difference was observed in WOMAC score changes from baseline to 12 months in the patient (−1.5 [95% CI, −5.1 to 2.0]; P = 0.40), provider (2.5 [CI, −0.9 to 5.9]; P = 0.152), or patient–provider (−0.7 [CI, −4.2 to 2.8]; P = 0.69) intervention groups compared with usual care. All groups had improvements in WOMAC scores at 12 months (range, −3.7 to −7.7). In addition, no differences were seen in objective physical function or depressive symptoms at 12 months in any of the intervention groups compared with usual care. Limitations: The study involved 1 health care network. Data on provider referrals were not collected. Conclusion: Contrary to a previous study of a combined patient and provider intervention for osteoarthritis in a Department of Veterans Affairs medical center, this study found no statistically significant improvements in the osteoarthritis intervention groups compared with usual care. [ABSTRACT FROM AUTHOR]

Cognitive Behavioral Therapy for Insomnia (CBTi) is recommended as first-line treatment for insomnia, yet patient access to CBTi is limited. Self-help CBTi could increase patient access. Self-help CBTI with provider sup]port is more effective and is preferred by patients. Self-help CBTi has not been evaluated in veterans; a population with greater medical and mental health morbidity and more severe sleep difficulties than non-veterans. Moreover, those with mental health conditions have been largely excluded from prior CBTi self-help trials. Stablishing the efficacy of provider-supported Self-help CBTi is an important first step for expanding veteran access to CBTi. In a 2-armed randomized controlled trial, a provider-supported self-help CBTi (Tele-Self CBTi) is compared to Health Education for improving insomnia severity (primary outcome) among treatment-seeking veterans with insomnia disorder. Tele-Self CBTi is comprised of two treatment components: self-help CBTi via a professionally designed manual developed using an iterative process of expert review and patient input; and 6 telephone-based support sessions lasting >20 min. Outcomes are assessed at baseline, 8 weeks, and 6 months after baseline. The primary outcome, insomnia severity, is measured using the Insomnia Severity Index. Secondary outcomes include self-reported and actigraphy-assessed sleep, fatigue, depression symptoms, and sleep-related quality of life. Innovative approaches are essential to improving overall health among veterans; a population with highly prevalent insomnia disorder. If effective, Tele-Self CBTi may bridge the gap between unavailable resources and high demand for CBTi and serve as the entry level intervention in a stepped model of care. NCT03727438 [ABSTRACT FROM AUTHOR]

Background: Management of osteoarthritis requires both medical and behavioral strategies, but some recommended therapies are underused.Objective: To examine the effectiveness of a combined patient and provider intervention for improving osteoarthritis outcomes.Design: Cluster randomized clinical trial with assignment to osteoarthritis intervention and usual care groups. (ClinicalTrials.gov: NCT01130740).Setting: Department of Veterans Affairs Medical Center in Durham, North Carolina.Participants: 30 providers (clusters) and 300 outpatients with symptomatic hip or knee osteoarthritis.Intervention: The telephone-based patient intervention focused on weight management, physical activity, and cognitive behavioral pain management. The provider intervention involved delivery of patient-specific osteoarthritis treatment recommendations to primary care providers through the electronic medical record.Measurements: The primary outcome was total score on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at 12 months. Secondary outcomes were WOMAC function and pain subscale scores, physical performance (Short Physical Performance Battery), and depressive symptoms (Patient Health Questionnaire-8). Linear mixed models that were adjusted for clustering of providers assessed between-group differences in improvement in outcomes.Results: At 12 months, WOMAC scores were 4.1 points lower (indicating improvement) in the osteoarthritis intervention group versus usual care (95% CI, -7.2 to -1.1 points; P = 0.009). WOMAC function subscale scores were 3.3 points lower in the intervention group (CI, -5.7 to -1.0 points; P = 0.005). WOMAC pain subscale scores (P = 0.126), physical performance, and depressive symptoms did not differ between groups. Although more patients in the osteoarthritis intervention group received provider referral for recommended osteoarthritis treatments, the numbers who received them did not differ.Limitation: The study was conducted in a single Veterans Affairs medical center.Conclusion: The combined patient and provider intervention resulted in modest improvement in self-reported physical function in patients with hip and knee osteoarthritis.Primary Funding Source: Department of Veterans Affairs, Health Services Research and Development Service. [ABSTRACT FROM AUTHOR]

Purpose: Patients often struggle to express their emotional concerns to their oncology providers and may therefore experience unmet needs. This paper describes the development and implementation of an online program that teaches patients how to communicate their emotions to their oncology providers.Methods: The intervention was developed by a multidisciplinary team consisting of palliative care physicians, psychologists, and an intervention software developer and included input from patients. It incorporated elements of Social Cognitive Theory and validated cognitive behavioral strategies for communication skills training. Strategies to increase intervention adherence were implemented midway through the study.Results: The intervention consists of four interactive, online modules to teach patients strategies for expressing emotional concerns to their providers and asking for support. In addition to skill-building, the intervention was designed to raise patients' expectations that expressing emotional concerns to providers would be helpful, to enhance their self-efficacy for doing so, and to help them overcome barriers to having these conversations. After implementing strategies to improve adherence, usage rates increased from 47 to 64 %.Conclusions: This intervention addresses an unmet educational need for patients with advanced cancer. Strategies to increase adherence led to improvements in usage rates in this population of older patients. We are currently evaluating the intervention in a randomized clinical trial to determine its efficacy in increasing patient expression of emotional concerns and requests for support. If successful, this intervention could serve as a model for future online patient education programs. [ABSTRACT FROM AUTHOR]

Background: The Patient and PRovider Interventions for Managing Osteoarthritis (OA) in Primary Care (PRIMO) study is one of the first health services trials targeting OA in a multi-site, primary care network. This multi-site approach is important for assessing generalizability of the interventions. These analyses describe heterogeneity in clinic and patient characteristics, as well as recruitment metrics, across PRIMO study clinics. Methods: Baseline data were obtained from the PRIMO study, which enrolled n = 537 patients from ten Duke Primary Care practices. The following items were examined across clinics with descriptive statistics: (1) Practice Characteristics, including primary care specialty, numbers and specialties of providers, numbers of patients age 55+, urban / rural location and county poverty level; (2) Recruitment Metrics, including rates of eligibility, refusal and randomization; (3) Participants' Characteristics, including demographic and clinical data (general and OA-related); and (4) Participants' Self-Reported OA Treatment Use, including pharmacological and non-pharmacological therapies. Intraclass correlation coefficients (ICCs) were computed for participant characteristics and OA treatment use to describe between-clinic variation. Results: Study clinics varied considerably across all measures, with notable differences in numbers of patients age 55+ (1,507-5,400), urban / rural location (ranging from "rural" to "small city"), and proportion of county households below poverty level (12%-26%). Among all medical records reviewed, 19% of patients were initially eligible (10%-31% across clinics), and among these, 17% were randomized into the study (13%-21% across clinics). There was considerable between-clinic variation, as measured by the ICC (>0.01), for the following patient characteristics and OA treatment use variables: age (means: 60.4-66.1 years), gender (66%-88% female), race (16%-61% non-white), low income status (5%-27%), presence of hip OA (26%-68%), presence both knee and hip OA (23%-61%), physical therapy for knee OA (24%-61%) and hip OA (0%-71%), and use of knee brace with metal supports (0%-18%). Conclusions: Although PRIMO study sites were part of one primary care practice network in one health care system, clinic and patient characteristics varied considerably, as did OA treatment use. This heterogeneity illustrates the importance of including multiple, diverse sites in trials for knee and hip OA, to enhance the generalizability and evaluate potential for real-world implementation. [ABSTRACT FROM AUTHOR]

Abstract: Background: Group medical clinics may improve diabetes and hypertension control, but data about dyslipidemia are limited. We examined the impact of group medical clinics on lipids among patients with uncontrolled diabetes and hypertension. Methods: Prespecified secondary analysis of 239 veterans randomized to group medical clinics or usual care. Lipids were assessed at study baseline, midpoint, and end. We used linear mixed models to compare lipid levels between arms and generalized estimating equation models to compare low-density lipoprotein cholesterol (LDL-C) goal attainment. An additional post hoc analysis examined intensification of cholesterol-lowering medications in both arms. Results: At baseline, mean total cholesterol was 169.7 mg/dL (SD 47.8), LDL-C 98.2 mg/dL (SD 41.7), and high-density lipoprotein cholesterol (HDL-C) 39.3 mg/dL (SD 13.0). Median baseline triglycerides were 131 mg/dL (interquartile range 122). By study end, mean total cholesterol and LDL-C in group medical clinics were 14.2 mg/dL (P = .01) and 9.2 mg/dL (P = .02) lower than usual care, respectively; 76% of group medical clinic patients met goals for LDL-C, versus 61% of usual care patients (P = .02). Triglycerides and HDL-C remained similar between study arms. Treatment intensification occurred in 52% of group medical clinic patients, versus 37% of usual care patients between study baseline and end (P = .04). The mean statin dose was higher in group medical clinic patients at study midpoint and end. Conclusions: Group medical clinics appear to enhance lipid management among patients with diabetes and hypertension. This may be a result of greater intensification of cholesterol-lowering medications in group medical clinics relative to usual care. [Copyright &y& Elsevier]

OBJECTIVE--Group medical clinics (GMC) combine medication management and self-management training, and may improve diabetes outcomes. It remains unclear which patients benefit most from GMC. This secondary analysis examined the impact of baseline insulin regimen on GMC response. RESEARCH DESIGN AND METHODS--We analyzed a trial of 239 veterans with type 2 diabetes randomized to GMC or usual care (UC). We categorized baseline insulin regimen as the following: no insulin; basal insulin only; or complex insulin (basal-prandial or mixed regimens). Using linear mixed models adjusted for clustering within GMC, we evaluated the differential impact of GMC relative to UC on hemoglobin A1c (HbA1c) and self-efficacy among patients on different baseline insulin regimens. RESULTS--From linear mixed models, the effect of GMC on HbAlc differed by baseline insulin regimen versus UC (P = 0.05); there was no differential effect on self-efficacy (P = 0.29). Among those using complex insulin regimens at baseline, GMC reduced HbA1c by study end compared with UC (-1.0%; 95% CI -1.8 to -0.2; P = 0.01). We found no such HbAlc difference between GMC and UC patients using no insulin (P = 0.65) or basal insulin only (P = 0.71). There were no clinically significant differences in hypoglycemia by baseline insulin regimen and intervention group. CONCLUSIONS--We found that compared with UC, GMC lowered HbA1c specifically among patients using complex insulin regimens at study baseline, which may relate to this group's demanding medication and self-management requirements. Implementing GMC among patients using complex insulin regimens may maximize this care delivery strategy's potential. [ABSTRACT FROM AUTHOR]

Abstract: The contracting, prompting and reinforcing (CPR) aftercare intervention has improved treatment adherence and outcomes in a number of clinical trials. In multisite randomized clinical trial 92 graduates of two intensive substance use disorder programs who received CPR were compared to 91 who received standard treatment (STX). The CPR group evidenced increased frequency of aftercare group therapy attendance and near significant findings suggested that more CPR than STX participants completed 3months (76 vs. 64%), 6months (48 vs. 35%), and 9months (35 vs. 22%) of aftercare. However, the groups did not differ on the majority of attendance measures and had similar abstinence rates at the 3-month (67% CPR vs. 71% STX), 6-month (52% CPR vs. 51% STX), and 12-month (the primary outcome measure; 48% CPR vs. 49% STX) follow-up points. Exploratory analyses suggest that CPR might be more effective among participants not required to attend aftercare. The incremental capital and labor cost of CPR compared to STX was $98.25 per participant. [Copyright &y& Elsevier]

Abstract: Objective: This randomized controlled trial evaluated the effectiveness of a telephone-delivered, spouse-assisted lifestyle intervention to reduce patient LDL-C. Method: From 2007 to 2010, 255 outpatients with LDL-C>76mg/dL and their spouses from the Durham Veterans Affairs Medical Center were randomized to intervention or usual care. The intervention comprised nine monthly goal-setting telephone calls to patients and support planning calls to spouses. Outcomes were assessed at 11months. Results: Patients were 95% male and 65% White. LDL-C did not differ between groups (mean difference=2.3mg/dL, 95% CI=−3.6, 8.3, p=0.44), nor did the odds of meeting goal LDL-C (OR=0.95, 95% CI=0.6, 1.7; p=0.87). Intakes of calories (p=0.03), total fat (p=0.02), and saturated fat (p=0.02) were lower for the intervention group. Cholesterol and fiber intake did not differ between groups (p=0.11 and 0.26, respectively). The estimated rate of moderate intensity physical activity per week was 20% higher in the intervention group (IRR=1.2, 95% CI=1.0, 1.5, p=0.06). Most participants did not experience a change in cholesterol medication usage during the study period in the intervention (71.7%) and usual care (78.9%) groups. Conclusion: This intervention might be an adjunct to usual primary care to improve adherence to lifestyle behaviors. [Copyright &y& Elsevier]

Background: Osteoarthritis (OA) of the hip and knee are among the most common chronic conditions, resulting in substantial pain and functional limitations. Adequate management of OA requires a combination of medical and behavioral strategies. However, some recommended therapies are under-utilized in clinical settings, and the majority of patients with hip and knee OA are overweight and physically inactive. Consequently, interventions at the provider-level and patient-level both have potential for improving outcomes. This manuscript describes two ongoing randomized clinical trials being conducted in two different health care systems, examining patient-based and provider-based interventions for managing hip and knee OA in primary care. Methods / Design: One study is being conducted within the Department of Veterans Affairs (VA) health care system and will compare a Combined Patient and Provider intervention relative to usual care among n = 300 patients (10 from each of 30 primary care providers). Another study is being conducted within the Duke Primary Care Research Consortium and will compare Patient Only, Provider Only, and Combined (Patient + Provider) interventions relative to usual care among n = 560 patients across 10 clinics. Participants in these studies have clinical and / or radiographic evidence of hip or knee osteoarthritis, are overweight, and do not meet current physical activity guidelines. The 12-month, telephone-based patient intervention focuses on physical activity, weight management, and cognitive behavioral pain management. The provider intervention involves provision of patientspecific recommendations for care (e.g., referral to physical therapy, knee brace, joint injection), based on evidencebased guidelines. Outcomes are collected at baseline, 6-months, and 12-months. The primary outcome is the Western Ontario and McMasters Universities Osteoarthritis Index (self-reported pain, stiffness, and function), and secondary outcomes are the Short Physical Performance Test Protocol (objective physical function) and the Patient Health Questionnaire-8 (depressive symptoms). Cost effectiveness of the interventions will also be assessed. Discussion: Results of these two studies will further our understanding of the most effective strategies for improving hip and knee OA outcomes in primary care settings. Trial registration: NCT01130740 (VA); NCT 01435109 (NIH) [ABSTRACT FROM AUTHOR]

Background: Quality cancer care requires addressing patients' emotions, which oncologists infrequently do. Multiday courses can teach oncologists skills to handle emotion; however, such workshops are long and costly.Objective: To test whether a brief, computerized intervention improves oncologist responses to patient expressions of negative emotion.Design: Randomized, controlled, parallel-group trial stratified by site, sex, and oncologic specialty. Oncologists were randomly assigned to receive a communication lecture or the lecture plus a tailored CD-ROM. (ClinicalTrials.gov registration number: NCT00276627)Setting: Oncology clinics at a comprehensive cancer center and Veterans Affairs Medical Center in Durham, North Carolina, and a comprehensive cancer center in Pittsburgh, Pennsylvania.Participants: 48 medical, gynecologic, and radiation oncologists and 264 patients with advanced cancer.Intervention: Oncologists were randomly assigned in a 1:1 ratio to receive an interactive CD-ROM about responding to patients' negative emotions. The CD-ROM included tailored feedback on the oncologists' own recorded conversations.Measurements: Postintervention audio recordings were used to identify the number of empathic statements and responses to patients' expressions of negative emotion. Surveys evaluated patients' trust in their oncologists and perceptions of their oncologists' communication skills.Results: Oncologists in the intervention group used more empathic statements (relative risk, 1.9 [95% CI, 1.1 to 3.3]; P = 0.024) and were more likely to respond to negative emotions empathically (odds ratio, 2.1 [CI, 1.1 to 4.2]; P = 0.028) than control oncologists. Patients of intervention oncologists reported greater trust in their oncologists than did patients of control oncologists (estimated mean difference, 0.1 [CI, 0.0 to 0.2]; P = 0.036). There was no significant difference in perceptions of communication skills.Limitations: Long-term effects were not examined. The findings may not be generalizable outside of academic medical centers.Conclusion: A brief computerized intervention improves how oncologists respond to patients' expressions of negative emotions.Primary Funding Source: National Cancer Institute. [ABSTRACT FROM AUTHOR]

Objective: To test the effects of patient and patient-oncologist relationship factors on the time spent communicating about health-related quality of life (HRQOL) during outpatient clinic encounters between oncologists and their patients with advanced cancer. Methods: Using mixed methods, we coded for duration of HRQOL talk in a subset of audio-recorded conversations from the Study of Communication in Oncologist-Patient Encounters (SCOPE) Trial. Multivariable linear regression modeling was used to investigate the relationship between duration of HRQOL talk and gender concordance, race concordance, patient education status, patient marital status, and length of the patient-oncologist relationship (i.e. number of previous visits). Results: Sixty-six encounters were analyzed that involved 63 patients and 34 oncologists. Patients were more likely to be female (51%), white (86%), married (78%), and possess a college or more advanced degree (33%). Most oncologists were male (82%) and white (82%). Mean ages were 58.8 years for patients and 44.9 years for oncologists. Regression results showed that the number of a patient's previous visits with their oncologist was significantly associated with a longer duration of HRQOL talk during their audio-recorded clinic visit. The remaining independent variables, gender concordance, race concordance, patient education status, and patient marital status were not significant predictors of duration of HRQOL talk. Conclusions: Our findings suggest that length of the patient-oncologist relationship is related to duration of HRQOL talk. Improvements in HRQOL communication may best be achieved through efforts directed at those in earlier stages of the doctor-patient relationship. Copyright © 2010 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

Abstract: Objective: Capitalizing on spousal support may enhance the effectiveness of interventions for chronic disease management. However, couples-based interventions present logistical challenges. We describe our experience and lessons learned while recruiting couples into the Couples Partnering for Lipid-Enhancing Strategies (CouPLES) trial. Methods: This trial seeks to reduce serum low-density lipoprotein cholesterol levels using a couples-based intervention designed to help patients engage in self-management behaviors. We proposed enrolling 250 couples over 13 months. Results: Due to practical challenges that we encountered, recruitment and enrollment lasted 21 months. Those challenges included: travel to study site; effectively marketing the study; participant burden; and establishing eligibility criteria. By modifying our protocol to address these challenges, the recruitment rate increased from 12 to 33%. Conclusion: In the absence of trials identifying the most effective recruitment strategies, investigators may need to experiment, amending their protocol intermittently until target enrollment numbers are reached. The lessons we present may help researchers conducting couples-based interventions develop more effective protocols. Practice implications: To achieve target enrollment numbers, researchers conducting couples-based interventions should consider minimizing travel to the study site; carefully crafting recruitment materials; budgeting more for participant incentives and staff effort; and limiting exclusion criteria. These practices may also enhance retention. [Copyright &y& Elsevier]

Purpose: Patients with advanced cancer often experience negative emotion; clinicians' empathic responses can alleviate patient distress. Much is known about how physicians respond to patient emotion; less is known about non-physician clinicians. Given that oncology care is increasingly provided by an interdisciplinary team, it is important to know more about how patients with advanced cancer express emotions to non-physician clinicians (NPCs) and how NPCs respond to those empathic opportunities.Method: We audio recorded conversations between non-physician clinicians and patients with advanced cancer. We analyzed 45 conversations between patients and oncology physician assistants, nurse practitioners, and nurse clinicians in which patients or their loved ones expressed at least one negative emotion to the NPC (i.e., an empathic opportunity). Empathic opportunities were coded three ways: type of emotion (anger, sadness, or fear), severity of emotion (least, moderate, or most severe), and NPC response to emotion (not empathic, on-topic medical response, and empathic response).Results: We identified 103 empathic opportunities presented to 25 different NPCs during 45 visits. Approximately half of the empathic opportunities contained anger (53%), followed by sadness (25%) and fear (21%). The majority of emotions expressed were moderately severe (73%), followed by most severe (16%), and least severe (12%). The severity of emotions presented was not found to be statistically different between types of NPCs. NPCs responded to empathic opportunities with empathic statements 30% of the time. Additionally, 40% of the time, NPCs responded to empathic opportunities with on-topic, medical explanations and 30% of the responses were not empathic.Conclusion: Patients expressed emotional concerns to NPCs typically in the form of anger; most emotions were moderately severe, with no statistical differences among types of NPC. On average, NPCs responded to patient emotion with empathic language only 30% of the time. A better understanding of NPC-patient interactions can contribute to improved communication training for NPCs and, ultimately, to higher quality patient care in cancer. [ABSTRACT FROM AUTHOR]

Purpose: Most patients with advanced cancer experience negative emotion. When patients express emotions, oncologists rarely respond empathically. Oncologists may respond more empathically to some patients, and patients may perceive different levels of empathy and trust given past documentation of disparities in cancer care.Methods: We audio-recorded 264 outpatient encounters between oncologists and patients with advanced cancer at three sites. We examined whether patient gender, age, race, marital status, education, economic security, and length of relationship with oncologist were related to oncologist empathic responses to patient's negative emotion and patient's perceptions of oncologist empathy and trust.Results: Half (51%) of the patients expressed a negative emotion. Oncologists sometimes responded with empathy (29%). Oncologists were equally empathic with all patients, except they were more empathic with patients with low economic security compared with those reporting high economic security (p = .002). Patients with low economic security viewed oncologists as more empathic (p = .06) compared with those with moderate security. Married patients also viewed oncologists as more empathic (p = .04). Patients who knew their oncologist for more than a year had more trust than patients who knew their oncologists for less time (p = .02).Conclusions: Oncologists, in general, did not respond empathically to patient's negative emotion, and did this equally for most patients. Oncologists responded more empathically to patients who were less economically advantaged. In turn, patients with lower economic security perceived more empathy. Although oncologists need more education in responding empathically, they may not need to correct many biases in care. [ABSTRACT FROM AUTHOR]

Background: Group medical clinics (GMCs) are widely used in the management of diabetes and hypertension, but data on their effectiveness are limited. Objective: To test the effectiveness of GMCs in the management of comorbid diabetes and hypertension. Design: Randomized, controlled trial. (ClinicalTrials.gov registration number: NCT00286741) Setting: 2 Veterans Affairs Medical Centers in North Carolina and Virginia. Patients: 239 patients with poorly controlled diabetes (hemoglobin A1c [HbA1c] level ⩾7.5%) and hypertension (systolic blood pressure >140 mm Hg or diastolic blood pressure >90 mm Hg). Intervention: Patients were randomly assigned within each center to either attend a GMC or receive usual care. Clinics comprised 7 to 8 patients and a care team that consisted of a primary care general internist, a pharmacist, and a nurse or other certified diabetes educator. Each session included structured group interactions moderated by the educator. The pharmacist and physician adjusted medication to manage each patient's HbA1c level and blood pressure. Measurements: Hemoglobin A1c level and systolic blood pressure, measured by blinded research personnel at baseline, study midpoint (median, 6.8 months), and study completion (median follow-up, 12.8 months). Linear mixed models, adjusted for clustering within GMCs, were used to compare HbA1c levels and systolic blood pressure between the intervention and control groups. Results: Mean baseline systolic blood pressure and HbA1c level were 152.9 mm Hg (SD, 14.2) and 9.2% (SD, 1.4), respectively. At the end of the study, mean systolic blood pressure improved by 13.7 mm Hg in the GMC group and 6.4 mm Hg in the usual care group (P = 0.011 by linear mixed model), whereas mean HbA1c level improved by 0.8% in the GMC group and 0.5% in the usual care group (P = 0.159). Limitation: Measurements of effectiveness may have been limited by concomitant improvements in the usual care group that were due to co-intervention. Conclusion: Group medical clinics are a potent strategy for improving blood pressure but not HbA1c level in diabetic patients. [ABSTRACT FROM AUTHOR]

Objective: To describe the content and frequency of communication about health-related quality of life (HRQOL) during outpatient encounters between oncologists and their patients with advanced cancer. Methods: We coded for HRQOL talk in a subset of audio-recorded conversations (each previously found to contain prognostic talk by the oncologist) from the Study of Communication in Oncologist–Patient Encounters Trial, a randomized controlled trial conducted from 2003 to 2008 in two large US academic medical centers and one Veterans Affairs Medical Center. Results: Seventy-three encounters involved 70 patients and 37 oncologists. Patients were more likely to be female (53%), White (86%), married (78%), and possessing some college education (62%). Most oncologists were male (78%) and White (78%). Mean ages were 59 years for patients and 44 years for oncologists. Every encounter included some talk about HRQOL and HRQOL discussions made up, on average, 25% of the visit time. HRQOL segments described symptoms (50%), general HRQOL (27%), and the following concerns: physical (27%), functional (22%), psychological (9%), social (7%), spiritual (1%), and other (28%). Topics included treatment (56%), disease (14%), and testing (3%), and conversations focused on past (44%), present (68%), and future HRQOL (59%). Conclusions: HRQOL discussions between oncologists and patients are common, but the emphasis is often on treatment (e.g. side effects) and symptoms (e.g. pain) even in patients with advanced disease. Given the often intense emotional experience of patients with advanced cancer, oncologists may need to pay more attention to psychological, social, and spiritual HRQOL concerns. Copyright © 2009 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

The article presents a randomized trial that compares low-carbohydrate ketogenic diet (LCKD) with orlistat therapy plus a low-fat diet (O + LFD) for weight loss for individuals with body mass index mean of 39.3. It states that obese patients were randomized from the Department of Veterans Affairs in Durham, North Carolina. It concludes that LCKD outcome is the same for O + LFD, in terms of serum lipid, body weight, and glycemic parameters and was more efficient for blood pressure.

Objective: Assess use of and reactions to an interactive, tailored CD-ROM to enhance oncologist-patient communication.Methods: Participating oncologists (n=48) agreed to have patient interactions audio recorded, be randomly assigned to receive/not receive a CD-ROM, have CD-ROM usage monitored (intervention group) and complete a follow-up survey.Results: Twenty-one of 24 in the intervention group reported using the CD-ROM. Median usage minutes were 63.8. At follow-up, oncologists rated the CD-ROM from 1 ("none" or "not at all helpful") to 5 ("a great deal" or "very helpful"). Mean responses were: 3.1 and 3.0 for 2 items assessing perceived impact on communications, 3.8-4.0 for 6 items assessing perceived helpfulness, 3.0 and 3.10 for 2 items assessing impact on affecting oncologists' communication with patients and assistance with challenging conversations, respectively, and 3.6 for whether using the CD-ROM was worth their time. Self-report of how much oncologists had used the covered skills before and after intervention showed a perceived increase (2.8 before and 3.2 after).Conclusions: Findings suggest the tailored interactive CD-ROM has promise for use and acceptance among oncologists.Practice Implications: If ultimately found effective in changing oncologist's communication with patients, the CD-ROM's widespread dissemination should be explored. [ABSTRACT FROM AUTHOR]

Objective: Assess use of and reactions to an interactive, tailored CD-ROM to enhance oncologist–patient communication. Methods: Participating oncologists (n =48) agreed to have patient interactions audio recorded, be randomly assigned to receive/not receive a CD-ROM, have CD-ROM usage monitored (intervention group) and complete a follow-up survey. Results: Twenty-one of 24 in the intervention group reported using the CD-ROM. Median usage minutes were 63.8. At follow-up, oncologists rated the CD-ROM from 1 (“none” or “not at all helpful”) to 5 (“a great deal” or “very helpful”). Mean responses were: 3.1 and 3.0 for 2 items assessing perceived impact on communications, 3.8–4.0 for 6 items assessing perceived helpfulness, 3.0 and 3.10 for 2 items assessing impact on affecting oncologists’ communication with patients and assistance with challenging conversations, respectively, and 3.6 for whether using the CD-ROM was worth their time. Self-report of how much oncologists had used the covered skills before and after intervention showed a perceived increase (2.8 before and 3.2 after). Conclusions: Findings suggest the tailored interactive CD-ROM has promise for use and acceptance among oncologists. Practice implications: If ultimately found effective in changing oncologist''s communication with patients, the CD-ROM''s widespread dissemination should be explored. [Copyright &y& Elsevier]

Objective: To examine how type and severity of patients' negative emotions influence oncologists' responses and subsequent conversations.Methods: We analyzed 264 audio-recorded conversations between advanced cancer patients and their oncologists. Conversations were coded for patients' expressions of negative emotion, which were categorized by type of emotion and severity. Oncologists' responses were coded as using either empathic language or blocking and distancing approaches.Results: Patients presented fear more often than anger or sadness; severity of disclosures was most often moderate. Oncologists responded to 35% of these negative emotional disclosures with empathic language. They were most empathic when patients presented intense emotions. Responding empathically to patients' emotional disclosures lengthened discussions by an average of only 21s.Conclusion: Greater response rates to severe emotions suggest oncologists may recognize negative emotions better when patients express them more intensely. Oncologists were least responsive to patient fear and responded with greatest empathy to sadness.Practice Implications: Oncologists may benefit from additional training to recognize negative emotions, even when displayed without intensity. Teaching cancer patients to better articulate their emotional concerns may also enhance patient-oncologist communication. [ABSTRACT FROM AUTHOR]

Objective: To examine how type and severity of patients’ negative emotions influence oncologists’ responses and subsequent conversations. Methods: We analyzed 264 audio-recorded conversations between advanced cancer patients and their oncologists. Conversations were coded for patients’ expressions of negative emotion, which were categorized by type of emotion and severity. Oncologists’ responses were coded as using either empathic language or blocking and distancing approaches. Results: Patients presented fear more often than anger or sadness; severity of disclosures was most often moderate. Oncologists responded to 35% of these negative emotional disclosures with empathic language. They were most empathic when patients presented intense emotions. Responding empathically to patients’ emotional disclosures lengthened discussions by an average of only 21s. Conclusion: Greater response rates to severe emotions suggest oncologists may recognize negative emotions better when patients express them more intensely. Oncologists were least responsive to patient fear and responded with greatest empathy to sadness. Practice implications: Oncologists may benefit from additional training to recognize negative emotions, even when displayed without intensity. Teaching cancer patients to better articulate their emotional concerns may also enhance patient–oncologist communication. [Copyright &y& Elsevier]

Background: Almost 50% of Americans have elevated low-density lipoprotein cholesterol (LDL-C). The behaviors required to lower LDL-C levels may be difficult to adhere to if they are inconsistent with spouses' health practices, and, alternatively, may be enhanced by enlisting support from the spouse. This trial extends previous trials by requiring spouse enrollment, teaching spouses how to provide emotional and instrumental support, allowing patients to decide which component of the intervention they would like to receive, and having patients determine their own goals and action plans. Methods: Veteran outpatients with above-goal LDL-C (N = 250) and their spouses are randomized, as a couple, to receive printed education materials only or the materials plus an 11-month, nurse-delivered, telephone-based intervention. The intervention contains four modules: medication adherence, diet, exercise, and patient-physician communication. Patients decide which modules they complete and in which order; modules may be repeated or omitted. Telephone calls are to patients and spouses separately and occur monthly. During each patient telephone call, patients' progress is reviewed, and patients create goals and action plans for the upcoming month. During spouse telephone calls, which occur within one week of patient calls, spouses are informed of patients' goals and action plans and devise strategies to increase emotional and instrumental support. The primary outcome is patients' LDL-C, measured at baseline, 6 months, and 11 months. Linear mixed models will be used to test the primary hypothesis that an 11-month, telephone-based patient-spouse intervention will result in a greater reduction in LDL-C as compared to printed education materials. Various process measures, including social support, self-efficacy, medication adherence, dietary behavior, and exercise, are also assessed to explain any change, or lack thereof, in LDL-C. Discussion: Given the social context in which self-management occurs, interventions that teach spouses to provide instrumental and emotional support may help patients initiate and adhere to behaviors that lower their LDL-C levels. Moreover, allowing patients to retain autonomy by deciding which behaviors they would like to change and how may improve adherence and clinical outcomes. Trial Registration: The ClinicalTrials.gov registration number is NCT00321789. [ABSTRACT FROM AUTHOR]

Goals Of Work: Advanced cancer patients' perceptions of prognosis, which are often overly optimistic compared to oncologist estimates, influence treatment preferences. The predictors of patients' perceptions and the effect of oncologist communication on patient understanding are unclear. This study was designed to identify the communication factors that influence patient-oncologist concordance about chance of cure.Materials and Methods: We analyzed audiorecorded encounters between 51 oncologists and 141 advanced cancer patients with good (n = 69) or poor (n = 72) concordance about chance of cure. Encounters were coded for communication factors that might influence oncologist-patient concordance, including oncologist statements of optimism and pessimism.Main Results: Oncologists made more statements of optimism (mean = 3.3 per encounter) than statements of pessimism (mean = 1.2 per encounter). When oncologists made at least one statement of pessimism, patients were more likely to agree with their oncologist's estimated chance of cure (OR = 2.59, 95%CI = 1.31-5.12). Statements of optimism and uncertainty were not associated with an increased likelihood that patients would agree or disagree with their oncologists about chance of cure.Conclusions: Communication of pessimistic information to patients with advanced cancer increases the likelihood that patients will report concordant prognostic estimates. Communication of optimistic information does not have any direct effect. The best communication strategy to maximize patient knowledge for informed decision making while remaining sensitive to patients' emotional needs may be to emphasize optimistic aspects of prognosis while also consciously and clearly communicating pessimistic aspects of prognosis. [ABSTRACT FROM AUTHOR]

Objective: Cancer patients have high levels of distress, yet oncologists often do not recognize patients' concerns. We sought to describe how patients with advanced cancer verbally express negative emotion to their oncologists.Materials and Methods: As part of the Studying Communication in Oncologist-Patient Encounters Trial, we audio-recorded 415 visits that 281 patients with advanced cancer made to their oncologists at three US cancer centers. Using qualitative methodology, we coded for verbal expressions of negative emotion, identified words patients used to express emotion, and categorized emotions by type and content.Results: Patients verbally expressed negative emotion in 17% of the visits. The most commonly used words were: "concern," "scared," "worried," "depressed," and "nervous." Types of emotion expressed were: anxiety (46%), fear (25%), depression (12%), anger (9%), and other (8%). Topics about which emotion was expressed were: symptoms and functional concerns (66%), medical diagnoses and treatments (54%), social issues (14%), and the health care system (9%). Although all patients had terminal cancer, they expressed negative emotion overtly related to death and dying only 2% of the time.Conclusions: Patients infrequently expressed negative emotion to their oncologists. When they did, they typically expressed anxiety and fear, indicating concern about the future. When patients use emotionally expressive words such as those we described, oncologists should respond empathically, allowing patients to express their distress and concerns more fully. [ABSTRACT FROM AUTHOR]

Study objective: Most oncologists have not received adequate training in physician–patient communication, and existing effective courses tend to be time and resource intensive. We are developing and testing a tailored CD-ROM educational intervention that includes feedback on oncologists' own audio-recorded conversations with their advanced cancer patients. In this report, we describe the study methods and identify challenges to implementation and how these were overcome. Study design: A three-phase, randomized, controlled trial. In Phase 1, we audio-recorded oncologist–patient clinic encounters. In Phase 2, oncologists were randomly assigned to a communication CD-ROM intervention or control. Phase 3 consisted of audio-recording all participating oncologists conversing with a new sample of patients, two to 12 months after the intervention, to assess its effectiveness. Setting: Oncology clinics at Duke University Medical Center (DUMC) and the Durham Veterans Affairs Medical Center (DVAMC) in Durham, NC, and the University of Pittsburgh Medical Center (UPMC) in Pittsburgh, PA. Participants: Medical, radiation and gynecological oncologists and their patients with advanced cancer. Intervention: A tailored CD-ROM that contains an interactive educational interface with reference materials and video-clips of model conversations, along with the oncologists' own Phase 1 audio-recorded conversations. Conclusion: We present challenges and solutions to oncologist recruitment, identifying appropriate patients with advanced cancer, adapting to clinic flow, and developing a self-administered communications intervention. [ABSTRACT FROM AUTHOR]

BACKGROUND: Integrative medicine is an individualized, patient-centered approach to health, combining a whole-person model with evidence-based medicine. Interventions based in integrative medicine theory have not been tested as cardiovascular risk-reduction strategies. Our objective was to determine whether personalized health planning (PHP), an intervention based on the theories and principles underlying integrative medicine, reduces 10-year risk of coronary heart disease (CHD). METHODS: We conducted a randomized, controlled trial among 154 outpatients age 45 or over, with 1 or more known cardiovascular risk factors. Subjects were enrolled from primary care practices near an academic medical center, and the intervention was delivered at a university Center for Integrative Medicine. Following a health risk assessment, each subject in the intervention arm worked with a health coach and a medical provider to construct a personalized health plan. The plan identified specific health behaviors important for each subject to modify; the choice of behaviors was driven both by cardiovascular risk reduction and the interests of each individual subject. The coach then assisted each subject in implementing her/his health plan. Techniques used in implementation included mindfulness meditation, relaxation training, stress management, motivational techniques, and health education and coaching. Subjects randomized to the comparison group received usual care (UC) without access to the intervention. Our primary outcome measure was 10-year risk of CHD, as measured by a standard Framingham risk score, and assessed at baseline, 5, and 10 months. Differences between arms were assessed by linear mixed effects modeling, with time and study arm as independent variables. RESULTS: Baseline 10-year risk of CHD was 11.1% for subjects randomized to UC (n=77), and 9.3% for subjects randomized to PHP (n=77). Over 10 months of the intervention, CHD risk decreased to 9.8% for UC subjects and 7.8% for intervention subjects. Based on a linear mixed-effects model, there was a statistically significant difference in the rate of risk improvement between the 2 arms (P=.04). In secondary analyses, subjects In the PHP arm were found to have increased days of exercise per week compared with UC (3.7 vs 2.4. P=.002), and subjects who were overweight on entry into the study had greater weight loss in the PHP arm compared with UC (P=.06). CONCLUSIONS: A multidimensional intervention based on integrative medicine principles reduced risk of CHD, possibly by increasing exercise and improving weight loss. [ABSTRACT FROM AUTHOR]

Patient-centered care requires clinicians to recognize and act on patients’ expectations. However, relatively little is known about the specific expectations patients bring to the primary care visit.To describe the nature and prevalence of patients’ specific expectations for tests, referrals, and new medications, and to examine the relationship between fulfillment of these expectations and patient satisfaction.Prospective cohort study.VA general medicine clinic.Two hundred fifty-three adult male outpatients seeing their primary care provider for a scheduled visit.Fifty-six percent of patients reported at least 1 expectation for a test, referral, or new medication. Thirty-one percent had 1 expectation, while 25% had 2 or more expectations. Expectations were evenly distributed among tests, referrals, and new medications (37%, 30%, and 33%, respectively). Half of the patients who expressed an expectation did not receive one or more of the desired tests, referrals, or new medications. Nevertheless, satisfaction was very high (median of 1.5 for visit-specific satisfaction on a 1 to 5 scale, with 1 representing“excellent”). Satisfaction was not related to whether expectations were met or unmet, except that patients who did not receive desired medications reported lower satisfaction.Patients’ expectations are varied and often vague. Clinicians trying to implement the values of patient-centered care must be prepared to elicit, identify, and address many expectations.J GEN INTERN MED 2004;19:1080–1087. [ABSTRACT FROM AUTHOR]