Barbara Clothier

The Magnitude of Acute Serum Creatinine Increase After Cardiac Surgery and the Risk of Chronic Kidney Disease, Progression of Kidney Disease, and Death

BACKGROUND Long-term outcomes after acute kidney injury remain poorly defined. We determined the association between the magnitude of creatinine increase after cardiac surgery and the risk of incident chronic kidney disease (CKD), CKD progression, and death. METHODS We identified 29,388 individuals who underwent cardiac surgery at Veterans Affairs hospitals between November 1999 and September 2005. The magnitude of creatinine increase was defined by the percent change from baseline to peak creatinine levels after cardiac surgery and categorized as none (≤0%) or as class I, (1%-24%), II (25%-49%), III (50%-99%), or IV (≥100%). Cox proportional hazard models were used to examine the association between the magnitude of creatinine increase and outcomes. RESULTS The relative hazards for outcomes increased monotonically with greater increases in creatinine levels compared with no change in creatinine levels. The relative hazards for adverse outcomes were significantly higher immediately after the creatinine increase and attenuated over time. Three months after surgery, creatinine increase classes I, II, III, and IV were associated with a greater risk of incident CKD (hazard ratios [HRs] 2.1, 4.0, 5.8, and 6.6, respectively; all P<.01), progression of CKD stage (HRs 2.5, 3.8, 4.4, and 8.0; all P<.01), and long-term mortality (HRs 1.4, 1.9, 2.8, and 5.0; all P<.01). At 5 years, the associations were lower in magnitude: incident CKD (HRs 1.4, 1.9, 2.3, and 2.3; all P<.01), CKD progression (HRs 1.5, 1.7, 1.7, and 2.4; all P<.01), and mortality (HRs 1.0, 1.2, 1.4, and 1.8; all P<.01, except class I). CONCLUSION The magnitude of creatinine increase after cardiac surgery is associated in a graded manner with an increased risk of incident CKD, CKD progression, and mortality.

Characteristics and Rehabilitation Outcomes Among Patients With Blast and Other Injuries Sustained During the Global War on Terror

OBJECTIVE To describe characteristics and rehabilitation outcomes among patients who received inpatient rehabilitation for blast and other injuries sustained in Iraq and Afghanistan during the Global War on Terror. DESIGN Observational study based on chart review and Department of Veterans Affairs (VA) administrative data. SETTING The 4 VA polytrauma rehabilitation centers (PRCs). PARTICIPANTS Service members (N=188) admitted to a PRC during the first 4 years of the Global War on Terror for injuries sustained during Operation Iraqi Freedom or Operation Enduring Freedom. INTERVENTION Multidisciplinary comprehensive rehabilitation program. MAIN OUTCOMES MEASURES Cognitive and motor FIM instrument gain scores and length of stay (LOS). RESULTS Most war-injured patients had traumatic brain injury, injuries to several other body systems and organs, and associated pain. Fifty-six percent had blast-related injuries, and the pattern of injuries was unique among those with injuries secondary to blasts. Soft tissue, eye, oral and maxillofacial, otologic, penetrating brain injuries, symptoms of post-traumatic stress disorder, and auditory impairments were more common in blast-injured patients than in those with war injuries of other etiologies. The mechanism of the injury did not predict functional outcomes. LOS was variable, particularly for those with blast injuries. Patients with low levels of independence at admissions made the most progress but remained more dependent at discharge compared with other PRC patients. The rate of gain was slower in this low-functioning group. CONCLUSIONS Blasts produce a unique constellation of injuries but do not make a unique contribution to functional gain scores. Findings underscore the need for assessment and treatment of pain and mental health problems among patients with polytrauma and blast-related injuries. Patients with polytrauma have lifelong needs, and future research should examine needs over time after community re-entry.

Menthol Cigarettes and Smoking Cessation During an Aided Quit Attempt

Menthol may make cigarettes more addictive and rates of menthol cigarette smoking are disproportionately higher among Black. However, few studies have examined the association between menthol cigarette smoking and cessation, and the studies to date have produced conflicting findings. The present study examines the effect of menthol cigarette smoking on cessation among a multi-ethnic sample of smokers making a pharmacotherapy-aided quit attempt. We hypothesized that menthol cigarette smoking would be associated with lower smoking abstinence rates and conducted a secondary analysis of data from a multi-site randomized controlled trial of an intervention designed to facilitate repeat tobacco cessation treatment (N = 1,343). The intervention consisted of a patient phone call and a computerized provider prompt. The primary outcome for this analysis was 7-day point prevalence smoking abstinence. The average age of the sample was 56 years old. Overall, 25% of the sample smoked menthol cigarettes: 19% of Whites, 62% of Blacks, and 25% of other ethnicity (p<.001). We observed no significant effects for menthol cigarette smoking or ethnicity on smoking abstinence rates. In conclusion, combined with findings from previous research, this study suggests that smoking menthol cigarettes does not decrease smoking cessation among older smokers during a quit attempt aided with pharmacotherapy.

Proactive tobacco treatment and population-level cessation a pragmatic randomized clinical trial

IMPORTANCE Current tobacco use treatment approaches require smokers to request treatment or depend on the provider to initiate smoking cessation care and are therefore reactive. Most smokers do not receive evidence-based treatments for tobacco use that include both behavioral counseling and pharmacotherapy. OBJECTIVE To assess the effect of a proactive, population-based tobacco cessation care model on use of evidence-based tobacco cessation treatments and on population-level smoking cessation rates (ie, abstinence among all smokers including those who use and do not use treatment) compared with usual care among a diverse population of current smokers. DESIGN, SETTING, AND PARTICIPANTS The Veterans Victory Over Tobacco Study, a pragmatic randomized clinical trial involving a population-based registry of current smokers aged 18 to 80 years. A total of 6400 current smokers, identified using the Department of Veterans Affairs (VA) electronic medical record, were randomized prior to contact to evaluate both the reach and effectiveness of the proactive care intervention. INTERVENTIONS Current smokers were randomized to usual care or proactive care. Proactive care combined (1) proactive outreach and (2) offer of choice of smoking cessation services (telephone or in-person). Proactive outreach included mailed invitations followed by telephone outreach to motivate smokers to seek treatment with choice of services. MAIN OUTCOMES AND MEASURES The primary outcome was 6-month prolonged smoking abstinence at 1 year and was assessed by a follow-up survey among all current smokers regardless of interest in quitting or treatment utilization. RESULTS A total of 5123 participants were included in the primary analysis. The follow-up survey response rate was 66%. The population-level, 6-month prolonged smoking abstinence rate at 1 year was 13.5% for proactive care compared with 10.9% for usual care (P = .02). Logistic regression mixed model analysis showed a significant effect of the proactive care intervention on 6-month prolonged abstinence (odds ratio [OR], 1.27 [95% CI, 1.03-1.57]). In analyses accounting for nonresponse using likelihood-based not-missing-at-random models, the effect of proactive care on 6-month prolonged abstinence persisted (OR, 1.33 [95% CI, 1.17-1.51]). CONCLUSIONS AND RELEVANCE Proactive, population-based tobacco cessation care using proactive outreach to connect smokers to evidence-based telephone or in-person smoking cessation services is effective for increasing long-term population-level cessation rates. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00608426.

Effect of Nurse Case Management Compared With Usual Care on Controlling Cardiovascular Risk Factors in Patients With Diabetes A randomized controlled trial

OBJECTIVE To determine whether nurse case management with a therapeutic algorithm could effectively improve rates of control for hypertension, hyperglycemia, and hyperlipidemia compared with usual care among veterans with diabetes. RESEARCH DESIGN AND METHODS A randomized controlled trial of diabetic patients that had blood pressure (BP) >140/90 mmHg, hemoglobin A1c (HbA1c) >9.0%, or LDL >100 mg/dL. Intervention patients received case management (n = 278) versus usual care (n = 278) over a 1-year period. The primary outcome was the percentage of patients achieving simultaneous control of all three parameters (defined by BP <130/80 mmHg, HbA1c <8.0%, and LDL <100 mg/dL) at 1 year. Secondary outcomes included improvements within each individual component of the composite primary outcome. Differences between groups were analyzed using t tests, Pearson χ2 tests, and linear and logistic regression. RESULTS A greater number of individuals assigned to case management achieved the primary study outcome of having all three outcome measures under control (61 [21.9%] compared with 28 [10.1%] in the usual care group [P < 0.01]). In addition, a greater number of individuals assigned to the intervention group achieved the individual treatment goals of HbA1c <8.0% (73.7 vs. 65.8%, P = 0.04) and BP <130/80 mmHg (45.0 vs. 25.4%, P < 0.01), but not for LDL <100 mg/dL (57.6 vs. 55.4%, P = 0.61), compared with those in the usual care group. CONCLUSIONS In patients with diabetes, nurse case managers using a treatment algorithm can effectively improve the number of individuals with control of multiple cardiovascular risk factors at 1 year.

Race and Nicotine Replacement Treatment Outcomes Among Low-Income Smokers

BACKGROUND Prior research suggests that racial/ethnic minority smokers experience more difficulty with cessation than white smokers and access formal treatment less often. Minority smokers may respond differently to treatment interventions than white smokers. This prospective, observational cohort study compared long-term cessation outcomes among four racial/ethnic groups after an aided quit attempt using nicotine replacement therapy (NRT). METHODS A random cohort of smokers (N=1782) who recently filled a prescription for NRT was selected, stratified by race, using Minnesota Health Care Programs (e.g., Medicaid) pharmacy claims databases between July 2005 and September 2006. The primary outcome was 7-day point prevalence abstinence, which was assessed about 8 months after the NRT index prescription fill date using a mixed-mode survey protocol. RESULTS The overall survey response was 58.2%. Overall, abstinence outcomes did not significantly vary by race. Unadjusted comparisons show that among survey respondents, at 8 months, 7-day point prevalence abstinence was 13.8% among whites, 13.6% among blacks, 14.1% among American Indians/Alaska Natives, and 20.7% among Asians (p=0.42). Similarly, the 30-day duration abstinence was 10.0% among whites, 11.5% among blacks, 8.9% among American Indians/Alaska Natives, and 18.3% among Asians (p=0.14). In multivariate analysis using propensity adjustment for potential confounding and response bias, there was no evidence that the effectiveness of NRT was lower for racial/ethnic minority smokers compared to white smokers. CONCLUSIONS These findings indicate that racial/ethnic minorities are as likely to quit smoking at a level similar to whites when using cessation treatment that includes NRT. Given documented disparities in the use of evidence-based cessation treatments such as NRT, interventions are sorely needed to improve access and utilization of these treatments in racial/ethnic minority groups.

Smoking Cessation Among African American and White Smokers in the Veterans Affairs Health Care System

OBJECTIVES We examined whether a proactive care smoking cessation intervention designed to overcome barriers to treatment would be especially effective at increasing cessation among African Americans receiving care in the Veterans Health Administration. METHODS We analyzed data from a randomized controlled trial, the Veterans Victory over Tobacco study, involving a population-based electronic registry of current smokers (702 African Americans, 1569 whites) and assessed 6-month prolonged smoking abstinence at 1 year via a follow-up survey of all current smokers. We also examined candidate risk adjustors for the race effect on smoking abstinence. RESULTS The interaction between patient race and intervention condition (proactive care vs. usual care) was not significant. Overall, African Americans had higher quit rates than Whites (13% vs. 9%; P < .006) regardless of condition. CONCLUSIONS African Americans quit at higher rates than Whites. These findings may be a result of the large number of veterans receiving smoking cessation services and the lack of racial differences in receipt of these services as well as racial differences in smoking history, self-efficacy, and motivation to quit that favor African Americans.

Population-based tobacco treatment: study design of a randomized controlled trial

BackgroundMost smokers do not receive comprehensive, evidence-based treatment for tobacco use that includes intensive behavioral counseling along with pharmacotherapy. Further, the use of proven, tobacco treatments is lower among minorities than among Whites. The primary objectives of this study are to: (1) Assess the effect of a proactive care intervention (PRO) on population-level smoking abstinence rates (i.e., abstinence among all smokers including those who use and do not utilize treatment) and on utilization of tobacco treatment compared to reactive/usual care (UC) among a diverse population of smokers, (2) Compare the effect of PRO on population-level smoking abstinence rates and utilization of tobacco treatments between African American and White smokers, and (3) Determine the cost-effectiveness of the proactive care intervention.Methods/DesignThis prospective randomized controlled trial identifies a population-based sample of current smokers from the Department of Veterans Affairs (VA) electronic medical record health factor dataset. The proactive care intervention combines: (1) proactive outreach and (2) offer of choice of smoking cessation services (telephone or face-to-face). Proactive outreach includes mailed invitation materials followed by an outreach call that encourages smokers to seek treatment with choice of services. Proactive care participants who choose telephone care receive VA telephone counseling and access to pharmacotherapy. Proactive care participants who choose face-to-face care are referred to their VA facilitys smoking cessation clinic. Usual care participants have access to standard smoking cessation services from their VA facility (e.g., pharmacotherapy, smoking cessation clinic) and from their state telephone quitline. Baseline data is collected from VA administrative databases and participant surveys. Outcomes from both groups are collected 12 months post-randomization from participant surveys and from VA administrative databases. The primary outcome is self-reported smoking abstinence, which is assessed at the population-level (i.e., among those who utilize and those who do not utilize tobacco treatment). Primary analyses will follow intention-to-treat methodology.DiscussionThis randomized trial is testing proactive outreach strategies offering choice of smoking cessation services, an innovation that if proven effective and cost-effective, will transform the way tobacco treatment is delivered. National dissemination of proactive treatment strategies could dramatically reduce tobacco-related morbidity, mortality, and health care costs.Clinical trials registrationClinicalTrials.gov: NCT00608426.

Smoking-Cessation Strategies for American Indians Should Smoking-Cessation Treatment Include a Prescription for a Complete Home Smoking Ban?

BACKGROUND The prevalence of cigarette smoking is particularly high among American Indian communities in the Upper Midwest. PURPOSE To evaluate the predictors of smoking cessation among a population-based sample of American Indians in the Upper Midwest during a quit attempt aided with nicotine replacement therapy (NRT). METHODS This study used the subsample of American Indian adults (n = 291, response rate = 55.4%) from a cohort study of smokers engaging in an aided NRT quit attempt. Eligible participants filled an NRT prescription between July 2005 and September 2006 through the Minnesota Health Care Programs (e.g., Medicaid). Administrative records and follow-up survey data were used to assess outcomes approximately 8 months after the NRT fill date. This analysis was conducted in 2009-2010. RESULTS Approximately 33% of American Indian respondents trying to quit smoking reported complete home smoking bans. Adoption of a complete home smoking ban and greater perceived advantages of NRT were cross-sectionally associated with 7-day smoking abstinence in univariate and multivariate analyses. Consistent with previous research, older age was a significant predictor of 7-day abstinence. Having a history of clinician-diagnosed anxiety in the past year was associated with decreased likelihood of 7-day abstinence in the unadjusted analysis, but not significant in multivariate analyses. CONCLUSIONS Results of this study suggest potential modifiable targets of interventions for future research to help American Indians quit smoking: (1) improved delivery of behavioral interventions to increase the intensity of smoking cessation treatment; (2) promotion and adoption of complete home smoking bans; and (3) education to increase awareness of the benefits of NRT.

Proactive tobacco treatment offering free nicotine replacement therapy and telephone counselling for socioeconomically disadvantaged smokers: a randomised clinical trial

Background Evidenced-based tobacco cessation treatments are underused, especially by socioeconomically disadvantaged smokers. This contributes to widening socioeconomic disparities in tobacco-related morbidity and mortality. Methods The Offering Proactive Treatment Intervention trial tested the effects of a proactive outreach tobacco treatment intervention on population-level smoking abstinence and tobacco treatment use among a population-based sample of socioeconomically disadvantaged smokers. Current smokers (n=2406), regardless of interest in quitting, who were enrolled in the Minnesota Health Care Programs, the states publicly funded healthcare programmes for low-income populations, were randomly assigned to proactive outreach or usual care. The intervention comprised proactive outreach (tailored mailings and telephone calls) and free cessation treatment (nicotine replacement therapy and intensive, telephone counselling). Usual care comprised access to a primary care physician, insurance coverage of Food and Drug Administration-approved smoking cessation medications, and the states telephone quitline. The primary outcome was self-reported 6-month prolonged smoking abstinence at 1 year and was assessed by follow-up survey. Findings The proactive intervention group had a higher prolonged abstinence rate at 1 year than usual care (16.5% vs 12.1%, OR 1.47, 95% CI 1.12 to 1.93). The effect of the proactive intervention on prolonged abstinence persisted in selection models accounting for non-response. In analysis of secondary outcomes, use of evidence-based tobacco cessation treatments were significantly greater among proactive outreach participants compared with usual care, particularly combination counselling and medications (17.4% vs 3.6%, OR 5.69, 95% CI 3.85 to 8.40). Interpretation Population-based proactive tobacco treatment increases engagement in evidence-based treatment and is effective in long-term smoking cessation among socioeconomically disadvantaged smokers. Findings suggest that dissemination of population-based proactive treatment approaches is an effective strategy to reduce the prevalence of smoking and socioeconomic disparities in tobacco use. Trial registration number NCT01123967.