Associations Between a Primary Care-Delivered Alcohol-Related Brief Intervention and Subsequent Opioid-Related Outcomes.

OBJECTIVE: The co-occurrence of unhealthy alcohol use and opioid misuse is high and associated with increased rates of overdose, emergency health care utilization, and death. The current study examined whether receipt of an alcohol-related brief intervention is associated with reduced risk of negative downstream opioid-related outcomes. METHODS: This retrospective cohort study included all VISN-6 Veterans Affairs (VA) patients with Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) screening results (N=492,748) from 2014 to 2019. Logistic regression was used to examine the association between documentation of an alcohol-related brief intervention and probability of a new 1) opioid prescription, 2) opioid use disorder (OUD) diagnosis, or 3) opioid-related hospitalization in the following year, controlling for demographic and clinical covariates. RESULTS: Of the veterans, 13% (N=63,804) had "positive" AUDIT-C screen results. Of those, 72% (N=46,216) had a documented alcohol-related brief intervention. Within 1 year, 8.5% (N=5,430) had a new opioid prescription, 1.1% (N=698) had a new OUD diagnosis, and 0.8% (N=499) had a new opioid-related hospitalization. In adjusted models, veterans with positive AUDIT-C screen results who did not receive an alcohol-related brief intervention had higher odds of new opioid prescriptions (adjusted odds ratio [OR]=1.10, 95% CI=1.03-1.17) and new OUD diagnoses (adjusted OR=1.19, 95% CI=1.02-1.40), while new opioid-related hospitalizations (adjusted OR=1.19, 95% CI=0.99-1.44) were higher although not statistically significant. Removal of medications for OUD (MOUD) did not impact associations. All outcomes were significantly associated with an alcohol-related brief intervention in unadjusted models. CONCLUSIONS: The VA's standard alcohol-related brief intervention is associated with subsequent lower odds of a new opioid prescription or a new OUD diagnosis. Results suggest a reduction in a cascade of new opioid-related outcomes from prescriptions through hospitalizations.

Association between patient-reported social and behavioral risks and health care costs in high-risk Veterans health administration patients.

OBJECTIVE: Social risks complicate patients' ability to manage their conditions and access healthcare, but their association with health expenditures is not well established. To identify patient-reported social risk, behavioral, and health factors associated with health expenditures in Veterans Affairs (VA) patients at high risk for hospitalization or death. DATA SOURCES, STUDY SETTING, AND STUDY DESIGN: Prospective cohort study among high-risk Veterans obtaining VA care. Patient-reported social risk, function, and other measures derived from a 2018 survey sent to 10,000 VA patients were linked to clinical and demographic characteristics extracted from VA data. Response-weighted generalized linear and marginalized two-part models were used to examine VA expenditures (total, outpatient, medication, inpatient) 1 year after survey completion in adjusted models. PRINCIPAL FINDINGS: Among 4680 survey respondents, the average age was 70.9 years, 6.3% were female, 16.7% were African American, 20% had body mass index ≥35, 42.4% had difficulty with two or more basic or instrumental activities of daily living, 19.3% reported transportation barriers, 12.5% reported medication insecurity and 21.8% reported food insecurity. Medication insecurity was associated with lower outpatient expenditures (-$1859.51 per patient per year, 95% confidence interval [CI]: -3200.77 to -518.25) and lower total expenditures (-$4304.99 per patient per year, 95% CI: -7564.87 to -1045.10). Transportation barriers were negatively associated with medication expenditures (-$558.42, 95% CI: -1087.93 to -31.91). Patients with one functional impairment had higher outpatient expenditures ($2997.59 per patient year, 95% CI: 1185.81-4809.36) than patients without functional impairments. No social risks were associated with inpatient expenditures. CONCLUSIONS: In this study of VA patients at high risk for hospitalization and mortality, few social and functional measures were independently associated with the costs of VA care. Individuals with functional limitations and those with barriers to accessing medications and transportation may benefit from targeted interventions to ensure that they are receiving the services that they need.

Ready, set, go! The role of organizational readiness to predict adoption of a family caregiver training program using the Rogers' diffusion of innovation theory.

BACKGROUND: Caregivers FIRST is an evidence-based program addressing gaps in caregivers' skills. In 2020, the Veterans Health Administration Caregiver Support Program (CSP) nationally endorsed Caregivers FIRST, offering credit in leadership performance plans to encourage all VA medical centers (VAMCs) to implement locally. This study examines the association of organizational readiness with VAMC adoption of Caregivers FIRST. METHODS: In a cohort observational study, we surveyed CSP managers about their facilities' readiness to implement using the Organizational Readiness for Implementing Change (ORIC) instrument and compared change commitment and change efficacy domains among VAMCs "adopters" defined as delivering Caregivers FIRST within 1 year of the national announcement to those that did not ("non-adopters"). Within "adopters," we categorized time to adoption based on Rogers' diffusion of innovation theory including "innovators," "early adopters," "early majority," "late adopters," and "laggards." Organizational readiness and site characteristics (facility complexity, staffing levels, volume of applications for caregiver assistance services) were compared between "adopters," "non-adopters," and between time to adoption subcategories. Separate logistic regression models were used to assess whether ORIC and site characteristics were associated with early adoption among "adopters." RESULTS: Fifty-one of 63 (81%) VAMCs with CSP manager survey respondents adopted Caregivers FIRST during the first year. ORIC change commitment and efficacy were similar for "adopters" and "non-adopters." However, sites that adopted earlier (innovators and early adopters) had higher ORIC change commitment and efficacy scores than the rest of the "adopters." Logistic regression results indicated that higher ORIC change commitment (odds ratio [OR] = 2.57; 95% confidence interval [CI], 1.11-5.95) and ORIC change efficacy (OR = 2.60; 95% CI, 1.12-6.03) scores were associated with increased odds that a VAMC was an early adopter (categorized as an "innovator," "early adopter", or "early majority"). Site-level characteristics were not associated with Caregivers FIRST early adoption. CONCLUSIONS: To our knowledge, this study is the first to prospectively assess organizational readiness and the timing of subsequent program adoption. Early adoption was associated with higher ORIC change commitment and change efficacy and not site-level characteristics. These findings yield insights into the role of organizational readiness to accelerate program adoption. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03474380. Registered on March 22, 2018.

Informing a home time measure reflective of quality of life: A data driven investigation of time frames and settings of health care utilization.

OBJECTIVE: To evaluate short- and long-term measures of health care utilization-days in the emergency department (ED), inpatient (IP) care, and rehabilitation in a post-acute care (PAC) facility-to understand how home time (i.e., days alive and not in an acute or PAC setting) corresponds to quality of life (QoL). DATA SOURCES: Survey data on community-residing veterans combined with multipayer administrative data on health care utilization. STUDY DESIGN: VA or Medicare health care utilization, quantified as days of care received in the ED, IP, and PAC in the 6 and 18 months preceding survey completion, were used to predict seven QoL-related measures collected during the survey. Elastic net machine learning was used to construct models, with resulting regression coefficients used to develop a weighted utilization variable. This was then compared with an unweighted count of days with any utilization. PRINCIPAL FINDINGS: In the short term (6 months), PAC utilization emerged as the most salient predictor of decreased QoL, whereas no setting predominated in the long term (18 months). Results varied by outcome and time frame, with some protective effects observed. In the 6-month time frame, each weighted day of utilization was associated with a greater likelihood of activity of daily living deficits (0.5%, 95% CI: 0.1%-0.9%), as was the case with each unweighted day of utilization (0.6%, 95% CI: 0.3%-1.0%). The same was true in the 18-month time frame (for both weighted and unweighted, 0.1%, 95% CI: 0.0%-0.3%). Days of utilization were also significantly associated with greater rates of instrumental ADL deficits and fair/poor health, albeit not consistently across all models. Neither measure outperformed the other in direct comparisons. CONCLUSIONS: These results can provide guidance on how to measure home time using multipayer administrative data. While no setting predominated in the long term, all settings were significant predictors of QoL measures.

A Cluster Randomized Trial of a Family Health History Platform to Identify and Manage Patients at Increased Risk for Colorectal Cancer.

BACKGROUND: Obtaining comprehensive family health history (FHH) to inform colorectal cancer (CRC) risk management in primary care settings is challenging. OBJECTIVE: To examine the effectiveness of a patient-facing FHH platform to identify and manage patients at increased CRC risk. DESIGN: Two-site, two-arm, cluster-randomized, implementation-effectiveness trial with primary care providers (PCPs) randomized to immediate intervention versus wait-list control. PARTICIPANTS: PCPs treating patients at least one half-day per week; patients aged 40-64 with no medical conditions that increased CRC risk. INTERVENTIONS: Immediate-arm patients entered their FHH into a web-based platform that provided risk assessment and guideline-driven decision support; wait-list control patients did so 12 months later. MAIN MEASURES: McNemar's test examined differences between the platform and electronic medical record (EMR) in rates of increased risk documentation. General estimating equations using logistic regression models compared arms in risk-concordant provider actions and patient screening test completion. Referral for genetic consultation was analyzed descriptively. KEY RESULTS: Seventeen PCPs were randomized to each arm. Patients (n = 252 immediate, n = 253 control) averaged 51.4 (SD = 7.2) years, with 83% assigned male at birth, 58% White persons, and 33% Black persons. The percentage of patients identified as increased risk for CRC was greater with the platform (9.9%) versus EMR (5.2%), difference = 4.8% (95% CI: 2.6%, 6.9%), p < .0001. There was no difference in PCP risk-concordant action [odds ratio (OR) = 0.7, 95% CI (0.4, 1.2; p = 0.16)]. Among 177 patients with a risk-concordant screening test ordered, there was no difference in test completion, OR = 0.8 [0.5,1.3]; p = 0.36. Of 50 patients identified by the platform as increased risk, 78.6% immediate and 68.2% control patients received a recommendation for genetic consultation, of which only one in each arm had a referral placed. CONCLUSIONS: FHH tools could accurately assess and document the clinical needs of patients at increased risk for CRC. Barriers to acting on those recommendations warrant further exploration. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT02247336 https://clinicaltrials.gov/ct2/show/NCT02247336.

Improving Veteran Access to Integrated Management of Back Pain (AIM-Back): Protocol for an Embedded Pragmatic Cluster-Randomized Trial.

BACKGROUND: Coordinated efforts between the National Institutes of Health, the Department of Defense, and the Department of Veterans Affairs have built the capacity for large-scale clinical research investigating the effectiveness of nonpharmacologic pain treatments. This is an encouraging development; however, what constitutes best practice for nonpharmacologic management of low back pain (LBP) is largely unknown. DESIGN: The Improving Veteran Access to Integrated Management of Back Pain (AIM-Back) trial is an embedded pragmatic cluster-randomized trial that will examine the effectiveness of two different care pathways for LBP. Sixteen primary care clinics will be randomized 1:1 to receive training in delivery of 1) an integrated sequenced-care pathway or 2) a coordinated pain navigator pathway. Primary outcomes are pain interference and physical function (Patient-Reported Outcomes Measurement Information System Short Form [PROMIS-SF]) collected in the electronic health record at 3 months (n=1,680). A subset of veteran participants (n=848) have consented to complete additional surveys at baseline and at 3, 6, and 12 months for supplementary pain and other measures. SUMMARY: AIM-Back care pathways will be tested for effectiveness, and treatment heterogeneity will be investigated to identify which veterans may respond best to a given pathway. Health care utilization patterns (including opioid use) will also be compared between care pathways. Therefore, the AIM-Back trial will provide important information that can inform the future delivery of nonpharmacologic treatment of LBP.

Patient-Reported Social and Behavioral Determinants of Health and Estimated Risk of Hospitalization in High-Risk Veterans Affairs Patients.

Importance: Despite recognition of the association between individual social and behavioral determinants of health (SDH) and patient outcomes, little is known regarding the value of SDH in explaining variation in outcomes for high-risk patients. Objective: To describe SDH factors among veterans who are at high risk for hospitalization, and to determine whether adding patient-reported SDH measures to electronic health record (EHR) measures improves estimation of 90-day and 180-day all-cause hospital admission. Design, Setting, and Participants: A survey was mailed between April 16 and June 29, 2018, to a nationally representative sample of 10 000 Veterans Affairs (VA) patients whose 1-year risk of hospitalization or death was in the 75th percentile or higher based on a VA EHR-derived risk score. The survey included multiple SDH measures, such as resilience, social support, health literacy, smoking status, transportation barriers, and recent life stressors. Main Outcomes and Measures: The EHR-based characteristics of survey respondents and nonrespondents were compared using standardized differences. Estimation of 90-day and 180-day hospital admission risk was assessed for 3 logistic regression models: (1) a base model of all prespecified EHR-based covariates, (2) a restricted model of EHR-based covariates chosen via forward selection based on minimizing Akaike information criterion (AIC), and (3) a model of EHR- and survey-based covariates chosen via forward selection based on AIC minimization. Results: In total, 4685 individuals (response rate 46.9%) responded to the survey. Respondents were comparable to nonrespondents in most characteristics, but survey respondents were older (eg, >80 years old, 881 [18.8%] vs 800 [15.1%]), comprised a higher percentage of men (4391 [93.7%] vs 4794 [90.2%]), and were composed of more White non-Hispanic individuals (3366 [71.8%] vs 3259 [61.3%]). Based on AIC, the regression model with survey-based covariates and EHR-based covariates better estimated hospital admission at 90 days (AIC, 1947.7) and 180 days (AIC, 2951.9) than restricted models with only EHR-based covariates (AIC, 1980.2 at 90 days; AIC, 2981.9 at 180 days). This result was due to inclusion of self-reported measures such as marital or partner status, health-related locus of control, resilience, smoking status, health literacy, and medication insecurity. Conclusions and Relevance: Augmenting EHR data with patient-reported social information improved estimation of 90-day and 180-day hospitalization risk, highlighting specific SDH factors that might identify individuals who are at high risk for hospitalization.

An electronic family health history tool to identify and manage patients at increased risk for colorectal cancer: protocol for a randomized controlled trial.

BACKGROUND: Colorectal cancer is the fourth most commonly diagnosed cancer in the United States. Approximately 3-10% of the population has an increased risk for colorectal cancer due to family history and warrants more frequent or intensive screening. Yet, < 50% of that high-risk population receives guideline-concordant care. Systematic collection of family health history and decision support may improve guideline-concordant screening for patients at increased risk of colorectal cancer. We seek to test the effectiveness of a web-based, systematic family health history collection tool and decision support platform (MeTree) to improve risk assessment and appropriate management of colorectal cancer risk among patients in the Department of Veterans Affairs primary care practices. METHODS: In this ongoing randomized controlled trial, primary care providers at the Durham Veterans Affairs Health Care System and the Madison VA Medical Center are randomized to immediate intervention or wait-list control. Veterans are eligible if assigned to enrolled providers, have an upcoming primary care appointment, and have no conditions that would place them at increased risk for colorectal cancer (such as personal history, adenomatous polyps, or inflammatory bowel disease). Those with a recent lower endoscopy (e.g. colonoscopy, sigmoidoscopy) are excluded. Immediate intervention patients put their family health history information into a web-based platform, MeTree, which provides both patient- and provider-facing decision support reports. Wait-list control patients access MeTree 12 months post-consent. The primary outcome is the risk-concordant colorectal cancer screening referral rate obtained via chart review. Secondary outcomes include patient completion of risk management recommendations (e.g. colonoscopy) and referral for genetic consultation. We will also conduct an economic analysis and an assessment of providers' experience with MeTree clinical decision support recommendations to inform future implementation efforts if the intervention is found to be effective. DISCUSSION: This trial will assess the feasibility and effectiveness of patient-collected family health history linked to decision support to promote risk-appropriate screening in a large healthcare system such as the Department of Veterans Affairs. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02247336 . Registered on 25 September 2014.

Limited Osteoporosis Screening Effectiveness Due to Low Treatment Rates in a National Sample of Older Men.

OBJECTIVE: To determine the association between dual-energy x-ray absorptiometry (DXA) testing for osteoporosis and subsequent fractures in US male veterans without a previous fracture. PATIENTS AND METHODS: This is a propensity score-matched observational study using Centers for Medicare and Medicaid Services and Veterans Affairs (VA) data from January 1, 2000, through December 31, 2010, with a mean follow-up time of 4.7 years (range, 0-10 years). Men receiving VA primary care aged 65 to 99 years without a previous fracture (N=2,539,812) were included. Men undergoing DXA testing were propensity score matched with untested controls in a 1:3 ratio, indicating the probability of DXA testing within the next year. Time to first clinical fracture was the primary outcome. Comorbidities, demographic characteristics, medications, DXA results, and osteoporosis treatment were defined using administrative data and natural language processing. A landmark analysis contingent on surviving to 12 months after screening was completed, accounting for competing risk of mortality. RESULTS: During follow-up of 153,311 men tested by DXA and 390,158 controls, 56,083 (10.3%) had sustained a fracture and 111,774 (20.6%) died. Overall, DXA testing was not associated with a decrease in fractures; conclusions are limited by unmeasured confounders and low medication initiation and adherence in those meeting treatment thresholds (12% of follow-up time). In contrast, DXA testing in prespecified subgroups was associated with a lower risk of fracture in comparison to the overall population who underwent DXA testing: androgen deprivation therapy (hazard ratio [HR], 0.77; 95% CI, 0.66-0.89), glucocorticoids (HR, 0.77; 95% CI, 0.72-0.84), age 80 years and older (HR, 0.85; 0.81-0.90), 1 or more VA guideline risk factors (HR, 0.91; 95% CI, 0.87-0.95), and high Fracture Risk Assessment Tool using body mass index score (HR, 0.90; 95% CI, 0.86-0.95). CONCLUSION: Current VA DXA testing practices are ineffective overall; interventions to improve treatment adherence are needed. Targeted DXA testing in higher-risk men was associated with a lower fracture risk.

Patient predictors of weight loss following a behavioral weight management intervention among US Veterans with severe obesity.

PURPOSE: Identification of patient characteristics that are associated with behavioral weight loss success among bariatric surgery candidates could inform selection of optimal bariatric surgery candidates. We examined the associations between psychosocial characteristics and weight loss in a group of Veterans with severe obesity who participated in a behavioral weight loss intervention. METHODS: The MAINTAIN trial involved a 16-week weight loss program followed by randomization among participants losing at least 4 kg to a maintenance intervention or usual care. This secondary analysis was performed on Veterans who participated in the 16-week weight loss program and met NIH criteria for bariatric surgery (body mass index [BMI] 35.0-39.9 with at least 1 obesity-related comorbidity or BMI ≥ 40). Unadjusted and adjusted associations between baseline patient characteristics and weight loss during the 16-week induction phase were evaluated with linear regression. Missing weight measurements were multiply imputed, and results combined across ten imputations. RESULTS: Among the 206 patients who met inclusion criteria, mean initial BMI was 40.8 kg/m2 (SD 6.0), and mean age was 59.2 years (SD 9.4). Approximately 20% of participants were female, 51.5% were Black, and 44.7% were White. Estimated mean 16-week weight loss was 5.16 kg (SD 4.31). In adjusted analyses, greater social support and older age were associated with greater weight loss (p < 0.05). None of the nine psychosocial characteristics we examined were associated with greater weight loss. CONCLUSIONS: Understanding and strengthening the level of social support for bariatric surgery candidates may be important given that it appears to be strongly correlated with behavioral weight loss success. LEVEL OF EVIDENCE: Level II, Evidence obtained from well-designed controlled trials without randomization. TRIAL REGISTRATION: ClinicalTrials.gov NCT01357551 http://clinicaltrials.gov/show/NCT01357551 .

Maintenance of Weight Loss After Initiation of Nutrition Training: A Randomized Trial.

BACKGROUND: Weight regain after successful weight loss interventions is common. OBJECTIVE: To establish the efficacy of a weight loss maintenance program compared with usual care in obese adults. DESIGN: 2-group, parallel, randomized trial stratified by initial weight loss (<10 kg vs. ≥10 kg), conducted from 20 August 2012 to 18 December 2015. Outcome assessors were blinded to treatment assignment. (ClinicalTrials.gov: NCT01357551). SETTING: 3 primary care clinics at the Veterans Affairs Medical Center in Durham and Raleigh, North Carolina. PATIENTS: Obese outpatients (body mass index ≥30 kg/m2) who lost 4 kg or more of body weight during a 16-week, group-based weight loss program. INTERVENTION: The maintenance intervention, delivered primarily by telephone, addressed satisfaction with outcomes, relapse-prevention planning, self-monitoring, and social support. Usual care involved no contact except for study measurements. MEASUREMENTS: Primary outcome was mean weight regain at week 56. Secondary outcomes included self-reported caloric intake, walking, and moderate physical activity. RESULTS: Of 504 patients in the initial program, 222 lost at least 4 kg of body weight and were randomly assigned to maintenance (n = 110) or usual care (n = 112). Retention was 85%. Most patients were middle-aged white men. Mean weight loss during initiation was 7.2 kg (SD, 3.1); mean weight at randomization was 103.6 kg (SD, 20.4). Estimated mean weight regain was statistically significantly lower in the intervention (0.75 kg) than the usual care (2.36 kg) group (estimated mean difference, 1.60 kg [95% CI, 0.07 to 3.13 kg]; P = 0.040). No statistically significant differences in secondary outcomes were seen at 56 weeks. No adverse events directly attributable to the intervention were observed. LIMITATIONS: Results may not generalize to other settings or populations. Dietary intake and physical activity were self-reported. Duration was limited to 56 weeks. CONCLUSION: An intervention focused on maintenance-specific strategies and delivered in a resource-conserving way modestly slowed the rate of weight regain in obese adults. PRIMARY FUNDING SOURCE: Veterans Affairs Health Services Research and Development Service.

Implementation of Lung Cancer Screening in the Veterans Health Administration.

Importance: The US Preventive Services Task Force recommends annual lung cancer screening (LCS) with low-dose computed tomography for current and former heavy smokers aged 55 to 80 years. There is little published experience regarding implementing this recommendation in clinical practice. Objectives: To describe organizational- and patient-level experiences with implementing an LCS program in selected Veterans Health Administration (VHA) hospitals and to estimate the number of VHA patients who may be candidates for LCS. Design, Setting, and Participants: This clinical demonstration project was conducted at 8 academic VHA hospitals among 93 033 primary care patients who were assessed on screening criteria; 2106 patients underwent LCS between July 1, 2013, and June 30, 2015. Interventions: Implementation Guide and support, full-time LCS coordinators, electronic tools, tracking database, patient education materials, and radiologic and nodule follow-up guidelines. Main Outcomes and Measures: Description of implementation processes; percentages of patients who agreed to undergo LCS, had positive findings on results of low-dose computed tomographic scans (nodules to be tracked or suspicious findings), were found to have lung cancer, or had incidental findings; and estimated number of VHA patients who met the criteria for LCS. Results: Of the 4246 patients who met the criteria for LCS, 2452 (57.7%) agreed to undergo screening and 2106 (2028 men and 78 women; mean [SD] age, 64.9 [5.1] years) underwent LCS. Wide variation in processes and patient experiences occurred among the 8 sites. Of the 2106 patients screened, 1257 (59.7%) had nodules; 1184 of these patients (56.2%) required tracking, 42 (2.0%) required further evaluation but the findings were not cancer, and 31 (1.5%) had lung cancer. A variety of incidental findings, such as emphysema, other pulmonary abnormalities, and coronary artery calcification, were noted on the scans of 857 patients (40.7%). Conclusions and Relevance: It is estimated that nearly 900 000 of a population of 6.7 million VHA patients met the criteria for LCS. Implementation of LCS in the VHA will likely lead to large numbers of patients eligible for LCS and will require substantial clinical effort for both patients and staff.

Underuse and Overuse of Colonoscopy for Repeat Screening and Surveillance in the Veterans Health Administration.

BACKGROUND & AIMS: Regular screening with colonoscopy lowers colorectal cancer incidence and mortality. We aimed to determine patterns of repeat and surveillance colonoscopy and identify factors associated with overuse and underuse of colonoscopy. METHODS: We analyzed data from participants in a previous Veterans Health Administration (VHA) study who underwent outpatient colonoscopy at 25 VHA facilities between October 2007 and September 2008 (n = 1455). The proportion of patients who received a follow-up colonoscopy was calculated for 3 risk groups, which were defined on the basis of the index colonoscopy: no adenoma, low-risk adenoma, or high-risk adenoma. RESULTS: Colonoscopy was overused (used more frequently than intervals recommended by guidelines) by 16% of patients with no adenomas, 26% with low-risk adenomas, and 29% with high-risk adenomas. Most patients with high-risk adenomas (54%) underwent colonoscopy after the recommended interval or did not undergo colonoscopy. Patients who received a follow-up recommendation that was discordant with guidelines were more likely to undergo colonoscopy too early (no adenoma odds ratio [OR], 3.80; 95% confidence interval [CI], 2.31-6.25 and low-risk adenoma OR, 5.28; 95% CI, 1.88-14.83). Receipt of colonoscopy at nonacademic facilities was associated with overuse among patients without adenomas (OR, 5.26; 95% CI, 1.96-14.29) or with low-risk adenomas (OR, 3.45; 95% CI, 1.52-7.69). Performance of colonoscopies by general surgeons vs gastroenterologists (OR, 2.08; 95% CI, 1.02-4.23) and female sex of the patient (OR, 3.28; 95% CI, 1.06-10.16) were associated with overuse of colonoscopy for patients with low-risk adenomas. No factors examined were associated with underuse of colonoscopy among patients with high-risk adenomas. CONCLUSIONS: In an analysis of patients in the VHA system, more than one fourth of patients with low-risk adenomas received follow-up colonoscopies too early, whereas more than one half of those with high-risk adenomas did not undergo surveillance colonoscopy as recommended. Our findings highlight the need for system-level improvements to facilitate the appropriate delivery of colonoscopy that is based on individual risk.

Does Type 2 Diabetes Genetic Testing and Counseling Reduce Modifiable Risk Factors? A Randomized Controlled Trial of Veterans.

OBJECTIVE: We examined the clinical utility of supplementing type 2 diabetes mellitus (DM) risk counseling with DM genetic test results and counseling. RESEARCH DESIGN AND METHODS: In this randomized controlled trial, non-diabetic overweight/obese veteran outpatients aged 21 to 65 years received DM risk estimates for lifetime risk, family history, and fasting plasma glucose, followed by either genetic test results (CR+G; N = 303) or control eye disease counseling (CR+EYE; N = 298). All participants received brief lifestyle counseling encouraging weight loss to reduce the risk of DM. RESULTS: The mean age was 54 years, 53% of participants were black, and 80% were men. There was no difference between arms in weight (estimated mean difference between CR+G vs. CR+EYE at 3 months = 0.2 kg, 95% CI: -0.3 to 0.7; at 6 months = 0.4 kg, 95 % CI: -0.3 to 1.1), insulin resistance, perceived risk, or physical activity at 3 or 6 months. Calorie and fat intake were lower in the CR+G arm at 3 months (p's ≤ 0.05) but not at 6 months (p's > 0.20). CONCLUSIONS: Providing patients with genetic test results was not more effective in changing patient behavior to reduce the risk of DM compared to conventional risk counseling. TRIAL REGISTRATION: ClinicalTrials.gov NCT01060540 http://clinicaltrials.gov/show/NCT01060540.

Implementation of new clinical programs in the VHA healthcare system: the importance of early collaboration between clinical leadership and research.

Collaboration between policy, research, and clinical partners is crucial to achieving proven quality care. The Veterans Health Administration has expended great efforts towards fostering such collaborations. Through this, we have learned that an ideal collaboration involves partnership from the very beginning of a new clinical program, so that the program is designed in a way that ensures quality, validity, and puts into place the infrastructure necessary for a reliable evaluation. This paper will give an example of one such project, the Lung Cancer Screening Demonstration Project (LCSDP). We will outline the ways that clinical, policy, and research partners collaborated in design, planning, and implementation in order to create a sustainable model that could be rigorously evaluated for efficacy and fidelity. We will describe the use of the Donabedian quality matrix to determine the necessary characteristics of a quality program and the importance of the linkage with engineering, information technology, and clinical paradigms to connect the development of an on-the-ground clinical program with the evaluation goal of a learning healthcare organization. While the LCSDP is the example given here, these partnerships and suggestions are salient to any healthcare organization seeking to implement new scientifically proven care in a useful and reliable way.

The Cholesterol, Hypertension, And Glucose Education (CHANGE) study: results from a randomized controlled trial in African Americans with diabetes.

BACKGROUND: Cardiovascular disease (CVD) and diabetes account for one-third of the mortality difference between African American and white patients. We evaluated the effect of a CVD risk reduction intervention in African Americans with diabetes. METHODS: We randomized 359 African Americans with type 2 diabetes to receive usual care or a nurse telephone intervention. The 12-month intervention provided monthly self-management support and quarterly medication management facilitation. Coprimary outcomes were changes in systolic blood pressure (SBP), hemoglobin A1c (HbA1c), and low-density lipoprotein cholesterol (LDL-C) over 12 months. We estimated between-intervention group differences over time using linear mixed-effects models. The secondary outcome was self-reported medication adherence. RESULTS: The sample was 72% female; 49% had low health literacy, and 37% had annual income <$10,000. Model-based estimates for mean baseline SBP, HbA1c, and LDL-C were 136.8 mm Hg (95% CI 135.0-138.6), 8.0% (95% CI 7.8-8.2), and 99.1 mg/dL (95% CI 94.7-103.5), respectively. Intervention patients received 9.9 (SD 3.0) intervention calls on average. Primary providers replied to 76% of nurse medication management facilitation contacts, 18% of these resulted in medication changes. There were no between-group differences over time for SBP (P = .11), HbA1c (P = .66), or LDL-C (P = .79). Intervention patients were more likely than those receiving usual care to report improved medication adherence (odds ratio 4.4, 95% CI 1.8-10.6, P = .0008), but adherent patients did not exhibit relative improvement in primary outcomes. CONCLUSIONS: This intervention improved self-reported medication adherence but not CVD risk factor control among African Americans with diabetes. Further research is needed to determine how to maximally impact CVD risk factors in African American patients.

Factors associated with non-adherence to three hypertension self-management behaviors: preliminary data for a new instrument.

BACKGROUND: Clinicians have difficulty in identifying patients that are unlikely to adhere to hypertension self-management. Identifying non-adherence is essential to addressing suboptimal blood pressure control and high costs. OBJECTIVES: 1) To identify risk factors associated with non-adherence to three key self-management behaviors in patients with hypertension: proper medication use, diet, and exercise; 2) To evaluate the extent to which an instrument designed to identify the number of risk factors present for non-adherence to each of the three hypertension self-management behaviors would be associated with self-management non-adherence and blood pressure. DESIGN: Cross-sectional analysis of randomized trial data. PATIENTS: Six hundred and thirty-six primary care patients with hypertension. MEASUREMENTS: 1) Demographic, socioeconomic, psychosocial, and health belief-related factors; 2) measures of self-reported adherence to recommended medication use, diet recommendations, and exercise recommendations, all collected at baseline assessment; 3) systolic blood pressure (SBP) and diastolic blood pressure (DBP). RESULTS: We identified patient factors associated with measures of non-adherence to medications, diet, and exercise in hypertension. We then combined risk factors associated with ≥1 adherence measure into an instrument that generated three composite variables (medication, diet, and exercise composites), reflecting the number of risk factors present for non-adherence to the corresponding self-management behavior. These composite variables identified subgroups with higher likelihood of medication non-adherence, difficulty following diet recommendations, and difficulty following exercise recommendations. Composite variable levels representing the highest number of self-management non-adherence risk factors were associated with higher SBP and DBP. CONCLUSIONS: We identified factors associated with measures of non-adherence to recommended medication use, diet, and exercise in hypertension. We then developed an instrument that was associated with non-adherence to these self-management behaviors, as well as with blood pressure. With further study, this instrument has potential to improve identification of non-adherent patients with hypertension.

Examining the impact of genetic testing for type 2 diabetes on health behaviors: study protocol for a randomized controlled trial.

BACKGROUND: We describe the study design, procedures, and development of the risk counseling protocol used in a randomized controlled trial to evaluate the impact of genetic testing for diabetes mellitus (DM) on psychological, health behavior, and clinical outcomes. METHODS/DESIGN: Eligible patients are aged 21 to 65 years with body mass index (BMI) ≥27 kg/m(2) and no prior diagnosis of DM. At baseline, conventional DM risk factors are assessed, and blood is drawn for possible genetic testing. Participants are randomized to receive conventional risk counseling for DM with eye disease counseling or with genetic test results. The counseling protocol was pilot tested to identify an acceptable graphical format for conveying risk estimates and match the length of the eye disease to genetic counseling. Risk estimates are presented with a vertical bar graph denoting risk level with colors and descriptors. After receiving either genetic counseling regarding risk for DM or control counseling on eye disease, brief lifestyle counseling for prevention of DM is provided to all participants. DISCUSSION: A standardized risk counseling protocol is being used in a randomized trial of 600 participants. Results of this trial will inform policy about whether risk counseling should include genetic counseling. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT01060540.

Racial differences in the effect of a telephone-delivered hypertension disease management program.

BACKGROUND: African Americans are significantly more likely than whites to have uncontrolled hypertension, contributing to significant disparities in cardiovascular disease and events. OBJECTIVE: The goal of this study was to examine whether there were differences in change in blood pressure (BP) for African American and non-Hispanic white patients in response to a medication management and tailored nurse-delivered telephone behavioral program. PARTICIPANTS: Five hundred and seventy-three patients (284 African American and 289 non-Hispanic white) primary care patients who participated in the Hypertension Intervention Nurse Telemedicine Study (HINTS) clinical trial. INTERVENTIONS: Study arms included: 1) nurse-administered, physician-directed medication management intervention, utilizing a validated clinical decision support system; 2) nurse-administered, behavioral management intervention; 3) combined behavioral management and medication management intervention; and 4) usual care. All interventions were activated based on poorly controlled home BP values. MAIN MEASURES: Post-hoc analysis of change in systolic and diastolic blood pressure. General linear models (PROC MIXED in SAS, version 9.2) were used to estimate predicted means at 6-month, 12-month, and 18-month time points, by intervention arm and race subgroups (separate models for systolic and diastolic blood pressure). KEY RESULTS: Improvement in mean systolic blood pressure post-baseline was greater for African American patients in the combined intervention, compared to African American patients in usual care, at 12 months (6.6 mmHg; 95 % CI: -12.5, -0.7; p=0.03) and at 18 months (9.7 mmHg; -16.0, -3.4; p=0.003). At 18 months, mean diastolic BP was 4.8 mmHg lower (95 % CI: -8.5, -1.0; p=0.01) among African American patients in the combined intervention arm, compared to African American patients in usual care. There were no analogous differences for non-Hispanic white patients. CONCLUSIONS: The combination of home BP monitoring, remote medication management, and telephone tailored behavioral self-management appears to be particularly effective for improving BP among African Americans. The effect was not seen among non-Hispanic white patients.

Racial differences in two self-management hypertension interventions.

BACKGROUND: Only one half of Americans have their blood pressure controlled, and there are significant racial differences in blood pressure control. The goal of this study was to examine the effectiveness of 2 patient-directed interventions designed to improve blood pressure control within white and non-white subgroups (African Americans, 49%). METHODS: Post hoc analysis of a 2 by 2 randomized trial with 2-year follow-up in 2 university-affiliated primary care clinics was performed. Within white and non-white patients (n=634), 4 groups were examined: 1) usual care; 2) home blood pressure monitoring (3 times per week); 3) tailored behavioral self-management intervention administered via telephone by a nurse every other month; and 4) a combination of the 2 interventions. RESULTS: The overall race by time by treatment group effect suggested differential intervention effects on blood pressure over time for whites and non-whites (systolic blood pressure, P=. 08; diastolic blood pressure, P=.01). Estimated trajectories indicated that among the 308 whites, there was no significant effect on blood pressure at 12 or 24 months for any intervention compared with the control group. At 12 months, the non-whites (n=328) in all 3 intervention groups had systolic blood pressure decreases of 5.3 to 5.7 mm Hg compared with usual care (P <.05). At 24 months, in the combined intervention, non-whites had sustained lower systolic blood pressure compared with usual care (7.5 mm Hg; P <.02). A similar pattern was observed for diastolic blood pressure. CONCLUSION: Combined home blood pressure monitoring and a tailored behavioral phone intervention seem to be particularly effective for improving blood pressure in non-white patients.