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Item The Association of Cerebral Palsy with Other Disability in Children with Perinatal Arterial Ischemic Stroke(2007-10) Golomb, Meredith R.; Saha, Chandan; Garg, Bhuwan P; Azzouz, Faouzi; Williams, Linda S.The association of cerebral palsy with other disabilities in children with perinatal stroke has not been well-studied. We examined this association in 111 children with perinatal stroke: 67 with neonatal presentation, and 44 with delayed presentation. Seventy-six children (68%) had cerebral palsy, which was hemiplegic in 66 and tri- or quadriplegic in 10. Fifty-five (72%) children with cerebral palsy had at least one other disability: 45 (59%) had a cognitive/speech impairment (moderate-severe in 20), and 36 (47%) had epilepsy (moderate-severe in 11). In children with neonatal presentation, cerebral palsy was associated with epilepsy (P = 0.0076) and cognitive impairment (P = 0.0001). These associations could not be tested in children with delayed presentation because almost all children in this group had cerebral palsy. In another analysis with multivariate logistic regression for children with cerebral palsy, children who had both neonatal presentation and history of cesarean-section delivery were more likely to have epilepsy (P = 0.001). Children with cerebral palsy after perinatal stroke who had neonatal presentation were more likely to have severe cognitive impairment (odds ratio, 7.78; 95% confidence interval, 1.80-47.32) or severe epilepsy (odds ratio, 6.64; 95% confidence interval, 1.21-69.21) than children with delayed presentation. Children with cerebral palsy after perinatal stroke are likely to have an additional disability; those with neonatal presentation are more likely to have a severe disability.Item Barriers to Insulin Initiation The Translating Research Into Action for Diabetes Insulin Starts Project(2010-04) Karter, Andrew J.; Subramanian, Usha; Saha, Chandan; Crosson, Jesse C.; Parker, Melissa M.; Swain, Bix E.; Moffet, Howard H.; Marrero, David G.OBJECTIVE Reasons for failing to initiate prescribed insulin (primary nonadherence) are poorly understood. We investigated barriers to insulin initiation following a new prescription. RESEARCH DESIGN AND METHODS We surveyed insulin-naïve patients with poorly controlled type 2 diabetes, already treated with two or more oral agents who were recently prescribed insulin. We compared responses for respondents prescribed, but never initiating, insulin (n = 69) with those dispensed insulin (n = 100). RESULTS Subjects failing to initiate prescribed insulin commonly reported misconceptions regarding insulin risk (35% believed that insulin causes blindness, renal failure, amputations, heart attacks, strokes, or early death), plans to instead work harder on behavioral goals, sense of personal failure, low self-efficacy, injection phobia, hypoglycemia concerns, negative impact on social life and job, inadequate health literacy, health care provider inadequately explaining risks/benefits, and limited insulin self-management training. CONCLUSIONS Primary adherence for insulin may be improved through better provider communication regarding risks, shared decision making, and insulin self-management training.Item Contributing Factors for Opioid Misuse Among U.S. Adolescents(2019-10) Hurse, Deidre N.; Arnold, Brent; Altenburger, Peter; Goering, Elizabeth; Saha, Chandan; Agho, AugustineThe United States is amidst an opioid overdose epidemic. Even with significant gaps in surveillance data on opioid-related deaths, the problem is undeniable and requires a systemic response. Despite the dangerous effects of opioid misuse, pathways that lead to opioid abuse for young people is understudied. This study sought to understand factors related to opioid misuse among youth. An exploratory approach used data from both quantitative and qualitative sources. The convergent parallel mixed method design used secondary data from a biannual school-based survey and three oral interviews. While opioid misuse is not limited to heroin, the 2013, 2015, and 2017 Youth Risk Behavior Surveillance Survey (YRBS) was used to determine associations between predictor variables and heroin use. Oral interviews added the perspective of adolescent users and were inclusive of persons that misused prescription and other forms of opioids. The synchronization of data analysis allowed observations to impact the study direction unilaterally. Opioid misuse for youth was related to experiences, access, and divergent substance use. Traumatic stressors, such as physical dating violence and sexual dating violence, had the most substantial relationship with heroin misuse. Findings confirmed that ease of access had a relationship with misuse. It is unclear if opioid misuse was a result of polysubstance use. However, the study identified that divergent substance use was correlated with opioid misuse in this population. The study findings support the use of early intervention before high school. Prevention must be inclusive of primary, secondary, and tertiary approaches. Future prevention for youth can be enhanced by addressing resilience from trauma, reducing access to opioids and addressing alcohol, and substance use among youth. Adopting a framework that acknowledges the root causes of misuse, can mitigate the impact of the opioid crisis and save lives.Item Cost-effectiveness of Community-Based Depression Interventions for Rural and Urban Adults With Type 2 Diabetes: Projections From Program ACTIVE (Adults Coming Together to Increase Vital Exercise) II(American Diabetes Association, 2021) Kuo, Shihchen; de Groot, Mary; Saha, Chandan; Shubrook, Jay H.; Hornsby, W. Guyton, Jr.; Pillay, Yegan; Mather, Kieren J.; Herman, William H.; Endocrinology, IU School of MedicineObjective: We estimated the cost-effectiveness of the Program ACTIVE (Adults Coming Together to Increase Vital Exercise) II community-based exercise (EXER), cognitive behavioral therapy (CBT), and EXER+CBT interventions in adults with type 2 diabetes and depression relative to usual care (UC) and each other. Research design and methods: Data were integrated into the Michigan Model for Diabetes to estimate cost and health outcomes over a 10-year simulation time horizon from the health care sector and societal perspectives, discounting costs and benefits at 3% annually. Primary outcome was cost per quality-adjusted life-year (QALY) gained. Results: From the health care sector perspective, the EXER intervention strategy saved $313 (USD) per patient and produced 0.38 more QALY (cost saving), the CBT intervention strategy cost $596 more and gained 0.29 more QALY ($2,058/QALY), and the EXER+CBT intervention strategy cost $403 more and gained 0.69 more QALY ($585/QALY) compared with UC. Both EXER and EXER+CBT interventions dominated the CBT intervention. Compared with EXER, the EXER+CBT intervention strategy cost $716 more and gained 0.31 more QALY ($2,323/QALY). From the societal perspective, compared with UC, the EXER intervention strategy saved $126 (cost saving), the CBT intervention strategy cost $2,838/QALY, and the EXER+CBT intervention strategy cost $1,167/QALY. Both EXER and EXER+CBT interventions still dominated the CBT intervention. In comparison with EXER, the EXER+CBT intervention strategy cost $3,021/QALY. Results were robust in sensitivity analyses. Conclusions: All three Program ACTIVE II interventions represented a good value for money compared with UC. The EXER+CBT intervention was highly cost-effective or cost saving compared with the CBT or EXER interventions.Item Design and methods of the Care Management for the Effective Use of Opioids (CAMEO) trial(Elsevier, 2021-07) Bushey, Michael A.; Slaven, James; Outcalt, Samantha D.; Kroenke, Kurt; Kempf, Carol; Froman, Amanda; Sargent, Christy; Baecher, Brad; Zillich, Alan; Damush, Teresa M.; Saha, Chandan; French, Dustin D.; Bair, Matthew J.; Medicine, School of MedicineLow back pain is the most common pain condition seen in primary care, with the most common treatment being analgesic medications, including opioids. A dramatic increase in opioid prescriptions for low back pain over the past few decades has led to increased non-medical use and opioid overdose deaths. Cognitive behavioral therapy (CBT) for chronic pain is an evidence-based non-pharmacological treatment for pain with demonstrated efficacy when delivered using collaborative care models. No previous studies have tested CBT compared to analgesic optimization that includes opioid management in primary care. This paper describes the study design and methods of the CAre Management for the Effective use of Opioids (CAMEO) trial, a 2-arm, randomized comparative effectiveness trial in seven primary care clinics. CAMEO enrolled 261 primary care veterans with chronic (6 months or longer) low back pain of at least moderate severity who were receiving long-term opioid therapy and randomized them to either nurse care management focused on analgesic treatment and optimization (MED) or cognitive behavioral therapy (CBT). All subjects undergo comprehensive outcome assessments at baseline, 3, 6, 9, and 12 months by interviewers blinded to treatment assignment. The primary outcome is pain severity and interference, measured by the Brief Pain Inventory (BPI) total score. Secondary outcomes include health-related quality of life, fatigue, sleep, functional improvement, pain disability, pain beliefs, alcohol and opioid problems, depression, anxiety, and stress.Item Effect of a Computer-Based Decision Support Intervention on Autism Spectrum Disorder Screening in Pediatric Primary Care Clinics: A Cluster Randomized Clinical Trial(JAMA Network, 2019-12-02) Downs, Stephen M.; Bauer, Nerissa S.; Saha, Chandan; Ofner, Susan; Carroll, Aaron E.; Pediatrics, School of MedicineImportance: Universal early screening for autism spectrum disorder (ASD) is recommended but not routinely performed. Objective: To determine whether computer-automated screening and clinical decision support can improve ASD screening rates in pediatric primary care practices. Design, Setting, and Participants: This cluster randomized clinical trial, conducted between November 16, 2010, and November 21, 2012, compared ASD screening rates among a random sample of 274 children aged 18 to 24 months in urban pediatric clinics of an inner-city county hospital system with or without an ASD screening module built into an existing decision support software system. Statistical analyses were conducted from February 6, 2017, to June 1, 2018. Interventions: Four clinics were matched in pairs based on patient volume and race/ethnicity, then randomized within pairs. Decision support with the Child Health Improvement Through Computer Automation system (CHICA) was integrated with workflow and with the electronic health record in intervention clinics. Main Outcomes and Measures: The main outcome was screening rates among children aged 18 to 24 months. Because the intervention was discontinued among children aged 18 months at the request of the participating clinics, only results for those aged 24 months were collected and analyzed. Rates of positive screening results, clinicians' response rates to screening results in the computer system, and new cases of ASD identified were also measured. Main results were controlled for race/ethnicity and intracluster correlation. Results: Two clinics were randomized to receive the intervention, and 2 served as controls. Records from 274 children (101 girls, 162 boys, and 11 missing information on sex; age range, 23-30 months) were reviewed (138 in the intervention clinics and 136 in the control clinics). Of 263 children, 242 (92.0%) were enrolled in Medicaid, 138 (52.5%) were African American, and 96 (36.5%) were Hispanic. Screening rates in the intervention clinics increased from 0% (95% CI, 0%-5.5%) at baseline to 68.4% (13 of 19) (95% CI, 43.4%-87.4%) in 6 months and to 100% (18 of 18) (95% CI, 81.5%-100%) in 24 months. Control clinics had no significant increase in screening rates (baseline, 7 of 64 children [10.9%]; 6-24 months after the intervention, 11 of 72 children [15.3%]; P = .46). Screening results were positive for 265 of 980 children (27.0%) screened by CHICA during the study period. Among the 265 patients with positive screening results, physicians indicated any response in CHICA in 151 (57.0%). Two children in the intervention group received a new diagnosis of ASD within the time frame of the study. Conclusions and Relevance: The findings suggest that computer automation, when integrated with clinical workflow and the electronic health record, increases screening of children for ASD, but follow-up by physicians is still flawed. Automation of the subsequent workup is still needed.Item Effect of Advanced Access Scheduling on Processes and Intermediate Outcomes of Diabetes Care and Utilization(2009-03) Subramanian, Usha; Ackermann, Ronald T.; Brizendine, Edward J.; Saha, Chandan; Rosenman, Marc B.; Willis, Deanna R.; Marrero, David G.BACKGROUND The impact of open access (OA) scheduling on chronic disease care and outcomes has not been studied. OBJECTIVE To assess the effect of OA implementation at 1 year on: (1) diabetes care processes (testing for A1c, LDL, and urine microalbumin), (2) intermediate outcomes of diabetes care (SBP, A1c, and LDL level), and (3) health-care utilization (ED visits, hospitalization, and outpatient visits). METHODS We used a retrospective cohort study design to compare process and outcomes for 4,060 continuously enrolled adult patients with diabetes from six OA clinics and six control clinics. Using a generalized linear model framework, data were modeled with linear regression for continuous, logistic regression for dichotomous, and Poisson regression for utilization outcomes. RESULTS Patients in the OA clinics were older, with a higher percentage being African American (51% vs 34%) and on insulin. In multivariate analyses, for A1c testing, the odds ratio for African-American patients in OA clinics was 0.47 (CI: 0.29-0.77), compared to non-African Americans [OR 0.27 (CI: 0.21-0.36)]. For urine microablumin, the odds ratio for non-African Americans in OA clinics was 0.37 (CI: 0.17-0.81). At 1 year, in adjusted analyses, patients in OA clinics had significantly higher SBP (mean 6.4 mmHg, 95% CI 5.4 – 7.5). There were no differences by clinic type in any of the three health-care utilization outcomes. CONCLUSION OA scheduling was associated with worse processes of care and SBP at 1 year. OA clinic scheduling should be examined more critically in larger systems of care, multiple health-care settings, and/or in a randomized controlled trial.Item Effect of Medication Optimization vs Cognitive Behavioral Therapy Among US Veterans With Chronic Low Back Pain Receiving Long-term Opioid Therapy: A Randomized Clinical Trial(American Medical Association, 2022-11-01) Bushey, Michael A.; Slaven, James E.; Outcalt, Samantha D.; Kroenke, Kurt; Kempf, Carol; Froman, Amanda; Sargent, Christy; Baecher, Brad; Zillich, Alan J.; Damush, Teresa M.; Saha, Chandan; French, Dustin D.; Bair, Matthew J.; Psychiatry, School of MedicineImportance: Medication management and cognitive behavioral therapy (CBT) are commonly used treatments for chronic low back pain (CLBP). However, little evidence is available comparing the effectiveness of these approaches. Objective: To compare collaborative care medication optimization vs CBT on pain intensity, interference, and other pain-related outcomes. Design, setting, and participants: The Care Management for the Effective Use of Opioids (CAMEO) trial was a 12-month, comparative effectiveness randomized clinical trial with blinded outcome assessment. Recruitment of veterans with CLBP prescribed long-term opioids occurred at 7 Veterans Affairs primary care clinics from September 1, 2011, to December 31, 2014, and follow-up was completed December 31, 2015. Analyses were based on intention to treat in all randomized participants and were performed from March 22, 2015, to November 1, 2021. Interventions: Patients were randomized to receive either collaborative care with nurse care manager-delivered medication optimization (MED group) (n = 131) or psychologist-delivered CBT (CBT group) (n = 130) for 6 months, with check-in visits at 9 months and final outcome assessment at 12 months. Main outcomes and measures: The primary outcome was change in Brief Pain Inventory (BPI) total score, a composite of the pain intensity and interference subscales at 6 (treatment completion) and 12 (follow-up completion) months. Scores on the BPI range from 0 to 10, with higher scores representing greater pain impact and a 30% improvement considered a clinically meaningful treatment response. Secondary outcomes included pain-related disability, pain catastrophizing, self-reported substance misuse, health-related quality of life, depression, and anxiety. Results: A total of 261 patients (241 [92.3%] men; mean [SD] age, 57.9 [9.5] years) were randomized and included in the analysis. Baseline mean (SD) BPI scores in the MED and CBT groups were 6.45 (1.79) and 6.49 (1.67), respectively. Improvements in BPI scores were significantly greater in the MED group at 12 months (between-group difference, -0.54 [95% CI, -1.18 to -0.31]; P = .04) but not at 6 months (between-group difference, -0.46 [95% CI, -0.94 to 0.11]; P = .07). Secondary outcomes did not differ significantly between treatment groups. Conclusions and relevance: In this randomized clinical trial among US veterans with CLBP who were prescribed long-term opioid therapy, collaborative care medication optimization was modestly more effective than CBT in reducing pain impact during the 12-month study. However, this difference may not be clinically meaningful or generalize to nonveteran populations.Item Effect of Self-Efficacy on Weight Loss: A Psychosocial Analysis of a Community-Based Adaptation of the Diabetes Prevention Program Lifestyle Intervention(American Diabetes Association, 2014-11) Hays, Laura M.; Finch, Emily A.; Saha, Chandan; Marrero, David G.; Ackermann, Ronald T.; Department of Medicine, School of MedicineObjective. Weight loss is the most effective approach to reducing diabetes risk. It is a research priority to identify factors that may enhance weight loss success, particularly among those at risk for diabetes. This analysis explored the relationships between self-efficacy, weight loss, and dietary fat intake among adults at risk for developing type 2 diabetes. Methods. This pilot, site-randomized trial was designed to compare group-based Diabetes Prevention Program lifestyle intervention delivery by YMCA staff to brief counseling alone (control) in 92 adults at risk for diabetes (BMI ≥ 24 kg/m2, ≥ 2 diabetes risk factors, and a random capillary blood glucose of 110–199 mg/dl). Self-efficacy was measured using the Weight Efficacy Lifestyle questionnaire. Data were collected at baseline, 6 months, and 12 months. A paired t test was used to determine within-group changes in self-efficacy and weight at 6 and 12 months. Using a fitted model, we estimated how much of an increase in self-efficacy was related to a 5% weight reduction at 6 and 12 months. Results. Self-efficacy was associated with a 5% reduction in baseline weight at 6 and 12 months but was not related to fat intake. Conclusion. These findings suggest that it is important to assess the level of self-efficacy when counseling adults at high risk for diabetes about weight loss. Certain aspects of self-efficacy seem to play a greater role, depending on the stage of weight loss.Item Effects of a Community-based Lifestyle Intervention on Change in Physical Activity Among Economically Disadvantaged Adults With Prediabetes(Taylor and Francis, 2016) Hays, Laura M.; Hoen, Helena M.; Slaven, James E.; Finch, Emily A.; Marrero, David G.; Saha, Chandan; Ackermann, Ronald T.; School of Nursing
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