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Corrigendum to "Extended-release naltrexone opioid treatment at jail reentry (XOR)" [Contemp. Clin. Trials 49 (2016) 57-64] [Correction]

McDonald, Ryan D; Tofighi, Babak; Laska, Eugene; Goldfeld, Keith; Bonilla, Wanda; Flannery, Mara; Santana-Correa, Nadina; Johnson, Christopher W; Leibowitz, Neil; Rotrosen, John; Gourevitch, Marc N; Lee, Joshua D
PMID: 27743800
ISSN: 1559-2030
CID: 2279732

Effects of ParentCorps in Prekindergarten on Child Mental Health and Academic Performance: Follow-up of a Randomized Clinical Trial Through 8 Years of Age

Brotman, Laurie Miller; Dawson-McClure, Spring; Kamboukos, Dimitra; Huang, Keng-Yen; Calzada, Esther J; Goldfeld, Keith; Petkova, Eva
Importance: Low-income minority children living in urban neighborhoods are at high risk for mental health problems and underachievement. ParentCorps, a family-centered, school-based intervention in prekindergarten, improves parenting and school readiness (ie, self-regulation and preacademic skills) in 2 randomized clinical trials. The longer-term effect on child mental health and academic performance is not known. Objective: To examine whether ParentCorps delivered as an enhancement to prekindergarten programs in high-poverty urban schools leads to fewer mental health problems and increased academic performance in the early elementary school years. Design, Setting, and Participants: This is a 3-year follow-up study of a cluster randomized clinical trial of ParentCorps in public schools with prekindergarten programs in New York City. Ten elementary schools serving a primarily low-income, black student population were randomized in 2005, and 4 consecutive cohorts of prekindergarten students were enrolled from September 12, 2005, through December 31, 2008. We report follow-up for the 3 cohorts enrolled after the initial year of implementation. Data analysis was performed from September 1, 2014, to December 31, 2015. Interventions: ParentCorps included professional development for prekindergarten and kindergarten teachers and a program for parents and prekindergarten students (13 two-hour group sessions delivered after school by teachers and mental health professionals). Main Outcomes and Measures: Annual teacher ratings of mental health problems and academic performance and standardized tests of academic achievement in kindergarten and second grade by testers masked to the intervention or control group randomization. Results: A total of 1050 children (4 years old; 518 boys [49.3%] and 532 girls [50.7%]) in 99 prekindergarten classrooms participated in the trial (88.1% of the prekindergarten population), with 792 students enrolled from 2006 to 2008. Most families in the follow-up study (421 [69.6%]) were low income; 680 (85.9%) identified as non-Latino black, 78 (9.8%) as Latino, and 34 (4.3%) as other. Relative to their peers in prekindergarten programs, children in ParentCorps-enhanced prekindergarten programs had lower levels of mental health problems (Cohen d = 0.44; 95% CI, 0.08-0.81) and higher teacher-rated academic performance (Cohen d = 0.21; 95% CI, 0.02-0.39) in second grade. Conclusions and Relevance: Intervention in prekindergarten led to better mental health and academic performance 3 years later. Family-centered early intervention has the potential to prevent problems and reduce disparities for low-income minority children. Trial Registration: clinicaltrials.gov Identifier: NCT01670227.
PMCID:5642293
PMID: 27695851
ISSN: 2168-6211
CID: 2273922

Testing the use of practice facilitation in a cluster randomized stepped-wedge design trial to improve adherence to cardiovascular disease prevention guidelines: HealthyHearts NYC

Shelley, Donna R; Ogedegbe, Gbenga; Anane, Sheila; Wu, Winfred Y; Goldfeld, Keith; Gold, Heather T; Kaplan, Sue; Berry, Carolyn
BACKGROUND: HealthyHearts NYC (HHNYC) will evaluate the effectiveness of practice facilitation as a quality improvement strategy for implementing the Million Hearts' ABCS treatment guidelines for reducing cardiovascular disease (CVD) among high-risk patients who receive care in primary care practices in New York City. ABCS refers to (A) aspirin in high-risk individuals; (B) blood pressure control; (C) cholesterol management; and (S) smoking cessation. The long-term goal is to create a robust infrastructure for implementing and disseminating evidence-based practice guidelines (EBPG) in primary care practices. METHODS/DESIGN: We are using a stepped-wedge cluster randomized controlled trial design to evaluate the implementation process and the impact of practice facilitation (PF) versus usual care on ABCS outcomes in 250 small primary care practices. Randomization is at the practice site level, all of which begin as part of the control condition. The intervention consists of one year of PF that includes a combination of one-on-one onsite visits and shared learning across practice sites. PFs will focus on helping sites implement evidence-based components of patient-centered medical home (PCMH) and the chronic care model (CCM), which include decision support, provider feedback, self-management tools and resources, and linkages to community-based services. DISCUSSION: We hypothesize that practice facilitation will result in superior clinical outcomes compared to usual care; that the effects of practice facilitation will be mediated by greater adoption of system changes in accord with PCMH and CCM; and that there will be increased adaptive reserve and change capacity. TRIAL REGISTRATION: NCT02646488.
PMCID:4932668
PMID: 27377404
ISSN: 1748-5908
CID: 2178972

Extended-release naltrexone opioid treatment at jail re-entry (XOR)

McDonald, Ryan D; Tofighi, Babak; Laska, Eugene; Goldfeld, Keith; Bonilla, Wanda; Flannery, Mara; Santana-Correa, Nadina; Johnson, Christopher W; Leibowitz, Neil; Rotrosen, John; Gourevitch, Marc N; Lee, Joshua D
BACKGROUND: Extended-release naltrexone (XR-NTX) is an injectable monthly sustained-release mu opioid receptor antagonist, which blocks the typical effects of heroin and other opioid agonists. Use of XR-NTX among opioid dependent persons leaving jails and prisons is increasing despite scant high-quality evidence regarding XR-NTX's effectiveness at re-entry. METHODS: This 24-week, open-label randomized controlled trial examines the effectiveness of XR-NTX as opioid relapse prevention at release from jail (N=85) compared to enhanced treatment as usual (ETAU, N=85). A third, non-randomized, quasi-experimental naturalistic arm of participants who have newly initiated a jail-to-community methadone treatment program (MTP, N=85) allows for comparisons to a methadone standard-of-care. RESULTS: We describe the rationale, design, and primary and secondary outcomes of the study. The primary outcome is an opioid relapse event; the primary contrast is a time-to-relapse comparison of XR-NTX and ETAU over a 24-week treatment phase. Secondary outcomes are rates of: (a) post-release opioid treatment participation, (b) opioid, alcohol, and cocaine use, (c) injection drug use and HIV sexual risk behaviors, (d) overdose (fatal and non-fatal) and all-cause mortality, and, (e) re-incarceration. CONCLUSIONS: XR-NTX is a potentially important, effective treatment and relapse prevention option for a large US population of persons with opioid use disorders leaving jails. This study will estimate XR-NTX's effectiveness relative to existing standards of care, including counseling-only treatment-as-usual and methadone maintenance.
PMCID:5455014
PMID: 27178765
ISSN: 1559-2030
CID: 2107872

Translating context to causality in cardiovascular disparities research

Benn, Emma K T; Goldfeld, Keith S
Moving from a descriptive focus to a comprehensive analysis grounded in causal inference can be particularly daunting for disparities researchers. However, even a simple model supported by the theoretical underpinnings of causality gives researchers a better chance to make correct inferences about possible interventions that can benefit our most vulnerable populations. This commentary provides a brief description of how race/ethnicity and context relate to questions of causality, and uses a hypothetical scenario to explore how different researchers might analyze the data to estimate causal effects of interest. Perhaps although not entirely removed of bias, these causal estimates will move us a step closer to understanding how to intervene. (PsycINFO Database Record
PMID: 27018732
ISSN: 1930-7810
CID: 2058572

Burden of Transitions After Invasive Mechanical Ventilation for U.S. Individuals with Severe Chronic Obstructive Pulmonary Disease: Opportunity to Prepare for Preference-Congruent End-of-Life Care? [Letter]

Hajizadeh, Negin; Goldfeld, Keith
PMID: 26889846
ISSN: 1532-5415
CID: 2045392

Changes in Discharge Location and Readmission Rates Under Medicare Bundled Payment

Jubelt, Lindsay E; Goldfeld, Keith S; Chung, Wei-Yi; Blecker, Saul B; Horwitz, Leora I
PMCID:5289893
PMID: 26595453
ISSN: 2168-6114
CID: 1856802

Psychiatric Comorbidity and Substance Use Outcomes in an Office-Based Buprenorphine Program Six Months Following Hurricane Sandy

Tofighi, Babak; Grossman, Ellie; Goldfeld, Keith S; Williams, Arthur Robinson; Rotrosen, John; Lee, Joshua D
BACKGROUND: On October 2012, Hurricane Sandy struck New York City, resulting in unprecedented damages, including the temporary closure of Bellevue Hospital Center and its primary care office-based buprenorphine program. OBJECTIVES: At 6 months, we assessed factors associated with higher rates of substance use in buprenorphine program participants that completed a baseline survey one month post-Sandy (i.e. shorter length of time in treatment, exposure to storm losses, a pre-storm history of positive opiate urine drug screens, and post-disaster psychiatric symptoms). METHODOLOGY: Risk factors of interest extracted from the electronic medical records included pre-disaster diagnosis of Axis I and/or II disorders and length of treatment up to the disaster. Factors collected from the baseline survey conducted approximately one month post-Sandy included self-reported buprenorphine supply disruption, health insurance status, disaster exposure, and post-Sandy screenings for PTSD and depression. Outcome variables reviewed 6 months post-Sandy included missed appointments, urine drug results for opioids, cocaine, and benzodiazepines. RESULTS: 129 (98%) patients remained in treatment at 6 months, and had no sustained increases in opioid-, cocaine-, and benzodiazepine-positive urine drug tests in any sub-groups with elevated substance use in the baseline survey. Contrary to our initial hypothesis, diagnosis of Axis I and/or II disorders pre-Sandy were associated with significantly less opioid-positive urine drug findings in the 6 months following Sandy compared to the rest of the clinic population. CONCLUSION: These findings demonstrate the adaptability of a safety net buprenorphine program to ensure positive treatment outcomes despite disaster-related factors.
PMID: 26623697
ISSN: 1532-2491
CID: 1863382

Comparative Effectiveness of Angiotensin-Converting Enzyme Inhibitor-Based Treatment on Cardiovascular Outcomes in Hypertensive Blacks Versus Whites

Ogedegbe, Gbenga; Shah, Nirav R; Phillips, Christopher; Goldfeld, Keith; Roy, Jason; Guo, Yu; Gyamfi, Joyce; Torgersen, Christopher; Capponi, Louis; Bangalore, Sripal
BACKGROUND: Clinical trial evidence suggests poorer outcomes in blacks compared with whites when treated with an angiotensin-converting enzyme (ACE) inhibitor-based regimen, but this has not been evaluated in clinical practice. OBJECTIVES: This study evaluated the comparative effectiveness of an ACE inhibitor-based regimen on a composite outcome of all-cause mortality, stroke, and acute myocardial infarction (AMI) in hypertensive blacks compared with whites. METHODS: We conducted a retrospective cohort study of 434,646 patients in a municipal health care system. Four exposure groups (Black-ACE, Black-NoACE, White-ACE, White-NoACE) were created based on race and treatment exposure (ACE or NoACE). Risk of the composite outcome and its components was compared across treatment groups and race using weighted Cox proportional hazard models. RESULTS: Our analysis included 59,316 new users of ACE inhibitors, 47% of whom were black. Baseline characteristics were comparable for all groups after inverse probability weighting adjustment. For the composite outcome, the race treatment interaction was significant (p = 0.04); ACE use in blacks was associated with poorer cardiovascular outcomes (ACE vs. NoACE: 8.69% vs. 7.74%; p = 0.05) but not in whites (6.40% vs. 6.74%; p = 0.37). Similarly, the Black-ACE group had higher rates of AMI (0.46% vs. 0.26%; p = 0.04), stroke (2.43% vs. 1.93%; p = 0.05), and congestive heart failure (3.75% vs. 2.25%; p < 0.0001) than the Black-NoACE group. However, the Black-ACE group was no more likely to develop adverse effects than the White-ACE group. CONCLUSIONS: ACE inhibitor-based therapy was associated with poorer cardiovascular outcomes in hypertensive blacks but not in whites. These findings confirm clinical trial evidence that hypertensive blacks have poorer outcomes than whites when treated with an ACE inhibitor-based regimen.
PMCID:4567693
PMID: 26361152
ISSN: 1558-3597
CID: 1772712

AN INTERVENTION TO IMPROVE HOSPITAL CARE DELIVERED ON WEEKENDS [Meeting Abstract]

Goldfeld, Keith; Park, Hannah; Radford, Martha J; Munson, Sarah; Francois, Fritz; Austrian, Jonathan; Braithwaite, RScott; Hochman, Katherine A; Donoghue, Richard; Birnbaum, Bernard; Gourevitch, Marc N
ISI:000358386900129
ISSN: 1525-1497
CID: 1729992