Dataset Information

A multicenter randomized placebo controlled trial of rifampin to reduce pedal amputations for osteomyelitis in veterans with diabetes (VA INTREPID).

ABSTRACT: BACKGROUND:The prevalence of diabetes mellitus continues to inexorably rise in the United States and throughout the world. Lower limb amputations are a devastating comorbid complication of diabetes mellitus. Osteomyelitis increases the risk of amputation fourfold and commonly presages death. Antimicrobial therapy for diabetic foot osteomyelitis (DFO) varies greatly, indicating that high quality data are needed to inform clinical decision making. Several small trials have indicated that the addition of rifampin to backbone antimicrobial regimens for osteomyelitis outside the setting of the diabetic foot results in 28 to 42% higher cure rates. METHODS/DESIGN:This is a prospective, randomized, double-blind investigation of the addition of 6 weeks of rifampin, 600?mg daily, vs. matched placebo (riboflavin) to standard-of-care, backbone antimicrobial therapy for DFO. The study population are patients enrolled in Veteran Health Administration (VHA), ages ?18 and???89?years with diabetes mellitus and definite or probable osteomyelitis of the foot for whom an extended course of oral or intravenous antibiotics is planned. The primary endpoint is amputation-free survival. The primary hypothesis is that using rifampin as adjunctive therapy will lower the hazard rate compared with the group that does not use rifampin as adjunctive therapy. The primary hypothesis will be tested by means of a two-sided log-rank test with a 5% significance level. The test has 90% power to detect a hazard ratio of 0.67 or lower with a total of 880 study participants followed on average for 1.8?years. DISCUSSION:VA INTREPID will test if a rifampin-adjunctive antibiotic regimen increases amputation-free survival in patients seeking care in the VHA with DFO. A positive finding and its adoption by clinicians would reduce lower extremity amputations and their associated physical and emotional impact and reduce mortality for Veterans and for the general population with diabetic foot osteomyelitis. Given that rifampin-adjunctive regimens are currently employed for therapy for the majority of DFO cases in Europe, and only in a small minority of cases in the United States, the trial results will impact therapeutic decisions, even if the null hypothesis is not rejected. TRIAL REGISTRATION:Registered January 6, 2017 at ClinicalTrials.gov, NCT03012529.

SUBMITTER: Bessesen MT

PROVIDER: S-EPMC6950878 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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A multicenter randomized placebo controlled trial of rifampin to reduce pedal amputations for osteomyelitis in veterans with diabetes (VA INTREPID).

Bessesen Mary T MT Doros Gheorghe G Henrie Adam M AM Harrington Kelly M KM Hermos John A JA Bonomo Robert A RA Ferguson Ryan E RE Huang Grant D GD Brown Sheldon T ST

BMC infectious diseases 20200108 1

<h4>Background</h4>The prevalence of diabetes mellitus continues to inexorably rise in the United States and throughout the world. Lower limb amputations are a devastating comorbid complication of diabetes mellitus. Osteomyelitis increases the risk of amputation fourfold and commonly presages death. Antimicrobial therapy for diabetic foot osteomyelitis (DFO) varies greatly, indicating that high quality data are needed to inform clinical decision making. Several small trials have indicated that t ...[more]

PMID: 31914940

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Project description:AbstractU.S. Veterans Affairs (VA) patients' multi-system use can create challenges for VA clinicians who are responsible for coordinating Veterans' use of non-VA care, including VA-purchased care ("Community Care") and Medicare.To examine the relationship between drive distance and time-key eligibility criteria for Community Care-and VA reliance (proportion of care received in VA versus Medicare and Community Care) among Veterans at high risk for hospitalization. We used prepolicy data to anticipate the impact of the 2014 Choice Act and 2018 Maintaining Internal Systems and Strengthening Integrated Outside Networks Act (MISSION Act), which expanded access to Community Care.Cross-sectional analysis using fractional logistic regressions to examine the relationship between a Veteran's reliance on VA for outpatient primary, mental health, and other specialty care and their drive distance/time to a VA facility.Thirteen thousand seven hundred three Veterans over the age of 65 years enrolled in VA and fee-for-service Medicare in federal fiscal year 2014 who were in the top 10th percentile for hospitalization risk.Key explanatory variables were patients' drive distance to VA > 40 miles (Choice Act criteria) and drive time to VA ≥ 30 minutes for primary and mental health care and ≥60 minutes for specialty care (MISSION Act criteria).Veterans at high risk for hospitalization with drive distance eligibility had increased odds of an outpatient specialty care visit taking place in VA when compared to Veterans who did not meet Choice Act eligibility criteria (odds ratio = 1.10, 95% confidence interval 1.05-1.15). However, drive time eligibility (MISSION Act criteria) was associated with significantly lower odds of an outpatient specialty care visit taking place in VA (odds ratio = 0.69, 95% confidence interval 0.67, 0.71). Neither drive distance nor drive time were associated with reliance for outpatient primary care or mental health care.VA patients who are at high risk for hospitalization may continue to rely on VA for outpatient primary care and mental health care despite access to outside services, but may increase use of outpatient specialty care in the community in the MISSION era, increasing demand for multi-system care coordination.

Project description:PurposeWomen Veterans have unique healthcare needs and often experience comorbid health conditions. Despite this, many women Veterans are not enrolled in the Veterans Health Administration (VHA) and do not use VHA services. Underutilization of VHA services may be particularly prevalent among rural women Veterans, who may experience unique barriers to using VHA care. Nonetheless, knowledge of rural women Veterans and their experiences remains limited. We sought to understand rural women Veterans' perceptions and needs related to VHA healthcare, including barriers to enrolling in and using VHA services, and perspectives on how to communicate with rural women Veterans about VHA services.MethodsRural women Veterans were recruited through community engagement with established partners and a mass mailing to rural women Veterans not enrolled in or using VHA healthcare. Ten virtual focus groups were conducted with a total of twenty-nine rural women Veterans (27 not enrolled in VHA care and 2 who had not used VHA care in the past 5 years) in 2021. A thematic inductive analytic approach was used to analyze focus group transcripts.FindingsPrimary themes regarding rural women Veterans' perceptions of barriers to enrollment and use of VHA healthcare included: (1) poor communication about eligibility and the process of enrollment; (2) belief that VHA does not offer sufficient women's healthcare services; and (3) inconvenience of accessing VHA facilities.ConclusionAlthough VHA has substantially expanded healthcare services for women Veterans, awareness of such services and the nuances of eligibility and enrollment remains an impediment to enrolling in and using VHA healthcare among rural women Veterans. Recommended strategies include targeted communication with rural women Veterans not enrolled in VHA care to increase their awareness of the enrollment process, eligibility, and expansion of women's healthcare services. Creative strategies to address access and transportation barriers in rural locations are also needed.

Project description:ObjectivesTo compare 90-day postoperative complication rates between Veterans receiving cataract surgery in VA vs Community Care (CC) during the first year of implementation of the Veterans Choice Act.Data sourcesFiscal Year (FY) 2015 VA and CC outpatient data from VA's Corporate Data Warehouse (CDW) 10/01/14-9/30/15). FY14 data were used to obtain baseline clinical information prior to surgery.Study designRetrospective one-year study using secondary data to compare 90-day complication rates following cataract surgery (measured using National Quality Forum (NQF) criteria) in VA vs CC. NQF defines major complications from a specified list of Current Procedural Terminology (CPT) codes. We ran a series of logistic regression models to predict 90-day complication rates, adjusting for Veterans' sociodemographic characteristics, comorbidities, preoperative ocular conditions, eye risk group, and type of cataract surgery (classified as routine vs complex).Data collectionWe linked VA and CC users through patient identifiers obtained from the CDW files. Our sample included all enrolled Veterans who received outpatient cataract surgery either in the VA or through CC during FY15. Cataract surgeries were identified through CPT codes 66 984 (routine) and 66 982 (complex).Principal findingsOf the 83,879 cataract surgeries performed in FY15, 31 percent occurred through CC. Undergoing complex surgery and having a high-risk eye (based on preoperative ocular conditions) were the strongest clinical predictors of 90-day postoperative complications. Overall, we found low complication rates, ranging from 1.1 percent in low-risk eyes to 3.6 percent in high-risk eyes. After adjustment for important confounders (eg, race, rurality, and preoperative ocular conditions), there were no statistically significant differences in 90-day complication rates between Veterans receiving cataract surgery in VA vs CC.ConclusionsAs more Veterans seek care through CC, future studies should continue to monitor quality of care across the two care settings to help inform VA's "make vs buy decisions."

Dataset Information

A multicenter randomized placebo controlled trial of rifampin to reduce pedal amputations for osteomyelitis in veterans with diabetes (VA INTREPID).

Publications

A multicenter randomized placebo controlled trial of rifampin to reduce pedal amputations for osteomyelitis in veterans with diabetes (VA INTREPID).

Similar Datasets

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