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: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."

Project description:BackgroundThe Veterans Affairs (VA) Healthcare System Community Hospital Transitions Program (CHTP) was implemented as a nurse-led intervention to reduce barriers that patients experience when transitioning from community hospitals to VA primary care settings. A previous analysis indicated that veterans who enrolled in CHTP received timely follow-up care and communications that improved care coordination, but did not examine cost implications for the VA.MethodsA budget impact analysis used the VA (payer) perspective. CHTP implementation team members and study records identified key resources required to initially implement and run the CHTP. Statistical analysis of program participants and matched controls at two study sites was used to estimate incremental VA primary care costs per veteran. Using combined program implementation, operations, and healthcare cost estimates to guide key model assumptions, overall CHTP costs were estimated for a 5-year time horizon, including a discount rate of 3%, annual inflation of 2.5%, and a sensitivity analysis that considered two options for staffing the program at VA Medical Center (VAMC) sites.ResultsImplementation at two VAMCs required 3 months, including central program support and site-level onboarding, with costs of $34,094 (range: $25,355-$51,602), which included direct and indirect resource costs of personnel time, materials, space, and equipment. Subsequent annual costs to run the program at each site depended heavily on the staffing mix and caseload of veterans, with a baseline estimate of $193,802 to $264,868. Patients enrolled in CHTP had post-hospitalization VA primary care costs that were higher than matched controls. Over 5 years, CHTP sites staffed to serve 25-30 veterans per full-time equivalent transition team member per month had an estimated budget impact of $625 per veteran served if the transitional team included a medical social worker to support veterans with more social behavioral needs and less complex medical cases or $815 per veteran if nurses served all cases.ConclusionsEvidence-based care coordination programs that support patients' return to VA primary care after a community hospital stay are feasible to implement and run. Further, flexibility in staffing this type of program is increasingly relevant as the VA and other healthcare systems consider methods to reduce provider burnout, optimize staffing, reduce costs, and address other staffing challenges while improving patient care.

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).

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