WU20315MOD1S
Title: Evaluating Hospital-Onset Bacteremia (HOB) and Fungemia as Preventable Healthcare-Associated Infections 1. Background and Need Blood stream infections (BSIs) are a serious and life threatening infection. For the purposes of tracking healthcare-associated infections (HAIs), most attention has been paid to central-line associated blood stream infections (CLABSIs). Prevention of CLABSIs has been shown to be feasible via well-studied bundles of care related to catheter insertion and maintenance. However, tracking CLABSIs is difficult, time consuming and has been shown to be subjective with substantial interrater variability. Researchers in the United States have begun to evaluate the utility of tracking hospital-onset bacteremia and fungemia (HOB) as a relevant HAI outcome in lieu of CLABSI. HOB comprises all positive blood cultures taken at least 48 hours post admission to the hospital. Thus, it includes CLABSIs and non-central line associated BSIs that presumably occurred within the hospital Initial HOB studies in the United States have shown that CLABSIs comprise less than 20% of total HOBs leading to questions of whether these non-CLABSI HOBs represent preventable infections. Additionally, studies have demonstrated that HOB may also be a reasonable proxy for CLABSI rates. Several studies have shown that HOB rates tracked well with CLABSI rates when both were measured simultaneously and in one study HOB rates trended downwards proportionally with CLABSI rate decreases after a CLABSI intervention was implemented. These data suggest that a healthcare facility may be able to expend less resources following HOB and still detect CLABSI decreases when implementing targeted prevention bundles. Ongoing work to determine the etiology and preventability of HOB is underway as well; preliminary data suggests that potentially half of HOB events might be avoidable with known interventions. In low and middle-income (LMIC) countries where both human and monetary resources are limited and epidemiology of HAI infections have been studied less robustly, using HOB as a HAI metric has several potential advantages. It can often be collected from microbiology data alone, rather than requiring a large review of a patienta s chart or medical records. Additionally, it is objective and likely requires less intensive training for staff than CLABSI surveillance. Finally, in LMICs where prompt treatment and prevention of sepsis is often inadequate, there are likely a pool of non-CLABSI HOB that are preventable with simple, known interventions. Currently, all studies on HOB have been in high-income countries. This project seeks to determine whether HOB is a feasible, useful, and acceptable metric for HAI surveillance in hospitals in LMIC. 2. Scope of Work This project seeks to evaluate HOB in hospitals in LMICs as a feasible, useful and acceptable metric for HAI surveillance. The specific goals of this project are to: x Set up HOB surveillance in one or more sites within a low or middle income country (according to World Bank classifications) and describe the following: o The etiologies and syndromes associated with HOB o The epidemiology of HOB in terms of person, place and time x Develop a framework for determining which HOB events are likely to be preventable with infection control measures and quality hospital care and collect clinical data to determine the proportion of HOB events observed that meet the criteria outlined in the framework. This should be done via prospective data collection that captures relevant clinical data and shall not rely solely on data from medical charts which likely will not have sufficient detail to make determinations. x Evaluate the cost, feasibility and acceptability of implementing an HOB surveillance system in 200-2016-91804 75D30119F00003 Page 5 of 28 LMIC. This will include collection of qualitative and quantitative data on acceptability of the surveillance system from staff and hospital administration as well as collection of direct and indirect costs of implementing the surveillance outside a research study. x Determine what data might be needed to be included in an HOB surveillance system to adequately target prevention efforts. 3. Tasks The contractor shall provide all labor, expertise, materials, and supplies and perform all services required to carry out the work under this contract. Task 1: Start Up Meeting x The contractor shall arrange and conduct an initial meeting (by teleconference) with the COR and other relevant staff within 2 weeks of the effective date of the task order. The purpose of the meeting will be to review and clarify the scope of work and delivery schedule for tasks, to delineate roles and responsibilities, and to establish communication protocols. Each task and deliverable will be reviewed. x The contractor shall submit an agenda for the above meeting within 1 week of the effective date of the task order. Task 2: Maintain Communication with the Science Officer x The contractor shall coordinate with the COR for all project related communications. The contractor shall maintain regular communications with the Science Officer and COR involved with the project. The chief means of communication will be via conference calls that will be scheduled every month throughout the project period and one in-person meeting. The contractor shall provide an agenda and meeting minutes for each call. All conference calls shall be scheduled and administered by the contractor. The contractor shall respond to all emails and telephone communications from the Science Officer within 2-3 working days. x The contractor shall coordinate with the COR for an in-person meeting associated with Task 5 & 6 (framework and protocol development meeting) where they will meet with the CDC Science Officer and other relevant CDC staff. The in-person meeting may be at the contractora s site or at CDCa s Atlanta, GA location. Task 3: Quarterly Progress Reports x On the 10th day following the 3 months being reported, the contractor shall prepare and submit a quarterly progress report containing the current status of work and project spending. The report shall contain, at a minimum, the current progress on each of the requirements set forth below, the financial status of the project, problems encountered during the month, solutions implemented, planned activity for the upcoming month and any other information mutually agreed upon between the contractor and the CDC Science Officer. Task 4: Finalize Work Plan and Timeline x The contractor shall finalize the detailed plan and timeline, submitted in their proposal, for developing and implementing a study evaluating the use of HOB as an HAI metric that addresses the specific aims outlined above in the Statement of Work. The work plan shall specify the approach to developing a study protocol and implementing activities outlined in the protocol. A finalized timeline for the completion of these tasks including the identification of potential factors that may hasten or impede the accomplishment of stated objectives will be presented to the COR and Science Officer for approval. Task 5: Develop a Framework and Guide for Determining HOB Preventability x The contractor shall develop a framework and set of criteria to determine the preventability of HOB events in this study as well as the data that needs to be collected to provide a preventable/not preventable determination for each HOB event. The final framework and criteria should be approved by the CDC Project Officer prior to use. 200-2016-91804 75D30119F00003 Page 6 of 28 x This framework shall be developed using input from an expert panel of physicians with backgrounds in critical care, infectious disease, and hospital epidemiology. Using Delphi methodology, the expert panel shall be convened to develop and define the Framework and Guide. The guiding question for preventability shall be a was this bacteremia or fungemia preventable in an ideal hospital setting, practicing perfect clinical care and infection prevention (even if that doesna texist)a . x The goal of the framework is to then develop a guide to operationalize the framework within the surveillance system and determine the data that needs to be collected for HOB events to make the determination. x The guide and framework shall also include contingency plans for how to deal with difficult cases or cases where the determination cannot be made with the existing framework (e.g., referral to a twoperson evaluation team to make a determination). x An in-person meeting of the contractor, subject matter experts and CDC representatives to develop and approve the draft framework shall be planned as outlined in Task 2. Due to PRA limitations, the expert panel should include not more than 9 external experts. Task 6: Develop a Protocol x The contractor shall work with the Project officer on the development of a protocol that specifically lays out the study question, methodology, data sources, laboratory methods, study population, analytic strategy and related tasks. x In order to improve generalizability it would be favored for the protocol to include implementation at several sites, though the areas of data collection could be subsets of the larger hospital population (e.g., within the ICUs of several hospitals). x The contractor shall develop a protocol that outlines the following: o How HOB rate data will be collected and compared at the given facility/facilities or ward/wards. o How the data required to determine the preventability of HOB infections (as defined in Task 5) will be collected, how difficult determinations will be adjudicated, and when determinations will be made. This data will need to be collected prospectively and shall make use of all available data including medical chart data (though shall not solely rely on this), interviews with clinical staff, review of laboratory data and other relevant medical information. o How feasibility and acceptability of HOB surveillance will be assessed, including potentially qualitative and quantitative data as appropriate. o How costs of HOB surveillance will be captured x In addition the protocol shall include: o Definitions to be used for HOB numerators o Denominator to be used to calculate rates o Sample size, power calculations as appropriate and needed Task 7: Obtain Institutional Review Board (IRB) and other Science or Administrative Approvals x The Contractor will prepare and submit the research protocol to all relevant and needed IRB bodies as well as any additional scientific or administrative approvals that may exist in country. The Contractor shall oversee all aspects of package development and submission as required prior to collection of any data. The Contractor shall prepare the packages including all forms and attachments for CDC Science Officer approval as needed. The Contractor shall submit the IRB package to the relevant IRB(s) and shall ensure that clinical sites involved in the study apply for and receive IRB approval. Copies of IRB approvals from the Contractor and all clinical sites shall be provided to the CDC Science Officer. Task 8: Collect Data x The Contractor shall have primary responsibility for collecting and managing relevant microbiology, clinical and other data to fulfill the objectives of the study. The data collected shall include, but is not limited to, the following: o Number of HOB events and microbiologic description including resistance data if available o Clinical and epidemiologic data as well as any other data a determined via Tasks 5 and 6 - to determine preventability of infections 200-2016-91804 75D30119F00003 Page 7 of 28 o Appropriate denominator data (e.g. patient-days) o Qualitative and quantitative feasibility and acceptability data o Cost data on implementation x Facility-wide data on IPC practices, knowledge gaps or other metrics may need to be collected if relevant to the study. x Data collection shall begin on or before the due date as noted in the deliverable schedule and continue for a minimum of 6 months. Data collected shall be presented in aggregate during two quarterly reports along with description of challenges and proposed solutions to any data collection issues. Any data collection issues shall be reported in a timely manner, by phone or email, no later than 2 weeks after onset. x Piloting of data collection shall be carried out to validate data elements, questions, collection logistics and make adjustments as needed to ensure high quality data collection during the study period. Task 9: Data Management and Analysis x The Contractor shall collect, manage, analyze and securely store all relevant data and shall design and maintain a data management structure and procedures that will ensure consistent data collection for the duration of the project. x The contractor shall revise their proposed data analytic plan in line with the developed protocol. The data analytic plan shall describe the data elements, data architecture, and detailed description of planned analyses. This data analytic plan shall be submitted to and approved by the CDC Science Officer before data analyses can proceed. The plan shall outline how the following outcomes will be output from the proposed analysis: o Descriptive epidemiology of HOB events o Proportion of preventable events o Measures of feasibility and cost x Once data analysis has begun, updates on data analytics shall be included in quarterly reports given to COR and CDC Science Officer. Potential data analysis issues shall be reported, by phone or by email, in a timely manner, no later than 2 weeks after onset. x Results of the final data analysis shall be included in the draft final report and shall be reviewed and approved by the CDC Science Officer prior to inclusion in the final report. Task 10: Final Report x The contractor shall present a draft final report of the project outcomes to the COR for review. The report shall include, in addition to final analyses on HOB epidemiology, preventable events and cost/feasibility data, suggestions for any HOB prevention efforts that might be effective based on data collected. After receiving comments and recommendations on the draft final report, the Contractor shall submit the final report, incorporating CDCa s comments and recommendations within 1 month of receiving CDC feedback. Both reports shall include with it all materials that were developed and transmitted to CDC electronically. x Writing manuscripts for publication will be the shared responsibility of CDC team and contractor, and authorship will be granted based on scientific contribution in accordance with CDC authorship policy (http://www.cdc.gov/maso/Policy/Authorship.pdf). DELIVERY AND PERFORMANCE INFORMATION Deliverables Summary & Performance of Work Requirements Summary Table: The following deliverables shall be provided to the COR/Science Officer no later than the dates specified below:
Amrita Institute Of Medical Science
Delivery Order HHSD200201691804I-75D30119F00003
$0 6/25/21 WU20342MOD1S
Hospital acquired infections (HAIs) are significant threat to patientsa safety worldwide. Low and middle-income countries (LMICs) have higher prevalence of HAIs and surgical site infections (SSIs) when compared to the United States (US) and Europe. The overall occurrence of HAIs in adults in intensive care units (ICUs) is at least 3 times higher in LMICs versus the United States. Although country-wide HAI rates are not available for India, a recent study of ICUs in 40 Indian hospitals reported HAI rates to be substantially higher than the Centers for Disease Control and Prevention's National Healthcare Safety Network (CDC-NHSN) median rates, despite Indian ICUs having lower utilization of devices. Central line associated blood stream infections (CLABSI) rates in Indian ICUs were at least 5 times higher than rates in US ICUs. However, recent US studies found that CLABSIs comprise less than 20% of total hospital onset bacteremia and fungemia (HOB). Importantly, two-thirds of the HOB events were judged to be preventable. Sub-optimal infection prevention practices in India, as evidenced by high CLABSI and other HAI rates, indicate that non-CLABSI HOB events may account for significant proportion of potentially preventable infections in Indian hospitals. These data suggest that evaluating the larger group of HOB events may allow us to expand the targets for HAI detection, and more appropriately develop strategies to reduce additional significant HAI events not being currently addressed in a systematic manner in resource limited settings. In this study we will identify and validate new strategies for HAI prevention in resource limited settings such as Indian hospitals with an aim to advance surveillance of HAI and guide infection prevention activities to improve healthcare quality and patient safety. Scope of Work Hospital-onset bacteremia and fungemia (HOB) is being evaluated in the United States as an objective metric for surveillance of healthcare-associated infections (HAI). Given the high burden of HAI and antimicrobial resistance in low and middle income countries, it is appropriate to expand the study of HOB to those countries. In the proposed study, the framework for the study of HOB developed for US hospitals will be adapted and evaluated in India to understand the epidemiology, sources, preventability, and feasibility of HOB surveillance in the Indian hospital setting. Aim 1: Assess the incidence of HOB through blood culture data collection prospectively for 6 months in two study hospitals in India We will conduct a prospective cohort study to examine HOB incidence among patients admitted to the two hospitals from March 1, 2020 to August 31, 2020. Every blood culture processed between March 1, 2020 and August 31, 2020 in microbiology laboratories of two hospitals will be included in the study. For each blood culture, information will be collected by infection control nurses. Aim 2: Assess the sources and preventability of HOB through a detailed review of specified number of HOB events in two study hospitals in India To assess the source and preventability of HOB cases, 300 consecutive HOB cases from Amrita Hospital and 150 HOB cases from Fortis Hospital will be examined in selected units (MICU, SICU, BMTU, NCU, PICU, Neuro ICU, inpatient medical and surgical wards including labor and delivery wards) prospectively from April 1, 2020 to August 31, 2020. At the two hospitals, a standardized data collection form will be used to capture key clinical, microbiologic, and demographic data, to determine the most likely cause or source of HOB, and determine degree of preventability using the expert-consensus based Likert scale preventability assessment tool developed for US hospitals in an ongoing study. Aim 3: Assess the feasibility and cost for conducting HOB surveillance in the two study hospitals in India To assess the feasibility, information on factors affecting HOB surveillance implementation will be collected at the two hospitals by conducting qualitative interviews with study infection control nurses, 3-5 clinicians, the Head of infection control program and the study staff. These interviews will be conducted by PIs either in person or via Skype. Co-I: Surbhi Leekha (8% effort) Dr. Leekha will work closely with Dr. Gandra in providing scientific input into the design and conduct of all aspects of this proposal. Specifically, she will use her expertise in developing the preventability framework including the Delphi consensus methodology used for the ongoing US study of HOB, as well as evaluation of sources of HOB. She will participate in the start-up meeting, regular communications with the study team and CDC, development of the preventability framework, protocol development, data collection, and data analysis.
University Of Maryland, Baltimore
Delivery Order HHSD200201691804I-75D30119F00003
$0 3/30/21 WU20315S
Title: Evaluating Hospital-Onset Bacteremia (HOB) and Fungemia as Preventable Healthcare-Associated Infections 1. Background and Need Blood stream infections (BSIs) are a serious and life threatening infection. For the purposes of tracking healthcare-associated infections (HAIs), most attention has been paid to central-line associated blood stream infections (CLABSIs). Prevention of CLABSIs has been shown to be feasible via well-studied bundles of care related to catheter insertion and maintenance. However, tracking CLABSIs is difficult, time consuming and has been shown to be subjective with substantial interrater variability. Researchers in the United States have begun to evaluate the utility of tracking hospital-onset bacteremia and fungemia (HOB) as a relevant HAI outcome in lieu of CLABSI. HOB comprises all positive blood cultures taken at least 48 hours post admission to the hospital. Thus, it includes CLABSIs and non-central line associated BSIs that presumably occurred within the hospital Initial HOB studies in the United States have shown that CLABSIs comprise less than 20% of total HOBs leading to questions of whether these non-CLABSI HOBs represent preventable infections. Additionally, studies have demonstrated that HOB may also be a reasonable proxy for CLABSI rates. Several studies have shown that HOB rates tracked well with CLABSI rates when both were measured simultaneously and in one study HOB rates trended downwards proportionally with CLABSI rate decreases after a CLABSI intervention was implemented. These data suggest that a healthcare facility may be able to expend less resources following HOB and still detect CLABSI decreases when implementing targeted prevention bundles. Ongoing work to determine the etiology and preventability of HOB is underway as well; preliminary data suggests that potentially half of HOB events might be avoidable with known interventions. In low and middle-income (LMIC) countries where both human and monetary resources are limited and epidemiology of HAI infections have been studied less robustly, using HOB as a HAI metric has several potential advantages. It can often be collected from microbiology data alone, rather than requiring a large review of a patienta s chart or medical records. Additionally, it is objective and likely requires less intensive training for staff than CLABSI surveillance. Finally, in LMICs where prompt treatment and prevention of sepsis is often inadequate, there are likely a pool of non-CLABSI HOB that are preventable with simple, known interventions. Currently, all studies on HOB have been in high-income countries. This project seeks to determine whether HOB is a feasible, useful, and acceptable metric for HAI surveillance in hospitals in LMIC. 2. Scope of Work This project seeks to evaluate HOB in hospitals in LMICs as a feasible, useful and acceptable metric for HAI surveillance. The specific goals of this project are to: x Set up HOB surveillance in one or more sites within a low or middle income country (according to World Bank classifications) and describe the following: o The etiologies and syndromes associated with HOB o The epidemiology of HOB in terms of person, place and time x Develop a framework for determining which HOB events are likely to be preventable with infection control measures and quality hospital care and collect clinical data to determine the proportion of HOB events observed that meet the criteria outlined in the framework. This should be done via prospective data collection that captures relevant clinical data and shall not rely solely on data from medical charts which likely will not have sufficient detail to make determinations. x Evaluate the cost, feasibility and acceptability of implementing an HOB surveillance system in 200-2016-91804 75D30119F00003 Page 5 of 28 LMIC. This will include collection of qualitative and quantitative data on acceptability of the surveillance system from staff and hospital administration as well as collection of direct and indirect costs of implementing the surveillance outside a research study. x Determine what data might be needed to be included in an HOB surveillance system to adequately target prevention efforts. 3. Tasks The contractor shall provide all labor, expertise, materials, and supplies and perform all services required to carry out the work under this contract. Task 1: Start Up Meeting x The contractor shall arrange and conduct an initial meeting (by teleconference) with the COR and other relevant staff within 2 weeks of the effective date of the task order. The purpose of the meeting will be to review and clarify the scope of work and delivery schedule for tasks, to delineate roles and responsibilities, and to establish communication protocols. Each task and deliverable will be reviewed. x The contractor shall submit an agenda for the above meeting within 1 week of the effective date of the task order. Task 2: Maintain Communication with the Science Officer x The contractor shall coordinate with the COR for all project related communications. The contractor shall maintain regular communications with the Science Officer and COR involved with the project. The chief means of communication will be via conference calls that will be scheduled every month throughout the project period and one in-person meeting. The contractor shall provide an agenda and meeting minutes for each call. All conference calls shall be scheduled and administered by the contractor. The contractor shall respond to all emails and telephone communications from the Science Officer within 2-3 working days. x The contractor shall coordinate with the COR for an in-person meeting associated with Task 5 & 6 (framework and protocol development meeting) where they will meet with the CDC Science Officer and other relevant CDC staff. The in-person meeting may be at the contractora s site or at CDCa s Atlanta, GA location. Task 3: Quarterly Progress Reports x On the 10th day following the 3 months being reported, the contractor shall prepare and submit a quarterly progress report containing the current status of work and project spending. The report shall contain, at a minimum, the current progress on each of the requirements set forth below, the financial status of the project, problems encountered during the month, solutions implemented, planned activity for the upcoming month and any other information mutually agreed upon between the contractor and the CDC Science Officer. Task 4: Finalize Work Plan and Timeline x The contractor shall finalize the detailed plan and timeline, submitted in their proposal, for developing and implementing a study evaluating the use of HOB as an HAI metric that addresses the specific aims outlined above in the Statement of Work. The work plan shall specify the approach to developing a study protocol and implementing activities outlined in the protocol. A finalized timeline for the completion of these tasks including the identification of potential factors that may hasten or impede the accomplishment of stated objectives will be presented to the COR and Science Officer for approval. Task 5: Develop a Framework and Guide for Determining HOB Preventability x The contractor shall develop a framework and set of criteria to determine the preventability of HOB events in this study as well as the data that needs to be collected to provide a preventable/not preventable determination for each HOB event. The final framework and criteria should be approved by the CDC Project Officer prior to use. 200-2016-91804 75D30119F00003 Page 6 of 28 x This framework shall be developed using input from an expert panel of physicians with backgrounds in critical care, infectious disease, and hospital epidemiology. Using Delphi methodology, the expert panel shall be convened to develop and define the Framework and Guide. The guiding question for preventability shall be a was this bacteremia or fungemia preventable in an ideal hospital setting, practicing perfect clinical care and infection prevention (even if that doesna texist)a . x The goal of the framework is to then develop a guide to operationalize the framework within the surveillance system and determine the data that needs to be collected for HOB events to make the determination. x The guide and framework shall also include contingency plans for how to deal with difficult cases or cases where the determination cannot be made with the existing framework (e.g., referral to a twoperson evaluation team to make a determination). x An in-person meeting of the contractor, subject matter experts and CDC representatives to develop and approve the draft framework shall be planned as outlined in Task 2. Due to PRA limitations, the expert panel should include not more than 9 external experts. Task 6: Develop a Protocol x The contractor shall work with the Project officer on the development of a protocol that specifically lays out the study question, methodology, data sources, laboratory methods, study population, analytic strategy and related tasks. x In order to improve generalizability it would be favored for the protocol to include implementation at several sites, though the areas of data collection could be subsets of the larger hospital population (e.g., within the ICUs of several hospitals). x The contractor shall develop a protocol that outlines the following: o How HOB rate data will be collected and compared at the given facility/facilities or ward/wards. o How the data required to determine the preventability of HOB infections (as defined in Task 5) will be collected, how difficult determinations will be adjudicated, and when determinations will be made. This data will need to be collected prospectively and shall make use of all available data including medical chart data (though shall not solely rely on this), interviews with clinical staff, review of laboratory data and other relevant medical information. o How feasibility and acceptability of HOB surveillance will be assessed, including potentially qualitative and quantitative data as appropriate. o How costs of HOB surveillance will be captured x In addition the protocol shall include: o Definitions to be used for HOB numerators o Denominator to be used to calculate rates o Sample size, power calculations as appropriate and needed Task 7: Obtain Institutional Review Board (IRB) and other Science or Administrative Approvals x The Contractor will prepare and submit the research protocol to all relevant and needed IRB bodies as well as any additional scientific or administrative approvals that may exist in country. The Contractor shall oversee all aspects of package development and submission as required prior to collection of any data. The Contractor shall prepare the packages including all forms and attachments for CDC Science Officer approval as needed. The Contractor shall submit the IRB package to the relevant IRB(s) and shall ensure that clinical sites involved in the study apply for and receive IRB approval. Copies of IRB approvals from the Contractor and all clinical sites shall be provided to the CDC Science Officer. Task 8: Collect Data x The Contractor shall have primary responsibility for collecting and managing relevant microbiology, clinical and other data to fulfill the objectives of the study. The data collected shall include, but is not limited to, the following: o Number of HOB events and microbiologic description including resistance data if available o Clinical and epidemiologic data as well as any other data a determined via Tasks 5 and 6 - to determine preventability of infections 200-2016-91804 75D30119F00003 Page 7 of 28 o Appropriate denominator data (e.g. patient-days) o Qualitative and quantitative feasibility and acceptability data o Cost data on implementation x Facility-wide data on IPC practices, knowledge gaps or other metrics may need to be collected if relevant to the study. x Data collection shall begin on or before the due date as noted in the deliverable schedule and continue for a minimum of 6 months. Data collected shall be presented in aggregate during two quarterly reports along with description of challenges and proposed solutions to any data collection issues. Any data collection issues shall be reported in a timely manner, by phone or email, no later than 2 weeks after onset. x Piloting of data collection shall be carried out to validate data elements, questions, collection logistics and make adjustments as needed to ensure high quality data collection during the study period. Task 9: Data Management and Analysis x The Contractor shall collect, manage, analyze and securely store all relevant data and shall design and maintain a data management structure and procedures that will ensure consistent data collection for the duration of the project. x The contractor shall revise their proposed data analytic plan in line with the developed protocol. The data analytic plan shall describe the data elements, data architecture, and detailed description of planned analyses. This data analytic plan shall be submitted to and approved by the CDC Science Officer before data analyses can proceed. The plan shall outline how the following outcomes will be output from the proposed analysis: o Descriptive epidemiology of HOB events o Proportion of preventable events o Measures of feasibility and cost x Once data analysis has begun, updates on data analytics shall be included in quarterly reports given to COR and CDC Science Officer. Potential data analysis issues shall be reported, by phone or by email, in a timely manner, no later than 2 weeks after onset. x Results of the final data analysis shall be included in the draft final report and shall be reviewed and approved by the CDC Science Officer prior to inclusion in the final report. Task 10: Final Report x The contractor shall present a draft final report of the project outcomes to the COR for review. The report shall include, in addition to final analyses on HOB epidemiology, preventable events and cost/feasibility data, suggestions for any HOB prevention efforts that might be effective based on data collected. After receiving comments and recommendations on the draft final report, the Contractor shall submit the final report, incorporating CDCa s comments and recommendations within 1 month of receiving CDC feedback. Both reports shall include with it all materials that were developed and transmitted to CDC electronically. x Writing manuscripts for publication will be the shared responsibility of CDC team and contractor, and authorship will be granted based on scientific contribution in accordance with CDC authorship policy (http://www.cdc.gov/maso/Policy/Authorship.pdf). DELIVERY AND PERFORMANCE INFORMATION Deliverables Summary & Performance of Work Requirements Summary Table: The following deliverables shall be provided to the COR/Science Officer no later than the dates specified below:
Amrita Institute Of Medical Science
Delivery Order HHSD200201691804I-75D30119F00003
$46.6k 2/13/20 WU20342S
Hospital acquired infections (HAIs) are significant threat to patientsa safety worldwide. Low and middle-income countries (LMICs) have higher prevalence of HAIs and surgical site infections (SSIs) when compared to the United States (US) and Europe. The overall occurrence of HAIs in adults in intensive care units (ICUs) is at least 3 times higher in LMICs versus the United States. Although country-wide HAI rates are not available for India, a recent study of ICUs in 40 Indian hospitals reported HAI rates to be substantially higher than the Centers for Disease Control and Prevention's National Healthcare Safety Network (CDC-NHSN) median rates, despite Indian ICUs having lower utilization of devices. Central line associated blood stream infections (CLABSI) rates in Indian ICUs were at least 5 times higher than rates in US ICUs. However, recent US studies found that CLABSIs comprise less than 20% of total hospital onset bacteremia and fungemia (HOB). Importantly, two-thirds of the HOB events were judged to be preventable. Sub-optimal infection prevention practices in India, as evidenced by high CLABSI and other HAI rates, indicate that non-CLABSI HOB events may account for significant proportion of potentially preventable infections in Indian hospitals. These data suggest that evaluating the larger group of HOB events may allow us to expand the targets for HAI detection, and more appropriately develop strategies to reduce additional significant HAI events not being currently addressed in a systematic manner in resource limited settings. In this study we will identify and validate new strategies for HAI prevention in resource limited settings such as Indian hospitals with an aim to advance surveillance of HAI and guide infection prevention activities to improve healthcare quality and patient safety. Scope of Work Hospital-onset bacteremia and fungemia (HOB) is being evaluated in the United States as an objective metric for surveillance of healthcare-associated infections (HAI). Given the high burden of HAI and antimicrobial resistance in low and middle income countries, it is appropriate to expand the study of HOB to those countries. In the proposed study, the framework for the study of HOB developed for US hospitals will be adapted and evaluated in India to understand the epidemiology, sources, preventability, and feasibility of HOB surveillance in the Indian hospital setting. Aim 1: Assess the incidence of HOB through blood culture data collection prospectively for 6 months in two study hospitals in India We will conduct a prospective cohort study to examine HOB incidence among patients admitted to the two hospitals from March 1, 2020 to August 31, 2020. Every blood culture processed between March 1, 2020 and August 31, 2020 in microbiology laboratories of two hospitals will be included in the study. For each blood culture, information will be collected by infection control nurses. Aim 2: Assess the sources and preventability of HOB through a detailed review of specified number of HOB events in two study hospitals in India To assess the source and preventability of HOB cases, 300 consecutive HOB cases from Amrita Hospital and 150 HOB cases from Fortis Hospital will be examined in selected units (MICU, SICU, BMTU, NCU, PICU, Neuro ICU, inpatient medical and surgical wards including labor and delivery wards) prospectively from April 1, 2020 to August 31, 2020. At the two hospitals, a standardized data collection form will be used to capture key clinical, microbiologic, and demographic data, to determine the most likely cause or source of HOB, and determine degree of preventability using the expert-consensus based Likert scale preventability assessment tool developed for US hospitals in an ongoing study. Aim 3: Assess the feasibility and cost for conducting HOB surveillance in the two study hospitals in India To assess the feasibility, information on factors affecting HOB surveillance implementation will be collected at the two hospitals by conducting qualitative interviews with study infection control nurses, 3-5 clinicians, the Head of infection control program and the study staff. These interviews will be conducted by PIs either in person or via Skype. Co-I: Surbhi Leekha (8% effort) Dr. Leekha will work closely with Dr. Gandra in providing scientific input into the design and conduct of all aspects of this proposal. Specifically, she will use her expertise in developing the preventability framework including the Delphi consensus methodology used for the ongoing US study of HOB, as well as evaluation of sources of HOB. She will participate in the start-up meeting, regular communications with the study team and CDC, development of the preventability framework, protocol development, data collection, and data analysis.
University Of Maryland, Baltimore
Delivery Order HHSD200201691804I-75D30119F00003
$38.1k 2/12/20