WU220119MOD2S
AMRITA INSTITUTE OF MEDICAL SCIENCES, KOCHI, KERALA STATE, INDIA DR. SANJEEV SINGH WILL BE THE LEAD INVESTIGATOR AT AMRITA HOSPITAL AND HE WILL WORK CLOSELY WITH DR. GANDRA AND ENSURE COMPLETION OF WORK AT AMRITA HOSPITAL. HE WILL PROVIDE HIS INPUT IN PROTOCOL DEVELOPMENT. HE WILL BE RESPONSIBLE FOR IRB SUBMISSION AND GETTING NECESSARY APPROVALS AT AMRITA HOSPITAL AND HIRING STAFF AT AMRITA HOSPITAL. HE WILL ALSO BE RESPONSIBLE FOR SUBMITTING THE PROTOCOL TO INDIAN HEALTH MINISTRY SCREENING COMMITTEE (HMSC) AND GETTING THEIR APPROVAL BEFORE STARTING THE PATIENT ENROLLMENT. HE WILL OVERSEE ACTIVITIES FOR TRAINING AND PILOT DATA COLLECTION AT AMRITA HOSPITAL WITH WASHU TEAM. HE WILL OVERSEE PATIENT ENROLLMENT PROCESS AND ENSURE THE TARGETS FOR PATIENT ENROLLMENT INCLUDED IN THIS STUDY PROTOCOL WILL REACH. HE WILL ENSURE ACCESS TO DOCUMENTS RELATED TO INFECTION PREVENTION PRACTICES AT AMRITA HOSPITAL AND PROVIDE INPUT ON THE INFECTION CONTROL INTERVENTIONS THAT CAN BE IMPLEMENTED AS PROPOSED IN THE STUDY PROTOCOL. HE WILL ENSURE THE INTERVENTIONS WILL BE IMPLEMENTED IN THE STUDY ICUS. HE WILL WORK WITH THE STUDY TEAM AT AMRITA HOSPITAL TO RESOLVE ANY ISSUES WITH DATA COLLECTION AND OVERSEE DATA COLLECTION PROCESS. HE WILL PARTICIPATE IN THE TWICE MONTHLY MEETINGS WITH THE WASHU TEAM ON ZOOM. HE WILL PROVIDE INPUT IN DATA ANALYSIS AND FINAL REPORT. DR. ANU GEROGE WILL BE THE PROJECT COORDINATOR AT AMRITA HOSPITAL, AND SHE WILL WORK CLOSELY WITH DR. SINGH TO ENSURE COMPLETION OF WORK AT AMRITA HOSPITAL. SHE WILL ASSIST DR. SINGH FOR IRB SUBMISSION, GETTING NECESSARY APPROVALS AT AMRITA HOSPITAL AND GETTING APPROVAL FROM INDIAN HMSC. SHE WILL ASSIST DR. SINGH TO COORDINATE ACTIVITIES FOR TRAINING AND PILOT DATA COLLECTION AT AMRITA HOSPITAL WITH DR. GANDRA AND DR. WARREN. SHE WILL OVERSEE DAY TO DAY PATIENT ENROLLMENT, DATA COLLECTION, SPECIMEN COLLECTION BY STUDY STAFF AND INFECTION CONTROL NURSES AND REPORT TO DR. SINGH WITH ANY ISSUES THAT ARISE. SHE WILL MAKE SURE INTERVENTIONS ARE IMPLEMENTED AS PART OF THE STUDY. SHE WILL COORDINATE THE TWICE MONTHLY MEETINGS WITH WASHU TEAM ON ZOOM. DR. ANIL KUMAR IS THE CLINICAL MICROBIOLOGIST AT AMRITA HOSPITAL. HE WILL ENSURE APPROPRIATE LABORATORY PROCEDURES ARE FOLLOWED IN PROCESSING THE PERI-RECTAL SWABS AND STORING THE ISOLATES DURING THE STUDY PERIOD. HE WILL MAINTAIN PAPER RECORDS FOR PERI-RECTAL SWAB CULTURE RESULTS. HE WILL DOCUMENT AND REPORT THE QUALITY CONTROL PROCESSES INVOLVED IN IDENTIFICATION OF THE ORGANISMS AND PERFORMING ANTIMICROBIAL SUSCEPTIBILITY TESTING BY VITEK AND REPORT THE RESULTS TO DR. GANDRA MONTHLY. HE WILL HELP IN GIVING ACCESS TO ALL POSITIVE CRE CULTURES TO STUDY STAFF FOR STUDY PERIOD. HE WILL PARTICIPATE IN THE TWICE MONTHLY MEETINGS WITH WASHU TEAM. DR. ZUBAIR MOHAMED IS THE MEDICAL INTENSIVE CARE UNIT SPECIALIST AT AMRITA HOSPITAL. HE WILL ASSIST THE STUDY STAFF WITH ENROLLMENT OF PATIENTS INTO THE STUDY, MAKE SURE NURSES OBTAIN SPECIMENS FORM ENROLLED PATIENTS, GIVE ACCESS TO NECESSARY MEDICAL RECORDS FOR DATA COLLECTION AND MAKE INFECTION CONTROL PRACTICES ARE FOLLOWED AS PER STUDY PROTOCOL. HE WILL WORK CLOSELY WITH DR. ANU GEORGE AND DR. SANJEEV SINGH. DR. DIPU SATYAPALAN IS THE SURGICAL INTENSIVE CARE UNIT SPECIALIST AT AMRITA HOSPITAL. HE WILL ASSIST THE STUDY STAFF WITH ENROLLMENT OF PATIENTS INTO THE STUDY, MAKE SURE NURSES OBTAIN SPECIMENS FORM ENROLLED PATIENTS, GIVE ACCESS TO NECESSARY MEDICAL RECORDS FOR DATA COLLECTION AND MAKE INFECTION CONTROL PRACTICES ARE FOLLOWED AS PER STUDY PROTOCOL. HE WILL WORK CLOSELY WITH DR. ANU GEORGE AND DR. SANJEEV SINGH. TWO STUDY COORDINATORS WILL BE INVOLVED FOR ENROLLMENT OF PATIENT INTO THE STUDY, OBTAINING CONSENT FROM PATIENT OR FAMILY, OBTAIN SPECIMEN FROM ENROLLED PATIENTS, TRACK SPECIMEN COLLECTION, COLLECT CLINICAL DATA FROM TWO ICUS AND THE CRE POSITIVE CULTURES FROM THE MICROBIOLOGY LAB OBTAINED FROM 2 ICUS DURING THE STUDY PERIOD. THEY WILL COLLECT DATA ON VARIABLES INDICATED IN THE STUDY PROTOCOL AND ENTER ALL DATA INTO REDCAP. THEY WILL COORDINATE WITH DR. ANIL KUMAR REGARDING PERI-RECTAL CULTURE DATA AND CRE CLINICAL CULTURE DATA FROM STUDY ICUS. THEY WILL PERFORM DIRECT OBSERVATIONS TO RECORD THE COMPLIANCE WITH INFECTION CONTROL PRACTICES DURING PRE-INTERVENTION AND INTERVENTION PHASES AND ENTER THAT INFORMATION INTO REDCAP. THEY WORK CLOSELY WITH DR. ANU GEORGE AND REPORTS ANY ISSUES TO DR. ANU GEORGE IMMEDIATELY. THEY MAY PARTICIPATE IN ZOOM MEETINGS ONCE A MONTH WITH WASHU TEAM. A MICROBIOLOGY LAB TECHNICIAN WILL BE RESPONSIBLE FOR PROCESSING THE SPECIMENS (PERI-RECTAL SWABS), PLATING THEM ON CHROMOGENIC AGAR, IDENTIFYING POTENTIAL CRE COLONIES, PERFORM IDENTIFICATION AND SUSCEPTIBILITY. HE WILL PERFORM NECESSARY QUALITY CONTROL EXPERIMENTS. HE/SHE WILL MAINTAIN A RECORD OF ALL STUDY SAMPLES WITH RESULTS. HE/SHE WILL WORK UNDER THE SUPERVISION OF DR. ANIL KUMAR. AIM 1: TO DETERMINE THE PREVALENCE AND ASSOCIATED RISK FACTORS FOR ASYMPTOMATIC INTESTINAL CRE COLONIZATION ON ADMISSION AND INCIDENCE OF INTESTINAL AND NON-INTESTINAL CRE ACQUISITION USING SCS STRATEGY AND CLINICAL CULTURE DATA DURING ICU STAY AMONG PATIENTS ADMITTED TO MEDICAL AND SURGICAL ICUS WE WILL PROSPECTIVELY ENROLL CONSENTED PATIENTS ADMITTED TO MEDICAL AND SURGICAL ICU AT AMRITHA HOSPITAL, KOCHI, INDIA. THE ENROLLMENT WILL HAPPEN FOR THREE MONTHS OR FOR A MAXIMUM OF 300 PATIENTS, WHICHEVER COMES EARLIER. PERIRECTAL SWABS WILL BE OBTAINED ON CONSENTED PATIENTS WITHIN 24-48 HOURS OF ICU ADMISSION, EVERY WEEK, AND AT THE TIME OF ICU DISCHARGE OR DEATH FOR A MAXIMUM OF FOUR WEEKS OR UNTIL THE PATIENT IS IDENTIFIED AS COLONIZED WITH CRE. FOR PATIENTS COLONIZED WITH CRE ON PERI-RECTAL SWABS ON ICU ADMISSION, WE WILL NOT OBTAIN FURTHER PERI-RECTAL SWABS. WE WILL ALSO COLLECT ALL CRE POSITIVE CLINICAL CULTURE DATA FROM PATIENTS IN THE TWO ICUS FOR A MAXIMUM OF THREE MONTHS CORRESPONDING TO THE ENROLLMENT PERIOD. THIS INFORMATION WILL BE OBTAINED FROM MICROBIOLOGY LABORATORY, BY REVIEWING THE CHARTS IF NEEDED AND HOSPITAL INFORMATION SYSTEM. WE WILL REQUEST WAIVER OF CONSENT FOR THIS INFORMATION AS IT IS MINIMAL RISK TO THE PATIENTS. ADDITIONALLY, WE WILL COLLECT BASIC INFORMATION ON EXISTING INFECTION PREVENTION PRACTICES AT BASELINE AND ANY CHANGES THAT OCCUR INDEPENDENT OF THE STUDY PROTOCOL DURING THE STUDY PERIOD. DETAILED INFORMATION ON INFECTION PREVENTION PRACTICES FOCUSING ON ENVIRONMENTAL CLEANING OF IMMEDIATE PATIENT ENVIRONMENT, HAND HYGIENE PRACTICES AND CONTACT ISOLATION PRECAUTION PRACTICES OF CRE POSITIVE PATIENTS IN TWO ICUS WILL BE COLLECTED. THIS WILL BE OBTAINED FROM INFECTION PREVENTION DEPARTMENT AND DIRECT OBSERVATION FROM STUDY TEAM (IF ABLE TO TRAVEL TO INDIA). A DATA COLLECTION FORM WILL BE CREATED BY ADAPTING THE WHO INFECTION PREVENTION AND CONTROL ASSESSMENT FRAMEWORK (IPCAF)(9) AND CDC TOOL KITS(10). EXPECTED OUTCOMES FROM SPECIFIC AIM 1 WILL INCLUDE THE FOLLOWING: A c ESTIMATES OF ADMISSION CRE PREVALENCE AND CRE ACQUISITION RATES IN THE STUDY ICUS USING SCS A c RISK FACTORS ASSOCIATED WITH CRE COLONIZATION ON ADMISSION AND CRE ACQUISITION DURING ICU STAY. A c ESTIMATES OF CRE PREVALENCE DETECTED BY ROUTINE CLINICAL CULTURES ADJUSTED FOR OVERALL CULTURES PERFORMED VERSUS SURVEILLANCE CULTURES. A c BASELINE INFECTION PREVENTION PRACTICES DETAILS IN STUDY ICUS AIM 2: TO DETERMINE THE OPTIMAL LOW INTENSITY ACTIVE CRE SURVEILLANCE (LCS) STRATEGY UTILIZING BASELINE PHASE DATA FROM AIM 1 THE GOAL IS TO IDENTIFY AN LCS STRATEGY WHICH HAS CRE RATE RATIOS COMPARABLE TO SCS STRATEGY BUT LESS BURDENSOME TO IMPLEMENT COMPARED TO SCS STRATEGY ( SEE TABLE 1 FOR STUDY ACTIVITIES). TABLE 1: STUDY PHASES, CRE SURVEILLANCE STRATEGIES IN EACH PHASE AND DURATION PHASE CRE SURVEILLANCE STRATEGY DURATION BASELINE PERIOD STANDARD ACTIVE CRE SURVEILLANCE (SCS): OBTAIN PERIRECTAL SWAB FOR ENROLLED NEW ADMISSIONS TO TWO ICUS ON ADMISSION, WEEKLY AND AT DISCHARGE 3 MONTHS OR 300 PATIENTS WHICHEVER COMES FIRST DATA ANALYSIS IDENTIFY OPTIMAL LOW INTENSITY ACTIVE CRE SURVEILLANCE (LCS) STRATEGY: THE OPTIMAL LCS STRATEGY WILL BE IDENTIFIED USING DATA OBTAINED FROM THE BASELINE PERIOD SCS STRATEGY. 3 MONTHS PRE-INTERVENTION LOW INTENSITY ACTIVE CRE SURVEILLANCE (LCS): THIS MAY INVOLVE SELECTING ONE DAY OR MULTIPLE DAYS OF THE WEEK AND OBTAIN PERIRECTAL SWABS ON PATIENTS ADMITTED WITHIN 24 HOURS TO THE ICU AND ON THEIR DISCHARGE, AS WELL AS ON ALL PATIENTS TO BE DISCHARGED FROM ICU ON THAT DAY. NO CHANGE IN INFECTION PREVENTION PRACTICES 3 MONTHS INTERVENTION LOW INTENSITY ACTIVE CRE SURVEILLANCE (LCS): SAME AS PRE-INTERVENTION PHASE AND PERFORM AN INFECTION PREVENTION INTERVENTION 3 MONTHS THE LCS STRATEGY MAY INVOLVE SELECTING ONE DAY OR MULTIPLE DAYS OF THE WEEK AND PERFORMING INTESTINAL CRE SCREENING BY OBTAINING PERIRECTAL SWABS ON PATIENTS ADMITTED WITHIN 24-48 HOURS TO THE ICU AND ON THEIR DISCHARGE AS WELL AS ON ALL PATIENTS TO BE DISCHARGED WITHIN 24 HOURS. THE OPTIMAL LCS STRATEGY WILL BE IDENTIFIED AFTER ANALYZING THE SCS DATA COLLECTED FOR 3 MONTHS IN AIM1 TAKING INTO ACCOUNT THE ACCURACY OF THE CRE RATE RATIOS COMPARED TO SCS STRATEGY, THE EFFORT OF HCWS, LABORATORY STAFF, RESOURCES NEEDED AND AFTER DISCUSSIONS WITH CDC SUBJECT MATTER EXPERTS (SMES). USING THE DATA COLLECTED FROM BASELINE PHASE, CRE RATE RATIOS WITH SELECTION OF DIFFERENT DAYS OR MULTIPLE DAYS WILL BE PERFORMED TO IDENTIFY AN LCS STRATEGY THAT IS COMPARABLE AND LESS BURDENSOME TO SCS STRATEGY FOR ESTIMATING CRE RATE RATIOS . THIS WILL ALLOW US TO DETERMINE THE BEST DAY/S OF THE WEEK TO PERFORM LCS IN MEDICAL AND SURGICAL ICUS, AS THEY MAY HAVE DIFFERENT PATTERNS OF PATIENT TURNOVER RATES. IN ADDITION, WE WILL EXAMINE THE UTILITY OF ADDING RISK FACTORS AND CLINICAL CULTURE DATA TO AUGMENT THE SELECTED LCS STRATEGY, ESPECIALLY TO DECREASE THE BURDEN ON HCWS AND THE LABORATORY STAFF FOR CONDUCTING CRE SURVEILLANCE. ADDITIONALLY, WE WILL DO A QUALITATIVE INTERVIEW WITH THE RESEARCH NURSE ON THE ACCESSIBILITY OF CLINICAL RISK FACTOR DATA. THE INTERVIEW WILL BE CONDUCTED BY PIS EITHER IN PERSON OR VIA SKYPE. AIM 3: TO DETERMINE THE IMPACT OF AN INFECTION PREVENTION INTERVENTION(S) ON CRE INCIDENCE RATE RATIOS USING LCS STRATEGY IN THIS AIM, WE WILL DETERMINE THE IMPACT AN INFECTION PREVENTION INTERVENTION(S) ON CRE INCIDENCE RATE RATIOS USING LCS STRATEGY. TO DO THIS, WE WILL HAVE A PRE-INTERVENTION PHASE AND INTERVENTION PHASE EACH OF 3 MONTHS DURATION AND PROSPECTIVELY ENROLL CONSENTED PATIENTS. THE PRE-INTERVENTION PHASE WILL BE INITIATED AFTER ANALYSIS OF BASELINE PHASE DATA TO DETERMINE THE OPTIMAL LCS STRATEGY AFTER DISCUSSION WITH CDC SMES. THE GOAL IS TO IDENTIFY A LCS STRATEGY WHICH INVOLVES SELECTING ONE OR TWO DAYS OF THE WEEK AND PERFORMING INTESTINAL CRE SCREENING BY OBTAINING PERIRECTAL SWABS ON CONSENTED PATIENTS ADMITTED WITHIN 24-48 HOURS TO THE ICU AND ON THEIR DISCHARGE AS WELL AS ON ALL CONSENTED PATIENTS TO BE DISCHARGED WITHIN 24 HOURS FROM ICU. THE INTERVENTION PHASE WILL BE INITIATED ONE MONTH AFTER THE PRE-INTERVENTION PHASE IS COMPLETED. AFTER DISCUSSIONS WITH THE CDC SMES, THE INTERVENTION WILL BE FINALIZED, AND IT WILL BE PILOTED IN THE MONTH BETWEEN PRE-INTERVENTION AND INTERVENTION PHASE. DURING THE INTERVENTION PHASE, THE LCS WILL BE RESUMED AND CONTINUED FOR THREE MONTHS. WE WILL ALSO COLLECT ALL CRE POSITIVE CLINICAL CULTURE DATA FROM PATIENTS IN THE TWO ICUS DURING THE TWO PHASES. THIS INFORMATION WILL BE OBTAINED FROM MICROBIOLOGY LABORATORY, BY REVIEWING THE CHARTS IF NEEDED AND HOSPITAL INFORMATION SYSTEM. WE WILL REQUEST WAIVER OF CONSENT FOR THIS INFORMATION AS IT IS MINIMAL RISK TO THE PATIENTS. ADDITIONALLY, WE WILL COLLECT DATA ON COMPLIANCE WITH INFECTION PREVENTION DURING PRE-INTERVENTION AND INTERVENTION PHASE USING A STANDARDIZED METHOD BY PERFORMING DIRECT OBSERVATIONS. THE DETAILS WILL BE DECIDED ONCE THE INTERVENTION IS DECIDED. SOME POTENTIAL INTERVENTIONS COULD BE ENHANCED TERMINAL CLEANING WITH EDUCATION AND FEEDBACK OR WITH MINIMAL EQUIPMENT CHANGES, COHORTING OF CRE POSITIVE PATIENTS AND ENHANCING HAND HYGIENE MEASURES WITH EDUCATION AND FEEDBACK. SPECIMEN COLLECTION AND MICROBIOLOGY PROCEDURES: PERI-RECTAL SWAB WILL BE OBTAINED FROM THE CONSENTED PATIENTS BY INSERTING TIP OF THE SWAB INTO RECTUM AND GENTLY ROTATING IT 360 DEGREES. VISIBLE BROWN PIGMENT SHOULD BE OBSERVED ON THE SWAB. IF NO PIGMENT IS PRESENT, THE SWAB WILL BE REINSERTED INTO THE RECTUM. ONCE PERIRECTAL SPECIMENS ARE OBTAINED USING HICULTUREA c TRANSPORT SWABS W/ AMIES MEDIUM (HIMEDIA LABORATORIES, INDIA) SPECIMEN COLLECTION AND TRANSPORT SYSTEM, THEY WILL BE TRANSPORTED TO MICROBIOLOGY LABORATORY IMMEDIATELY AT ROOM TEMPERATURE AND WILL BE PROCESSED WITHIN 24 HOURS. THE SWABS WILL BE DIRECTLY PLATED ONTO MSUPERCARBA (CHROMAGAR)(11, 12). QUALITY CONTROL OF THE MSUPERCARBA MEDIA WILL BE PERFORMED AS PER MANUFACTURERA S RECOMMENDATIONS USING FOLLOWING ATCC STRAINS: E. COLI IMP NCTC 1347 & K. PNEUMONIAE ATCCA BAA 1705 AS POSITIVE CONTROLS AND E. FAECALIS ATCCA 29212 AND K. PNEUMONIAE ESBL ATCCA 700603 AS NEGATIVE CONTROLS. THE PLATES WILL BE INCUBATED AT 35 AC IN AN INCUBATOR FOR 24 HOURS IN AIR ATMOSPHERE. COLONIES WHICH ARE DARK PINK TO REDDISH (E. COLI) AND METALLIC BLUE (KLEBSIELLA, ENTEROBACTER, CITROBACTER) ARE CONSIDERED AS POSSIBLE CRE. THESE COLONIES WILL BE PICKED TO PERFORM MCIM AND ECIM TESTS TO RULE OUT NONA CARBAPENEMASE-PRODUCING ENTEROBACTERALES AND TO DIFFERENTIATE METALLO-I2-LACTAMASES FROM SERINE CARBAPENEMASES (13). ONCE CONFIRMED BY MCIM TEST, ONLY ONE ISOLATE (PREFERABLY E.COLI OR KLEBSIELLA SPP.) PER PATIENT WILL BE TESTED USING VITEK2 (BIOMERIEUX) FOR IDENTIFICATION AND ANTIMICROBIAL SUSCEPTIBILITY. THE GRAM NEGATIVE VITEK2 ANTIMICROBIAL SUSCEPTIBILITY PANEL INCLUDES FOLLOWING ANTIBIOTICS- AMIKACIN, AZTREONAM, CEFEPIME, CEFTAZIDIME, CIPROFLOXACIN, COLISTIN, DORIPENEM, GENTAMICIN, IMIPENEM, LEVOFLOXACIN, MEROPENEM, MINOCYCLINE, PIPERACILLIN/TAZOBACTAM, TIGECYCLINE, AND TRIMETHOPRIM/SULFAMETHOXAZOLE. ALL CRE ISOLATES WILL BE STORED FROZEN IN TSB-GLYCEROL AT -800C.
Amrita Institute Of Medical Science
Definitive Contract 75D30121C11969
$0 1/23/24 WU220119MOD1S
AMRITA INSTITUTE OF MEDICAL SCIENCES, KOCHI, KERALA STATE, INDIA DR. SANJEEV SINGH WILL BE THE LEAD INVESTIGATOR AT AMRITA HOSPITAL AND HE WILL WORK CLOSELY WITH DR. GANDRA AND ENSURE COMPLETION OF WORK AT AMRITA HOSPITAL. HE WILL PROVIDE HIS INPUT IN PROTOCOL DEVELOPMENT. HE WILL BE RESPONSIBLE FOR IRB SUBMISSION AND GETTING NECESSARY APPROVALS AT AMRITA HOSPITAL AND HIRING STAFF AT AMRITA HOSPITAL. HE WILL ALSO BE RESPONSIBLE FOR SUBMITTING THE PROTOCOL TO INDIAN HEALTH MINISTRY SCREENING COMMITTEE (HMSC) AND GETTING THEIR APPROVAL BEFORE STARTING THE PATIENT ENROLLMENT. HE WILL OVERSEE ACTIVITIES FOR TRAINING AND PILOT DATA COLLECTION AT AMRITA HOSPITAL WITH WASHU TEAM. HE WILL OVERSEE PATIENT ENROLLMENT PROCESS AND ENSURE THE TARGETS FOR PATIENT ENROLLMENT INCLUDED IN THIS STUDY PROTOCOL WILL REACH. HE WILL ENSURE ACCESS TO DOCUMENTS RELATED TO INFECTION PREVENTION PRACTICES AT AMRITA HOSPITAL AND PROVIDE INPUT ON THE INFECTION CONTROL INTERVENTIONS THAT CAN BE IMPLEMENTED AS PROPOSED IN THE STUDY PROTOCOL. HE WILL ENSURE THE INTERVENTIONS WILL BE IMPLEMENTED IN THE STUDY ICUS. HE WILL WORK WITH THE STUDY TEAM AT AMRITA HOSPITAL TO RESOLVE ANY ISSUES WITH DATA COLLECTION AND OVERSEE DATA COLLECTION PROCESS. HE WILL PARTICIPATE IN THE TWICE MONTHLY MEETINGS WITH THE WASHU TEAM ON ZOOM. HE WILL PROVIDE INPUT IN DATA ANALYSIS AND FINAL REPORT. DR. ANU GEROGE WILL BE THE PROJECT COORDINATOR AT AMRITA HOSPITAL, AND SHE WILL WORK CLOSELY WITH DR. SINGH TO ENSURE COMPLETION OF WORK AT AMRITA HOSPITAL. SHE WILL ASSIST DR. SINGH FOR IRB SUBMISSION, GETTING NECESSARY APPROVALS AT AMRITA HOSPITAL AND GETTING APPROVAL FROM INDIAN HMSC. SHE WILL ASSIST DR. SINGH TO COORDINATE ACTIVITIES FOR TRAINING AND PILOT DATA COLLECTION AT AMRITA HOSPITAL WITH DR. GANDRA AND DR. WARREN. SHE WILL OVERSEE DAY TO DAY PATIENT ENROLLMENT, DATA COLLECTION, SPECIMEN COLLECTION BY STUDY STAFF AND INFECTION CONTROL NURSES AND REPORT TO DR. SINGH WITH ANY ISSUES THAT ARISE. SHE WILL MAKE SURE INTERVENTIONS ARE IMPLEMENTED AS PART OF THE STUDY. SHE WILL COORDINATE THE TWICE MONTHLY MEETINGS WITH WASHU TEAM ON ZOOM. DR. ANIL KUMAR IS THE CLINICAL MICROBIOLOGIST AT AMRITA HOSPITAL. HE WILL ENSURE APPROPRIATE LABORATORY PROCEDURES ARE FOLLOWED IN PROCESSING THE PERI-RECTAL SWABS AND STORING THE ISOLATES DURING THE STUDY PERIOD. HE WILL MAINTAIN PAPER RECORDS FOR PERI-RECTAL SWAB CULTURE RESULTS. HE WILL DOCUMENT AND REPORT THE QUALITY CONTROL PROCESSES INVOLVED IN IDENTIFICATION OF THE ORGANISMS AND PERFORMING ANTIMICROBIAL SUSCEPTIBILITY TESTING BY VITEK AND REPORT THE RESULTS TO DR. GANDRA MONTHLY. HE WILL HELP IN GIVING ACCESS TO ALL POSITIVE CRE CULTURES TO STUDY STAFF FOR STUDY PERIOD. HE WILL PARTICIPATE IN THE TWICE MONTHLY MEETINGS WITH WASHU TEAM. DR. ZUBAIR MOHAMED IS THE MEDICAL INTENSIVE CARE UNIT SPECIALIST AT AMRITA HOSPITAL. HE WILL ASSIST THE STUDY STAFF WITH ENROLLMENT OF PATIENTS INTO THE STUDY, MAKE SURE NURSES OBTAIN SPECIMENS FORM ENROLLED PATIENTS, GIVE ACCESS TO NECESSARY MEDICAL RECORDS FOR DATA COLLECTION AND MAKE INFECTION CONTROL PRACTICES ARE FOLLOWED AS PER STUDY PROTOCOL. HE WILL WORK CLOSELY WITH DR. ANU GEORGE AND DR. SANJEEV SINGH. DR. DIPU SATYAPALAN IS THE SURGICAL INTENSIVE CARE UNIT SPECIALIST AT AMRITA HOSPITAL. HE WILL ASSIST THE STUDY STAFF WITH ENROLLMENT OF PATIENTS INTO THE STUDY, MAKE SURE NURSES OBTAIN SPECIMENS FORM ENROLLED PATIENTS, GIVE ACCESS TO NECESSARY MEDICAL RECORDS FOR DATA COLLECTION AND MAKE INFECTION CONTROL PRACTICES ARE FOLLOWED AS PER STUDY PROTOCOL. HE WILL WORK CLOSELY WITH DR. ANU GEORGE AND DR. SANJEEV SINGH. TWO STUDY COORDINATORS WILL BE INVOLVED FOR ENROLLMENT OF PATIENT INTO THE STUDY, OBTAINING CONSENT FROM PATIENT OR FAMILY, OBTAIN SPECIMEN FROM ENROLLED PATIENTS, TRACK SPECIMEN COLLECTION, COLLECT CLINICAL DATA FROM TWO ICUS AND THE CRE POSITIVE CULTURES FROM THE MICROBIOLOGY LAB OBTAINED FROM 2 ICUS DURING THE STUDY PERIOD. THEY WILL COLLECT DATA ON VARIABLES INDICATED IN THE STUDY PROTOCOL AND ENTER ALL DATA INTO REDCAP. THEY WILL COORDINATE WITH DR. ANIL KUMAR REGARDING PERI-RECTAL CULTURE DATA AND CRE CLINICAL CULTURE DATA FROM STUDY ICUS. THEY WILL PERFORM DIRECT OBSERVATIONS TO RECORD THE COMPLIANCE WITH INFECTION CONTROL PRACTICES DURING PRE-INTERVENTION AND INTERVENTION PHASES AND ENTER THAT INFORMATION INTO REDCAP. THEY WORK CLOSELY WITH DR. ANU GEORGE AND REPORTS ANY ISSUES TO DR. ANU GEORGE IMMEDIATELY. THEY MAY PARTICIPATE IN ZOOM MEETINGS ONCE A MONTH WITH WASHU TEAM. A MICROBIOLOGY LAB TECHNICIAN WILL BE RESPONSIBLE FOR PROCESSING THE SPECIMENS (PERI-RECTAL SWABS), PLATING THEM ON CHROMOGENIC AGAR, IDENTIFYING POTENTIAL CRE COLONIES, PERFORM IDENTIFICATION AND SUSCEPTIBILITY. HE WILL PERFORM NECESSARY QUALITY CONTROL EXPERIMENTS. HE/SHE WILL MAINTAIN A RECORD OF ALL STUDY SAMPLES WITH RESULTS. HE/SHE WILL WORK UNDER THE SUPERVISION OF DR. ANIL KUMAR. AIM 1: TO DETERMINE THE PREVALENCE AND ASSOCIATED RISK FACTORS FOR ASYMPTOMATIC INTESTINAL CRE COLONIZATION ON ADMISSION AND INCIDENCE OF INTESTINAL AND NON-INTESTINAL CRE ACQUISITION USING SCS STRATEGY AND CLINICAL CULTURE DATA DURING ICU STAY AMONG PATIENTS ADMITTED TO MEDICAL AND SURGICAL ICUS WE WILL PROSPECTIVELY ENROLL CONSENTED PATIENTS ADMITTED TO MEDICAL AND SURGICAL ICU AT AMRITHA HOSPITAL, KOCHI, INDIA. THE ENROLLMENT WILL HAPPEN FOR THREE MONTHS OR FOR A MAXIMUM OF 300 PATIENTS, WHICHEVER COMES EARLIER. PERIRECTAL SWABS WILL BE OBTAINED ON CONSENTED PATIENTS WITHIN 24-48 HOURS OF ICU ADMISSION, EVERY WEEK, AND AT THE TIME OF ICU DISCHARGE OR DEATH FOR A MAXIMUM OF FOUR WEEKS OR UNTIL THE PATIENT IS IDENTIFIED AS COLONIZED WITH CRE. FOR PATIENTS COLONIZED WITH CRE ON PERI-RECTAL SWABS ON ICU ADMISSION, WE WILL NOT OBTAIN FURTHER PERI-RECTAL SWABS. WE WILL ALSO COLLECT ALL CRE POSITIVE CLINICAL CULTURE DATA FROM PATIENTS IN THE TWO ICUS FOR A MAXIMUM OF THREE MONTHS CORRESPONDING TO THE ENROLLMENT PERIOD. THIS INFORMATION WILL BE OBTAINED FROM MICROBIOLOGY LABORATORY, BY REVIEWING THE CHARTS IF NEEDED AND HOSPITAL INFORMATION SYSTEM. WE WILL REQUEST WAIVER OF CONSENT FOR THIS INFORMATION AS IT IS MINIMAL RISK TO THE PATIENTS. ADDITIONALLY, WE WILL COLLECT BASIC INFORMATION ON EXISTING INFECTION PREVENTION PRACTICES AT BASELINE AND ANY CHANGES THAT OCCUR INDEPENDENT OF THE STUDY PROTOCOL DURING THE STUDY PERIOD. DETAILED INFORMATION ON INFECTION PREVENTION PRACTICES FOCUSING ON ENVIRONMENTAL CLEANING OF IMMEDIATE PATIENT ENVIRONMENT, HAND HYGIENE PRACTICES AND CONTACT ISOLATION PRECAUTION PRACTICES OF CRE POSITIVE PATIENTS IN TWO ICUS WILL BE COLLECTED. THIS WILL BE OBTAINED FROM INFECTION PREVENTION DEPARTMENT AND DIRECT OBSERVATION FROM STUDY TEAM (IF ABLE TO TRAVEL TO INDIA). A DATA COLLECTION FORM WILL BE CREATED BY ADAPTING THE WHO INFECTION PREVENTION AND CONTROL ASSESSMENT FRAMEWORK (IPCAF)(9) AND CDC TOOL KITS(10). EXPECTED OUTCOMES FROM SPECIFIC AIM 1 WILL INCLUDE THE FOLLOWING: A c ESTIMATES OF ADMISSION CRE PREVALENCE AND CRE ACQUISITION RATES IN THE STUDY ICUS USING SCS A c RISK FACTORS ASSOCIATED WITH CRE COLONIZATION ON ADMISSION AND CRE ACQUISITION DURING ICU STAY. A c ESTIMATES OF CRE PREVALENCE DETECTED BY ROUTINE CLINICAL CULTURES ADJUSTED FOR OVERALL CULTURES PERFORMED VERSUS SURVEILLANCE CULTURES. A c BASELINE INFECTION PREVENTION PRACTICES DETAILS IN STUDY ICUS AIM 2: TO DETERMINE THE OPTIMAL LOW INTENSITY ACTIVE CRE SURVEILLANCE (LCS) STRATEGY UTILIZING BASELINE PHASE DATA FROM AIM 1 THE GOAL IS TO IDENTIFY AN LCS STRATEGY WHICH HAS CRE RATE RATIOS COMPARABLE TO SCS STRATEGY BUT LESS BURDENSOME TO IMPLEMENT COMPARED TO SCS STRATEGY ( SEE TABLE 1 FOR STUDY ACTIVITIES). TABLE 1: STUDY PHASES, CRE SURVEILLANCE STRATEGIES IN EACH PHASE AND DURATION PHASE CRE SURVEILLANCE STRATEGY DURATION BASELINE PERIOD STANDARD ACTIVE CRE SURVEILLANCE (SCS): OBTAIN PERIRECTAL SWAB FOR ENROLLED NEW ADMISSIONS TO TWO ICUS ON ADMISSION, WEEKLY AND AT DISCHARGE 3 MONTHS OR 300 PATIENTS WHICHEVER COMES FIRST DATA ANALYSIS IDENTIFY OPTIMAL LOW INTENSITY ACTIVE CRE SURVEILLANCE (LCS) STRATEGY: THE OPTIMAL LCS STRATEGY WILL BE IDENTIFIED USING DATA OBTAINED FROM THE BASELINE PERIOD SCS STRATEGY. 3 MONTHS PRE-INTERVENTION LOW INTENSITY ACTIVE CRE SURVEILLANCE (LCS): THIS MAY INVOLVE SELECTING ONE DAY OR MULTIPLE DAYS OF THE WEEK AND OBTAIN PERIRECTAL SWABS ON PATIENTS ADMITTED WITHIN 24 HOURS TO THE ICU AND ON THEIR DISCHARGE, AS WELL AS ON ALL PATIENTS TO BE DISCHARGED FROM ICU ON THAT DAY. NO CHANGE IN INFECTION PREVENTION PRACTICES 3 MONTHS INTERVENTION LOW INTENSITY ACTIVE CRE SURVEILLANCE (LCS): SAME AS PRE-INTERVENTION PHASE AND PERFORM AN INFECTION PREVENTION INTERVENTION 3 MONTHS THE LCS STRATEGY MAY INVOLVE SELECTING ONE DAY OR MULTIPLE DAYS OF THE WEEK AND PERFORMING INTESTINAL CRE SCREENING BY OBTAINING PERIRECTAL SWABS ON PATIENTS ADMITTED WITHIN 24-48 HOURS TO THE ICU AND ON THEIR DISCHARGE AS WELL AS ON ALL PATIENTS TO BE DISCHARGED WITHIN 24 HOURS. THE OPTIMAL LCS STRATEGY WILL BE IDENTIFIED AFTER ANALYZING THE SCS DATA COLLECTED FOR 3 MONTHS IN AIM1 TAKING INTO ACCOUNT THE ACCURACY OF THE CRE RATE RATIOS COMPARED TO SCS STRATEGY, THE EFFORT OF HCWS, LABORATORY STAFF, RESOURCES NEEDED AND AFTER DISCUSSIONS WITH CDC SUBJECT MATTER EXPERTS (SMES). USING THE DATA COLLECTED FROM BASELINE PHASE, CRE RATE RATIOS WITH SELECTION OF DIFFERENT DAYS OR MULTIPLE DAYS WILL BE PERFORMED TO IDENTIFY AN LCS STRATEGY THAT IS COMPARABLE AND LESS BURDENSOME TO SCS STRATEGY FOR ESTIMATING CRE RATE RATIOS . THIS WILL ALLOW US TO DETERMINE THE BEST DAY/S OF THE WEEK TO PERFORM LCS IN MEDICAL AND SURGICAL ICUS, AS THEY MAY HAVE DIFFERENT PATTERNS OF PATIENT TURNOVER RATES. IN ADDITION, WE WILL EXAMINE THE UTILITY OF ADDING RISK FACTORS AND CLINICAL CULTURE DATA TO AUGMENT THE SELECTED LCS STRATEGY, ESPECIALLY TO DECREASE THE BURDEN ON HCWS AND THE LABORATORY STAFF FOR CONDUCTING CRE SURVEILLANCE. ADDITIONALLY, WE WILL DO A QUALITATIVE INTERVIEW WITH THE RESEARCH NURSE ON THE ACCESSIBILITY OF CLINICAL RISK FACTOR DATA. THE INTERVIEW WILL BE CONDUCTED BY PIS EITHER IN PERSON OR VIA SKYPE. AIM 3: TO DETERMINE THE IMPACT OF AN INFECTION PREVENTION INTERVENTION(S) ON CRE INCIDENCE RATE RATIOS USING LCS STRATEGY IN THIS AIM, WE WILL DETERMINE THE IMPACT AN INFECTION PREVENTION INTERVENTION(S) ON CRE INCIDENCE RATE RATIOS USING LCS STRATEGY. TO DO THIS, WE WILL HAVE A PRE-INTERVENTION PHASE AND INTERVENTION PHASE EACH OF 3 MONTHS DURATION AND PROSPECTIVELY ENROLL CONSENTED PATIENTS. THE PRE-INTERVENTION PHASE WILL BE INITIATED AFTER ANALYSIS OF BASELINE PHASE DATA TO DETERMINE THE OPTIMAL LCS STRATEGY AFTER DISCUSSION WITH CDC SMES. THE GOAL IS TO IDENTIFY A LCS STRATEGY WHICH INVOLVES SELECTING ONE OR TWO DAYS OF THE WEEK AND PERFORMING INTESTINAL CRE SCREENING BY OBTAINING PERIRECTAL SWABS ON CONSENTED PATIENTS ADMITTED WITHIN 24-48 HOURS TO THE ICU AND ON THEIR DISCHARGE AS WELL AS ON ALL CONSENTED PATIENTS TO BE DISCHARGED WITHIN 24 HOURS FROM ICU. THE INTERVENTION PHASE WILL BE INITIATED ONE MONTH AFTER THE PRE-INTERVENTION PHASE IS COMPLETED. AFTER DISCUSSIONS WITH THE CDC SMES, THE INTERVENTION WILL BE FINALIZED, AND IT WILL BE PILOTED IN THE MONTH BETWEEN PRE-INTERVENTION AND INTERVENTION PHASE. DURING THE INTERVENTION PHASE, THE LCS WILL BE RESUMED AND CONTINUED FOR THREE MONTHS. WE WILL ALSO COLLECT ALL CRE POSITIVE CLINICAL CULTURE DATA FROM PATIENTS IN THE TWO ICUS DURING THE TWO PHASES. THIS INFORMATION WILL BE OBTAINED FROM MICROBIOLOGY LABORATORY, BY REVIEWING THE CHARTS IF NEEDED AND HOSPITAL INFORMATION SYSTEM. WE WILL REQUEST WAIVER OF CONSENT FOR THIS INFORMATION AS IT IS MINIMAL RISK TO THE PATIENTS. ADDITIONALLY, WE WILL COLLECT DATA ON COMPLIANCE WITH INFECTION PREVENTION DURING PRE-INTERVENTION AND INTERVENTION PHASE USING A STANDARDIZED METHOD BY PERFORMING DIRECT OBSERVATIONS. THE DETAILS WILL BE DECIDED ONCE THE INTERVENTION IS DECIDED. SOME POTENTIAL INTERVENTIONS COULD BE ENHANCED TERMINAL CLEANING WITH EDUCATION AND FEEDBACK OR WITH MINIMAL EQUIPMENT CHANGES, COHORTING OF CRE POSITIVE PATIENTS AND ENHANCING HAND HYGIENE MEASURES WITH EDUCATION AND FEEDBACK. SPECIMEN COLLECTION AND MICROBIOLOGY PROCEDURES: PERI-RECTAL SWAB WILL BE OBTAINED FROM THE CONSENTED PATIENTS BY INSERTING TIP OF THE SWAB INTO RECTUM AND GENTLY ROTATING IT 360 DEGREES. VISIBLE BROWN PIGMENT SHOULD BE OBSERVED ON THE SWAB. IF NO PIGMENT IS PRESENT, THE SWAB WILL BE REINSERTED INTO THE RECTUM. ONCE PERIRECTAL SPECIMENS ARE OBTAINED USING HICULTUREA c TRANSPORT SWABS W/ AMIES MEDIUM (HIMEDIA LABORATORIES, INDIA) SPECIMEN COLLECTION AND TRANSPORT SYSTEM, THEY WILL BE TRANSPORTED TO MICROBIOLOGY LABORATORY IMMEDIATELY AT ROOM TEMPERATURE AND WILL BE PROCESSED WITHIN 24 HOURS. THE SWABS WILL BE DIRECTLY PLATED ONTO MSUPERCARBA (CHROMAGAR)(11, 12). QUALITY CONTROL OF THE MSUPERCARBA MEDIA WILL BE PERFORMED AS PER MANUFACTURERA S RECOMMENDATIONS USING FOLLOWING ATCC STRAINS: E. COLI IMP NCTC 1347 & K. PNEUMONIAE ATCCA BAA 1705 AS POSITIVE CONTROLS AND E. FAECALIS ATCCA 29212 AND K. PNEUMONIAE ESBL ATCCA 700603 AS NEGATIVE CONTROLS. THE PLATES WILL BE INCUBATED AT 35 AC IN AN INCUBATOR FOR 24 HOURS IN AIR ATMOSPHERE. COLONIES WHICH ARE DARK PINK TO REDDISH (E. COLI) AND METALLIC BLUE (KLEBSIELLA, ENTEROBACTER, CITROBACTER) ARE CONSIDERED AS POSSIBLE CRE. THESE COLONIES WILL BE PICKED TO PERFORM MCIM AND ECIM TESTS TO RULE OUT NONA CARBAPENEMASE-PRODUCING ENTEROBACTERALES AND TO DIFFERENTIATE METALLO-I2-LACTAMASES FROM SERINE CARBAPENEMASES (13). ONCE CONFIRMED BY MCIM TEST, ONLY ONE ISOLATE (PREFERABLY E.COLI OR KLEBSIELLA SPP.) PER PATIENT WILL BE TESTED USING VITEK2 (BIOMERIEUX) FOR IDENTIFICATION AND ANTIMICROBIAL SUSCEPTIBILITY. THE GRAM NEGATIVE VITEK2 ANTIMICROBIAL SUSCEPTIBILITY PANEL INCLUDES FOLLOWING ANTIBIOTICS- AMIKACIN, AZTREONAM, CEFEPIME, CEFTAZIDIME, CIPROFLOXACIN, COLISTIN, DORIPENEM, GENTAMICIN, IMIPENEM, LEVOFLOXACIN, MEROPENEM, MINOCYCLINE, PIPERACILLIN/TAZOBACTAM, TIGECYCLINE, AND TRIMETHOPRIM/SULFAMETHOXAZOLE. ALL CRE ISOLATES WILL BE STORED FROZEN IN TSB-GLYCEROL AT -800C.
Amrita Institute Of Medical Science
Definitive Contract 75D30121C11969
$117.2k 5/4/23