Introduction
Even in settings with limited resources, prevention of hospital-acquired infections (HAIs) is central to providing high quality and safe health-care. The two important preventable factors involved in many HAIs are transmission of infectious agents between patients by health workers and irrational use of antibiotics.1, 2, 3 HAIs are among the most significant causes of morbidity and mortality in healthcare settings throughout the world. 4 In developed countries, many studies have shown that infection control programme, including campaigns to improve hand hygiene, are effective in reducing HAIs.5, 6, 7 In developing countries, studies on the effectiveness of interventions to reduce HAIs are limited.
This study aimed to develop and evaluate the effectiveness of a multifaceted infection control programme on rates of HAIs, including rational use of antibiotics and hand hygiene compliance throughout the wards and ICUs of a tertiary care hospital in Bangalore.
Materials and Methods
The study was conducted at the Vydehi Hospital, Bangalore in ICUs and general wards. The total bed strength of the hospital is 1600.
Design
The research design was a retrospective study consisting of two periods: The intervention (6 months, June 2021 to November 2021) and the post-intervention (5 months, December 2021 to April 2022).
Sample size
Calculation of sample size was done using the formula (a difference between intervention and post-intervention groups with proportional comparison using the power of 80%, type 1 error of 5%). The study included 2,342 ICU patients admitted in Vydehi hospital from June 2021 to April 2022 (11 months). Study also included 1,398 patients admitted in the wards. A total of 5,524 post surgery patients during the same period were included for the calculation of SSI.
Inclusion criteria
Patients who remained in the ICU or wards for more than 48 h and post-surgery patients were included in the study.
Outcome measures and data collection
Hospital-acquired infection
Centers for Disease Control and Prevention (CDC) and National Healthcare Safety Network8, 9 definition for HAI was followed in the study. Investigations of the causes of fever and other signs of infection were at the discretion of the treating clinical staff. If clinical criteria for suspected HAIs were fulfilled and the patient had not been investigated by the treating doctors, the clinical staff was advised by the HICC team, so they could collect a culture of blood, urine or other sterile sites, as appropriate, on the same day.
The rational use of antibiotics
During the intervention period, the antibiotic policy was revised as per hospital antibiogram from microbiology laboratory and periodic monitoring by HICC team with emphasis on antibiotic stewardship was done. Medical record of each patient for daily antibiotic use was checked during this period. Inappropriate antibiotic use was classified according to the spectrum, dose and duration. 10, 11
Hand hygiene compliance
Hand hygiene compliance was defined as for each of WHO’s five moments for hand hygiene, hand washing with antiseptic soap and water or alcohol-based hand rubs by the health worker. 12, 13 When there was an indication for hand hygiene whether the hand hygiene compliance was achieved by the health worker and performed it correctly. Health care workers (doctors, nurses, ward boys, house keeping staff and technicians) were systematically observed over a fixed time period (20±10 min each). During these periods of observation, the actions of the first health worker who was involved in the care of the patient was recorded by the Infection control nurses. 14 Direct hand hygiene observation began when the healthcare worker entered the patient’s room or bed area and was observed during activities that involved contact with the patient or their environment, and the observation ended when the healthcare worker completed the activity and left the bed space.
Bacterial culture
According to CLSI guidelines, bacterial isolation and antibiotic susceptibility testing were performed.15 Vitek-2 (Bio-Mereuix) was used for all specimens except blood for which the BACTEC 9120 (BD Diagnostics, Sparks, Maryland, USA) was used. For each positive culture result, isolated organism, time taken for culture positivity, number of positive culture sites, the presence of focal or generalized clinical signs of infection and an overall assessment of illness were recorded. This enabled an assessment of whether the isolate was a true pathogen or a contaminant
Intervention period
Engaging the target group prior to the commencement of the intervention, HICC team reviewed the pre-intervention data and to provide feedback about the educational tools to be used and the implementation processes.
Intervention phase
Educational seminars, reminders, audit and performance feedback on all aspects of infection control were the tools used in the intervention aimed to reach all doctors, nurses and allied workers at the wards and ICUs. Seminars were conducted at least twice for each topic for approximately 1 h to cover all the health workers on different shifts. Topics of the seminars and other interventions were related to HAIs, hand hygiene practices, isolation of MDRO patients, water and air quality analysis, improving the rational use of antibiotics based on antibiotic policy and measures to prevent central line associated bloodstream infections, ventilator associated pneumonia, catheter associated urinary tract infections, and surgical site infections.
The HICC team consisting of doctors and the infection control nurses provided the seminars and feedback to the health workers. During the intervention period, the audit data were also collected and feed back to the health workers individually were given, and were presented at the monthly HICC meetings.
A bottle of alcohol hand rub had already been made available in every patient care room and another bottle was placed at the entrance of each room. There was a water sink and antiseptic soap in every ward.
Post-intervention period
In the, intervention and post-intervention periods, an identical method was used to collect data. While the main educational push was in the 6-months intervention period, ongoing education was provided where needed. This was the rationale for including the intervention period in the analysis of effectiveness.
Data analysis
When comparing proportions from both time periods, the Chi-sqauare test was used to analyse the results . For comparison of means student t test was used. The statistical significance was set at p<0.05. To compare the effect of the interventions between both periods, the relative risk (RR) was also calculated. To quantify the relationship between the HAI and the multifaceted intervention allowing for statistical control of potential con-founders Regression analyses were used. Vydehi Institutional Ethics Committee approved the study.
Results
Study population
A total of 2,342 ICU patients, 1,398 ward patients and 5,524 post- surgery patients were enrolled between 1ST June 2021 and 30th April 2022 (11 months).
The effectiveness of the multifaceted intervention on HAIs
The number of patients developing HAI decreased from 89% (198/222) in the intervention period to 10.8% (24/222) in the post-intervention period (relative risk (RR) (95% CI) 0.48 (0.31 to 0.56) (Table 1).
Table 1
Trends in the reduction of HAI
The reduction was observed gradually and consistently during the post-intervention period as the analyses of HAI incidence every 4 months showed. (December 2021 to April 2022) (Table 1).
Table 2
Effect of the multifaceted intervention on the incidence of CAUTI in ICU patients.
The use of urinary catheters in ICUs (catheter days) decreased significantly from 60.6% (2862/4720) to 39% (1858/4720) in the post-intervention period (p=0.01). Consequently, from 32% in the beginning of intervention period to 4.3% in the post-intervention period CAUTI dropped significantly (Table 2), showing the effectiveness of the intervention with RR=0.24(95% CI 0.11-0.49).
Table 3
Effect of the multifaceted intervention on the incidence of CLABSI in ICU patients.
The use of invasive devices in ICUs and HAIs related to invasive devices was varied in the post-intervention period. The use of central line catheters increased from 14.2% (191/1,347) to 19.8% (197/995) in the post-intervention period ( p=0.007).The Central line catheter days decreased from 65% (802/1234) in the intervention period to 35% (432/1,234) in the post-intervention period (p =0.10). CLABSI decreased significantly from 31% during the beginning of intervention period to nil in the post-intervention period RR 0.45 (95% CI 0.33 - 0.62) (Table 3).
Table 4
Effect of the multifaceted intervention on the incidence of VAP in ICU
The use and the duration of mechanical ventilation (ventilator days) decreased from 74.5% (1,985/ 2666) in the intervention period to 25.5% (681/2,666) in the post-intervention period (p=0.12). Consequently, the risk of developing ventilator-associated pneumonia decreased significantly from 45% during the beginning of intervention period to nil in the post-intervention period (Table 4) showing the effectiveness of the intervention with RR-0.13(95% CI 0.05-0.31).
Table 5
Effect of the multifaceted intervention on the incidence of SSI
SSI in clean surgeries decreased from 93.8% (46/49) in the intervention period to 6.1% (3/49) in the post intervention period. Similarly SSI in clean contaminated surgeries decreased from 92.8% (52/56) to 10.7% (6/56) (Table 5), showing the effectiveness of intervention.
Table 6
Effect of the multifaceted intervention on the incidence of CAUTI in WARD patients.
The use of urinary catheters in wards (catheter days) increased significantly from 39.8% (1,558/3912) to 60% (2354/3912) in the post-intervention period. However, CAUTI dropped significantly from 100% in the intervention period to nil in the post-intervention period (Table 6), showing the effectiveness of the intervention.
Table 7
Effect of the multifaceted intervention on the incidence of CLABSI in WARD patients.
The central line catheter days increased from 49% (196/398) in the intervention period to 50.8% (202/398) in the post-intervention period, though CLABSI was not detected in any of the patients in both the periods (Table 7).
Table 8
Hand hygiene compliance
Hand hygiene compliance among Doctors, Nurses, ward boys, house keeping staffs and technicians was 100% during the intervention period in ICU and the general wards (Table 8). Overall, hand hygiene compliance among the health- care workers was maintained at 100% during both the periods.
Table 9
Device audit details
The number of IV cannula audited in the intervention period was 57.3% (1342/2341) and in post intervention period, 42.7% (999/2341). The number of undated IV cannula decreased from 99% (116/117) in the intervention period to 0.85% (1/117) in the post intervention period. Similarly the number of over dated IV cannula decreased from 95% (37/39) to 5% (2/39) in the post-intermention period.
The number of IV sets audited in the intervention period was 53.7% (962/1,791) and in post intervention period, 46.2% (829/1,791). The number of undated IV sets decreased from 97% (68/70) in the intervention period to 3% (2/70) in the post intervention period. Similarly the number of over dated IV sets decreased from 91.5% (43/47) to 8.5% (4/47) in the post intervention period.
The number of central lines audited in the intervention period was 66.6% (126/189) and in post intervention period, 33.3% (63/189). The number of undated central lines decreased from 100% (2/2) in the beginning of the intervention period to nil in the post intervention period
The number of Foley’s catheter audited in the intervention period was 57.5% (337/586) and in post intervention period, 42.5% (249/586). The number of undated Foley’s catheter decreased from 100% (43/43) in the intervention period to nil in the post intervention period
Adjustment for potential confounding
We performed a multi-variable analysis to adjust for factors that might be different between the two time periods, including factors that might reflect different disease severity among patients or which might interact with the intervention. We adjusted for patient characteristics, independent risk factors of HAI and independent risk factors of mortality derived from this study. After adjusting with those factors, we found that none of those patient characteristics, independent risk factors for HAI or independent risk factors of mortality significantly changed the effect of the multifaceted intervention in reducing HAIs in the post-intervention period: adjusted OR 0.28 (95% CI 0.21 to 0.38) (p<0.001)
The effectiveness of a multifaceted intervention on irrational antibiotic use
The overall use of antibiotics in the ICUs decreased from intervention to post-intervention periods; these were prescribed for 58% (780/1347) and 44% (442/995) of all patients in the ICUs, respectively (RR 0.44 (0.40 to 0.55) (p=0.43).
Discussion
HAIs are a universal healthcare problem. The largest burden is in developing countries where surveillance is rarely performed and intervention research is limited. However, it is in these settings where basic infection control interventions may have the greatest impact.
Infection control programme should integrate two fundamental strategies in order to reduce HAIs: reducing transmission of pathogens between patients and reducing the emergence and spread of antibiotic resistance. Despite financial constraints in settings with limited resources, we have shown that simple infection control measures, principally, hand hygiene and the more rational use of antibiotics, are feasible and effective. To our knowledge, this is the first quality improvement study that has evaluated the effectiveness of an infection control and antibiotic stewardship programme among hospitalized patients in a tertiary care hospital in southern India.
Patients in the intervention and post-intervention periods of this study had similar characteristics, including gender, age and underlying diseases, and could be expected to have similar intrinsic infection risks in both periods. However, there are a number of other sources of potential bias in any before-and-after study, including ascertainment bias. We addressed this in several ways. First, there was no difference in the proportion of cultures collected when patients had signs and symptoms of infection between the two time periods (data not shown). Second, there were no changes to laboratory procedures between the intervention and post-intervention periods that might lead to more false-positive cultures in the intervention period, or false-negative cultures in the post-intervention period.
Adjustment for characteristics of the patient populations was done to make a reliable estimation of the effect of the intervention and reduce confounding. 16, 17, 18 Such differences included patient demographic and illness severity characteristics, intrinsic infection risk factors and other risks and treatment differences. 17, 18 None of these significantly changed the effectiveness of the intervention for reducing HAIs; the impact of such an intervention on decreasing the rates of HAIs was greater than 75%.
Previous studies involving hand hygiene campaigns to reduce HAIs in developing countries provided effect sizes ranging from 12.7% to 100%. 19 However, those studies were mostly undertaken in neonates and adults. Two previous developing country studies involving adult populations were solely in ICUs. 20, 21
The number of patients developing HAI decreased from 89% (198/222) in the intervention period to 10.8% (24/222) in the post-intervention period (relative risk (RR) (95% CI) 0.48 (0.31 to 0.56). The most common causes of HAIs in both periods were Gram-negative bacteria. A similar finding was also observed in the previous review conducted in developing countries.1 Hand hygiene has been shown to be effective in preventing transmission of Gram-negative bacteria.22, 23
Hand hygiene is inexpensive and fundamental to infection prevention programme, and our data provide strong evidence of its value in developing countries. Overall, hand hygiene compliance among the health-care workers was maintained at 100% during both the periods, which is more than of other studies with post-intervention hand hygiene compliance rates reported between 40% and 60%.24, 25
The overall use of antibiotics in the ICUs decreased from intervention to post-intervention periods; these were prescribed for 58% (780/1347) and 44% (442/995) of all patients in the ICUs, respectively ( p=0.43). More rational prescribing was achieved, particularly, de-escalation of antibiotics. In a developing country, referral hospitals where infectious diseases remain the major cause of hospital admissions and where bacterial infection rates are high, antibiotic prescribing at this level is understandable. The greatest gains in reducing antibiotic prescribing may not be in limiting the initiation of antibiotic treatment, but in earlier cessation or scaling down when serious bacterial infection is unlikely. 26
Inappropriate use of antibiotics is a universal problem. It has been described well in developed countries, but a renewed focus is needed in developing countries, where the major burden of antibiotic resistance may exist.26
Although the multifaceted intervention was not primarily aimed at reducing overall hospital mortality, we observed a significant reduction in deaths. After adjustment for several high- risk patient characteristics, types of treatments and the severity of illness, the multifaceted intervention was associated with a risk of in-hospital mortality that was at least 6% lower in the post-intervention period.
While it is difficult to isolate the most effective components of the intervention we used, such an effectiveness study reflects the complexity of clinical practice. 27 A before-and-after study design is a practical choice for the evaluation of the effective- ness of a complex quality improvement intervention, and it is commonly used for implementation of best practice guidelines when a randomized controlled trial is not feasible or ethical. The 11-month period before and after the intervention was chosen so as to reduce any effect of seasonal variation of HAIs 27 or other infections, and an identical method of data collection before and after the intervention was used to minimise bias. 27
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