Setting and participants:
The study was conducted from February 1, 2022 to May 01, 2023., in the Neonatal Intensive Care Unit of Tibebe – Ghion Specialized Hospital, a teaching hospital of Bahir Dar University, a large referral center that provides primary and tertiary medical care for residents of Bahir Dar city, Amhara National Regional State and the surrounding National Regional States.
Approximately 2,000 neonates are admitted annually to the fifty six (56)-bed NICU. There was scarcity of Hand-washing facilities throughout the unit. Though limited practice, use of alcohol-based hand rub has been the primary method for hand hygiene. The NICU ward Infrastructure design is lacking the minimum recommended NICU Design Standards.(13, 14) The WHO recommended IPC guideline Implementation status was below the expected (0 – 200).(10)
Study Design:
Institution based Pre – Post – Interventional study was conducted. The study was conducted in three phases. The Baseline phase(Phase 1, 6months) consisted of studying the Health Care set up as per the recommended minimum NICU Design standards for level III and IV NICUs,(9, 13) assessing the Unit’s WHO recommended Infection Prevention and Control Practice implementation status,(10) surveying Health Care Workers (HCWs) Hand Hygiene Compliance, (11) and conducting Pre – Intervention prospective data collection by simple random sampling technique and analysis of the health care associated infection rate and its associated factors. The intervention phase (Phase 2, 6 months) was approached through “the Model for Improvement approach” and was based on the results of Phase 1 assessments. Continuous prospective surveillance of HCAIs was performed throughout the entire phase. Hand Hygiene Compliance, the WHO Infection prevention and control guideline Implementation and the recommended minimum NICU Design Standards assessment were being done every two weeks. The Follow up Phase ( 3 months) was conducted in phase 3 of the study with no active intervention. Prospective data collection by simple random sampling technique was conducted to assess the post intervention status of HCAI.
Baseline study (Phase One): From February 01, 2022 – July 31, 2022;
Pre – Intervention data for Sociodemographic, HCAIs associated factors, and comorbidities were collected by simple random sampling technique. Structured observation and assessment sessions were conducted to evaluate the Infection prevention practice and Hand Hygiene compliance using the WHO IPCAF tool and Hand Hygiene Compliance assessment formats. The NICU design standard was also assessed as per the recommended Minimum standard for level III and IV NICU care(13). Descriptive analysis was done. The output from the analysis was used to formulate high impact low cost interventions to be implemented in phase 2 of this study to reduce the HCAI incidence.
Intervention (Phase two): From August 1, 2022 – January 31, 2023;
We Used “The Model for Improvement Approach” to implement change ideas/interventions which were generated during root cause analysis/RCA sessions after the baseline/Phase one assessment. Aim statement formulated, root cause analysis done to generate change ideas from the phase one findings and prioritized by focusing matrix for implementation. Using the Plan – Do – Study – Act (PDSA) Cycle methodology, change ideas were implemented simultaneously with small scale and escalated subsequently throughout the intervention phase to implement at larger scales.(15)
The Change Ideas generated were grouped under three umbrella categories; Hand Hygiene Practice, Infection prevention and control guideline implementation status and the recommended minimum NICU standards. Hence; we use the WHO Hand hygiene Compliance Checklist(11), the WHO Infection Prevention and Control Assessment Framework (IPCAF)(10) and the Recommended NICU Design Standards for level III and IV NICUs.(9, 13). The interventions and HCAIs rate were being monitored every two week and Plotted to monitor the process throughout the Intervention phase.
Four teams were organized with a team leader to handle HCAI surveillance, Hand Hygiene Compliance assessment, Infection Prevention and control Practice assessment and the NICU Design standards assessment. The changes from the interventions were plotted to monitor the process and analyse the significance of the intervention by run chart.(16)
Minimum Recommended NICU Design Standards for level III and IV NICUs:(9, 12, 13)
Thirteen surveys including the baseline assessment were conducted by the team who were trained before the intervention period to assess the unit as per the recommended NICU Design Standards. They see the status of the unit against list of the standards in team and score it from hundred (%) twice in a month. Percent achieved in the implementation status of the NICU Design Standards was considered as process indicator and plotted on run chart to follow progress.
Hand Hygiene Compliance:
Thirteen surveys including the baseline assessment were conducted by the team assigned and trained to assess, monitor and provide feedback on the status. The Hand Hygiene compliance was assessed using the WHO Hand Hygiene compliance assessment checklist.(11) The team was assessing the health care providers and auxiliary staff practicing in the unit after providing onsite trainings. Assessment was being done twice in a month. Percent achieved during assessment was used as process indicator and Plotted on run chart to follow progress.
Infection Prevention and Control Guideline Implementation:
Using the WHO Infection Prevention and Control Assessment Framework (IPCAF), surveys were done to assess the implementation status of the WHO Infection Prevention and control by the team trained and deployed to assess, monitor, and Provide feedback. The tool categorizes facilities level in to four after computing the scores (Inadequate (0 – 200 or 0 – 25%); Basic (201 – 400 or 25.1% - 50%); Intermediate (401 – 600 or 50.1% - 75%) and Advanced (601 – 800 or 75.1% - 100%)).(10) Surveys were being done twice in a month for a total of thirteen times including the baseline. Percent achieved was used as process indicator and plotted on run chart to follow progress.
Surveillance of Health Care associated Infection:
The team conducted prospective surveillance of Health Care associated infection. All neonates were being followed from admission to discharge. HCAI was diagnosed by chart review, direct patient evaluation, laboratory finding interpretations and information from the round team.(17, 18) An updated information was provided to the research team on twice in a month basis. Percent achieved every two week was used as process indicator and plotted on run chart.(16, 19)
Follow up (Phase three): From February 01, 2023 – April 30, 2023;
Sociodemographic parameters, HCAIs associated factors and comorbidities were collected for the determined sample size on prospective basis using simple random sampling technique. This was computed with the pre - intervention
Sample size and Selection:
Sample Size formula for Two Independent Samples with Dichotomous Outcome was used to estimate the difference in proportions between two independent populations (HCAI before Vs. after intervention). Level of significance = 5%; margin of error = 0.05%; proportion of HCAIs (one category = 0.076). with this, sample size was calculated to be 216 for each of pre – and Post – Intervention groups. Simple random sampling method using Microsoft excel was used for sampling.
Exclusion criteria:
Newborns admitted after diagnosis of HCAIs at some other health facility.
Newborns with Incomplete documentation.
Newborns whose caregivers were not willing to participate in the study and
Newborns who stayed less than forty eight hours before discharge.
Definitions, Diagnosis and Classification:
Health Care associated Infections(HCAIs): are infections that occur while receiving health care, in a hospital or other health care facility that first appear 48 hours or more after hospital admission, or within 30 days after having received health care.(2, 20, 21)
Hand Hygiene: Handwashing, antiseptic handwash/ hand rub, or surgical hand antisepsis.(22)
Hand Rubbing: with an alcohol-based (75% vol/vol, isopropanol) preparation of chlorhexidine gluconate (0.5%) was defined as the standard procedure for hand hygiene before and after patient care activities, unless hands were visibly soiled.(23)
Hand washing: is the act of cleaning one’s hands with the use of any liquid with or without soap for the purpose of removing dirt or microorganisms.(22)
Diagnosis: HCAI is considered, when reported as infection acquired while receiving Medical care based on culture confirmation or clinical and laboratory methods.(17, 18)
Classification(24, 25)
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Diagnosis
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Blood Stream Infections (BSI)
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A first positive blood culture ≥ 48 hours after hospital admission or within 48 hours of discharge from hospital.(26)
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Lower Respiratory Tract Infections.(27)
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Respiratory decompensation with new and persistent infiltrates on CXR or
Infants with worsening gas exchange and at least 3 of the following:
- Temperature instability with no other recognized cause
- Leukopenia (white blood cell count <4000/mm3)
- Change in character of sputum or increased respiratory secretions
- Apnea, tachypnea, nasal flaring, or grunting
- Wheezing, rales, rhonchi, or cough
- Bradycardia (<100/min) or tachycardia (>170/min).
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Surgical Site Infections.(28)
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Infections occurring up to 30 days after surgery and affecting either the incision or deep tissue at the operation site.
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Urinary Tract Infections.(29)
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Catheter-associated urinary tract infection (CAUTI) is defined as a urinary tract infection (UTI) where an indwelling urinary catheter was in place for more than 2 calendar days on the date of event, with day of device placement being day 1, and an indwelling urinary catheter was in place on the date of event or the day before.
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Skin and Soft tissue Infections.(30)
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A patient without any evidence of infection on admission and who was culture positive >48 h after admission.
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Nosocomial diarrhea.(31)
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Diarrhea that develops during a hospital stay or up to 3 days after discharge.
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Statistical Analysis:
“The Model for Improvement Approach” was used to do the intervention (phase two)(15). Goal was set using the best achievements worldwide so far.(32) Run chart was utilized to determine the statistical significance of the intervention and monitor process indicators during intervention.(16)
Phase one and three were compared to evaluate the impact of the intervention implemented during phase two on the prevalence of HCAIs. Categorical variables were compared using Chi – squared test. Adjusted odds ratio ( 95%CI) was computed for variables. P – value < 0.05 was considered statistically Significant. We used SPSS Version 25 for analysis.
Ethical Considerations:
Our protocol was approved by Bahir Dar University, College of Medicine and Health Sciences, IRB with protocol number 793/2023. Formal letter of cooperation was secured from Tibebe – Ghion Specialized Hospital. Informed consent to participate in the study was obtained from all parents or legal guardians. All information collected was kept in the way that could not interfere in personal confidentiality during data collection, analysis and then after.