Research design
This research used a quasi-experimental design. Quasi-experimental designs facilitate the examination of causality in situations in which a complete control of the research setting is not possible [18]. These designs aim to control as many threats to validity as possible in a situation in which at least one of the three components of true experimental design including randomization, comparison of groups, and controlled manipulation of the treatment is lacking [18].
Study setting
The setting of this study was Sina Educational, Research and Treatment Center. This is a teaching referral hospital in the northwest of Iran. The facility has an IPC team to address HCAIs.
Randomization
The study used cluster randomization to randomly assign 16 medical-surgical wards and intensive care units to the study groups. First, the hospital wards were divided into two matching groups in terms of type of ward, type of patients, and nursing care provided. The groups were then randomly allocated to intervention group (the ICLN program) or control. An overall 154 nurses from the 16 participating wards were involved in the study, 77 nurse participants in each study group. To be included in the study, nurses needed to be working as a floor nurse providing direct care to patients, and to consent to participate in the research.
Outcome Measures
The primary outcome was compliance with standard precautions and hand hygiene.
Definitions of terms
Standard precautions refer to a system of actions that applies to all patients, regardless of their presumed or confirmed infectious status. Standard precautions represent the primary strategy for preventing HCAIs. They include but are not limited to hand hygiene, the use of personal protective equipment (PPE), proper handling of patient care equipment and linen, environmental control, prevention of injury from sharp devices, correct waste disposal, and correct management of used needles and other sharp objects [19]. The definitions of the key concepts were adopted from the WHO’s Hand Hygiene Technical Reference Manual [20]; hand hygiene was defined as a general term referring to a hand cleansing using an alcohol-based hand rub or handwashing with water and soap with the aim of aimed at reducing or inhibiting the growth of micro-organisms on hands [20]; a hand hygiene opportunity was defined as a moment during healthcare activities when hand hygiene is required, regardless of the number of indications. Indications (five indications) were defined as before touching a patient, before a clean/aseptic procedure, after body fluid exposure risk, after touching a patient, after touching patient surroundings. Several indications may arise simultaneously, creating a single opportunity and requiring a single hand hygiene action [20]. Compliance with hand hygiene was defined as the observable behaviour of nurses following the guidelines for hand hygiene in the care of all patients [21]. Hand hygiene compliance was calculated by dividing the number of performed hand hygiene moments by the number of hand hygiene opportunities [21]. The infection control link nurse (ICLN) in this study was an experienced nurse interested in infection prevention and control, who was selected via self- nomination or nomination by the nurse unit manager. ICLN acted as a liaison between his colleagues in ward and the ICP team in the hospital. They contributed to raising the awareness of infection prevention and control among other nurses and promoting infection control practices in the workplace.
Data collection
Data were collected using the Compliance with Standard Precautions Scale (CSPS) [22], and Hand Hygiene Audit Checklist [5, 20].
Compliance with Standard Precautions Scale (CSPS)
The CSPS is a widely used self- report scale that assesses nurses’ level of compliance with standard precautions. It consists of 20 items and five dimensions, and uses a 4-point Likert type scale with response options ranging from never to always. ‘Always’ responses are scored one and ‘sometimes’, ‘rarely’, and ‘never’ are scored zero. For reverse items (items 2, 4, 6, and 15), ‘never’ responses are scored one and the remaining zero. Individual item scores are summed up to compute the total score, which can range from 0 to 20, with higher values indicating a better compliance [22]. The CSPS has adequate psychometric properties to measure nurses’ compliance with standard precautions [13, 23, 24].
Hand Hygiene Audit Checklist
Internationally, health care workers’ hand hygiene practices are guided by evidence-based guidelines published by WHO [2, 5, 25]. In this study hand hygiene was assessed using Hand Hygiene Audit Checklist, a widley used to assess health professionals’ compliance with hand hygiene [20]. The checklist assesses compliance with hand hygiene in the five opportunities, indications, or “moments” recommended by the WHO and the action taken, with three possibilities of: 1) rubbed with alcohol; 2) washed with water and soap; 3) not performed. Option 3 includes using gloves instead of performing hand hygiene [20].
Data were collected before the intervention and 6 months after. Nurses in intervention and control group were invited to complete a paper-based survey including questions about sociodemographic characteristics and work-related factors, and the CSPS.
Direct observation of healthcare workers during patient care activities by trained and validated observers is recognized as the gold standard for hand hygiene monitoring (Sax, Allegranzi et al. 2009). In this study, data on hand hygiene compliance were collected before and 6 months after the intervention by a trained observer (ShGM), who was also a member of the research team. A non-participant direct observation was conducted. The timings of the observation sessions were randomly distributed throughout the week days. The observer researcher registered the opportunity for hand hygiene and whether hand hygiene was performed, in accordance with the WHO’s five moments for hand hygiene.
Development of the ICLNs program
The researchers developed the ICLNs program following a comprehensive review of literature on the ICLN programs and identifying factors that contributed to the success of the programs in acute care settings [14, 15, 26-29]. Previous studies suggest that the success of the ICLN program depends to a great deal on identifying and preparing right ICLNs, and the support available for them [14]. Education, commitment, and coordination by the IPC team, support from the ward management, support from the senior hospital management, and peer support are essential and should be considered in developing ICLN programs [14].
In the current study, two ICLNs were selected from each participating ward in the intervention group. They received training with the aim of promoting standard precautions and hand hygiene within their ward. The research team (ShSh and ShGM) conducted the training of the ICLNs by cooperation of the hospital’s infection control nurse and the educational supervisor. The training included reviewing the guidelines on standard precaution measures and hand hygiene and discussing the rationale for maintaining an optimal level of compliance with standard precautions and hand hygiene. The ICLNs also received a hard copy of the educational materials for future reference. They worked closely with the infection control nurse of the hospital and attended monthly meetings with the research team. They educated staff in their ward about infection control and encouraged them to comply with ensuring compliance with infection control guidelines promoted compliance with infection control guidelines (e.g. hand hygiene and personal protective equipment). The role of the head nurses were to support the ICLNS and consider and address any critical organizational problems reported by the ICLNS.
Training of observer
Before commencing actual observations, the observer was trained and tested in assessing compliance with hand hygiene according to the observation guidelines of WHO. Training included watching an educational video of healthcare workers performing patient care tasks and listening to several educational presentations [30]. Then, the observer was engaged in inter-rater reliability testing, in which a series of hand hygiene practices were co-assessed by the observer and another member of the research team (SHSH), and disagreements were discussed and resolved according to WHO hand hygiene training tools [30]. In addition, two assessors performed assessments on randomly selected subset of observation sessions. The inter-rater reliabilities, using Kappa coefficients, for these sessions ranged from + 0.62 to +1, indicating a good- to- very good inter-rater agreement [31, 32].
Sample size
In order to determine the sample size for compliance with Standard Precautions variable in this study and to calculate effect size, the primary information including mean and standard deviation of compliance with the Standard Precautions was derived from Donati et al.’s study [13]. Considering a two-sided 5% significance level and a power of 80%, a sample size of 77 participants per group was necessary.
Sample size for hand hygiene observations was determined based on the WHO Hand Hygiene Technical Reference Manual, which suggests 200 opportunities per unit per observation period [20]. Considering this recommendation, a sample size of 1600 opportunities per observation period per group was considered necessary.
Data analysis
Analyses were done with the Statistical Package for Social Sciences (IBM SPSS software (version 26; SPSS, Chicago, IL). Two independent sample t-tests were used to examine differences between hand hygiene practices among nurses in intervention and control group. Multiple linear regression analysis was used to assess the effect size. All p values were based on two-tailed tests, with statistically significance defined as p<0·05.