Antimicrobial Resistance in HemodialysisNCT06632132
Antimicrobial Resistance Training for Hemodialysis Nurses
A study testing Antimicrobial resistance Training in Hemodialysis Units in people with Antimicrobial Resistance in Hemodialysis, run by Jordan University of Science and Technology at 1 site in Jordan.
Trial summary
Objective: To evaluate the impact of an m-health training program on nurses' knowledge, attitudes, and practices concerning antimicrobial resistance (AMR) within hemodialysis units. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Antimicrobial Resistance in Hemodialysis
- What is being tested?
- Antimicrobial resistance Training in Hemodialysis Units
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteJordan
- Study dates
- 1 Jun 2024to 2 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Nurses working at hemodialysis unit
- having smart phones
- ability of reading and writing in English
- commitment to complete all study protocol
Who cannot join
- Hemodialysis nurses who have taken training about the prevention of AMR and antibiotic uses or the infection control measures in hemodialysis units
- Hemodialysis nurses with less than three months of clinical experience.
Trial locations and contacts
1 site in 1 country.
Jordan1 site
Prince Rashid Ben AL-Hasan Militarily Hospital under the Jordanian Royal Medical Services (JRMS), Al-Hussein Hospital at King Hussein Medical City, Princess Haya Bent Al-Hussein military hospital, and King Abdullah University Hospital (KAUH).
Irbid, None Selected, 22110
About this study
Official title: Boosting Knowledge, Attitudes, and Practices: An Experimental Study Evaluating the Effectiveness of mHealth Training on Antimicrobial Resistance for Hemodialysis Nurses
Objective: To evaluate the impact of an m-health training program on nurses' knowledge, attitudes, and practices concerning antimicrobial resistance (AMR) within hemodialysis units.
Design: This study utilized a controlled experimental design with cluster random assignment, adhering to the Consolidated Standards of Reporting Trials (CONSORT) guidelines.
Method: A convenience sample of 64 nurses was cluster-randomized into either an experimental group (n = 32) or a control group (n = 32). The experimental group received AMR education via WhatsApp using Chabot software, while the control group received the same content through leaflets. The nurses' knowledge, attitudes, and practices regarding AMR were assessed with self-developed instruments at three time points: baseline (Time 1), immediately after the intervention (Time 2), and one month later (Time 3).
Read the detailed description
Introduction
Patients undergoing hemodialysis treatment are at an increased risk for infections because these patients require prolonged healthcare interventions, have weakened immune system, use antibiotics, receive treatment in a shred healthcare setting, and require vascular accesses such as catheters, fistulas and venous central lines. Infection is the second master cause of mortality in hemodialysis population, accounting for 8% of all deaths. to the general population, hemodialysis patients have higher rates of infection, particularly sepsis and its associated mortality.
Due to the high rate of infections among hemodialysis patients, there is a significant utilization of antimicrobial agents in this population. This extensive use has led to the emergence of multidrug-resistant organisms in hemodialysis units. Antimicrobial resistance (AMR) arises when microorganisms, including bacteria, fungi, viruses, and parasites, evolve mechanisms to resist the effects of antimicrobial agents. In recent years, there has been an increase in the prevalence of AMR in hemodialysis facilities worldwide, particularly among bacteria such as Staphylococcus aureus, Escherichia coli, and Klebsiella pneumonia. Staphylococcus aureus causes up to 70 % of vascular access infections in hemodialysis patients, and the problem worsens by the dissemination of methicillin-resistant S. aureus (MRSA) isolates. About 90 % of patients with MRSA infections require hospitalization, and 17 % die during hospital stay.
In Jordan, gram-positive bacterial infections and antibiotic resistance rates were high in Jordan. Methicillin-resistant S. aureus (MRSA) and methicillin-resistant coagulase-negative Staphylococci (MR-CoNS) infections were common and exhibited high rates of antibiotic resistance. Furthermore, streptococcus pneumonia showed increased resistance rates to most antimicrobials. Reports form Jordanian hospitals also showed a high prevalence of AMR, with particular note to methicillin-resistant Staphylococcus aureus (MRSA) that reached a rate of 45% (Ministry of Health National Action Plan, 2018).
Antimicrobial resistance is a complex and multifaceted global public health issue that threatens the effective prevention and treatment of infections. In 2019, the World Health Organization (WHO) announced AMR as one of the top 10 global public health threats facing humanity in 2019. Antimicrobial resistance renders standard treatments ineffective, complicating infection management, and elevating the risk of disease transmission, prolonged illness, and adverse outcomes. It also leads to increased morbidity, mortality, and hospital stays. The cost of AMR to the economy is significant as well. In addition to death and disability, prolonged illness results in longer hospital stays, leading to more expensive medications and increased financial burdens for those effected. AMR is predicted to cost the world economy between $300 billion and $1 trillion by 2050.
To mitigate the risk of antimicrobial resistance among patients undergoing hemodialysis, it is essential to implement stringent infection prevention and control measures. Additionally, raising awareness among healthcare providers, patients, and caregivers about the importance of responsible antibiotic use and infection prevention is crucial. Nurses play a crucial role in the management of AMR generally and in hemodialysis facilities specifically. They can promote the appropriate use of antimicrobial drugs and implement effective infection prevention and control measures. However, existing literature indicates that nurses often lack knowledge, attitudes, and skills related to various dimensions of antimicrobial resistance (AMR) in hemodialysis patients. This highlights the need for developing and implementing effective and innovative continuous educational programs to address these gaps.
Recently, advanced technology has made it possible to implement new types of behavioral change education. Mobile health (m-Health) is an example. The WHO defines m-Health as medical and public health practice supported by mobile devices, such as mobile phones, patient monitoring devices, personal digital assistants (PDAs), and other wireless devices. By making health information and existing health services more easily and remotely accessible, m-Health technologies are used to improve health and change health behaviors. Short Messaging Service (SMS) and Multimedia Messaging Service (MMS) as common examples of m-health are used to deliver cost-effective health promotion or behavior change interventions, regardless of geography. SMS and MMS require less effort, time, and human resources than phone calls or face-to-face meetings or appointments because they can be sent quickly and easily. Thus, given the ease of use of SMS or MMS, they could be used for potential health behavioral changes or risk reduction with little demand on staff or clinic resources.
Few studies have examined AMR training for nurses. Hendy et al. and Lutfiyati et al. both found that training on antimicrobial stewardship significantly improved nurses' knowledge, attitudes, and practices. Boban et al. observed significant improvement in the antimicrobial resistance knowledge and attitudes in higher education students, including nurses. Similarly, Kpokiri et al. noted that AMR training enhanced overall knowledge of antibiotic use and resistance among healthcare professionals.
Most prior research has focused on traditional training interventions, highlighting a gap in exploring the potential, advantages, and effectiveness of mobile technology for AMR training. Although mobile health applications (MHAs) have been utilized for AMR training in various healthcare settings, their application in hemodialysis units remains unexplored. This identified gap is particularly relevant given the increasing need for mobile technologies to enable continuous education and provide timely cost-effective assistance to health professionals. The current study aimed to address this gap by examining the effectiveness of a mobile health training program on antimicrobial resistance among the knowledge, attitudes, and practices of nurses employed in hemodialysis units.
The results of this study are clinically significant to improve patient care and safety by enhancing practices regarding AMR. Theoretically, it helps facilitate insight on the use of technology for effective health education and behavior change. This research improves the theoretical understanding of the effectiveness of mobile learning platforms by measuring their impact on specific learning outcomes-knowledge, attitudes, and practices-within a specialized health care context. It also adds to the growing body of evidence regarding the role of innovative educational methods in professional development.
Method and Materials Research Design The study employed a pre/posttest randomized controlled experimental design. The study participants were selected using a convenience sampling method and then distributed randomly into the study groups (1:1) by a cluster random assignment, sequence generated by Random Allocation Software, this precaution taken to reduce contamination. The study involved two groups including the experimental and control groups. The experimental group received education about the use of antibiotics and prevention of AMR in HD units using the WhatsApp application via Chatbot software. However, the control group received the same educational content using the leaflets. The details of interventions were explained under the intervention section below.
Sample and Setting
Participants were selected from four major hospitals representing the private, military, public sectors.
The sample size was calculated using the G-power software (Version 3.1.7). With an alpha level of 0.05, a statistical power of 0.9, an effect size of .19 (Alhawatmeh et al., 2022), and a repeated-measures ANOVA test (mixed model), the minimum required total sample size was calculated to be 60 participants. Considering a 15% attrition rate, 9 participants were added, resulting in a final required sample size of 69. Out of the 69 participants initially recruited, 64 completed the study.
Intervention
The educational program developed by the researcher is meticulously designed, drawing on extensive insights from the WHO curricula guide (nurses' education and training on antimicrobial resistance; 2019) and the literature review addressed the use of antibiotics and prevention of AMR in hemodialysis facilities. The curriculum, using simple English, provides a broad set of learning objectives tailored to the expected roles of nurses.
The education program includes four main modular outline:
- Foundations that build awareness of antimicrobial resistance, which includes the subtopics of Systemic approach to the individual with an infection and Understanding antimicrobial agents and their management.
- Appropriate use of antimicrobial agents, which include the subtopic of Use of antimicrobial agents in clinical management.
- Infection prevention and control, which includes the subtopics of Health care-associated infection, antimicrobial resistance and infection prevention and control.
- Diagnostic stewardship and surveillance, which includes the subtopics of Interaction between diagnostic stewardship and surveillance of antimicrobial resistance and overall antimicrobial stewardship.
For the experimental group, the educational material was sent by a study researcher (X) to the WhatsApp number for all members of the experimental group via Chatbot software, which was designed by software engineer. This software is a strategic move that holds immense potential for transforming the way nurses access information and support. In the dynamic and demanding field of healthcare, nurses often face time constraints and require immediate access to relevant resources. A WhatsApp Chatbot designed for nursing education can serve as a virtual companion, providing real-time assistance and information crucial to their roles. The way information is presented and shared in a Chatbot is one of the most important factors that directly affects the user experience. In contrast to conventional interfaces, a Chatbot method is usually more dynamic and user-friendly since information is frequently communicated through conversational engagements (Fitria et al, 2023). AMR training program was presented in Chatbot software as outlines. The educational materials were sent in the form of written materials, photos, and videos. The study researcher (X) who was an experienced nurse with a master's degree in nursing explained how to use program to each nurse in experimental group by the following instructions and directions:
The program was auto-reply with the educational dialogue that had been previously entered to this program. Also, the researcher advised the participant to read each part carefully. Nurses were able to return to the researchers in order to clarify the vague points and answer any questions via telephone numbers. The application allows the researcher to view the parts that have been accessed and read by participants in the educational program. During one week, nurses in experimental group completed the AMR training program, then the Chabot software was closed before evaluation phase started.
For the control group, they were given the same educational content using leaflets. Nurses in control group were provided with the educational material received by experimental group via Chatbot software after evaluation completed.
Pilot Testing and Content Validity
The tools and educational program were subjected to content validity assessment (CVI) by a panel of four experts in the field of medicine, clinical pharmacology, infection control and nursing. The tool items were overlaid in a matrix with tow option rating scale: 1) Importance which is divided to 3 rating scales (Not necessary, Useful but not necessary, Essential), and 2) relevance that is divided into 4 rating scales (Not relevant/not clear, Item needs some revision, Relevant/ clear but need minor revision, very relevant/clear).
Statistics were subsequently used to assess the degree of reviewers' agreement on the importance and relevance of the tool items. The Content Validity Index values for the Knowledge of Antimicrobial Use and Antimicrobial Resistance, the Attitudes Toward Antimicrobial Use and Antimicrobial Resistance, the practice of Antimicrobial Use and Antimicrobial Resistance were 0.978 0.927 and 0.977 respectively. These values indicated an acceptable level of validity index values.
A pilot study was conducted on 15 registered nurses working in HD units to assess the clarity, objectivity, and feasibility of the study self-developed instruments and the educational programs' content. Through the pilot study, the time required for data collection was estimated. The nurses in the pilot study were not included in the main study sample.
Data Collection Procedure
Institutional Review Board (IRB) approval was obtained prior to commencing the study, followed by securing administrative approvals from the respective study settings. A list of nurses working in the hemodialysis units was then acquired from the head nurse of each unit at the target hospitals. This list included the names and telephone numbers of the nurses. After obtaining the list of nurses, each nurse was contacted by phone. The call followed these steps: the researcher introduced themselves, explained the purpose of the call and the study, and sought verbal consent from the nurse to participate if they met the study criteria. The researcher then gathered information from each nurse to assess their eligibility for the study.
A list of nurses who met the study criteria was compiled, including their work shifts (A, B, and C) and the names of their respective hospitals. We ensured that the nurses in each shift remained in the same shift throughout the duration of the study. Each shift at each hospital was treated as a cluster, with 6 participants recruited from each cluster. This resulted in the identification of 12 clusters (4 hospitals × 3 shifts). These 12 clusters were then randomly assigned to either the experimental or control group using computer-generated randomization, resulting in 6 clusters in each group. This randomization strategy was carried out by an independent researcher who was not involved in the recruitment process and remained blinded to the participant list. The purpose of employing cluster randomization was to prevent contamination between the intervention and control groups.
The researchers scheduled a meeting and interviewed each eligible nurse individually to obtain written consent and implement the baseline measurement. Upon written consent obtained by the study researchers, a well-trained nurse - a research assistant- from each hospital took the nurses' names from the researchers without knowing which of the two groups the nurse was assigned to. A well-trained nurse - a research assistant- from each hospital took the nurses' names from the researcher without knowing which of the two groups the nurse was assigned to. All nurses received the self-administered questionnaire from the research assistants. On the same day, the questionnaires were collected once the nurses had finished. The average time to complete the questionnaire was 30 minutes. The data obtained during this phase served as the baseline (Time 1). The same questionnaire, excluding the demographic characteristics, was completed again by the two study groups immediately at the end of interventions (Time 2) and one month later (Time 3). Each participant completed the study questionnaire individually in a private, quiet room in the hospital without anyone else present, including the research assistant.
Ethical Consideration Ethical approval was obtained from the Institutional Review Board (IRB) (Number: 2023/581). Informed written consent was obtained from participants following a thorough explanation of the study. All data were securely stored in a locked cabinet at the principal investigator's office, and participants' names were replaced with codes to ensure confidentiality. Participants were informed of their right to withdraw from the study at any time.
Data Analysis The Statistical Package for Social Sciences (SPSS version 26) will be used for analyzing the study data. The internal consistency reliability of the study instruments was tested using Cronbach's alpha. Descriptive statistics such as mean, standard deviation, percentage and frequency will be used to describe the study variables. For each main study variable, repeated-measures ANOVA test (within groups) will examine the mean differences over time for each group separately. Also, repeated-measures ANOVA tests (mixed model) will examine the mean score differences between the study groups over time. P-values of 0.05 or less will be used to determine whether the results are statistically significant.
- Conditions
- Antimicrobial Resistance in Hemodialysis
- Being tested
- Antimicrobial resistance Training in Hemodialysis Units
- Keywords
- Antimicrobial Resistance, Hemodialysis Unit, mhealth, Chatbot, Knowledge, Practice, Attitudes
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antimicrobial resistance Training in Hemodialysis UnitsOther
The educational program developed by the researcher is meticulously designed, drawing on extensive insights from the WHO curricula guide (nurses' education and training on antimicrobial resistance; 2019) and the literature review addressed the use of antibiotics and prevention of AMR in hemodialysis facilities. The curriculum, using simple English, provides a broad set of learning objectives tailored to the expected roles of nurses.
The education program includes four main modular outline:
- Foundations that build awareness of antimicrobial resistance
- Appropriate use of antimicrobial agents
- Infection prevention and control
- Diagnostic stewardship and surveillance
The educational material was sent by a study researcher (X) to the WhatsApp number for all members of the experimental group via Chatbot software, which was designed by software engineer. The educational materials were sent in the form of written materials, photos, and videos.
| Study group | Role | What they receive |
|---|---|---|
| Hemodialysis nurses receiving antimicrobial resistance training | Experimental | Hemodialysis nurses received educational program about antimicrobial resistance and uses in hemodialysis units. The program developed by the researcher is meticulously designed, drawing on extensive insights from the WHO curricula guide (nurses' education and training on antimicrobial resistance; 2019) and the literature review addressed the use of antibiotics and prevention of AMR in hemodialysis facilities. Receives: Other: Antimicrobial resistance Training in Hemodialysis Units |
| Control group | No intervention | they were no given any educational content about the study intervention during the study. However, they were provided with the educational material received by experimental group via Chatbot software after evaluation completed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge of Antimicrobial Use and Resistance
A Self- developed questionnaire to assess the dialysis nurses' knowledge of antimicrobial use and resistance included 28 true and false questions. The answer choices constituting each of the questions were True, False, and I do not know. One point was given for each right answer and 0 points for each wrong answer. If participants selected the choice of "I do not know" for certain question, they would be given 0 on that question. The maximum possible score was 28 points with a range from 0 to 28 points. A higher total score indicated a higher level of knowledge of antimicrobial use and resistance
Measured: From enrollment to one month post-training completion
Attitudes Toward Antimicrobial Use and Resistance
The self-developed scale to measure the dialysis nurses' attitude toward antimicrobial use and resistance includes 11 well-formulated items. Each item was rated on a five-point Likert-type scale (strongly disagree (1) to strongly agree (5)). The maximum possible score was 55 with a range from 11 to 55 points. A higher score means the participants had a more positive attitude toward the appropriate use of antimicrobials and higher sensitivity to antimicrobial resistance
Measured: From enrollment to one month post-training completion
Practice of Antimicrobial Use and Resistance
The self-developed questionnaire to evaluate the dialysis nurses' practice regarding the proper use of antimicrobials and the issue of antimicrobial resistance, includes 27 well-formulated items. Each item was assessed on five-point Likert scale, which ranges from 1 (never) to 5 (always). The total scale ranges from 27 to 135. A higher score of this scale indicated higher strictness of antimicrobial use practices and strong compliance with protocols to prevent antimicrobial resistance
Measured: From enrollment to one month post-training completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start1 Jun 2024
- Primary completion1 Jul 2024
- Study completion2 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Antimicrobial Resistance in HemodialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jordan University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hossam Najjem Alhawatmeh, Jordan University of Science and Technology
- Investigators
- Hossam Alhawatmeh, Principal investigator, Hossam alhawatmeh, associate professor, Jordan university of science and technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06632132
- Sponsor's protocol ID
- 2023/581
- Status last verified
- Oct 2024
- First submitted
- 6 Oct 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to ethical constraints, we are unable to share the study data with external parties
Publications
AbuTaha SA, Al-Kharraz T, Belkebir S, Abu Taha A, Zyoud SH. Patterns of microbial resistance in bloodstream infections of hemodialysis patients: a cross-sectional study from Palestine. Sci Rep. 2022 Oct 26;12(1):18003. doi: 10.1038/s41598-022-21979-7.
PubMed 36289278Al-Tamimi, M., Albalawi, H., Isied, W., Musallam, A., Qazzaz, F., Azab, M., & Abu-raideh, J. (2022). Gram-positive bacterial infections and antibiotics resistance in jordan: current status and future perspective. Jordan Medical Journal, 56(1), Article 1. https://doi.org/10.35516/jmj.v56i1.219.
Boban, D., Kaur, K., Greco, S., Pradhan, H. S., Joshi, R., Rakshitha, K., & Prakash, J. (2023). The impact of antibiotic resistance training programs on knowledge, attitude, and practice reflection among Indian higher education students. International Journal of One Health, 87-94. https://doi.org/10.14202/IJOH.2023.87-94.
Buhi, E. R., Trudnak, T. E., Martinasek, M. P., Oberne, A. B., Fuhrmann, H. J., & McDermott, R. J. (2013). Mobile phone-based behavioural interventions for health: A systematic review. Health Education Journal, 72(5), 564-583. https://doi.org/10.1177/0017896912452071.
Burki TK. Superbugs: An Arms Race Against Bacteria. Lancet Respir Med. 2018 Sep;6(9):668. doi: 10.1016/S2213-2600(18)30271-6. Epub 2018 Jun 21. No abstract available.
PubMed 29937248Cave R, Ter-Stepanyan MM, Kotsinyan N, Mkrtchyan HV. An Emerging Lineage of Uropathogenic Extended Spectrum beta-Lactamase Escherichia coli ST127. Microbiol Spectr. 2022 Dec 21;10(6):e0251122. doi: 10.1128/spectrum.02511-22. Epub 2022 Nov 23.
PubMed 36416548Dadgostar P. Antimicrobial Resistance: Implications and Costs. Infect Drug Resist. 2019 Dec 20;12:3903-3910. doi: 10.2147/IDR.S234610. eCollection 2019.
PubMed 31908502D'Agata EMC. Addressing the Problem of Multidrug-Resistant Organisms in Dialysis. Clin J Am Soc Nephrol. 2018 Apr 6;13(4):666-668. doi: 10.2215/CJN.13781217. Epub 2018 Mar 22. No abstract available.
PubMed 29567862Eysenck, M. W., & Keane, M. T. (2015). Cognitive Psychology: A Student's Handbook (7th ed.). Psychology Press. https://doi.org/10.4324/9781315778006.
Festinger, L. (1957). A theory of cognitive dissonance (pp. xi, 291). Stanford University Press.
Fitria, T. N., Simbolon, N. E., & Afdaleni, A. (2023). Chatbots as online chat conversation in the education sector. International Journal of Computer and Information System (IJCIS), 4(3), 93-104.
Hendy A, Al-Sharkawi S, Hassanein SMA, Soliman SM. Effect of educational intervention on nurses' perception and practice of antimicrobial stewardship programs. Am J Infect Control. 2023 Jan;51(1):41-47. doi: 10.1016/j.ajic.2022.05.001. Epub 2022 May 10.
PubMed 35561943Istepanian RSH. Mobile Health (m-Health) in Retrospect: The Known Unknowns. Int J Environ Res Public Health. 2022 Mar 22;19(7):3747. doi: 10.3390/ijerph19073747.
PubMed 35409431Kpokiri EE, Ladva M, Dodoo CC, Orman E, Aku TA, Mensah A, Jato J, Mfoafo KA, Folitse I, Hutton-Nyameaye A, Okon-Ben I, Mensah-Kane P, Sarkodie E, Awadzi B, Jani YH. Knowledge, Awareness and Practice with Antimicrobial Stewardship Programmes among Healthcare Providers in a Ghanaian Tertiary Hospital. Antibiotics (Basel). 2021 Dec 22;11(1):6. doi: 10.3390/antibiotics11010006.
PubMed 35052883Lally, P., van Jaarsveld, C. H., Potts, H. W., & Wardle, J. (2010). How habits are formed: Modelling habit formation in the real world. European Journal of Social Psychology, 40(6), 998-1009.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Boosting Knowledge, Attitudes, and Practices: An Experimental Study Evaluating the Effectiveness of mHealth Training on Antimicrobial Resistance for Hemodialysis Nurses
- ClinicalTrials.gov ID
- NCT06632132
- Acronym / sponsor ID
- 2023/581
- Conditions
- Antimicrobial Resistance in Hemodialysis
- Keywords
- Antimicrobial Resistance, Hemodialysis Unit, mhealth, Chatbot, Knowledge, Practice, Attitudes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Jordan University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 2 Jul 2024 (actual)
- First posted
- 8 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objective: To evaluate the impact of an m-health training program on nurses' knowledge, attitudes, and practices concerning antimicrobial resistance (AMR) within hemodialysis units.
Design: This study utilized a controlled experimental design with cluster random assignment, adhering to the Consolidated Standards of Reporting Trials (CONSORT) guidelines.
Method: A convenience sample of 64 nurses was cluster-randomized into either an experimental group (n = 32) or a control group (n = 32). The experimental group received AMR education via WhatsApp using Chabot software, while the control group received the same content through leaflets. The nurses' knowledge, attitudes, and practices regarding AMR were assessed with self-developed instruments at three time points: baseline (Time 1), immediately after the intervention (Time 2), and one month later (Time 3).
Detailed description
Introduction
Patients undergoing hemodialysis treatment are at an increased risk for infections because these patients require prolonged healthcare interventions, have weakened immune system, use antibiotics, receive treatment in a shred healthcare setting, and require vascular accesses such as catheters, fistulas and venous central lines. Infection is the second master cause of mortality in hemodialysis population, accounting for 8% of all deaths. to the general population, hemodialysis patients have higher rates of infection, particularly sepsis and its associated mortality.
Due to the high rate of infections among hemodialysis patients, there is a significant utilization of antimicrobial agents in this population. This extensive use has led to the emergence of multidrug-resistant organisms in hemodialysis units. Antimicrobial resistance (AMR) arises when microorganisms, including bacteria, fungi, viruses, and parasites, evolve mechanisms to resist the effects of antimicrobial agents. In recent years, there has been an increase in the prevalence of AMR in hemodialysis facilities worldwide, particularly among bacteria such as Staphylococcus aureus, Escherichia coli, and Klebsiella pneumonia. Staphylococcus aureus causes up to 70 % of vascular access infections in hemodialysis patients, and the problem worsens by the dissemination of methicillin-resistant S. aureus (MRSA) isolates. About 90 % of patients with MRSA infections require hospitalization, and 17 % die during hospital stay.
In Jordan, gram-positive bacterial infections and antibiotic resistance rates were high in Jordan. Methicillin-resistant S. aureus (MRSA) and methicillin-resistant coagulase-negative Staphylococci (MR-CoNS) infections were common and exhibited high rates of antibiotic resistance. Furthermore, streptococcus pneumonia showed increased resistance rates to most antimicrobials. Reports form Jordanian hospitals also showed a high prevalence of AMR, with particular note to methicillin-resistant Staphylococcus aureus (MRSA) that reached a rate of 45% (Ministry of Health National Action Plan, 2018).
Antimicrobial resistance is a complex and multifaceted global public health issue that threatens the effective prevention and treatment of infections. In 2019, the World Health Organization (WHO) announced AMR as one of the top 10 global public health threats facing humanity in 2019. Antimicrobial resistance renders standard treatments ineffective, complicating infection management, and elevating the risk of disease transmission, prolonged illness, and adverse outcomes. It also leads to increased morbidity, mortality, and hospital stays. The cost of AMR to the economy is significant as well. In addition to death and disability, prolonged illness results in longer hospital stays, leading to more expensive medications and increased financial burdens for those effected. AMR is predicted to cost the world economy between $300 billion and $1 trillion by 2050.
To mitigate the risk of antimicrobial resistance among patients undergoing hemodialysis, it is essential to implement stringent infection prevention and control measures. Additionally, raising awareness among healthcare providers, patients, and caregivers about the importance of responsible antibiotic use and infection prevention is crucial. Nurses play a crucial role in the management of AMR generally and in hemodialysis facilities specifically. They can promote the appropriate use of antimicrobial drugs and implement effective infection prevention and control measures. However, existing literature indicates that nurses often lack knowledge, attitudes, and skills related to various dimensions of antimicrobial resistance (AMR) in hemodialysis patients. This highlights the need for developing and implementing effective and innovative continuous educational programs to address these gaps.
Recently, advanced technology has made it possible to implement new types of behavioral change education. Mobile health (m-Health) is an example. The WHO defines m-Health as medical and public health practice supported by mobile devices, such as mobile phones, patient monitoring devices, personal digital assistants (PDAs), and other wireless devices. By making health information and existing health services more easily and remotely accessible, m-Health technologies are used to improve health and change health behaviors. Short Messaging Service (SMS) and Multimedia Messaging Service (MMS) as common examples of m-health are used to deliver cost-effective health promotion or behavior change interventions, regardless of geography. SMS and MMS require less effort, time, and human resources than phone calls or face-to-face meetings or appointments because they can be sent quickly and easily. Thus, given the ease of use of SMS or MMS, they could be used for potential health behavioral changes or risk reduction with little demand on staff or clinic resources.
Few studies have examined AMR training for nurses. Hendy et al. and Lutfiyati et al. both found that training on antimicrobial stewardship significantly improved nurses' knowledge, attitudes, and practices. Boban et al. observed significant improvement in the antimicrobial resistance knowledge and attitudes in higher education students, including nurses. Similarly, Kpokiri et al. noted that AMR training enhanced overall knowledge of antibiotic use and resistance among healthcare professionals.
Most prior research has focused on traditional training interventions, highlighting a gap in exploring the potential, advantages, and effectiveness of mobile technology for AMR training. Although mobile health applications (MHAs) have been utilized for AMR training in various healthcare settings, their application in hemodialysis units remains unexplored. This identified gap is particularly relevant given the increasing need for mobile technologies to enable continuous education and provide timely cost-effective assistance to health professionals. The current study aimed to address this gap by examining the effectiveness of a mobile health training program on antimicrobial resistance among the knowledge, attitudes, and practices of nurses employed in hemodialysis units.
The results of this study are clinically significant to improve patient care and safety by enhancing practices regarding AMR. Theoretically, it helps facilitate insight on the use of technology for effective health education and behavior change. This research improves the theoretical understanding of the effectiveness of mobile learning platforms by measuring their impact on specific learning outcomes-knowledge, attitudes, and practices-within a specialized health care context. It also adds to the growing body of evidence regarding the role of innovative educational methods in professional development.
Method and Materials Research Design The study employed a pre/posttest randomized controlled experimental design. The study participants were selected using a convenience sampling method and then distributed randomly into the study groups (1:1) by a cluster random assignment, sequence generated by Random Allocation Software, this precaution taken to reduce contamination. The study involved two groups including the experimental and control groups. The experimental group received education about the use of antibiotics and prevention of AMR in HD units using the WhatsApp application via Chatbot software. However, the control group received the same educational content using the leaflets. The details of interventions were explained under the intervention section below.
Sample and Setting
Participants were selected from four major hospitals representing the private, military, public sectors.
The sample size was calculated using the G-power software (Version 3.1.7). With an alpha level of 0.05, a statistical power of 0.9, an effect size of .19 (Alhawatmeh et al., 2022), and a repeated-measures ANOVA test (mixed model), the minimum required total sample size was calculated to be 60 participants. Considering a 15% attrition rate, 9 participants were added, resulting in a final required sample size of 69. Out of the 69 participants initially recruited, 64 completed the study.
Intervention
The educational program developed by the researcher is meticulously designed, drawing on extensive insights from the WHO curricula guide (nurses' education and training on antimicrobial resistance; 2019) and the literature review addressed the use of antibiotics and prevention of AMR in hemodialysis facilities. The curriculum, using simple English, provides a broad set of learning objectives tailored to the expected roles of nurses.
The education program includes four main modular outline:
- Foundations that build awareness of antimicrobial resistance, which includes the subtopics of Systemic approach to the individual with an infection and Understanding antimicrobial agents and their management.
- Appropriate use of antimicrobial agents, which include the subtopic of Use of antimicrobial agents in clinical management.
- Infection prevention and control, which includes the subtopics of Health care-associated infection, antimicrobial resistance and infection prevention and control.
- Diagnostic stewardship and surveillance, which includes the subtopics of Interaction between diagnostic stewardship and surveillance of antimicrobial resistance and overall antimicrobial stewardship.
For the experimental group, the educational material was sent by a study researcher (X) to the WhatsApp number for all members of the experimental group via Chatbot software, which was designed by software engineer. This software is a strategic move that holds immense potential for transforming the way nurses access information and support. In the dynamic and demanding field of healthcare, nurses often face time constraints and require immediate access to relevant resources. A WhatsApp Chatbot designed for nursing education can serve as a virtual companion, providing real-time assistance and information crucial to their roles. The way information is presented and shared in a Chatbot is one of the most important factors that directly affects the user experience. In contrast to conventional interfaces, a Chatbot method is usually more dynamic and user-friendly since information is frequently communicated through conversational engagements (Fitria et al, 2023). AMR training program was presented in Chatbot software as outlines. The educational materials were sent in the form of written materials, photos, and videos. The study researcher (X) who was an experienced nurse with a master's degree in nursing explained how to use program to each nurse in experimental group by the following instructions and directions:
The program was auto-reply with the educational dialogue that had been previously entered to this program. Also, the researcher advised the participant to read each part carefully. Nurses were able to return to the researchers in order to clarify the vague points and answer any questions via telephone numbers. The application allows the researcher to view the parts that have been accessed and read by participants in the educational program. During one week, nurses in experimental group completed the AMR training program, then the Chabot software was closed before evaluation phase started.
For the control group, they were given the same educational content using leaflets. Nurses in control group were provided with the educational material received by experimental group via Chatbot software after evaluation completed.
Pilot Testing and Content Validity
The tools and educational program were subjected to content validity assessment (CVI) by a panel of four experts in the field of medicine, clinical pharmacology, infection control and nursing. The tool items were overlaid in a matrix with tow option rating scale: 1) Importance which is divided to 3 rating scales (Not necessary, Useful but not necessary, Essential), and 2) relevance that is divided into 4 rating scales (Not relevant/not clear, Item needs some revision, Relevant/ clear but need minor revision, very relevant/clear).
Statistics were subsequently used to assess the degree of reviewers' agreement on the importance and relevance of the tool items. The Content Validity Index values for the Knowledge of Antimicrobial Use and Antimicrobial Resistance, the Attitudes Toward Antimicrobial Use and Antimicrobial Resistance, the practice of Antimicrobial Use and Antimicrobial Resistance were 0.978 0.927 and 0.977 respectively. These values indicated an acceptable level of validity index values.
A pilot study was conducted on 15 registered nurses working in HD units to assess the clarity, objectivity, and feasibility of the study self-developed instruments and the educational programs' content. Through the pilot study, the time required for data collection was estimated. The nurses in the pilot study were not included in the main study sample.
Data Collection Procedure
Institutional Review Board (IRB) approval was obtained prior to commencing the study, followed by securing administrative approvals from the respective study settings. A list of nurses working in the hemodialysis units was then acquired from the head nurse of each unit at the target hospitals. This list included the names and telephone numbers of the nurses. After obtaining the list of nurses, each nurse was contacted by phone. The call followed these steps: the researcher introduced themselves, explained the purpose of the call and the study, and sought verbal consent from the nurse to participate if they met the study criteria. The researcher then gathered information from each nurse to assess their eligibility for the study.
A list of nurses who met the study criteria was compiled, including their work shifts (A, B, and C) and the names of their respective hospitals. We ensured that the nurses in each shift remained in the same shift throughout the duration of the study. Each shift at each hospital was treated as a cluster, with 6 participants recruited from each cluster. This resulted in the identification of 12 clusters (4 hospitals × 3 shifts). These 12 clusters were then randomly assigned to either the experimental or control group using computer-generated randomization, resulting in 6 clusters in each group. This randomization strategy was carried out by an independent researcher who was not involved in the recruitment process and remained blinded to the participant list. The purpose of employing cluster randomization was to prevent contamination between the intervention and control groups.
The researchers scheduled a meeting and interviewed each eligible nurse individually to obtain written consent and implement the baseline measurement. Upon written consent obtained by the study researchers, a well-trained nurse - a research assistant- from each hospital took the nurses' names from the researchers without knowing which of the two groups the nurse was assigned to. A well-trained nurse - a research assistant- from each hospital took the nurses' names from the researcher without knowing which of the two groups the nurse was assigned to. All nurses received the self-administered questionnaire from the research assistants. On the same day, the questionnaires were collected once the nurses had finished. The average time to complete the questionnaire was 30 minutes. The data obtained during this phase served as the baseline (Time 1). The same questionnaire, excluding the demographic characteristics, was completed again by the two study groups immediately at the end of interventions (Time 2) and one month later (Time 3). Each participant completed the study questionnaire individually in a private, quiet room in the hospital without anyone else present, including the research assistant.
Ethical Consideration Ethical approval was obtained from the Institutional Review Board (IRB) (Number: 2023/581). Informed written consent was obtained from participants following a thorough explanation of the study. All data were securely stored in a locked cabinet at the principal investigator's office, and participants' names were replaced with codes to ensure confidentiality. Participants were informed of their right to withdraw from the study at any time.
Data Analysis The Statistical Package for Social Sciences (SPSS version 26) will be used for analyzing the study data. The internal consistency reliability of the study instruments was tested using Cronbach's alpha. Descriptive statistics such as mean, standard deviation, percentage and frequency will be used to describe the study variables. For each main study variable, repeated-measures ANOVA test (within groups) will examine the mean differences over time for each group separately. Also, repeated-measures ANOVA tests (mixed model) will examine the mean score differences between the study groups over time. P-values of 0.05 or less will be used to determine whether the results are statistically significant.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hemodialysis nurses receiving antimicrobial resistance training | Experimental | Other: Antimicrobial resistance Training in Hemodialysis UnitsHemodialysis nurses received educational program about antimicrobial resistance and uses in hemodialysis units. The program developed by the researcher is meticulously designed, drawing on extensive insights from the WHO curricula guide (nurses' education and training on antimicrobial resistance; 2019) and the literature review addressed the use of antibiotics and prevention of AMR in hemodialysis facilities. |
| Control group | No intervention | –they were no given any educational content about the study intervention during the study. However, they were provided with the educational material received by experimental group via Chatbot software after evaluation completed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Nurses working at hemodialysis unit
- having smart phones
- ability of reading and writing in English
- commitment to complete all study protocol
Key exclusion criteria (2 listed)
- Hemodialysis nurses who have taken training about the prevention of AMR and antibiotic uses or the infection control measures in hemodialysis units
- Hemodialysis nurses with less than three months of clinical experience.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antimicrobial resistance Training in Hemodialysis UnitsThe educational program developed by the researcher is meticulously designed, drawing on extensive insights from the WHO curricula guide (nurses' education and training on antimicrobial resistance; 2019) and the literature review addressed the use of antibiotics and prevention of AMR in hemodialysis facilities. The curriculum, using simple English, provides a broad set of learning objectives tailored to the expected roles of nurses. The education program includes four main modular outline: 1. Foundations that build awareness of antimicrobial resistance 2. Appropriate use of antimicrobial agents 3. Infection prevention and control 4. Diagnostic stewardship and surveillance The educational material was sent by a study researcher (X) to the WhatsApp number for all members of the experimental group via Chatbot software, which was designed by software engineer. The educational materials were sent in the form of written materials, photos, and videos. | Other | Hemodialysis nurses receiving antimicrobial resistance training |
Primary outcome
Knowledge of Antimicrobial Use and Resistance
Time frame: From enrollment to one month post-training completion
A Self- developed questionnaire to assess the dialysis nurses' knowledge of antimicrobial use and resistance included 28 true and false questions. The answer choices constituting each of the questions were True, False, and I do not know. One point was given for each right answer and 0 points for each wrong answer. If participants selected the choice of "I do not know" for certain question, they would be given 0 on that question. The maximum possible score was 28 points with a range from 0 to 28 points. A higher total score indicated a higher level of knowledge of antimicrobial use and resistance
Attitudes Toward Antimicrobial Use and Resistance
Time frame: From enrollment to one month post-training completion
The self-developed scale to measure the dialysis nurses' attitude toward antimicrobial use and resistance includes 11 well-formulated items. Each item was rated on a five-point Likert-type scale (strongly disagree (1) to strongly agree (5)). The maximum possible score was 55 with a range from 11 to 55 points. A higher score means the participants had a more positive attitude toward the appropriate use of antimicrobials and higher sensitivity to antimicrobial resistance
Practice of Antimicrobial Use and Resistance
Time frame: From enrollment to one month post-training completion
The self-developed questionnaire to evaluate the dialysis nurses' practice regarding the proper use of antimicrobials and the issue of antimicrobial resistance, includes 27 well-formulated items. Each item was assessed on five-point Likert scale, which ranges from 1 (never) to 5 (always). The total scale ranges from 27 to 135. A higher score of this scale indicated higher strictness of antimicrobial use practices and strong compliance with protocols to prevent antimicrobial resistance
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Background: PubMed 36289278AbuTaha SA, Al-Kharraz T, Belkebir S, Abu Taha A, Zyoud SH. Patterns of microbial resistance in bloodstream infections of hemodialysis patients: a cross-sectional study from Palestine. Sci Rep. 2022 Oct 26;12(1):18003. doi: 10.1038/s41598-022-21979-7.
- BackgroundAl-Tamimi, M., Albalawi, H., Isied, W., Musallam, A., Qazzaz, F., Azab, M., & Abu-raideh, J. (2022). Gram-positive bacterial infections and antibiotics resistance in jordan: current status and future perspective. Jordan Medical Journal, 56(1), Article 1. https://doi.org/10.35516/jmj.v56i1.219.
- BackgroundBoban, D., Kaur, K., Greco, S., Pradhan, H. S., Joshi, R., Rakshitha, K., & Prakash, J. (2023). The impact of antibiotic resistance training programs on knowledge, attitude, and practice reflection among Indian higher education students. International Journal of One Health, 87-94. https://doi.org/10.14202/IJOH.2023.87-94.
- BackgroundBuhi, E. R., Trudnak, T. E., Martinasek, M. P., Oberne, A. B., Fuhrmann, H. J., & McDermott, R. J. (2013). Mobile phone-based behavioural interventions for health: A systematic review. Health Education Journal, 72(5), 564-583. https://doi.org/10.1177/0017896912452071.
- Background: PubMed 29937248Burki TK. Superbugs: An Arms Race Against Bacteria. Lancet Respir Med. 2018 Sep;6(9):668. doi: 10.1016/S2213-2600(18)30271-6. Epub 2018 Jun 21. No abstract available.
- Background: PubMed 36416548Cave R, Ter-Stepanyan MM, Kotsinyan N, Mkrtchyan HV. An Emerging Lineage of Uropathogenic Extended Spectrum beta-Lactamase Escherichia coli ST127. Microbiol Spectr. 2022 Dec 21;10(6):e0251122. doi: 10.1128/spectrum.02511-22. Epub 2022 Nov 23.
- Background: PubMed 31908502Dadgostar P. Antimicrobial Resistance: Implications and Costs. Infect Drug Resist. 2019 Dec 20;12:3903-3910. doi: 10.2147/IDR.S234610. eCollection 2019.
- Background: PubMed 29567862D'Agata EMC. Addressing the Problem of Multidrug-Resistant Organisms in Dialysis. Clin J Am Soc Nephrol. 2018 Apr 6;13(4):666-668. doi: 10.2215/CJN.13781217. Epub 2018 Mar 22. No abstract available.
- BackgroundEysenck, M. W., & Keane, M. T. (2015). Cognitive Psychology: A Student's Handbook (7th ed.). Psychology Press. https://doi.org/10.4324/9781315778006.
- BackgroundFestinger, L. (1957). A theory of cognitive dissonance (pp. xi, 291). Stanford University Press.
- BackgroundFitria, T. N., Simbolon, N. E., & Afdaleni, A. (2023). Chatbots as online chat conversation in the education sector. International Journal of Computer and Information System (IJCIS), 4(3), 93-104.
- Background: PubMed 35561943Hendy A, Al-Sharkawi S, Hassanein SMA, Soliman SM. Effect of educational intervention on nurses' perception and practice of antimicrobial stewardship programs. Am J Infect Control. 2023 Jan;51(1):41-47. doi: 10.1016/j.ajic.2022.05.001. Epub 2022 May 10.
- Individual participant dataSharing planned: No. Due to ethical constraints, we are unable to share the study data with external parties
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hossam Alhawatmeh principal investigator
Hossam alhawatmeh, associate professor, Jordan university of science and technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antimicrobial resistance Training in Hemodialysis Units in people with Antimicrobial Resistance in Hemodialysis, run by Jordan University of Science and Technology at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge of Antimicrobial Use and Resistance (time frame: From enrollment to one month post-training completion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06632132, which also lists 27 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.