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The VRESIST trial: Evaluating the effectiveness of a hospital-based antimicrobial stewardship intervention upon antibiotic use in Vietnam

A cluster randomised controlled trial of the effect of an Antimicrobial Stewardship interventions upon antibiotic use in district health facilities in Vietnam

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622000715774
Acronym
VRESIST Study C
Enrollment
4087
Registered
2022-05-18
Start date
2022-04-13
Completion date
2022-10-13
Last updated
2023-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This cluster randomised controlled trial aims to evaluate the effectiveness of a multi-faceted, Antimicrobial Stewardship (AMS) intervention on overall antibiotic use, and appropriate antibiotic use, in district health facilities. The unit of randomisation (cluster) is the district clinic. The intervention will be implemented by research staff in cooperation with healthcare workers in district facilities, pharmacists, academic and community partners. The intervention will be delivered over a four-month period in the intervention group. After the intervention period the intervention will also be implemented in control sites. The co-primary outcomes will be measured before and after the intervention period. The co-primary outcomes are: - The difference in the proportion of patients treated with appropriate antimicrobials according to a clinical audit of patient files, before and after the four-month intervention period, assessed using a locally-adapted version of the Australian National Antimicrobial Prescribing Survey (NAPS) tool, in the intervention group compared to the control arm. - The difference in Defined Daily Doses (DDD) of antibiotics per 1,000 bed-days prescribed for inpatients, before and after the four-month intervention period, in the intervention group compared to the control arm.

Interventions

The intervention comprises an Antimicrobial Stewardship (AMS) program that includes: 1. Formation and training of a local AMS committee and AMS team - The AMS Committee will be appointed by the District Hospital leader. Members will include hospital administrators, heads of departments, doctors and pharmacists from the hospital that have an understanding of their respective hospital's antibiotic use and knowledge on antimicrobial stewardship. Furthermore, an AMS team will be formed which will in

The intervention comprises an Antimicrobial Stewardship (AMS) program that includes: 1. Formation and training of a local AMS committee and AMS team - The AMS Committee will be appointed by the District Hospital leader. Members will include hospital administrators, heads of departments, doctors and pharmacists from the hospital that have an understanding of their respective hospital's antibiotic use and knowledge on antimicrobial stewardship. Furthermore, an AMS team will be formed which will include at least one doctor and one pharmacist who will conduct the audits. Individuals are selected based upon their clinical experience using antimicrobials. Research team will organise one presentation to the AMS committee to present an overview of VRESIST C Study that will be 30 minutes long. The AMS committee continues to meet monthly during the intervention to discuss AMS issues, review the audits and surveys of healthcare workers in their hospital. This meeting will be no more than 2 hours. As for the AMS team: Initial training comprises (i) a 1-hour offline training powerpoint session by the research team Topics during training will include (a) knowledge about appropriate antimicrobial prescribing; (b) instructions about the audit and feedback process; (c) using study and Ministry of Health(MoH) guidelines for the audits - Following the initial training session, additional training will be provided based upon the results of the baseline audit. This will include feedback regarding the accuracy of the audit process and tips for improving the audit process. 2. Introduction of comprehensive guidelines for antibiotic use to treat common infectious conditions - Treatment guidelines were developed specifically for the study, based upon national Vietnam Ministry of Health antibiotic guidelines. For guidelines that are not available in the study, MoH guidelines are used. - A physical copy of the treatment guidelines will be given to doctors, doctor assistants and pharmacists in hospitals in the intervention sites. Control sites will use their current standard of care, comprising national or local guidelines according to their standard practice. - The treatment guidelines will be distributed by the hospital administrators to departments for all relevant healthcare workers. Digital copies were presented to the hospital administrators to make further physical copies of these guidelines if required for distribution. 3. Regular audits of antimicrobial use, including an analysis of the appropriateness of antimicrobial use and adherence to guidelines, with collective feedback to prescribers - The audit tool is adapted from National Antimicrobial Prescriber Survey (NAPS) Australia. Audits will be conducted by the hospital’s AMS team as well as at least one of our study team members. -In intervention sites, audits will occur at the start of the study (baseline), after 2 months, as well as at the end of the intervention period (4 months) in the intervention sites. - In control sites, the audits will only be conducted at baseline (by an audit team not based at the hospital, without providing the results to staff) and at the end of the intervention (Month 4) - Audits will be carried out on hospital records including patient files and medication charts. Information including antibiotics, duration, indication, procedures or surgeries if applicable are noted down. Then, an assessment on the antibiotic appropriateness is done according to the NAPS appropriateness guideline. No interviews or patient interaction will occur - Feedback sessions will be carried out after the audits in a collective session - such as hospital grand rounds or departmental meetings to identify areas where antibiotic prescription can be improved. 4. Healthcare worker education and training regarding appropriate antimicrobial use - In intervention sites, 2 workshops will be carried out in the 4 month intervention period. The first workshop will happen a month into the intervention, and the second one in the third month of intervention. Each session will be an hour and be carried out face to face. This will go through the antibiotic guidelines, principles of antimicrobial stewardship as well as the audit feedback process. It will also include case study examples as a tool for educating healthcare workers. - In control sites, there will be no workshops during the intervention period. A workshop will be implemented during the post-intervention period (i.e. cross-over period), allowing for this approach to be implemented in the control districts. 5. Health promotion campaign focusing upon appropriate antimicrobial use for patients and clinicians. The health promotion campaign in intervention sites (and in control sites during the cross-over period) will include: - The research team will distribute posters during days of audits in each ward as well as outpatient departments and also pass it on to the hospital administrators to arrange for it to be displayed in high traffic areas of the hospital. These posters have important AMS messages such as not needing antibiotics for common viral infections, facts on antibiotics and on antibiotic resistance in lay terms. Occurrence of each component - Hospital facility surveys and surveys of healthcare workers in the facility pre-intervention - Appointment of local AMS committee and AMS team done concurrently - AMS team will be trained within the first 2 weeks - Baseline NAPS audit performed soon after training - Interventions begin within 2 weeks after baseline audit - Introduction of antibiotic guidelines immediately after - 2 Workshops (Month 1 and Month 3) - Audit at Month 2 and feedback process - Audit at Month 4 and feedback process Strategies to monitor adherence - Attendance records for workshops - Feedback sessions within 2 weeks of audit to the doctors in departmental meetings where there will be opportunities for discussion with the AMS team

Sponsors

Woolcock Institute of Medical Research Sydney
Lead SponsorOther Collaborative groups

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Healthy volunteers
Yes

Inclusion criteria

Eligibility of study health facilities: - District health facility located within Hanoi or Ca Mau Provinces - The facility has inpatients - The leader of the facility agrees to participate in the study - Selected by stratified random sampling Eligibility of hospital wards to participate - The leader of the ward agrees to participate - The ward has inpatients - Antimicrobials are available on the ward Eligibility for inclusion of patient files in the antimicrobial stewardship audit: - Patient is a current inpatient in the ward on the day of the audit

Exclusion criteria

- Wards where antibiotics are not available. - Wards that will be closed for at least 8 weeks during the intervention period.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026