An interventional study of Basic antimicrobial stewardship education and Participatory action research group in commune health center and community in Antibiotic Use, sponsored by Oxford University Clinical Research Unit, Vietnam. Recruiting at 1 site in Vietnam. Per ClinicalTrials.gov, last updated 2023-12-06.
Sponsored by Oxford University Clinical Research Unit, Vietnam · Not applicable, Interventional, and Other
The study aims to develop community-based interventions targetting inappropriate antibiotic dispensing and use behaviours in rural Vietnam and has 3 research components.
Community and primary healthcare interventions: The investigators will conduct a four-armed cluster randomised controlled trial. The first arm will be a control arm with no interventions. The second intervention arm will have a basic antimicrobial stewardship intervention, involving working with the Ministry of Health, Medical Services Administration to revise guidelines for antibiotic prescribing for acute respiratory infections (ARI) in primary care, and then training primary healthcare doctors in their use. The third intervention arm will have basic antimicrobial stewardship guidelines and training for primary healthcare doctors, plus educational materials for the community, disseminated through posters, leaflets and local media channels. The fourth intervention arm will use a participatory action research approach to engage primary healthcare doctors and communities, in addition to the basic guidelines and training materials. The participatory action research approach will train local facilitators to lead community and health-worker groups through a cycle of problem identification, strategy development, implementation and review, focusing on inappropriate human and small-scale agricultural use of antibiotics.
Hospital interventions: The investigators will work with Provincial and District Hospitals serving these communities to implement quality improvement cycles for antibiotic stewardship, also using a participatory action research approach. This will also follow a cycle of a cycle of problem identification, strategy development, implementation and review.
Main research questions:
1.2.1 Community interventions: Can educational and participatory action research interventions delivered in the community reduce the inappropriate use of antibiotics? 1.2.2 Primary healthcare interventions: Can educational and participatory action research interventions delivered in primary healthcare reduce prescription of antibiotics for patients with acute respiratory infections, outside of the research context? 1.2.3 Hospital interventions: Can participatory action research interventions delivered in hospitals improve antibiotic stewardship and reduce prescription of antibiotics?
3.1.3 Hospital interventions: The hospital interventions will use quality improvement using a participatory action research approach to improve antibiotic stewardship. These activities will be evaluated through a before and after knowledge, attitudes and practice (KAP) survey, to assess whether or not the engagement activities had a measurable impact on knowledge and behaviour. There are not sufficient hospitals in the area to conduct a cluster randomized evaluation, so the investigators will conduct a before and after survey, patient record review, and overall antibiotic use data from the Pharmacy Department.
3.1.4 Qualitative evaluation: The goal of the qualitative evaluation is to understand the group processes and community and health-worker engagement with the action groups, how the engagement activities affect behaviour, and in what contexts they work better or worse, in order to develop a theory of change. The investigators will conduct in-depth interviews and participant observation in selected communities, and at each of the participating hospitals, during each of the four phases of the meeting cycle, in order to understand decision-making processes, as well as influential social and power dynamics in the groups. Participant observation is a method used in research where the investigators engage with people and document the information: investigators document what people said, what they did, how they interacted within a given setting.
3.2 Study location The target population for both phases will be the general resident population of two to three districts in Nam Dinh Province, covering 64 rural communes. Investigators at the National Institute for Hygiene and Epidemiology (NIHE), have longstanding connections and experience of working with communities in this region and will take the lead in developing relationships with Provincial representatives.
3.3 Communities and study participants Engagement with communities will be run through Women's Union and Farmers' Union groups. The Women's Union is a national organisation promoting the health and wellbeing of women and families in Vietnam, and has widespread coverage and membership at community-level. Women's Union groups are run by paid representatives and meet regularly. The Farmers' Union is also a national organisation that promotes good farming practices. Farmers' Union groups are also run by paid representatives and meet regularly. During the strategy development phase of group activities, groups will be encouraged to invite local stakeholders to participate, including community healthcare workers, primary healthcare workers, animal healthcare workers, and pharmacists.
3.4 Commune health centres Commune health centres (CHCs) deliver most primary care services and national targeted health programmes to the population, especially in rural and mountainous areas including hygiene, vaccinations, antenatal care, safe delivery and health education. Screening examination, treatment and referrals for CHC attendees are also provided. Regarding coverage of commune health network in Vietnam, 99% of communes have a health centre, 70% have a doctor; and 79.3% provide traditional medicine services13.
Oxford University Clinical Research Unit, Vietnam is the lead sponsor of 37 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
For communities:
Inclusion criteria:
Exclusion criteria:
For study participants:
Inclusion criteria:
Exclusion criteria:
For Commune Health Centers:
Inclusion criteria:
Exclusion criteria:
For Patient records:
Inclusion criteria:
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
For commune health center and community
For commune health center and community
Other: Basic antimicrobial stewardship education
For commune health center and community
Other: Basic antimicrobial stewardship education · Other: Community education
For commune health center and community
Other: Basic antimicrobial stewardship education · Other: Participatory action research group in commune health center and community · Other: Community education
For hospital: The hospital interventions will use quality improvement using a participatory action research approach to improve antibiotic stewardship. These activities will be evaluated through a before and after knowledge, attitudes and practice (KAP) survey, to assess whether or not the engagement activities had a measurable impact on knowledge and behaviour. There are not sufficient hospitals in the area to conduct a cluster randomized evaluation, so we will conduct a before and after survey, patient record review, and overall antibiotic use data from the Pharmacy Department
Other: Antimicrobial stewardship program in hospitals
Commune health center: Revision of guidelines for antibiotic prescribing for respiratory infections in primary care, Training primary healthcare doctors in the application of the new guidelines
* Establish a participatory action research group * Engagement with the group through participatory action research involving problem identification, planning change strategies, implementing strategies, and evaluation
The intervention activities in hospitals will include: training a health-worker in each of the participating hospitals to act as a facilitator or "activator"; forming an antibiotic stewardship group; meeting regularly and following an action-research cycle that includes problem identification, planning change strategies, implementing strategies, and evaluating strategies
Development of educational materials for the community and farmers; Disseminated of messages through posters, leaflets and local media channels
Community: Proportion of the population reporting antibiotic use in the last month
Time frame: After the last interview/survey, up to 18 months since study implementation
Community: Proportion of the population with a mild respiratory illness in the last month who didn't seek medical consultation and treatment (at a health facility or a pharmacy)
Time frame: After the last interview/survey, up to 18 months since study implementation
Community: Proportion of farmers reporting antibiotic use for their animals in the last month
Time frame: After the last interview/survey, up to 18 months since study implementation
Primary healthcare: Proportion of patients aged 1 to 65 years, consulting for ARI, who are prescribed antibiotics
Time frame: After the last interview/survey, up to 18 months since study implementation
Primary healthcare: Proportion of the population reporting antibiotic use in the last month
Time frame: After the last interview/survey, up to 18 months since study implementation
Hospital: Proportion of patients receiving antibiotic treatment in the three months preceding the survey
Time frame: After the last interview/survey, up to 18 months since study implementation
Community: Proportion of the population who have heard about antibiotic resistance
Time frame: After the last interview/survey, up to 18 months since study implementation
Community: Proportion of the population who can correctly define antibiotic resistance (from a list of options)
Time frame: After the last interview/survey, up to 18 months since study implementation
Community: Proportion of the population who can correctly identify at least two human health behaviours that can lead to antibiotic resistance (from a list of options)
Time frame: After the last interview/survey, up to 18 months since study implementation
Community: Average number of days of illness in the last month
Time frame: After the last interview/survey, up to 18 months since study implementation
Community: Average number of days unable to do usual activities due to illness (e.g. absent from school/work/farm work) in the last month
Time frame: After the last interview/survey, up to 18 months since study implementation
Community: Proportion of farmers who can correctly identify at least two farming behaviours that can lead to antibiotic resistance (from a list of options)
Time frame: After the last interview/survey, up to 18 months since study implementation
Primary healthcare: The proportion of patients that consulted with ARI in the preceding year
Time frame: After the last interview/survey, up to 18 months since study implementation
Primary healthcare: Prescription rates for ARI patients in the preceding year
Time frame: After the last interview/survey, up to 18 months since study implementation
Primary healthcare: Proportion of patients receiving an antibiotic with the denominator being
Time frame: After the last interview/survey, up to 18 months since study implementation
Primary healthcare: Proportion of patients receiving an antibiotic prescription by diagnosis, age, season, recorded fever, sex
Time frame: After the last interview/survey, up to 18 months since study implementation
Primary healthcare: The proportion of patients referred to a higher-level facility at the initial consultation by checking the e-database of health insurance (HI) reimbursement
Time frame: After the last interview/survey, up to 18 months since study implementation
Hospital: Changes in knowledge and perceptions pf doctors in the month before the intervention starts, and the last month of intervention implementation
Based on a knowledge, attitude and practice survey.
Time frame: After the last interview/survey, up to 18 months since study implementation
Hospital: Proportion of patients receiving appropriate antibiotic treatment in the three months preceding the survey (Days of Therapy)
Time frame: After the last interview/survey, up to 18 months since study implementation
Hospital: Number and proportion of patients whose antibiotic therapy was reviewed with feedback to the treating doctor by the stewardship team per month
Time frame: After the last interview/survey, up to 18 months since study implementation
Hospital: Proportion of patients who had samples taken for culture before antibiotic initiation (where available)
Time frame: After the last interview/survey, up to 18 months since study implementation
Hospital: Proportion of patients who received targeted antibiotic groups as empiric or culture adjusted therapy
Time frame: After the last interview/survey, up to 18 months since study implementation
Hospital: Proportion of patients who had de-escalation after culture results were available
Time frame: After the last interview/survey, up to 18 months since study implementation
Hospital: Proportion of patients who received appropriate antibiotic therapy after culture results were available
Time frame: After the last interview/survey, up to 18 months since study implementation
Hospital: Count and proportion of resistant isolates for priority antibiotic-organism combinations (where available)
Time frame: After the last interview/survey, up to 18 months since study implementation
Hospital: Cost of antibiotic treatment (Total monthly cost by department)
Time frame: After the last interview/survey, up to 18 months since study implementation
Hospital: Cost of antibiotic treatment (Average cost per patient)
Time frame: After the last interview/survey, up to 18 months since study implementation
Hospital: In-hospital mortality (Departmental wide)
Time frame: After the last interview/survey, up to 18 months since study implementation
Hospital: In-hospital mortality (Patients receiving antibiotics)
Time frame: After the last interview/survey, up to 18 months since study implementation
Hospital: Hospital length of stay
Time frame: After the last interview/survey, up to 18 months since study implementation
The number of meetings that subject participates in Participatory Action Group 's meetings
Time frame: After the last interview/survey, up to 18 months since study implementation
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Oxford University Clinical Research Unit, Vietnam