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Antibiotic UseNCT04358289

Generating Collective Solutions to Reduce Unnecessary Antibiotic Use in Vietnam

A study testing Basic antimicrobial stewardship education, Participatory action research group in commune health center and community and Antimicrobial stewardship program in hospitals in people with Antibiotic Use, run by Oxford University Clinical Research Unit, Vietnam at 1 site in Vietnam.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Antibiotic Use
What is being tested?
Basic antimicrobial stewardship education, Participatory action research group in commune health center and community and Antimicrobial stewardship program in hospitals
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,315 participants
Where
1 siteVietnam
Study dates
27 Feb 2020to Sep 2026
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 Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Commune officials consent to take part;
  • Have a commune population larger than 3000 individuals;
  • Have active Women's Union and Farmers' Union groups with a paid commune-level representative;
  • Commune health centre has a doctor;
  • Commune health centre has electronic database.
  • Participant is willing and able to give informed consent for participation in the study;
Show all 11Show fewer
  • Community members normally resident in the study commune (living in the study commune and resident for at least three months);
  • Serve a commune population larger than 3000 individuals;
  • Have an average caseload of at least 10 consultations per facility per week for ARI verified by checking the database system of the provincial centre for disease control and prevention (CDC) where the implementation study is being conducted;
  • Health centre doctor is normally employed at the centre and has been there for at least three months.
  • All patients' anonymised records.

Who cannot join

  • Urban areas with a low proportion of farmers or low utilisation of CHCs for primary healthcare.
  • For study participants:
  • No one will be actively excluded from participating in this population-based study.
  • For Commune Health Centers:
  • Low antibiotic prescription rate for ARI of below 40%.
  • For Patient records:
  • Don't have national health insurance/not recorded.

Trial locations and contacts

1 site in 1 country.

Sonia Lewycka, Doctor contact

0868140261

slewycka@oucru.org

Vietnam1 site, 1 recruiting
  • Nam Dinh province

    Nam Định, 07000

    Thai Q. Pham, Doctor, 0913092777, pqt@nihe.org.vn

    Recruiting

Other trials in Vietnam

About this study

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.

Read the detailed description
  1. 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?
  2. OBJECTIVES 2.1 Community interventions: to evaluate the impact of educational and participatory action research interventions in communities on the proportion of the population reporting antibiotic use in the last month 2.2 Primary healthcare interventions: to evaluate the impact of antibiotic stewardship training and participatory action research interventions on the proportion of patients with ARI prescribed an antibiotic in routine primary health care 2.3 Hospital interventions: to evaluate the impact of quality improvement using a participatory action research approach on antibiotic stewardship and the proportion of patients receiving antibiotic treatment 2.4 Qualitative evaluation: to understand community processes and engagement with behaviour change interventions
  3. STUDY DESIGN 3.1 Design 3.1.1 and 3.1.2 Community and primary healthcare interventions: The community and primary healthcare interventions will be evaluated together through a four-armed cluster-randomised controlled trial design, consisting of 16 communes in each arm, with interventions delivered either at the commune health centre, the community, or both. The goal of the evaluation is to assess whether or not the community and primary healthcare interventions had a measurable impact on knowledge and behaviour. Each of the three intervention arms will be done in 16 communes, and the investigators will select a further 16 communes as controls, where there will be no intervention activities. At the beginning of the project, the investigators will randomly allocate 64 communes to receive one of the three interventions or no intervention.

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.

Conditions
Antibiotic Use
Being tested
Basic antimicrobial stewardship education, Participatory action research group in commune health center and community, Antimicrobial stewardship program in hospitals, Community education
Keywords
AMR, primary health care, Antimicrobial resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Basic antimicrobial stewardship educationOther

    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

  • Participatory action research group in commune health center and communityOther

    • Establish a participatory action research group
    • Engagement with the group through participatory action research involving problem identification, planning change strategies, implementing strategies, and evaluation
  • Antimicrobial stewardship program in hospitalsOther

    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

  • Community educationOther

    Development of educational materials for the community and farmers; Disseminated of messages through posters, leaflets and local media channels

Study groups in NCT04358289
Study groupRoleWhat they receive
Arm 1: Control groupNo interventionFor commune health center and community
Arm 2: Basic antimicrobial stewardship educationOtherFor commune health center and community
Receives: Other: Basic antimicrobial stewardship education
Arm 3: 3. Basic AS education + community educationOtherFor commune health center and community
Receives: Other: Basic antimicrobial stewardship education; Other: Community education
Arm 4: Education + participatory action researchOtherFor commune health center and community
Receives: Other: Basic antimicrobial stewardship education; Other: Participatory action research group in commune health center and community; Other: Community education
Hospital interventionOtherFor 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
Receives: Other: Antimicrobial stewardship program in hospitals

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Community: Proportion of the population reporting antibiotic use in the last month

    Measured: After the last interview/survey, up to 18 months since study implementation

  2. 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)

    Measured: After the last interview/survey, up to 18 months since study implementation

  3. Community: Proportion of farmers reporting antibiotic use for their animals in the last month

    Measured: After the last interview/survey, up to 18 months since study implementation

  4. Primary healthcare: Proportion of patients aged 1 to 65 years, consulting for ARI, who are prescribed antibiotics

    Measured: After the last interview/survey, up to 18 months since study implementation

  5. Primary healthcare: Proportion of the population reporting antibiotic use in the last month

    Measured: After the last interview/survey, up to 18 months since study implementation

  6. Hospital: Proportion of patients receiving antibiotic treatment in the three months preceding the survey

    Measured: After the last interview/survey, up to 18 months since study implementation

Secondary outcomes (25)
  1. Community: Proportion of the population who have heard about antibiotic resistance

    Measured: After the last interview/survey, up to 18 months since study implementation

  2. Community: Proportion of the population who can correctly define antibiotic resistance (from a list of options)

    Measured: After the last interview/survey, up to 18 months since study implementation

  3. 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)

    Measured: After the last interview/survey, up to 18 months since study implementation

  4. Community: Average number of days of illness in the last month

    Measured: After the last interview/survey, up to 18 months since study implementation

  5. 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

    Measured: After the last interview/survey, up to 18 months since study implementation

  6. Community: Proportion of farmers who can correctly identify at least two farming behaviours that can lead to antibiotic resistance (from a list of options)

    Measured: After the last interview/survey, up to 18 months since study implementation

  7. Primary healthcare: The proportion of patients that consulted with ARI in the preceding year

    Measured: After the last interview/survey, up to 18 months since study implementation

  8. Primary healthcare: Prescription rates for ARI patients in the preceding year

    Measured: After the last interview/survey, up to 18 months since study implementation

  9. Primary healthcare: Proportion of patients receiving an antibiotic with the denominator being

    Measured: After the last interview/survey, up to 18 months since study implementation

  10. Primary healthcare: Proportion of patients receiving an antibiotic prescription by diagnosis, age, season, recorded fever, sex

    Measured: After the last interview/survey, up to 18 months since study implementation

  11. 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

    Measured: After the last interview/survey, up to 18 months since study implementation

  12. 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.

    Measured: After the last interview/survey, up to 18 months since study implementation

  13. Hospital: Proportion of patients receiving appropriate antibiotic treatment in the three months preceding the survey (Days of Therapy)

    Measured: After the last interview/survey, up to 18 months since study implementation

  14. Hospital: Number and proportion of patients whose antibiotic therapy was reviewed with feedback to the treating doctor by the stewardship team per month

    Measured: After the last interview/survey, up to 18 months since study implementation

  15. Hospital: Proportion of patients who had samples taken for culture before antibiotic initiation (where available)

    Measured: After the last interview/survey, up to 18 months since study implementation

  16. Hospital: Proportion of patients who received targeted antibiotic groups as empiric or culture adjusted therapy

    Measured: After the last interview/survey, up to 18 months since study implementation

  17. Hospital: Proportion of patients who had de-escalation after culture results were available

    Measured: After the last interview/survey, up to 18 months since study implementation

  18. Hospital: Proportion of patients who received appropriate antibiotic therapy after culture results were available

    Measured: After the last interview/survey, up to 18 months since study implementation

  19. Hospital: Count and proportion of resistant isolates for priority antibiotic-organism combinations (where available)

    Measured: After the last interview/survey, up to 18 months since study implementation

  20. Hospital: Cost of antibiotic treatment (Total monthly cost by department)

    Measured: After the last interview/survey, up to 18 months since study implementation

  21. Hospital: Cost of antibiotic treatment (Average cost per patient)

    Measured: After the last interview/survey, up to 18 months since study implementation

  22. Hospital: In-hospital mortality (Departmental wide)

    Measured: After the last interview/survey, up to 18 months since study implementation

  23. Hospital: In-hospital mortality (Patients receiving antibiotics)

    Measured: After the last interview/survey, up to 18 months since study implementation

  24. Hospital: Hospital length of stay

    Measured: After the last interview/survey, up to 18 months since study implementation

  25. The number of meetings that subject participates in Participatory Action Group 's meetings

    Measured: After the last interview/survey, up to 18 months since study implementation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2020
  2. Study start27 Feb 2020
  3. Primary completionSep 2026 (estimated)
  4. Study completionSep 2026 (estimated)

Resources

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
None (open label)
Enrolment
3,315 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04358289
Sponsor's protocol ID
30HN
Status last verified
Dec 2023
First submitted
3 Apr 2020
Last updated
6 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Basic antimicrobial stewardship education, Participatory action research group in commune health center and community and Antimicrobial stewardship program in hospitals in people with Antibiotic Use, run by Oxford University Clinical Research Unit, Vietnam at 1 site in Vietnam.

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 11 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 6 Dec 2023. 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 Vietnam. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Sonia Lewycka, Doctor (0868140261, slewycka@oucru.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 6 Dec 2023.

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