Generating Collective Solutions to Reduce Unnecessary Antibiotic Use in Vietnam

NCT04358289 | Recruiting

• 1 other identifier: 30HN
• Study Type: interventional
• Target: 3,315
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Antibiotic Use

Keywords

AMR; primary health care; Antimicrobial resistance

Outcome Measures

Primary Outcomes (6)

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

  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)

  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

  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

  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

  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

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

Secondary Outcomes (25)

• Community: Proportion of the population who have heard about antibiotic resistance

  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)

  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)

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

• Community: Average number of days of illness in the last month

  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

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

Study Arms (5)

Arm 1: Control group

NO INTERVENTION

For commune health center and community

Arm 2: Basic antimicrobial stewardship education

OTHER

For commune health center and community

Other: Basic antimicrobial stewardship education

Arm 3: 3. Basic AS education + community education

OTHER

For commune health center and community

Other: Basic antimicrobial stewardship education; Other: Community education

Arm 4: Education + participatory action research

OTHER

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

Hospital intervention

OTHER

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

Interventions

Basic antimicrobial stewardship education OTHER

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

Arm 2: Basic antimicrobial stewardship education; Arm 3: 3. Basic AS education + community education; Arm 4: Education + participatory action research

Participatory action research group in commune health center and community OTHER

* Establish a participatory action research group * Engagement with the group through participatory action research involving problem identification, planning change strategies, implementing strategies, and evaluation

Arm 4: Education + participatory action research

Antimicrobial stewardship program in hospitals OTHER

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

Hospital intervention

Community education OTHER

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

Arm 3: 3. Basic AS education + community education; Arm 4: Education + participatory action research

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Urban areas with a low proportion of farmers or low utilisation of CHCs for primary healthcare.
• For study participants:
• Participant is willing and able to give informed consent for participation in the study;
• Community members normally resident in the study commune (living in the study commune and resident for at least three months);
• No one will be actively excluded from participating in this population-based study.
• For Commune Health Centers:
• 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.
• Low antibiotic prescription rate for ARI of below 40%.
• For Patient records:
• All patients' anonymised records.
• Don't have national health insurance/not recorded.

Sponsors & Collaborators

• Oxford University Clinical Research Unit, Vietnam: lead
• National Institute of Hygiene and Epidemiology, Vietnam: collaborator

Study Sites (1)

Nam Dinh province

Nam Định, 07000, Vietnam

RECRUITING

MeSH Terms

Interventions

Residence Characteristics; Hospitals

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics; Epidemiologic Measurements; Public Health; Environment and Public Health; Health Facilities; Health Care Facilities Workforce and Services

Central Study Contacts

Sonia Lewycka, Doctor

CONTACT

0868140261; slewycka@oucru.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2020
• First Posted: April 24, 2020
• Study Start: February 27, 2020
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: December 6, 2023

Record last verified: 2023-12

Locations

VN (1)