Lao Anti-Microbial Prescribing Guidelines Mobile Phone Application (LAMPA)

NCT04914793 | Completed

• 1 other identifier: 541-20
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The overall aim of this study is to compare the proportion of antimicrobial prescriptions adherent with prescribing guidelines delivered by mobile phone application (app) versus paper-based prescribing guidelines in both in- and outpatients in six hospitals in Laos. This is an open cohort stepped-wedge cluster randomized controlled trial 3-step trial (4-month intervals at each step) with a 4-month pre-intervention period). The study conducts in six hospitals across Laos. This is 16 months-study. The intervention is a MicroGuide antimicrobial prescribing guideline mobile phone application and antimicrobial stewardship (AMS) training; whilst the reference is paper-based antimicrobial prescribing guidelines. The main outcome of interest is the proportion of antimicrobial prescriptions adherent with prescribing guidelines delivered by app-based versus paper-based prescribing guidelines at month 16 (12 months' exposure in each group). Outcome measurements are Point prevalence surveys (PPS) of hospital antimicrobial use, prescriber questionnaires and AMS knowledge survey of the prescribers. Simple random sampling will be used to select the order (step) of interventions implementation for a group of hospitals (two hospitals per group and one group per step). Neither hospitals nor investigators are blinded to the timing of intervention. Open Data Kit (ODK) system will be used as data collection instrument. All data will be kept securely, protected by password access with automatic daily backup. A logistic mixed-effects regression model will be used to compare the proportion of antimicrobial prescription adherence measured cross-sectionally at month 0, 4, 8, 12 and month 16 after introduction of prescribing guidelines delivered by mobile phone application versus paper-based. This study was approved by University of Health Sciences, Vientiane, Lao PDR and Oxford Tropical Ethics Committee (OxTREC), University of Oxford, United Kingdom.

Conditions

Infectious Disease

Keywords

Laos; antimicrobial Prescription; Antimicrobial used Guideline; Hospital; MicroGuide Mobile phone application

Outcome Measures

Primary Outcomes (1)

• Proportion of antimicrobial prescriptions adherent with prescribing guidelines

  Point prevalence surveys of hospital antimicrobial prescribing in both in- and outpatients (every 4 months until month 16)

  16 months (12 months' exposure in each group)

Secondary Outcomes (6)

• Antimicrobial defined daily doses (DDDs)

  16 months (12 months' exposure in each group)

• Proportion of antimicrobials oral administration

  16 months (12 months' exposure in each group)

• AMS knowledge level of prescribers

  16 months (12 months' exposure in each group)

• Prescriber satisfaction/acceptability of the prescribing guidelines

  16 months (12 months' exposure in each group)

• Total costs of antimicrobials prescribed

  16 months (12 months' exposure in each group)

Study Arms (2)

Reference phase

NO INTERVENTION

At the start (month 0), a point prevalence surveys (PPS) on hospital antimicrobial use are performed (more details on conduct of PPS are given in following section) to collect baseline data before introducing paper-based guidelines. All medical doctors of each participating hospital are asked to complete an AMS knowledge survey and pre-prescribing guidelines survey after PPS is conducted. Then, paper-based prescribing guidelines in both adult and paediatric versions (one adult guideline and one paediatric guideline) are distributed to all doctors at participating hospitals, followed by guideline introductory session of the guidelines. After introduction of the paper-based guidelines, all six hospitals are formally included in the reference period.

Intervention phase

EXPERIMENTAL

1. Antimicrobial Prescribing guidelines mobile phone application (MicroGuide) Both paediatric and adult antimicrobial prescribing guidelines are transferred to MicroGuide; which is a medical guideline application. MicroGuide is an offline application, free-of-charge for the individual users. The app can monitor the number of users and which guidelines are being accessed. The app is installed to the personal smart phones of local physicians by the PI. Both mobile app and paper guidelines will be available in Lao languages. 2. Antimicrobial stewardship (AMS) training AMS training sessions are given to prescribers in participating hospitals when they firstly enter to the intervention phase. This session is given alongside an introduction of mobile phone app prescribing guideline. The training focus on good practices of antimicrobial prescription. Providing training after introducing treatment guidelines is not routine practice in many hospitals in Laos.

Device: Antimicrobial prescribing guideline mobile phone application (MicroGuide)

Interventions

Antimicrobial prescribing guideline mobile phone application (MicroGuide) DEVICE

This session is given to all hospital doctors in all study hospitals at the start of the intervention period of each paired hospital. All participating hospitals will join AMS knowledge survey three times during the study period (1st time= at the start of the project, 2nd time= before entering to the intervention period and 3rd time= at the end of the project).

Also known as: Antimicrobial stewardship (AMS) training

Intervention phase

Eligibility Criteria

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

You may qualify if:

• Six hospitals have been purposively selected based on their capacity, location, previous participation in our PPS program with available hospital antimicrobial use and antimicrobial susceptibility data

Sponsors & Collaborators

• Lao-Oxford-Mahosot Hospital Wellcome Trust Research Unit: lead
• Mahidol Oxford Tropical Medicine Research Unit: collaborator

Study Sites (1)

Lao-Oxford-Mahosot Hospital-Wellcome Trust Research Unit (LOMWRU)

Vientiane, Vientaine, 0103, Laos

Location

MeSH Terms

Conditions

Communicable Diseases

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Vilada Chansamouth

  Lao-Oxford-Mahosot Hospital Wellcome Trust Research Unit

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: The study design is an open cohort stepped wedge cluster randomized controlled trial (SW-CRT) in six central/provincial hospitals across Laos. SW-CRT is appropriate in the Lao context because it requires fewer sites than a parallel cluster trial, but has similar observational periods for reference and intervention phases. As the interventions are delivered by one team travelling to each cluster in turn, implementing in stages is more practical. In addition, all participating hospitals have access to the novel interventions at the end of the study. Prescribers are allowed to move in and out of clusters during the trial.

Study Record Dates

• First Submitted: May 10, 2021
• First Posted: June 7, 2021
• Study Start: January 11, 2021
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: October 4, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

LA (1)