A mixed methods observational study to evaluate the implementation of a smartphone software application (App) and computerised decision-support system (CDSS) for antibiotic treatment guidelines in 50 NHS hospitals and to explore its potential impact on trends in antibiotic prescribing, resistance and inpatient clinical outcomes using interrupted time series analysis (The MicroGuide Study)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Mixed methods observational (survey & qualitative interviews, exploratory analysis of quantitative outcome variables)

Population studied

• Age groups:
  Preterm newborn infants (0 – 27 days)

  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)

  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  0

Study design details

• Main study objective:
  To explore whether there are changes in trends of antibiotic prescribing after implementation of the MicroGuide App.
• Data analysis plan:
  Quantitative variables will be analysed by comparison of trends during the two years before and two years after implementation of the App to identify statistically significant changes in slope and/or level, potentially associated with App implementation, using segmented regression analysis of interrupted time series (SRA-ITS). A meta-analysis of participating hospitals will be carried out by comparing relative changes in efficacy and safety variables at fixed time points of 6 months, 12 months and 24 months following App implementation.Qualitative interview data will be analysed by thematic analysis according to the methods described by Braun and Clarke.