title: Effective Feedback to Improve Primary Care Prescribing Safety (EFIPPS) a pragmatic three-arm cluster randomised trial: designing the intervention (ClinicalTrials.gov registration NCT01602705).
abstract: BACKGROUND
  High-risk prescribing in primary care is common and causes considerable harm. Feedback interventions have small/moderate effects on clinical practice, but few trials explicitly compare different forms of feedback. There is growing recognition that intervention development should be theory-informed, and that comprehensive reporting of intervention design is required by potential users of trial findings. The paper describes intervention development for the Effective Feedback to Improve Primary Care Prescribing Safety (EFIPPS) study, a pragmatic three-arm cluster randomised trial in 262 Scottish general practices.
  
  
  METHODS
  The NHS chose to implement a feedback intervention to utilise a new resource, new Prescribing Information System (newPIS). The development phase required selection of high-risk prescribing outcome measures and design of intervention components: (1) educational material (the usual care comparison), (2) feedback of practice rates of high-risk prescribing received by both intervention arms and (3) a theory-informed behaviour change component to be received by one intervention arm. Outcome measures, educational material and feedback design, were developed with a National Health Service Advisory Group. The behaviour change component was informed by the Theory of Planned Behaviour and the Health Action Process Approach. A focus group elicitation study and an email Delphi study with general practitioners (GPs) identified key attitudes and barriers of responding to the prescribing feedback. Behaviour change techniques were mapped to the psychological constructs, and the content was informed by the results of the elicitation and Delphi study.
  
  
  RESULTS
  Six high-risk prescribing measures were selected in a consensus process based on importance and feasibility. Educational material and feedback design were based on current NHS Scotland practice and Advisory Group recommendations. The behaviour change component was resource constrained in development, mirroring what is feasible in an NHS context. Four behaviour change interventions were developed and embedded in five quarterly rounds of feedback targeting attitudes, subjective norms, perceived behavioural control and action planning (2×).
  
  
  CONCLUSIONS
  The paper describes a process which is feasible to use in the resource-constrained environment of NHS-led intervention development and documents the intervention to make its design and implementation explicit to potential users of the trial findings.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT01602705.
authors.affiliation: Centre of Population Health Sciences, University of Edinburgh Medical Quad, Teviot Place EH8 9AG, Edinburgh, UK. Karen.barnett@ed.ac.uk.
authors.forename: Karen N
authors.initials: KN
authors.lastname: Barnett
authors.forename: Marion
authors.initials: M
authors.lastname: Bennie
authors.forename: Shaun
authors.initials: S
authors.lastname: Treweek
authors.forename: Christopher
authors.initials: C
authors.lastname: Robertson
authors.forename: Dennis J
authors.initials: DJ
authors.lastname: Petrie
authors.forename: Lewis D
authors.initials: LD
authors.lastname: Ritchie
authors.forename: Bruce
authors.initials: B
authors.lastname: Guthrie
mesh_terms: D003697:Delphi Technique; D011307:Drug Prescriptions / Q000592:standards*; D004502:Education, Medical, Continuing / Q000379:methods; D005246:Feedback; D017144:Focus Groups; D006801:Humans; D061214:Patient Safety; D011320:Primary Health Care / Q000379:methods* / Q000592:standards; D058996:Quality Improvement; D013222:State Medicine; D011795:Surveys and Questionnaires