title: Multimethod study of a large-scale programme to improve patient safety using a harm-free care approach.
abstract: OBJECTIVE
  We aimed to evaluate whether a large-scale two-phase quality improvement programme achieved its aims and to characterise the influences on achievement.
  
  
  METHODS
  National Health Service (NHS) in England.
  
  
  METHODS
  NHS staff.
  
  
  METHODS
  The programme sought to (1) develop a shared national, regional and locally aligned safety focus for 4 high-cost, high volume harms; (2) establish a new measurement system based on a composite measure of 'harm-free' care and (3) deliver improved outcomes. Phase I involved a quality improvement collaborative intended to involve 100 organisations; phase II used financial incentives for data collection.
  
  
  METHODS
  Multimethod evaluation of the programme. In phase I, analysis of regional plans and of rates of data submission and clinical outcomes reported to the programme. A concurrent process evaluation was conducted of phase I, but only data on submission rates and clinical outcomes were available for phase II.
  
  
  RESULTS
  A context of extreme policy-related structural turbulence impacted strongly on phase I. Most regions' plans did not demonstrate full alignment with the national programme; most fell short of recruitment targets and attrition in attendance at the collaborative meetings occurred over time. Though collaborative participants saw the principles underlying the programme as attractive, useful and innovative, they often struggled to convert enthusiasm into change. Developing the measurement system was arduous, yet continued to be met by controversy. Data submission rates remained patchy throughout phase I but improved in reach and consistency in phase II in response to financial incentives. Some evidence of improvement in clinical outcomes over time could be detected but was hard to interpret owing to variability in the denominators.
  
  
  CONCLUSIONS
  These findings offer important lessons for large-scale improvement programmes, particularly when they seek to develop novel concepts and measures. External contexts may exert far-reaching influence. The challenges of developing measurement systems should not be underestimated.
authors.affiliation: HAELO, Salford Royal NHS Foundation Trust, Salford, UK.
authors.forename: Maxine
authors.initials: M
authors.lastname: Power
authors.affiliation: Faculty of Health and Medicine, Lancaster Medical School, Lancaster University, Lancaster, UK.
authors.forename: Liz
authors.initials: L
authors.lastname: Brewster
authors.affiliation: Institute for Healthcare Improvement, Cambridge, Massachusetts, USA.
authors.forename: Gareth
authors.initials: G
authors.lastname: Parry
authors.affiliation: HAELO, Salford Royal NHS Foundation Trust, Salford, UK.
authors.forename: Ailsa
authors.initials: A
authors.lastname: Brotherton
authors.affiliation: Data to Knowledge Group, School of Social and Community Medicine, University of Bristol, Bristol, UK.
authors.forename: Joel
authors.initials: J
authors.lastname: Minion
authors.affiliation: Department of Social and Policy Sciences, University of Bath, Bath, UK.
authors.forename: Piotr
authors.initials: P
authors.lastname: Ozieranski
authors.affiliation: Education and Social Research Institute, Manchester Metropolitan University, Crewe, UK.
authors.forename: Sarah
authors.initials: S
authors.lastname: McNicol
authors.affiliation: HAELO, Salford Royal NHS Foundation Trust, Salford, UK.
authors.forename: Abigail
authors.initials: A
authors.lastname: Harrison
authors.affiliation: Cambridge Centre for Health Services Research, University of Cambridge School of Clinical Medicine, Cambridge, UK.
authors.forename: Mary
authors.initials: M
authors.lastname: Dixon-Woods
keywords: improvement programmes; measurement; mixed-methods; patient safety; quality improvement collaboratives