title: Protocol for the process evaluation of a complex intervention designed to increase the use of research in health policy and program organisations (the SPIRIT study).
abstract: BACKGROUND
  Process evaluation is vital for understanding how interventions function in different settings, including if and why they have different effects or do not work at all. This is particularly important in trials of complex interventions in 'real world' organisational settings where causality is difficult to determine. Complexity presents challenges for process evaluation, and process evaluations that tackle complexity are rarely reported. This paper presents the detailed protocol for a process evaluation embedded in a randomised trial of a complex intervention known as SPIRIT (Supporting Policy In health with Research: an Intervention Trial). SPIRIT aims to build capacity for using research in health policy and program agencies.
  
  
  METHODS
  We describe the flexible and pragmatic methods used for capturing, managing and analysing data across three domains: (a) the intervention as it was implemented; (b) how people participated in and responded to the intervention; and (c) the contextual characteristics that mediated this relationship and may influence outcomes. Qualitative and quantitative data collection methods include purposively sampled semi-structured interviews at two time points, direct observation and coding of intervention activities, and participant feedback forms. We provide examples of the data collection and data management tools developed.
  
  
  CONCLUSIONS
  This protocol provides a worked example of how to embed process evaluation in the design and evaluation of a complex intervention trial. It tackles complexity in the intervention and its implementation settings. To our knowledge, it is the only detailed example of the methods for a process evaluation of an intervention conducted as part of a randomised trial in policy organisations. We identify strengths and weaknesses, and discuss how the methods are functioning during early implementation. Using 'insider' consultation to develop methods is enabling us to optimise data collection while minimising discomfort and burden for participants. Embedding the process evaluation within the trial design is facilitating access to data, but may impair participants' willingness to talk openly in interviews. While it is challenging to evaluate the process of conducting a randomised trial of a complex intervention, our experience so far suggests that it is feasible and can add considerably to the knowledge generated.
authors.affiliation: Sax Institute, 235 Jones Street, Ultimo 2007, NSW, Australia. abby.haynes@saxinstitute.org.au.
authors.forename: Abby
authors.initials: A
authors.lastname: Haynes
authors.forename: Sue
authors.initials: S
authors.lastname: Brennan
authors.forename: Stacy
authors.initials: S
authors.lastname: Carter
authors.forename: Denise
authors.initials: D
authors.lastname: O'Connor
authors.forename: Carmen Huckel
authors.initials: CH
authors.lastname: Schneider
authors.forename: Tari
authors.initials: T
authors.lastname: Turner
authors.forename: Gisselle
authors.initials: G
authors.lastname: Gallego
mesh_terms: D003625:Data Collection / Q000379:methods; D004282:Documentation; D006077:Government Agencies / Q000458:organization & administration; D006284:Health Plan Implementation / Q000458:organization & administration*; D006291:Health Policy; D006302:Health Services Research / Q000706:statistics & numerical data*; D006801:Humans; D009517:New South Wales; D017064:Process Assessment, Health Care / Q000458:organization & administration*; D016032:Randomized Controlled Trials as Topic