title: Promoting Recruitment using Information Management Efficiently (PRIME): statistical analysis plan for a stepped wedge cluster randomised trial within the REstart or STop Antithrombotics Randomised Trial (RESTART).
abstract: Promoting Recruitment using Information Management Efficiently (PRIME) is a stepped wedge, cluster randomised trial-within-a-trial of a complex intervention to help sites in the United Kingdom to attain their own target number of participants to recruit to the REstart or STop Antithrombotics Randomised Trial (RESTART, ISRCTN71907627).
  
  
  
  Seventy-two hospital sites had opted into PRIME and were randomly allocated (using a computer-generated block randomisation algorithm, stratified by hospital location) to one of 12 months in which a complex intervention would be delivered. All sites began in the control state. The primary outcome is the total number of patients randomised into RESTART per month per site, which will be analysed in a negative binomial generalised linear mixed model. Secondary outcomes include the proportion of sites using stroke databases to identify potentially eligible patients before PRIME, frequency of using bespoke stroke audit data exports during PRIME, barriers to recruitment in PRIME, barriers to using the bespoke stroke audit data exports, and disadvantages of the bespoke stroke audit exports identified by PRIME sites. PRIME began in September 2015. The last intervention will be delivered in August 2016. Six-month follow-up will be complete in February 2017. This statistical analysis plan was written and submitted for publication before all sites received the PRIME intervention and before outcome data were known.
  
  
  
  Final results of PRIME will be analysed and disseminated in 2017.
  
  
  
  Northern Ireland Hub for Trials Methodology Research SWAT repository (SWAT22).
authors.affiliation: Edinburgh Clinical Trials Unit and Centre for Population Health Sciences, Usher Institute of Population Health Sciences and Informatics, Old Medical School, Teviot Place, Edinburgh, UK. Richard.Parker@ed.ac.uk.
authors.forename: Richard A
authors.initials: RA
authors.lastname: Parker
authors.affiliation: Edinburgh Clinical Trials Unit and Centre for Population Health Sciences, Usher Institute of Population Health Sciences and Informatics, Old Medical School, Teviot Place, Edinburgh, UK.
authors.forename: Christopher J
authors.initials: CJ
authors.lastname: Weir
authors.affiliation: Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK.
authors.forename: Amy E
authors.initials: AE
authors.lastname: Maxwell
authors.affiliation: Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK.
authors.forename: Rustam
authors.initials: R
authors.lastname: Al-Shahi Salman
mesh_terms: D002543:Cerebral Hemorrhage / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control*; D002985:Clinical Protocols; D003627:Data Interpretation, Statistical; D004334:Drug Administration Schedule; D057286:Electronic Health Records / Q000706:statistics & numerical data; D005343:Fibrinolytic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D019451:Information Management / Q000706:statistics & numerical data; D015233:Models, Statistical; D018579:Patient Selection; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D012008:Recurrence; D012307:Risk Factors; D018401:Sample Size; D055502:Secondary Prevention / Q000379:methods* / Q000706:statistics & numerical data; D020521:Stroke / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control*; D013997:Time Factors; D016896:Treatment Outcome; D006113:United Kingdom
chemical_list: D005343:Fibrinolytic Agents; D010975:Platelet Aggregation Inhibitors
keywords: Cluster randomised trial; Complex intervention; Recruitment; Statistical analysis plan; Stepped wedge trial; Study-within-a-trial; Trial-within-a-trial