title: Study protocol: improving patient choice in treating low back pain (IMPACT-LBP): a randomised controlled trial of a decision support package for use in physical therapy.
abstract: BACKGROUND
  Low back pain is a common and costly condition. There are several treatment options for people suffering from back pain, but there are few data on how to improve patients' treatment choices. This study will test the effects of a decision support package (DSP), designed to help patients seeking care for back pain to make better, more informed choices about their treatment within a physiotherapy department. The package will be designed to assist both therapist and patient.
  
  
  METHODS
  Firstly, in collaboration with physiotherapists, patients and experts in the field of decision support and decision aids, we will develop the DSP. The work will include: a literature and evidence review; secondary analysis of existing qualitative data; exploration of patients' perspectives through focus groups and exploration of experts' perspectives using a nominal group technique and a Delphi study.Secondly, we will carry out a pilot single centre randomised controlled trial within NHS Coventry Community Physiotherapy. We will randomise physiotherapists to receive either training for the DSP or not. We will randomly allocate patients seeking treatment for non specific low back pain to either a physiotherapist trained in decision support or to receive usual care. Our primary outcome measure will be patient satisfaction with treatment at three month follow-up. We will also estimate the cost-effectiveness of the intervention, and assess the value of conducting further research.
  
  
  CONCLUSIONS
  Informed shared decision-making should be an important part of any clinical consultation, particularly when there are several treatments, which potentially have moderate effects. The results of this pilot will help us determine the benefits of improving the decision-making process in clinical practice on patient satisfaction.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN46035546.
authors.affiliation: University of Warwick, Clinical Trials Unit, Warwick Medical School, Gibbet Hill Road, Coventry CV47AL, UK. shilpa.patel@warwick.ac.uk
authors.forename: Shilpa
authors.initials: S
authors.lastname: Patel
authors.forename: Sally
authors.initials: S
authors.lastname: Brown
authors.forename: Tim
authors.initials: T
authors.lastname: Friede
authors.forename: Frances
authors.initials: F
authors.lastname: Griffiths
authors.forename: Joanne
authors.initials: J
authors.lastname: Lord
authors.forename: Anne
authors.initials: A
authors.lastname: Ngunjiri
authors.forename: Jill
authors.initials: J
authors.lastname: Thistlethwaite
authors.forename: Colin
authors.initials: C
authors.lastname: Tysall
authors.forename: Mark
authors.initials: M
authors.lastname: Woolvine
authors.forename: Martin
authors.initials: M
authors.lastname: Underwood
mesh_terms: D002755:Choice Behavior; D003362:Cost-Benefit Analysis; D020000:Decision Support Systems, Clinical / Q000191:economics; D006801:Humans; D017116:Low Back Pain / Q000628:therapy*; D017063:Outcome Assessment, Health Care; D010358:Patient Participation / Q000639:trends*; D017060:Patient Satisfaction; D026741:Physical Therapy Modalities; D010865:Pilot Projects; D016896:Treatment Outcome