title: Goal-setting intervention in patients with active asthma: protocol for a pilot cluster-randomised controlled trial.
abstract: BACKGROUND
  Supporting self-management behaviours is recommended guidance for people with asthma. Preliminary work suggests that a brief, intensive, patient-centred intervention may be successful in supporting people with asthma to participate in life roles and activities they value. We seek to assess the feasibility of undertaking a cluster-randomised controlled trial (cRCT) of a brief, goal-setting intervention delivered in the context of an asthma review consultation.
  
  
  METHODS
  A two armed, single-blinded, multi-centre, cluster-randomised controlled feasibility trial will be conducted in UK primary care. Randomisation will take place at the practice level. We aim to recruit a total of 80 primary care patients with active asthma from at least eight practices across two health boards in Scotland (10 patients per practice resulting in ~40 in each arm). Patients in the intervention arm will be asked to complete a novel goal-setting tool immediately prior to an asthma review consultation. This will be used to underpin a focussed discussion about their goals during the asthma review. A tailored management plan will then be negotiated to facilitate achieving their prioritised goals. Patients in the control arm will receive a usual care guideline-based review of asthma. Data on quality of life, asthma control and patient confidence will be collected from both arms at baseline and 3 and 6 months post-intervention. Data on health services resource use will be collected from all patient records 6 months pre- and post-intervention. Semi-structured interviews will be carried out with healthcare staff and a purposive sample of patients to elicit their views and experiences of the trial. The outcomes of interest in this feasibility trial are the ability to recruit patients and healthcare staff, the optimal method of delivering the intervention within routine clinical practice, and acceptability and perceived utility of the intervention among patients and staff.
  
  
  BACKGROUND
  ISRCTN18912042.
authors.affiliation: Nursing, Midwifery and Allied Health Professionals Research Unit, University of Stirling, Unit 13 Scion House, Stirling University Innovation Park, Stirling, Scotland FK9 4NF, UK. gaylor.hoskins@stir.ac.uk.
authors.forename: Gaylor
authors.initials: G
authors.lastname: Hoskins
authors.forename: Purva
authors.initials: P
authors.lastname: Abhyankar
authors.forename: Anne D
authors.initials: AD
authors.lastname: Taylor
authors.forename: Edward
authors.initials: E
authors.lastname: Duncan
authors.forename: Aziz
authors.initials: A
authors.lastname: Sheikh
authors.forename: Hilary
authors.initials: H
authors.lastname: Pinnock
authors.forename: Marjon
authors.initials: M
authors.lastname: van der Pol
authors.forename: Peter T
authors.initials: PT
authors.lastname: Donnan
authors.forename: Brian
authors.initials: B
authors.lastname: Williams
mesh_terms: D001249:Asthma / Q000175:diagnosis / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D002985:Clinical Protocols; D017281:Cost of Illness; D005240:Feasibility Studies; D006040:Goals; D015438:Health Behavior; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D018802:Patient-Centered Care; D010865:Pilot Projects; D011320:Primary Health Care; D011788:Quality of Life; D012017:Referral and Consultation; D012107:Research Design; D012606:Scotland; D012648:Self Care; D016037:Single-Blind Method; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome
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