title: Intervention fidelity in primary care complex intervention trials: qualitative study using telephone interviews of patients and practitioners.
abstract: BACKGROUND
  Treatment fidelity has previously been defined as the degree to which a treatment or intervention is delivered to participants as intended. Underreporting of fidelity in primary care randomised controlled trials (RCTs) of complex interventions reduces our confidence that findings are due to the treatment or intervention being investigated, rather than unknown confounders.
  
  
  OBJECTIVE
  We aimed to investigate treatment fidelity (for the purpose of this paper, hereafter referred to as intervention fidelity), of an educational intervention delivered to general practice teams and designed to improve the primary care management of insomnia.
  
  
  METHODS
  We conducted telephone interviews with patients and practitioners participating in the intervention arm of the trial to explore trial fidelity. Qualitative analysis was undertaken using constant comparison and a priori themes (categories): 'adherence to the delivery of the intervention', 'patients received and understood intervention' and 'patient enactment'.
  
  
  RESULTS
  If the intervention protocol was not adhered to by the practitioner then patient receipt, understanding and enactment levels were reduced. Recruitment difficulties in terms of the gap between initially being recruited into the study and attending an intervention consultation also reduced the effectiveness of the intervention. Patient attributes such as motivation to learn and engage contributed to the success of the uptake of the intervention.
  
  
  CONCLUSIONS
  Qualitative methods using brief telephone interviews are an effective way of collecting the depth of data required to assess intervention fidelity. Intervention fidelity monitoring should be an important element of definitive trial design.
  
  
  BACKGROUND
  ClinicalTrials. gov id isrctn 55001433 - www.controlled-trials.com/isrctn55001433.
authors.affiliation: National Institute for Health Research, Research Design Service East Midlands, Tower Building, University Park, Nottingham NG7 2RD, UK. Jane.Dyas@nottingham.ac.uk.
authors.forename: Jane V
authors.initials: JV
authors.lastname: Dyas
authors.affiliation: Community and Health Research Unit (CaHRU), University of Lincoln, UK.
authors.forename: Fiona
authors.initials: F
authors.lastname: Togher
authors.affiliation: Prehospital Health Care, Community and Health Research Unit (CaHRU), University of Lincoln, UK.
authors.forename: A Niroshan
authors.initials: AN
authors.lastname: Siriwardena
mesh_terms: D005260:Female; D019983:Guideline Adherence / Q000592:standards*; D006282:Health Personnel / Q000193:education*; D006801:Humans; D007407:Interviews as Topic; D008297:Male; D010348:Patient Care Team / Q000458:organization & administration* / Q000592:standards; D010865:Pilot Projects; D011320:Primary Health Care / Q000592:standards*; D011369:Professional-Patient Relations; D036301:Qualitative Research; D016032:Randomized Controlled Trials as Topic / Q000592:standards; D007319:Sleep Initiation and Maintenance Disorders / Q000628:therapy*; D013689:Telephone; D000078329:Workforce