title: A preconsultation web-based tool to generate an agenda for discussion in diabetes outpatient clinics to improve patient outcomes (DIAT): a feasibility study.
abstract: To test the feasibility of running a randomised controlled trial of a preconsultation web-based intervention (Presenting Asking Checking Expressing (PACE-D)) to improve the quality of care and clinical outcomes in patients with diabetes.
  
  
  
  A feasibility study (with randomisation) conducted at outpatient diabetes clinics at two secondary care hospitals in Devon, UK.
  
  
  
  People with diabetes (type 1 and type 2) attending secondary care general diabetes outpatient clinics.
  
  
  
  The PACE-D, a web-based tool adapted for patients with diabetes to use before their consultation to generate an agenda of topics to discuss with their diabetologist.
  
  
  
  The percentage of eligible patients who were recruited and the percentage of participants for whom routine glycosylated haemoglobin (HbA1c) data (the putative primary outcome) could be extracted from medical notes and who completed secondary outcome assessments via questionnaire at follow-up were reported.
  
  
  
  In contrast with the planned recruitment of 120 participants, only 71 participants were randomised during the 7-month recruitment period. This comprised 18.7% (95% CI 14.9% to 23.0%) of those who were eligible. Mean (SD) age of the participants was 56.5 (12.4) years and 66.2% had type 1 diabetes. Thirty-eight patients were randomised to the intervention arm and 33 to the control arm. HbA1c data were available for only 73% (95% CI 61% to 83%) of participants at the 6 months follow-up. The questionnaire-based data were collected for 66% (95% CI 54% to 77%) of the participants at 6 months follow-up. Participants reported that the PACE-D tool was easy to use.
  
  
  
  A randomised controlled trial of the preconsultation web-based intervention as set out in our current protocol is not feasible without significant modification to improve recruitment and follow-up of participants. The study also provides insights into the feasibility and challenges of conducting complex intervention trials in everyday clinical practice.
  
  
  
  ISRCTN75070242.
authors.affiliation: NIHR CLAHRC South West Peninsula (PenCLAHRC), University of Exeter Medical School, Exeter, UK.
authors.forename: Obioha C
authors.identifier: 0000-0002-0551-9157
authors.initials: OC
authors.lastname: Ukoumunne
authors.affiliation: Department of Diabetes & Endocrinology, Royal Devon and Exeter Hospital, University of Exeter Medical School, Exeter, UK.
authors.forename: Bijay
authors.initials: B
authors.lastname: Vaidya
authors.affiliation: Institute of Health Research, University of Exeter Medical School, Exeter, UK.
authors.forename: Julia
authors.initials: J
authors.lastname: Frost
authors.affiliation: Peninsula Technology Assessment Group (PenTAG), Institute of Health Research, University of Exeter Medical School, Exeter, UK.
authors.forename: Rob
authors.initials: R
authors.lastname: Anderson
authors.affiliation: Macleod Diabetes and Endocrine Centre, Royal Devon and Exeter Foundation Trust, Exeter, UK.
authors.forename: Catherine
authors.initials: C
authors.lastname: Argyle
authors.affiliation: Macleod Diabetes and Endocrine Centre, Royal Devon and Exeter Foundation Trust, Exeter, UK.
authors.forename: Mark
authors.initials: M
authors.lastname: Daly
authors.affiliation: Peninsula Public Involvement Group (PenPIG), NIHR CLAHRC South West Peninsula (PenCLAHRC), University of Exeter Medical School, Exeter, UK.
authors.forename: Faith
authors.initials: F
authors.lastname: Harris-Golesworthy
authors.affiliation: Peninsula Public Involvement Group (PenPIG), NIHR CLAHRC South West Peninsula (PenCLAHRC), University of Exeter Medical School, Exeter, UK.
authors.forename: Jim
authors.initials: J
authors.lastname: Harris
authors.affiliation: Institute of Health Research, University of Exeter Medical School, Exeter, UK.
authors.forename: Andy
authors.initials: A
authors.lastname: Gibson
authors.affiliation: Peninsula Clinical Trials Unit, Plymouth University Peninsula Schools of Medicine and Dentistry, Plymouth, UK.
authors.forename: Wendy
authors.initials: W
authors.lastname: Ingram
authors.affiliation: Plymouth University and Peninsula Schools of Medicine and Dentistry, Derriford Hospital, Plymouth Hospitals NHS Trust, Plymouth, UK.
authors.forename: Jon
authors.initials: J
authors.lastname: Pinkney
authors.affiliation: Peninsula Clinical Trials Unit, Plymouth University Peninsula Schools of Medicine and Dentistry, Plymouth, UK.
authors.forename: Jane
authors.initials: J
authors.lastname: Vickery
authors.affiliation: NIHR CLAHRC South West Peninsula (PenCLAHRC), University of Exeter Medical School, Exeter, UK.
authors.forename: Nicky
authors.initials: N
authors.lastname: Britten
mesh_terms: D000554:Ambulatory Care Facilities; D003920:Diabetes Mellitus / Q000097:blood / Q000628:therapy*; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006442:Glycated Hemoglobin; D006801:Humans; D020407:Internet; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care / Q000379:methods*; D015397:Program Evaluation / Q000379:methods*; D012017:Referral and Consultation; D011795:Surveys and Questionnaires; D006113:United Kingdom
chemical_list: D006442:Glycated Hemoglobin
keywords: diabetes; patient enablement; pre-consultation; self-management