Objective 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.
Design and setting A feasibility study (with randomisation) conducted at outpatient diabetes clinics at two secondary care hospitals in Devon, UK.
Participants People with diabetes (type 1 and type 2) attending secondary care general diabetes outpatient clinics.
Intervention 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.
Outcomes 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.
Results 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.
Conclusions 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.
Trial registration ISRCTN75070242.
- patient enablement
This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/
Statistics from Altmetric.com
Contributors NB, CA, FH-G, JH, AG, OCU, BV, MD, JP and JF conceived the original study and developed the protocol with WI, JV and RA. NB, CA, FH-G, JH, AG, OCU, BV, MD, JP, JF, WI, JV and RA were involved in the analysis and interpretation of the study. OCU and BV led the writing of the first draft of the manuscript, with contributions from JF, RA, CA, MD, AG, WI, JP, JV and NB. All authors contributed to the editing and redrafting.
Funding This research is funded by the National Institute of Health Research (NIHR) under its Research for Patient Benefit (RfPB) Programme (grant reference number PB-PG-0711-25087). NB and OU were partially supported by the NIHR Collaboration for Leadership in Applied Health Research and Care South West Peninsula.
Disclaimer The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health.
Competing interests None declared.
Patient consent Obtained.
Ethics approval Ethical approval was granted on 4 April 2013 by the NHS Research Ethics Committee North West (Preston) (Reference number: 13/NW/0123). Written informed consent was obtained from the patients before they entered the study.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement Participant level data, the full data set and statistical code are available from the corresponding author.
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.