M10 Evaluation of participant experience in the NIHR HTA OPACE (optimising azithromycin prevention treatment in COPD to reduce exacerbations) trial – a pragmatic trial of continued vs discontinued azithromycin prophylaxis in COPD

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Background The patient voice is vital to shaping research that reflects what matters most to patients. OPACE is a double-blind placebo-controlled randomised trial of continued azithromycin vs discontinuation trial in COPD patients on long-term azithromycin prophylaxis to reduce exacerbations. We performed a trial sub-study to gain feedback on participants’ trial experiences. Methods The trial is recruiting, and this optional sub-study involves a questionnaire at baseline and end of trial and a 3-month interview in a smaller group. OPACE is a pragmatic trial that uses patient information sheets, trial website and video as patient-facing materials. The trial design permits home or in-person participation and home delivery of trial medication. For people who declined trial participation, where possible, reasons for declining were collated. Results Currently, 71 participants completed the baseline questionnaire, 18 participants completed the 3-month interview, none have yet completed their end of trial questionnaires. Participants were from across the UK regions, 55% were male, median (interquartile range) age was 72 (64–77) years, 96% were white, 59% considered themselves to be disabled, 8% were carers, 32% lived alone. 75% of participants in the OPACE trial are taking part in research for the first time. 73% found the trial participant information sheet very useful, but only 11% watched the trial video, and only 14% had seen the OPACE website. 80% liked the choice of taking part in the trial from home or in-person, 60% preferred to take part from home, 30% preferred a combination of home/in-person consultations. 93% found it very helpful that trial medication was home delivered. 73% were very comfortable/comfortable that their azithromycin may be discontinued as part of the trial. Analysis of interview data is ongoing but emerging themes to support trial participation include trial team support and ability to restart standard azithromycin in the trial. Reasons for declining trial participation include not wanting to take part in research, carer responsibilities, too unwell and risk of exacerbation. Conclusion Participants value the choice of taking part in the trial from home and are comfortable with the trial intervention. Future analysis from interviews and end of trial participation is planned.

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