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Open Access Highly Accessed Study protocol

Protocol for a randomised controlled trial to estimate the effects and costs of a patient centred educational intervention in glaucoma management

Heidi Cate12*, Debi Bhattacharya2, Allan Clark3, Richard Fordham3, Caitlin Notley3 and David C Broadway1

Author Affiliations

1 Ophthalmology, Norfolk & Norwich University Hospital NHS Foundation Trust, Colney Lane, Norwich, NR4 7UY, UK

2 School of Pharmacy, University of East Anglia, Norwich, NR4 7TJ, UK

3 Norwich Medical School, University of East Anglia, Norwich, NR4 7TJ, UK

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BMC Ophthalmology 2012, 12:57  doi:10.1186/1471-2415-12-57

Published: 22 November 2012

Abstract

Background

Poor glaucoma education is thought to be a causative factor of non-adherence to glaucoma therapy. However, the multi-factorial nature of non-adherent behaviour may explain the failure of purely educational interventions to achieve significant improvement in adherence. Behaviour Change Counselling (BCC) allows both the imparting of information and assessment of patient ambivalence to medication use and may elicit behaviour change in order to achieve better adherence. The chronic and complex nature of glaucoma means that patient non-adherence to glaucoma therapy does not easily correlate with measureable objective clinical endpoints. However, electronic medication monitoring offers an objective method of measuring adherence without reliance on clinical endpoints.

Methods/design

The study is a randomised controlled trial (RCT) with glaucoma (open angle) or ocular hypertension patients attending a glaucoma clinic and prescribed travoprost. The study will determine whether additional glaucoma education using BCC is beneficial and cost effective in improving adherence with glaucoma therapy. An 8-month follow-up period, using an electronic adherence monitoring device (Travalert® dosing aid, TDA), will indicate if the intervention is likely to be sustained in the longer term. Additionally, a cost-effectiveness framework will be used to estimate the cost benefit of improving adherence. The development of a novel intervention to deliver glaucoma education using BCC required practitioner training and fidelity testing. Five practitioners were successfully trained to become Glaucoma Support Assistants able to deliver the BCC intervention. The research group had prior clinical and investigative experience in this setting, and used multiple strategies to design a method to address the study objectives.

Discussion

This RCT, using BCC to improve adherence to ocular hypotensive therapy, to our knowledge is the first within this disease area. Using a variety of adherence measures allows examination of the known inaccuracies of patient self-report with respect to glaucoma medication. The novel BCC component has undergone fidelity testing using BECCI and the BCC template will ensure conformity to a standardised intervention.

Trial registration

Current Controlled Trials: ISRCTN89683704

Keywords:
Adherence; Compliance; Glaucoma; Ocular hypotension medication; Motivational interviewing; Behaviour change counselling; Travalert® dosing aid