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Trials
Published in: Trials 1/2016

Open Access 01-12-2016 | Study protocol

Effectiveness of a medication-adherence tool: study protocol for a randomized controlled trial

Published in: Trials | Issue 1/2016

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Abstract

Background

Research shows that more than half of the people taking medication for a chronic condition are non-adherent. Nonadherence hinders disease control with a burden on patient quality of life and healthcare systems. We developed a tool that provides insight into nonadherence risks and barriers for medication-adherence including an intervention strategy to overcome those barriers. This study aims to assess the effectiveness of using this adherence tool in starters with cardiovascular or oral blood glucose-lowering medication to improve medication-adherence.

Methods/design

In a cluster-randomized controlled trial 25 pharmacies in the Netherlands will be randomized to the intervention or control arm. Patients registered in a general practice participating in a collaborative can be included when they start cardiovascular or oral blood glucose-lowering medication prescribed by their general practitioner.
Participants complete an assessment consisting of measuring nonadherence risk and potential barriers to adherence. For patients with an increased nonadherence risk, a graphic barrier profile is created, showing to what extent eight cognitive, emotional, or practical barriers are present.
All patients will fill in the medication-adherence assessment twice: between 1 and 2 weeks after the start of the medication and after 8 months.
The intervention strategy consists of discussing this barrier profile to overcome barriers. Pharmacists and assistants of the intervention pharmacies are trained in discussing the profile and to offer a tailored intervention to overcome barriers. In the control arm, patients receive care as usual.
The primary outcome is medication-adherence of patients with a high risk of nonadherence at 8 months follow-up.
Secondary outcomes include the difference in the percentage of patients with an increased nonadherence risk between intervention and control group after 8 months, the predictive values of the baseline questionnaire in the control group in relation to medication-adherence after 8 months, medication-adherence after 1 year follow-up, and barriers and facilitators in the implementation of the tool.

Discussion

This manuscript presents the protocol for a cluster-randomized clinical trial on the use of an adherence tool to improve medication-adherence. This study will provide insight into the effectiveness of the tool in starters with cardiovascular or oral blood glucose-lowering medication in improvement of medication-adherence.

Trial registration

The Netherlands National Trial Register, NTR5186. Registered on 18 May 2015.
Appendix
Available only for authorised users
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Metadata
Title
Effectiveness of a medication-adherence tool: study protocol for a randomized controlled trial
Publication date
01-12-2016
Published in
Trials / Issue 1/2016
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-016-1393-2

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