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

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.

journal_name

Trials

journal_title

Trials

authors

Hilbink M,Lacroix J,Bremer-van der Heiden L,van Halteren A,Teichert M,van Lieshout J

doi

10.1186/s13063-016-1393-2

subject

Has Abstract

pub_date

2016-06-03 00:00:00

pages

274

issue

1

issn

1745-6215

pii

10.1186/s13063-016-1393-2

journal_volume

17

pub_type

杂志文章,随机对照试验

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