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Effectiveness of a medication-adherence tool: study protocol for a randomized controlled trial.
- Source :
- Trials; 6/3/2016, Vol. 17, p1-10, 10p, 2 Diagrams, 3 Charts
- Publication Year :
- 2016
-
Abstract
- <bold>Background: </bold>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.<bold>Methods/design: </bold>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.<bold>Discussion: </bold>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.<bold>Trial Registration: </bold>The Netherlands National Trial Register, NTR5186 . Registered on 18 May 2015. [ABSTRACT FROM AUTHOR]
- Subjects :
- PREVENTIVE medicine
QUALITY of life
DRUGSTORES
FAMILY medicine
RANDOMIZED controlled trials
MEDICAL needs assessment
CARDIOVASCULAR disease diagnosis
DIAGNOSIS of diabetes
CARDIOVASCULAR agents
BLOOD sugar
CARDIOVASCULAR diseases
COGNITION
COMPARATIVE studies
DIABETES
DRUGS
EMOTIONS
EXPERIMENTAL design
HEALTH attitudes
HYPOGLYCEMIC agents
RESEARCH methodology
MEDICAL cooperation
ORAL drug administration
PATIENT compliance
PHARMACISTS
PRIMARY health care
RESEARCH
TIME
EVALUATION research
TREATMENT effectiveness
THERAPEUTICS
Subjects
Details
- Language :
- English
- ISSN :
- 17456215
- Volume :
- 17
- Database :
- Complementary Index
- Journal :
- Trials
- Publication Type :
- Academic Journal
- Accession number :
- 115925919
- Full Text :
- https://doi.org/10.1186/s13063-016-1393-2