title: Effectiveness of a medication-adherence tool: study protocol for a randomized controlled trial.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  The Netherlands National Trial Register, NTR5186 . Registered on 18 May 2015.
authors.affiliation: Radboud University Medical Center, Radboud Institute for Health Sciences, IQ healthcare, PO box 9101, Code: 114 IQ healthcare, 6500 HB, Nijmegen, The Netherlands.
authors.forename: Mirrian
authors.initials: M
authors.lastname: Hilbink
authors.affiliation: Behavior, Cognition & Perception, Philips Research, Eindhoven, The Netherlands.
authors.forename: Joyca
authors.initials: J
authors.lastname: Lacroix
authors.affiliation: Behavior, Cognition & Perception, Philips Research, Eindhoven, The Netherlands.
authors.forename: Linda
authors.initials: L
authors.lastname: Bremer-van der Heiden
authors.affiliation: Behavior, Cognition & Perception, Philips Research, Eindhoven, The Netherlands.
authors.forename: Aart
authors.initials: A
authors.lastname: van Halteren
authors.affiliation: Radboud University Medical Center, Radboud Institute for Health Sciences, IQ healthcare, PO box 9101, Code: 114 IQ healthcare, 6500 HB, Nijmegen, The Netherlands.
authors.forename: Martina
authors.initials: M
authors.lastname: Teichert
authors.affiliation: Radboud University Medical Center, Radboud Institute for Health Sciences, IQ healthcare, PO box 9101, Code: 114 IQ healthcare, 6500 HB, Nijmegen, The Netherlands. Jan.vanLieshout@radboudumc.nl.
authors.forename: Jan
authors.initials: J
authors.lastname: van Lieshout
mesh_terms: D000284:Administration, Oral; D015415:Biomarkers / Q000097:blood; D001786:Blood Glucose / Q000187:drug effects / Q000378:metabolism; D002317:Cardiovascular Agents / Q000627:therapeutic use*; D002318:Cardiovascular Diseases / Q000175:diagnosis / Q000188:drug therapy*; D003071:Cognition; D003157:Community Pharmacy Services; D003920:Diabetes Mellitus / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy*; D004644:Emotions; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D055118:Medication Adherence; D009426:Netherlands; D010595:Pharmacists; D011320:Primary Health Care; D012107:Research Design; D012307:Risk Factors; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D015415:Biomarkers; D001786:Blood Glucose; D002317:Cardiovascular Agents; D007004:Hypoglycemic Agents
keywords: Barriers; Cardiovascular diseases; Diabetes; Medication adherence; Primary care