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

Mirrian Hilbink, Joyca Lacroix, Linda Bremer-van der Heiden, Aart van Halteren, Martina Teichert, Jan van Lieshout

Research output: Contribution to JournalArticleAcademicpeer-review

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.

Original languageEnglish
Article number274
JournalTrials
Volume17
Issue number1
DOIs
Publication statusPublished - 3 Jun 2016

Fingerprint

Medication Adherence
Randomized Controlled Trials
Blood Glucose
Pharmacies
Netherlands
Control Groups
Quality of Health Care
Pharmacists
General Practice
General Practitioners
Patient Care
Quality of Life
Delivery of Health Care
Research

Keywords

  • Barriers
  • Cardiovascular diseases
  • Diabetes
  • Medication adherence
  • Primary care

Cite this

Hilbink, M., Lacroix, J., Bremer-van der Heiden, L., van Halteren, A., Teichert, M., & van Lieshout, J. (2016). Effectiveness of a medication-adherence tool: Study protocol for a randomized controlled trial. Trials, 17(1), [274]. https://doi.org/10.1186/s13063-016-1393-2
Hilbink, Mirrian ; Lacroix, Joyca ; Bremer-van der Heiden, Linda ; van Halteren, Aart ; Teichert, Martina ; van Lieshout, Jan. / Effectiveness of a medication-adherence tool : Study protocol for a randomized controlled trial. In: Trials. 2016 ; Vol. 17, No. 1.
@article{4eacbbbd16d34395a7ef786ee3aa6dd4,
title = "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.",
keywords = "Barriers, Cardiovascular diseases, Diabetes, Medication adherence, Primary care",
author = "Mirrian Hilbink and Joyca Lacroix and {Bremer-van der Heiden}, Linda and {van Halteren}, Aart and Martina Teichert and {van Lieshout}, Jan",
year = "2016",
month = "6",
day = "3",
doi = "10.1186/s13063-016-1393-2",
language = "English",
volume = "17",
journal = "Trials",
issn = "1745-6215",
publisher = "BioMed Central",
number = "1",

}

Hilbink, M, Lacroix, J, Bremer-van der Heiden, L, van Halteren, A, Teichert, M & van Lieshout, J 2016, 'Effectiveness of a medication-adherence tool: Study protocol for a randomized controlled trial' Trials, vol. 17, no. 1, 274. https://doi.org/10.1186/s13063-016-1393-2

Effectiveness of a medication-adherence tool : Study protocol for a randomized controlled trial. / Hilbink, Mirrian; Lacroix, Joyca; Bremer-van der Heiden, Linda; van Halteren, Aart; Teichert, Martina; van Lieshout, Jan.

In: Trials, Vol. 17, No. 1, 274, 03.06.2016.

Research output: Contribution to JournalArticleAcademicpeer-review

TY - JOUR

T1 - Effectiveness of a medication-adherence tool

T2 - Study protocol for a randomized controlled trial

AU - Hilbink, Mirrian

AU - Lacroix, Joyca

AU - Bremer-van der Heiden, Linda

AU - van Halteren, Aart

AU - Teichert, Martina

AU - van Lieshout, Jan

PY - 2016/6/3

Y1 - 2016/6/3

N2 - 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.

AB - 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.

KW - Barriers

KW - Cardiovascular diseases

KW - Diabetes

KW - Medication adherence

KW - Primary care

UR - http://www.scopus.com/inward/record.url?scp=84975230582&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84975230582&partnerID=8YFLogxK

U2 - 10.1186/s13063-016-1393-2

DO - 10.1186/s13063-016-1393-2

M3 - Article

VL - 17

JO - Trials

JF - Trials

SN - 1745-6215

IS - 1

M1 - 274

ER -