Effectiveness of Medisinstart

Study Overview
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Brief Summary
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Medisinstart is a new service developed for use in Norwegian pharmacies. It is intended for patients that are about to start a new medicine for a chronic or long-term condition. It is based on research showing that problems with newly prescribed medicines appear rapidly and that a significant portion of patients quickly becomes non-adherent. The service consists of two follow-up consultations with a pharmacist. The first at 1-2 weeks and the second at 3-5 weeks after start of the new medicine. The main purpose of this study is to investigate whether Medisinstart increases patients' adherence to the prescribed medication. Patients' beliefs about their medicines and their motivation for adherence will also be examined. The study also aims at revealing if Medisinstart has additional benefits for the patient, the society and the pharmacies.

Official Title
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Effectiveness of Medisinstart - an Open Randomized Controlled Trial of a Newly Developed Pharmacy Service

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Other: Medisinstart


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: First time prescription for a drug belonging to one of the following groups (ATC-code): Dabigatran etexilate (B01AE07) Rivaroxaban (B01AF01) Apixaban (B01AF02) Beta blocking agents (C07) Calcium channel blockers (C08) Agents acting on the renin-angiotensin system (C09) HMG CoA reductase inhibitors (statins) (C10AA) Exclusion Criteria: Prior use (within the last 3 years) of the drug in question independent of strength, dose and formulation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Medisinstart<br>Patients in this arm will receive the service; Medisinstart | Other: Medisinstart<br>* Medisinstart is a newly developed pharmacy service for patients about to start a new medicine for a chronic or long-term condition. It consists of two follow-up consultations with a pharmacist. The first at 1-2 weeks and the second at 3-5 weeks after start of the new medicine.<br>|
| No Intervention: Current Practice<br>Patients in this arm will receive the current pharmacy practice of advice and guidance with their new medicine. This involves dispensing the medicine and briefly providing information regarding its use and potential side-effects. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence by Morisky 8-item Medication Adherence Scale (MMAS-8) at 7 weeks | Adherence will be measured by a validated Norwegian translation of the MMAS-8 | 7 weeks after dispensing the new medicine | 
| Adherence by Morisky 8-item Medication Adherence Scale (MMAS-8) at 18 weeks | Adherence will be measured by a validated Norwegian translation of the MMAS-8 | 18 weeks after dispensing the new medicine | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self reported adherence at 7 weeks | Adherence will be measured by a Norwegian translation of the question: People often miss taking doses of their medicines, for a wide range of reasons. Have you missed any doses of your new medicine the last week? | 7 weeks after dispensing the new medicine | 
| Adherence by Medication Possession Ratio (MPR) at 18 weeks | Adherence by MPR will be calculated from data collected from the Norwegian Prescription Database | 18 weeks after dispensing the new medicine | 
| Patients' beliefs about their medicines by Beliefs about Medicines Questionnaire (BMQ) at inclusion | Patients' beliefs about their medicines will be measured by a validated Norwegian translation of the BMQ | At inclusion | 
| Self reported adherence at 18 weeks | Adherence will be measured by a Norwegian translation of the question: People often miss taking doses of their medicines, for a wide range of reasons. Have you missed any doses of your new medicine the last week? | 18 weeks after dispensing the new medicine | 
| Adherence by Medication Possession Ratio (MPR) at 1 year | Adherence by MPR will be calculated from data collected from the Norwegian Prescription Database | 1 year after dispensing the new medicine | 
| Patients' beliefs about their medicines by Beliefs about Medicines Questionnaire (BMQ) at 7 weeks | Patients' beliefs about their medicines will be measured by a validated Norwegian translation of the BMQ | 7 weeks after dispensing the new medicine | 
| Patients' beliefs about their medicines by Beliefs about Medicines Questionnaire (BMQ) at 18 weeks | Patients' beliefs about their medicines will be measured by a validated Norwegian translation of the BMQ | 18 weeks after dispensing the new medicine | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adherence, Pharmacist Intervention, Pharmacy, Pharmacy Service, Pharmacy Practice, Hypertension, Antihypertensive Agents, Anticoagulants, Statins, Dyslipidemia, Morisky Medication Adherence Scale, Beliefs about Medicines Questionnaire, Medication Possession Ratio, Medication-Related Problems, Pharmacist