Skip to content

Effectiveness of Medisinstart

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02261402
Enrollment
1480
Registered
2014-10-10
Start date
2014-10-31
Completion date
2017-12-31
Last updated
2021-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases

Keywords

Adherence, Morisky Medication Adherence Scale, Beliefs about Medicines Questionnaire, Medication Possession Ratio, Medication-Related Problems, Pharmacist, Pharmacist Intervention, Pharmacy, Pharmacy Service, Pharmacy Practice, Hypertension, Antihypertensive Agents, Anticoagulants, Statins, Dyslipidemia

Brief summary

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.

Interventions

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.

Sponsors

Norwegian Pharmacy Association
CollaboratorOTHER
Apokus AS
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Adherence by Morisky 8-item Medication Adherence Scale (MMAS-8) at 7 weeks7 weeks after dispensing the new medicineAdherence will be measured by a validated Norwegian translation of the MMAS-8
Adherence by Morisky 8-item Medication Adherence Scale (MMAS-8) at 18 weeks18 weeks after dispensing the new medicineAdherence will be measured by a validated Norwegian translation of the MMAS-8

Secondary

MeasureTime frameDescription
Adherence by Medication Possession Ratio (MPR) at 18 weeks18 weeks after dispensing the new medicineAdherence by MPR will be calculated from data collected from the Norwegian Prescription Database
Self reported adherence at 18 weeks18 weeks after dispensing the new medicineAdherence 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?
Adherence by Medication Possession Ratio (MPR) at 1 year1 year after dispensing the new medicineAdherence by MPR will be calculated from data collected from the Norwegian Prescription Database
Patients' beliefs about their medicines by Beliefs about Medicines Questionnaire (BMQ) at 7 weeks7 weeks after dispensing the new medicinePatients' beliefs about their medicines will be measured by a validated Norwegian translation of the BMQ
Patients' beliefs about their medicines by Beliefs about Medicines Questionnaire (BMQ) at 18 weeks18 weeks after dispensing the new medicinePatients' beliefs about their medicines will be measured by a validated Norwegian translation of the BMQ
Patients' beliefs about their medicines by Beliefs about Medicines Questionnaire (BMQ) at inclusionAt inclusionPatients' beliefs about their medicines will be measured by a validated Norwegian translation of the BMQ
Self reported adherence at 7 weeks7 weeks after dispensing the new medicineAdherence 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?

Other

MeasureTime frameDescription
Pharmacy costs by performing the service1 year after study startPharmacies will report the COSTs for carrying out the service
Pharmacists' evaluation of patient benefit7 months after start of the studyPharmacists performing the service will answer the following question (translated from Norwegian): You have currently performed Medisinstart with at least 5 patients. Do you regard it to be beneficial for the patients?
Patients' evaluation of Medisinstart7 weeks after dispensing the new medicinePatients' in the intervention arm will evaluate the service by answering a questionnaire
Number of reported Medication-Related Problems in the intervention armDuring the interventionThe pharmacist carrying out the intervention will report all discovered Medication-Related Problems

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026