Effectiveness of "Medisinstart"
July 19, 2021 updated by: Apokus AS
Effectiveness of "Medisinstart" - an Open Randomized Controlled Trial of a Newly Developed Pharmacy Service
"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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
1480
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alta, Norway
- Apotek 1 Alta
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Andselv, Norway
- Apotek 1 Andselv
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Arendal, Norway
- Boots apotek Harebakken
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Arendal, Norway
- Sykehusapoteket Arendal
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Bergen, Norway
- Apotek 1 Horisont
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Bergen, Norway
- Boots apotek Bryggen
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Bergen, Norway
- Sjukehusapoteket i Bergen
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Bodø, Norway
- Sykehusapoteket i Bodø
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Brandbu, Norway
- Apotek 1 Brandbu
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Bremnes, Norway
- Apotek 1 Bømlo
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Drammen, Norway
- Apotek 1 Åssiden
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Drammen, Norway
- Sykehusapoteket Drammen
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Elverum, Norway
- Boots apotek Elverum
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Elverum, Norway
- Sykehusapoteket Elverum
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Flisa, Norway
- Boots apotek Flisa
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Fredrikstad, Norway
- Apotek 1 Helsehuset Fredrikstad
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Førde, Norway
- Sjukehusapoteket i Førde
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Hamar, Norway
- Boots apotek Hamar
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Haugesund, Norway
- Sjukehusapoteket i Haugesund
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Kleppe, Norway
- Apotek 1 Lerka
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Kopervik, Norway
- Apotek 1 Kopervik
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Kristiansand, Norway
- Vitusapotek Sørlandssenteret
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Larvik, Norway
- Boots apotek Larvik
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Leknes, Norway
- Apotek 1 Lofotsenteret
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Malvik, Norway
- Apotek 1 Malvik
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Mandal, Norway
- Apotek 1 Mandal
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Maura, Norway
- Ditt apotek Maura
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Mo i Rana, Norway
- Ditt apotek Meyer
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Mo i Rana, Norway
- Ditt apotek Ytteren
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Mosjøen, Norway
- Apotek 1 Sjøsiden
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Moss, Norway
- Vitusapotek Varnaveien Moss
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Mysen, Norway
- Apotek 1 Morenen
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Nesbru, Norway
- Vitusapotek Nesbru
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Oslo, Norway
- Apotek 1 St. Hanshaugen senter
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Oslo, Norway
- Boots apotek Bogstadveien
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Oslo, Norway
- Boots apotek Skøyen
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Oslo, Norway
- Boots apotek Solli
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Oslo, Norway
- Diakonhjemmets sykehusapotek
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Oslo, Norway
- Lovisenberg sykehusapotek
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Oslo, Norway
- Sykehusapoteket Oslo, Ullevål
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Oslo, Norway
- Vitusapotek Storo
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Raufoss, Norway
- Vitusapotek Raufoss
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Sandnes, Norway
- Apotek 1 Kvadrat
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Sandnes, Norway
- Vitusapotek Ganddal
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Sandnessjøen, Norway
- Vitusapotek Syv Søstre
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Sandvika, Norway
- Apotek 1 Sandvika Storsenter
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Sandvika, Norway
- Sykehusapoteket Bærum
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Sarpsborg, Norway
- Boots apotek Lande
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Saupstad, Norway
- Boots apotek Saupstad
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Sellebakk, Norway
- Vitusapotek Selbak
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Ski, Norway
- Apotek 1 Ski Amfi
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Skien, Norway
- Sykehusapoteket Skien
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Stavanger, Norway
- Apotek 1 Hjorten Stavanger
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Stavanger, Norway
- Sjukehusapoteket i Stavanger
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Stavanger, Norway
- Vitusapotek Løven Stavanger
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Steinkjer, Norway
- Vitusapotek Medisinsk senter - Steinkjer
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Strømmen, Norway
- Sykehusapoteket Lørenskog
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Strømmen, Norway
- Vitusapotek Strømmen storsenter
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Tromsø, Norway
- Vitusapotek K1 Tromsø
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Trondheim, Norway
- Boots apotek Nordre
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Trondheim, Norway
- Vitusapotek Solsiden
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Tønsberg, Norway
- Sykehusapoteket Tønsberg
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Verdal, Norway
- Vitusapotek Innherred
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Ålesund, Norway
- Boots apotek Moa
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Årnes, Norway
- Vitusapotek Raumnes
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Årnes, Norway
- Vitusapotek Årnes
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Østre Gausdal, Norway
- Gausdal apotek
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Medisinstart
Patients in this arm will receive the service; Medisinstart
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"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.
|
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No Intervention: Current Practice
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Adherence by Morisky 8-item Medication Adherence Scale (MMAS-8) at 7 weeks
Time Frame: 7 weeks after dispensing the new medicine
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Adherence will be measured by a validated Norwegian translation of the MMAS-8
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7 weeks after dispensing the new medicine
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Adherence by Morisky 8-item Medication Adherence Scale (MMAS-8) at 18 weeks
Time Frame: 18 weeks after dispensing the new medicine
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Adherence will be measured by a validated Norwegian translation of the MMAS-8
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18 weeks after dispensing the new medicine
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Self reported adherence at 7 weeks
Time Frame: 7 weeks after dispensing the new medicine
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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?"
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7 weeks after dispensing the new medicine
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Adherence by Medication Possession Ratio (MPR) at 18 weeks
Time Frame: 18 weeks after dispensing the new medicine
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Adherence by MPR will be calculated from data collected from the Norwegian Prescription Database
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18 weeks after dispensing the new medicine
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Patients' beliefs about their medicines by Beliefs about Medicines Questionnaire (BMQ) at inclusion
Time Frame: At inclusion
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Patients' beliefs about their medicines will be measured by a validated Norwegian translation of the BMQ
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At inclusion
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Self reported adherence at 18 weeks
Time Frame: 18 weeks after dispensing the new medicine
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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?"
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18 weeks after dispensing the new medicine
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Adherence by Medication Possession Ratio (MPR) at 1 year
Time Frame: 1 year after dispensing the new medicine
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Adherence by MPR will be calculated from data collected from the Norwegian Prescription Database
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1 year after dispensing the new medicine
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Patients' beliefs about their medicines by Beliefs about Medicines Questionnaire (BMQ) at 7 weeks
Time Frame: 7 weeks after dispensing the new medicine
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Patients' beliefs about their medicines will be measured by a validated Norwegian translation of the BMQ
|
7 weeks after dispensing the new medicine
|
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Patients' beliefs about their medicines by Beliefs about Medicines Questionnaire (BMQ) at 18 weeks
Time Frame: 18 weeks after dispensing the new medicine
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Patients' beliefs about their medicines will be measured by a validated Norwegian translation of the BMQ
|
18 weeks after dispensing the new medicine
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Number of reported Medication-Related Problems in the intervention arm
Time Frame: During the intervention
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The pharmacist carrying out the intervention will report all discovered Medication-Related Problems
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During the intervention
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Patients' evaluation of "Medisinstart"
Time Frame: 7 weeks after dispensing the new medicine
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Patients' in the intervention arm will evaluate the service by answering a questionnaire
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7 weeks after dispensing the new medicine
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Pharmacists' evaluation of patient benefit
Time Frame: 7 months after start of the study
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Pharmacists 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?"
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7 months after start of the study
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Pharmacy costs by performing the service
Time Frame: 1 year after study start
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Pharmacies will report the COSTs for carrying out the service
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1 year after study start
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Karine W Ruud, PhD, Apokus AS
- Study Director: Sara Bremer, PhD, Apokus AS
- Study Director: Ragnar Hovland, PhD, Photocure ASA (current affiliation), Apokus AS (until Dec. 2016)
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Morisky DE, Ang A, Krousel-Wood M, Ward HJ. Predictive validity of a medication adherence measure in an outpatient setting. J Clin Hypertens (Greenwich). 2008 May;10(5):348-54. doi: 10.1111/j.1751-7176.2008.07572.x.
- Clifford S, Barber N, Elliott R, Hartley E, Horne R. Patient-centred advice is effective in improving adherence to medicines. Pharm World Sci. 2006 Jun;28(3):165-70. doi: 10.1007/s11096-006-9026-6. Epub 2006 Sep 27.
- Haynes RB, McDonald H, Garg AX, Montague P. Interventions for helping patients to follow prescriptions for medications. Cochrane Database Syst Rev. 2002;(2):CD000011. doi: 10.1002/14651858.CD000011.
- Horne R, Weinman J. Patients' beliefs about prescribed medicines and their role in adherence to treatment in chronic physical illness. J Psychosom Res. 1999 Dec;47(6):555-67. doi: 10.1016/s0022-3999(99)00057-4.
- Barber N, Parsons J, Clifford S, Darracott R, Horne R. Patients' problems with new medication for chronic conditions. Qual Saf Health Care. 2004 Jun;13(3):172-5. doi: 10.1136/qhc.13.3.172.
- Boyd M, Waring J, Barber N, Mehta R, Chuter A, Avery AJ, Salema NE, Davies J, Latif A, Tanajewski L, Elliott RA. Protocol for the New Medicine Service Study: a randomized controlled trial and economic evaluation with qualitative appraisal comparing the effectiveness and cost effectiveness of the New Medicine Service in community pharmacies in England. Trials. 2013 Dec 1;14:411. doi: 10.1186/1745-6215-14-411.
- Elliott RA, Barber N, Clifford S, Horne R, Hartley E. The cost effectiveness of a telephone-based pharmacy advisory service to improve adherence to newly prescribed medicines. Pharm World Sci. 2008 Jan;30(1):17-23. doi: 10.1007/s11096-007-9134-y. Epub 2007 Jun 8.
- Hov I, Bjartnes M, Slordal L, Spigset O. [Are drugs taken as prescribed?]. Tidsskr Nor Laegeforen. 2012 Feb 21;132(4):418-22. doi: 10.4045/tidsskr.11.0225. Norwegian.
- Ruths S, Viktil KK, Blix HS. [Classification of drug-related problems]. Tidsskr Nor Laegeforen. 2007 Nov 29;127(23):3073-6. Norwegian.
- Sabate E. (Ed.) (2003), Adherence to Long-Term Therapies: Evidence for Action. Geneva, Switzerland: World Health Organization
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2014
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
December 1, 2017
Study Registration Dates
First Submitted
October 7, 2014
First Submitted That Met QC Criteria
October 7, 2014
First Posted (Estimate)
October 10, 2014
Study Record Updates
Last Update Posted (Actual)
July 20, 2021
Last Update Submitted That Met QC Criteria
July 19, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Apokus-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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