Effectiveness of "Medisinstart"

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02261402
• Other study ID #: Apokus-001
• Status: Completed
• Phase: N/A
• Start date: October 2014
• Est. completion date: December 2017

Study information

• Verified date: July 2021
• Source: Apokus AS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1480
• Est. completion date: December 2017
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Other:
• Medisinstart
"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.

Locations

Country	Name	City	State
Norway	Boots apotek Moa	Ålesund
Norway	Apotek 1 Alta	Alta
Norway	Apotek 1 Andselv	Andselv
Norway	Boots apotek Harebakken	Arendal
Norway	Sykehusapoteket Arendal	Arendal
Norway	Vitusapotek Årnes	Årnes
Norway	Vitusapotek Raumnes	Årnes
Norway	Apotek 1 Horisont	Bergen
Norway	Boots apotek Bryggen	Bergen
Norway	Sjukehusapoteket i Bergen	Bergen
Norway	Sykehusapoteket i Bodø	Bodø
Norway	Apotek 1 Brandbu	Brandbu
Norway	Apotek 1 Bømlo	Bremnes
Norway	Apotek 1 Åssiden	Drammen
Norway	Sykehusapoteket Drammen	Drammen
Norway	Boots apotek Elverum	Elverum
Norway	Sykehusapoteket Elverum	Elverum
Norway	Boots apotek Flisa	Flisa
Norway	Sjukehusapoteket i Førde	Førde
Norway	Apotek 1 Helsehuset Fredrikstad	Fredrikstad
Norway	Boots apotek Hamar	Hamar
Norway	Sjukehusapoteket i Haugesund	Haugesund
Norway	Apotek 1 Lerka	Kleppe
Norway	Apotek 1 Kopervik	Kopervik
Norway	Vitusapotek Sørlandssenteret	Kristiansand
Norway	Boots apotek Larvik	Larvik
Norway	Apotek 1 Lofotsenteret	Leknes
Norway	Apotek 1 Malvik	Malvik
Norway	Apotek 1 Mandal	Mandal
Norway	Ditt apotek Maura	Maura
Norway	Ditt apotek Meyer	Mo i Rana
Norway	Ditt apotek Ytteren	Mo i Rana
Norway	Apotek 1 Sjøsiden	Mosjøen
Norway	Vitusapotek Varnaveien Moss	Moss
Norway	Apotek 1 Morenen	Mysen
Norway	Vitusapotek Nesbru	Nesbru
Norway	Apotek 1 St. Hanshaugen senter	Oslo
Norway	Boots apotek Bogstadveien	Oslo
Norway	Boots apotek Skøyen	Oslo
Norway	Boots apotek Solli	Oslo
Norway	Diakonhjemmets sykehusapotek	Oslo
Norway	Lovisenberg sykehusapotek	Oslo
Norway	Sykehusapoteket Oslo, Ullevål	Oslo
Norway	Vitusapotek Storo	Oslo
Norway	Gausdal apotek	Østre Gausdal
Norway	Vitusapotek Raufoss	Raufoss
Norway	Apotek 1 Kvadrat	Sandnes
Norway	Vitusapotek Ganddal	Sandnes
Norway	Vitusapotek Syv Søstre	Sandnessjøen
Norway	Apotek 1 Sandvika Storsenter	Sandvika
Norway	Sykehusapoteket Bærum	Sandvika
Norway	Boots apotek Lande	Sarpsborg
Norway	Boots apotek Saupstad	Saupstad
Norway	Vitusapotek Selbak	Sellebakk
Norway	Apotek 1 Ski Amfi	Ski
Norway	Sykehusapoteket Skien	Skien
Norway	Apotek 1 Hjorten Stavanger	Stavanger
Norway	Sjukehusapoteket i Stavanger	Stavanger
Norway	Vitusapotek Løven Stavanger	Stavanger
Norway	Vitusapotek Medisinsk senter - Steinkjer	Steinkjer
Norway	Sykehusapoteket Lørenskog	Strømmen
Norway	Vitusapotek Strømmen storsenter	Strømmen
Norway	Sykehusapoteket Tønsberg	Tønsberg
Norway	Vitusapotek K1 Tromsø	Tromsø
Norway	Boots apotek Nordre	Trondheim
Norway	Vitusapotek Solsiden	Trondheim
Norway	Vitusapotek Innherred	Verdal

Sponsors (2)

Lead Sponsor	Collaborator
Apokus AS	Norwegian Pharmacy Association

Country where clinical trial is conducted

Norway, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. Epub 2006 Sep 27. — View Citation

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. Epub 2007 Jun 8. — View Citation

Haynes RB, McDonald H, Garg AX, Montague P. Interventions for helping patients to follow prescriptions for medications. Cochrane Database Syst Rev. 2002;(2):CD000011. Review. Update in: Cochrane Database Syst Rev. 2005;(4):CD000011. — View Citation

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. — View Citation

Hov I, Bjartnes M, Slørdal L, Spigset O. [Are drugs taken as prescribed?]. Tidsskr Nor Laegeforen. 2012 Feb 21;132(4):418-22. doi: 10.4045/tidsskr.11.0225. Review. Norwegian. — View Citation

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. — View Citation

Ruths S, Viktil KK, Blix HS. [Classification of drug-related problems]. Tidsskr Nor Laegeforen. 2007 Nov 29;127(23):3073-6. Norwegian. — View Citation

Sabate E. (Ed.) (2003), Adherence to Long-Term Therapies: Evidence for Action. Geneva, Switzerland: World Health Organization

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of reported Medication-Related Problems in the intervention arm	The pharmacist carrying out the intervention will report all discovered Medication-Related Problems	During the intervention
Other	Patients' evaluation of "Medisinstart"	Patients' in the intervention arm will evaluate the service by answering a questionnaire	7 weeks after dispensing the new medicine
Other	Pharmacists' evaluation of patient benefit	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?"	7 months after start of the study
Other	Pharmacy costs by performing the service	Pharmacies will report the COSTs for carrying out the service	1 year after study start
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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