Clinical trial NCT02261402: Effectiveness of "Medisinstart"
Official title: Effectiveness of "Medisinstart" - an Open Randomized Controlled Trial of a Newly Developed Pharmacy Service
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Apokus AS
Sponsor class: OTHER
Collaborators: name: Norwegian Pharmacy Association
First posted: 2014-10-10
Enrollment: 1480
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Adherence by Morisky 8-item Medication Adherence Scale (MMAS-8) at 7 weeks
timeFrame: 7 weeks after dispensing the new medicine
measure: Adherence by Morisky 8-item Medication Adherence Scale (MMAS-8) at 18 weeks
timeFrame: 18 weeks after dispensing the new medicine
Secondary outcomes:
measure: Self reported adherence at 7 weeks
timeFrame: 7 weeks after dispensing the new medicine
measure: Adherence by Medication Possession Ratio (MPR) at 18 weeks
timeFrame: 18 weeks after dispensing the new medicine
measure: Patients' beliefs about their medicines by Beliefs about Medicines Questionnaire (BMQ) at inclusion
timeFrame: At inclusion
measure: Self reported adherence at 18 weeks
timeFrame: 18 weeks after dispensing the new medicine
measure: Adherence by Medication Possession Ratio (MPR) at 1 year
timeFrame: 1 year after dispensing the new medicine
measure: Patients' beliefs about their medicines by Beliefs about Medicines Questionnaire (BMQ) at 7 weeks
timeFrame: 7 weeks after dispensing the new medicine
measure: Patients' beliefs about their medicines by Beliefs about Medicines Questionnaire (BMQ) at 18 weeks
timeFrame: 18 weeks after dispensing the new medicine
Other outcomes:
measure: Number of reported Medication-Related Problems in the intervention arm
timeFrame: During the intervention
measure: Patients' evaluation of "Medisinstart"
timeFrame: 7 weeks after dispensing the new medicine
measure: Pharmacists' evaluation of patient benefit
timeFrame: 7 months after start of the study
measure: Pharmacy costs by performing the service
timeFrame: 1 year after study start
Locations:
city: Alta
country: Norway
facility: Apotek 1 Alta
city: Andselv
country: Norway
facility: Apotek 1 Andselv
city: Arendal
country: Norway
facility: Boots apotek Harebakken
city: Arendal
country: Norway
facility: Sykehusapoteket Arendal
city: Bergen
country: Norway
facility: Apotek 1 Horisont
city: Bergen
country: Norway
facility: Boots apotek Bryggen
city: Bergen
country: Norway
facility: Sjukehusapoteket i Bergen
city: Bodø
country: Norway
facility: Sykehusapoteket i Bodø
city: Brandbu
country: Norway
facility: Apotek 1 Brandbu
city: Bremnes
country: Norway
facility: Apotek 1 Bømlo
city: Drammen
country: Norway
facility: Apotek 1 Åssiden
city: Drammen
country: Norway
facility: Sykehusapoteket Drammen
city: Elverum
country: Norway
facility: Boots apotek Elverum
city: Elverum
country: Norway
facility: Sykehusapoteket Elverum
city: Flisa
country: Norway
facility: Boots apotek Flisa
city: Fredrikstad
country: Norway
facility: Apotek 1 Helsehuset Fredrikstad
city: Førde
country: Norway
facility: Sjukehusapoteket i Førde
city: Hamar
country: Norway
facility: Boots apotek Hamar
city: Haugesund
country: Norway
facility: Sjukehusapoteket i Haugesund
city: Kleppe
country: Norway
facility: Apotek 1 Lerka
city: Kopervik
country: Norway
facility: Apotek 1 Kopervik
city: Kristiansand
country: Norway
facility: Vitusapotek Sørlandssenteret
city: Larvik
country: Norway
facility: Boots apotek Larvik
city: Leknes
country: Norway
facility: Apotek 1 Lofotsenteret
city: Malvik
country: Norway
facility: Apotek 1 Malvik
city: Mandal
country: Norway
facility: Apotek 1 Mandal
city: Maura
country: Norway
facility: Ditt apotek Maura
city: Mo i Rana
country: Norway
facility: Ditt apotek Meyer
city: Mo i Rana
country: Norway
facility: Ditt apotek Ytteren
city: Mosjøen
country: Norway
facility: Apotek 1 Sjøsiden
city: Moss
country: Norway
facility: Vitusapotek Varnaveien Moss
city: Mysen
country: Norway
facility: Apotek 1 Morenen
city: Nesbru
country: Norway
facility: Vitusapotek Nesbru
city: Oslo
country: Norway
facility: Apotek 1 St. Hanshaugen senter
city: Oslo
country: Norway
facility: Boots apotek Bogstadveien
city: Oslo
country: Norway
facility: Boots apotek Skøyen
city: Oslo
country: Norway
facility: Boots apotek Solli
city: Oslo
country: Norway
facility: Diakonhjemmets sykehusapotek
city: Oslo
country: Norway
facility: Lovisenberg sykehusapotek
city: Oslo
country: Norway
facility: Sykehusapoteket Oslo, Ullevål
city: Oslo
country: Norway
facility: Vitusapotek Storo
city: Raufoss
country: Norway
facility: Vitusapotek Raufoss
city: Sandnessjøen
country: Norway
facility: Vitusapotek Syv Søstre
city: Sandnes
country: Norway
facility: Apotek 1 Kvadrat
city: Sandnes
country: Norway
facility: Vitusapotek Ganddal
city: Sandvika
country: Norway
facility: Apotek 1 Sandvika Storsenter
city: Sandvika
country: Norway
facility: Sykehusapoteket Bærum
city: Sarpsborg
country: Norway
facility: Boots apotek Lande
city: Saupstad
country: Norway
facility: Boots apotek Saupstad
city: Sellebakk
country: Norway
facility: Vitusapotek Selbak
city: Skien
country: Norway
facility: Sykehusapoteket Skien
city: Ski
country: Norway
facility: Apotek 1 Ski Amfi
city: Stavanger
country: Norway
facility: Apotek 1 Hjorten Stavanger
city: Stavanger
country: Norway
facility: Sjukehusapoteket i Stavanger
city: Stavanger
country: Norway
facility: Vitusapotek Løven Stavanger
city: Steinkjer
country: Norway
facility: Vitusapotek Medisinsk senter - Steinkjer
city: Strømmen
country: Norway
facility: Sykehusapoteket Lørenskog
city: Strømmen
country: Norway
facility: Vitusapotek Strømmen storsenter
city: Tromsø
country: Norway
facility: Vitusapotek K1 Tromsø
city: Trondheim
country: Norway
facility: Boots apotek Nordre
city: Trondheim
country: Norway
facility: Vitusapotek Solsiden
city: Tønsberg
country: Norway
facility: Sykehusapoteket Tønsberg
city: Verdal
country: Norway
facility: Vitusapotek Innherred
city: Ålesund
country: Norway
facility: Boots apotek Moa
city: Årnes
country: Norway
facility: Vitusapotek Raumnes
city: Årnes
country: Norway
facility: Vitusapotek Årnes
city: Østre Gausdal
country: Norway
facility: Gausdal apotek
Study officials:
affiliation: Apokus AS
name: Karine W Ruud, PhD
role: STUDY_DIRECTOR
affiliation: Apokus AS
name: Sara Bremer, PhD
role: STUDY_DIRECTOR
affiliation: Photocure ASA (current affiliation), Apokus AS (until Dec. 2016)
name: Ragnar Hovland, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
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.
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. doi: 10.1007/s11096-006-9026-6. Epub 2006 Sep 27.
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. doi: 10.1007/s11096-007-9134-y. Epub 2007 Jun 8.
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. doi: 10.1002/14651858.CD000011.
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. doi: 10.1016/s0022-3999(99)00057-4.
citation: 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.
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. doi: 10.1111/j.1751-7176.2008.07572.x.
citation: Ruths S, Viktil KK, Blix HS. [Classification of drug-related problems]. Tidsskr Nor Laegeforen. 2007 Nov 29;127(23):3073-6. Norwegian.
citation: Sabate E. (Ed.) (2003), Adherence to Long-Term Therapies: Evidence for Action. Geneva, Switzerland: World Health Organization