Contact information
Type
Scientific
Primary contact
Dr A. Faber
ORCID ID
Contact details
SIR Institute for Pharmacy Practice and Policy
Leiden
2331 JE
Netherlands
+31 (0)71 576 6157
a.faber@stevenshof.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR1036
Study information
Scientific title
Acronym
Study hypothesis
An home-based medication review intervention conducted by a community pharmacists in close collaboration with the General Practitioner (GP) and patient improves the quality of pharmacotherapy in elderly patients.
Ethics approval
Ethics approval received from the Medical Ethics Board of UMC Utrecht (University Medical Centre in Utrecht) (The Netherlands) on the 7th August 2007 (ref: 07-120/E; CCMO no.: 16412.041.07).
Study design
Multicentre, randomised, placebo-controlled, parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Quality of life
Patient information sheet
Condition
Home-based medication review
Intervention
A medication review will be performed by the patients pharmacist, using the medication list and GP clinical records. The medication review is evaluated and, if necessary, completed by an independent pharmacist panel. All potential drug related problems are identified and classified. The pharmacist visits the patient at home for an interview about the patient's medicines and to identify other possible drug related problems. The medication review will be completed using the information from the patient's interview. Adjustments in pharmacotherapy will be proposed and discussed with the patients GP. A treatment plan will be formulated. The GP or pharmacist will discuss the treatment plan with the patient.
Patients in the control group receive regular care.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
1. The number of drug related problems per patient
2. The number of patients achieving target levels concerning blood pressure, cholesterol and HbA1C
Outcomes will be measured at baseline (t = 0), and after 6 and 12 months after the intervention.
Secondary outcome measures
1. The number of patient being treated optimally according to clinical guidelines
2. The number of medicines per patient
3. The number unplanned hospital admissions
4. Change in mean values for HBA1C, cholesterol level and/or blood pressure
5. Quality of life
6. Satisfaction of GPs, pharmacists and patient with the intervention
7. The capability of pharmacists to perform a comprehensive medication review
Outcomes will be measured at baseline (t = 0), and after 6 and 12 months after the intervention.
Overall trial start date
01/09/2007
Overall trial end date
01/09/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Persons aged 65 years or older
2. Prescribed five or more regular medicines, including at least one cardiovascular or anti-diabetic drug
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
400
Participant exclusion criteria
Persons receiving repeat prescriptions solely from a specialist.
Recruitment start date
01/09/2007
Recruitment end date
01/09/2009
Locations
Countries of recruitment
Netherlands
Trial participating centre
SIR Institute for Pharmacy Practice and Policy
Leiden
2331 JE
Netherlands
Sponsor information
Organisation
Lloyds Apotheken (The Netherlands)
Sponsor details
Postbus 191
Baarn
3740 AD
Netherlands
info@lloydsapotheken.nl
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
AstraZeneca (The Netherlands)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
corporate
Location
United Kingdom
Funder name
Menzis Healthcare Insurance (Menzis Zorgverzekeraar) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Lloyds Apotheken (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Achmea (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Royal Dutch Pharmaceutical Society (Koninklijke Nederlandse Maatschappij ter bevordering der Pharmacie [KNMP]) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list