Condition category
Not Applicable
Date applied
05/09/2007
Date assigned
05/09/2007
Last edited
17/09/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 patient’s 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 patient’s 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 measures

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

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

http://www.lloydsapotheken.nl/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes