Studying the Impact of a Medication Use Evaluation by the Community Pharmacist

Aging Clinical Trial

— SIMENON  

Official title:

Studying the Impact of a Medication Use Evaluation by the Community Pharmacist

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03179722
• Other study ID #: SIMENONv3
• Status: Completed
• Phase: N/A
• Start date: November 8, 2016
• Est. completion date: October 30, 2018

Study information

• Verified date: July 2019
• Source: KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this intervention study, 75 Belgian community pharmacies each recruit 12 patients for an intermediate medication review. For each patient, the identified drug-related problems and subsequent interventions are registered using the PharmDisc classification. In a subset of Dutch speaking patients, a pretest-posttest single group design is used to measure the impact of this review on patient related outcomes using questionnaires. The primary outcome is the medication related quality of life, measured via the living with medicines questionnaire. Other patient reported outcomes include adherence, self-management, patient satisfaction, fall incidents and use of emergency healthcare services. Medication records are also collected to objectively measure adherence before and after the intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 453
• Est. completion date: October 30, 2018
• Est. primary completion date: October 11, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 70 Years and older

Eligibility

Inclusion Criteria:

• Patients should be 70 years or older

• Use five or more drugs on a regular basis (prescription or non-prescription drugs)

• Live in the ambulatory setting

• Obtain his medication from this pharmacy on a regular basis

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Aging

Intervention

Behavioral:
• Medication review
The intervention consists of a medicines use review provided by community pharmacists in Belgium. A medicines use review is a medication review type 2a in which both a patient interview and dispensing data are used as information sources to identify drug-related problems with a specific focus on the medicines use of the patient.
• Additional data collection: questionnaires
Pre-post study design. At three timepoints, data is collected: before the medication review (T-1week) during the review (Tweek 3) after the review (Tweek12) The questionnaire provide data for the outcomes: medication related quality of life, adherence questionnaire, service satisfaction, use of emergency health services, self-management

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Joke Wuyts	Association of Belgian Pharmacies (APB)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Drug-related problems & interventions	Using the validated PharmDisc classification tool	One timeframe: during the medication review
Primary	Change in medication related quality of life	using the Living with medicines questionnaire	Three timepoints: Before the review, during review (week 3), after the review (week 12)
Secondary	Change in adherence	using dispensing data	9 months before and after the intervention
Secondary	Change in adherence	using the PROMAS questionnaire	Two timepoints: Before the review, after the review (week 12)
Secondary	Change in self-management	using the PAM questionnaire	Two timepoints: Before the review, after the review (week 12)
Secondary	Change in use of emergency healthcare services & fall incidents	using own questions	Two timepoints: Before the review, after the review (week 12)
Secondary	Satisfaction with the new service	Using the PSPSQ2 questionnaire	One timepoint: during the review (week 3)

External Links

•   Protocol Abstract for the PCNE conference 2017 (DOI: 10.1007/s11096-017-0462-2)