Studying the Impact of a Medication Use Evaluation by the Community Pharmacist (SIMENON)

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.

Study Overview

• Status: Completed
• Conditions: Aging
• Intervention / Treatment: Behavioral: Medication review; Behavioral: Additional data collection: questionnaires

• Study Type: Interventional
• Enrollment (Actual): 453
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group: Frenchspeaking patients; Intervention: Medication review	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.; Other Names: Medication use review; Medication review type 2a; Intermediate medication review
Experimental: Intervention group: Dutchspeaking patients; Intervention: Medication review Intervention: Dutchspeaking patients are also invited to participate to Additional data collection: questionnaires	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.; Other Names: Medication use review; Medication review type 2a; Intermediate medication review; Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drug-related problems & interventions	Using the validated PharmDisc classification tool	One timeframe: during the medication review
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in adherence	using dispensing data	9 months before and after the intervention
Change in adherence	using the PROMAS questionnaire	Two timepoints: Before the review, after the review (week 12)
Change in self-management	using the PAM questionnaire	Two timepoints: Before the review, after the review (week 12)
Change in use of emergency healthcare services & fall incidents	using own questions	Two timepoints: Before the review, after the review (week 12)
Satisfaction with the new service	Using the PSPSQ2 questionnaire	One timepoint: during the review (week 3)

Collaborators and Investigators

• Sponsor: Joke Wuyts
• Collaborators: Association of Belgian Pharmacies (APB)

Publications and helpful links

General Publications

• Wuyts J, Maesschalck J, De Wulf I, Foubert K, Boussery K, De Lepeleire J, Foulon V. Studying the impact of a medication use evaluation for polymedicated older patients by the community pharmacist (SIMENON): study protocol. BMC Health Serv Res. 2018 Aug 8;18(1):623. doi: 10.1186/s12913-018-3440-z.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2016
• Primary Completion (Actual): October 11, 2017
• Study Completion (Actual): October 30, 2018

Study Registration Dates

• First Submitted: June 1, 2017
• First Submitted That Met QC Criteria: June 6, 2017
• First Posted (Actual): June 7, 2017

Study Record Updates

• Last Update Posted (Actual): July 24, 2019
• Last Update Submitted That Met QC Criteria: July 23, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Aging; Medication review; Drug-related problems; Community pharmacist; Medication use
• Other Study ID Numbers: SIMENONv3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No