NCT03179722

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
453

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2016

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 8, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 7, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 11, 2017

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2018

Completed
Last Updated

July 24, 2019

Status Verified

July 1, 2019

Enrollment Period

11 months

First QC Date

June 1, 2017

Last Update Submit

July 23, 2019

Conditions

Aging

Keywords

AgingDrug-related problemsMedication reviewCommunity pharmacistMedication use

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (5)

  • Change in adherence

    9 months before and after the intervention

  • Change in adherence

    Two timepoints: Before the review, after the review (week 12)

  • Change in self-management

    Two timepoints: Before the review, after the review (week 12)

  • Change in use of emergency healthcare services & fall incidents

    Two timepoints: Before the review, after the review (week 12)

  • Satisfaction with the new service

    One timepoint: during the review (week 3)

Study Arms (2)

Intervention group: Frenchspeaking patients

EXPERIMENTAL

Intervention: Medication review

Behavioral: Medication review

Intervention group: Dutchspeaking patients

EXPERIMENTAL

Intervention: Medication review Intervention: Dutchspeaking patients are also invited to participate to Additional data collection: questionnaires

Behavioral: Medication reviewBehavioral: Additional data collection: questionnaires

Interventions

Medication reviewBEHAVIORAL

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.

Also known as: Medication use review, Medication review type 2a, Intermediate medication review
Intervention group: Dutchspeaking patientsIntervention group: Frenchspeaking patients
Additional data collection: questionnairesBEHAVIORAL

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

Intervention group: Dutchspeaking patients

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 30089523DERIVED

Related Links

MeSH Terms

Interventions

Medication Review

Intervention Hierarchy (Ancestors)

Medication SystemsOrganization and AdministrationHealth Services AdministrationPatient Care Management

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Parallel group intervention study. In a subset of 140 patients, a pre-post study design is used.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PharmD

Study Record Dates

First Submitted

June 1, 2017

First Posted

June 7, 2017

Study Start

November 8, 2016

Primary Completion

October 11, 2017

Study Completion

October 30, 2018

Last Updated

July 24, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share