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OpenTrials
Completed

NCT Number: NCT03179722

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

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.

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Key information

Conditions

Aging

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Medication review

Behavioral

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

Additional data collection: questionnaires

Behavioral

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

Primary outcomes

  1. Drug-related problems & interventions

    Time frame: One timeframe: during the medication review

    Using the validated PharmDisc classification tool

  2. Change in medication related quality of life

    Time frame: Three timepoints: Before the review, during review (week 3), after the review (week 12)

    using the Living with medicines questionnaire

Secondary outcomes

  1. Change in adherence

    Time frame: 9 months before and after the intervention

    using dispensing data

  2. Change in adherence

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

    using the PROMAS questionnaire

  3. Change in self-management

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

    using the PAM questionnaire

  4. Change in use of emergency healthcare services & fall incidents

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

    using own questions

  5. Satisfaction with the new service

    Time frame: One timepoint: during the review (week 3)

    Using the PSPSQ2 questionnaire

Sponsors and collaborators

Lead sponsor

Joke Wuyts

Other

Collaborators

  • Association of Belgian Pharmacies (APB)

Registry information

Acronym: SIMENON

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Jun 7, 2017
Registry last updated
Jul 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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