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Completed

NCT Number: NCT03912103

Interdisciplinary Medication Review Interventions in an Integrated Outpatient Department.

Inappropriate medication prescribing is highly prevalent among comorbid medical patients and leading to adverse drug events (ADE), re-admissions, quality of life and mortality. Thus, the aim of this study is primary to investigate the feasibility of a interdisciplinary intervention focused on deprescribing and medication optimization in the Integrated Outpatient Department at Copenhagen University Hospital, Amager, Denmark.

Participants in the intervention group receives a medication review by a clinical pharmacist and physician with a follow up after 7 and 30 days. The control group receives standard care.

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Key information

Conditions

Comorbidity Cognition Disorders Cognitive Dysfunction Cognitive Impairment Drug Prescribing Language Problems Mental Disorders Multimorbidity Neurocognitive Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Capital Regional Hospital, Amager, Integrated Outpatient Department

Copenhagen, 2300, Denmark

About this study

The FMA-CPH trial is designed as a single-blinded randomized controlled pilot trial starting at the first consultation and end 30 days after.

Patients that meet all inclusion criteria and none of the exclusion criteria are invited to participate. After signing a written informed consent, the participants are block randomized to either the intervention or control group.

Medication prescription for comorbid patients is challenging and may be attributed to marked inter-individual variations in general health, organ function, pharmacokinetic and pharmacodynamic properties, biological age and physical performance. The intervention group receive a medication review.

It is hypothesized that the intervention is feasible and more patients in the intervention group will complete ≥1 deprescribing and/or ≥1 medication optimization 30 days after the beginning of the intervention than the patients in the control group.

Secondary it is hypothesized the patients in the intervention group:

A. Complete more deprescribing compared to the control group (30 days after intervention) B. Complete more medication optimization compared to the control group (30 days after intervention) C. Have a higher knowledge about own medication (14 days after intervention) D. Have a higher level of satisfaction with medication information (14 days after intervention)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Consultation at Integrated Outpatient Department subacute track
  • Multi morbidity/Comorbidity
  • Drug Prescribing
  • Mentally fresh
  • Understand and speak Danish

Exclusion criteria

  • Unable to cooperate cognitively
  • Language problems
  • Admission

Treatment and study plan

Interdisciplinary Deprescribing and Medication Optimization Intervention

Other

as current

Primary outcomes

  1. Feasibility of a deprescribing and medication optimization: Number of patients who complete ≥1 deprescribing and/or ≥1 medication optimization 30 days after enrolment in each group.

    Time frame: Baseline to 30 days after enrolment

    Number og patients who complete ≥1 deprescribing and/or ≥1 medication optimization 30 days after enrolment in the study.

Secondary outcomes

  1. Difference in patients between the two groups who completed ≥1 deprescribing and/or dose reduction 30 days after enrolment. Difference as %.

    Time frame: Baseline to 30 days after enrolment

    Number of patients in the intervention group who complete ≥1 deprescribing and/or dose reduction than control group 30 days after enrolment in each group. Difference expressed as a percentage.

  2. Difference in patients between the two groups who completed ≥1 medication optimization 30 days after enrolment in each group. Difference as %

    Time frame: Baseline to 30 days after enrolment

    Number of patients in the intervention group who complete ≥1 medication optimization more than control group 30 days after enrolment in each group. Difference expressed as a percentage.

  3. Difference in Knowledge between the two groups who gains more knowledge about their medication measured by ≥1 point on Likert scale (1-5 p).

    Time frame: Baseline to 14 days after enrolment

    Number of patients in the intervention group who gains more knowledge about their medication measured by ≥1 point more than patients in the control group measured in difference in points on Likert scale (1-5 points). Where 5 points indicates high knowledge and 1 point is no knowledge. Difference expressed as a percentage

  4. Difference in patients who are satisfied with medication information measured by ≥1 point on Likert scale (1-5 p).

    Time frame: Baseline to 14 days after enrolment

    Number of patients in the intervention group who are more satisfied with medication information given by the Interdisciplinary team measured by ≥1 point than patients in control group measured in difference in points on Likert scale (1-5p). Where 5 points indicates high knowledge and 1 point is no knowledge. Difference expressed as a percentage

Sponsors and collaborators

Lead sponsor

Region Hovedstadens Apotek

Other Gov

Collaborators

  • Copenhagen University Hospital, Hvidovre

Registry information

Official study title

An Interdisciplinary Deprescribing and Medication Optimization Intervention in an Integrated Outpatient Department: a Randomized Controlled Pilot Trial (FMA-CPH)

Acronym: FMA-CPH

Important dates

Study start
2019
Primary completion
2019
Study completion
2021
First posted
Apr 11, 2019
Registry last updated
Apr 13, 2021

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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