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Interdisciplinary Medication Review Interventions in an Integrated Outpatient Department.

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03912103
Acronym
FMA-CPH
Enrollment
72
Registered
2019-04-11
Start date
2019-03-19
Completion date
2021-03-05
Last updated
2021-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Impairment, Comorbidity, Drug Prescribing, Language Problems, Multimorbidity

Keywords

Deprescibing, Multimorbidity/comorbidity, Knowledge, Interdiciplinary intervention, Medication information, Motivation

Brief summary

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.

Detailed description

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)

Interventions

OTHERInterdisciplinary Deprescribing and Medication Optimization Intervention

as current

Sponsors

Copenhagen University Hospital, Hvidovre
CollaboratorOTHER
Region Hovedstadens Apotek
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Masking description

The evaluation of completed deprescribing and/or medication optimization are performed by two blinded assessors (senior clinical pharmacist and/or medical physicians).

Intervention model description

Interdisciplinary medicine intervention focused on deprescribing and medication optimization. The control group receives standard care. Finally we investigate the number of patients who have completed at least one deprescribing and/or medication optimization in each group.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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.Baseline to 30 days after enrolmentNumber og patients who complete ≥1 deprescribing and/or ≥1 medication optimization 30 days after enrolment in the study.

Secondary

MeasureTime frameDescription
Difference in patients between the two groups who completed ≥1 deprescribing and/or dose reduction 30 days after enrolment. Difference as %.Baseline to 30 days after enrolmentNumber 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.
Difference in patients between the two groups who completed ≥1 medication optimization 30 days after enrolment in each group. Difference as %Baseline to 30 days after enrolmentNumber 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.
Difference in Knowledge between the two groups who gains more knowledge about their medication measured by ≥1 point on Likert scale (1-5 p).Baseline to 14 days after enrolmentNumber 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
Difference in patients who are satisfied with medication information measured by ≥1 point on Likert scale (1-5 p).Baseline to 14 days after enrolmentNumber 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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026