Clinical trial NCT03912103: Interdisciplinary Medication Review Interventions in an Integrated Outpatient Department.
Official title: An Interdisciplinary Deprescribing and Medication Optimization Intervention in an Integrated Outpatient Department: a Randomized Controlled Pilot Trial (FMA-CPH)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Comorbidity
Multimorbidity
Drug Prescribing
Cognitive Impairment
Language Problems
Keywords: Deprescibing
Multimorbidity/comorbidity
Knowledge
Interdiciplinary intervention
Medication information
Motivation
Lead sponsor: Region Hovedstadens Apotek
Sponsor class: OTHER_GOV
Collaborators: name: Copenhagen University Hospital, Hvidovre
First posted: 2019-04-11
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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)

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: Baseline to 30 days after enrolment
Secondary outcomes:
measure: Difference in patients between the two groups who completed ≥1 deprescribing and/or dose reduction 30 days after enrolment. Difference as %.
timeFrame: Baseline to 30 days after enrolment
measure: Difference in patients between the two groups who completed ≥1 medication optimization 30 days after enrolment in each group. Difference as %
timeFrame: Baseline to 30 days after enrolment
measure: Difference in Knowledge between the two groups who gains more knowledge about their medication measured by ≥1 point on Likert scale (1-5 p).
timeFrame: Baseline to 14 days after enrolment
measure: Difference in patients who are satisfied with medication information measured by ≥1 point on Likert scale (1-5 p).
timeFrame: Baseline to 14 days after enrolment
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Capital Regional Hospital, Amager, Integrated Outpatient Department
Study officials:
affiliation: Region Hovedstadens Apotek
name: Helle Ø McNulty, cand pharm
role: STUDY_DIRECTOR
affiliation: Region Hovedstadens Apotek
name: Charlotte Treldal, Phd
role: STUDY_CHAIR
References: