Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2026-01-05 @ 6:34 PM
Study NCT ID:
NCT03912103
Status:
COMPLETED
Last Update Posted:
2021-04-13
First Post:
2019-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interdisciplinary Medication Review Interventions in an Integrated Outpatient Department.
Sponsor:
Region Hovedstadens Apotek
Organization:
Study Overview
Official Title:
An Interdisciplinary Deprescribing and Medication Optimization Intervention in an Integrated Outpatient Department: a Randomized Controlled Pilot Trial (FMA-CPH)
Status:
COMPLETED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FMA-CPH
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.
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)
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)
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: