Interdisciplinary Medication Review Interventions in an Integrated Outpatient Department.

Cognitive Impairment Clinical Trial

— FMA-CPH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03912103
• Other study ID #: VD-2019-09
• Status: Completed
• Phase: N/A
• Start date: March 19, 2019
• Est. completion date: March 5, 2021

Study information

• Verified date: March 2019
• Source: Region Hovedstadens Apotek
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: March 5, 2021
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Comorbidity
• Drug Prescribing
• Language Problems
• Multimorbidity

Intervention

Other:
• Interdisciplinary Deprescribing and Medication Optimization Intervention
as current

Locations

Country	Name	City	State
Denmark	Capital Regional Hospital, Amager, Integrated Outpatient Department	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Region Hovedstadens Apotek	Copenhagen University Hospital, Hvidovre

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Number og patients who complete =1 deprescribing and/or =1 medication optimization 30 days after enrolment in the study.	Baseline to 30 days after enrolment
Secondary	Difference in patients between the two groups who completed =1 deprescribing and/or dose reduction 30 days after enrolment. Difference as %.	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.	Baseline to 30 days after enrolment
Secondary	Difference in patients between the two groups who completed =1 medication optimization 30 days after enrolment in each group. Difference as %	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.	Baseline to 30 days after enrolment
Secondary	Difference in Knowledge between the two groups who gains more knowledge about their medication measured by =1 point on Likert scale (1-5 p).	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	Baseline to 14 days after enrolment
Secondary	Difference in patients who are satisfied with medication information measured by =1 point on Likert scale (1-5 p).	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	Baseline to 14 days after enrolment