Interdisciplinary Medication Review Interventions in an Integrated Outpatient Department.
FMA-CPH
An Interdisciplinary Deprescribing and Medication Optimization Intervention in an Integrated Outpatient Department: a Randomized Controlled Pilot Trial (FMA-CPH)
1 other identifier
interventional
72
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 19, 2019
CompletedFirst Submitted
Initial submission to the registry
April 8, 2019
CompletedFirst Posted
Study publicly available on registry
April 11, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 5, 2021
CompletedApril 13, 2021
March 1, 2019
10 months
April 8, 2019
April 12, 2021
Conditions
Keywords
Outcome Measures
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.
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 Outcomes (4)
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 enrolment
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 enrolment
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 enrolment
Difference in patients who are satisfied with medication information measured by ≥1 point on Likert scale (1-5 p).
Baseline to 14 days after enrolment
Study Arms (2)
Interdiciplinary medication review intervention
ACTIVE COMPARATORThe clinical pharmacist perform medication review and presents medication interventions orally and written to the physician. The physician perform the changes and inform the patient about the changes. 7 days after intervention the patient receives a follow up phone call from the pharmacist about the medication interventions. If the pharmacist during the follow up phone call identify any complications due to compliance/add on/deprescribing the pharmacist uses motivational conversation to come to a solution.14 days after the beginning of the intervention the patients knowledge about their medication and satisfaction with medication information is investigated by a phone questionnaire and measured on a Likert scale (1-5). 30 days after the beginning of the intervention the pharmacist collect an updated medication history. Finally we investigate the number of patients who have completed at least one deprescribing and/or medication optimization in each group.
Control group
NO INTERVENTIONStandard treatment without a medication review and follow up related to medication changes (standard treatment).14 days after the enrollment the patients knowledge about their medication and satisfaction with medication information is investigated by a phone questionnaire measured on a Likert scale (1-5). 30 days after the enrollment the pharmacist collect an updated medication history.Finally we investigate the number of patients who have completed at least one deprescribing and/or medication optimization in each group
Interventions
as current
Eligibility Criteria
You may qualify if:
- Consultation at Integrated Outpatient Department subacute track
- Multi morbidity/Comorbidity
- Drug Prescribing
- Mentally fresh
- Understand and speak Danish
You may not qualify if:
- Unable to cooperate cognitively
- Language problems
- Admission
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Capital Regional Hospital, Amager, Integrated Outpatient Department
Copenhagen, 2300, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Helle Ø McNulty, cand pharm
Region Hovedstadens Apotek
- STUDY CHAIR
Charlotte Treldal, Phd
Region Hovedstadens Apotek
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The evaluation of completed deprescribing and/or medication optimization are performed by two blinded assessors (senior clinical pharmacist and/or medical physicians).
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical pharmacist
Study Record Dates
First Submitted
April 8, 2019
First Posted
April 11, 2019
Study Start
March 19, 2019
Primary Completion
December 30, 2019
Study Completion
March 5, 2021
Last Updated
April 13, 2021
Record last verified: 2019-03