NCT03912103

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

April 8, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 11, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2021

Completed
Last Updated

April 13, 2021

Status Verified

March 1, 2019

Enrollment Period

10 months

First QC Date

April 8, 2019

Last Update Submit

April 12, 2021

Conditions

Keywords

DeprescibingMultimorbidity/comorbidityKnowledgeInterdiciplinary interventionMedication informationMotivation

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 COMPARATOR

The 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.

Other: Interdisciplinary Deprescribing and Medication Optimization Intervention

Control group

NO INTERVENTION

Standard 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

Interdiciplinary medication review intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Helle Ø McNulty, cand pharm

    Region Hovedstadens Apotek

    STUDY DIRECTOR
  • Charlotte Treldal, Phd

    Region Hovedstadens Apotek

    STUDY CHAIR

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
Model Details: 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.
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

Locations