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Interdisciplinary Medication Review Interventions in an Integrated Outpatient Department. (FMA-CPH)

Primary Purpose

Comorbidity, Multimorbidity, Drug Prescribing

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Interdisciplinary Deprescribing and Medication Optimization Intervention
Sponsored by
Region Hovedstadens Apotek
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Comorbidity focused on measuring Deprescibing, Multimorbidity/comorbidity, Knowledge, Interdiciplinary intervention, Medication information, Motivation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Capital Regional Hospital, Amager, Integrated Outpatient Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Interdiciplinary medication review intervention

Control group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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
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

Full Information

First Posted
April 8, 2019
Last Updated
April 12, 2021
Sponsor
Region Hovedstadens Apotek
Collaborators
Copenhagen University Hospital, Hvidovre
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1. Study Identification

Unique Protocol Identification Number
NCT03912103
Brief Title
Interdisciplinary Medication Review Interventions in an Integrated Outpatient Department.
Acronym
FMA-CPH
Official Title
An Interdisciplinary Deprescribing and Medication Optimization Intervention in an Integrated Outpatient Department: a Randomized Controlled Pilot Trial (FMA-CPH)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
March 19, 2019 (Actual)
Primary Completion Date
December 30, 2019 (Actual)
Study Completion Date
March 5, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Region Hovedstadens Apotek
Collaborators
Copenhagen University Hospital, Hvidovre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Comorbidity, Multimorbidity, Drug Prescribing, Cognitive Impairment, Language Problems
Keywords
Deprescibing, Multimorbidity/comorbidity, Knowledge, Interdiciplinary intervention, Medication information, Motivation

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Outcomes Assessor
Masking Description
The evaluation of completed deprescribing and/or medication optimization are performed by two blinded assessors (senior clinical pharmacist and/or medical physicians).
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interdiciplinary medication review intervention
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Interdisciplinary Deprescribing and Medication Optimization Intervention
Intervention Description
as current
Primary Outcome Measure Information:
Title
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.
Description
Number og patients who complete ≥1 deprescribing and/or ≥1 medication optimization 30 days after enrolment in the study.
Time Frame
Baseline to 30 days after enrolment
Secondary Outcome Measure Information:
Title
Difference in patients between the two groups who completed ≥1 deprescribing and/or dose reduction 30 days after enrolment. Difference as %.
Description
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.
Time Frame
Baseline to 30 days after enrolment
Title
Difference in patients between the two groups who completed ≥1 medication optimization 30 days after enrolment in each group. Difference as %
Description
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.
Time Frame
Baseline to 30 days after enrolment
Title
Difference in Knowledge between the two groups who gains more knowledge about their medication measured by ≥1 point on Likert scale (1-5 p).
Description
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
Time Frame
Baseline to 14 days after enrolment
Title
Difference in patients who are satisfied with medication information measured by ≥1 point on Likert scale (1-5 p).
Description
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
Time Frame
Baseline to 14 days after enrolment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helle Ø McNulty, cand pharm
Organizational Affiliation
Region Hovedstadens Apotek
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Charlotte Treldal, Phd
Organizational Affiliation
Region Hovedstadens Apotek
Official's Role
Study Chair
Facility Information:
Facility Name
Capital Regional Hospital, Amager, Integrated Outpatient Department
City
Copenhagen
ZIP/Postal Code
2300
Country
Denmark

12. IPD Sharing Statement

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Interdisciplinary Medication Review Interventions in an Integrated Outpatient Department.

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