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

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ClinicalTrials.gov Identifier: NCT03912103
Recruitment Status : Recruiting
First Posted : April 11, 2019
Last Update Posted : April 11, 2019
Sponsor:
Collaborator:
Copenhagen University Hospital, Hvidovre
Information provided by (Responsible Party):
Anissa Aharaz, Region Hovedstadens Apotek

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.


Condition or disease Intervention/treatment Phase
Comorbidity Multimorbidity Drug Prescribing Cognitive Impairment Language Problems Other: Interdisciplinary Deprescribing and Medication Optimization Intervention Not Applicable

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)


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Single (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).
Primary Purpose: Health Services Research
Official Title: An Interdisciplinary Deprescribing and Medication Optimization Intervention in an Integrated Outpatient Department: a Randomized Controlled Pilot Trial (FMA-CPH)
Actual Study Start Date : March 19, 2019
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 30, 2019

Arm Intervention/treatment
Active Comparator: Interdiciplinary medication review intervention
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
as current

No Intervention: Control 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



Primary Outcome Measures :
  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. [ Time Frame: Baseline to 30 days after enrolment ]
    Number og patients who complete ≥1 deprescribing and/or ≥1 medication optimization 30 days after enrolment in the study.


Secondary Outcome Measures :
  1. Difference in patients between the two groups who completed ≥1 deprescribing and/or dose reduction 30 days after enrolment. Difference as %. [ Time Frame: Baseline to 30 days after enrolment ]
    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.

  2. Difference in patients between the two groups who completed ≥1 medication optimization 30 days after enrolment in each group. Difference as % [ Time Frame: Baseline to 30 days after enrolment ]
    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.

  3. Difference in Knowledge between the two groups who gains more knowledge about their medication measured by ≥1 point on Likert scale (1-5 p). [ Time Frame: Baseline to 14 days after enrolment ]
    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

  4. Difference in patients who are satisfied with medication information measured by ≥1 point on Likert scale (1-5 p). [ Time Frame: Baseline to 14 days after enrolment ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03912103


Contacts
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Contact: Anissa Aharaz, cand pharm 004538628723 anissa.aharaz@regionh.dk
Contact: Morten B Houlind, Phdstudent 004528838563 morten.baltzer.houlind@regionh.dk

Locations
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Denmark
Capital Regional Hospital, Amager, Integrated Outpatient Department Recruiting
Copenhagen, Denmark, 2300
Contact: Arne Cyron, L.Med.Phys    004538628723    arne.cyron@regionh.dk   
Sponsors and Collaborators
Region Hovedstadens Apotek
Copenhagen University Hospital, Hvidovre
Investigators
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Study Director: Helle Ø McNulty, cand pharm Region Hovedstadens Apotek
Study Chair: Charlotte Treldal, Phd Region Hovedstadens Apotek

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Responsible Party: Anissa Aharaz, Clinical pharmacist, Region Hovedstadens Apotek
ClinicalTrials.gov Identifier: NCT03912103     History of Changes
Other Study ID Numbers: VD-2019-09
First Posted: April 11, 2019    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anissa Aharaz, Region Hovedstadens Apotek:
Deprescibing
Multimorbidity/comorbidity
Knowledge
Interdiciplinary intervention
Medication information
Motivation
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders