Interdisciplinary Medication Review Interventions in an Integrated Outpatient Department.

NCT ID: NCT03912103

Last Updated: 2021-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-19
• Study Completion Date: 2021-03-05

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)

Conditions

Comorbidity; Multimorbidity; Drug Prescribing; Cognitive Impairment; Language Problems

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Interdisciplinary Deprescribing and Medication Optimization Intervention

Intervention Type: OTHER

as current

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Interdisciplinary Deprescribing and Medication Optimization Intervention

as current

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Copenhagen University Hospital, Hvidovre

OTHER

Sponsor Role: collaborator

Region Hovedstadens Apotek

OTHER_GOV

Sponsor Role: lead

Responsible Party

Anissa Aharaz

Clinical pharmacist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Helle Ø McNulty, cand pharm

Role: STUDY_DIRECTOR

Region Hovedstadens Apotek

Charlotte Treldal, Phd

Role: STUDY_CHAIR

Region Hovedstadens Apotek

Locations

Capital Regional Hospital, Amager, Integrated Outpatient Department

Copenhagen, , Denmark

Countries

Denmark

Other Identifiers

VD-2019-09

Identifier Type: -

Identifier Source: org_study_id