ComorbidityFMA-CPHNCT03912103
Interdisciplinary Medication Review Interventions in an Integrated Outpatient Department.
A study testing Interdisciplinary Deprescribing and Medication Optimization Intervention in people with Comorbidity and Multimorbidity, run by Region Hovedstadens Apotek at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Comorbidity, Multimorbidity, Drug Prescribing
- What is being tested?
- Interdisciplinary Deprescribing and Medication Optimization Intervention
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteDenmark
- Study dates
- 19 Mar 2019to 5 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consultation at Integrated Outpatient Department subacute track
- Multi morbidity/Comorbidity
- Drug Prescribing
- Mentally fresh
- Understand and speak Danish
Who cannot join
- Unable to cooperate cognitively
- Language problems
- Admission
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Capital Regional Hospital, Amager, Integrated Outpatient Department
Copenhagen, 2300
About this study
Official title: An Interdisciplinary Deprescribing and Medication Optimization Intervention in an Integrated Outpatient Department: a Randomized Controlled Pilot Trial (FMA-CPH)
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.
Read the 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:
- 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)
- Being tested
- Interdisciplinary Deprescribing and Medication Optimization Intervention
- Keywords
- Deprescibing, Multimorbidity/comorbidity, Knowledge, Interdiciplinary intervention, Medication information, Motivation
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interdisciplinary Deprescribing and Medication Optimization InterventionOther
as current
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 %.
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.
Measured: 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 %
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.
Measured: 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).
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
Measured: 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).
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
Measured: Baseline to 14 days after enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2019
- Study start19 Mar 2019
- Primary completion30 Dec 2019
- Study completion5 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ComorbidityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Hovedstadens Apotek
- Sponsor type
- Other government
- Collaborators
- Copenhagen University Hospital, Hvidovre
- Responsible party
- Principal investigator, Anissa Aharaz, Region Hovedstadens Apotek
- Investigators
- Helle Ø McNulty, cand pharm, Study director, Region Hovedstadens ApotekCharlotte Treldal, Phd, Study chair, Region Hovedstadens Apotek
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03912103
- Sponsor's protocol ID
- VD-2019-09
- Acronym
- FMA-CPH
- Status last verified
- Mar 2019
- First submitted
- 8 Apr 2019
- Last updated
- 13 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Interdisciplinary Deprescribing and Medication Optimization Intervention in an Integrated Outpatient Department: a Randomized Controlled Pilot Trial (FMA-CPH)
- ClinicalTrials.gov ID
- NCT03912103
- Acronym / sponsor ID
- FMA-CPH / VD-2019-09
- Keywords
- Deprescibing, Multimorbidity/comorbidity, Knowledge, Interdiciplinary intervention, Medication information, Motivation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Region Hovedstadens ApotekOther government
- Collaborators
- Copenhagen University Hospital, Hvidovre
- Study start
- 19 Mar 2019 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 5 Mar 2021 (actual)
- First posted
- 11 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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)
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Interdiciplinary medication review intervention | Active comparator | Other: Interdisciplinary Deprescribing and Medication Optimization InterventionThe 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 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Consultation at Integrated Outpatient Department subacute track
- Multi morbidity/Comorbidity
- Drug Prescribing
- Mentally fresh
- Understand and speak Danish
Key exclusion criteria (3 listed)
- Unable to cooperate cognitively
- Language problems
- Admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interdisciplinary Deprescribing and Medication Optimization Interventionas current | Other | Interdiciplinary medication review intervention |
Primary outcome
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.
4 secondary outcomes
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helle Ø McNulty, cand pharm study director
Region Hovedstadens Apotek
Charlotte Treldal, Phd study chair
Region Hovedstadens Apotek
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interdisciplinary Deprescribing and Medication Optimization Intervention in people with Comorbidity and Multimorbidity, run by Region Hovedstadens Apotek at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2021.