Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2026-02-22 @ 6:47 PM
Study NCT ID:
NCT03912103
Status:
COMPLETED
Last Update Posted:
2021-04-13
First Post:
2019-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interdisciplinary Medication Review Interventions in an Integrated Outpatient Department.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The evaluation of completed deprescribing and/or medication optimization are performed by two blinded assessors (senior clinical pharmacist and/or medical physicians).'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Interdisciplinary medicine intervention focused on deprescribing and medication optimization. The control group receives standard care.\n\nFinally we investigate the number of patients who have completed at least one deprescribing and/or medication optimization in each group.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2021-03-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-12', 'studyFirstSubmitDate': '2019-04-08', 'studyFirstSubmitQcDate': '2019-04-10', 'lastUpdatePostDateStruct': {'date': '2021-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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.', 'timeFrame': 'Baseline to 30 days after enrolment', 'description': 'Number og patients who complete ≥1 deprescribing and/or ≥1 medication optimization 30 days after enrolment in the study.'}], 'secondaryOutcomes': [{'measure': 'Difference in patients between the two groups who completed ≥1 deprescribing and/or dose reduction 30 days after enrolment. Difference as %.', 'timeFrame': 'Baseline to 30 days after enrolment', '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.'}, {'measure': 'Difference in patients between the two groups who completed ≥1 medication optimization 30 days after enrolment in each group. Difference as %', 'timeFrame': 'Baseline to 30 days after enrolment', '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.'}, {'measure': 'Difference in Knowledge between the two groups who gains more knowledge about their medication measured by ≥1 point on Likert scale (1-5 p).', 'timeFrame': 'Baseline to 14 days after enrolment', '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'}, {'measure': 'Difference in patients who are satisfied with medication information measured by ≥1 point on Likert scale (1-5 p).', 'timeFrame': 'Baseline to 14 days after enrolment', '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'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Deprescibing', 'Multimorbidity/comorbidity', 'Knowledge', 'Interdiciplinary intervention', 'Medication information', 'Motivation'], 'conditions': ['Comorbidity', 'Multimorbidity', 'Drug Prescribing', 'Cognitive Impairment', 'Language Problems']}, 'descriptionModule': {'briefSummary': '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.\n\nParticipants 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.', 'detailedDescription': 'The FMA-CPH trial is designed as a single-blinded randomized controlled pilot trial starting at the first consultation and end 30 days after.\n\nPatients 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.\n\nMedication 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.\n\nIt 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.\n\nSecondary it is hypothesized the patients in the intervention group:\n\nA. 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)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Consultation at Integrated Outpatient Department subacute track\n* Multi morbidity/Comorbidity\n* Drug Prescribing\n* Mentally fresh\n* Understand and speak Danish\n\nExclusion Criteria:\n\n* Unable to cooperate cognitively\n* Language problems\n* Admission'}, 'identificationModule': {'nctId': 'NCT03912103', 'acronym': 'FMA-CPH', 'briefTitle': 'Interdisciplinary Medication Review Interventions in an Integrated Outpatient Department.', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Region Hovedstadens Apotek'}, 'officialTitle': 'An Interdisciplinary Deprescribing and Medication Optimization Intervention in an Integrated Outpatient Department: a Randomized Controlled Pilot Trial (FMA-CPH)', 'orgStudyIdInfo': {'id': 'VD-2019-09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Interdiciplinary medication review intervention', '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.', 'interventionNames': ['Other: Interdisciplinary Deprescribing and Medication Optimization Intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', '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'}], 'interventions': [{'name': 'Interdisciplinary Deprescribing and Medication Optimization Intervention', 'type': 'OTHER', 'description': 'as current', 'armGroupLabels': ['Interdiciplinary medication review intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2300', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Capital Regional Hospital, Amager, Integrated Outpatient Department', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Helle Ø McNulty, cand pharm', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Region Hovedstadens Apotek'}, {'name': 'Charlotte Treldal, Phd', 'role': 'STUDY_CHAIR', 'affiliation': 'Region Hovedstadens Apotek'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Region Hovedstadens Apotek', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Copenhagen University Hospital, Hvidovre', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical pharmacist', 'investigatorFullName': 'Anissa Aharaz', 'investigatorAffiliation': 'Region Hovedstadens Apotek'}}}}