Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2025-12-29 @ 6:11 PM
Study NCT ID:
NCT01534559
Status:
COMPLETED
Last Update Posted:
2019-03-25
First Post:
2012-02-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacist-led Medicines Management Outpatient Service
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2018-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-21', 'studyFirstSubmitDate': '2012-02-13', 'studyFirstSubmitQcDate': '2012-02-15', 'lastUpdatePostDateStruct': {'date': '2019-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-02-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to readmission to hospital', 'timeFrame': 'Over 12 month post discharge'}], 'secondaryOutcomes': [{'measure': 'Number of Readmission', 'timeFrame': 'Over 12 months post discharge'}, {'measure': 'Number of GP consultations and GP home visits', 'timeFrame': 'over 12 month post discharge'}, {'measure': 'Number of Accident and Emergency (A&E) visits', 'timeFrame': 'over 12 month post discharge'}, {'measure': 'Medication Appropriateness Index (MAI) score', 'timeFrame': 'Will be assessed at dischrge and 4, 8 and 12 month post discharge'}, {'measure': 'Health-related quality of life (HRQOL)', 'timeFrame': 'Over 12 months post discharge, every 4 months', 'description': 'This will be assessed using EQ-5D questionnaire'}, {'measure': 'Medication Adherence Assessments;', 'timeFrame': 'Over 12 month post discharge. Every 4 months.', 'description': 'Adherence will be assessed using the medication adherence report scale (MARS). Beliefs about medicines will be assessed using the validated beliefs about medicines questionnaire (BMQ).'}, {'measure': 'Cost Utility Analysis', 'timeFrame': 'Over 12 month post discharge.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Patients at High Risk of Medicine-related Problems']}, 'descriptionModule': {'briefSummary': 'It widely accepted that a number of medication related problems can occur after the patient has been discharged from the hospital. An obvious extension of the ongoing integrated medicines management programme (IMMP) is therefore to provide a medicines management clinic within an outpatient setting as well as follow-up telephone calls from a clinical pharmacist. This study aims to assess the influence a pharmacist-led medicines management outpatient service on patients at high risk of medication related problems.\n\nIt is anticipated that this service will\n\n* Ensure continuity of pharmaceutical care for patients post discharge.\n* Reinforce patient education in order to improve knowledge and understanding of the medication prescribed.\n* Ensure that both prescription medicines and OTC preparations are used appropriately.\n* Facilitate the communication with other members of healthcare team in order to agree and implement measures to overcome medication related problems.', 'detailedDescription': "Patient safety and wellbeing are central concerns within the health service. Recent publications have highlighted the importance of medicines management and have called for local strategies to be introduced. An Integrated Medicines Management Programme (IMMP) has been implemented within Northern Health and Social Care Trust to ensure that a co-ordinated pharmacy service is available throughout the hospital stay for its medical patients. The IMMP has resulted in a number of benefits including improved patient safety, more effective use of medications, reduced length of stay, reduced readmissions rates, improved communication across the healthcare interface and user satisfaction.\n\nIt is widely accepted that a number of medication related problems can occur post discharge when complicated medication regimens can often prove confusing. This can lead to mismanagement of medicines and early rehospitalisation of patients. Although these problems are frequently commented upon, research in this area is still lacking. The present project aims to examine an extension of the present IMM service by evaluating the impact/patient benefit of a customised outpatient service provided by clinical pharmacy staff to patients post-discharge. An increase in patients' medicines adherence, a greater satisfaction with information about their medicines, improved beliefs about the necessity of their medicines, a decrease in medicines-related problems, a decrease in re-hospitalisation rates, extended time to re-hospitalisation, and a decrease in overall costs of patients care is anticipated.\n\nThis study will be carried out as a collaboration between the School of Pharmacy at Queen's University Belfast and the Northern Health and Social Care Trust (2 sites; Antrim Area Hospital and Whiteabbey Hospital)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nPatients (\\>= 18 years old) admitted into one of the study hospitals as acute/unscheduled medical admission and meet at least one of the following criteria:\n\n* Prescribed five or more regular long term medications.\n* Have three or more changes to medications during hospital stay.\n* Past history of medication related problems.\n* Patient referred to the medicines management clinic service by hospital doctor or clinical pharmacist due to concerns about ability to manage medicines in primary care.\n\nExclusion Criteria:\n\n* Patient being discharged to residential/nursing homes\n* Palliative care patients\n* Patients unable to give informed consent e.g. Alzheimer's Disease\n* Patients unable to use telephone at home."}, 'identificationModule': {'nctId': 'NCT01534559', 'acronym': 'MMC', 'briefTitle': 'Pharmacist-led Medicines Management Outpatient Service', 'organization': {'class': 'OTHER', 'fullName': "Queen's University, Belfast"}, 'officialTitle': 'A Pharmacist-led Medicines Management Outpatient Service for Patients at High Risk of Medication Related Problems', 'orgStudyIdInfo': {'id': 'QUB B11/34'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Outpatient Medicine Management Clinic', 'description': 'Consented patients will attend two outpatient clinic appointments to receive help with any (potential) medicine-related problems', 'interventionNames': ['Other: Medicines Management Outpatient service']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Patients will receive the normal care provided by the hospital'}], 'interventions': [{'name': 'Medicines Management Outpatient service', 'type': 'OTHER', 'otherNames': ['Medicines Management Clinic', 'Pharmacist-led outpatient service'], 'description': 'New customised clinical pharmacy service (medicines management clinic and follow-up phone calls)', 'armGroupLabels': ['Outpatient Medicine Management Clinic']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'BT41 2RL', 'city': 'Antrim', 'state': 'Northern Ireland', 'country': 'United Kingdom', 'facility': 'Northern Health and Social Care Trust', 'geoPoint': {'lat': 54.7175, 'lon': -6.211}}], 'overallOfficials': [{'name': 'James C McElnay, BSc, PhD', 'role': 'STUDY_CHAIR', 'affiliation': "Queen's University, Belfast"}, {'name': 'Michael G Scott, BSc, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northern Health and Social Care Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Queen's University, Belfast", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief Investigator', 'investigatorFullName': 'James McElnay', 'investigatorAffiliation': "Queen's University, Belfast"}}}}