Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-26 @ 1:30 AM
Study NCT ID:
NCT03955133
Status:
COMPLETED
Last Update Posted:
2021-08-17
First Post:
2019-05-15
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
The Adverse Drug Reaction (ADRe) Profile for Polypharmacy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019338', 'term': 'Polypharmacy'}], 'ancestors': [{'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D000088922', 'term': 'Overtreatment'}, {'id': 'D000069342', 'term': 'Medical Overuse'}, {'id': 'D006300', 'term': 'Health Services Misuse'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D001294', 'term': 'Attitude to Health'}, {'id': 'D003695', 'term': 'Delivery of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 's.e.jordan@swansea.ac.uk', 'phone': '+44 (0) 1792518541', 'title': 'Professor Sue Jordan', 'organization': 'Swansea University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '5 months (throughout the study period)', 'description': 'Standard definitions were used. However, adverse events were unlikely to emanate from the use of a paper-based checklist.', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention. This is a Single Arm Before and After Study.', 'description': 'There were no adverse events related to the use of the intervention. (The intervention was a paper-based checklist with supporting information.)', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Changes in Signs and Symptoms Related to Adverse Effects of Prescribed Medicines. Clinical Gains and Benefits to Residents', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': "This is a single arm before and after study with data collection at 4 time points.\n\nAdverse Drug Reaction ADRe Profile for Polypharmacy: PADRe asks nurses to systematically check patients for the manifestation of itemised adverse side effects or undesirable effects of their primary care medicines, as listed in the BNF and manufacturers' Summaries of Product Characteristics (SmPCs), and seminal texts documenting known ADRs. Nurses are asked to share the identified problems with prescribers and pharmacists overseeing medicines charts. A full description is published (references below)."}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months from start of intervention', 'description': 'Number of participant with a change in signs and symptoms related to adverse effects of prescribed medicines. Care quality/ clinical gain/ benefit to patients as recorded in notes and on the Profile by the number and nature of all health problems addressed, particularly serious adverse events.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'care home residents'}, {'type': 'SECONDARY', 'title': 'Number of Clinical Gains Per Resident Between Baseline and 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': "This is a single arm before and after study with data collection at 4 time points.\n\nAdverse Drug Reaction ADRe Profile for Polypharmacy: PADRe asks nurses to systematically check patients for the manifestation of itemised adverse side effects or undesirable effects of their primary care medicines, as listed in the BNF and manufacturers' Summaries of Product Characteristics (SmPCs), and seminal texts documenting known ADRs. Nurses are asked to share the identified problems with prescribers and pharmacists overseeing medicines charts. A full description is published (references below)."}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, then 3 months from start of intervention', 'description': 'Number of problems addressed or ameliorated per resident e.g. pain, falls, sedation. Number at baseline minus number at 3 months.', 'unitOfMeasure': 'number of problems addressed per residen', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'problems recorded for each resident. Change between start and end of study.'}, {'type': 'SECONDARY', 'title': 'Number of Medicines Prescribed: Change Between Baseline and 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': "This is a single arm before and after study with data collection at 4 time points.\n\nAdverse Drug Reaction ADRe Profile for Polypharmacy: PADRe asks nurses to systematically check patients for the manifestation of itemised adverse side effects or undesirable effects of their primary care medicines, as listed in the BNF and manufacturers' Summaries of Product Characteristics (SmPCs), and seminal texts documenting known ADRs. Nurses are asked to share the identified problems with prescribers and pharmacists overseeing medicines charts. A full description is published (references below)."}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-1', 'upperLimit': '2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, then 3 months from start of intervention', 'description': 'number of medicines prescribed, including all prescription items, supplements and topical preparations. change in number during the intervention period (baseline minus 3 months)', 'unitOfMeasure': 'number of medicines per resident', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'care home residents'}, {'type': 'SECONDARY', 'title': 'Number of Problems Listed on Profile', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm Study', 'description': 'before and after - change in number of problems'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, then 3 months from start of intervention', 'description': 'Number of problems listed on the ADRe-p profile per resident. All problems might be attributable to prescribed medicines. Change in number.', 'unitOfMeasure': 'number of problems per resident', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'care home residents'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention', 'description': "This is a single arm before and after study with data collection at 4 time points. The full range of signs and symptoms possibly related to adverse effects of commonly prescribed medicines was collected. Only the first and last data sets were analysed.\n\nAdverse Drug Reaction ADRe Profile for Polypharmacy: PADRe asks nurses to systematically check patients for the manifestation of itemised adverse side effects or undesirable effects of their primary care medicines, as listed in the BNF and manufacturers' Summaries of Product Characteristics (SmPCs), and seminal texts documenting known ADRs. Nurses are asked to share the identified problems with prescribers and pharmacists overseeing medicines charts. A full description is published (references below)."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'participants recruited', 'achievements': [{'comment': 'participants recruited from 3 care homes', 'groupId': 'FG000', 'numUnits': '3', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'comment': 'All care homes that started the intervention completed the study. However, numbers of care homes and participants fell far short of planned.', 'achievements': [{'comment': 'End of study funding', 'groupId': 'FG000', 'numUnits': '3', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'care homes', 'preAssignmentDetails': 'There was no arm / group assignment. This was a single arm study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention', 'description': "This is a single arm before and after study with data collection at 4 time points. Only the first and last results were analysed. The results comprise the full range of signs and symptoms associated with possible adverse effects of commonly prescribed medicines.\n\nAdverse Drug Reaction ADRe Profile for Polypharmacy: PADRe asks nurses to systematically check patients for the manifestation of itemised adverse side effects or undesirable effects of their primary care medicines, as listed in the BNF and manufacturers' Summaries of Product Characteristics (SmPCs), and seminal texts documenting known ADRs. Nurses are asked to share the identified problems with prescribers and pharmacists overseeing medicines charts. A full description is published (references below)."}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '74.8', 'spread': '15.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'problems identified per resident', 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000', 'lowerLimit': '14', 'upperLimit': '19'}]}]}], 'paramType': 'MEDIAN', 'description': "A problem was defined as a sign or symptom noted as an 'undesirable' effect in the Summaries of Product Characteristics (SmPCs) of prescribed medicines. These were ticked on a list shared with clinicians and researchers. Researchers counted the numbers of problems.", 'unitOfMeasure': 'problems', 'dispersionType': 'INTER_QUARTILE_RANGE'}], 'populationDescription': 'care home residents, aged \\>18, receiving \\>3 prescribed medicines, expecting to remain in the home for at least 1 year, able to give informed consent or with a consultee willing to do this on their behalf.'}}, 'documentSection': {'largeDocumentModule': {'noSap': True, 'largeDocs': [{'date': '2017-11-15', 'size': 1855365, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-02-22T17:07', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Use of the intervention could not be blinded.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': "All participating care homes will receive the intervention at the same time. Residents' records and medicines charts will be reviewed sequentially."}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-16', 'studyFirstSubmitDate': '2019-05-15', 'resultsFirstSubmitDate': '2021-02-03', 'studyFirstSubmitQcDate': '2019-05-16', 'lastUpdatePostDateStruct': {'date': '2021-08-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-08-06', 'studyFirstPostDateStruct': {'date': '2019-05-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Changes in Signs and Symptoms Related to Adverse Effects of Prescribed Medicines. Clinical Gains and Benefits to Residents', 'timeFrame': '3 months from start of intervention', 'description': 'Number of participant with a change in signs and symptoms related to adverse effects of prescribed medicines. Care quality/ clinical gain/ benefit to patients as recorded in notes and on the Profile by the number and nature of all health problems addressed, particularly serious adverse events.'}], 'secondaryOutcomes': [{'measure': 'Number of Clinical Gains Per Resident Between Baseline and 3 Months', 'timeFrame': 'Baseline, then 3 months from start of intervention', 'description': 'Number of problems addressed or ameliorated per resident e.g. pain, falls, sedation. Number at baseline minus number at 3 months.'}, {'measure': 'Number of Medicines Prescribed: Change Between Baseline and 3 Months', 'timeFrame': 'Baseline, then 3 months from start of intervention', 'description': 'number of medicines prescribed, including all prescription items, supplements and topical preparations. change in number during the intervention period (baseline minus 3 months)'}, {'measure': 'Number of Problems Listed on Profile', 'timeFrame': 'Baseline, then 3 months from start of intervention', 'description': 'Number of problems listed on the ADRe-p profile per resident. All problems might be attributable to prescribed medicines. Change in number.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['medicines management', 'adverse drug reaction', 'care homes', 'nurses'], 'conditions': ['Polypharmacy']}, 'referencesModule': {'references': [{'pmid': '30231573', 'type': 'BACKGROUND', 'citation': 'Jordan S, Logan PA, Panes G, Vaismoradi M, Hughes D. Adverse Drug Reactions, Power, Harm Reduction, Regulation and the ADRe Profiles. Pharmacy (Basel). 2018 Sep 18;6(3):102. doi: 10.3390/pharmacy6030102.'}, {'pmid': '30269073', 'type': 'BACKGROUND', 'citation': "Jordan S, Banner T, Gabe-Walters M, Mikhail JM, Round J, Snelgrove S, Storey M, Wilson D, Hughes D; Medicines Management Group. Nurse-led medicines' monitoring in care homes study protocol: a process evaluation of the impact and sustainability of the adverse drug reaction (ADRe) profile for mental health medicines. BMJ Open. 2018 Sep 28;8(9):e023377. doi: 10.1136/bmjopen-2018-023377."}, {'pmid': '33411824', 'type': 'RESULT', 'citation': 'Jordan S, Prout H, Carter N, Dicomidis J, Hayes J, Round J, Carson-Stevens A. Nobody ever questions-Polypharmacy in care homes: A mixed methods evaluation of a multidisciplinary medicines optimisation initiative. PLoS One. 2021 Jan 7;16(1):e0244519. doi: 10.1371/journal.pone.0244519. eCollection 2021.'}]}, 'descriptionModule': {'briefSummary': 'Polypharmacy, the use of multiple or inappropriate medications, has the potential to harm older adults by causing cognitive impairment, falls, and hospitalisations. The nurse-led intervention (The ADRe Profile) to review mental health medicines has demonstrated improved care quality by: identifying serious adverse drug reactions (ADRs); reducing prescription of mental health medicines; reducing the prevalence of pain and nausea; and, increasing non-urgent national health service (NHS) contacts. The investigators will develop ADRe to encompass medicines commonly prescribed in primary care and evaluate intervention implementation in care homes in Aneurin Bevan University Health Board.', 'detailedDescription': "The investigators will introduce medicines' monitoring using the PADRe Profile into up to 7 care homes, each with up to 26 residents prescribed \\>4 medicines (estimated \\~90% residents).\n\nEach home will identify a nurse lead and a deputy. Nurses will be asked to administer the PADRe Profile with all patients prescribed \\>4 medicines.\n\nBarriers, facilitators, and feasibility of the Profile will be explored. This will identify how, in which contexts medicines' monitoring can be integrated into routine care, relate the Profile to improved processes and outcomes of care, and inform implementation strategies (see logic model in cited papers).\n\nData collection:\n\n* Record review before and after each of 3 administrations of the intervention to identify clinical and prescription changes. Narrative accounts of problems causing moderate or severe harm will be prepared.\n* Serial interviews and debriefs with nurses: three per nurse.\n* Stakeholder interviews with patients, participating pharmacists and prescribers for an overview of implementation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Resident at the care home and expected to continue to live there for 1 year\n\n * Currently taking \\>3 prescribed medicines daily\n * Willing and able to give informed, signed consent themselves, or where capacity is lacking, a consultee is willing to give advice and assent to the resident participating.\n\nExclusion Criteria:\n\n* age \\<18\n\n * Prescribed \\<4 medicines daily;\n * Receiving active palliative care\n * Not well enough to participate, as screened by their nurses'}, 'identificationModule': {'nctId': 'NCT03955133', 'acronym': 'ADRe-p', 'briefTitle': 'The Adverse Drug Reaction (ADRe) Profile for Polypharmacy', 'organization': {'class': 'OTHER', 'fullName': 'Swansea University'}, 'officialTitle': 'Polypharmacy and Adverse Drug Reactions: Nurse-led Intervention to Minimise Adverse Drug Reactions for Older Adults in Care Homes: a Quality Improvement Process Intervention', 'orgStudyIdInfo': {'id': 'SwanseaNursing'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intervention', 'description': 'This is a single arm before and after study with data collection at 4 time points.', 'interventionNames': ['Other: Adverse Drug Reaction ADRe Profile for Polypharmacy']}], 'interventions': [{'name': 'Adverse Drug Reaction ADRe Profile for Polypharmacy', 'type': 'OTHER', 'description': "PADRe asks nurses to systematically check patients for the manifestation of itemised adverse side effects or undesirable effects of their primary care medicines, as listed in the British National Formulary (BNF) and manufacturers' Summaries of Product Characteristics (SmPCs), and seminal texts documenting known ADRs. Nurses are asked to share the identified problems with prescribers and pharmacists overseeing medicines charts. A full description is published (references below).", 'armGroupLabels': ['intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'sa2 8pp', 'city': 'Swansea', 'country': 'United Kingdom', 'facility': 'Swansea University', 'geoPoint': {'lat': 51.62079, 'lon': -3.94323}}], 'overallOfficials': [{'name': 'sue jordan, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Swansea University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The terms of our ethical approval would not allow this.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Swansea University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aneurin Bevan University Health Board', 'class': 'OTHER'}, {'name': 'Cardiff University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}