Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2026-03-01 @ 1:45 PM
Study NCT ID:
NCT03655405
Status:
COMPLETED
Last Update Posted:
2021-05-19
First Post:
2018-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Randomised, Controlled Trial of an Individual Deprescribing Intervention for Nursing Homes Residents
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'anne.niquille@unisante.ch', 'phone': '+41213144845', 'title': 'Dr Anne Niquille', 'organization': 'a. Community Pharmacy, Center for Primary Care and Public Health (Unisanté), University of Lausanne, Switzerland'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '4 months', 'description': 'Adverse events were collected for the intervention group only.', 'eventGroups': [{'id': 'EG000', 'title': '0.911 0.911 Individual Deprescribing Intervention', 'description': 'Participants allocated to the intervention arm will receive the Individual Deprescribing Intervention (pharmacist-led medication review, followed by the creation of a deprescribing plan by the pharmacist, physician and responsible nurse).\n\nIndividual Deprescribing Intervention: The pharmacist responsible for the nursing home will perform a medication review (type 3). The results of this review will be discussed with the physician and nurse responsible for this participant, with the goal of creating a personalised deprescribing plan. Once validated by the physician, this plan will be submitted to the participant for approval.', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 32, 'otherNumAffected': 0, 'seriousNumAtRisk': 31, 'deathsNumAffected': 5, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Control', 'description': 'Participants allocated to the control group will receive usual care.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 4, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematemesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gout crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Inappropriate Medication at Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Individual Deprescribing Intervention', 'description': 'Participants allocated to the intervention arm will receive the Individual Deprescribing Intervention (pharmacist-led medication review, followed by the creation of a deprescribing plan by the pharmacist, physician and responsible nurse).\n\nIndividual Deprescribing Intervention: The pharmacist responsible for the nursing home will perform a medication review (type 3). The results of this review will be discussed with the physician and nurse responsible for this participant, with the goal of creating a personalised deprescribing plan. Once validated by the physician, this plan will be submitted to the participant for approval.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants allocated to the control group will receive usual care.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.35', 'spread': '2.72', 'groupId': 'OG000'}, {'value': '4.85', 'spread': '2.58', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.723', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Incidence Rate Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.972', 'ciLowerLimit': '0.830', 'ciUpperLimit': '1.138', 'statisticalMethod': 'Regression, Poisson', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Number of PIMs at follow-up, adjusted for baseline value'}], 'paramType': 'MEAN', 'timeFrame': '4 months', 'description': 'Number of inappropriate medications prescribed at follow-up, assessed using the French translation of STOPP v2.', 'unitOfMeasure': 'drugs', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Potentially Inappropriate DDDs Prescribed to Participants at Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Individual Deprescribing Intervention', 'description': 'Participants allocated to the intervention arm will receive the Individual Deprescribing Intervention (pharmacist-led medication review, followed by the creation of a deprescribing plan by the pharmacist, physician and responsible nurse).\n\nIndividual Deprescribing Intervention: The pharmacist responsible for the nursing home will perform a medication review (type 3). The results of this review will be discussed with the physician and nurse responsible for this participant, with the goal of creating a personalised deprescribing plan. Once validated by the physician, this plan will be submitted to the participant for approval.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants allocated to the control group will receive usual care.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.73', 'spread': '2.97', 'groupId': 'OG000'}, {'value': '3.10', 'spread': '1.99', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.033', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Incidence Rate Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.763', 'ciLowerLimit': '0.594', 'ciUpperLimit': '0.979', 'statisticalMethod': 'Regression, Poisson', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Number of potentially inappropriate DDD at follow-up, adjusted for baseline value'}], 'paramType': 'MEAN', 'timeFrame': '4 months', 'description': 'Appropriateness assessed using the French translation of STOPP v2; DDD defined by WHO.', 'unitOfMeasure': 'DDD', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Chronic Drugs Prescribed to Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Individual Deprescribing Intervention', 'description': 'Participants allocated to the intervention arm will receive the Individual Deprescribing Intervention (pharmacist-led medication review, followed by the creation of a deprescribing plan by the pharmacist, physician and responsible nurse).\n\nIndividual Deprescribing Intervention: The pharmacist responsible for the nursing home will perform a medication review (type 3). The results of this review will be discussed with the physician and nurse responsible for this participant, with the goal of creating a personalised deprescribing plan. Once validated by the physician, this plan will be submitted to the participant for approval.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants allocated to the control group will receive usual care.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.68', 'spread': '3.59', 'groupId': 'OG000'}, {'value': '9.67', 'spread': '3.10', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.064', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Incidence Rate Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.915', 'ciLowerLimit': '0.834', 'ciUpperLimit': '1.005', 'statisticalMethod': 'Regression, Poisson', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Number of chronic drugs at follow-up, adjusted for baseline value'}], 'paramType': 'MEAN', 'timeFrame': '4 months', 'description': 'Number of Chronic Drugs Prescribed to Participants', 'unitOfMeasure': 'drugs', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Chronic DDDs Prescribed to Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Individual Deprescribing Intervention', 'description': 'Participants allocated to the intervention arm will receive the Individual Deprescribing Intervention (pharmacist-led medication review, followed by the creation of a deprescribing plan by the pharmacist, physician and responsible nurse).\n\nIndividual Deprescribing Intervention: The pharmacist responsible for the nursing home will perform a medication review (type 3). The results of this review will be discussed with the physician and nurse responsible for this participant, with the goal of creating a personalised deprescribing plan. Once validated by the physician, this plan will be submitted to the participant for approval.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants allocated to the control group will receive usual care.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.82', 'spread': '3.85', 'groupId': 'OG000'}, {'value': '7.65', 'spread': '2.74', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.857', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Incidence Rate Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.019', 'ciLowerLimit': '0.833', 'ciUpperLimit': '1.246', 'statisticalMethod': 'Regression, Poisson', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Number of chronic drugs at follow-up, adjusted for baseline value'}], 'paramType': 'MEAN', 'timeFrame': '4 months', 'description': 'Number of chronic DDDs prescribed to participants', 'unitOfMeasure': 'DDD', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of New Drugs Prescribed as a Result of the Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Individual Deprescribing Intervention', 'description': 'Participants allocated to the intervention arm will receive the Individual Deprescribing Intervention (pharmacist-led medication review, followed by the creation of a deprescribing plan by the pharmacist, physician and responsible nurse).\n\nIndividual Deprescribing Intervention: The pharmacist responsible for the nursing home will perform a medication review (type 3). The results of this review will be discussed with the physician and nurse responsible for this participant, with the goal of creating a personalised deprescribing plan. Once validated by the physician, this plan will be submitted to the participant for approval.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants allocated to the control group will receive usual care.'}], 'timeFrame': '4 months', 'description': 'This outcome was not analysed', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome was not analyzed, as the drugs newly prescribed as a result of the intervention could not be distinguished from the other drugs newly prescribed.'}, {'type': 'SECONDARY', 'title': 'Health-related Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Individual Deprescribing Intervention', 'description': 'Participants allocated to the intervention arm will receive the Individual Deprescribing Intervention (pharmacist-led medication review, followed by the creation of a deprescribing plan by the pharmacist, physician and responsible nurse).\n\nIndividual Deprescribing Intervention: The pharmacist responsible for the nursing home will perform a medication review (type 3). The results of this review will be discussed with the physician and nurse responsible for this participant, with the goal of creating a personalised deprescribing plan. Once validated by the physician, this plan will be submitted to the participant for approval.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants allocated to the control group will receive usual care.'}], 'classes': [{'title': 'EQ-5D-5L scale', 'categories': [{'measurements': [{'value': '63.5', 'spread': '17.2', 'groupId': 'OG000'}, {'value': '65.4', 'spread': '22.4', 'groupId': 'OG001'}]}]}, {'title': 'EQ-5D-l index', 'categories': [{'measurements': [{'value': '0.51', 'spread': '0.31', 'groupId': 'OG000'}, {'value': '0.61', 'spread': '0.33', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.769', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.36', 'ciLowerLimit': '-10.60', 'ciUpperLimit': '7.89', 'groupDescription': 'Analysis for the scale component', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Scale value at follow-up, adjusted for baseline value'}, {'pValue': '0.075', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.096', 'ciLowerLimit': '-0.202', 'ciUpperLimit': '0.01', 'groupDescription': 'Analysis for the index component', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Scale value at follow-up, adjusted for baseline value'}], 'paramType': 'MEAN', 'timeFrame': '4 months', 'description': 'The EuroQol 5-Dimensions 5-Levels (EQ-5D-5L) tool was used to assess quality of life; this tool includes\n\n* a visual analog scale, ranging from 0 to 100, 100 indicating "the best health you can imagine" and 0 "the worst health you can imagine". Higher results indicate an higher quality of life.\n* 5 questions, each with 5 possible answers. Using a valuation set, the answers to individual questions were transformed in a numeric index value for each participants, with a maximum of 1 and an infinitely low minimum. Higher values indicates higher perceived health-related quality of life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data on this outcome were missing for some participants'}, {'type': 'SECONDARY', 'title': 'Number of Common Drug-related Complaints at Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Individual Deprescribing Intervention', 'description': 'Participants allocated to the intervention arm will receive the Individual Deprescribing Intervention (pharmacist-led medication review, followed by the creation of a deprescribing plan by the pharmacist, physician and responsible nurse).\n\nIndividual Deprescribing Intervention: The pharmacist responsible for the nursing home will perform a medication review (type 3). The results of this review will be discussed with the physician and nurse responsible for this participant, with the goal of creating a personalised deprescribing plan. Once validated by the physician, this plan will be submitted to the participant for approval.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants allocated to the control group will receive usual care.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.35', 'spread': '2.60', 'groupId': 'OG000'}, {'value': '1.44', 'spread': '1.26', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.212', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Incidence Rate Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.237', 'ciLowerLimit': '0.886', 'ciUpperLimit': '1.727', 'statisticalMethod': 'Mixed-effect regression, Poisson', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Number at follow-up, adjusted for baseline value'}], 'paramType': 'MEAN', 'timeFrame': '4 months', 'description': 'Number of common drug-related complaints at follow-up', 'unitOfMeasure': 'Number of complaints', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data on this outcome at follow-up were missing for some participants, because of death or hospitalisation.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Deaths', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Individual Deprescribing Intervention', 'description': 'Participants allocated to the intervention arm will receive the Individual Deprescribing Intervention (pharmacist-led medication review, followed by the creation of a deprescribing plan by the pharmacist, physician and responsible nurse).\n\nIndividual Deprescribing Intervention: The pharmacist responsible for the nursing home will perform a medication review (type 3). The results of this review will be discussed with the physician and nurse responsible for this participant, with the goal of creating a personalised deprescribing plan. Once validated by the physician, this plan will be submitted to the participant for approval.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants allocated to the control group will receive usual care.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.675', 'groupIds': ['OG000', 'OG001'], 'paramType': 'p-value', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.675', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 months', 'description': 'Number of deaths', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants Hospitalized', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Individual Deprescribing Intervention', 'description': 'Participants allocated to the intervention arm will receive the Individual Deprescribing Intervention (pharmacist-led medication review, followed by the creation of a deprescribing plan by the pharmacist, physician and responsible nurse).\n\nIndividual Deprescribing Intervention: The pharmacist responsible for the nursing home will perform a medication review (type 3). The results of this review will be discussed with the physician and nurse responsible for this participant, with the goal of creating a personalised deprescribing plan. Once validated by the physician, this plan will be submitted to the participant for approval.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants allocated to the control group will receive usual care.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.615', 'groupIds': ['OG000', 'OG001'], 'paramType': 'p-value', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.615', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 months', 'description': 'Number of participants hospitalized at any time during the study', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Days Spent in Hospital', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Individual Deprescribing Intervention', 'description': 'Participants allocated to the intervention arm will receive the Individual Deprescribing Intervention (pharmacist-led medication review, followed by the creation of a deprescribing plan by the pharmacist, physician and responsible nurse).\n\nIndividual Deprescribing Intervention: The pharmacist responsible for the nursing home will perform a medication review (type 3). The results of this review will be discussed with the physician and nurse responsible for this participant, with the goal of creating a personalised deprescribing plan. Once validated by the physician, this plan will be submitted to the participant for approval.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants allocated to the control group will receive usual care.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.6', 'spread': '15.8', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '2.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.366', 'groupIds': ['OG000', 'OG001'], 'paramType': 'p-value', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.366', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '4 months', 'description': 'Average number of days spent in hospital during the study period', 'unitOfMeasure': 'Number of days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Falls Per Participant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Individual Deprescribing Intervention', 'description': 'Participants allocated to the intervention arm will receive the Individual Deprescribing Intervention (pharmacist-led medication review, followed by the creation of a deprescribing plan by the pharmacist, physician and responsible nurse).\n\nIndividual Deprescribing Intervention: The pharmacist responsible for the nursing home will perform a medication review (type 3). The results of this review will be discussed with the physician and nurse responsible for this participant, with the goal of creating a personalised deprescribing plan. Once validated by the physician, this plan will be submitted to the participant for approval.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants allocated to the control group will receive usual care.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.45', 'spread': '0.89', 'groupId': 'OG000'}, {'value': '0.48', 'spread': '0.80', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.738', 'groupIds': ['OG000', 'OG001'], 'paramType': 'p-value', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.738', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '4 months', 'description': 'Average number of falls during the study period', 'unitOfMeasure': 'falls', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants Who Fell', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Individual Deprescribing Intervention', 'description': 'Participants allocated to the intervention arm will receive the Individual Deprescribing Intervention (pharmacist-led medication review, followed by the creation of a deprescribing plan by the pharmacist, physician and responsible nurse).\n\nIndividual Deprescribing Intervention: The pharmacist responsible for the nursing home will perform a medication review (type 3). The results of this review will be discussed with the physician and nurse responsible for this participant, with the goal of creating a personalised deprescribing plan. Once validated by the physician, this plan will be submitted to the participant for approval.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants allocated to the control group will receive usual care.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.781', 'groupIds': ['OG000', 'OG001'], 'paramType': 'p-value', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.781', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 months', 'description': 'Number of participants who fell at least once during the study period', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Falls in Participants That Fell at Least Once', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Individual Deprescribing Intervention', 'description': 'Participants allocated to the intervention arm will receive the Individual Deprescribing Intervention (pharmacist-led medication review, followed by the creation of a deprescribing plan by the pharmacist, physician and responsible nurse).\n\nIndividual Deprescribing Intervention: The pharmacist responsible for the nursing home will perform a medication review (type 3). The results of this review will be discussed with the physician and nurse responsible for this participant, with the goal of creating a personalised deprescribing plan. Once validated by the physician, this plan will be submitted to the participant for approval.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants allocated to the control group will receive usual care.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.6', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '0.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.958', 'groupIds': ['OG000', 'OG001'], 'paramType': 'p-value', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.958', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '4 months', 'unitOfMeasure': 'Number of falls', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only the participants who fell at least once were included in this analysis'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Days Spent With Physical Restraints', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Individual Deprescribing Intervention', 'description': 'Participants allocated to the intervention arm will receive the Individual Deprescribing Intervention (pharmacist-led medication review, followed by the creation of a deprescribing plan by the pharmacist, physician and responsible nurse).\n\nIndividual Deprescribing Intervention: The pharmacist responsible for the nursing home will perform a medication review (type 3). The results of this review will be discussed with the physician and nurse responsible for this participant, with the goal of creating a personalised deprescribing plan. Once validated by the physician, this plan will be submitted to the participant for approval.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants allocated to the control group will receive usual care.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.6', 'spread': '39.1', 'groupId': 'OG000'}, {'value': '15.1', 'spread': '39.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.911', 'groupIds': ['OG000', 'OG001'], 'paramType': 'p-value', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.911', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '4 months', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Individual Deprescribing Intervention', 'description': 'Participants allocated to the intervention arm will receive the Individual Deprescribing Intervention (pharmacist-led medication review, followed by the creation of a deprescribing plan by the pharmacist, physician and responsible nurse).\n\nIndividual Deprescribing Intervention: The pharmacist responsible for the nursing home will perform a medication review (type 3). The results of this review will be discussed with the physician and nurse responsible for this participant, with the goal of creating a personalised deprescribing plan. Once validated by the physician, this plan will be submitted to the participant for approval.'}, {'id': 'FG001', 'title': 'Control', 'description': 'Participants allocated to the control group will receive usual care.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Death after initial data collection', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Died before initial data collection', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Individual Deprescribing Intervention', 'description': 'Participants allocated to the intervention arm will receive the Individual Deprescribing Intervention (pharmacist-led medication review, followed by the creation of a deprescribing plan by the pharmacist, physician and responsible nurse).\n\nIndividual Deprescribing Intervention: The pharmacist responsible for the nursing home will perform a medication review (type 3). The results of this review will be discussed with the physician and nurse responsible for this participant, with the goal of creating a personalised deprescribing plan. Once validated by the physician, this plan will be submitted to the participant for approval.'}, {'id': 'BG001', 'title': 'Control', 'description': 'Participants allocated to the control group will receive usual care.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '87', 'groupId': 'BG000', 'lowerLimit': '80', 'upperLimit': '91'}, {'value': '84', 'groupId': 'BG001', 'lowerLimit': '78', 'upperLimit': '88'}, {'value': '87', 'groupId': 'BG002', 'lowerLimit': '80', 'upperLimit': '90'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Switzerland', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Duration of stay in years', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3.1', 'spread': '2.3', 'groupId': 'BG000'}, {'value': '3.6', 'spread': '3.6', 'groupId': 'BG001'}, {'value': '3.4', 'spread': '2.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Number of drugs prescribed', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000', 'lowerLimit': '12', 'upperLimit': '19'}, {'value': '15', 'groupId': 'BG001', 'lowerLimit': '13', 'upperLimit': '18'}, {'value': '15', 'groupId': 'BG002', 'lowerLimit': '12', 'upperLimit': '19'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'drugs', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Number of chronic drugs', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000', 'lowerLimit': '10', 'upperLimit': '14'}, {'value': '11', 'groupId': 'BG001', 'lowerLimit': '8', 'upperLimit': '12'}, {'value': '11', 'groupId': 'BG002', 'lowerLimit': '9', 'upperLimit': '13'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'drugs', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Number of PIMs', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000', 'lowerLimit': '4', 'upperLimit': '7'}, {'value': '6', 'groupId': 'BG001', 'lowerLimit': '3', 'upperLimit': '7'}, {'value': '5', 'groupId': 'BG002', 'lowerLimit': '3', 'upperLimit': '7'}]}]}], 'paramType': 'MEDIAN', 'description': "Number of Potentially Inappropriate Medications (PIMs); appropriateness is assessed using the French translation of the Screening Tool of Older People's Prescription (STOPP) v2.", 'unitOfMeasure': 'potentially inappropriate medications', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Number of chronic DDDs', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '9.6', 'spread': '3.5', 'groupId': 'BG000'}, {'value': '9.3', 'spread': '3.6', 'groupId': 'BG001'}, {'value': '9.5', 'spread': '4.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "Number of chronic Defined Daily Dose (DDD); chronicity is defined as the absence of a planned cessation date in the participant's record. DDDs are assigned according the the World Health Organization's (WHO) DDD set.", 'unitOfMeasure': 'chronic DDD', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Number of PIM DDDs', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3.6', 'spread': '2.8', 'groupId': 'BG000'}, {'value': '3.4', 'spread': '2.1', 'groupId': 'BG001'}, {'value': '3.5', 'spread': '2.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "Sum of potentially inappropriate DDDs; appropriateness is assessed using the French translation of STOPP v2; DDDs are assigned according to the WHO's DDD set.", 'unitOfMeasure': 'PIM DDD', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Quality of life: EQ-5D-5L analog scale', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '56.5', 'spread': '24.8', 'groupId': 'BG000'}, {'value': '61.4', 'spread': '20.5', 'groupId': 'BG001'}, {'value': '58.9', 'spread': '22.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The EuroQol 5-Dimensions 5-Levels (EQ-5D-5L) tool was used to assess quality of life; this tool includes a visual analog scale, ranging from 0 to 100, 100 indicating "the best health you can imagine" and 0 "the worst health you can imagine". Higher results indicate an higher quality of life.', 'unitOfMeasure': 'analog scale units', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Quality of life: EQ-5D-5L index', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0.46', 'spread': '0.34', 'groupId': 'BG000'}, {'value': '0.50', 'spread': '0.33', 'groupId': 'BG001'}, {'value': '0.48', 'spread': '0.34', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The quality of life was assessed using EQ-5D-5L; this tool includes 5 questions, each with 5 possible answers. Using a valuation set, the answers to individual questions were transformed in a numeric index value for each participants, with a maximum of 1 and an infinitely low minimum. Higher values indicates higher perceived health-related quality of life.', 'unitOfMeasure': 'index', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Intervention: 1 participant excluded, died before initial data collection; Control: 3 participants excluded: 2 died before initial data collection, no data was collected on one.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-08-27', 'size': 1834426, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-10-14T10:13', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2019-08-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-28', 'studyFirstSubmitDate': '2018-08-30', 'resultsFirstSubmitDate': '2020-11-10', 'studyFirstSubmitQcDate': '2018-08-30', 'lastUpdatePostDateStruct': {'date': '2021-05-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-04-28', 'studyFirstPostDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Deaths', 'timeFrame': '4 months', 'description': 'Number of deaths'}, {'measure': 'Number of Participants Hospitalized', 'timeFrame': '4 months', 'description': 'Number of participants hospitalized at any time during the study'}, {'measure': 'Days Spent in Hospital', 'timeFrame': '4 months', 'description': 'Average number of days spent in hospital during the study period'}, {'measure': 'Number of Falls Per Participant', 'timeFrame': '4 months', 'description': 'Average number of falls during the study period'}, {'measure': 'Number of Participants Who Fell', 'timeFrame': '4 months', 'description': 'Number of participants who fell at least once during the study period'}, {'measure': 'Number of Falls in Participants That Fell at Least Once', 'timeFrame': '4 months'}, {'measure': 'Number of Days Spent With Physical Restraints', 'timeFrame': '4 months'}], 'primaryOutcomes': [{'measure': 'Number of Inappropriate Medication at Follow-up', 'timeFrame': '4 months', 'description': 'Number of inappropriate medications prescribed at follow-up, assessed using the French translation of STOPP v2.'}], 'secondaryOutcomes': [{'measure': 'Number of Potentially Inappropriate DDDs Prescribed to Participants at Follow-up', 'timeFrame': '4 months', 'description': 'Appropriateness assessed using the French translation of STOPP v2; DDD defined by WHO.'}, {'measure': 'Number of Chronic Drugs Prescribed to Participants', 'timeFrame': '4 months', 'description': 'Number of Chronic Drugs Prescribed to Participants'}, {'measure': 'Number of Chronic DDDs Prescribed to Participants', 'timeFrame': '4 months', 'description': 'Number of chronic DDDs prescribed to participants'}, {'measure': 'Number of New Drugs Prescribed as a Result of the Intervention', 'timeFrame': '4 months', 'description': 'This outcome was not analysed'}, {'measure': 'Health-related Quality of Life', 'timeFrame': '4 months', 'description': 'The EuroQol 5-Dimensions 5-Levels (EQ-5D-5L) tool was used to assess quality of life; this tool includes\n\n* a visual analog scale, ranging from 0 to 100, 100 indicating "the best health you can imagine" and 0 "the worst health you can imagine". Higher results indicate an higher quality of life.\n* 5 questions, each with 5 possible answers. Using a valuation set, the answers to individual questions were transformed in a numeric index value for each participants, with a maximum of 1 and an infinitely low minimum. Higher values indicates higher perceived health-related quality of life.'}, {'measure': 'Number of Common Drug-related Complaints at Follow-up', 'timeFrame': '4 months', 'description': 'Number of common drug-related complaints at follow-up'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Deprescribing', 'Nursing Home', 'Potentially Inappropriate Medication'], 'conditions': ['Polypharmacy', 'Inappropriate Prescribing']}, 'referencesModule': {'references': [{'pmid': '32622774', 'type': 'DERIVED', 'citation': 'Cateau D, Ballabeni P, Mena S, Bugnon O, Niquille A. Deprescribing in nursing homes: Protocol for nested, randomised controlled hybrid trials of deprescribing interventions. Res Social Adm Pharm. 2021 Apr;17(4):786-794. doi: 10.1016/j.sapharm.2020.05.026. Epub 2020 May 27.'}], 'seeAlsoLinks': [{'url': 'http://www.nfp74.ch/fr/projets/soins-stationnaires/projet-bugnon', 'label': 'Project description on the funding body website'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the effects of a pharmacist-led, deprescribing-focused medication review on the use of inappropriate medications by nursing home residents', 'detailedDescription': 'Nursing home residents are often prescribed inappropriate medication, drugs whose negative effects outweigh potential benefits or which are not useful anymore. Inappropriate medication have been linked with worse health outcomes, hospitalisations and death. Deprescribing, the structured process of withdrawing or tapering inappropriate medications, has been studied as a potential solution to this problem.\n\nIn this study, nursing home residents living in institution which are already engaged in a deprescribing process will be randomly allocated to receive a medication review or usual care. The medication review will be performed by the nursing home pharmacist an its results will be discussed with the responsible physicians and nurses to create a deprescribing plan specifically tailored to the needs of the resident.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Take 5 or more prescribed drugs daily;\n* Reside in the Nursing Home since at least 4 months.\n\nExclusion Criteria:\n\n* Physician judges that discussing deprescribing with them risks destabilising them.'}, 'identificationModule': {'nctId': 'NCT03655405', 'acronym': 'OLD-NH-IDeI', 'briefTitle': 'Randomised, Controlled Trial of an Individual Deprescribing Intervention for Nursing Homes Residents', 'organization': {'class': 'OTHER', 'fullName': 'University of Geneva, Switzerland'}, 'officialTitle': 'Opportunities and Limits to Deprescribing in Nursing Homes: Randomised, Controlled Trial of an Individual Deprescribing Intervention for Nursing Homes Residents.', 'orgStudyIdInfo': {'id': 'OLD-NH-IDeI-2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Individual Deprescribing Intervention', 'description': 'Participants allocated to the intervention arm will receive the Individual Deprescribing Intervention (pharmacist-led medication review, followed by the creation of a deprescribing plan by the pharmacist, physician and responsible nurse).', 'interventionNames': ['Other: Individual Deprescribing Intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Participants allocated to the control group will receive usual care.'}], 'interventions': [{'name': 'Individual Deprescribing Intervention', 'type': 'OTHER', 'description': 'The pharmacist responsible for the nursing home will perform a medication review (type 3). The results of this review will be discussed with the physician and nurse responsible for this participant, with the goal of creating a personalised deprescribing plan. Once validated by the physician, this plan will be submitted to the participant for approval.', 'armGroupLabels': ['Individual Deprescribing Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1011', 'city': 'Lausanne', 'state': 'Canton of Vaud', 'country': 'Switzerland', 'facility': 'Centre de Pharmacie Communautaire', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}], 'overallOfficials': [{'name': 'Olivier Bugnon, Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'ISPSO, Universties of Geneva and Lausanne, Switzerland'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': '10-year availability', 'ipdSharing': 'YES', 'description': 'Data are available from the investigators upon reasonable request.', 'accessCriteria': 'Data are available from the investigators upon reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Anne Niquille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Anne Niquille', 'investigatorAffiliation': 'University of Geneva, Switzerland'}}}}