Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-02-26 @ 12:42 AM
Study NCT ID:
NCT02604056
Status:
COMPLETED
Last Update Posted:
2018-03-23
First Post:
2015-11-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pragmatic Cluster Trial for Nursing Home Antipsychotic Prescribing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-22', 'studyFirstSubmitDate': '2015-11-05', 'studyFirstSubmitQcDate': '2015-11-11', 'lastUpdatePostDateStruct': {'date': '2018-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Antipsychotic dispensing', 'timeFrame': '6 months post-intervention', 'description': 'Number of days with antipsychotic prescriptions in the last week (count, range 0 - 7)'}], 'secondaryOutcomes': [{'measure': 'Antipsychotic prescribing', 'timeFrame': '3 and 6 months post-intervention', 'description': 'Any antipsychotic prescription during the past month (dichotomous)'}, {'measure': 'Mean Antipsychotic dose', 'timeFrame': '3 and 6 months post-intervention', 'description': 'Dose equivalent of antipsychotic dispensed in the past month (continuous)'}, {'measure': 'Benzodiazepine (or sedative) prescribing', 'timeFrame': '3 and 6 months post-intervention', 'description': 'Any prescription during the past month (dichotomous)'}, {'measure': 'Anti-depressant prescribing', 'timeFrame': '3 and 6 months post-intervention', 'description': 'Any prescription during the past month (dichotomous)'}, {'measure': 'Acetaminophen prescribing', 'timeFrame': '3 and 6 months post-intervention', 'description': 'Any prescription during the past month (dichotomous)'}, {'measure': 'Difficulty in performing activities', 'timeFrame': '3 and 6 months post-intervention', 'description': 'Activities of Daily Living long form scale (continuous variable, range 0-28)'}, {'measure': 'Aggressive behaviour scale', 'timeFrame': '3 and 6 months post-intervention', 'description': 'Extent of aggressive behaviour (continuous variable, range 0-12)'}, {'measure': 'Pain', 'timeFrame': '3 and 6 months post-intervention', 'description': 'Pain scale (continuous variable, range 0-3)'}, {'measure': 'Depression', 'timeFrame': '3 and 6 months post-intervention', 'description': 'Depression rating scale (continuous variable, range 0-14)'}, {'measure': 'Falls', 'timeFrame': '3 and 6 months post-intervention', 'description': 'Number of falls in the past month (count)'}, {'measure': 'Emergency Room visits', 'timeFrame': '3 months post-intervention', 'description': 'Number of ER visits during the previous 3 months (count)'}, {'measure': 'Hospitalizations', 'timeFrame': '3 months post-intervention', 'description': 'Number of hospital visits visit during the previous 3 months (count)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Adverse Effect of Other Antipsychotics and Neuroleptics']}, 'referencesModule': {'references': [{'pmid': '32453383', 'type': 'DERIVED', 'citation': 'Tadrous M, Fung K, Desveaux L, Gomes T, Taljaard M, Grimshaw JM, Bell CM, Ivers NM. Effect of Academic Detailing on Promoting Appropriate Prescribing of Antipsychotic Medication in Nursing Homes: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2020 May 1;3(5):e205724. doi: 10.1001/jamanetworkopen.2020.5724.'}, {'pmid': '28549480', 'type': 'DERIVED', 'citation': 'Desveaux L, Saragosa M, Rogers J, Bevan L, Loshak H, Moser A, Feldman S, Regier L, Jeffs L, Ivers NM. Improving the appropriateness of antipsychotic prescribing in nursing homes: a mixed-methods process evaluation of an academic detailing intervention. Implement Sci. 2017 May 26;12(1):71. doi: 10.1186/s13012-017-0602-z.'}, {'pmid': '27026584', 'type': 'DERIVED', 'citation': 'Desveaux L, Gomes T, Tadrous M, Jeffs L, Taljaard M, Rogers J, Bell CM, Ivers NM. Appropriate prescribing in nursing homes demonstration project (APDP) study protocol: pragmatic, cluster-randomized trial and mixed methods process evaluation of an Ontario policy-maker initiative to improve appropriate prescribing of antipsychotics. Implement Sci. 2016 Mar 29;11:45. doi: 10.1186/s13012-016-0410-x.'}]}, 'descriptionModule': {'briefSummary': "Two arm, pragmatic, cluster-randomized trial, with nursing homes allocated to the full, active intervention (featuring educational outreach offered to each prescriber and team members in the home) or standard quality improvement supports (including online audit and feedback reports for each prescriber in the home). The 'standard' quality improvement supports represent 'usual care' as these are to be launched province-wide; a concurrent control arm with no exposure to a quality improvement intervention is not feasible.", 'detailedDescription': "The Ministry of Health and Long-Term Care and Ontario Medical Association have initiated a project aiming to improve appropriateness of prescribing in long-term care facilities (aka nursing homes) through integrated educational supports for nursing home prescribers, inter-professional care teams, as well as residents and family members. The first focus of the project is appropriate prescribing of antipsychotic medications. Working with Health Quality Ontario, the policy makers have determined that all prescribers will have the opportunity to review practice reports detailing their prescribing performance for this class of medication (aka audit and feedback).\n\nThe primary question of this pragmatic, cluster-randomized trial is: What is the effect of adding educational outreach compared to the 'usual' quality improvement supports (i.e. audit and feedback) on prescribing of antipsychotic medications in long-term care?\n\nSecondary questions include the following:\n\ni. What is the effect of the intervention on acute care utilization (e.g., emergency room) rates? ii. What is the effect of the intervention on incidence of patient clinical outcomes and/or adverse effects associated with antipsychotic medications (e.g., falls, aggressive behaviours)? iii. What is the effect of the interventions on medications that might be used as alternatives to antipsychotic medications (e.g., benzodiazepines)? iv. What is the cost-benefit, focusing on prescribing outcomes?\n\nProcess evaluation questions include the following:\n\n1. How and why do the interventions work as observed?\n2. Was the intervention implemented as desired in nursing homes?\n3. What were the contextual factors associated with implementation?\n4. Do the interventions affect precursors of behaviour (e.g., motivation, capability)?"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Nursing homes within pre-determined regions of Ontario that expressed an interest in the full intervention (the regions, or hubs, contain a wide variety of nursing home types within a reasonable travel distance \\[i.e., \\<100 km\\])\n* Nursing homes within the hubs in which the medical and administrative leads agree to and support the project\n\nExclusion criteria:\n\n* Nursing homes with a previous or ongoing involvement in externally supported quality improvement initiatives focusing on antipsychotic medications\n* Nursing homes without any prescribers caring for at least 10 residents routinely\n* Nursing homes with fewer than 30 residents'}, 'identificationModule': {'nctId': 'NCT02604056', 'briefTitle': 'Pragmatic Cluster Trial for Nursing Home Antipsychotic Prescribing', 'organization': {'class': 'OTHER', 'fullName': "Women's College Hospital"}, 'officialTitle': 'Ontario Appropriate Prescribing Demonstration Project: Pragmatic, Cluster-Randomized Clinical Trial to Reduce Antipsychotic Medication Prescribing in Long-Term Care Homes', 'orgStudyIdInfo': {'id': 'MOHLTCAPDP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Audit + Feedback', 'description': "'Usual care' / standard quality improvement supports (including online Audit and Feedback reports for each prescriber in the home)", 'interventionNames': ['Behavioral: Audit + Feedback']}, {'type': 'EXPERIMENTAL', 'label': 'Audit + Feedback + Educational Outreach', 'description': "'Active/full' intervention (featuring Educational Outreach offered to each prescriber and team members in the home)", 'interventionNames': ['Behavioral: Audit + Feedback', 'Behavioral: Audit + Feedback + Educational Outreach']}], 'interventions': [{'name': 'Audit + Feedback', 'type': 'BEHAVIORAL', 'description': 'Online Audit + Feedback practice reports detailing prescribing performance for this class of medication for each prescriber in the nursing home. (Details: http://www.hqontario.ca/Quality-Improvement/Practice-Reports/Primary-Care)', 'armGroupLabels': ['Audit + Feedback', 'Audit + Feedback + Educational Outreach']}, {'name': 'Audit + Feedback + Educational Outreach', 'type': 'BEHAVIORAL', 'description': 'The Educational Outreach program will be delivered by academic detailers, health professionals (often nurses or pharmacists) who have received specific intensive training to support prescribing providers in a particular environment, in this case long-term care homes, to make the best or appropriate clinical decisions as possible. It is defined as: "an innovative method of service-oriented educational outreach for front-line clinicians. It combines the interactive, one-on-one communication approach of industry detailers with the evidence-based, non-commercial information of academia." The Educational Outreach will be delivered in addition to online Audit + Feedback practice reports, which detail prescribing performance for this class of medication for each prescriber in the nursing home.', 'armGroupLabels': ['Audit + Feedback + Educational Outreach']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Noah Ivers', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Family Doctor and Research Scientist'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Women's College Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'Ontario Ministry of Health and Long Term Care', 'class': 'OTHER_GOV'}, {'name': 'Ontario Medical Association', 'class': 'OTHER'}, {'name': 'Health Quality Ontario', 'class': 'OTHER'}, {'name': 'Centre for Effective Practice', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}