Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2026-02-23 @ 8:56 PM
Study NCT ID:
NCT02053194
Status:
COMPLETED
Last Update Posted:
2018-01-25
First Post:
2014-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial to De-prescribe Inappropriate Medications in the Community Dwelling Elderly
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D006266', 'term': 'Health Education'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D000099060', 'term': 'Adherence Interventions'}, {'id': 'D055118', 'term': 'Medication Adherence'}, {'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 600}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-23', 'studyFirstSubmitDate': '2014-01-31', 'studyFirstSubmitQcDate': '2014-01-31', 'lastUpdatePostDateStruct': {'date': '2018-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-02-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in risk perception around inappropriate prescriptions', 'timeFrame': 'Baseline, 6 months', 'description': "Baseline and post-intervention evaluation of participant's, pharmacist's and physician's beliefs about the risks associated with certain inappropriate prescriptions, as listed on the Beers Criteria of inappropriate medication in the elderly."}], 'primaryOutcomes': [{'measure': 'Complete discontinuation of inappropriate prescriptions.', 'timeFrame': '6 months', 'description': 'Provincial prescription insurance claims will be used to measure whether the inappropriate prescription has been discontinued in the intervention and control group at 6-months. Prescription data contain information on all dispensed prescriptions including drug name, dispensation date, dosage, drug form, duration and quantity of the drug dispensed, as well as the license number of the physician who wrote the prescription. Discontinuation of an inappropriate prescription will be defined as the lack of a claims renewal for that medication during a minimum of three or more consecutive months (with no subsequent renewals) during the nine months following receipt of the intervention.'}], 'secondaryOutcomes': [{'measure': "The frequency, timing and type of pharmaceutical opinions sent by the pharmacist to the patient's primary care physician.", 'timeFrame': '6 months', 'description': "The occurrence and delivery date of any pharmaceutical opinion sent to the patient's physician will be ascertained by the presence of a pharmacist billing claim recorded within 6 months after randomization of pharmacies to the intervention group. The type of opinion (evidence-based example provided by the research team vs customized by the pharmacist) will be ascertained by obtaining a photocopied paper copy of the pharmaceutical opinion from the patient's pharmacy record at the end of the trial (by law, the pharmacist must keep a copy in the patient's dossier). The dates of the paper copy will be matched to the date of the billing registered in the billing database to validate that the latter relates to the drug under study."}, {'measure': "Effect of the pharmaceutical opinion on the prescriber's behaviour.", 'timeFrame': '6 months', 'description': 'Pharmacists will be provided with a "study response card" to accompany any pharmaceutical opinion sent to a physician for study patients with inappropriate prescriptions. The "response card" will ask the physician to endorse one of the following three options: 1) I agree with the proposed recommendation and have signed the prescription recommendation you have provided to discontinue or substitute the inappropriate prescription 2) I will discuss with the patient at the next visit; or 3) no change required. The physician will be asked to fax back the response card to the pharmacist. A copy of all response cards received by the pharmacist will be collected by the research team at the end of the trial. The pharmacist will also be asked whether the physician acknowledged the pharmaceutical opinion in any other way. Lack of acknowledgment of the pharmaceutical opinion by the physician will be coded as a non-response.'}, {'measure': 'Patient-physician encounters to discuss inappropriate prescriptions.', 'timeFrame': '6 months', 'description': 'Patient visits to their primary care provider within the 6-months post-intervention will be ascertained by physician billing claims. Visits to physicians where discussions about inappropriate prescriptions occurred will be determined by patient self-report during the 6-month semi-structured telephone follow-up interview by asking whether patients met with their physician to discuss their prescriptions and what happened during these encounters. We will also query any phone call discussions with physician on this subject and conversations with pharmacists to discuss prescription changes.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Inappropriate prescribing', 'Health Education', 'Community Pharmacy Services', 'Medication Therapy Management', 'Preventive Health Services', 'Polypharmacy', 'Inappropriate prescriptions', 'Aged'], 'conditions': ['Inappropriate Dose of Drug Administered', 'Health Behavior']}, 'referencesModule': {'references': [{'pmid': '31303479', 'type': 'DERIVED', 'citation': 'Turner JP, Martin P, Zhang YZ, Tannenbaum C. Patients beliefs and attitudes towards deprescribing: Can deprescribing success be predicted? Res Social Adm Pharm. 2020 Apr;16(4):599-604. doi: 10.1016/j.sapharm.2019.07.007. Epub 2019 Jul 10.'}, {'pmid': '30422193', 'type': 'DERIVED', 'citation': 'Martin P, Tamblyn R, Benedetti A, Ahmed S, Tannenbaum C. Effect of a Pharmacist-Led Educational Intervention on Inappropriate Medication Prescriptions in Older Adults: The D-PRESCRIBE Randomized Clinical Trial. JAMA. 2018 Nov 13;320(18):1889-1898. doi: 10.1001/jama.2018.16131.'}, {'pmid': '26058676', 'type': 'DERIVED', 'citation': 'Martin P, Tamblyn R, Ahmed S, Benedetti A, Tannenbaum C. A consumer-targeted, pharmacist-led, educational intervention to reduce inappropriate medication use in community older adults (D-PRESCRIBE trial): study protocol for a cluster randomized controlled trial. Trials. 2015 Jun 10;16:266. doi: 10.1186/s13063-015-0791-1.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this trial is to test the beneficial effect of a pharmacist-initiated knowledge transfer intervention to both patients and prescribers on the discontinuation of inappropriate prescriptions, compared to usual care. The investigators hypothesize that the pharmacist-led intervention will reduce inappropriate prescriptions by at least 20% over 6-months compared to usual care. The intervention consists of simultaneously educating consumers and providing physicians with an evidence-based pharmaceutical opinion on inappropriate prescriptions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women 65 years of age and older (no upper age limit)\n* Individuals for whom prescription claims derive from only one pharmacy identifier\n* Chronic consumption (\\> 3 month claims) of one of the target inappropriate prescriptions. (benzodiazepine/non benzodiazepine hypnotic, long-acting sulfonylurea oral hypoglycemic agents, anticholinergic agents (in the form of first-generation antihistamines) or Nonsteroidal anti-inflammatory drugs \\[NSAIDs\\] )\n* Patients who are willing to participate in the study.\n\nExclusion Criteria:\n\n* A probable diagnosis of dementia (persons without the capacity to provide informed consent), as determined by a) a prescription for memantine or a cholinesterase inhibitor; b) report from a caregiver or family-member; or c) a baseline screening score on the Folstein Mini-Mental State Exam \\< 24\n* Inability to understand and or communicate in English and/or French\n* Patients living in a long-term care facility\n* Concomitant use of any antipsychotic medication'}, 'identificationModule': {'nctId': 'NCT02053194', 'acronym': 'D-PRESCRIBE', 'briefTitle': 'A Trial to De-prescribe Inappropriate Medications in the Community Dwelling Elderly', 'organization': {'class': 'OTHER', 'fullName': "Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal"}, 'officialTitle': 'Developing Pharmacist-led Research to Educate and Sensitive Community Residents to the Inappropriate Prescription Burden in the Elderly', 'orgStudyIdInfo': {'id': 'CIHR 201303MOP-299872-KTR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pharmacist-led educational intervention', 'description': "Participants will receive an educational brochure on an inappropriate prescription they are currently taking from their pharmacists. Participants' physicians will receive an evidence-based pharmaceutical opinion for the same medication.", 'interventionNames': ['Behavioral: Pharmacist-led educational intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Participants in the control group will be wait-listed and observed for 6 months prior to receiving the intervention.'}], 'interventions': [{'name': 'Pharmacist-led educational intervention', 'type': 'BEHAVIORAL', 'description': '1\\) Educational material to participants in the form of a written educational brochure on inappropriate prescriptions that was developed and tested during the EMPOWER study. 2) Evidence-based pharmaceutical opinions sent to the treating physicians.', 'armGroupLabels': ['Pharmacist-led educational intervention']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Cara Tannenbaum, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Centre de Recherche de l'Institut Universitaire de Gériatrie de Montréal"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal", 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Cara Tannenbaum', 'investigatorFullName': 'Cara Tannenbaum', 'investigatorAffiliation': "Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal"}}}}