A Trial to De-prescribe Inappropriate Medications in the Community Dwelling Elderly (D-PRESCRIBE)
23 janvier 2018 mis à jour par: Cara Tannenbaum, Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
Developing Pharmacist-led Research to Educate and Sensitive Community Residents to the Inappropriate Prescription Burden in the Elderly
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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
600
Phase
- Phase 4
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
65 ans et plus (Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Men and women 65 years of age and older (no upper age limit)
- Individuals for whom prescription claims derive from only one pharmacy identifier
- 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] )
- Patients who are willing to participate in the study.
Exclusion Criteria:
- 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
- Inability to understand and or communicate in English and/or French
- Patients living in a long-term care facility
- Concomitant use of any antipsychotic medication
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Pharmacist-led educational intervention
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.
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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.
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Aucune intervention: Control
Participants in the control group will be wait-listed and observed for 6 months prior to receiving the intervention.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Complete discontinuation of inappropriate prescriptions.
Délai: 6 months
|
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.
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6 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
The frequency, timing and type of pharmaceutical opinions sent by the pharmacist to the patient's primary care physician.
Délai: 6 months
|
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.
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6 months
|
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Effect of the pharmaceutical opinion on the prescriber's behaviour.
Délai: 6 months
|
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.
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6 months
|
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Patient-physician encounters to discuss inappropriate prescriptions.
Délai: 6 months
|
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.
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6 months
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in risk perception around inappropriate prescriptions
Délai: Baseline, 6 months
|
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.
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Baseline, 6 months
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Collaborateurs
Les enquêteurs
- Chercheur principal: Cara Tannenbaum, MD, MSc, Centre de recherche de l'institut Universitaire de Gériatrie de Montreal
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
- 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.
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 mars 2014
Achèvement primaire (Réel)
1 octobre 2017
Achèvement de l'étude (Réel)
1 décembre 2017
Dates d'inscription aux études
Première soumission
31 janvier 2014
Première soumission répondant aux critères de contrôle qualité
31 janvier 2014
Première publication (Estimation)
3 février 2014
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
25 janvier 2018
Dernière mise à jour soumise répondant aux critères de contrôle qualité
23 janvier 2018
Dernière vérification
1 janvier 2018
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- CIHR 201303MOP-299872-KTR
Plan pour les données individuelles des participants (IPD)
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INDÉCIS
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