- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT04055896
Team Approach to Polypharmacy Evaluation and Reduction in a Long-Term Care Setting (TAPER-LTC)
2 juin 2021 mis à jour par: Derelie Mangin, McMaster University
Team Approach to Polypharmacy Evaluation and Reduction in a Long-Term Care Setting: A Feasibility Randomized Controlled Trial
Medication side effects and interactions between medications are very common in older adults and are related to negative health outcomes.
In this study, the investigators will test a new process aimed at reducing unnecessary medication use and drug side effects in seniors using the best medical evidence and patient preferences for treatment.
This study will assess how feasible the implementation of this intervention is within a long-term care facility as well as if it is possible.
Participants in two long-term care facilities will participate in this study.
Measures will include feasibility outcomes regarding the logistics of the intervention as well as patients outcomes (falls, hospitalizations, and medications) collected before and after implementation.
This trial will be a randomized control trial with an adaptive trial design.
Aperçu de l'étude
Statut
Résilié
Les conditions
Intervention / Traitement
Description détaillée
There are substantial associations between polypharmacy and reduced function from older adults and this is likely to be important in frail older adults both in long term care and in the community.
The reversibility of drug-induced mobility impairment is unclear therefore the investigators plan to investigate signals of any impact of reducing polypharmacy on mobility.
The investigators chose the long-term care setting given the presence of complete medication administration records and this patient population's high prevalence of polypharmacy and risk of adverse drug events.
TaperMD is an electronic tool for systematic medication reduction that incorporates patient priorities, electronic screening for potentially harmful medicines,supporting evidence tools and a monitoring pathway to support medication reduction.
This study will examine the feasibility of this tool in a long-term care setting as well as examine.
Participants in two long-term care facilities will participate in this study.
Measures will include feasibility outcomes regarding the logistics of the intervention as well as patients outcomes (falls, hospitalizations, and medications) collected before and after implementation.
The study will be an adaptive trial design with two phases.
Phase 1 will be an internal pilot.
This will allow the investigators to re-evaluate and modify outcome measures and processes as necessary.
Phase 2 of this trial will allow for continuation after adjustments to the process or design has been made in a larger randomized controlled trial.
Type d'étude
Interventionnel
Inscription (Réel)
15
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Ontario
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Brampton, Ontario, Canada, L6Y 5P2
- Holland Christian Homes - Faith Manor
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Brampton, Ontario, Canada, L6Y 5P2
- Holland Christian Homes - Grace Manor
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-
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
70 ans et plus (Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- residing in 2 long-term care facilities in Brampton, ON
- on 5 or more long-term medications
- 70 years of age or older
- adequate English language
Exclusion Criteria:
- terminal illness or other circumstance precluding 6 month study period
- recent (within 12 months) comprehensive medication review
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: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Aucune intervention: Control Group
Standard of Care as wait list control.
Control group will be offered intervention as part of usual clinical care at 6 months.
|
|
Expérimental: TAPER
The intervention is medication reduction. This arm is comprised of:
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Systematic approach to reduction in polypharmacy
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Successful Discontinuation (Difference in mean number of medications; reduction in dose)
Délai: 6 months
|
Difference in mean number of medications; number of medications reduced in dose
|
6 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Difference in level of cognition
Délai: Baseline, 6 months
|
The Mini Mental Status Examination
|
Baseline, 6 months
|
Difference in level of quality of life
Délai: Baseline, 6 months
|
EuroQol five dimensions questionnaire (EQ5D-5L) will measure quality of life.
Scores range from 0 (low quality of life) to 1 (high quality of life).
|
Baseline, 6 months
|
Difference in number of falls
Délai: Baseline, 6 months
|
Total number of falls resulting in medication consultation or treatment recorded in hospital admission and primary care records, and by patient
|
Baseline, 6 months
|
Difference in level of sleep
Délai: Baseline, 6 months
|
The sleep question on the 15-Dimensional (15-D) scale will be used.
Scores range from 1 (no sleep problems) to 5 (severe sleep problems).
|
Baseline, 6 months
|
Changes in medication side effects and symptoms (adverse)
Délai: 1-week, 3 months, 6 months
|
Patient self-report of appearance (new or worsening) of side effects associated with medications
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1-week, 3 months, 6 months
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Changes in medication side effects and symptoms (positive)
Délai: 1-week, 3 months, 6 months
|
Patient self-report of disappearance (improvement or disappearance) of side effects associated with medications
|
1-week, 3 months, 6 months
|
Difference in number of serious adverse events
Délai: 1-week, 3 months, 6 months
|
Any event that requires in-patient hospitalization or prolongation of existing hospitalization, causes congenital malformation, results in persistent or significant disability or incapacity, is life-threatening or results in death (Health Canada (2011) Guidance Document for Industry - Reporting Adverse Reactions to Marketed Health Products)
|
1-week, 3 months, 6 months
|
Difference in level of physical functioning capacity and ability
Délai: Baseline, 6 months
|
Time on the timed-up-and-go test
|
Baseline, 6 months
|
Difference in level of performance of activities of daily living
Délai: Baseline, 6 months
|
Barthel Index will be used to measure performance of activities of daily living.
Ten activities are scored in terms of level of independence or assistance, with higher scores reflecting higher level of independent performance.
|
Baseline, 6 months
|
Difference in level of frailty
Délai: Baseline, 6 months
|
The total score on the Edmonton Frail Scale will be used to measure frailty.
The scale included 11 items, with scores ranging from 0 (not frail) to 17 (severe frailty).
|
Baseline, 6 months
|
Difference in level of healthcare utilization use (hospitalizations)
Délai: Baseline, 6 months
|
Number of hospitalizations
|
Baseline, 6 months
|
Difference in level of healthcare utilization use (emergency department visits)
Délai: Baseline, 6 months
|
Number of emergency department visits
|
Baseline, 6 months
|
Difference in level of healthcare utilization use (physician visits)
Délai: Baseline, 6 months
|
Number of physician visits
|
Baseline, 6 months
|
Enrollment rate
Délai: 6 months
|
Number of participants that enroll in study relative to number of participant invited to participant
|
6 months
|
Completion rate
Délai: 6 months
|
Number of participants that complete 6-month collection relative to number of participants enrolled
|
6 months
|
Time to complete measures
Délai: Baseline, 6 months
|
Average duration of data collection appointments
|
Baseline, 6 months
|
Difference in level of mood
Délai: Baseline, 6 months
|
The total score on the Geriatric Depression Scale (Short Form) will be used to measure mood.
The scale includes 15 yes/no items and score range from 0 to 15, with high scores indicating depression.
|
Baseline, 6 months
|
Difference in level of concern over falling
Délai: Baseline, 6 months
|
The score on the Falls Efficacy Scale-International (Short Version) will be used to measure falling-related concerns.
The scale includes 7 items, with scores ranging from 7 (no concern) to 28 (severe concern of falling)
|
Baseline, 6 months
|
Difference in level of pain
Délai: Baseline, 6 months
|
The Brief Pain Inventory (short form) will be used to measure pain severity (mean of 4 items, rated 0-10) and pain interference (mean of 7 items, rated 0-10).
Higher scores represent higher pain severity and interference.
|
Baseline, 6 months
|
Difference in level of incontinence
Délai: Baseline, 6 months
|
Frequency of incontinence as recorded in patient electronic medical record
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Baseline, 6 months
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Loved one's perspective of deprescribing
Délai: 6 months
|
Perspectives from focus groups
|
6 months
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Dee Mangin, MBChB, DPH, FRNZC, MD, McMaster University
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 (Réel)
15 octobre 2019
Achèvement primaire (Réel)
30 mars 2021
Achèvement de l'étude (Réel)
30 mars 2021
Dates d'inscription aux études
Première soumission
12 août 2019
Première soumission répondant aux critères de contrôle qualité
12 août 2019
Première publication (Réel)
14 août 2019
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
7 juin 2021
Dernière mise à jour soumise répondant aux critères de contrôle qualité
2 juin 2021
Dernière vérification
1 juin 2021
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2727 (Amendment)
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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