- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT04055896
Team Approach to Polypharmacy Evaluation and Reduction in a Long-Term Care Setting (TAPER-LTC)
2. Juni 2021 aktualisiert von: 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.
Studienübersicht
Status
Beendet
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
15
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
Ontario
-
Brampton, Ontario, Kanada, L6Y 5P2
- Holland Christian Homes - Faith Manor
-
Brampton, Ontario, Kanada, L6Y 5P2
- Holland Christian Homes - Grace Manor
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
70 Jahre und älter (Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Kein Eingriff: Control Group
Standard of Care as wait list control.
Control group will be offered intervention as part of usual clinical care at 6 months.
|
|
Experimental: TAPER
The intervention is medication reduction. This arm is comprised of:
|
Systematic approach to reduction in polypharmacy
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Successful Discontinuation (Difference in mean number of medications; reduction in dose)
Zeitfenster: 6 months
|
Difference in mean number of medications; number of medications reduced in dose
|
6 months
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Difference in level of cognition
Zeitfenster: Baseline, 6 months
|
The Mini Mental Status Examination
|
Baseline, 6 months
|
Difference in level of quality of life
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 1-week, 3 months, 6 months
|
Patient self-report of appearance (new or worsening) of side effects associated with medications
|
1-week, 3 months, 6 months
|
Changes in medication side effects and symptoms (positive)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Baseline, 6 months
|
Time on the timed-up-and-go test
|
Baseline, 6 months
|
Difference in level of performance of activities of daily living
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: Baseline, 6 months
|
Number of hospitalizations
|
Baseline, 6 months
|
Difference in level of healthcare utilization use (emergency department visits)
Zeitfenster: Baseline, 6 months
|
Number of emergency department visits
|
Baseline, 6 months
|
Difference in level of healthcare utilization use (physician visits)
Zeitfenster: Baseline, 6 months
|
Number of physician visits
|
Baseline, 6 months
|
Enrollment rate
Zeitfenster: 6 months
|
Number of participants that enroll in study relative to number of participant invited to participant
|
6 months
|
Completion rate
Zeitfenster: 6 months
|
Number of participants that complete 6-month collection relative to number of participants enrolled
|
6 months
|
Time to complete measures
Zeitfenster: Baseline, 6 months
|
Average duration of data collection appointments
|
Baseline, 6 months
|
Difference in level of mood
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Baseline, 6 months
|
Frequency of incontinence as recorded in patient electronic medical record
|
Baseline, 6 months
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Loved one's perspective of deprescribing
Zeitfenster: 6 months
|
Perspectives from focus groups
|
6 months
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Dee Mangin, MBChB, DPH, FRNZC, MD, McMaster University
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
15. Oktober 2019
Primärer Abschluss (Tatsächlich)
30. März 2021
Studienabschluss (Tatsächlich)
30. März 2021
Studienanmeldedaten
Zuerst eingereicht
12. August 2019
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
12. August 2019
Zuerst gepostet (Tatsächlich)
14. August 2019
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
7. Juni 2021
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
2. Juni 2021
Zuletzt verifiziert
1. Juni 2021
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2727 (Amendment)
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Gebrechlichkeit
-
University of PennsylvaniaAbgeschlossen
-
University of Erlangen-Nürnberg Medical SchoolAbgeschlossen
-
University of ValenciaAbgeschlossen
-
Sengkang General HospitalUnbekanntGebrechlichkeit | Frailty-SyndromSingapur
-
Charite University, Berlin, GermanyAbgeschlossenFrailty-SyndromDeutschland
-
Instituto Tecnologico y de Estudios Superiores...Noch keine Rekrutierung
-
Xijing HospitalUnbekanntFrailty-SyndromChina
-
Region ZealandUniversity of Southern DenmarkAktiv, nicht rekrutierend
-
Chinese University of Hong KongAbgeschlossen
-
Meridigen Biotech Co., Ltd.Rekrutierung
Klinische Studien zur Medication Reduction
-
SolitonEmergent Clinical Consulting, LLCAbgeschlossen
-
University of California, San FranciscoAbgeschlossenDepression | Angst | TinnitusVereinigte Staaten
-
University of WashingtonAmerican Association of Diabetes EducatorsUnbekannt
-
Anjali Raja BeharelleMediService AGAnmeldung auf EinladungHypertonie | MedikamentenhaftungSchweiz
-
Collabree AGUniversity Hospital, Basel, SwitzerlandRekrutierungHypertonie | MedikamentenhaftungSchweiz
-
Vanderbilt University Medical CenterAbgeschlossenDepression | Betonen | Ausbrennen | Angst | SelbstmitgefühlVereinigte Staaten
-
PHCC LPNational Heart, Lung, and Blood Institute (NHLBI)AbgeschlossenHerz-Kreislauf-ErkrankungenVereinigte Staaten
-
University of California, San FranciscoNational Center for Complementary and Integrative Health (NCCIH)Aktiv, nicht rekrutierend
-
Amasya UniversityAbgeschlossenAngst | Schwangerschaft bezogenTruthahn
-
Amasya UniversityAbgeschlossenBetonen | Schwangerschaft, hohes RisikoTruthahn