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Team Approach to Polypharmacy Evaluation and Reduction in a Long-Term Care Setting (TAPER-LTC)

2 juni 2021 bijgewerkt door: 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.

Studie Overzicht

Toestand

Beëindigd

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

15

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Canada
    • Ontario
      • Brampton, Ontario, Canada, L6Y 5P2
        • Holland Christian Homes - Faith Manor
      • Brampton, Ontario, Canada, L6Y 5P2
        • Holland Christian Homes - Grace Manor

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

70 jaar en ouder (Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Geen tussenkomst: Control Group
Standard of Care as wait list control. Control group will be offered intervention as part of usual clinical care at 6 months.
Experimenteel: TAPER

The intervention is medication reduction. This arm is comprised of:

  1. Medication reconciliation
  2. Identification of patient priorities for care
  3. Identification of medications that are potentially appropriate for discontinuation/dose reduction
  4. Linked pharmacist/family physician consultations with patient to discuss medication with intention to reduce
  5. Identification of medications for trial of discontinuation/dose reduction (shared decision making) Pause of medication and clinical monitoring
Ander: Medication Reduction
Systematic approach to reduction in polypharmacy
Andere namen:
  • Stopzetting van de medicatie/dosisverlaging

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Successful Discontinuation (Difference in mean number of medications; reduction in dose)
Tijdsspanne: 6 months
Difference in mean number of medications; number of medications reduced in dose
6 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Difference in level of cognition
Tijdsspanne: Baseline, 6 months
The Mini Mental Status Examination
Baseline, 6 months
Difference in level of quality of life
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Baseline, 6 months
Time on the timed-up-and-go test
Baseline, 6 months
Difference in level of performance of activities of daily living
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: Baseline, 6 months
Number of hospitalizations
Baseline, 6 months
Difference in level of healthcare utilization use (emergency department visits)
Tijdsspanne: Baseline, 6 months
Number of emergency department visits
Baseline, 6 months
Difference in level of healthcare utilization use (physician visits)
Tijdsspanne: Baseline, 6 months
Number of physician visits
Baseline, 6 months
Enrollment rate
Tijdsspanne: 6 months
Number of participants that enroll in study relative to number of participant invited to participant
6 months
Completion rate
Tijdsspanne: 6 months
Number of participants that complete 6-month collection relative to number of participants enrolled
6 months
Time to complete measures
Tijdsspanne: Baseline, 6 months
Average duration of data collection appointments
Baseline, 6 months
Difference in level of mood
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Baseline, 6 months
Frequency of incontinence as recorded in patient electronic medical record
Baseline, 6 months

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Loved one's perspective of deprescribing
Tijdsspanne: 6 months
Perspectives from focus groups
6 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

McMaster University

Medewerkers

Canadian Frailty Network
Labarge Optimal Aging

Onderzoekers

  • Hoofdonderzoeker: Dee Mangin, MBChB, DPH, FRNZC, MD, McMaster University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

15 oktober 2019

Primaire voltooiing (Werkelijk)

30 maart 2021

Studie voltooiing (Werkelijk)

30 maart 2021

Studieregistratiedata

Eerst ingediend

12 augustus 2019

Eerst ingediend dat voldeed aan de QC-criteria

12 augustus 2019

Eerst geplaatst (Werkelijk)

14 augustus 2019

Updates van studierecords

Laatste update geplaatst (Werkelijk)

7 juni 2021

Laatste update ingediend die voldeed aan QC-criteria

2 juni 2021

Laatst geverifieerd

1 juni 2021

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2727 (Amendment)

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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