Team Approach to Polypharmacy Reduction to Improve Mobility Long-Term Care

Polypharmacy Clinical Trial

Official title:

Team Approach to Polypharmacy Reduction to Improve Mobility (TAPER-Mobility): A Pilot Feasibility Study in a Long-Term Care Setting

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03202264
• Other study ID #: TAPER-Mobility
• Status: Terminated
• Start date: July 1, 2017
• Est. completion date: November 13, 2019

Study information

• Verified date: August 2021
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Medication side effects and interactions between medications are very common in older adults and are related to negative health outcomes, including mobility. 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. The study will also assess for any signals of reversal of medications related mobility impairments to reduce medications-related mobility impairment (fatigue, pain, falls) using the intervention. 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. Findings will inform the design of a randomized controlled trial to test the effect of this intervention on health outcomes.

Description:

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. Findings will inform a randomized controlled trial to measure the effect of this intervention on health outcomes.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: November 13, 2019
• Est. primary completion date: November 13, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

Inclusion Criteria:

• residing in 2 long-term care facilities in Brampton, ON

• on 5 or more medications

• 70 years of age or older

• adequate English language

Related Conditions & MeSH terms

• Medication Therapy Management
• Multi-morbidity
• Polypharmacy

Intervention

Other:
• TAPER
The intervention is medication reduction. This arm is comprised of: Medication reconciliation Identification of patient priorities for care Identification of medications that are potentially appropriate for discontinuation/dose reduction Linked pharmacist/family physician consultations with patient to discuss medication with intention to reduce Identification of medications for trial of discontinuation/dose reduction (shared decision making) Pause of medication and clinical monitoring

Locations

Country	Name	City	State
Canada	McMaster University	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
McMaster University	Labarge Optimal Aging Initiative

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful Discontinuation (Difference in Mean Number of Medications; Reduction in Dose)	Difference in mean number of medications; number of medications reduced in dose	6 months
Secondary	Mobility-related Fatigue	Avlund Mob-T Scale	Baseline, 6 months
Secondary	Level of Physical Functioning	Manty survey	Baseline, 6 Months
Secondary	Pain	Brief Pain Inventory	Baseline, 6 Months
Secondary	Falls	Total count of falls recorded in hospital admissions, primary care records and patient report	Baseline, 6 Months
Secondary	Sleep	Pittsburgh Sleep Quality Index	Baseline, 6 Months
Secondary	Decrease in Medication Side Effects and Symptoms	Patient self-report change in symptoms, side effects, health improvements and problems	1-week, 3-month, 6-month
Secondary	Serious Adverse Events	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-month, 6-month
Secondary	Quality of Life	EQ5D-5L	Baseline, 6-months
Secondary	Physical Functioning Performance	Timed-up and go Test	Baseline, 6-months
Secondary	Physical Functioning Performance	Timed 8-foot walk test	Baseline, 6-months
Secondary	Performance of Activities of Daily Living	Barthel Index	Baseline, 6-months
Secondary	Strength	Hand grip	Baseline, 6-months
Secondary	Functional Ability	Functional ability scale for the elderly	Baseline, 6-months
Secondary	Healthcare Utilization	Cost of hospitalizations	Baseline, 6-months
Secondary	Healthcare Utilization	Count of Emergency room visits	Baseline, 6-months
Secondary	Healthcare Utilization	Number of clinic visits	Baseline, 6-months
Secondary	Feasibility Outcomes	Number of participants that refuse recruitment	6 months
Secondary	Feasibility Outcomes	Retention rates	6 months
Secondary	Feasibility Outcomes	number of canceled appointments	Baseline, 6 months
Secondary	Feasibility Outcomes	Time to complete measures	Baseline, 6 months