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

• ClinicalTrials.gov Identifier: NCT03202264
• Recruitment Status: Terminated
• First Posted: June 28, 2017
• Results First Posted: September 8, 2021
• Last Update Posted: September 8, 2021
• Sponsor: McMaster University
• Collaborator: Labarge Optimal Aging Initiative
• Information provided by (Responsible Party): McMaster University

Study Description

Brief 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.

Condition or disease	Intervention/treatment
Multi-morbidity; Medication Therapy Management; Polypharmacy	Other: TAPER

Detailed 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.

Study Design

• Study Type: Observational
• Actual Enrollment: 30 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Team Approach to Polypharmacy Reduction to Improve Mobility (TAPER-Mobility): A Pilot Feasibility Study in a Long-Term Care Setting
• Actual Study Start Date: July 1, 2017
• Actual Primary Completion Date: November 13, 2019
• Actual Study Completion Date: November 13, 2019

Groups and Cohorts

Group/Cohort

Intervention/treatment

TAPERMD; 80 Long term care residents on 5 or more medications aged over 70 from 2 long term care facilities

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

Outcome Measures

Primary Outcome Measures :

1. Successful Discontinuation (Difference in Mean Number of Medications; Reduction in Dose) [ Time Frame: 6 months ]
   Difference in mean number of medications; number of medications reduced in dose

Secondary Outcome Measures :

1. Mobility-related Fatigue [ Time Frame: Baseline, 6 months ]
   Avlund Mob-T Scale
2. Level of Physical Functioning [ Time Frame: Baseline, 6 Months ]
   Manty survey
3. Pain [ Time Frame: Baseline, 6 Months ]
   Brief Pain Inventory
4. Falls [ Time Frame: Baseline, 6 Months ]
   Total count of falls recorded in hospital admissions, primary care records and patient report
5. Sleep [ Time Frame: Baseline, 6 Months ]
   Pittsburgh Sleep Quality Index
6. Decrease in Medication Side Effects and Symptoms [ Time Frame: 1-week, 3-month, 6-month ]
   Patient self-report change in symptoms, side effects, health improvements and problems
7. Serious Adverse Events [ Time Frame: 1-week, 3-month, 6-month ]
   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)
8. Quality of Life [ Time Frame: Baseline, 6-months ]
   EQ5D-5L
9. Physical Functioning Performance [ Time Frame: Baseline, 6-months ]
   Timed-up and go Test
10. Physical Functioning Performance [ Time Frame: Baseline, 6-months ]
    Timed 8-foot walk test
11. Performance of Activities of Daily Living [ Time Frame: Baseline, 6-months ]
    Barthel Index
12. Strength [ Time Frame: Baseline, 6-months ]
    Hand grip
13. Functional Ability [ Time Frame: Baseline, 6-months ]
    Functional ability scale for the elderly
14. Healthcare Utilization [ Time Frame: Baseline, 6-months ]
    Cost of hospitalizations
15. Healthcare Utilization [ Time Frame: Baseline, 6-months ]
    Count of Emergency room visits
16. Healthcare Utilization [ Time Frame: Baseline, 6-months ]
    Number of clinic visits
17. Feasibility Outcomes [ Time Frame: 6 months ]
    Number of participants that refuse recruitment
18. Feasibility Outcomes [ Time Frame: 6 months ]
    Retention rates
19. Feasibility Outcomes [ Time Frame: Baseline, 6 months ]
    number of canceled appointments
20. Feasibility Outcomes [ Time Frame: Baseline, 6 months ]
    Time to complete measures

Eligibility Criteria

• Ages Eligible for Study: 70 Years and older (Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Adults, 70 years of age or older, residing in 2 long-term care facilities located in the Brampton, Ontario, Canada.

Criteria

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

Contacts and Locations

Locations

Canada, Ontario

McMaster University

Hamilton, Ontario, Canada, L8P 1H6

Sponsors and Collaborators

McMaster University

Labarge Optimal Aging Initiative

  Study Documents (Full-Text)

Documents provided by McMaster University:

Study Protocol and Statistical Analysis Plan  [PDF] November 14, 2017

More Information

• Responsible Party: McMaster University
• ClinicalTrials.gov Identifier: NCT03202264
• Other Study ID Numbers: TAPER-Mobility
• First Posted: June 28, 2017
• Results First Posted: September 8, 2021
• Last Update Posted: September 8, 2021
• Last Verified: August 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: Data will be available on request to the Principal investigator. The data set will be uploaded as required for publication.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by McMaster University:

Polypharmacy; Mobility; Multimorbidity; Drug Discontinuation; Patient Preference; eHealth