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

Tracking Information

• First Submitted Date: February 23, 2017
• First Posted Date: June 28, 2017
• Results First Submitted Date: August 11, 2021
• Results First Posted Date: September 8, 2021
• Last Update Posted Date: September 8, 2021
• Actual Study Start Date: July 1, 2017
• Actual Primary Completion Date: November 13, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 11, 2021)

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

Original Primary Outcome Measures (submitted: June 26, 2017)

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

Current Secondary Outcome Measures (submitted: August 11, 2021)

• Mobility-related Fatigue [ Time Frame: Baseline, 6 months ]
  Avlund Mob-T Scale
• Level of Physical Functioning [ Time Frame: Baseline, 6 Months ]
  Manty survey
• Pain [ Time Frame: Baseline, 6 Months ]
  Brief Pain Inventory
• Falls [ Time Frame: Baseline, 6 Months ]
  Total count of falls recorded in hospital admissions, primary care records and patient report
• Sleep [ Time Frame: Baseline, 6 Months ]
  Pittsburgh Sleep Quality Index
• 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
• 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)
• Quality of Life [ Time Frame: Baseline, 6-months ]
  EQ5D-5L
• Physical Functioning Performance [ Time Frame: Baseline, 6-months ]
  Timed-up and go Test
• Physical Functioning Performance [ Time Frame: Baseline, 6-months ]
  Timed 8-foot walk test
• Performance of Activities of Daily Living [ Time Frame: Baseline, 6-months ]
  Barthel Index
• Strength [ Time Frame: Baseline, 6-months ]
  Hand grip
• Functional Ability [ Time Frame: Baseline, 6-months ]
  Functional ability scale for the elderly
• Healthcare Utilization [ Time Frame: Baseline, 6-months ]
  Cost of hospitalizations
• Healthcare Utilization [ Time Frame: Baseline, 6-months ]
  Count of Emergency room visits
• Healthcare Utilization [ Time Frame: Baseline, 6-months ]
  Number of clinic visits
• Feasibility Outcomes [ Time Frame: 6 months ]
  Number of participants that refuse recruitment
• Feasibility Outcomes [ Time Frame: 6 months ]
  Retention rates
• Feasibility Outcomes [ Time Frame: Baseline, 6 months ]
  number of canceled appointments
• Feasibility Outcomes [ Time Frame: Baseline, 6 months ]
  Time to complete measures

Original Secondary Outcome Measures (submitted: June 26, 2017)

• Mobility-related fatigue [ Time Frame: Baseline, 6 months ]
  Avlund Mob-T Scale
• Level of physical functioning [ Time Frame: Baseline, 6 Months ]
  Manty survey
• Pain [ Time Frame: Baseline, 6 Months ]
  Brief Pain Inventory
• Falls [ Time Frame: Baseline, 6 Months ]
  Total count of falls recorded in hospital admissions, primary care records and patient report
• Sleep [ Time Frame: Baseline, 6 Months ]
  Pittsburgh Sleep Quality Index
• 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
• 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)
• Quality of life [ Time Frame: Baseline, 6-months ]
  EQ5D-5L
• Physical functioning performance [ Time Frame: Baseline, 6-months ]
  Timed-up and go Test
• Physical functioning performance [ Time Frame: Baseline, 6-months ]
  Timed 8-foot walk test
• Performance of activities of daily living [ Time Frame: Baseline, 6-months ]
  Barthel Index
• Strength [ Time Frame: Baseline, 6-months ]
  Hand grip
• Functional ability [ Time Frame: Baseline, 6-months ]
  Functional ability scale for the elderly
• Healthcare utilization [ Time Frame: Baseline, 6-months ]
  Cost of hospitalizations
• Healthcare utilization [ Time Frame: Baseline, 6-months ]
  Count of Emergency room visits
• Healthcare utilization [ Time Frame: Baseline, 6-months ]
  Number of clinic visits
• Feasibility outcomes [ Time Frame: 6 months ]
  Number of participants that refuse recruitment
• Feasibility outcomes [ Time Frame: 6 months ]
  Retention rates
• Feasibility outcomes [ Time Frame: Baseline, 6 months ]
  number of canceled appointments
• Feasibility outcomes [ Time Frame: Baseline, 6 months ]
  Time to complete measures

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Team Approach to Polypharmacy Reduction to Improve Mobility Long-Term Care
• Official Title: Team Approach to Polypharmacy Reduction to Improve Mobility (TAPER-Mobility): A Pilot Feasibility Study in a Long-Term Care Setting
• 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.
• 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 Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.

Condition

• Multi-morbidity
• Medication Therapy Management
• 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

Study Groups/Cohorts

TAPERMD

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

Intervention: Other: TAPER

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: August 11, 2021): 30
• Original Estimated Enrollment (submitted: June 26, 2017): 80
• Actual Study Completion Date: November 13, 2019
• Actual Primary Completion Date: November 13, 2019 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 70 Years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT03202264
• Other Study ID Numbers: TAPER-Mobility
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

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

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.

• Current Responsible Party: McMaster University
• Original Responsible Party: Same as current
• Current Study Sponsor: McMaster University
• Original Study Sponsor: Same as current
• Collaborators: Labarge Optimal Aging Initiative
• Investigators: Not Provided
• PRS Account: McMaster University
• Verification Date: August 2021