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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03202264
Recruitment Status : Terminated (Difficulty with recruitment and staff retention.)
First Posted : June 28, 2017
Results First Posted : September 8, 2021
Last Update Posted : September 8, 2021
Sponsor:
Collaborator:
Labarge Optimal Aging Initiative
Information provided by (Responsible Party):
McMaster University

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Conditions Multi-morbidity
Medication Therapy Management
Polypharmacy
Intervention Other: TAPER
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title TAPERMD
Hide Arm/Group Description

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

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
Period Title: Overall Study
Started 30
Completed 14
Not Completed 16
Arm/Group Title TAPERMD
Hide Arm/Group Description

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

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
Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 28 participants
90  (6.94)
[1]
Measure Analysis Population Description: Two participants died prior to data collection.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
Female
21
  75.0%
Male
7
  25.0%
[1]
Measure Analysis Population Description: Two participants died prior to data collection.
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
28
  93.3%
Unknown or Not Reported
2
   6.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
2
   6.7%
White
25
  83.3%
More than one race
0
   0.0%
Unknown or Not Reported
3
  10.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 30 participants
30
1.Primary Outcome
Title Successful Discontinuation (Difference in Mean Number of Medications; Reduction in Dose)
Hide Description Difference in mean number of medications; number of medications reduced in dose
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TAPERMD
Hide Arm/Group Description:

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

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
Overall Number of Participants Analyzed 30
Mean (Standard Deviation)
Unit of Measure: Medications Changed
2.43  (2.98)
2.Secondary Outcome
Title Mobility-related Fatigue
Hide Description Avlund Mob-T Scale
Time Frame Baseline, 6 months
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Level of Physical Functioning
Hide Description Manty survey
Time Frame Baseline, 6 Months
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Pain
Hide Description Brief Pain Inventory
Time Frame Baseline, 6 Months
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Falls
Hide Description Total count of falls recorded in hospital admissions, primary care records and patient report
Time Frame Baseline, 6 Months
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Sleep
Hide Description Pittsburgh Sleep Quality Index
Time Frame Baseline, 6 Months
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Decrease in Medication Side Effects and Symptoms
Hide Description Patient self-report change in symptoms, side effects, health improvements and problems
Time Frame 1-week, 3-month, 6-month
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Serious Adverse Events
Hide Description 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)
Time Frame 1-week, 3-month, 6-month
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Quality of Life
Hide Description EQ5D-5L
Time Frame Baseline, 6-months
Outcome Measure Data Not Reported
10.Secondary Outcome
Title Physical Functioning Performance
Hide Description Timed-up and go Test
Time Frame Baseline, 6-months
Outcome Measure Data Not Reported
11.Secondary Outcome
Title Physical Functioning Performance
Hide Description Timed 8-foot walk test
Time Frame Baseline, 6-months
Outcome Measure Data Not Reported
12.Secondary Outcome
Title Performance of Activities of Daily Living
Hide Description Barthel Index
Time Frame Baseline, 6-months
Outcome Measure Data Not Reported
13.Secondary Outcome
Title Strength
Hide Description Hand grip
Time Frame Baseline, 6-months
Outcome Measure Data Not Reported
14.Secondary Outcome
Title Functional Ability
Hide Description Functional ability scale for the elderly
Time Frame Baseline, 6-months
Outcome Measure Data Not Reported
15.Secondary Outcome
Title Healthcare Utilization
Hide Description Cost of hospitalizations
Time Frame Baseline, 6-months
Outcome Measure Data Not Reported
16.Secondary Outcome
Title Healthcare Utilization
Hide Description Count of Emergency room visits
Time Frame Baseline, 6-months
Outcome Measure Data Not Reported
17.Secondary Outcome
Title Healthcare Utilization
Hide Description Number of clinic visits
Time Frame Baseline, 6-months
Outcome Measure Data Not Reported
18.Secondary Outcome
Title Feasibility Outcomes
Hide Description Number of participants that refuse recruitment
Time Frame 6 months
Outcome Measure Data Not Reported
19.Secondary Outcome
Title Feasibility Outcomes
Hide Description Retention rates
Time Frame 6 months
Outcome Measure Data Not Reported
20.Secondary Outcome
Title Feasibility Outcomes
Hide Description number of canceled appointments
Time Frame Baseline, 6 months
Outcome Measure Data Not Reported
21.Secondary Outcome
Title Feasibility Outcomes
Hide Description Time to complete measures
Time Frame Baseline, 6 months
Outcome Measure Data Not Reported
Time Frame 6 months from Physician Visit to Follow-up.
Adverse Event Reporting Description Events were recorded via patient chart audit.
 
Arm/Group Title TAPERMD
Hide Arm/Group Description

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

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
All-Cause Mortality
TAPERMD
Affected / at Risk (%)
Total   8/30 (26.67%)    
Hide Serious Adverse Events
TAPERMD
Affected / at Risk (%) # Events
Total   5/30 (16.67%)    
Infections and infestations   
wound infested with maggots   1/30 (3.33%)  1
Musculoskeletal and connective tissue disorders   
vertebral fracture   1/30 (3.33%)  1
Nervous system disorders   
decreased level of consciousness   2/30 (6.67%)  2
Respiratory, thoracic and mediastinal disorders   
AECOPD   1/30 (3.33%)  1
Pneumonia   2/30 (6.67%)  2
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
TAPERMD
Affected / at Risk (%) # Events
Total   14/30 (46.67%)    
Cardiac disorders   
increased leg edema  [1]  1/30 (3.33%)  1
Injury, poisoning and procedural complications   
Fall resulting in no or minor injury   9/30 (30.00%)  16
Tooth extraction & complications   2/30 (6.67%)  4
Metabolism and nutrition disorders   
diagnosed with diabetes mellitus   1/30 (3.33%)  1
Musculoskeletal and connective tissue disorders   
Osteoarthritis   1/30 (3.33%)  1
Nervous system disorders   
worsening of Parkinson's Disease with dementia   1/30 (3.33%)  1
Respiratory, thoracic and mediastinal disorders   
bronchitis   1/30 (3.33%)  1
Skin and subcutaneous tissue disorders   
large skin tear/pressure ulcer   1/30 (3.33%)  2
Indicates events were collected by systematic assessment
[1]
History of congestive heart failure
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Dee Mangin
Organization: McMaster University
Phone: 905-525-9140 ext 21219
EMail: mangind@mcmaster.ca
Layout table for additonal information
Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT03202264    
Other Study ID Numbers: TAPER-Mobility
First Submitted: February 23, 2017
First Posted: June 28, 2017
Results First Submitted: August 11, 2021
Results First Posted: September 8, 2021
Last Update Posted: September 8, 2021