Trial Outcomes & Findings for Team Approach to Polypharmacy Reduction to Improve Mobility Long-Term Care (NCT NCT03202264)

Results Overview

Difference in mean number of medications; number of medications reduced in dose

Recruitment status

TERMINATED

Target enrollment

30 participants

Primary outcome timeframe

6 months

Results posted on

2021-09-08

Participant Flow

Participant milestones

Participant milestones
Measure	TAPERMD 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 Study STARTED	30
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	16

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Two participants died prior to data collection.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TAPERMD n=30 Participants 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
Age, Continuous	90 years STANDARD_DEVIATION 6.94 • n=28 Participants • Two participants died prior to data collection.
Sex: Female, Male Female	21 Participants n=28 Participants • Two participants died prior to data collection.
Sex: Female, Male Male	7 Participants n=28 Participants • Two participants died prior to data collection.
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=30 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	28 Participants n=30 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=30 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=30 Participants
Race (NIH/OMB) Asian	0 Participants n=30 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=30 Participants
Race (NIH/OMB) Black or African American	2 Participants n=30 Participants
Race (NIH/OMB) White	25 Participants n=30 Participants
Race (NIH/OMB) More than one race	0 Participants n=30 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=30 Participants
Region of Enrollment Canada	30 participants n=30 Participants

PRIMARY outcome

Timeframe: 6 months

Difference in mean number of medications; number of medications reduced in dose

Outcome measures

Outcome measures
Measure	TAPERMD n=30 Participants 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
Successful Discontinuation (Difference in Mean Number of Medications; Reduction in Dose)	2.43 Medications Changed Standard Deviation 2.98

SECONDARY outcome

Timeframe: Baseline, 6 months

Avlund Mob-T Scale

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 6 Months

Manty survey

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 6 Months

Brief Pain Inventory

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 6 Months

Total count of falls recorded in hospital admissions, primary care records and patient report

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 6 Months

Pittsburgh Sleep Quality Index

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1-week, 3-month, 6-month

Patient self-report change in symptoms, side effects, health improvements and problems

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 6-months

EQ5D-5L

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 6-months

Timed-up and go Test

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 6-months

Timed 8-foot walk test

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 6-months

Barthel Index

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 6-months

Hand grip

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 6-months

Functional ability scale for the elderly

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 6-months

Cost of hospitalizations

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 6-months

Count of Emergency room visits

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 6-months

Number of clinic visits

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Number of participants that refuse recruitment

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Retention rates

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 6 months

number of canceled appointments

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 6 months

Time to complete measures

Outcome measures

Outcome data not reported

Adverse Events

TAPERMD

Serious events: 5 serious events

Other events: 14 other events

Deaths: 8 deaths

Serious adverse events

Serious adverse events
Measure	TAPERMD n=30 participants at risk 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
Respiratory, thoracic and mediastinal disorders AECOPD	3.3% 1/30 • Number of events 1 • 6 months from Physician Visit to Follow-up. Events were recorded via patient chart audit.
Respiratory, thoracic and mediastinal disorders Pneumonia	6.7% 2/30 • Number of events 2 • 6 months from Physician Visit to Follow-up. Events were recorded via patient chart audit.
Nervous system disorders decreased level of consciousness	6.7% 2/30 • Number of events 2 • 6 months from Physician Visit to Follow-up. Events were recorded via patient chart audit.
Musculoskeletal and connective tissue disorders vertebral fracture	3.3% 1/30 • Number of events 1 • 6 months from Physician Visit to Follow-up. Events were recorded via patient chart audit.
Infections and infestations wound infested with maggots	3.3% 1/30 • Number of events 1 • 6 months from Physician Visit to Follow-up. Events were recorded via patient chart audit.

Other adverse events

Other adverse events
Measure	TAPERMD n=30 participants at risk 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
Injury, poisoning and procedural complications Fall resulting in no or minor injury	30.0% 9/30 • Number of events 16 • 6 months from Physician Visit to Follow-up. Events were recorded via patient chart audit.
Musculoskeletal and connective tissue disorders Osteoarthritis	3.3% 1/30 • Number of events 1 • 6 months from Physician Visit to Follow-up. Events were recorded via patient chart audit.
Injury, poisoning and procedural complications Tooth extraction & complications	6.7% 2/30 • Number of events 4 • 6 months from Physician Visit to Follow-up. Events were recorded via patient chart audit.
Skin and subcutaneous tissue disorders large skin tear/pressure ulcer	3.3% 1/30 • Number of events 2 • 6 months from Physician Visit to Follow-up. Events were recorded via patient chart audit.
Metabolism and nutrition disorders diagnosed with diabetes mellitus	3.3% 1/30 • Number of events 1 • 6 months from Physician Visit to Follow-up. Events were recorded via patient chart audit.
Nervous system disorders worsening of Parkinson's Disease with dementia	3.3% 1/30 • Number of events 1 • 6 months from Physician Visit to Follow-up. Events were recorded via patient chart audit.
Cardiac disorders increased leg edema	3.3% 1/30 • Number of events 1 • 6 months from Physician Visit to Follow-up. Events were recorded via patient chart audit.
Respiratory, thoracic and mediastinal disorders bronchitis	3.3% 1/30 • Number of events 1 • 6 months from Physician Visit to Follow-up. Events were recorded via patient chart audit.

Additional Information

Dr. Dee Mangin

McMaster University

Phone: 905-525-9140

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place