Medication Therapy Management, Multi-morbidity, Polypharmacy
Conditions
Keywords
Polypharmacy, Mobility, Multimorbidity, Drug Discontinuation, Patient Preference, eHealth
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.
Interventions
OTHERTAPER
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
Sponsors
The Labarge Optimal Aging Initiative
McMaster University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful Discontinuation (Difference in Mean Number of Medications; Reduction in Dose) | 6 months | Difference in mean number of medications; number of medications reduced in dose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Level of Physical Functioning | Baseline, 6 Months | Manty survey |
| Pain | Baseline, 6 Months | Brief Pain Inventory |
| Falls | Baseline, 6 Months | Total count of falls recorded in hospital admissions, primary care records and patient report |
| Sleep | Baseline, 6 Months | Pittsburgh Sleep Quality Index |
| Decrease in Medication Side Effects and Symptoms | 1-week, 3-month, 6-month | Patient self-report change in symptoms, side effects, health improvements and problems |
| Serious Adverse Events | 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) |
| Mobility-related Fatigue | Baseline, 6 months | Avlund Mob-T Scale |
| Physical Functioning Performance | Baseline, 6-months | Timed-up and go Test |
| Performance of Activities of Daily Living | Baseline, 6-months | Barthel Index |
| Strength | Baseline, 6-months | Hand grip |
| Functional Ability | Baseline, 6-months | Functional ability scale for the elderly |
| Healthcare Utilization | Baseline, 6-months | Cost of hospitalizations |
| Feasibility Outcomes | 6 months | Number of participants that refuse recruitment |
| Quality of Life | Baseline, 6-months | EQ5D-5L |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | TAPERMD |
|---|---|
| Age, Continuous | 90 years STANDARD_DEVIATION 6.94 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 28 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 25 Participants |
| Region of Enrollment Canada | 30 participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 8 / 30 |
| other Total, other adverse events | 14 / 30 |
| serious Total, serious adverse events | 5 / 30 |
Outcome results
Primary
Successful Discontinuation (Difference in Mean Number of Medications; Reduction in Dose)
Difference in mean number of medications; number of medications reduced in dose
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TAPERMD | Successful Discontinuation (Difference in Mean Number of Medications; Reduction in Dose) | 2.43 Medications Changed | Standard Deviation 2.98 |
Secondary
Decrease in Medication Side Effects and Symptoms
Patient self-report change in symptoms, side effects, health improvements and problems
Time frame: 1-week, 3-month, 6-month
Secondary
Falls
Total count of falls recorded in hospital admissions, primary care records and patient report
Time frame: Baseline, 6 Months
Secondary
Feasibility Outcomes
Time to complete measures
Time frame: Baseline, 6 months
Secondary
Feasibility Outcomes
number of canceled appointments
Time frame: Baseline, 6 months
Secondary
Feasibility Outcomes
Number of participants that refuse recruitment
Time frame: 6 months
Secondary
Feasibility Outcomes
Retention rates
Time frame: 6 months
Secondary
Functional Ability
Functional ability scale for the elderly
Time frame: Baseline, 6-months
Secondary
Healthcare Utilization
Cost of hospitalizations
Time frame: Baseline, 6-months
Secondary
Healthcare Utilization
Number of clinic visits
Time frame: Baseline, 6-months
Secondary
Healthcare Utilization
Count of Emergency room visits
Time frame: Baseline, 6-months
Secondary
Level of Physical Functioning
Manty survey
Time frame: Baseline, 6 Months
Secondary
Mobility-related Fatigue
Avlund Mob-T Scale
Time frame: Baseline, 6 months
Secondary
Pain
Brief Pain Inventory
Time frame: Baseline, 6 Months
Secondary
Performance of Activities of Daily Living
Barthel Index
Time frame: Baseline, 6-months
Secondary
Physical Functioning Performance
Timed 8-foot walk test
Time frame: Baseline, 6-months
Secondary
Physical Functioning Performance
Timed-up and go Test
Time frame: Baseline, 6-months
Secondary
Quality of Life
EQ5D-5L
Time frame: Baseline, 6-months
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)
Time frame: 1-week, 3-month, 6-month
Secondary
Sleep
Pittsburgh Sleep Quality Index
Time frame: Baseline, 6 Months
Secondary
Strength
Hand grip
Time frame: Baseline, 6-months