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Difficulty with recruitment and staff retention.
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| Name | Class |
|---|---|
| The Labarge Optimal Aging Initiative | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAPERMD | 80 Long term care residents on 5 or more medications aged over 70 from 2 long term care facilities |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAPER | Other | The intervention is medication reduction. This arm is comprised of:
|
| Measure | Description | Time Frame |
|---|---|---|
| Successful Discontinuation (Difference in Mean Number of Medications; Reduction in Dose) | Difference in mean number of medications; number of medications reduced in dose | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mobility-related Fatigue | Avlund Mob-T Scale | Baseline, 6 months |
| Level of Physical Functioning | Manty survey | Baseline, 6 Months |
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Inclusion Criteria:
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Adults, 70 years of age or older, residing in 2 long-term care facilities located in the Brampton, Ontario, Canada.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McMaster University | Hamilton | Ontario | L8P 1H6 | Canada |
Data will be available on request to the Principal investigator. The data set will be uploaded as required for publication.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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:
|
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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:
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Two participants died prior to data collection. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Successful Discontinuation (Difference in Mean Number of Medications; Reduction in Dose) | Difference in mean number of medications; number of medications reduced in dose | Posted | Mean | Standard Deviation | Medications Changed | 6 months |
|
6 months from Physician Visit to Follow-up.
Events were recorded via patient chart audit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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:
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| AECOPD | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall resulting in no or minor injury | Injury, poisoning and procedural complications | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Dee Mangin | McMaster University | 905-525-9140 | 21219 | mangind@mcmaster.ca |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 14, 2017 | Jun 2, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D057240 | Patient Preference |
| ID | Term |
|---|---|
| D017060 | Patient Satisfaction |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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|
| Pain | Brief Pain Inventory | Baseline, 6 Months |
| Falls | Total count of falls recorded in hospital admissions, primary care records and patient report | Baseline, 6 Months |
| Sleep | Pittsburgh Sleep Quality Index | Baseline, 6 Months |
| Decrease in Medication Side Effects and Symptoms | Patient self-report change in symptoms, side effects, health improvements and problems | 1-week, 3-month, 6-month |
| 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) | 1-week, 3-month, 6-month |
| Quality of Life | EQ5D-5L | Baseline, 6-months |
| Physical Functioning Performance | Timed-up and go Test | Baseline, 6-months |
| Physical Functioning Performance | Timed 8-foot walk test | Baseline, 6-months |
| Performance of Activities of Daily Living | Barthel Index | Baseline, 6-months |
| Strength | Hand grip | Baseline, 6-months |
| Functional Ability | Functional ability scale for the elderly | Baseline, 6-months |
| Healthcare Utilization | Cost of hospitalizations | Baseline, 6-months |
| Healthcare Utilization | Count of Emergency room visits | Baseline, 6-months |
| Healthcare Utilization | Number of clinic visits | Baseline, 6-months |
| Feasibility Outcomes | Number of participants that refuse recruitment | 6 months |
| Feasibility Outcomes | Retention rates | 6 months |
| Feasibility Outcomes | number of canceled appointments | Baseline, 6 months |
| Feasibility Outcomes | Time to complete measures | Baseline, 6 months |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Two participants died prior to data collection. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Mobility-related Fatigue | Avlund Mob-T Scale | Not Posted | Baseline, 6 months | Participants |
| Secondary | Level of Physical Functioning | Manty survey | Not Posted | Baseline, 6 Months | Participants |
| Secondary | Pain | Brief Pain Inventory | Not Posted | Baseline, 6 Months | Participants |
| Secondary | Falls | Total count of falls recorded in hospital admissions, primary care records and patient report | Not Posted | Baseline, 6 Months | Participants |
| Secondary | Sleep | Pittsburgh Sleep Quality Index | Not Posted | Baseline, 6 Months | Participants |
| Secondary | Decrease in Medication Side Effects and Symptoms | Patient self-report change in symptoms, side effects, health improvements and problems | Not Posted | 1-week, 3-month, 6-month | Participants |
| 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) | Not Posted | 1-week, 3-month, 6-month | Participants |
| Secondary | Quality of Life | EQ5D-5L | Not Posted | Baseline, 6-months | Participants |
| Secondary | Physical Functioning Performance | Timed-up and go Test | Not Posted | Baseline, 6-months | Participants |
| Secondary | Physical Functioning Performance | Timed 8-foot walk test | Not Posted | Baseline, 6-months | Participants |
| Secondary | Performance of Activities of Daily Living | Barthel Index | Not Posted | Baseline, 6-months | Participants |
| Secondary | Strength | Hand grip | Not Posted | Baseline, 6-months | Participants |
| Secondary | Functional Ability | Functional ability scale for the elderly | Not Posted | Baseline, 6-months | Participants |
| Secondary | Healthcare Utilization | Cost of hospitalizations | Not Posted | Baseline, 6-months | Participants |
| Secondary | Healthcare Utilization | Count of Emergency room visits | Not Posted | Baseline, 6-months | Participants |
| Secondary | Healthcare Utilization | Number of clinic visits | Not Posted | Baseline, 6-months | Participants |
| Secondary | Feasibility Outcomes | Number of participants that refuse recruitment | Not Posted | 6 months | Participants |
| Secondary | Feasibility Outcomes | Retention rates | Not Posted | 6 months | Participants |
| Secondary | Feasibility Outcomes | number of canceled appointments | Not Posted | Baseline, 6 months | Participants |
| Secondary | Feasibility Outcomes | Time to complete measures | Not Posted | Baseline, 6 months | Participants |
| 8 |
| 30 |
| 5 |
| 30 |
| 14 |
| 30 |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| decreased level of consciousness | Nervous system disorders | Systematic Assessment |
|
| vertebral fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| wound infested with maggots | Infections and infestations | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Tooth extraction & complications | Injury, poisoning and procedural complications | Systematic Assessment |
|
| large skin tear/pressure ulcer | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| diagnosed with diabetes mellitus | Metabolism and nutrition disorders | Systematic Assessment |
|
| worsening of Parkinson's Disease with dementia | Nervous system disorders | Systematic Assessment |
|
| increased leg edema | Cardiac disorders | Systematic Assessment | History of congestive heart failure |
|
| bronchitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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