Multi-morbidityNCT03202264
Team Approach to Polypharmacy Reduction to Improve Mobility Long-Term Care
An observational study of Multi-morbidity and Medication Therapy Management, run by McMaster University at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Multi-morbidity, Medication Therapy Management, Polypharmacy
- What is being tested?
- TAPER
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jul 2017to 13 Nov 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Adults, 70 years of age or older, residing in 2 long-term care facilities located in the Brampton, Ontario, Canada.
Who may be able to join
- residing in 2 long-term care facilities in Brampton, ON
- on 5 or more medications
- 70 years of age or older
- adequate English language
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Team Approach to Polypharmacy Reduction to Improve Mobility (TAPER-Mobility): A Pilot Feasibility Study in a Long-Term Care Setting
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.
Read the 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.
- Conditions
- Multi-morbidity, Medication Therapy Management, Polypharmacy
- Being tested
- TAPER
- Keywords
- Polypharmacy, Mobility, Multimorbidity, Drug Discontinuation, Patient Preference, eHealth
- Medical subject headings
- Patient Preference
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAPEROther
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 group | Role | What they receive |
|---|---|---|
| TAPERMD | 80 Long term care residents on 5 or more medications aged over 70 from 2 long term care facilities Receives: Other: TAPER |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful Discontinuation (Difference in Mean Number of Medications; Reduction in Dose)
Difference in mean number of medications; number of medications reduced in dose
Measured: 6 months
Secondary outcomes (20)
Mobility-related Fatigue
Avlund Mob-T Scale
Measured: Baseline, 6 months
Level of Physical Functioning
Manty survey
Measured: Baseline, 6 Months
Pain
Brief Pain Inventory
Measured: Baseline, 6 Months
Falls
Total count of falls recorded in hospital admissions, primary care records and patient report
Measured: Baseline, 6 Months
Sleep
Pittsburgh Sleep Quality Index
Measured: Baseline, 6 Months
Decrease in Medication Side Effects and Symptoms
Patient self-report change in symptoms, side effects, health improvements and problems
Measured: 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)
Measured: 1-week, 3-month, 6-month
Quality of Life
EQ5D-5L
Measured: Baseline, 6-months
Physical Functioning Performance
Timed-up and go Test
Measured: Baseline, 6-months
Physical Functioning Performance
Timed 8-foot walk test
Measured: Baseline, 6-months
Performance of Activities of Daily Living
Barthel Index
Measured: Baseline, 6-months
Strength
Hand grip
Measured: Baseline, 6-months
Functional Ability
Functional ability scale for the elderly
Measured: Baseline, 6-months
Healthcare Utilization
Cost of hospitalizations
Measured: Baseline, 6-months
Healthcare Utilization
Count of Emergency room visits
Measured: Baseline, 6-months
Healthcare Utilization
Number of clinic visits
Measured: Baseline, 6-months
Feasibility Outcomes
Number of participants that refuse recruitment
Measured: 6 months
Feasibility Outcomes
Retention rates
Measured: 6 months
Feasibility Outcomes
number of canceled appointments
Measured: Baseline, 6 months
Feasibility Outcomes
Time to complete measures
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2017
- Study start1 Jul 2017
- Primary completion13 Nov 2019
- Study completion13 Nov 2019
Why it stopped: Difficulty with recruitment and staff retention.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multi-morbidityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- The Labarge Optimal Aging Initiative
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03202264
- Sponsor's protocol ID
- TAPER-Mobility
- Status last verified
- Aug 2021
- First submitted
- 23 Feb 2017
- Last updated
- 8 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available on request to the Principal investigator. The data set will be uploaded as required for publication.
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Team Approach to Polypharmacy Reduction to Improve Mobility (TAPER-Mobility): A Pilot Feasibility Study in a Long-Term Care Setting
- ClinicalTrials.gov ID
- NCT03202264
- Acronym / sponsor ID
- TAPER-Mobility
- Conditions
- Multi-morbidity, Medication Therapy Management, Polypharmacy
- Keywords
- Polypharmacy, Mobility, Multimorbidity, Drug Discontinuation, Patient Preference, eHealth
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Difficulty with recruitment and staff retention.
- Enrolment
- 30 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- The Labarge Optimal Aging Initiative
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 13 Nov 2019 (actual)
- Study completion
- 13 Nov 2019 (actual)
- First posted
- 28 Jun 2017 (actual)
- Results
- Posted 8 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAPERMD | – | Other: TAPER80 Long term care residents on 5 or more medications aged over 70 from 2 long term care facilities |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Adults, 70 years of age or older, residing in 2 long-term care facilities located in the Brampton, Ontario, Canada.
Key inclusion criteria (4 listed)
- residing in 2 long-term care facilities in Brampton, ON
- on 5 or more medications
- 70 years of age or older
- adequate English language
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAPERThe 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 | Other | TAPERMD |
Primary outcome
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
20 secondary outcomes
Mobility-related Fatigue
Time frame: Baseline, 6 months
Level of Physical Functioning
Time frame: Baseline, 6 Months
Pain
Time frame: Baseline, 6 Months
Falls
Time frame: Baseline, 6 Months
Sleep
Time frame: Baseline, 6 Months
Decrease in Medication Side Effects and Symptoms
Time frame: 1-week, 3-month, 6-month
Serious Adverse Events
Time frame: 1-week, 3-month, 6-month
Quality of Life
Time frame: Baseline, 6-months
Physical Functioning Performance
Time frame: Baseline, 6-months
Physical Functioning Performance
Time frame: Baseline, 6-months
Performance of Activities of Daily Living
Time frame: Baseline, 6-months
Strength
Time frame: Baseline, 6-months
Functional Ability
Time frame: Baseline, 6-months
Healthcare Utilization
Time frame: Baseline, 6-months
Healthcare Utilization
Time frame: Baseline, 6-months
Healthcare Utilization
Time frame: Baseline, 6-months
Feasibility Outcomes
Time frame: 6 months
Feasibility Outcomes
Time frame: 6 months
Feasibility Outcomes
Time frame: Baseline, 6 months
Feasibility Outcomes
Time frame: Baseline, 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Data will be available on request to the Principal investigator. The data set will be uploaded as required for publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multi-morbidity and Medication Therapy Management, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful Discontinuation (Difference in Mean Number of Medications; Reduction in Dose) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2021.