Multi-morbidityNCT03557944
Team Approach to Polypharmacy Evaluation and Reduction (Pharmacy)
A study testing Medication reduction in people with Multi-morbidity and Medication Therapy Management, run by McMaster University at 1 site in Canada.
Trial summary
In an aging population, most seniors suffer from multiple chronic conditions. When the number of medications taken is ≥5 (polypharmacy), the burden of taking multiple concurrent medications can do more harm than good. 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?
- Medication reduction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 16 Jun 2019to Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Aged 70 years of age or older
- Patient must have a family doctor
- Participating family doctor as most responsible provider
- Currently taking 5 or more long-term medications
- Has not had a recent comprehensive medication review
- Patient willing to try discontinuation
Who cannot join
- English language or cognitive skills inadequate to understand and respond to rating scales
- Terminal illness or other circumstance precluding 6 month study period
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Dr. Dee Mangin
Hamilton, Ontario, L8S 4K1
Dee Mangin, 9055259140 ext. 21219, mangind@mcmaster.ca
About this study
Official title: Team Approach to Polypharmacy Evaluation and Reduction Pharmacy
In an aging population, most seniors suffer from multiple chronic conditions. When the number of medications taken is ≥5 (polypharmacy), the burden of taking multiple concurrent medications can do more harm than good. Seniors take an average of 7 regular medications and studies link polypharmacy with adverse effects on morbidity, function and health service use. However, it is not clear to what extent these are reversible if medication burden is reduced.
This trial will test the effects on medication numbers and patient health outcomes of an intervention to polypharmacy. This study will test a program focused on medication reduction number and dose. Prioritizing medications according to the patient's preference as reducing the dose also reduces the risk of drug side effects.
Read more
Patients, aged 70 years of age or older and taking ≥5 medications will receive the TAPER program. The program involves information gathering from the patient, including systematically seeking patients priorities and preferences, medication review with the pharmacist and then a consultation with the family doctor. The intervention is focused on discontinuing/reducing the dose of medications where possible using a 'pause and monitor' framework to assess the need for restart. An electronic program that detects drug adverse effects and flags potentially inappropriate medications will be integrated into an electronic clinical pathway incorporating monitoring and follow-up systems.
This study will examine whether implementing a deprescribing care pathway with community pharmacists as point-of-entry can signal improvements in prescribing and patient health outcomes in older adults with polypharmacy.
Read the detailed description
This study uses a single-arm, longitudinal cohort feasibility design. Patients will receive the intervention following baseline data collection. Initial baseline data collection from the patient will include information on demographics, medications, and illness characteristics. The patient will then attend an appointment with a pharmacist to review medications appropriate for discontinuation/dose reduction, after which the patient will meet with their family physician to discuss patient preferences for discontinuation/dose reduction. Both health care providers will have access to TaperMD, a web-based program linked to evidence and tools to support reduction in polypharmacy. Follow-up research assessments will take place at one week, 3 months and 6 months (study end). Outcome assessments and a semi-structured interview will take place at the 6 month appointment.
- Conditions
- Multi-morbidity, Medication Therapy Management, Polypharmacy
- Being tested
- Medication reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medication reductionOther
Also called Medication discontinuation/dose reduction
Systematic approach to reduction in polypharmacy.
| Study group | Role | What they receive |
|---|---|---|
| TAPER | Experimental | The intervention is medication reduction. This arm is comprised of:
1. Medication reconciliation
2. Identification of patient priorities for care
3. Identification of medications that are potentially appropriate for discontinuation/dose reduction
4. Linked pharmacist/family physician consultations with patient to discuss medication with intention to reduce
5. Identification of medications for trial of discontinuation/dose reduction (shared decision making)
6. Pause of medication and clinical monitoring Receives: Other: Medication reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility (recruitment number)
Number of people who are invited to participate in the study.
Measured: 6 months
Secondary outcomes (9)
Feasibility (proportion consented)
Number of participants who consent divided by the number of potential participants invited.
Measured: 6 months
Feasibility (proportion completed)
Number of participants who complete 6-month data collection divided by the number of people who consented.
Measured: 6 months
Feasibility (barriers to recruitment)
Challenges to recruitment as identified by pharmacists via field notes and interviews.
Measured: 6 months
Feasibility (time to complete surveys)
Total time to complete all surveys
Measured: Baseline, 6 months
Feasibility (capacity for pharmacist to implement)
Challenges regarding implementation for pharmacists from field notes and interviews
Measured: 6 months
Feasibility (issues with TaperMD tool)
Communication between pharmacists and research team noting TaperMD issues from regular meetings.
Measured: 6 months
Feasibility (missing data)
Nature and percentage of missing data.
Measured: 6 months
Feasibility (variance of measures)
The calculated range of scores for surveys (where applicable)
Measured: Baseline, 6 months
Feasibility (intervention implementation proportion)
Number of plans containing deprescribing actions divided by the total number of plans.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study start16 Jun 2019
- Primary completionOct 2023 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm, longitudinal cohort feasibility study.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), David Braley and Nancy Gordon Chair in Family Medicine, RxISK
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03557944
- Sponsor's protocol ID
- 4619
- Status last verified
- Mar 2023
- First submitted
- 5 Jun 2018
- Last updated
- 15 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Team Approach to Polypharmacy Evaluation and Reduction Pharmacy
- ClinicalTrials.gov ID
- NCT03557944
- Acronym / sponsor ID
- 4619
- Conditions
- Multi-morbidity, Medication Therapy Management, Polypharmacy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), David Braley and Nancy Gordon Chair in Family Medicine, RxISK
- Study start
- 16 Jun 2019 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 15 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In an aging population, most seniors suffer from multiple chronic conditions. When the number of medications taken is ≥5 (polypharmacy), the burden of taking multiple concurrent medications can do more harm than good. Seniors take an average of 7 regular medications and studies link polypharmacy with adverse effects on morbidity, function and health service use. However, it is not clear to what extent these are reversible if medication burden is reduced.
This trial will test the effects on medication numbers and patient health outcomes of an intervention to polypharmacy. This study will test a program focused on medication reduction number and dose. Prioritizing medications according to the patient's preference as reducing the dose also reduces the risk of drug side effects.
Patients, aged 70 years of age or older and taking ≥5 medications will receive the TAPER program. The program involves information gathering from the patient, including systematically seeking patients priorities and preferences, medication review with the pharmacist and then a consultation with the family doctor. The intervention is focused on discontinuing/reducing the dose of medications where possible using a 'pause and monitor' framework to assess the need for restart. An electronic program that detects drug adverse effects and flags potentially inappropriate medications will be integrated into an electronic clinical pathway incorporating monitoring and follow-up systems.
This study will examine whether implementing a deprescribing care pathway with community pharmacists as point-of-entry can signal improvements in prescribing and patient health outcomes in older adults with polypharmacy.
Detailed description
This study uses a single-arm, longitudinal cohort feasibility design. Patients will receive the intervention following baseline data collection. Initial baseline data collection from the patient will include information on demographics, medications, and illness characteristics. The patient will then attend an appointment with a pharmacist to review medications appropriate for discontinuation/dose reduction, after which the patient will meet with their family physician to discuss patient preferences for discontinuation/dose reduction. Both health care providers will have access to TaperMD, a web-based program linked to evidence and tools to support reduction in polypharmacy. Follow-up research assessments will take place at one week, 3 months and 6 months (study end). Outcome assessments and a semi-structured interview will take place at the 6 month appointment.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm, longitudinal cohort feasibility study.
| Arm | Type | Receives |
|---|---|---|
| TAPER | Experimental | Other: Medication reductionThe intervention is medication reduction. This arm is comprised of: 1. Medication reconciliation 2. Identification of patient priorities for care 3. Identification of medications that are potentially appropriate for discontinuation/dose reduction 4. Linked pharmacist/family physician consultations with patient to discuss medication with intention to reduce 5. Identification of medications for trial of discontinuation/dose reduction (shared decision making) 6. Pause of medication and clinical monitoring |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Aged 70 years of age or older
- Patient must have a family doctor
- Participating family doctor as most responsible provider
- Currently taking 5 or more long-term medications
- Has not had a recent comprehensive medication review
Key exclusion criteria (2 listed)
- English language or cognitive skills inadequate to understand and respond to rating scales
- Terminal illness or other circumstance precluding 6 month study period
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 |
|---|---|---|
| Medication reductionAlso: Medication discontinuation/dose reductionSystematic approach to reduction in polypharmacy. | Other | TAPER |
Primary outcome
Feasibility (recruitment number)
Time frame: 6 months
Number of people who are invited to participate in the study.
9 secondary outcomes
Feasibility (proportion consented)
Time frame: 6 months
Feasibility (proportion completed)
Time frame: 6 months
Feasibility (barriers to recruitment)
Time frame: 6 months
Feasibility (time to complete surveys)
Time frame: Baseline, 6 months
Feasibility (capacity for pharmacist to implement)
Time frame: 6 months
Feasibility (issues with TaperMD tool)
Time frame: 6 months
Feasibility (missing data)
Time frame: 6 months
Feasibility (variance of measures)
Time frame: Baseline, 6 months
Feasibility (intervention implementation proportion)
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medication reduction in people with 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 6 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 15 Mar 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dee Mangin, MBChB, DPH, FRNZC, MD (905-525-9140 ext. 21219, mangind@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (recruitment number) (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 15 Mar 2023.