PolypharmacyNCT03091153
Deprescribing in a Long Term Care Facility
A study testing Medication Review in people with Polypharmacy, run by Memorial University of Newfoundland at 1 site in Canada.
Trial summary
This study will develop, implement and evaluate a deprescribing initiative at a Canadian Long Term Care (LTC) Facility. Residents currently undergo an annual medication review as part of the clinical pharmacy services provided in the LTC facility. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Polypharmacy
- What is being tested?
- Medication Review
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteCanada
- Study dates
- 30 Mar 2017to 1 Jun 2019
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Over 65 years of age
- Reside in St. Patrick's Mercy Home (2nd or 3rd floor units)
Who cannot join
- Do not take any regularly scheduled medications
- Are receiving palliative care
- Resident's physician or nursing team do not support participation
- Resident or their substitute decision maker decline participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of a Deprescribing Intervention on Nursing Home Residents: a Randomized Controlled Trial
This study will develop, implement and evaluate a deprescribing initiative at a Canadian Long Term Care (LTC) Facility. Residents currently undergo an annual medication review as part of the clinical pharmacy services provided in the LTC facility. For this study, eligible residents will be randomized to receive either a deprescribing focused medication review or usual care.
The deprescribing focused medication therapy assessments will be done on half of the 143 residents residing on the second and third floors of the facility. The other half of residents will serve as the control group and continue to receive their annual medication review and regular care from the attending physicians and nurses.
The deprescribing intervention will be delivered by final year pharmacy students completing their practice experiences, under the supervision of clinical pharmacists at the LTC facility and clinical pharmacists from Memorial University's Medication Therapy Services (MTS) Clinic. Currently the clinic has a well developed procedure for providing in depth medication therapy reviews for residents of the community, upon referral by their primary care physician. Students will adapt this model of medication review to have a stronger deprescribing focus and be applicable to elderly residents of a LTC facility. The intervention will consist of an in depth medication therapy review with a focus on identifying any medications that may no longer be required or are deemed to be inappropriate or potentially unsafe in the elderly based on currently guidelines/criteria. The students will work closely with members of the resident's care team on a daily basis, as well as the resident and their family, to develop and implement a deprescribing plan.
- Conditions
- Polypharmacy
- Being tested
- Medication Review
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medication ReviewOther
In depth medication review with a focus on deprescribing
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Standard care. Annual medication review |
| Intervention | Experimental | In depth medication review with a focus on deprescribing Receives: Other: Medication Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in number of medications taken daily by residents
Measured using facility medication logs and patient health records
Measured: 3 and 6 months after receiving intervention
Secondary outcomes (10)
All cause mortality rate
Measured using patient health records
Measured: 3 and 6 months after receiving the intervention
Instance of falls in the last 30 days
Measured using facility fall report logs
Measured: 3 and 6 months after receiving the intervention
Frequency of emergency room visits, unplanned hospital admission and/or unplanned GP visits
Measured using patient health records
Measured: 3 and 6 months after receiving the intervention
Cognitive function score
Measured using Cognitive Performance Scale (CPS) obtained from Resident Assessment Instrument (RAI) MDS 2.0
Measured: 3 and 6 months after receiving the intervention
Bowel function
Measured using bowel chart data for the 14 days prior to the assessment date
Measured: baseline, 3 and 6 months after receiving the intervention
Independence in activities of daily living
Measured using the Activities of Daily Living Scale (ADL) obtained from RAI MDS 2.0
Measured: 3 and 6 months after receiving the intervention
Changes in general health
Measured using the Changes in Health, End-Stage Disease and Signs and Symptoms (CHESS) Score obtained from RAI MDS 2.0
Measured: 3 and 6 months after receiving the intervention
Social engagement
Measured using Index of Social Engagement (ISE) Score obtained from RAI MDS 2.0
Measured: 3 and 6 months after receiving the intervention
Aggressive behaviour
Measured using the Aggressive Behaviour Scale (ABS) obtained from RAI MDS 2.0
Measured: 3 and 6 months after receiving the intervention
Frequency of pain
Measured using the Pain Scale obtained from RAI MDS 2.0
Measured: 3 and 6 months after receiving the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2017
- Study start30 Mar 2017
- Primary completion31 Dec 2018
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PolypharmacyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial University of Newfoundland
- Sponsor type
- University, hospital or other
- Collaborators
- Eastern Health
- Responsible party
- Principal investigator, Deborah Kelly, Memorial University of Newfoundland
- Investigators
- Deborah Kelly, PharmD, Principal investigator, Memorial University of Newfoundland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03091153
- Sponsor's protocol ID
- HREB - 2016.312
- Status last verified
- Jul 2019
- First submitted
- 21 Mar 2017
- Last updated
- 22 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Deprescribing Intervention on Nursing Home Residents: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03091153
- Acronym / sponsor ID
- HREB - 2016.312
- Conditions
- Polypharmacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Memorial University of NewfoundlandUniversity, hospital or other
- Collaborators
- Eastern Health
- Study start
- 30 Mar 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 27 Mar 2017 (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.
This study will develop, implement and evaluate a deprescribing initiative at a Canadian Long Term Care (LTC) Facility. Residents currently undergo an annual medication review as part of the clinical pharmacy services provided in the LTC facility. For this study, eligible residents will be randomized to receive either a deprescribing focused medication review or usual care.
The deprescribing focused medication therapy assessments will be done on half of the 143 residents residing on the second and third floors of the facility. The other half of residents will serve as the control group and continue to receive their annual medication review and regular care from the attending physicians and nurses.
The deprescribing intervention will be delivered by final year pharmacy students completing their practice experiences, under the supervision of clinical pharmacists at the LTC facility and clinical pharmacists from Memorial University's Medication Therapy Services (MTS) Clinic. Currently the clinic has a well developed procedure for providing in depth medication therapy reviews for residents of the community, upon referral by their primary care physician. Students will adapt this model of medication review to have a stronger deprescribing focus and be applicable to elderly residents of a LTC facility. The intervention will consist of an in depth medication therapy review with a focus on identifying any medications that may no longer be required or are deemed to be inappropriate or potentially unsafe in the elderly based on currently guidelines/criteria. The students will work closely with members of the resident's care team on a daily basis, as well as the resident and their family, to develop and implement a deprescribing plan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Standard care. Annual medication review |
| Intervention | Experimental | Other: Medication ReviewIn depth medication review with a focus on deprescribing |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Over 65 years of age
- Reside in St. Patrick's Mercy Home (2nd or 3rd floor units)
Key exclusion criteria (4 listed)
- Do not take any regularly scheduled medications
- Are receiving palliative care
- Resident's physician or nursing team do not support participation
- Resident or their substitute decision maker decline participation
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 ReviewIn depth medication review with a focus on deprescribing | Other | Intervention |
Primary outcome
Change in number of medications taken daily by residents
Time frame: 3 and 6 months after receiving intervention
Measured using facility medication logs and patient health records
10 secondary outcomes
All cause mortality rate
Time frame: 3 and 6 months after receiving the intervention
Instance of falls in the last 30 days
Time frame: 3 and 6 months after receiving the intervention
Frequency of emergency room visits, unplanned hospital admission and/or unplanned GP visits
Time frame: 3 and 6 months after receiving the intervention
Cognitive function score
Time frame: 3 and 6 months after receiving the intervention
Bowel function
Time frame: baseline, 3 and 6 months after receiving the intervention
Independence in activities of daily living
Time frame: 3 and 6 months after receiving the intervention
Changes in general health
Time frame: 3 and 6 months after receiving the intervention
Social engagement
Time frame: 3 and 6 months after receiving the intervention
Aggressive behaviour
Time frame: 3 and 6 months after receiving the intervention
Frequency of pain
Time frame: 3 and 6 months after receiving the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2019.
- Individual participant dataSharing planned: No
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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.
Deborah Kelly, PharmD principal investigator
Memorial University of Newfoundland
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 Review in people with Polypharmacy, run by Memorial University of Newfoundland 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 22 Jul 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in number of medications taken daily by residents (time frame: 3 and 6 months after receiving intervention). 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 22 Jul 2019.