PolypharmacyWiseMedNCT01932632
Medication Minimization for Long-term Care Residents
A study testing Medication Minimization in people with Polypharmacy, run by University of British Columbia at 6 sites in Canada.
Trial summary
The purpose of this experiment is to test the effect of medication minimization on mortality and hospitalization in long-term care residents. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Polypharmacy
- What is being tested?
- Medication Minimization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 6 sitesCanada
- Study dates
- Sep 2013to Nov 2016
- 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
- Healthy volunteers accepted
- Older adult
Who may be able to join
- age>70
- Living in one of the 6 participating residential care facilities:
- Youville Residence, PHC, 4950 Heather Street, Vancouver, BC, V5Z 3L9
- Brock Fahrni Residence, 4650 Oak Street, Vancouver, BC, V6H 4J4
- Mount St. Joseph's LTC, PHC, 3080 Prince Edward Street, Vancouver, BC, V5T 3N4
- Holy Family Hospital, PHC, 7801 Argyle Street, Vancouver, BC, V5P 3L6
Show all 12Show fewer
- St. Vincent's Langara, PHC, 255 West 62nd Avenue, BC, V5X 4V4
- Minoru Residence, VCH, 6111 Minoru Boulevard, Richmond, BC V6Y 1Y4
- Attending GP has agreed to participate in study
- Taking more that 5 medications
- If unable to provide consent (due to cognitive impairment, aphasia or any other barrier), that there is a family member or designated decision maker able and willing to sign consent
- Cognitive impairment will be identified by the attending GP. Any participant who is deemed unable to consent as a result of cognitive impairment will be offered a chance to participate by the research team contacting the alternate decision maker identified in the patient's chart. If appropriate, an assent form will be made available to those participants who agree to sign the consent form for their loved one
Who cannot join
- On hemodialysis (due to multiple active prescribing MD's at anyone time)
- If cognitively impaired, but family member, (or designated decision maker) cannot be contacted to discuss and sign consent
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Canada6 sites
Holy Family Hospital
Vancouver, British Columbia, V5P 3L6
Mount St. Joseph's
Vancouver, British Columbia, V5T 3N4
St. Vincent's Langara
Vancouver, British Columbia, V5X 4V4
Youville Residence
Vancouver, British Columbia, V5Z 3L9
Brock Fahrni Residence
Vancouver, British Columbia, V6H 4J4
Minoru Residence
Vancouver, British Columbia, V6Y 1Y4
About this study
Official title: The Effect of Medication Minimization on Mortality and Hospitalization in Long-Term Care Residents: The WiseMed RCT
The purpose of this experiment is to test the effect of medication minimization on mortality and hospitalization in long-term care residents.
Read the detailed description
People living in residential care are typically elderly and often have complex co-morbid illnesses that are not expected to improve and which they are unable to manage on their own at home. Many of these patients have been prescribed multiple medications to:
- treat individual conditions
- theoretically prevent unwanted sequelae of chronic conditions and/or
- treat side effects of medications given for a) and b).
Advancing age has been found to be a significant factor in adverse drug events and polypharmacy has been found to be a stand alone risk factor for higher mortality and morbidity. However, in British Columbia, the average number of medications taken by patients in residential care is 9, with a range of 0-55 (hospital reporting data, specific reference pending).
Frail elders are often being treated for chronic diseases using published guidelines for both symptom modification and prevention despite the fact that very few of these guidelines are able to include convincing evidence about efficacy in the frail elder population.
Despite the available knowledge of the possible harm of adverse effects in the aged, polypharmacy and a lack of appropriate population-specific evidence, many residential care patients do not have medications stopped or tapered. The lack of change may be explained by the admitting physicians' belief that there is appropriate evidence or a reluctance to stop a medication that was started by a specialist. Other research has also suggested that there is little or no experience/education for many physicians about which medications to address and exactly how to stop/taper medications, and/or a concern/belief that patients or families will fear that the care provider is "giving up" on a patient or relegating her/him to a quicker death.
Medication reviews at point of admission to residential care facilities typically do not result in a significant reduction in the number of medications nor dose reductions.
However, there have been some promising initial studies looking at more formalized approaches to medication discontinuation and minimization as well as a review of the ethics of such programs(23). In a 2007 prospective cohort study, Garfinkel et al were able to demonstrate a reduction in 1-year mortality (45% in control and 21% in study group, p<0.001, chi-square test), fewer transfers to acute care (30 % in control and 11.8% in study group, p<0.002) as well as a reduction in costs of medication.
I propose to do a randomized control study of medication minimization for residential care patients. I will use a modified version of the "GP-GP protocol" developed by Garfinkel, et al and randomly assign patients to either "medication prescribing as usual" or the medication minimization protocol.
To see if reducing polypharmacy (i.e. the number and dosage of medications) for elders living in residential care increases time between admission and death (i.e. improves mortality) and reduces the number of transfers to acute care (i.e. improves morbidity).
- Conditions
- Polypharmacy
- Being tested
- Medication Minimization
- Keywords
- Polypharmacy, De-prescribing, Frailty
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medication MinimizationOther
Series of specific medication reviews done by attending MD using standardized study protocol forms and MD's clinical assessment.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | This group will receive care as similar as possible to care that they received prior to the study beginning. Their attending MDs will be instructed and reminded to avoid making parallel changes in the prescribing for the control patients unless there is a specific medical indication to which they would normally respond with a medication reduction. No other reminders or prompts about the study will be provided for these patients. |
| Medication Minimization | Experimental | 1. Initial Medication Review (IMR) Completed by Attending MD and identifies potential medications to be considered for minimization as well as those UNSUITABLE (as per usual MD opinion)
2. Orders-Medication Update (OMU) (ref form) The attending MD will have identified one or more medications to be considered for minimization and in the IMR suggested a time when a reduced dose will be reviewed (recommended every 4 weeks). Each review will generate an OMU. This process will be repeated for every participant in the Medication Minimization arm until all medications are marked as having no further changes, ie no need for further OMU. At that time a participant's record will be marked as having completed medication minimization. Receives: Other: Medication Minimization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality Rate Compared Between Control and Intervention Group
This information will be gathered from acute care and facility electronic health records and where needed validated using participant paper chart. A request will be made to facilities for this information every three months during the study.
Measured: Up to 2 years
Secondary outcomes (4)
Survival Analysis Compared Between Control and Intervention Group
Survival Analysis and Acute Care Transfers will be calculated every 3 months from the same data collected for the primary outcome.
Measured: Up to 2 years
Difference in Acute Care Transfers Between Control and Intervention Group
Lengths of stay for each transfer, measured in days. Survival Analysis and Acute Care Transfers will be calculated every 3 months from the same data collected for the primary outcome.
Measured: Up to 2 years
Number of Attending MD emergency facility visits and nurse to physician phone calls billed by the attending physician (captures significant medical issues not requiring transfer to acute care problems)
Number of unscheduled MD visits + phone calls billed(this data will be collected as an encrypted file from participating GP's billing data, only the number of 00115, 00118 and 13005 Medical Services Plan billing codes will be requested, no additional data will be contained in this file) A request will be made for this information every three months during the study.
Measured: Up to 2 years
Comparison of Total Cost of Care Between Control and Intervention Group
This will be estimated from medication costs, number of acute care inpatient days, and number of family physician telephone and emergency visit billings. This will be calculated at the termination of the study from the data collected above.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2013 (estimated)
- Study startSep 2013
- Primary completionNov 2016
- Study completionNov 2016
Why it stopped: unable to recruit
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.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, R McCracken, University of British Columbia
- Investigators
- Rita McCracken, MD, PhD (student), Principal investigator, UBC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01932632
- Sponsor's protocol ID
- H12-03169
- Acronym
- WiseMed
- Status last verified
- May 2017
- First submitted
- 24 Jul 2013
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Medication Minimization on Mortality and Hospitalization in Long-Term Care Residents: The WiseMed RCT
- ClinicalTrials.gov ID
- NCT01932632
- Acronym / sponsor ID
- WiseMed / H12-03169
- Conditions
- Polypharmacy
- Keywords
- Polypharmacy, De-prescribing, Frailty
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: unable to recruit
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 30 Aug 2013 (estimated)
- 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.
The purpose of this experiment is to test the effect of medication minimization on mortality and hospitalization in long-term care residents.
Detailed description
People living in residential care are typically elderly and often have complex co-morbid illnesses that are not expected to improve and which they are unable to manage on their own at home. Many of these patients have been prescribed multiple medications to:
- treat individual conditions
- theoretically prevent unwanted sequelae of chronic conditions and/or
- treat side effects of medications given for a) and b).
Advancing age has been found to be a significant factor in adverse drug events and polypharmacy has been found to be a stand alone risk factor for higher mortality and morbidity. However, in British Columbia, the average number of medications taken by patients in residential care is 9, with a range of 0-55 (hospital reporting data, specific reference pending).
Frail elders are often being treated for chronic diseases using published guidelines for both symptom modification and prevention despite the fact that very few of these guidelines are able to include convincing evidence about efficacy in the frail elder population.
Despite the available knowledge of the possible harm of adverse effects in the aged, polypharmacy and a lack of appropriate population-specific evidence, many residential care patients do not have medications stopped or tapered. The lack of change may be explained by the admitting physicians' belief that there is appropriate evidence or a reluctance to stop a medication that was started by a specialist. Other research has also suggested that there is little or no experience/education for many physicians about which medications to address and exactly how to stop/taper medications, and/or a concern/belief that patients or families will fear that the care provider is "giving up" on a patient or relegating her/him to a quicker death.
Medication reviews at point of admission to residential care facilities typically do not result in a significant reduction in the number of medications nor dose reductions.
However, there have been some promising initial studies looking at more formalized approaches to medication discontinuation and minimization as well as a review of the ethics of such programs(23). In a 2007 prospective cohort study, Garfinkel et al were able to demonstrate a reduction in 1-year mortality (45% in control and 21% in study group, p<0.001, chi-square test), fewer transfers to acute care (30 % in control and 11.8% in study group, p<0.002) as well as a reduction in costs of medication.
I propose to do a randomized control study of medication minimization for residential care patients. I will use a modified version of the "GP-GP protocol" developed by Garfinkel, et al and randomly assign patients to either "medication prescribing as usual" or the medication minimization protocol.
To see if reducing polypharmacy (i.e. the number and dosage of medications) for elders living in residential care increases time between admission and death (i.e. improves mortality) and reduces the number of transfers to acute care (i.e. improves morbidity).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –This group will receive care as similar as possible to care that they received prior to the study beginning. Their attending MDs will be instructed and reminded to avoid making parallel changes in the prescribing for the control patients unless there is a specific medical indication to which they would normally respond with a medication reduction. No other reminders or prompts about the study will be provided for these patients. |
| Medication Minimization | Experimental | Other: Medication Minimization1. Initial Medication Review (IMR) Completed by Attending MD and identifies potential medications to be considered for minimization as well as those UNSUITABLE (as per usual MD opinion) 2. Orders-Medication Update (OMU) (ref form) The attending MD will have identified one or more medications to be considered for minimization and in the IMR suggested a time when a reduced dose will be reviewed (recommended every 4 weeks). Each review will generate an OMU. This process will be repeated for every participant in the Medication Minimization arm until all medications are marked as having no further changes, ie no need for further OMU. At that time a participant's record will be marked as having completed medication minimization. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (12 listed)
- age>70
- Living in one of the 6 participating residential care facilities:
- Attending GP has agreed to participate in study
- Taking more that 5 medications
- If unable to provide consent (due to cognitive impairment, aphasia or any other barrier), that there is a family member or designated decision maker able and willing to sign consent
Key exclusion criteria (2 listed)
- On hemodialysis (due to multiple active prescribing MD's at anyone time)
- If cognitively impaired, but family member, (or designated decision maker) cannot be contacted to discuss and sign consent
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 MinimizationSeries of specific medication reviews done by attending MD using standardized study protocol forms and MD's clinical assessment. | Other | Medication Minimization |
Primary outcome
Mortality Rate Compared Between Control and Intervention Group
Time frame: Up to 2 years
This information will be gathered from acute care and facility electronic health records and where needed validated using participant paper chart. A request will be made to facilities for this information every three months during the study.
4 secondary outcomes
Survival Analysis Compared Between Control and Intervention Group
Time frame: Up to 2 years
Difference in Acute Care Transfers Between Control and Intervention Group
Time frame: Up to 2 years
Number of Attending MD emergency facility visits and nurse to physician phone calls billed by the attending physician (captures significant medical issues not requiring transfer to acute care problems)
Time frame: Up to 2 years
Comparison of Total Cost of Care Between Control and Intervention Group
Time frame: Up to 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
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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.
Rita McCracken, MD, PhD (student) principal investigator
UBC
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medication Minimization in people with Polypharmacy, run by University of British Columbia at 6 sites 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 12 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: withdrawn, as of the sponsor's last update on 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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 was withdrawn before enrolling participants, so there are no results.
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?
Mortality Rate Compared Between Control and Intervention Group (time frame: Up to 2 years). 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 9 May 2017.