Potentially Inappropriate Medication UsePhase 4NCT02570945
Trial of a Pharmacist-physician Intervention Model to Reduce High-risk Drug Use by Hospitalised Elderly Patients
A Phase 4 study testing Pharmacist-physician intervention to reduce high-risk medication use by elderly inpatients in people with Potentially Inappropriate Medication Use, run by Centre de recherche du Centre hospitalier universitaire de Sherbrooke.
Trial summary
The study population will consist of all elderly (65 and older) patients hospitalized at the Centre hospitalier universitaire de Sherbrooke. The patients who present a pharmacotherapeutic problem will be randomly allocated between intervention and control groups. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Potentially Inappropriate Medication Use
- What is being tested?
- Pharmacist-physician intervention to reduce high-risk medication use by elderly inpatients
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 321 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Dec 2015
- Phase
- Phase 4
- 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
- Patients 65 and older admitted at the Centre hospitalier universitaire de Sherbrooke
Who cannot join
- Patients admitted in psychiatry and intensive care
- Patients seen only in the emergency room
About this study
Official title: Randomized Controlled Trial of a Pharmacist-physician Intervention Model to Reduce High-risk Drug Use by Elderly Inpatients
The study population will consist of all elderly (65 and older) patients hospitalized at the Centre hospitalier universitaire de Sherbrooke. The patients who present a pharmacotherapeutic problem will be randomly allocated between intervention and control groups. Practically, the relevant data will be extracted from the Electronic Medical Record (EMR) on a daily basis and analysed by a Computerized Alert System (CAS) to identify pharmacotherapeutic problems. These problems will be analysed a pharmacist specialised in geriatrics to determine their clinical relevance and the modifications that can be made. Clinically relevant pharmacotherapeutic problems will be discussed by the pharmacist and treating physician to establish the changes needed to optimize drug therapy. A geriatrician will also be available to assist the pharmacist in his initial assessment for particularly complex cases. For control patients, a CAS analysis will be conducted to identify patients with a pharmacotherapeutic problem but there will not be a formal discussion amongst the health care providers (usual care) and the physicians of the control group will provide usual care to their patients. The investigators believe that it is ethical to provide usual care to the control group since the beneficial impact on patients outcomes of the investigators' intervention has not been demonstrated.
Pharmacotherapeutic problems were prioritized by the CHUS Elderly Adapted Care-medication committee and are based on the Beers criteria with an emphasis on drugs involved in the development of delirium. Selected pharmacotherapeutic problems are: 1) For patients 75 and older: i) taking a PIM; ii) concomitant use of 4 or more drugs from a list of drugs active at the CNS; iii) positive test for delirium with a PIM; 2) For patients 65 years and older: i) taking levodopa (Parkinson indicator) with a PIM; ii) taking cholinesterase inhibitor or memantine (indicators of dementia) with a PIM. The use of levodopa, a cholinesterase inhibitor or memantine are frailty indicators.
- Conditions
- Potentially Inappropriate Medication Use
- Being tested
- Pharmacist-physician intervention to reduce high-risk medication use by elderly inpatients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist-physician intervention to reduce high-risk medication use by elderly inpatientsProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Pharmacist-physician medication review Receives: Procedure: Pharmacist-physician intervention to reduce high-risk medication use by elderly inpatients |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change rate in medication
The main outcome was the change rate in medications, defined as the number of patient-days with a change in at least one medication out of the total number of patient-days with a pharmacist intervention with the treating physician.
Measured: 48 hours
Secondary outcomes (5)
Clinical relevance of the Computerized Alert System alerts
The clinical relevance of the CAS alerts is defined as the proportion of alerts requiring an intervention (as assessed by the pharmacist) out of the total number of alerts.
Measured: 1 day
Number of falls
Falls documented in the discharge summary and in the incident reports will be included
Measured: From randomisation to the end of the hospitalisation, an average of 12 days
Delirium
Delirium will be assessed with the Confusion assessment Method (CAM) questionnaire
Measured: From randomisation to the end of the hospitalisation, an average of 12 days
Death
Death
Measured: From randomisation to the end of the hospitalisation, an average of 12 days
Readmission within 30 days of hospital discharge
Measured: 30 days after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2015 (estimated)
- Study startSep 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Potentially Inappropriate Medication UseStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 321 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre de recherche du Centre hospitalier universitaire de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benoit Cossette, Centre de recherche du Centre hospitalier universitaire de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02570945
- Sponsor's protocol ID
- 2015-965
- Status last verified
- Feb 2017
- First submitted
- 25 Sep 2015
- Last updated
- 3 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of a Pharmacist-physician Intervention Model to Reduce High-risk Drug Use by Elderly Inpatients
- ClinicalTrials.gov ID
- NCT02570945
- Acronym / sponsor ID
- 2015-965
- Conditions
- Potentially Inappropriate Medication Use
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 321 participants (actual)
- Lead sponsor
- Centre de recherche du Centre hospitalier universitaire de SherbrookeUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 7 Oct 2015 (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 study population will consist of all elderly (65 and older) patients hospitalized at the Centre hospitalier universitaire de Sherbrooke. The patients who present a pharmacotherapeutic problem will be randomly allocated between intervention and control groups. Practically, the relevant data will be extracted from the Electronic Medical Record (EMR) on a daily basis and analysed by a Computerized Alert System (CAS) to identify pharmacotherapeutic problems. These problems will be analysed a pharmacist specialised in geriatrics to determine their clinical relevance and the modifications that can be made. Clinically relevant pharmacotherapeutic problems will be discussed by the pharmacist and treating physician to establish the changes needed to optimize drug therapy. A geriatrician will also be available to assist the pharmacist in his initial assessment for particularly complex cases. For control patients, a CAS analysis will be conducted to identify patients with a pharmacotherapeutic problem but there will not be a formal discussion amongst the health care providers (usual care) and the physicians of the control group will provide usual care to their patients. The investigators believe that it is ethical to provide usual care to the control group since the beneficial impact on patients outcomes of the investigators' intervention has not been demonstrated.
Pharmacotherapeutic problems were prioritized by the CHUS Elderly Adapted Care-medication committee and are based on the Beers criteria with an emphasis on drugs involved in the development of delirium. Selected pharmacotherapeutic problems are: 1) For patients 75 and older: i) taking a PIM; ii) concomitant use of 4 or more drugs from a list of drugs active at the CNS; iii) positive test for delirium with a PIM; 2) For patients 65 years and older: i) taking levodopa (Parkinson indicator) with a PIM; ii) taking cholinesterase inhibitor or memantine (indicators of dementia) with a PIM. The use of levodopa, a cholinesterase inhibitor or memantine are frailty indicators.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Procedure: Pharmacist-physician intervention to reduce high-risk medication use by elderly inpatientsPharmacist-physician medication review |
| Control | No intervention | – |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Patients 65 and older admitted at the Centre hospitalier universitaire de Sherbrooke
Key exclusion criteria (2 listed)
- Patients admitted in psychiatry and intensive care
- Patients seen only in the emergency room
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 |
|---|---|---|
| Pharmacist-physician intervention to reduce high-risk medication use by elderly inpatients | Procedure or surgery | Intervention |
Primary outcome
Change rate in medication
Time frame: 48 hours
The main outcome was the change rate in medications, defined as the number of patient-days with a change in at least one medication out of the total number of patient-days with a pharmacist intervention with the treating physician.
5 secondary outcomes
Clinical relevance of the Computerized Alert System alerts
Time frame: 1 day
Number of falls
Time frame: From randomisation to the end of the hospitalisation, an average of 12 days
Delirium
Time frame: From randomisation to the end of the hospitalisation, an average of 12 days
Death
Time frame: From randomisation to the end of the hospitalisation, an average of 12 days
Readmission within 30 days of hospital discharge
Time frame: 30 days after hospital discharge
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 3 Feb 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pharmacist-physician intervention to reduce high-risk medication use by elderly inpatients in people with Potentially Inappropriate Medication Use, run by Centre de recherche du Centre hospitalier universitaire de Sherbrooke.
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 1 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: finished, as of the sponsor's last update on 3 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 rate in medication (time frame: 48 hours). 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 3 Feb 2017.