Inappropriate PrescribingTaIPENCT04028583
Tool for Inappropriate Prescription Evaluation: The TaIPE Study
A study testing PIM-Check and STOPP/START in people with Inappropriate Prescribing, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
Trial summary
A mono-center, randomized controlled trial will be conducted at the University Hospital of Lausanne. Hospitalized patients will be randomly assigned from the emergency department to two sub-units composing the acute care for elders (ACE) unit. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Inappropriate Prescribing
- What is being tested?
- PIM-Check and STOPP/START
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 464 participants
- Where
- 1 siteSwitzerland
- Study dates
- 26 Feb 2018to 4 Aug 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
- All patients meeting the admission criteria of the acute care for elders (ACE) unit will be eligible.
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Akram FARHAT, PharmD, MPH, PhD contact
Switzerland1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire Vaudois
Lausanne, Canton of Vaud, 1011
Akram FARHAT, PharmD, MPH, PhD, akram.farhat@hotmail.com
Chantal Csajka, PharmD, PhD
About this study
A mono-center, randomized controlled trial will be conducted at the University Hospital of Lausanne. Hospitalized patients will be randomly assigned from the emergency department to two sub-units composing the acute care for elders (ACE) unit. In one subunit, potentially inappropriate prescriptions will be detected and treatment optimized according PIM-Check. In the other, STOPP/START criteria will be independently applied.
- Conditions
- Inappropriate Prescribing
- Being tested
- PIM-Check, STOPP/START
- Keywords
- Inappropriate Prescribing, Potentially Inappropriate Medication List, Aged, Practice Guideline, Education, Medical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PIM-CheckOther
In the PIM-Check group, a medication review will be conducted using PIM-Check within 72 hours of patient's admittance to the unit. The physician will decide whether to accept these recommendations or not and implement prescribing changes if agreed.
STOPP/STARTOther
In the STOPP/START group, medication lists will be analyzed within 72 hours of patient's admittance and optimized according to STOPP/START criteria. The second physician will decide whether to accept these recommendations or not and implement prescribing changes if agreed.
| Study group | Role | What they receive |
|---|---|---|
| PIM-Check group | Experimental | Not described Receives: Other: PIM-Check |
| STOPP/START group | Active comparator | Not described Receives: Other: STOPP/START |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Potentially Inappropriate Prescriptions (PIPs) reduction in the PIM-Check group compared to STOPP/START
Measured: 18 months
Secondary outcomes (10)
Number and type of PIPs detected by each tool
Measured: 18 months
Rate of acceptability
Measured: 18 months
Number of treatment (mean and median) modification by clinicians
Measured: 18 months
Number of drugs at discharge
Measured: 18 months
Incidence rate of falls
Measured: 18 months
Activities of daily living (ADL) score
Activities of daily living are routine activities people do every day without assistance (6 basic activities) : eating, bathing, getting dressed, toileting, transferring, and continence. The score is the number of activities performed without assistance. Score ranges : from 0/6 (minimum) to 6/6 (maximum). Higher values represent a better outcome of activities of daily living.
Measured: 18 months
Confusion Assessment Method (CAM)
Result ranges : [negative result (-) = no confusion] ; [positive result (+) = confusion].
Measured: 18 months
Length of stay
Measured: 18 months
Number of unplanned readmission
Measured: up to 3 months after discharge
Association between the number and type of PIPs at discharge with rate of re-admission
Measured: up to 3 months after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2019
- Study start26 Feb 2018
- Primary completion30 Apr 2019
- Study completion4 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inappropriate PrescribingStudies 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
- Participant
- Enrolment
- 464 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chantal Csajka, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04028583
- Sponsor's protocol ID
- TaIPE
- Acronym
- TaIPE
- Status last verified
- Jul 2019
- First submitted
- 17 Jul 2019
- Last updated
- 23 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Farhat A, Al-Hajje A, Lang PO, Csajka C. Impact of Pharmaceutical Interventions with STOPP/START and PIM-Check in Older Hospitalized Patients: A Randomized Controlled Trial. Drugs Aging. 2022 Nov;39(11):899-910. doi: 10.1007/s40266-022-00974-7. Epub 2022 Sep 30.
PubMed 36175740
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tool for Inappropriate Prescription Evaluation: The TaIPE Study
- ClinicalTrials.gov ID
- NCT04028583
- Acronym / sponsor ID
- TaIPE / TaIPE
- Conditions
- Inappropriate Prescribing
- Keywords
- Inappropriate Prescribing, Potentially Inappropriate Medication List, Aged, Practice Guideline, Education, Medical
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 464 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- 26 Feb 2018 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 4 Aug 2019 (estimated)
- First posted
- 22 Jul 2019 (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.
A mono-center, randomized controlled trial will be conducted at the University Hospital of Lausanne. Hospitalized patients will be randomly assigned from the emergency department to two sub-units composing the acute care for elders (ACE) unit. In one subunit, potentially inappropriate prescriptions will be detected and treatment optimized according PIM-Check. In the other, STOPP/START criteria will be independently applied.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PIM-Check group | Experimental | Other: PIM-Check |
| STOPP/START group | Active comparator | Other: STOPP/START |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- All patients meeting the admission criteria of the acute care for elders (ACE) unit will be eligible.
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| PIM-CheckIn the PIM-Check group, a medication review will be conducted using PIM-Check within 72 hours of patient's admittance to the unit. The physician will decide whether to accept these recommendations or not and implement prescribing changes if agreed. | Other | PIM-Check group |
| STOPP/STARTIn the STOPP/START group, medication lists will be analyzed within 72 hours of patient's admittance and optimized according to STOPP/START criteria. The second physician will decide whether to accept these recommendations or not and implement prescribing changes if agreed. | Other | STOPP/START group |
Primary outcome
Rate of Potentially Inappropriate Prescriptions (PIPs) reduction in the PIM-Check group compared to STOPP/START
Time frame: 18 months
10 secondary outcomes
Number and type of PIPs detected by each tool
Time frame: 18 months
Rate of acceptability
Time frame: 18 months
Number of treatment (mean and median) modification by clinicians
Time frame: 18 months
Number of drugs at discharge
Time frame: 18 months
Incidence rate of falls
Time frame: 18 months
Activities of daily living (ADL) score
Time frame: 18 months
Confusion Assessment Method (CAM)
Time frame: 18 months
Length of stay
Time frame: 18 months
Number of unplanned readmission
Time frame: up to 3 months after discharge
Association between the number and type of PIPs at discharge with rate of re-admission
Time frame: up to 3 months after discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2019.
- Derived from this study: PubMed 36175740Farhat A, Al-Hajje A, Lang PO, Csajka C. Impact of Pharmaceutical Interventions with STOPP/START and PIM-Check in Older Hospitalized Patients: A Randomized Controlled Trial. Drugs Aging. 2022 Nov;39(11):899-910. doi: 10.1007/s40266-022-00974-7. Epub 2022 Sep 30.
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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.
Akram FARHAT, PharmD, MPH, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PIM-Check and STOPP/START in people with Inappropriate Prescribing, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
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 1 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 23 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 Switzerland. 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 Chantal Csajka, PharmD, PhD (+41 21 314 42 63, chantal.csajka@chuv.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Potentially Inappropriate Prescriptions (PIPs) reduction in the PIM-Check group compared to STOPP/START (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04028583, which also lists 1 linked publication.
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 23 Jul 2019.