PolypharmacyNCT05816967
Rationalisation of Polypharmacy by the RASP-instrument and Discharge Counselling of Geriatric Inpatients
A study testing Medication review and discharge counseling in people with Polypharmacy, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Systematic evaluation of polypharmacy in geriatric patients, through a validated list by a clinical pharmacist. The goal is reduction of potentially inappropriate medications (PIMs). A brief counseling session with the patient and/or his/her caregiver will be part of the intervention. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Polypharmacy
- What is being tested?
- Medication review and discharge counseling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2018to Sep 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Informed consent by the patient and/or his/her caregiver
- Admission through the emergency department of patients coming from home or a residential care facility
Who cannot join
- Patients not speaking Dutch
- Patients admitted for end of life care
- Patients not taking any drugs on admission
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rationalisation of Polypharmacy by the RASP-instrument (Rationalisation of Home Medication by an Adjusted STOPP-list and Discharge Counselling of Geriatric Inpatients: a Prospective, Clinical Trial
Systematic evaluation of polypharmacy in geriatric patients, through a validated list by a clinical pharmacist. The goal is reduction of potentially inappropriate medications (PIMs). A brief counseling session with the patient and/or his/her caregiver will be part of the intervention.
Read the detailed description
This project is focused on the systematic evaluation of polypharmacy in older patients admitted to the acute geriatric wards of a university hospital. Polypharmacy will be identified through a validated list by a clinical pharmacist. The goal is reduction of potentially inappropriate medications (PIMs). Before hospital discharge the hospital pharmacist will have a brief counseling session with the patient and/or his/her caregiver in order to discuss the medication list and to enhance compliance.
- Conditions
- Polypharmacy
- Being tested
- Medication review and discharge counseling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medication review and discharge counselingProcedure or surgery
Medication reconciliation of home therapy will be performed by the clinical pharmacist through a standardized form. Next, the clinical pharmacist will perform a medication review, based on but not limited to the RASP list (Van der Linden 2014). The goal is optimization of therapy. Before discharge the clinical pharmacist will perform a second medication review, together with the treating physician and a medication reconciliation in orde to provide the best possible discharge medication list. The medication list will be provided 3 times: once for the patient and/or his/her caregiver, once for the general practitioner and once for the primary care pharmacist. Finally the clinical pharmacist will have a counseling session with the patient and/or his/her caregiver.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | In the monocentric interventional part of the study, the effect of discharge counseling on the acceptance of pharmacotherapeutic recommendations will be evaluated 1 and 3 months after discharge. Receives: Procedure: Medication review and discharge counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptance rate of the pharmacotherapeutic recommendations, provided by the clinical pharmacist by the general practitioner.
Acceptance rate of the pharmacotherapeutic recommendations, provided by the clinical pharmacist by the general practitioner.
Measured: 1 month (30 days) after discharge
Acceptance rate of the pharmacotherapeutic recommendations, provided by the clinical pharmacist by the general practitioner.
Acceptance rate of the pharmacotherapeutic recommendations, provided by the clinical pharmacist by the general practitioner.
Measured: 3 month (90 days) after discharge
Secondary outcomes (17)
Number of drug intakes at discharge versus at admission.
Number of drug intakes at discharge versus at admission.
Measured: At discharge from the index hospitalization (as mentioned in the discharge medication scheme) vs on admission (during the first 72 hours of the index hospitalization)
Number of drugs at discharge versus at admission.
Number of drugs at discharge versus at admission.
Measured: At discharge from the index hospitalization (as mentioned in the discharge medication scheme) vs on admission (during the first 72 hours of the index hospitalization)
Number of drugs adapted by the treating physician based on recommendations by the clinical pharmacist that are not included in the RASP list.
Number of drugs adapted by the treating physician based on recommendations by the clinical pharmacist that are not included in the RASP list.
Measured: At discharge from the index hospitalization (as mentioned in the discharge medication scheme), compared to the medication list obtained on admission (this is, during the first 72 hours of the hospitalization)
Difference in number of potentially inappropriate medications identified through the RASP list on admission versus at discharge
Difference in number of potentially inappropriate medications identified through the RASP list on admission versus at discharge
Measured: At discharge from the index hospitalisation (as mentioned in the discharge medication scheme) versus on admission (medication list obtained in the first 72 hours) of the index hospitalization
Number of potentially inappropriate medications on admission, at discharge and at the follow-up moments (1 and 3 months after discharge)
Number of potentially inappropriate medications on admission, at discharge and at the follow-up moments (1 and 3 months after discharge)
Measured: On admission (medication list obtained in the first 72 hours of the admission), at discharge (as mentioned in the discharge medication scheme), 1 (30 days) month after discharge, 3 months (90 days) after discharge
Mortality during admission
Mortality during admission
Measured: During the index hospitalization, from admission to the emergency ward until moment of death on the geriatric ward, assessed up to 72 hours after death.
Number of falls during hospitalization
Number of falls during hospitalization
Measured: During the index hospitalization, from admission on the emergency ward until discharge from the geriatric ward, assessed within 72 hours after discharge.
Number of fractures during hospitalization
Number of fractures during hospitalization
Measured: during the index hospitalization, from admission to the emergency ward until discharge from the geriatric ward, assessed within 72 hours after discharge.
Length of stay
Length of stay
Measured: During the index hospitalization, from admission to the emergency ward until discharge from the geriatric ward, assessed within 72 hours after discharge.
Readmission rate 3 months after discharge
Readmission rate 3 months after discharge
Measured: 3 months (90 days) after discharge from the geriatric ward (index hospitalization), assessed at day 90
Number of fractures at 3 months after discharge
Number of fractures at 3 months after discharge
Measured: 3 months (90 days) after discharge from the geriatric ward (index hospitalization), assessed at day 90
Number of falls 3 months after discharge
Number of falls 3 months after discharge
Measured: 3 months (90 days) after discharge from the geriatric ward (index hospitalization), assessed at day 90
Mortality at 3 months after discharge
Mortality at 3 months after discharge
Measured: 3 months (90 days) after discharge from the geriatric ward (index hospitalization), assessed at day 90
Category of potentially inappropriate medications identified through the RASP list on admission and at discharge
Category of potentially inappropriate medications identified through the RASP list on admission and at discharge
Measured: On admission (medication list obtained in the first 72 hours of the admission), at discharge (as mentioned in the discharge medication scheme)
Category of drugs adapted by the treating physician based on recommendations by the clinical pharmacist that are not included in the RASP list.
Category of drugs adapted by the treating physician based on recommendations by the clinical pharmacist that are not included in the RASP list.
Measured: During the course of the index hospitalization, defined as the period between discharge from the geriatric ward and admission to the geriatric department. The outcome parameter will be assessed within 72 hours of discharge.
Number of drugs at follow-up (1 month and 3 months after discharge)
Number of drugs at follow-up (1 month and 3 months after discharge)
Measured: 1 month (30 days) and 3 months (90 days) after the index hospitalization
Number of drug intakes at follow-up (1 month and 3 months after discharge)
Number of drug intakes at follow-up (1 month and 3 months after discharge)
Measured: 1 month (30 days) and 3 months (90 days) after the index hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study startOct 2018 (estimated)
- Primary completionSep 2019 (estimated)
- Study completionSep 2019 (estimated)
Why it stopped: Interference with other trials on the same ward
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 Universitaire Ziekenhuizen KU LeuvenThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julie Hias, Pharm D, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05816967
- Sponsor's protocol ID
- S59694
- Status last verified
- Apr 2023
- First submitted
- 24 May 2022
- Last updated
- 18 Apr 2023
- 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 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rationalisation of Polypharmacy by the RASP-instrument (Rationalisation of Home Medication by an Adjusted STOPP-list and Discharge Counselling of Geriatric Inpatients: a Prospective, Clinical Trial
- ClinicalTrials.gov ID
- NCT05816967
- Acronym / sponsor ID
- S59694
- Conditions
- Polypharmacy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Interference with other trials on the same ward
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Oct 2018 (estimated)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 18 Apr 2023 (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.
Systematic evaluation of polypharmacy in geriatric patients, through a validated list by a clinical pharmacist. The goal is reduction of potentially inappropriate medications (PIMs). A brief counseling session with the patient and/or his/her caregiver will be part of the intervention.
Detailed description
This project is focused on the systematic evaluation of polypharmacy in older patients admitted to the acute geriatric wards of a university hospital. Polypharmacy will be identified through a validated list by a clinical pharmacist. The goal is reduction of potentially inappropriate medications (PIMs). Before hospital discharge the hospital pharmacist will have a brief counseling session with the patient and/or his/her caregiver in order to discuss the medication list and to enhance compliance.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Procedure: Medication review and discharge counselingIn the monocentric interventional part of the study, the effect of discharge counseling on the acceptance of pharmacotherapeutic recommendations will be evaluated 1 and 3 months after discharge. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Informed consent by the patient and/or his/her caregiver
- Admission through the emergency department of patients coming from home or a residential care facility
Key exclusion criteria (3 listed)
- Patients not speaking Dutch
- Patients admitted for end of life care
- Patients not taking any drugs on admission
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 review and discharge counselingMedication reconciliation of home therapy will be performed by the clinical pharmacist through a standardized form. Next, the clinical pharmacist will perform a medication review, based on but not limited to the RASP list (Van der Linden 2014). The goal is optimization of therapy. Before discharge the clinical pharmacist will perform a second medication review, together with the treating physician and a medication reconciliation in orde to provide the best possible discharge medication list. The medication list will be provided 3 times: once for the patient and/or his/her caregiver, once for the general practitioner and once for the primary care pharmacist. Finally the clinical pharmacist will have a counseling session with the patient and/or his/her caregiver. | Procedure or surgery | Intervention group |
Primary outcome
Acceptance rate of the pharmacotherapeutic recommendations, provided by the clinical pharmacist by the general practitioner.
Time frame: 1 month (30 days) after discharge
Acceptance rate of the pharmacotherapeutic recommendations, provided by the clinical pharmacist by the general practitioner.
Acceptance rate of the pharmacotherapeutic recommendations, provided by the clinical pharmacist by the general practitioner.
Time frame: 3 month (90 days) after discharge
Acceptance rate of the pharmacotherapeutic recommendations, provided by the clinical pharmacist by the general practitioner.
17 secondary outcomes
Number of drug intakes at discharge versus at admission.
Time frame: At discharge from the index hospitalization (as mentioned in the discharge medication scheme) vs on admission (during the first 72 hours of the index hospitalization)
Number of drugs at discharge versus at admission.
Time frame: At discharge from the index hospitalization (as mentioned in the discharge medication scheme) vs on admission (during the first 72 hours of the index hospitalization)
Number of drugs adapted by the treating physician based on recommendations by the clinical pharmacist that are not included in the RASP list.
Time frame: At discharge from the index hospitalization (as mentioned in the discharge medication scheme), compared to the medication list obtained on admission (this is, during the first 72 hours of the hospitalization)
Difference in number of potentially inappropriate medications identified through the RASP list on admission versus at discharge
Time frame: At discharge from the index hospitalisation (as mentioned in the discharge medication scheme) versus on admission (medication list obtained in the first 72 hours) of the index hospitalization
Number of potentially inappropriate medications on admission, at discharge and at the follow-up moments (1 and 3 months after discharge)
Time frame: On admission (medication list obtained in the first 72 hours of the admission), at discharge (as mentioned in the discharge medication scheme), 1 (30 days) month after discharge, 3 months (90 days) after discharge
Mortality during admission
Time frame: During the index hospitalization, from admission to the emergency ward until moment of death on the geriatric ward, assessed up to 72 hours after death.
Number of falls during hospitalization
Time frame: During the index hospitalization, from admission on the emergency ward until discharge from the geriatric ward, assessed within 72 hours after discharge.
Number of fractures during hospitalization
Time frame: during the index hospitalization, from admission to the emergency ward until discharge from the geriatric ward, assessed within 72 hours after discharge.
Length of stay
Time frame: During the index hospitalization, from admission to the emergency ward until discharge from the geriatric ward, assessed within 72 hours after discharge.
Readmission rate 3 months after discharge
Time frame: 3 months (90 days) after discharge from the geriatric ward (index hospitalization), assessed at day 90
Number of fractures at 3 months after discharge
Time frame: 3 months (90 days) after discharge from the geriatric ward (index hospitalization), assessed at day 90
Number of falls 3 months after discharge
Time frame: 3 months (90 days) after discharge from the geriatric ward (index hospitalization), assessed at day 90
Mortality at 3 months after discharge
Time frame: 3 months (90 days) after discharge from the geriatric ward (index hospitalization), assessed at day 90
Category of potentially inappropriate medications identified through the RASP list on admission and at discharge
Time frame: On admission (medication list obtained in the first 72 hours of the admission), at discharge (as mentioned in the discharge medication scheme)
Category of drugs adapted by the treating physician based on recommendations by the clinical pharmacist that are not included in the RASP list.
Time frame: During the course of the index hospitalization, defined as the period between discharge from the geriatric ward and admission to the geriatric department. The outcome parameter will be assessed within 72 hours of discharge.
Number of drugs at follow-up (1 month and 3 months after discharge)
Time frame: 1 month (30 days) and 3 months (90 days) after the index hospitalization
Number of drug intakes at follow-up (1 month and 3 months after discharge)
Time frame: 1 month (30 days) and 3 months (90 days) after the index hospitalization
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 18 Apr 2023.
- 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.
Julie Hias, Pharm D principal investigator
UZ Leuven
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 and discharge counseling in people with Polypharmacy, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 3 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 18 Apr 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 Belgium. 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?
Acceptance rate of the pharmacotherapeutic recommendations, provided by the clinical pharmacist by the general practitioner. (time frame: 1 month (30 days) after discharge). The study lists 2 primary outcomes in all. 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 18 Apr 2023.