HealthyRASPNCT01513265
Rationalisation of Polypharmacy in the Elderly by the RASP Instrument
A study testing Pharmaceutical care plan, mostly based on the RASP in people with Healthy, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
The aim of this study is to determine whether a clinical pharmacist using the RASP list (RASP = Rationalisation of home medication by an adjusted STOPP-list in older patients; STOPP = Screening Tool of Older Persons' potentially inappropriate Prescriptions) can optimise the drug use in elderly inpatients. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Pharmaceutical care plan, mostly based on the RASP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteBelgium
- Study dates
- Dec 2011to Oct 2012
- 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
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Signed informed consent by the patient or a caregiver if the patient is incompetent to sign
- Consecutive inclusion of all newly admitted patients to the wards coming from home or the emergency room department
Who cannot join
- Patients not admitted to the hospital from home or a nursing home
- Patients unable to communicate in Dutch
- Patients admitted for palliative care
- Patients who do not take any drugs at admission
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rationalisation of Polypharmacy in the Elderly by the RASP Instrument (Rationalisation of Home Medication by an Adjusted STOPP-list in Older Patients): a Prospective, Clinical Trial.
The aim of this study is to determine whether a clinical pharmacist using the RASP list (RASP = Rationalisation of home medication by an adjusted STOPP-list in older patients; STOPP = Screening Tool of Older Persons' potentially inappropriate Prescriptions) can optimise the drug use in elderly inpatients.
Read the detailed description
Older persons take on average multiple drugs. As people age, there is an apparent increase in pharmacodynamic sensitivity to different making the patient more prone to experience side effects. Alterations in body composition and concomitant changes in pharmacokinetic parameters can also result in a higher risk for adverse drug events. All these factors make the older person, notwithstanding the heterogeneity of this population, more vulnerable for the negative consequences of polypharmacy.
Polypharmacy is a cause of negative clinical outcomes but it still remains unclear which intervention or set of interventions should be used to optimize the prescription of pharmacotherapy in the elderly patient. Therefore, the investigators developed the RASP (RASP = Rationalisation of home medication by an adjusted STOPP-list in older patients; STOPP = Screening Tool of Older Persons' potentially inappropriate Prescriptions), a list as tool to reduce polypharmacy adapted to Belgian national prescribing tendencies within geriatric wards. Content and reliability of the RASP have been validated and the investigators aim to further study the impact of the systematic implementation of this RASP on geriatric wards in a prospective cluster randomized controlled trial.
- Conditions
- Healthy
- Being tested
- Pharmaceutical care plan, mostly based on the RASP
- Keywords
- reduction polypharmacy, clinical outcomes, pharmaceutical care, clinical pharmacy, geriatrics, medication review, potentially inappropriate drugs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmaceutical care plan, mostly based on the RASPOther
Drug use of subjects enrolled in this arm will be systematically evaluated by a clinical pharmacist, using the RASP list. Potentially inappropriate drug use will be pointed out to the treating physician. The pharmaceutical advice is not limited to the RASP list. Any actual change in drug prescription will be decided by the treating physician based upon comprehensive medical evaluations in each individual patient.
| Study group | Role | What they receive |
|---|---|---|
| RASP | Active comparator | Not described Receives: Other: Pharmaceutical care plan, mostly based on the RASP |
| Control group | No intervention | Subjects enrolled in this arm will undergo usual medical and pharmaceutical care with registration of drug use at admission and discharge without interference of RASP or clinical pharmacist. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of actually stopped or adjusted drugs
At hospital discharge the number of stopped or adjusted drugs will be determined. This variable will be compared between the two arms.
Measured: Patients will be followed for the duration of hospital stay, an expected average of 14 days.
Secondary outcomes (10)
Number of potentially inappropriate drug prescriptions as defined by the RASP.
Measured: Patients will be followed for the duration of hospital stay, an expected average of 14 days.
Actual drug use
Measured: Measured on 30 and 90 days post-discharge.
Number and category of drugs adjusted on recommendations of the clinical pharmacist independent of RASP
Measured: Patients will be followed for the duration of hospital stay, an expected average of 14 days.
Mortality
Measured: Measured during hospitalisation, an expected average of 14 days and within 90 days after discharge.
Number of falls
Measured: Measured during hospitalisation, an expected average of 14 days and within 90 days after discharge
Quality of Life (EQ-5D-3L)
Measured: Patients will be followed for the duration of hospital stay, an expected average of 14 days.
Length of stay
Measured: Determined at discharge, on average after 14 days
Rehospitalisation
Measured: Within 90 days post-discharge.
Incidence of delirium
Measured: Patients will be followed for the duration of hospital stay, an expected average of 14 days
Number of falls post-discharge
Measured: Within 90 days post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2012 (estimated)
- Study startDec 2011
- Primary completionAug 2012
- Study completionOct 2012
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 HealthyStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lorenz Van der Linden, PharmD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01513265
- Sponsor's protocol ID
- S-53664
- Acronym
- RASP
- Status last verified
- Dec 2011
- First submitted
- 27 Dec 2011
- Last updated
- 22 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Van der Linden L, Decoutere L, Walgraeve K, Milisen K, Flamaing J, Spriet I, Tournoy J. Combined Use of the Rationalization of Home Medication by an Adjusted STOPP in Older Patients (RASP) List and a Pharmacist-Led Medication Review in Very Old Inpatients: Impact on Quality of Prescribing and Clinical Outcome. Drugs Aging. 2017 Feb;34(2):123-133. doi: 10.1007/s40266-016-0424-8.
PubMed 27915457
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rationalisation of Polypharmacy in the Elderly by the RASP Instrument (Rationalisation of Home Medication by an Adjusted STOPP-list in Older Patients): a Prospective, Clinical Trial.
- ClinicalTrials.gov ID
- NCT01513265
- Acronym / sponsor ID
- RASP / S-53664
- Conditions
- Healthy
- Keywords
- reduction polypharmacy, clinical outcomes, pharmaceutical care, clinical pharmacy, geriatrics, medication review, potentially inappropriate drugs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 20 Jan 2012 (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 aim of this study is to determine whether a clinical pharmacist using the RASP list (RASP = Rationalisation of home medication by an adjusted STOPP-list in older patients; STOPP = Screening Tool of Older Persons' potentially inappropriate Prescriptions) can optimise the drug use in elderly inpatients.
Detailed description
Older persons take on average multiple drugs. As people age, there is an apparent increase in pharmacodynamic sensitivity to different making the patient more prone to experience side effects. Alterations in body composition and concomitant changes in pharmacokinetic parameters can also result in a higher risk for adverse drug events. All these factors make the older person, notwithstanding the heterogeneity of this population, more vulnerable for the negative consequences of polypharmacy.
Polypharmacy is a cause of negative clinical outcomes but it still remains unclear which intervention or set of interventions should be used to optimize the prescription of pharmacotherapy in the elderly patient. Therefore, the investigators developed the RASP (RASP = Rationalisation of home medication by an adjusted STOPP-list in older patients; STOPP = Screening Tool of Older Persons' potentially inappropriate Prescriptions), a list as tool to reduce polypharmacy adapted to Belgian national prescribing tendencies within geriatric wards. Content and reliability of the RASP have been validated and the investigators aim to further study the impact of the systematic implementation of this RASP on geriatric wards in a prospective cluster randomized controlled trial.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RASP | Active comparator | Other: Pharmaceutical care plan, mostly based on the RASP |
| Control group | No intervention | –Subjects enrolled in this arm will undergo usual medical and pharmaceutical care with registration of drug use at admission and discharge without interference of RASP or clinical pharmacist. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Signed informed consent by the patient or a caregiver if the patient is incompetent to sign
- Consecutive inclusion of all newly admitted patients to the wards coming from home or the emergency room department
Key exclusion criteria (4 listed)
- Patients not admitted to the hospital from home or a nursing home
- Patients unable to communicate in Dutch
- Patients admitted for palliative care
- Patients who do not take any drugs at 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 |
|---|---|---|
| Pharmaceutical care plan, mostly based on the RASPDrug use of subjects enrolled in this arm will be systematically evaluated by a clinical pharmacist, using the RASP list. Potentially inappropriate drug use will be pointed out to the treating physician. The pharmaceutical advice is not limited to the RASP list. Any actual change in drug prescription will be decided by the treating physician based upon comprehensive medical evaluations in each individual patient. | Other | RASP |
Primary outcome
Number of actually stopped or adjusted drugs
Time frame: Patients will be followed for the duration of hospital stay, an expected average of 14 days.
At hospital discharge the number of stopped or adjusted drugs will be determined. This variable will be compared between the two arms.
10 secondary outcomes
Number of potentially inappropriate drug prescriptions as defined by the RASP.
Time frame: Patients will be followed for the duration of hospital stay, an expected average of 14 days.
Actual drug use
Time frame: Measured on 30 and 90 days post-discharge.
Number and category of drugs adjusted on recommendations of the clinical pharmacist independent of RASP
Time frame: Patients will be followed for the duration of hospital stay, an expected average of 14 days.
Mortality
Time frame: Measured during hospitalisation, an expected average of 14 days and within 90 days after discharge.
Number of falls
Time frame: Measured during hospitalisation, an expected average of 14 days and within 90 days after discharge
Quality of Life (EQ-5D-3L)
Time frame: Patients will be followed for the duration of hospital stay, an expected average of 14 days.
Length of stay
Time frame: Determined at discharge, on average after 14 days
Rehospitalisation
Time frame: Within 90 days post-discharge.
Incidence of delirium
Time frame: Patients will be followed for the duration of hospital stay, an expected average of 14 days
Number of falls post-discharge
Time frame: Within 90 days post-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 22 May 2014.
- Derived from this study: PubMed 27915457Van der Linden L, Decoutere L, Walgraeve K, Milisen K, Flamaing J, Spriet I, Tournoy J. Combined Use of the Rationalization of Home Medication by an Adjusted STOPP in Older Patients (RASP) List and a Pharmacist-Led Medication Review in Very Old Inpatients: Impact on Quality of Prescribing and Clinical Outcome. Drugs Aging. 2017 Feb;34(2):123-133. doi: 10.1007/s40266-016-0424-8.
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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.
Lorenz Van der Linden, PharmD principal investigator
Universitaire Ziekenhuizen KU 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 Pharmaceutical care plan, mostly based on the RASP in people with Healthy, 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 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 May 2014. 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 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?
Number of actually stopped or adjusted drugs (time frame: Patients will be followed for the duration of hospital stay, an expected average of 14 days.). 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 NCT01513265, 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 22 May 2014.