Iatrogenic DiseaseRASP-GCTNCT02165618
Rationalisation of Polypharmacy by the Geriatric Consultation Team
A study testing Medication review, based on but not limited to the RASP list in people with Iatrogenic Disease, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Polypharmacy is a common problem in elderly, leading among others to increased adverse drug events. The aim of this pilot study was to evaluate whether a systematic medication evaluation by a geriatric consultation team using the RASP (Rationalisation of drugs on admission by an adjusted STOPP*-list in older patients)… Read more about this study
- Who is it for?
- Ages 75 years and olderHealthy volunteers can take part
- Conditions the study is for
- Iatrogenic Disease
- What is being tested?
- Medication review, based on but not limited to the RASP list
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2014to Feb 2014
- 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
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Admitted to a non-geriatric ward
- 75 years or older
- Dutch speaking
- Consultation by the GCT
Who cannot join
- End-of-life
- No drugs on admission
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rationalisation of Polypharmacy by the Geriatric Consultation Team Using the RASP List: a Pilot Study
Polypharmacy is a common problem in elderly, leading among others to increased adverse drug events. The aim of this pilot study was to evaluate whether a systematic medication evaluation by a geriatric consultation team using the RASP (Rationalisation of drugs on admission by an adjusted STOPP*-list in older patients) list could reduce inappropriate prescribing for elderly admitted patients, admitted to non-geriatric departments.
(* = Screening Tool of Older Persons' potentially inappropriate Prescriptions)
Read the detailed description
Polypharmacy and (potentially) inappropriate prescribing is highly prevalent in the older population, associated with increase health care expenditures, morbidity and avoidable adverse events .
The aim of this pilot study was to evaluate whether a systematic medication evaluation by a geriatric consultation team (GCT) using the RASP (Rationalisation of drugs on admission by an adjusted STOPP-list in older patients) list could reduce inappropriate prescribing for older admitted patients, admitted to non-geriatric departments. The GCT could offer the ideal format to deliver the intervention to a broad older hospitalised population.
- Conditions
- Iatrogenic Disease
- Being tested
- Medication review, based on but not limited to the RASP list
- Keywords
- frailty, geriatric, elderly, polypharmacy
- Medical subject headings
- Iatrogenic Disease, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medication review, based on but not limited to the RASP listOther
Also called RASP, RASP list, Systematic medication review
Systematic approach:
- Medication reconciliation
- Applying the RASP list
- Expert review (not based on the RASP list)
- Multidisciplinary discussion
| Study group | Role | What they receive |
|---|---|---|
| GCT | No intervention | In a before phase, data on how the GCT operated (i.e. good clinical practice) was gathered. |
| GCT-RASP | Active comparator | Medication review, based on but not limited to the RASP list Receives: Other: Medication review, based on but not limited to the RASP list |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of medication-related recommendations by the geriatric consultation team.
Measured: The number was ascertained at time of discharge from the ward, taking into account an average hospital stay of 14 days.
Secondary outcomes (3)
Number of potentially inappropriate drugs at discharge, as identified by the RASP list.
Measured: The number was ascertained at time of discharge from the ward, taking into account an average hospital stay of 14 days.
Number of drugs at discharge, relative to the drugs on admission.
Measured: The number was ascertained at time of discharge from the ward, taking into account an average hospital stay of 14 days.
Acceptance rate of the GCT interventions by the treating physician.
Measured: Up to 72 hours after the GCT had given its recommendations.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2014 (estimated)
- Study startJan 2014
- Primary completionFeb 2014
- Study completionFeb 2014
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 Iatrogenic DiseaseStudies 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
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lorenz R Van der Linden, PharmD, Principal investigator, Universitaire Ziekenhuizen KU LeuvenJohan Flamaing, MD, PhD, Principal investigator, Universitaire Ziekenhuizen KU LeuvenJos Tournoy, MD, PhD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02165618
- Sponsor's protocol ID
- S-54896
- Acronym
- RASP-GCT
- Status last verified
- May 2014
- First submitted
- 26 May 2014
- Last updated
- 17 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Van der Linden L, Hias J, Dreessen L, Milisen K, Flamaing J, Spriet I, Tournoy J. Medication review versus usual care to improve drug therapies in older inpatients not admitted to geriatric wards: a quasi-experimental study (RASP-IGCT). BMC Geriatr. 2018 Jul 3;18(1):155. doi: 10.1186/s12877-018-0843-y.
PubMed 29970005
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rationalisation of Polypharmacy by the Geriatric Consultation Team Using the RASP List: a Pilot Study
- ClinicalTrials.gov ID
- NCT02165618
- Acronym / sponsor ID
- RASP-GCT / S-54896
- Conditions
- Iatrogenic Disease
- Keywords
- frailty, geriatric, elderly, polypharmacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 17 Jun 2014 (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.
Polypharmacy is a common problem in elderly, leading among others to increased adverse drug events. The aim of this pilot study was to evaluate whether a systematic medication evaluation by a geriatric consultation team using the RASP (Rationalisation of drugs on admission by an adjusted STOPP*-list in older patients) list could reduce inappropriate prescribing for elderly admitted patients, admitted to non-geriatric departments.
(* = Screening Tool of Older Persons' potentially inappropriate Prescriptions)
Detailed description
Polypharmacy and (potentially) inappropriate prescribing is highly prevalent in the older population, associated with increase health care expenditures, morbidity and avoidable adverse events .
The aim of this pilot study was to evaluate whether a systematic medication evaluation by a geriatric consultation team (GCT) using the RASP (Rationalisation of drugs on admission by an adjusted STOPP-list in older patients) list could reduce inappropriate prescribing for older admitted patients, admitted to non-geriatric departments. The GCT could offer the ideal format to deliver the intervention to a broad older hospitalised population.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GCT | No intervention | –In a before phase, data on how the GCT operated (i.e. good clinical practice) was gathered. |
| GCT-RASP | Active comparator | Other: Medication review, based on but not limited to the RASP listMedication review, based on but not limited to the RASP list |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Admitted to a non-geriatric ward
- 75 years or older
- Dutch speaking
- Consultation by the GCT
Key exclusion criteria (2 listed)
- End-of-life
- No 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, based on but not limited to the RASP listAlso: RASP, RASP list, Systematic medication reviewSystematic approach: 1. Medication reconciliation 2. Applying the RASP list 3. Expert review (not based on the RASP list) 4. Multidisciplinary discussion | Other | GCT-RASP |
Primary outcome
Number of medication-related recommendations by the geriatric consultation team.
Time frame: The number was ascertained at time of discharge from the ward, taking into account an average hospital stay of 14 days.
3 secondary outcomes
Number of potentially inappropriate drugs at discharge, as identified by the RASP list.
Time frame: The number was ascertained at time of discharge from the ward, taking into account an average hospital stay of 14 days.
Number of drugs at discharge, relative to the drugs on admission.
Time frame: The number was ascertained at time of discharge from the ward, taking into account an average hospital stay of 14 days.
Acceptance rate of the GCT interventions by the treating physician.
Time frame: Up to 72 hours after the GCT had given its recommendations.
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 17 Jun 2014.
- Derived from this study: PubMed 29970005Van der Linden L, Hias J, Dreessen L, Milisen K, Flamaing J, Spriet I, Tournoy J. Medication review versus usual care to improve drug therapies in older inpatients not admitted to geriatric wards: a quasi-experimental study (RASP-IGCT). BMC Geriatr. 2018 Jul 3;18(1):155. doi: 10.1186/s12877-018-0843-y.
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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 R Van der Linden, PharmD principal investigator
Universitaire Ziekenhuizen KU Leuven
Johan Flamaing, MD, PhD principal investigator
Universitaire Ziekenhuizen KU Leuven
Jos Tournoy, MD, PhD 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 Medication review, based on but not limited to the RASP list in people with Iatrogenic Disease, 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 4 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 17 Jun 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 medication-related recommendations by the geriatric consultation team. (time frame: The number was ascertained at time of discharge from the ward, taking into account an average hospital stay 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 NCT02165618, 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 17 Jun 2014.