Frail Elderly InpatientPhase 4NCT00279656
Benefit of a Collaborative Approach to Improve the Quality of Medicines Use in Elderly Inpatients
A Phase 4 study testing Pharmaceutical care in people with Frail Elderly Inpatient, run by Université Catholique de Louvain at 1 site in Belgium.
Trial summary
The purpose of this study is to evaluate the impact of a collaborative approach (geriatric care involving the collaboration with a clinical pharmacist) to optimize the prescription of medicines for elderly inpatients. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Frail Elderly Inpatient
- What is being tested?
- Pharmaceutical care
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 180 participants
- Where
- 1 siteBelgium
- Study dates
- Nov 2003to Jun 2005
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patient admitted on the acute geriatric unit of the university teaching hospital Mont-Godinne, Belgium
- no time for the clinical pharmacist to compound the abstracted chart within 3 days of admission
Who cannot join
- a terminal illness and life expectancy of less than 3 month
- expected length of stay of 2 days or less
- transfer from another unit where the patient had already been cared for by a GEM team
- refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Collaborative Approach to Improve the Quality of Medicines Use in Elderly Inpatients - Randomized Controlled Trial
The purpose of this study is to evaluate the impact of a collaborative approach (geriatric care involving the collaboration with a clinical pharmacist) to optimize the prescription of medicines for elderly inpatients.
Read the detailed description
Widespread evidence reveals frequent inadequate use of medicines in elderly patients. This includes inappropriate prescribing (overuse, underuse, misuse) that can lead to adverse drug events and drug-related admissions to hospital. In addition, when a patient is transferred from acute care settings to ambulatory care settings, discrepancies in medicines used often occur and can be hazardous.
Despite this, only limited data exist on the effectiveness of optimization strategies targeted at frail elderly inpatients.
Comparison: elderly inpatients receiving geriatric evaluation and management (GEM) care versus elderly inpatients receiving pharmaceutical care in addition to GEM care.
- Conditions
- Frail Elderly Inpatient
- Being tested
- Pharmaceutical care
- Keywords
- Frail elderly, Pharmaceutical services, Drug therapy, Geriatrics, Randomized controlled trial, Hospitals, teaching
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmaceutical careBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Appropriateness of prescribing (using the Medication Appropriateness Index, the Beers criteria, and the ACOVE criteria of underuse) on admission, at discharge, and 3 months post-discharge
Secondary outcomes (3)
Polymedication on admission, at discharge, and 1,3,12 months after discharge
Mortality, readmission to hospital and visit to the emergency department 1,3,12 months after discharge
Satisfaction with information received on medicines
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2006 (estimated)
- Study startNov 2003
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frail Elderly InpatientStudies of the same condition, open and under way.
- More trials run by Université Catholique de LouvainThe 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 4
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Collaborators
- Fonds National de la Recherche Scientifique
- Investigators
- Anne Spinewine, MSc, Principal investigator, Université Catholique de LouvainChristian Swine, MD, Study chair, Université Catholique de LouvainPaul M Tulkens, PhD, Study director, Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00279656
- Sponsor's protocol ID
- om050-40/2003
- Status last verified
- Jun 2004
- First submitted
- 17 Jan 2006
- Last updated
- 19 Jan 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collaborative Approach to Improve the Quality of Medicines Use in Elderly Inpatients - Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00279656
- Acronym / sponsor ID
- om050-40/2003
- Conditions
- Frail Elderly Inpatient
- Keywords
- Frail elderly, Pharmaceutical services, Drug therapy, Geriatrics, Randomized controlled trial, Hospitals, teaching
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Collaborators
- Fonds National de la Recherche Scientifique
- Study start
- Nov 2003
- Study completion
- Jun 2005
- First posted
- 19 Jan 2006 (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 purpose of this study is to evaluate the impact of a collaborative approach (geriatric care involving the collaboration with a clinical pharmacist) to optimize the prescription of medicines for elderly inpatients.
Detailed description
Widespread evidence reveals frequent inadequate use of medicines in elderly patients. This includes inappropriate prescribing (overuse, underuse, misuse) that can lead to adverse drug events and drug-related admissions to hospital. In addition, when a patient is transferred from acute care settings to ambulatory care settings, discrepancies in medicines used often occur and can be hazardous.
Despite this, only limited data exist on the effectiveness of optimization strategies targeted at frail elderly inpatients.
Comparison: elderly inpatients receiving geriatric evaluation and management (GEM) care versus elderly inpatients receiving pharmaceutical care in addition to GEM care.
Study design
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Patient admitted on the acute geriatric unit of the university teaching hospital Mont-Godinne, Belgium
- no time for the clinical pharmacist to compound the abstracted chart within 3 days of admission
Key exclusion criteria (4 listed)
- a terminal illness and life expectancy of less than 3 month
- expected length of stay of 2 days or less
- transfer from another unit where the patient had already been cared for by a GEM team
- refusal to participate
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 | Behavioural | – |
Primary outcome
Appropriateness of prescribing (using the Medication Appropriateness Index, the Beers criteria, and the ACOVE criteria of underuse) on admission, at discharge, and 3 months post-discharge
3 secondary outcomes
Polymedication on admission, at discharge, and 1,3,12 months after discharge
Mortality, readmission to hospital and visit to the emergency department 1,3,12 months after discharge
Satisfaction with information received on medicines
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 19 Jan 2006.
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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.
Anne Spinewine, MSc principal investigator
Université Catholique de Louvain
Christian Swine, MD study chair
Université Catholique de Louvain
Paul M Tulkens, PhD study director
Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pharmaceutical care in people with Frail Elderly Inpatient, run by Université Catholique de Louvain 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 19 Jan 2006. 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.
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?
Appropriateness of prescribing (using the Medication Appropriateness Index, the Beers criteria, and the ACOVE criteria of underuse) on admission, at discharge, and 3 months post-discharge. 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 19 Jan 2006.