HealthyPhase 4NCT00915824
Prevention of Potentially Inappropriate Prescribing in Late Life Using Screening Tool of Older Persons' Potentially Inappropriate Prescriptions (STOPP) and Screening Tool to Alert Doctors to Right Treatment (START) Criteria
A Phase 4 study testing STOPP/START criteria in people with Healthy, run by Cork University Hospital at 1 site in Ireland.
Trial summary
Potentially inappropriate prescribing is common in older patients and encompasses overuse, misuse and underuse of medications. Potentially inappropriate prescribing is associated with negative outcomes including adverse drug events and hospitalization. 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?
- STOPP/START criteria
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteIreland
- Study dates
- Nov 2007to Jun 2009
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- All patients aged 65 years and older admitted to the general medical services of Cork University Hospital, Cork, Ireland
Who cannot join
- Patient admitted to a geriatric medicine service, psychiatry of old age service or clinical pharmacology service, or under review of these services during the previous 12 months
- Critically ill patient (admitted to the intensive care unit)
- Terminally ill patient
- Refusal of patient or hospital physician to participate
- No time for the research physician to enrol the patient within 3 days of admission
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention of Potentially Inappropriate Prescribing in Late Life Using STOPP (Screening Tool of Older Persons' Potentially Inappropriate Prescriptions) and START (Screening Tool to Alert Doctors to Right i.e. Appropriate Indicated Treatment): A Randomized Controlled Trial.
Potentially inappropriate prescribing is common in older patients and encompasses overuse, misuse and underuse of medications. Potentially inappropriate prescribing is associated with negative outcomes including adverse drug events and hospitalization.
STOPP (Screening Tool of Older Person's potentially inappropriate Prescriptions) and START (Screening Tool to Alert doctors to Right Treatment) is a new screening tool designed to detect instances of potentially inappropriate medication use and under-prescribing of clinically indicated medications in older patients. The purpose of this study is to determine whether clinical implementation of STOPP/START criteria in hospitalized older patients is effective in improving prescribing quality.
- Conditions
- Healthy
- Being tested
- STOPP/START criteria
- Keywords
- Drug therapy, Prescribing, Appropriateness, Randomized controlled trial, STOPP/START criteria, Appropriateness of prescribing in older patients, Prescription Drugs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STOPP/START criteriaOther
Application of STOPP/START criteria to the patient's prescription and diagnostic information with subsequent written recommendation on pharmaceutical care to the patient's medical team
| Study group | Role | What they receive |
|---|---|---|
| STOPP/START intervention | Experimental | STOPP/START intervention group Receives: Other: STOPP/START criteria |
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 and the Assessment of Underutilization of Medication Tool
Measured: Measured on admission, discharge and at 2, 4 and 6 months post-discharge
Secondary outcomes (1)
Composite health resource utilization including hospital readmission and primary care consultations
Measured: at 2, 4 and 6 months post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2009 (estimated)
- Study startNov 2007
- Primary completionJun 2009
- Study completionJun 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cork University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Paul Gallagher, MB MRCPI, Principal investigator, Cork University HospitalDenis O'Mahony, MD FRCPI, Study director, Cork University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00915824
- Sponsor's protocol ID
- CRT2006029
- Status last verified
- Oct 2009
- First submitted
- 4 Jun 2009
- Last updated
- 29 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Potentially Inappropriate Prescribing in Late Life Using STOPP (Screening Tool of Older Persons' Potentially Inappropriate Prescriptions) and START (Screening Tool to Alert Doctors to Right i.e. Appropriate Indicated Treatment): A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT00915824
- Acronym / sponsor ID
- CRT2006029
- Conditions
- Healthy
- Keywords
- Drug therapy, Prescribing, Appropriateness, Randomized controlled trial, STOPP/START criteria, Appropriateness of prescribing in older patients, Prescription Drugs
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Cork University HospitalUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (estimated)
- First posted
- 8 Jun 2009 (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.
Potentially inappropriate prescribing is common in older patients and encompasses overuse, misuse and underuse of medications. Potentially inappropriate prescribing is associated with negative outcomes including adverse drug events and hospitalization.
STOPP (Screening Tool of Older Person's potentially inappropriate Prescriptions) and START (Screening Tool to Alert doctors to Right Treatment) is a new screening tool designed to detect instances of potentially inappropriate medication use and under-prescribing of clinically indicated medications in older patients. The purpose of this study is to determine whether clinical implementation of STOPP/START criteria in hospitalized older patients is effective in improving prescribing quality.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| STOPP/START intervention | Experimental | Other: STOPP/START criteriaSTOPP/START intervention group |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- All patients aged 65 years and older admitted to the general medical services of Cork University Hospital, Cork, Ireland
Key exclusion criteria (5 listed)
- Patient admitted to a geriatric medicine service, psychiatry of old age service or clinical pharmacology service, or under review of these services during the previous 12 months
- Critically ill patient (admitted to the intensive care unit)
- Terminally ill patient
- Refusal of patient or hospital physician to participate
- No time for the research physician to enrol the patient within 3 days of 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 |
|---|---|---|
| STOPP/START criteriaApplication of STOPP/START criteria to the patient's prescription and diagnostic information with subsequent written recommendation on pharmaceutical care to the patient's medical team | Other | STOPP/START intervention |
Primary outcome
Appropriateness of prescribing using the Medication Appropriateness Index and the Assessment of Underutilization of Medication Tool
Time frame: Measured on admission, discharge and at 2, 4 and 6 months post-discharge
1 secondary outcome
Composite health resource utilization including hospital readmission and primary care consultations
Time frame: at 2, 4 and 6 months post-discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2009.
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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.
Paul Gallagher, MB MRCPI principal investigator
Cork University Hospital
Denis O'Mahony, MD FRCPI study director
Cork University Hospital
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 STOPP/START criteria in people with Healthy, run by Cork University Hospital at 1 site in Ireland.
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 5 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 29 Oct 2009. 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 Ireland. 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?
Results are not available in the source record.
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 and the Assessment of Underutilization of Medication Tool (time frame: Measured on admission, discharge and at 2, 4 and 6 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 29 Oct 2009.