Adverse Drug ReactionsPhase 4NCT01467128
Adverse Drug Event Prevention Using Structured Pharmacist Review
A Phase 4 study testing Structured expert pharmacist review in people with Adverse Drug Reactions, run by University College Cork at 1 site in Ireland.
Trial summary
The next four decades will see a marked expansion of the elderly population in Ireland, in particular people aged over 80 yrs. Persons aged over 80 are the highest consumers of prescription medicines in Ireland and have the highest prevalence rates of major polypharmacy. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Adverse Drug Reactions
- What is being tested?
- Structured expert pharmacist review
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 720 participants
- Where
- 1 siteIreland
- Study dates
- Jun 2011to Jun 2012
- 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
- No healthy volunteers
- Older adult
Who may be able to join
- All patients aged 65 years and over presenting to CUH Accident and Emergency Departments with acute illness for admission under a medical team will be eligible for the study.
Who cannot join
- Age less than 65 years.
- Patient to be admitted under the care of a Geriatrician Psychiatrist of Old Age or Clinical Pharmacologist, or having been admitted under these services or attended their outpatient clinics in the previous 12 months. (These doctor groups are likely to minimise inappropriate medications in this population).
- Terminally ill patient attended by palliative care team.
- Critically ill patient e.g. admitted to Intensive Care Unit.
- Patients who do not wish to participate in the study.
- Patients whose hospital physician does not wish to participate in the study ver, its efficacy in terms of ADE prevention is not yet demonstrated.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Title of Study: Adverse Drug Event (ADE) Incidence in Older Patients Following Hospital Admission and Pharmacist Review to Older Persons' Prescriptions and Its' Effect on ADE Reduction in Hospital: a Randomised Controlled Trial
The next four decades will see a marked expansion of the elderly population in Ireland, in particular people aged over 80 yrs. Persons aged over 80 are the highest consumers of prescription medicines in Ireland and have the highest prevalence rates of major polypharmacy. Polypharmacy is intimately linked with serious adverse drug events (ADEs) and consequent major morbidity and mortality. Epidemiological data from the Unites States indicate that ADEs is the fifth most common cause of death nationally. Experts suggest that effective evidence based interventions can be applied to this major public health problem.
A recently described approach to hospitalised older patients' medication optimisation is that of Spinewine and colleagues at Louvain University, Belgium. In this model, a pharmacist with expertise in geriatric pharmacotherapy routinely reviews the prescriptions of older patients from admission to discharge. The pharmacist provides a detailed pharmaceutical care plan for older patients and their carers where appropriate as well as feedback information to prescribers in the event of detecting instances of probable medication inappropriateness. Whenever an opportunity for medication optimisation is identified, the pharmacist discusses the opportunity with the prescriber who can accept or reject the intervention. At discharge from hospital, the pharmacist also provides written and verbal information on treatment changes to the patient / caregiver and GP. The intervention therefore represents a comprehensive pharmaceutical care approach that is based upon careful review and subsequent consensus on individualised pharmacotherapy. In an RCT comparison of this approach with standard care, older patients in the intervention arm of the study had significant improvements in medication appropriateness (medication appropriateness index (MAI), Beers' criteria, and Assessing Care of Vulnerable Elders (ACOVE) criteria.). Expert pharmacist review of older peoples' medication in hospital is a proven intervention in term of reducing inappropriateness of medication.
- Conditions
- Adverse Drug Reactions
- Being tested
- Structured expert pharmacist review, No Intervention
- Keywords
- Elderly, Hospital, Adverse Drug, Pharmacist, Prevention
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured expert pharmacist reviewOther
Also called expert pharmacist review
The researcher will apply the pharmacist intervention to the cases randomised to this arm of the study. This consists of an expert pharmacist review of the patients prescribed medications at the time of recruitment into the study. Recommendations following the intervention will be communicated both verbally and in writing to the medical team with primary responsibility for the patient. Recommendations arising from the intervention will be printed out and inserted into the patients' notes, in addition to the relevant registrar being informed in person or via the telephone.
No InterventionOther
Normal hospital pharmaceutical care
| Study group | Role | What they receive |
|---|---|---|
| Structured expert pharmacist review | Active comparator | Not described Receives: Other: Structured expert pharmacist review |
| Normal pharmaceutical care in hospital | No intervention | Not described Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with definite and possible adverse drug events during their hospital admission
Measured: From point of randomization to Day 14
Secondary outcomes (3)
Drug ingredient cost at hospital discharge
Measured: Up to Day 14
Medication Appropriateness Index score
Measured: measured at Day 14 and again at three months post hospital discharge.
Composite health resource utilization including hospital admissions and primary care consultations
Measured: Measured at 3 months post hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2011 (estimated)
- Study startJun 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Adverse Drug ReactionsStudies 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 720 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Cork
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Denis O'Mahony, University College Cork
- Investigators
- David O'Sullivan, MPharm, Study director, University College Cork, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01467128
- Sponsor's protocol ID
- HRA_HSR/2010/14(a)
- Status last verified
- Jun 2012
- First submitted
- 2 Sep 2011
- Last updated
- 6 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Spinewine A, Dhillon S, Mallet L, Tulkens PM, Wilmotte L, Swine C. Implementation of ward-based clinical pharmacy services in Belgium--description of the impact on a geriatric unit. Ann Pharmacother. 2006 Apr;40(4):720-8. doi: 10.1345/aph.1G515. Epub 2006 Mar 28.
PubMed 16569792Spinewine A, Swine C, Dhillon S, Lambert P, Nachega JB, Wilmotte L, Tulkens PM. Effect of a collaborative approach on the quality of prescribing for geriatric inpatients: a randomized, controlled trial. J Am Geriatr Soc. 2007 May;55(5):658-65. doi: 10.1111/j.1532-5415.2007.01132.x.
PubMed 17493184Hamilton H, Gallagher P, Ryan C, Byrne S, O'Mahony D. Potentially inappropriate medications defined by STOPP criteria and the risk of adverse drug events in older hospitalized patients. Arch Intern Med. 2011 Jun 13;171(11):1013-9. doi: 10.1001/archinternmed.2011.215.
PubMed 21670370
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Title of Study: Adverse Drug Event (ADE) Incidence in Older Patients Following Hospital Admission and Pharmacist Review to Older Persons' Prescriptions and Its' Effect on ADE Reduction in Hospital: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT01467128
- Acronym / sponsor ID
- HRA_HSR/2010/14(a)
- Conditions
- Adverse Drug Reactions
- Keywords
- Elderly, Hospital, Adverse Drug, Pharmacist, Prevention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 720 participants (actual)
- Lead sponsor
- University College CorkUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 8 Nov 2011 (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 next four decades will see a marked expansion of the elderly population in Ireland, in particular people aged over 80 yrs. Persons aged over 80 are the highest consumers of prescription medicines in Ireland and have the highest prevalence rates of major polypharmacy. Polypharmacy is intimately linked with serious adverse drug events (ADEs) and consequent major morbidity and mortality. Epidemiological data from the Unites States indicate that ADEs is the fifth most common cause of death nationally. Experts suggest that effective evidence based interventions can be applied to this major public health problem.
A recently described approach to hospitalised older patients' medication optimisation is that of Spinewine and colleagues at Louvain University, Belgium. In this model, a pharmacist with expertise in geriatric pharmacotherapy routinely reviews the prescriptions of older patients from admission to discharge. The pharmacist provides a detailed pharmaceutical care plan for older patients and their carers where appropriate as well as feedback information to prescribers in the event of detecting instances of probable medication inappropriateness. Whenever an opportunity for medication optimisation is identified, the pharmacist discusses the opportunity with the prescriber who can accept or reject the intervention. At discharge from hospital, the pharmacist also provides written and verbal information on treatment changes to the patient / caregiver and GP. The intervention therefore represents a comprehensive pharmaceutical care approach that is based upon careful review and subsequent consensus on individualised pharmacotherapy. In an RCT comparison of this approach with standard care, older patients in the intervention arm of the study had significant improvements in medication appropriateness (medication appropriateness index (MAI), Beers' criteria, and Assessing Care of Vulnerable Elders (ACOVE) criteria.). Expert pharmacist review of older peoples' medication in hospital is a proven intervention in term of reducing inappropriateness of medication.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Structured expert pharmacist review | Active comparator | Other: Structured expert pharmacist review |
| Normal pharmaceutical care in hospital | No intervention | Other: No Intervention |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- All patients aged 65 years and over presenting to CUH Accident and Emergency Departments with acute illness for admission under a medical team will be eligible for the study.
Key exclusion criteria (6 listed)
- Age less than 65 years.
- Patient to be admitted under the care of a Geriatrician Psychiatrist of Old Age or Clinical Pharmacologist, or having been admitted under these services or attended their outpatient clinics in the previous 12 months. (These doctor groups are likely to minimise inappropriate medications in this population).
- Terminally ill patient attended by palliative care team.
- Critically ill patient e.g. admitted to Intensive Care Unit.
- Patients who do not wish to participate in the study.
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 |
|---|---|---|
| Structured expert pharmacist reviewAlso: expert pharmacist reviewThe researcher will apply the pharmacist intervention to the cases randomised to this arm of the study. This consists of an expert pharmacist review of the patients prescribed medications at the time of recruitment into the study. Recommendations following the intervention will be communicated both verbally and in writing to the medical team with primary responsibility for the patient. Recommendations arising from the intervention will be printed out and inserted into the patients' notes, in addition to the relevant registrar being informed in person or via the telephone. | Other | Structured expert pharmacist review |
| No InterventionNormal hospital pharmaceutical care | Other | Normal pharmaceutical care in hospital |
Primary outcome
Number of patients with definite and possible adverse drug events during their hospital admission
Time frame: From point of randomization to Day 14
3 secondary outcomes
Drug ingredient cost at hospital discharge
Time frame: Up to Day 14
Medication Appropriateness Index score
Time frame: measured at Day 14 and again at three months post hospital discharge.
Composite health resource utilization including hospital admissions and primary care consultations
Time frame: Measured at 3 months post hospital 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 6 Jun 2012.
- Background: PubMed 16569792Spinewine A, Dhillon S, Mallet L, Tulkens PM, Wilmotte L, Swine C. Implementation of ward-based clinical pharmacy services in Belgium--description of the impact on a geriatric unit. Ann Pharmacother. 2006 Apr;40(4):720-8. doi: 10.1345/aph.1G515. Epub 2006 Mar 28.
- Background: PubMed 17493184Spinewine A, Swine C, Dhillon S, Lambert P, Nachega JB, Wilmotte L, Tulkens PM. Effect of a collaborative approach on the quality of prescribing for geriatric inpatients: a randomized, controlled trial. J Am Geriatr Soc. 2007 May;55(5):658-65. doi: 10.1111/j.1532-5415.2007.01132.x.
- Background: PubMed 21670370Hamilton H, Gallagher P, Ryan C, Byrne S, O'Mahony D. Potentially inappropriate medications defined by STOPP criteria and the risk of adverse drug events in older hospitalized patients. Arch Intern Med. 2011 Jun 13;171(11):1013-9. doi: 10.1001/archinternmed.2011.215.
- Health Research Board (Ireland) websiteLink provided by the sponsor.
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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.
David O'Sullivan, MPharm study director
University College Cork, Ireland
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 Structured expert pharmacist review in people with Adverse Drug Reactions, run by University College Cork 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 6 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 6 Jun 2012. 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?
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 patients with definite and possible adverse drug events during their hospital admission (time frame: From point of randomization to Day 14). 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 NCT01467128, which also lists 3 linked publications.
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 6 Jun 2012.