- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01467128
Adverse Drug Event Prevention Using Structured Pharmacist Review
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Munster
-
Cork, Munster, Ireland
- Cork University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Structured 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.
Other Names:
|
No Intervention: Normal pharmaceutical care in hospital
|
Normal hospital pharmaceutical care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of patients with definite and possible adverse drug events during their hospital admission
Time Frame: From point of randomization to Day 14
|
From point of randomization to Day 14
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Drug ingredient cost at hospital discharge
Time Frame: Up to Day 14
|
Up to Day 14
|
Medication Appropriateness Index score
Time Frame: measured at Day 14 and again at three months post hospital discharge.
|
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
|
Measured at 3 months post hospital discharge
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: David O'Sullivan, MPharm, University College Cork, Ireland
Publications and helpful links
General Publications
- Spinewine 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.
- Hamilton 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HRA_HSR/2010/14(a)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Adverse Drug Reactions
-
Zhong WangShanxi Zhendong Pharmacy Co., LtdRecruitingAdverse Drug Events | Adverse Drug Reactions | Severe Adverse Events | Safety Surveillance | Severe Adverse ReactionsChina
-
CHU de ReimsCompletedChild With Adverse Drug Reactions
-
Zhong WangShanxi Zhendong pharmaceutical Co. LTD.CompletedAdverse Drug Events | Adverse Drug Reactions | Severe Adverse Events | Safety Surveillance | Severe Adverse ReactionsChina
-
University of British ColumbiaCanadian Institutes of Health Research (CIHR); Vancouver Coastal Health; Ministry...Not yet recruitingAdverse Drug Event | Adverse Drug Reaction
-
Texas A&M UniversityInnovativeGx; Texas A&M Health Family Care Clinic; iC42 Clinical Research and... and other collaboratorsRecruiting
-
Leiden University Medical Centerbio.logis digital health GmbHRecruiting
-
Fayoum UniversityCompletedAdverse Drug ReactionEgypt
-
J.J.SwenKarolinska Institutet; Medical University of Vienna; Uppsala University; St. Antonius... and other collaboratorsCompletedAdverse Drug ReactionAustria, Netherlands, Italy, Greece, Slovenia, Spain, United Kingdom
-
Universidade Estadual Paulista Júlio de Mesquita...CompletedAdverse Drug ReactionBrazil
-
Indiana UniversityNational Human Genome Research Institute (NHGRI)CompletedAdverse Drug ReactionUnited States
Clinical Trials on Structured expert pharmacist review
-
Lahey ClinicTerminatedLumbar Spinal Stenosis | Lumbar Spondylolisthesis | Degenerative Spondylolisthesis | Grade 1 SpondylolisthesisUnited States, Canada
-
Fundacio d'Investigacio en Atencio Primaria Jordi...Institut Català de la Salut; University Rovira i VirgiliRecruitingPolypharmacy | Potentially Inappropriate MedicationsSpain
-
Mayo ClinicTerminatedPalliative MedicineUnited States
-
Rutgers, The State University of New JerseyUnknown
-
University of British ColumbiaCompletedAdverse Drug Events | Adverse Drug Reactions | Medication-related ProblemsCanada
-
University of AlbertaPfizerActive, not recruiting
-
Assistance Publique Hopitaux De MarseilleTerminatedRe-hospitalizationFrance
-
University of SouthamptonUniversity of PortsmouthRecruiting
-
University of WaterlooCompletedMedication Therapy Management | Home Care | PharmacistsCanada
-
Centre Hospitalier Universitaire de NīmesRecruitingChronic DiseaseFrance