Clinical trial NCT01467128: Adverse Drug Event Prevention Using Structured Pharmacist Review
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Adverse Drug Reactions
Keywords: Elderly
Hospital
Adverse Drug
Pharmacist
Prevention
Lead sponsor: University College Cork
Sponsor class: OTHER
First posted: 2011-11-08
Enrollment: 720
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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. 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.


Eligibility criteria: 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:

1. Age less than 65 years.
2. 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).
3. Terminally ill patient attended by palliative care team.
4. Critically ill patient e.g. admitted to Intensive Care Unit.
5. Patients who do not wish to participate in the study.
6. Patients whose hospital physician does not wish to participate in the study ver, its efficacy in terms of ADE prevention is not yet demonstrated.

Primary outcomes:
measure: Number of patients with definite and possible adverse drug events during their hospital admission
timeFrame: From point of randomization to Day 14
Secondary outcomes:
measure: Drug ingredient cost at hospital discharge
timeFrame: Up to Day 14
measure: Medication Appropriateness Index score
timeFrame: measured at Day 14 and again at three months post hospital discharge.
measure: Composite health resource utilization including hospital admissions and primary care consultations
timeFrame: Measured at 3 months post hospital discharge
Other outcomes:
Locations:
city: Cork
country: Ireland
facility: Cork University Hospital
state: Munster
Study officials:
affiliation: University College Cork, Ireland
name: David O'Sullivan, MPharm
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.