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Completed

NCT Number: NCT01467128

Adverse Drug Event Prevention Using Structured Pharmacist Review

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cork University Hospital

Cork, Munster, Ireland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Structured expert pharmacist review

Other

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: expert pharmacist review

No intervention

Other

Normal hospital pharmaceutical care

Primary outcomes

  1. Number of patients with definite and possible adverse drug events during their hospital admission

    Time frame: From point of randomization to Day 14

Secondary outcomes

  1. Drug ingredient cost at hospital discharge

    Time frame: Up to Day 14

  2. Medication Appropriateness Index score

    Time frame: measured at Day 14 and again at three months post hospital discharge.

  3. Composite health resource utilization including hospital admissions and primary care consultations

    Time frame: Measured at 3 months post hospital discharge

Sponsors and collaborators

Lead sponsor

University College Cork

Other

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Nov 8, 2011
Registry last updated
Jun 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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