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Adverse Drug Reaction | the Pharmacy Intervention Team Hospital-based (PITH) for People Study: Effect on Clinical and Economic Outcomes

Adverse Drug Reaction research study

What is the primary objective of this study?

The purpose of this study is to determine whether a hospital pharmacy team (pharmacy technicians and pharmacists) together with (recently admitted) patients are able to diminish the number of drug related problems including adverse drug events, made before, during and after admissions resulting in reductions of re-hospitalizations and costs.

Who is eligible to participate?

Inclusion Criteria: - > three prescribed systemic drugs intended for chronic use at admission and discharge - an expected length of stay of 48 hours or longer - insured with the Dutch insurance company Agis/Achmea - patients or their carers are able to express themselves in Dutch or English Exclusion Criteria: - scheduled chemotherapy - radiation therapy - transplantation - transfer from another hospital - transfer from another non-eligible ward within the same hospital - no informed consent has been signed - a live expectancy less than 6 months - deceased during admission - inability to be counselled (e.g. cognitive dysfunction, language constraints) - discharge to a nursing home (presuming dependence on medication administration). Patients will only be included once.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Adverse Drug Reaction

Medication Administered in Error

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Other:integrated medicines managementPITH includes the following interventions: A) MR on admission to obtain an up-to-date medication list, B) Intermediate medication review during hospitalization C) MR at discharge to maintain an up-to-date medication overview, counseling of the patient at hospital discharge and preparation of the patient to manage their medication at home., Written material is provided for oral support, which includes an overview of the current medication, a summary of potentially important side effects, advices on medication use and hospital pharmacy contact information in order to answer any possible questions, D) Information transfer to GP/community pharmacist at discharge

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

usual careDuring admission patients receive standard, non - ward based, pharmaceutical care from a pharmacy team in taking responsibility for the appropriate, safe and cost-effective use of medication from a central hospital pharmacy. The pharmaceutical care consist of daily screening of generated alerts by the Computerized physician order entry (CPOE) system and consultation by phone. Dependent on the local situation the current medication reconciliation process is being performed by nursing and/or medical staff either protocolised or not.

integrated medicines managementintegrated medicines management consists of patient centred medication reconciliation intermediate medication review discharge counseling transfer of information to primary care

Study Status

Unknown status

Start Date: January 2013

Completed Date: December 2014

Phase: N/A

Type: Interventional

Design:

Primary Outcome: number of rehospitalizations

Secondary Outcome: numbers of ADEs

Study sponsors, principal investigator, and references

Principal Investigator: Bart van den Bemt, PharmD, PhD

Lead Sponsor: Clementine CM Stuijt PharmD, MSc

Collaborator: Insurance company Achmea Zorg

More information:https://clinicaltrials.gov/show/NCT01906710

Using medication reconciliation to prevent errors. Jt Comm J Qual Patient Saf. 2006 Apr;32(4):230-2.

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