Medicines Reconciliation at an Intensive Care Unit

Intensive Care Unit Clinical Trial

Official title:

Medicines Reconciliation at an Intensive Care Unit

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03173690
• Other study ID #: 16-186
• Status: Recruiting
• Phase: N/A
• First received: May 22, 2017
• Last updated: July 7, 2017
• Start date: February 6, 2017
• Est. completion date: October 2017

Study information

• Verified date: June 2017
• Source: University Hospital, Akershus
• Contact: Silje E Oernes, phD
• Phone: 004767960302
• Email: silje.engdal.ornes[@]sykehusapotekene.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates the effect of performing medicines reconciliation on patients admitted to an intensive care unit. Half of the patients will receive a medicines reconciliation at the intensive care unit. The other half will not. All included patients will receive medicines reconciliation after transfer to the ward.

Description:

Transfer of patients from one level of care to another is known to increase the risk of medication errors. Medication reconciliation is an accepted intervention to increase the knowledge on the patients medication use, thus reducing the risk of avoidable medication errors. For patients in the intensive care unit treatment of the imminent threat is obviously the most important. Nevertheless, knowledge about previous medications are important.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 2017
• Est. primary completion date: July 6, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• belonging to the hospitals intake area

• written informed concent by the patient or his/her next to kin

Exclusion Criteria:

• Patients without next to kin

• Not Norwegian speaking, in need of a translator

• medication reconciliation performed earlier

• Patients with Guillain-Barre or Myasthenia Gravis, due to long expectancy of stay

• Short life expectancy, decided in cooperation with the physician

Related Conditions & MeSH terms

• Intensive Care Unit
• Medicines Reconciliation

Intervention

Other:
• Medication reconciliation at the ICU
Medication reconciliation performed according to Integrated Medicines Management model
• Medication Reconciliation at the Ward
Medication reconciliation performed according to Integrated Medicines Management model

Locations

Country	Name	City	State
Norway	Akershus university Hospital	Lørenskog	Akershus

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Akershus	Hospital Pharmacies Enterprise, South Eastern Norway

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with at least one discrepancy between medications listed on hospital chart and medications used at home before hospital admittance	Medications listed on the medication chart were recorded on a predefined form, this included information on dosage form, strength, dosage and administration time for each drug. The pharmacist performed medicines reconciliation either by interviewing the patient or by gathering information from other sources as the patient's general practitioner, next-to-kin or if relevant nursing home. Any deviations between the information from the medication chart and information obtained during medicines reconciliation was defined as a discrepancy.	Medicines reconciliation is performed at randomisation and within 48 hours after transmission to the ward, assessed up to 28 days after randomisation
Secondary	Retrospective evaluation on the clinical relevance of the observed medical discrepancies	One clinical pharmacist and one senior geriatrician retrospectively asses the potential clinical relevance of the registered discrepancies. The expert panel use the following information for each patient when assessing the clinical relevance: medication list before and after reconciliation, age, gender, reason for hospitalisation, former and current diseases and the level of care before admission	Retrospectively, based on the information gathered from the day of randomisation up until 28 days after randomisation