Medicines Reconciliation at an Intensive Care Unit

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.

Study Overview

• Status: Unknown
• Conditions: Intensive Care Unit; Medicines Reconciliation
• Intervention / Treatment: Other: Medication reconciliation at the ICU; Other: Medication Reconciliation at the Ward

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Silje E Oernes, phD; Phone Number: 004767960302; Email: silje.engdal.ornes@sykehusapotekene.no

Study Locations

• Norway
  • Akershus
    • Lørenskog, Akershus, Norway
      • Recruiting
      • Akershus University Hospital
      • Contact: Per Martin Baadstolokken

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention group; Receive medication reconciliation at the ICU, pluss medication reconciliation at the ward	Other: Medication reconciliation at the ICU; Medication reconciliation performed according to Integrated Medicines Management model; Other: Medication Reconciliation at the Ward; Medication reconciliation performed according to Integrated Medicines Management model
OTHER: Control group; No intervention at the ICU, medication reconciliation at the ward	Other: Medication Reconciliation at the Ward; Medication reconciliation performed according to Integrated Medicines Management model

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Akershus
• Collaborators: Hospital Pharmacy Enterprise, South Eastern Norway
• Investigators: Principal Investigator: Silje E Oernes, PhD, Hospital Pharmacy Enterprise, South Eastern Norway

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 6, 2017
• Primary Completion (ACTUAL): July 6, 2017
• Study Completion (ANTICIPATED): October 1, 2017

Study Registration Dates

• First Submitted: May 22, 2017
• First Submitted That Met QC Criteria: May 30, 2017
• First Posted (ACTUAL): June 2, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 11, 2017
• Last Update Submitted That Met QC Criteria: July 7, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 16-186

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No