Medicines Reconciliation at an Intensive Care Unit

NCT03173690 | Unknown

• 1 other identifier: 16-186
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Medicines Reconciliation; Intensive Care Unit

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Retrospective evaluation on the clinical relevance of the observed medical discrepancies

  Retrospectively, based on the information gathered from the day of randomisation up until 28 days after randomisation

Study Arms (2)

Intervention group

EXPERIMENTAL

Receive medication reconciliation at the ICU, pluss medication reconciliation at the ward

Other: Medication reconciliation at the ICU; Other: Medication Reconciliation at the Ward

Control group

OTHER

No intervention at the ICU, medication reconciliation at the ward

Other: Medication Reconciliation at the Ward

Interventions

Medication reconciliation at the ICU OTHER

Medication reconciliation performed according to Integrated Medicines Management model

Intervention group

Medication Reconciliation at the Ward OTHER

Medication reconciliation performed according to Integrated Medicines Management model

Control group; Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• belonging to the hospitals intake area
• written informed concent by the patient or his/her next to kin

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Akershus: lead
• Hospital Pharmacy Enterprise, South Eastern Norway: collaborator

Study Sites (1)

Akershus university Hospital

Lørenskog, Akershus, Norway

RECRUITING

Study Officials

• Silje E Oernes, PhD

  Hospital Pharmacy Enterprise, South Eastern Norway

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Silje E Oernes, phD

CONTACT

004767960302; silje.engdal.ornes@sykehusapotekene.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: The care provider performing medicines reconciliation at ward is semimasked. The masking might be broken if the patients tells if he/she has been interviewed earlier in the study
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical pharmacist, Ph.d

Model Details: The included patients are randomized to either intervention or control group. The intervention group receives medicines reconciliation at the intensive care unit. The control group receive standard pharmaceutical care, which now does not include medicines reconciliation. After the patients are transferred to care at the ward, medicines reconciliation is performed for all patients.

Study Record Dates

• First Submitted: May 22, 2017
• First Posted: June 2, 2017
• Study Start: February 6, 2017
• Primary Completion: July 6, 2017
• Study Completion: October 1, 2017
• Last Updated: July 11, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)