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Medicines Reconciliation at an Intensive Care Unit

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ClinicalTrials.gov Identifier: NCT03173690
Recruitment Status : Recruiting
First Posted : June 2, 2017
Last Update Posted : July 11, 2017
Sponsor:
Collaborator:
Hospital Pharmacies Enterprise, South Eastern Norway
Information provided by (Responsible Party):
Silje Engdal Ørnes, University Hospital, Akershus

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.

Condition or disease Intervention/treatment Phase
Medicines Reconciliation Intensive Care Unit Other: Medication reconciliation at the ICU Other: Medication Reconciliation at the Ward Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Single (Care Provider)
Masking Description: 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
Primary Purpose: Supportive Care
Official Title: Medicines Reconciliation at an Intensive Care Unit
Actual Study Start Date : February 6, 2017
Actual Primary Completion Date : July 6, 2017
Estimated Study Completion Date : October 2017

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

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




Primary Outcome Measures :
  1. Number of patients with at least one discrepancy between medications listed on hospital chart and medications used at home before hospital admittance [ Time Frame: Medicines reconciliation is performed at randomisation and within 48 hours after transmission to the ward, assessed up to 28 days after randomisation ]
    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.


Secondary Outcome Measures :
  1. Retrospective evaluation on the clinical relevance of the observed medical discrepancies [ Time Frame: Retrospectively, based on the information gathered from the day of randomisation up until 28 days after randomisation ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03173690


Contacts
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Contact: Silje E Oernes, phD 004767960302 silje.engdal.ornes@sykehusapotekene.no

Locations
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Norway
Akershus university Hospital Recruiting
Lørenskog, Akershus, Norway
Contact: Per Martin Baadstolokken         
Sponsors and Collaborators
University Hospital, Akershus
Hospital Pharmacies Enterprise, South Eastern Norway
Investigators
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Principal Investigator: Silje E Oernes, PhD Hospital Pharmacies Enterprise, South Eastern Norway

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Responsible Party: Silje Engdal Ørnes, Clinical pharmacist, Ph.d, University Hospital, Akershus
ClinicalTrials.gov Identifier: NCT03173690     History of Changes
Other Study ID Numbers: 16-186
First Posted: June 2, 2017    Key Record Dates
Last Update Posted: July 11, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No