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Oslo Pharmacist Intervention Study - Effect on Readmissions (OPERA)

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ClinicalTrials.gov Identifier: NCT02336113
Recruitment Status : Active, not recruiting
First Posted : January 12, 2015
Last Update Posted : October 16, 2018
Sponsor:
Collaborators:
Hospital Pharmacies Enterprise, South Eastern Norway
South-Eastern Norway Regional Health Authority
University of Oslo
Information provided by (Responsible Party):
Morten Mowe, Oslo University Hospital

Brief Summary:

Earlier studies have shown that pharmacists detect and solve drug related problems (DRPs) when they are a part of the multidisciplinary treatment-team at hospital wards. However, in the Norwegian health care system, there is a lack of studies on the effect of pharmacist intervention on clinically relevant outcomes. Hospital readmissions has both clinical and economical negative effects, and time outside the hospital until an eventual readmission is considered as a clinical relevant outcome measure. The investigators are conducting a randomized controlled trial at an internal medicine ward at Oslo University Hospital. 400 acute admitted patients using minimum 4 regular drugs from minimum 2 drug groups will be enrolled in the study. Patients randomized to the Control group will receive standard care (without a pharmacist involved) and patients randomized to the Intervention group will receive a pharmacist in their treatment team during the hospital stay. The study hypothesis is that including a pharmacist in the multidisciplinary treatment team at a hospital ward, will improve the patients drug treatment, hence lead to an increased time outside the hospital until an eventual readmission.

The inclusion of patients was completed March 17th 2016 With 399 patients randomised. Data from Norwegian Patient Registry and Norwegian Cause of Death Registry until december 2017 was collected october 2018.

The investigators have received approval for protocol amendment to use the data from the study. The investigators aim to identify these patients by building a statistical model based on significant variables from the data collected in the ongoing randomised controlled trial. The hypothesis for the first part of the project is that a set of patient characteristics can identify patients who are at high risk of drug-related readmissions and who would benefit most from the pharmaceutical intervention. The model will be validated using data from 100 new patients admitted to the internal medicine ward.

The inclusion of patients to this New sample was finalised July 6th 2018 (primary completion). Data on readmission and Death will be collected from Norwegian Patient Registry and Norwegian Cause of Death Registry february 2020.


Condition or disease Intervention/treatment Phase
Acute Admitted Multimorbid Patients Behavioral: multidisciplinary treatment Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Oslo Pharmacist Intervention Study - Effect on Readmissions
Study Start Date : August 2014
Actual Primary Completion Date : July 6, 2018
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control group
Standard care during hospital stay, without pharmacist involved
Experimental: Pharmacist intervention
A pharmacist is included in the multidisciplinary treatment team during the hospital stay
Behavioral: multidisciplinary treatment
The pharmacist will conduct medication reconciliation at admission, perform medication reviews during the hospital stay and provide drug information (written and oral) to the patient before discharge, as well as written drug information to the next level of care




Primary Outcome Measures :
  1. Days outside hospital until an eventual first readmission [ Time Frame: 12 months after hospital discharge ]
    Calculated as the difference between the Control- and intervention group in the intention-to-treat population with data from The Norwegian Patient Register



Information from the National Library of Medicine

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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:

  • acute admitted patients using minimum 4 regular drugs from minimum 2 drug groups at admittance
  • Norwegian personal identification number

Exclusion Criteria:

  • terminally ill
  • not able no communicate in Norwegian or English and an interpreter is not available
  • patients isolated due to severe infections
  • readmitted patients earlier included are not re-included

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): NCT02336113


Locations
Norway
Oslo University Hospital
Oslo, Norway, 0450
Sponsors and Collaborators
Oslo University Hospital
Hospital Pharmacies Enterprise, South Eastern Norway
South-Eastern Norway Regional Health Authority
University of Oslo
Investigators
Principal Investigator: Morten Mowe, Associate professor Oslo University Hospital

Responsible Party: Morten Mowe, Associate professor, senior consultant, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT02336113     History of Changes
Other Study ID Numbers: 2014/704
First Posted: January 12, 2015    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018