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Acute Admitted Multimorbid PatientsOPERANCT02336113

Oslo Pharmacist Intervention Study - Effect on Readmissions

A study testing multidisciplinary treatment in people with Acute Admitted Multimorbid Patients, run by Oslo University Hospital at 1 site in Norway.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Admitted Multimorbid Patients
What is being tested?
multidisciplinary treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
1 siteNorway
Study dates
Aug 2014to 30 Jun 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Norway1 site
  • Oslo University Hospital

    Oslo, 0450

Other trials in Norway

About this study

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. The last day of follow-up on readmission and mortality was December 31, 2017. The Application process for outcome data to the Norwegian Patient Registry and the Norwegian Cause of Death Registry started in June 2017 and lasted until May 2018. Huge workload at the Registers entails a very long processing time for outcome data. On May 25, 2018 the statistical analysis plan was finalized and signed, hereunder the analysis population defined and the endpoint analyses detailed. Outcome datafiles from patient registries was prepared for analysis May 29 to June 6, 2018. Blinded outcome analyses was conducted June 8, 2018.

Read more

_______________________________

The investigators have obtained approval for a protocol amendment to use the data from the study in further analyses togheter with data from 100 new patients admitted to the internal medicine ward. The hypothesis 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 investigators aim to identify these patients by building a statistical model based on significant variables from the 399 patients collected in the randomised controlled trial. The statistical 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 hospital readmissions and death will be collected from the Norwegian Patient Registry and the Norwegian Cause of Death Registry in June 2020.

Being tested
multidisciplinary treatment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • multidisciplinary treatmentBehavioural

    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

Study groups in NCT02336113
Study groupRoleWhat they receive
Control groupNo interventionStandard care during hospital stay, without pharmacist involved
Pharmacist interventionExperimentalA pharmacist is included in the multidisciplinary treatment team during the hospital stay
Receives: Behavioral: multidisciplinary treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Days outside hospital until an eventual first readmission

    Calculated as the difference between the Control- and intervention group in the intention-to-treat population with data from The Norwegian Patient Register

    Measured: 12 months after hospital discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2015 (estimated)
  2. Study startAug 2014
  3. Primary completion6 Jul 2018
  4. Study completion30 Jun 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02336113
Sponsor's protocol ID
2014/704
Acronym
OPERA
Status last verified
Mar 2020
First submitted
26 Jun 2014
Last updated
5 Mar 2020
Results posted
No
Data monitoring committee
No

Publications

  • Lea M, Mowe M, Molden E, Kvernrod K, Skovlund E, Mathiesen L. Effect of medicines management versus standard care on readmissions in multimorbid patients: a randomised controlled trial. BMJ Open. 2020 Dec 29;10(12):e041558. doi: 10.1136/bmjopen-2020-041558.

    PubMed 33376173

Questions about this trial

What is this clinical trial studying?

A study testing multidisciplinary treatment in people with Acute Admitted Multimorbid Patients, run by Oslo University Hospital at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Days outside hospital until an eventual first readmission (time frame: 12 months after hospital discharge). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02336113, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2020.

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