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.
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
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- 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.
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.
- Conditions
- Acute Admitted Multimorbid Patients
- 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 group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Standard care during hospital stay, without pharmacist involved |
| Pharmacist intervention | Experimental | A 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.
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.
- First posted12 Jan 2015 (estimated)
- Study startAug 2014
- Primary completion6 Jul 2018
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Admitted Multimorbid PatientsStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Pharmacy Enterprise, South Eastern Norway, South-Eastern Norway Regional Health Authority, University of Oslo
- Responsible party
- Principal investigator, Morten Mowe, Oslo University Hospital
- Investigators
- Morten Mowe, Associate professor, Principal investigator, Oslo University Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oslo Pharmacist Intervention Study - Effect on Readmissions
- ClinicalTrials.gov ID
- NCT02336113
- Acronym / sponsor ID
- OPERA / 2014/704
- Conditions
- Acute Admitted Multimorbid Patients
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Hospital Pharmacy Enterprise, South Eastern Norway, South-Eastern Norway Regional Health Authority, University of Oslo
- Study start
- Aug 2014
- Primary completion
- 6 Jul 2018 (actual)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 12 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
_______________________________
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Standard care during hospital stay, without pharmacist involved |
| Pharmacist intervention | Experimental | Behavioral: multidisciplinary treatmentA pharmacist is included in the multidisciplinary treatment team during the hospital stay |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- acute admitted patients using minimum 4 regular drugs from minimum 2 drug groups at admittance
- Norwegian personal identification number
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| multidisciplinary treatmentThe 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 | Behavioural | Pharmacist intervention |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2020.
- Derived from this study: PubMed 33376173Lea 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.
Related trials for Acute Admitted Multimorbid Patients
Not yet recruiting
Poland Integrated Medicines Management (PL-IMM) - Study Assessing the Provision of Complex Clinical Pharmacy Services to Hospitalized Patients
Acute Admitted Multimorbid Patients
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Morten Mowe, Associate professor principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
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.