Medicines ReconciliationNCT03173690
Medicines Reconciliation at an Intensive Care Unit
A study testing Medication reconciliation at the ICU and Medication Reconciliation at the Ward in people with Medicines Reconciliation and Intensive Care Unit, run by University Hospital, Akershus at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medicines Reconciliation, Intensive Care Unit
- What is being tested?
- Medication reconciliation at the ICU and Medication Reconciliation at the Ward
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteNorway
- Study dates
- 6 Feb 2017to Oct 2017
- 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
- belonging to the hospitals intake area
- written informed concent by the patient or his/her next to kin
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Akershus university Hospital
Lørenskog, Akershus
Per Martin Baadstolokken
About this study
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.
Read the 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.
- Conditions
- Medicines Reconciliation, Intensive Care Unit
- Being tested
- Medication reconciliation at the ICU, Medication Reconciliation at the Ward
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medication reconciliation at the ICUOther
Medication reconciliation performed according to Integrated Medicines Management model
Medication Reconciliation at the WardOther
Medication reconciliation performed according to Integrated Medicines Management model
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Receive medication reconciliation at the ICU, pluss medication reconciliation at the ward Receives: 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 Receives: Other: Medication Reconciliation at the Ward |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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
Measured: Retrospectively, based on the information gathered from the day of randomisation up until 28 days after randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2017
- Study start6 Feb 2017
- Primary completion6 Jul 2017
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medicines ReconciliationStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Care provider
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Akershus
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Pharmacy Enterprise, South Eastern Norway
- Responsible party
- Principal investigator, Silje Engdal Ørnes, University Hospital, Akershus
- Investigators
- Silje E Oernes, PhD, Principal investigator, Hospital Pharmacy Enterprise, South Eastern Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03173690
- Sponsor's protocol ID
- 16-186
- Status last verified
- Jun 2017
- First submitted
- 22 May 2017
- Last updated
- 11 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medicines Reconciliation at an Intensive Care Unit
- ClinicalTrials.gov ID
- NCT03173690
- Acronym / sponsor ID
- 16-186
- Conditions
- Medicines Reconciliation, Intensive Care Unit
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, AkershusUniversity, hospital or other
- Collaborators
- Hospital Pharmacy Enterprise, South Eastern Norway
- Study start
- 6 Feb 2017 (actual)
- Primary completion
- 6 Jul 2017 (actual)
- Study completion
- Oct 2017 (estimated)
- First posted
- 2 Jun 2017 (actual)
- 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.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Medication reconciliation at the ICU, Other: Medication Reconciliation at the WardReceive medication reconciliation at the ICU, pluss medication reconciliation at the ward |
| Control group | Other | Other: Medication Reconciliation at the WardNo intervention at the ICU, medication reconciliation at the ward |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- belonging to the hospitals intake area
- written informed concent by the patient or his/her next to kin
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Medication reconciliation at the ICUMedication reconciliation performed according to Integrated Medicines Management model | Other | Intervention group |
| Medication Reconciliation at the WardMedication reconciliation performed according to Integrated Medicines Management model | Other | Control group, Intervention group |
Primary outcome
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.
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2017.
- Individual participant dataSharing planned: No
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.
Silje E Oernes, PhD principal investigator
Hospital Pharmacy Enterprise, South Eastern Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medication reconciliation at the ICU and Medication Reconciliation at the Ward in people with Medicines Reconciliation and Intensive Care Unit, run by University Hospital, Akershus 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 5 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 11 Jul 2017. 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?
Contact Silje E Oernes, phD (004767960302, silje.engdal.ornes@sykehusapotekene.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jul 2017; AzTrials last refreshed its copy on 31 Oct 2026.