Emergency DepartmentED-PHARMNCT04722588
Integrating the Clinical Pharmacists Into Emergency Department Teams
A study testing Introducing clinical pharmacists to the interdisciplinary ED team. in people with Emergency Department and Clinical Pharmacist, run by Hospital Pharmacy of North Norway Trust at 3 sites in Norway.
Trial summary
The "Emergency Department (ED) Pharmacist" is an integrated part of the ED interdisciplinary team in many countries, which have shown to improve medication safety and reduce costs related to hospitalisations. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Emergency Department, Clinical Pharmacist
- What is being tested?
- Introducing clinical pharmacists to the interdisciplinary ED team.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30,888 participants
- Where
- 3 sitesNorway
- Study dates
- 1 Feb 2021to 31 Dec 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients presenting to the EDs during the study period will be included.
Who cannot join
- Patients for whom data is not available retrospectively.
- Patients who actively ask not to be included in the study.
Trial locations and contacts
3 sites in 1 country.
Norway3 sites
Nordlandssykehuset HF
Bodø, 8001
University hospital of north norway
Harstad
University hospital of North Norway
Tromsø, 9000
About this study
Official title: Integrating the Clinical Pharmacist Into the Emergency Department Interdisciplinary Team: A Study Protocol for a Multicentre Trial Applying a Non-randomized Stepped Wedge Study Design
The "Emergency Department (ED) Pharmacist" is an integrated part of the ED interdisciplinary team in many countries, which have shown to improve medication safety and reduce costs related to hospitalisations. In Norway, few EDs are equipped with an ED pharmacist, and research describing effects on patients has not been conducted.
This is a multicentre study where the intervention will be implemented in the regular operation of three EDs in Northern Norway; Tromsø, Bodø and Harstad.
Read more
Clinical pharmacists will work as an integrated part of the ED team, and provide pharmaceutical care services such as medication reconciliation, medication review or medication counselling. The medical condition and complexity of the patient's disease will influence the extend and type of service from the pharmacist.
A non-randomized stepped wedge study design will be applied, where the ED pharmacist will be implemented in all three EDs after a three, six- and nine- month control period, respectively. Each ED will consequently have both intervention and control periods.
All patients going through the three EDs during the 12-month study period will be included. Patients admitted in the control periods will be allocated to the control group, while patients admitted in the intervention periods will be allocated to the intervention group.
The primary endpoint is "Time in hospital during 30 days after admission to the ED", which is a composite endpoint combining i) time in ED during stay, ii) time in hospital during stay if hospitalized and iii) time in urgent care clinic, ED and/or hospital if rehospitalized within 30 days after admission to ED Secondary endpoints include time to rehospitalization, length of stay (LOS) during first hospitalisation, LOS in EDs, rehospitalisation rates and mortality rates.
Patient data will be collected retrospectively from national data registries, from the hospital system and from patient records.
The Regional Committee for Medical and Health Research Ethics and Local Patient Protection Officers in all hospitals have approved the study.
Read the detailed description
The intervention will be assessed using a non-randomized stepped wedge trial design. A stepped wedge design allows for the intervention to be rolled out at different times, thus allowing us to control for differences between study sites (vertical control) and secular trends (horizontal control) during the study period. This is the gold standard when a conventional randomized controlled trial is not possible.
The stepped wedge study design is based on a staggered implementation of the intervention in the intervention sites. This will be done over a 12-month period, starting with a three-month control period in all EDs (planned start-up February 1st, 2021). This period allows for baseline data collection before the intervention. After this period, the investigators will consecutively roll out the intervention at three months interval to the EDs. The intervention will start in Tromsø which is the largest ED, continue in Bodø and finish in Harstad, which is the smallest of the three EDs. After nine months, all EDs will have clinical pharmacists. When the intervention is implemented in an ED, it will continue until the trial is terminated (planned January 31th, 2022).
This is a multicentre study including three EDs in Northern Norway Health Authority region; the University Hospital of North Norway (UNN) Tromsø, Nordland Hospital (NLSH) in Bodø and UNN Harstad with approximately 15 000, 12 000 and 6000 patients presenting annually in the respective EDs. These numbers include patients being admitted more than once to the ED. The three EDs operate similarly and receive patients who need immediate health care in case of acute illness or injury. Norway has a well-functioning primary care system, including municipal urgent care clinics providing ambulatory care outside of general practitioner (GP) office hours. In order to be admitted to the ED, the patients need a referral either from GP or from a physician at an urgent care clinic. At the ED, the patient is met by an ED nurse and an ED physician (either an intern or a resident in specialty training), who perform the initial examinations and assessments of the patient. A senior physician is always on call in case of the need for a consultation. NLSH is the only ED with senior physicians situated in the ED during day-time. From the ED, patients are either admitted to a hospital ward, transferred to a municipally run health institution or discharged to their homes.
All patients presenting to the EDs during the study period will be included. Patients presenting during the control period, will be allocated to the control group (n≈14400), while patients presenting during the intervention period will be allocated to the intervention group (n≈19200), independently of whether they receive clinical pharmacist services or not. Patients for whom data is not available retrospectively, will be excluded.
- Conditions
- Emergency Department, Clinical Pharmacist
- Being tested
- Introducing clinical pharmacists to the interdisciplinary ED team.
- Keywords
- Medication therapy, Clinical pharmacist, Interdisciplinary team collaboration, Emergency department, Stepped-wedge trial
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Introducing clinical pharmacists to the interdisciplinary ED team.Other
There will be two shifts, one shift from 08.00 - 15.00 and one from 12.00 - 19.00. Consequently, the hours of the day when the majority of patients arrives, are covered and the pharmacist capacity is doubled during the busiest time of the day. Early mornings are normally relatively slowed paced and the pharmacist may use this time to follow up on patients admitted during the night (from 19.00 - 08.00), in particularly those who have been admitted to wards without an assigned pharmacist.
| Study group | Role | What they receive |
|---|---|---|
| Control period | No intervention | The control period is represented by standard care procedures, which are similar in all three EDs: Patients cared for in the EDs receive treatment from ED physicians and nurses, and no pharmacists are involved in any of the EDs. |
| Intervention period | Experimental | During the intervention period, clinical pharmacists will be present in the EDs from 08.00 - 19.00 Monday to Friday.
The ED pharmacists will collaborate with the interdisciplinary team and perform the following tasks as appropriately as possible and by prioritized need; medication history taking, medication reconciliation, medication review, drug therapy recommendations, guidance on drug administration, medication information and counseling to patients/next of kin and health care personnel and communication about medications and changes in medication regimes. Standardized procedures, like the integrated medicines management (IMM) methodology, will be applied where possible. How, when and which task will be performed for each patient cannot be predetermined, but must be performed according to patient's needs and eventual time constraints. Receives: Other: Introducing clinical pharmacists to the interdisciplinary ED team. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in hospital during 30 days after admission to the ED
This is a composite endpoint adding times during a 30-day period accounted from admission in ED for the first time in trial period (index stay): 1) time in ED during index stay, 2) time in hospital during index stay if hospitalized and 3) time in ED or hospital if rehospitalized within 30 days after index admission to ED.
Measured: 30 days
Secondary outcomes (6)
Time to rehospitalization (unplanned) or visit to urgent care clinic
Time before the first unplanned rehospitalization or visit to urgent care clinic will be measured and the duration from the control period to the duration from the intervention period will be compared.
Measured: 30 days
30-day rate for rehospitalization or visit to urgent care clinic (unplanned)
The 30-day rate for rehospitalization or visit to urgent care clinic during the control period will be compared with the trial period where an ED pharmacist will be present in the ED. The rate will be measured by the number of patients who are rehospitalized within 30 days after their stay.
Measured: 30 days
Length of stay in hospital
Length of stay (LOS) in hospital will be calculated as discharge date minus admission date. The LOS in hospital for all patients in the trial period in all three EDs will be calculated.
Measured: 30 days
Length of stay in ED
The ED LOS will be represented in minutes as discharge time from the ED (or time transferred to a hospital ward) minus admission time in the ED.
Measured: 48 hours
Mortality ratio
The proportion of patients who died within 30 days of admission to the ED in the control period compared to the intervention period.
Measured: 30 days
Time to death
Number of days from admission to the ED until death will be measured and compared between control and intervention period.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start1 Feb 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2025 (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 Emergency DepartmentStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- The intervention comprises implementing the clinical pharmacists in the interdisciplinary team in three emergency departments (EDs) in Northern Norway. A non-randomized stepped-wedge design will be applied. This design allows the intervention to be rolled out sequential, allowing us to control for differences between study sites (vertical control) and secular trends (horizontal control) during the study period. This is the gold standard when a conventional randomized controlled trial is not possible. The intervention will be implemented over a 12-month period, starting with a three-month control period in all EDs. This period allows for baseline data collection before the intervention. After this period, the investigators will consecutively roll out the intervention at three months interval to the EDs. The intervention will start in Tromsø, which is the largest ED, continue in Bodø and finish in Harstad, which is the smallest of the three EDs.
- Masking
- None (open label)
- Enrolment
- 30,888 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Pharmacy of North Norway Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital of North Norway, Nordlandssykehuset HF, The Royal Norwegian Ministry of Health, University of Tromso
- Responsible party
- Principal investigator, Renate Elenjord, Hospital Pharmacy of North Norway Trust
- Investigators
- Renate Elenjord, PhD, Principal investigator, Hospital Pharmacy of North Norway Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04722588
- Sponsor's protocol ID
- HPNorhNorway
- Acronym
- ED-PHARM
- Status last verified
- Nov 2023
- First submitted
- 20 Jan 2021
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vesela R, Elenjord R, Lehnbom EC, Ofstad EH, Johnsgard T, Zahl-Holmstad B, Risor T, Wisloff T, Roslie L, Filseth OM, Valle PC, Svendsen K, Froyshov HM, Garcia BH. Integrating the clinical pharmacist into the emergency department interdisciplinary team: a study protocol for a multicentre trial applying a non-randomised stepped-wedge study design. BMJ Open. 2021 Nov 25;11(11):e049645. doi: 10.1136/bmjopen-2021-049645.
PubMed 34824109
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating the Clinical Pharmacist Into the Emergency Department Interdisciplinary Team: A Study Protocol for a Multicentre Trial Applying a Non-randomized Stepped Wedge Study Design
- ClinicalTrials.gov ID
- NCT04722588
- Acronym / sponsor ID
- ED-PHARM / HPNorhNorway
- Conditions
- Emergency Department, Clinical Pharmacist
- Keywords
- Medication therapy, Clinical pharmacist, Interdisciplinary team collaboration, Emergency department, Stepped-wedge trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30,888 participants (actual)
- Lead sponsor
- Hospital Pharmacy of North Norway TrustUniversity, hospital or other
- Collaborators
- University Hospital of North Norway, Nordlandssykehuset HF, The Royal Norwegian Ministry of Health, University of Tromso
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 25 Jan 2021 (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.
The "Emergency Department (ED) Pharmacist" is an integrated part of the ED interdisciplinary team in many countries, which have shown to improve medication safety and reduce costs related to hospitalisations. In Norway, few EDs are equipped with an ED pharmacist, and research describing effects on patients has not been conducted.
This is a multicentre study where the intervention will be implemented in the regular operation of three EDs in Northern Norway; Tromsø, Bodø and Harstad.
Clinical pharmacists will work as an integrated part of the ED team, and provide pharmaceutical care services such as medication reconciliation, medication review or medication counselling. The medical condition and complexity of the patient's disease will influence the extend and type of service from the pharmacist.
A non-randomized stepped wedge study design will be applied, where the ED pharmacist will be implemented in all three EDs after a three, six- and nine- month control period, respectively. Each ED will consequently have both intervention and control periods.
All patients going through the three EDs during the 12-month study period will be included. Patients admitted in the control periods will be allocated to the control group, while patients admitted in the intervention periods will be allocated to the intervention group.
The primary endpoint is "Time in hospital during 30 days after admission to the ED", which is a composite endpoint combining i) time in ED during stay, ii) time in hospital during stay if hospitalized and iii) time in urgent care clinic, ED and/or hospital if rehospitalized within 30 days after admission to ED Secondary endpoints include time to rehospitalization, length of stay (LOS) during first hospitalisation, LOS in EDs, rehospitalisation rates and mortality rates.
Patient data will be collected retrospectively from national data registries, from the hospital system and from patient records.
The Regional Committee for Medical and Health Research Ethics and Local Patient Protection Officers in all hospitals have approved the study.
Detailed description
The intervention will be assessed using a non-randomized stepped wedge trial design. A stepped wedge design allows for the intervention to be rolled out at different times, thus allowing us to control for differences between study sites (vertical control) and secular trends (horizontal control) during the study period. This is the gold standard when a conventional randomized controlled trial is not possible.
The stepped wedge study design is based on a staggered implementation of the intervention in the intervention sites. This will be done over a 12-month period, starting with a three-month control period in all EDs (planned start-up February 1st, 2021). This period allows for baseline data collection before the intervention. After this period, the investigators will consecutively roll out the intervention at three months interval to the EDs. The intervention will start in Tromsø which is the largest ED, continue in Bodø and finish in Harstad, which is the smallest of the three EDs. After nine months, all EDs will have clinical pharmacists. When the intervention is implemented in an ED, it will continue until the trial is terminated (planned January 31th, 2022).
This is a multicentre study including three EDs in Northern Norway Health Authority region; the University Hospital of North Norway (UNN) Tromsø, Nordland Hospital (NLSH) in Bodø and UNN Harstad with approximately 15 000, 12 000 and 6000 patients presenting annually in the respective EDs. These numbers include patients being admitted more than once to the ED. The three EDs operate similarly and receive patients who need immediate health care in case of acute illness or injury. Norway has a well-functioning primary care system, including municipal urgent care clinics providing ambulatory care outside of general practitioner (GP) office hours. In order to be admitted to the ED, the patients need a referral either from GP or from a physician at an urgent care clinic. At the ED, the patient is met by an ED nurse and an ED physician (either an intern or a resident in specialty training), who perform the initial examinations and assessments of the patient. A senior physician is always on call in case of the need for a consultation. NLSH is the only ED with senior physicians situated in the ED during day-time. From the ED, patients are either admitted to a hospital ward, transferred to a municipally run health institution or discharged to their homes.
All patients presenting to the EDs during the study period will be included. Patients presenting during the control period, will be allocated to the control group (n≈14400), while patients presenting during the intervention period will be allocated to the intervention group (n≈19200), independently of whether they receive clinical pharmacist services or not. Patients for whom data is not available retrospectively, will be excluded.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The intervention comprises implementing the clinical pharmacists in the interdisciplinary team in three emergency departments (EDs) in Northern Norway. A non-randomized stepped-wedge design will be applied. This design allows the intervention to be rolled out sequential, allowing us to control for differences between study sites (vertical control) and secular trends (horizontal control) during the study period. This is the gold standard when a conventional randomized controlled trial is not possible. The intervention will be implemented over a 12-month period, starting with a three-month control period in all EDs. This period allows for baseline data collection before the intervention. After this period, the investigators will consecutively roll out the intervention at three months interval to the EDs. The intervention will start in Tromsø, which is the largest ED, continue in Bodø and finish in Harstad, which is the smallest of the three EDs.
| Arm | Type | Receives |
|---|---|---|
| Control period | No intervention | –The control period is represented by standard care procedures, which are similar in all three EDs: Patients cared for in the EDs receive treatment from ED physicians and nurses, and no pharmacists are involved in any of the EDs. |
| Intervention period | Experimental | Other: Introducing clinical pharmacists to the interdisciplinary ED team.During the intervention period, clinical pharmacists will be present in the EDs from 08.00 - 19.00 Monday to Friday. The ED pharmacists will collaborate with the interdisciplinary team and perform the following tasks as appropriately as possible and by prioritized need; medication history taking, medication reconciliation, medication review, drug therapy recommendations, guidance on drug administration, medication information and counseling to patients/next of kin and health care personnel and communication about medications and changes in medication regimes. Standardized procedures, like the integrated medicines management (IMM) methodology, will be applied where possible. How, when and which task will be performed for each patient cannot be predetermined, but must be performed according to patient's needs and eventual time constraints. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients presenting to the EDs during the study period will be included.
Key exclusion criteria (2 listed)
- Patients for whom data is not available retrospectively.
- Patients who actively ask not to be included in the study.
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 |
|---|---|---|
| Introducing clinical pharmacists to the interdisciplinary ED team.There will be two shifts, one shift from 08.00 - 15.00 and one from 12.00 - 19.00. Consequently, the hours of the day when the majority of patients arrives, are covered and the pharmacist capacity is doubled during the busiest time of the day. Early mornings are normally relatively slowed paced and the pharmacist may use this time to follow up on patients admitted during the night (from 19.00 - 08.00), in particularly those who have been admitted to wards without an assigned pharmacist. | Other | Intervention period |
Primary outcome
Time in hospital during 30 days after admission to the ED
Time frame: 30 days
This is a composite endpoint adding times during a 30-day period accounted from admission in ED for the first time in trial period (index stay): 1) time in ED during index stay, 2) time in hospital during index stay if hospitalized and 3) time in ED or hospital if rehospitalized within 30 days after index admission to ED.
6 secondary outcomes
Time to rehospitalization (unplanned) or visit to urgent care clinic
Time frame: 30 days
30-day rate for rehospitalization or visit to urgent care clinic (unplanned)
Time frame: 30 days
Length of stay in hospital
Time frame: 30 days
Length of stay in ED
Time frame: 48 hours
Mortality ratio
Time frame: 30 days
Time to death
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Derived from this study: PubMed 34824109Vesela R, Elenjord R, Lehnbom EC, Ofstad EH, Johnsgard T, Zahl-Holmstad B, Risor T, Wisloff T, Roslie L, Filseth OM, Valle PC, Svendsen K, Froyshov HM, Garcia BH. Integrating the clinical pharmacist into the emergency department interdisciplinary team: a study protocol for a multicentre trial applying a non-randomised stepped-wedge study design. BMJ Open. 2021 Nov 25;11(11):e049645. doi: 10.1136/bmjopen-2021-049645.
- Individual participant dataSharing planned: No
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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.
Renate Elenjord, PhD principal investigator
Hospital Pharmacy of North Norway Trust
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Introducing clinical pharmacists to the interdisciplinary ED team. in people with Emergency Department and Clinical Pharmacist, run by Hospital Pharmacy of North Norway Trust at 3 sites 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 1 inclusion and 2 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 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Time in hospital during 30 days after admission to the ED (time frame: 30 days). 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 NCT04722588, 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 28 Nov 2023; AzTrials last refreshed its copy on 8 Nov 2026.