Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04722588 |
| Other study ID # |
HPNorhNorway |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2021 |
| Est. completion date |
December 31, 2025 |
Study information
| Verified date |
November 2023 |
| Source |
Hospital Pharmacy of North Norway Trust |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
