Ignite Creation Date:
2024-05-06 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04722588
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-11-28
First Post:
2021-01-20
Brief Title:
Integrating the Clinical Pharmacists Into Emergency Department Teams
Sponsor:
Hospital Pharmacy of North Norway Trust
Organization:
Hospital Pharmacy of North Norway Trust
Study Overview
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ED-PHARM
Brief 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 patients 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 andor 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
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 patients 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 andor 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 n14400 while patients presenting during the intervention period will be allocated to the intervention group n19200 independently of whether they receive clinical pharmacist services or not Patients for whom data is not available retrospectively will be excluded
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 n14400 while patients presenting during the intervention period will be allocated to the intervention group n19200 independently of whether they receive clinical pharmacist services or not Patients for whom data is not available retrospectively will be excluded
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None