Integrating the Clinical Pharmacists Into Emergency Department Teams

NCT04722588 | Unknown

• 1 other identifier: HPNorhNorway
• Study Type: interventional
• Target: 30,888
• Locations: 1 country
• Sites: 3

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 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.

Conditions

Emergency Department; Clinical Pharmacist

Keywords

Medication therapy; Clinical pharmacist; Interdisciplinary team collaboration; Emergency department; Stepped-wedge trial

Outcome Measures

Primary Outcomes (1)

• 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.

  30 days

Secondary Outcomes (6)

• Time to rehospitalization (unplanned) or visit to urgent care clinic

  30 days

• 30-day rate for rehospitalization or visit to urgent care clinic (unplanned)

  30 days

• Length of stay in hospital

  30 days

• Length of stay in ED

  48 hours

• Mortality ratio

  30 days

Study Arms (2)

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.

Other: Introducing clinical pharmacists to the interdisciplinary ED team.

Interventions

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.

Intervention period

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients presenting to the EDs during the study period will be included.

You may not qualify if:

• Patients for whom data is not available retrospectively.
• Patients who actively ask not to be included in the study.

Sponsors & Collaborators

• Hospital Pharmacy of North Norway Trust: lead
• University Hospital of North Norway: collaborator
• Nordlandssykehuset HF: collaborator
• The Royal Norwegian Ministry of Health: collaborator
• University of Tromso: collaborator

Study Sites (3)

Nordlandssykehuset HF

Bodø, 8001, Norway

Location

University hospital of north norway

Harstad, Norway

Location

University hospital of North Norway

Tromsø, 9000, Norway

Location

Related Publications (1)

• 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.

  PMID: 34824109 DERIVED

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Renate Elenjord, PhD

  Hospital Pharmacy of North Norway Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Masking members of the interdisciplinary team is not possible as a new member of staff is being introduced. However, the study will not be announced to patients presenting to the EDs. Patients will know that there is a study ongoing, but will not have to consent to participation.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Philosophia Doctor

Model Details: 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.

Study Record Dates

• First Submitted: January 20, 2021
• First Posted: January 25, 2021
• Study Start: February 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2025
• Last Updated: November 28, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

NO (3)