NCT05476705

Brief Summary

Up to a third of patients who visit emergency departments (EDs) do so because they have an issue with medicines prescribed by their doctor or purchased over the counter. For example, some patients might experience side effects (e.g., sickness), whereas others may feel their prescribed medicine is not working and want an alternative. While some patients who visit EDs know they have a problem with their medication, some are not aware. Furthermore, drug-related problems (DRPs) may not be identified by ED triage systems which are used to sort patients' priority for treatment. The currently used system in the UK (Manchester Triage System) mentions drugs infrequently and does not support the identification of the most common DRPs. For this project, DRPs include medication errors, adverse drug events, and adverse drug reactions. This project aims to revise the triage system to support the discovery of patients' medication problems when they are triaged by a nurse upon arrival to the ED. After identification, problems with a patient's medication should be dealt with by the healthcare professional who is most appropriate to manage that particular issue. For example, a patient who has been prescribed a new medicine but already takes 20 medicines will likely benefit from a review by a pharmacist in the ED. This project will aim to support the management of patients who might benefit from care provided by pharmacists by providing them with this care. As well as ensuring medication problems are identified at triage, and that pharmacists are involved in helping to deal with those problems, this project will also try to understand how we can investigate how pharmacists actually make a difference to the care of ED patients. A multi-step approach (Stages A-F) is proposed to answer the question "How can patient DRPs be identified, triaged and managed in the ED?" In summary, the steps include: STAGE A, a systematic review and scoping survey; STAGE B, researcher visits to ED sites to shadow ED staff; STAGE C, Interviews with healthcare professionals (including those shadowed in STAGE B) to validate findings of site visits and explore topics in more depth; STAGE D, developing additional drug-related content for the Manchester Triage System; STAGE E, involving a panel of experts in a RAND appropriateness method to rate the content developed in STAGE D; STAGE F, testing the revised triage system for a future pilot study involving interviews with staff visited in STAGE B.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2023

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 27, 2022

Completed
8 months until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

February 1, 2023

Status Verified

July 1, 2022

Enrollment Period

5 months

First QC Date

July 22, 2022

Last Update Submit

January 31, 2023

Conditions

Keywords

Drug-related problemsEmergency departmentTriageIdentificationManagementPharmacists

Outcome Measures

Primary Outcomes (1)

  • Suitability of a revised Manchester Triage System (MTS)

    The suitability of a revised MTS to support identification and management of drug-related problems in the Emergency Department

    13 months (the revised MTS will be an output from the analysis of data collected months 1 - 13)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hospital Emergency Department staff and clinicians and academics with expertise in Emergency Care and/or ED Triage

You may qualify if:

  • STAGE A: ED clinicians at UK-wide NHS trusts
  • STAGE B: ED staff from 8 NHS sites across the UK
  • STAGE C: ED staff from 8 NHS sites across the UK
  • STAGE E: Clinicians and academics with expertise in Emergency Care and/or ED Triage
  • STAGE F: ED staff from 8 NHS sites across the UK

You may not qualify if:

  • Those who do not consent or who are unable to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse ReactionsEmergencies

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Daniel Greenwood

    Anglia Ruskin University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2022

First Posted

July 27, 2022

Study Start

April 1, 2023

Primary Completion

September 1, 2023

Study Completion

September 1, 2023

Last Updated

February 1, 2023

Record last verified: 2022-07