Understanding Psychological Distress and Therapeutic Environment in the Emergency Department (UPDATE-ED)

December 8, 2024 updated by: Rajendra Raman, NHS Fife
This research aims to establish the number of patients coming to Emergency Departments (EDs) with issues relating to mental health, alcohol or drugs, or in some form of psychological distress, including those for whom this was not the main reason for attending ED. We will collect anonymous information on age, gender, ethnicity, when and how they came to the ED, where and how they are cared for whilst in the ED, and what happens to them afterwards. With this information we hope to build a better picture of these patients so we can go on to design and test ways to improve their care in the future.

Study Overview

Status

Not yet recruiting

Intervention / Treatment

Detailed Description

Those presenting to the Emergency Department with mental ill health, substance misuse or in crisis have a worse patient journey than those presenting with physical issues alone. They wait twice as long to be seen1 and have poorer experiences. Recognising this, the RCEM/James Lind Alliance Priority Setting Partnership has placed mental health at the top of the Emergency Medicine research agenda. The question asked is: "How can care for mental health patients be optimised, whether presenting with either/both physical and mental health needs; including appropriate space to see patients, staff training, early recognition of symptoms, prioritisation, and patient experience?" An explicit research agenda has yet to emerge from this very broad question. At the most basic level, the patient population needs to be defined, the scale of the problem quantified, and current practice patterns and variation described in detail.

It has been estimated that the proportion of ED attendances related to "mental health disorders" is 4%. However these estimates are derived from retrospective data and are dependent on accurate diagnosis coding. There is a lack of data on dual diagnoses, which Scotland's Mental Health strategy has outlined as a key area for action, recommending opportunities to "pilot improved arrangements for dual diagnosis for people with problem substance use and mental health diagnosis". A literature review aiming to build a 'Typology' of psychiatric emergency services in the UK emphasised wide variation in provision and heterogeneity of models. No prospective study has yet quantified this variation in terms of waiting times, types of assessment offered, disposition and outcomes. The success of other large observational studies on ED presentations such as syncope, acute aortic syndromes and frailty suggests that a similar methodology could be applied to mental health and related presentations.

Study Type

Observational

Enrollment (Estimated)

398

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients presenting to the Emergency Department (ED) with issues of mental health, substance use or psychological distress, whether or not this was the primary reason for presentation.

Description

Inclusion Criteria:

  • Issues of mental health AND/OR
  • Issues of substance use AND/OR
  • Psychological distress (this refers to patients without an established mental health or substance use disorder who nonetheless present in a distressed state, where distress is not caused by a readily identifiable and treatable physical condition) AND/OR
  • Where the treating ED team feel the patient would benefit from some form of mental health or addictions assessment or intervention, whether carried out by ED staff, specialist services or third sector agencies.

Exclusion Criteria:

  1. Patients aged 10 and under.
  2. Patients with distress caused by a physical condition, relieved by appropriate treatment.
  3. Delirium, unless caused by a mental health- or substance-related disorder.
  4. Patients with alcohol intoxication alone, without other evidence of harmful use of alcohol and without evidence of psychological distress.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion fo ED attendance related to issues of mental health, substance use or psychological distress
Time Frame: 7 days
Number of patients meeting eligibility criteria, expressed as a proportion of all ED attendances at each site during the study period.
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients physically in ED who meet inclusion criteria at any one time
Time Frame: 7 days
Proportion of patients physically in the ED who meet inclusion criteria at any given time over the 7-day study period.
7 days
Comparison with coding data
Time Frame: 7 days
Proportion of total ED patients meeting inclusion criteria during the study period compared with coding data from a recent historical cohort at one site (NHS Fife).
7 days
Admission rate
Time Frame: 7 days
Proportion of patients meeting inclusion criteria who are admitted to hospital on an informal basis, and proportion admitted under detention.
7 days
Length of stay
Time Frame: 30 days
Mean, standard deviation (or nonparametric equivalents) and range of lengths of ED and hospital stay for patients meeting inclusion criteria.
30 days
Specialist mental health or addictions input in ED
Time Frame: 7 days
Proportion of patients meeting inclusion criteria who receive specialist mental health or addictions input whilst in ED.
7 days
Specialist referrals from ED
Time Frame: 7 days
Proportion of patients meeting inclusion criteria who are referred by the ED team for specialist mental health or addictions input after ED discharge.
7 days
7-day and 30-day follow-up
Time Frame: 30 days
Proportion of patients meeting inclusion criteria who return to ED, are admitted to hospital or die within 7 and 30 days of index ED visit.
30 days
Clinician Confidence Scale
Time Frame: 7 days
Self-reported confidence of ED clinicians (Visual Analog Scale) in managing an individual patient presenting with issues of mental health, substance use or psychological distress. Values may range from 0 (no confidence at all) to 10 (complete confidence).
7 days
Resource Availability Scale
Time Frame: 7 days
Perception of resource availability (self-reported by ED clinicians on a Visual Analog Scale) for managing an individual patient presenting with issues of mental health, substance use or psychological distress. Values may range from 0 (complete lack of resources) to 10 (all resources available).
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 3, 2025

Primary Completion (Estimated)

March 18, 2025

Study Completion (Estimated)

March 18, 2025

Study Registration Dates

First Submitted

October 21, 2024

First Submitted That Met QC Criteria

October 21, 2024

First Posted (Actual)

October 23, 2024

Study Record Updates

Last Update Posted (Estimated)

December 12, 2024

Last Update Submitted That Met QC Criteria

December 8, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 24/EM/0245

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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