Mental HealthUPDATE-EDNCT06655467
Understanding Psychological Distress and Therapeutic Environment in the Emergency Department
An observational study of Mental Health and Substance Use (Drugs, Alcohol), run by NHS Fife at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 11 years and older
- Conditions the study is for
- Mental Health, Substance Use (Drugs, Alcohol), Psychological Distress
- What is being tested?
- Routine Care
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 398 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Feb 2025to 18 Mar 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients aged 10 and under.
- Patients with distress caused by a physical condition, relieved by appropriate treatment.
- Delirium, unless caused by a mental health- or substance-related disorder.
- Patients with alcohol intoxication alone, without other evidence of harmful use of alcohol and without evidence of psychological distress.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Victoria Hospital
Kirkcaldy, Fife, KY2 5AH
Rajendra Raman, MBBChir, 07803814111, rajendra.raman@nhs.scot
About this study
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.
Read the 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.
- Being tested
- Routine Care
- Medical subject headings
- Psychological Well-Being, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine CareBehavioural
Also called Standard Care
This study involves no change in clinical care and no study specific interventions for participants.
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion fo ED attendance related to issues of mental health, substance use or psychological distress
Number of patients meeting eligibility criteria, expressed as a proportion of all ED attendances at each site during the study period.
Measured: 7 days
Secondary outcomes (9)
Proportion of patients physically in ED who meet inclusion criteria at any one time
Proportion of patients physically in the ED who meet inclusion criteria at any given time over the 7-day study period.
Measured: 7 days
Comparison with coding data
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).
Measured: 7 days
Admission rate
Proportion of patients meeting inclusion criteria who are admitted to hospital on an informal basis, and proportion admitted under detention.
Measured: 7 days
Length of stay
Mean, standard deviation (or nonparametric equivalents) and range of lengths of ED and hospital stay for patients meeting inclusion criteria.
Measured: 30 days
Specialist mental health or addictions input in ED
Proportion of patients meeting inclusion criteria who receive specialist mental health or addictions input whilst in ED.
Measured: 7 days
Specialist referrals from ED
Proportion of patients meeting inclusion criteria who are referred by the ED team for specialist mental health or addictions input after ED discharge.
Measured: 7 days
7-day and 30-day follow-up
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.
Measured: 30 days
Clinician Confidence Scale
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).
Measured: 7 days
Resource Availability Scale
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).
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start3 Feb 2025 (estimated)
- Primary completion18 Mar 2025 (estimated)
- Study completion18 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 398 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Fife
- Sponsor type
- Other government
- Collaborators
- Royal College of Emergency Medicine
- Responsible party
- Principal investigator, Rajendra Raman, NHS Fife
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06655467
- Sponsor's protocol ID
- 24/EM/0245
- Acronym
- UPDATE-ED
- Status last verified
- Dec 2024
- First submitted
- 21 Oct 2024
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
European Taskforce on Geriatric Emergency Medicine (ETGEM) collaborators. Prevalence of Frailty in European Emergency Departments (FEED): an international flash mob study. Eur Geriatr Med. 2024 Apr;15(2):463-470. doi: 10.1007/s41999-023-00926-3. Epub 2024 Feb 10.
PubMed 38340282McLatchie R, Reed MJ, Freeman N, Parker RA, Wilson S, Goodacre S, Cowan A, Boyle J, Clarke B, Clarke E; DAShED investigators. Diagnosis of Acute Aortic Syndrome in the Emergency Department (DAShED) study: an observational cohort study of people attending the emergency department with symptoms consistent with acute aortic syndrome. Emerg Med J. 2024 Feb 20;41(3):136-144. doi: 10.1136/emermed-2023-213266.
PubMed 37945311Reed MJ, Karuranga S, Kearns D, Alawiye S, Clarke B, Mockel M, Karamercan M, Janssens K, Riesgo LG, Torrecilla FM, Golea A, Fernandez Cejas JA, Lupan-Muresan EM, Zaimi E, Nuernberger A, Rennet O, Skjaerbaek C, Polyzogopoulou E, Imecz J, Groff P, Camilleri R, Cimpoesu D, Jovic M, Miro O, Anderson R, Laribi S; SEED investigators. Management of syncope in the Emergency Department: a European prospective cohort study (SEED). Eur J Emerg Med. 2024 Apr 1;31(2):136-146. doi: 10.1097/MEJ.0000000000001101. Epub 2023 Nov 27.
PubMed 38015745Odejimi O, Bagchi D, Tadros G. Typology of psychiatric emergency services in the United Kingdom: a narrative literature review. BMC Psychiatry. 2020 Dec 10;20(1):587. doi: 10.1186/s12888-020-02983-5.
PubMed 33302905Scottish Government (2017) Mental Health Strategy: 2017-2027. Crown Copyright. Available at: https://www.gov.scot/binaries/content/documents/govscot/publications/strategy-plan/2017/03/mental-health-strategy-2017-2027/documents/00516047-pdf/00516047-pdf/govscot%3Adocument/00516047.pdf
Barratt H, Rojas-Garcia A, Clarke K, Moore A, Whittington C, Stockton S, Thomas J, Pilling S, Raine R. Epidemiology of Mental Health Attendances at Emergency Departments: Systematic Review and Meta-Analysis. PLoS One. 2016 Apr 27;11(4):e0154449. doi: 10.1371/journal.pone.0154449. eCollection 2016.
PubMed 27120350Baracaia S, McNulty D, Baldwin S, Mytton J, Evison F, Raine R, Giacco D, Hutchings A, Barratt H. Mental health in hospital emergency departments: cross-sectional analysis of attendances in England 2013/2014. Emerg Med J. 2020 Dec;37(12):744-751. doi: 10.1136/emermed-2019-209105. Epub 2020 Nov 5.
PubMed 33154100Royal College of Emergency Medicine (2022) James Lind Alliance Emergency Medicine Priority Setting Partnership Refresh 2022. Available at: https://rcem.ac.uk/research-priorities/
Digel Vandyk A, Young L, MacPhee C, Gillis K. Exploring the Experiences of Persons Who Frequently Visit the Emergency Department for Mental Health-Related Reasons. Qual Health Res. 2018 Mar;28(4):587-599. doi: 10.1177/1049732317746382. Epub 2017 Dec 12.
PubMed 29231128Clarke DE, Dusome D, Hughes L. Emergency department from the mental health client's perspective. Int J Ment Health Nurs. 2007 Apr;16(2):126-31. doi: 10.1111/j.1447-0349.2007.00455.x.
PubMed 17348963Royal College of Emergency Medicine (2022) RCEM Acute Insight Series: Mental Health Emergency Care. Available at: https://rcem.ac.uk/wp-content/uploads/2022/09/RCEM-Acute-Insight-Series-Mental-Health-Emergency-Care.pdf
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Psychological Distress and Therapeutic Environment in the Emergency Department
- ClinicalTrials.gov ID
- NCT06655467
- Acronym / sponsor ID
- UPDATE-ED / 24/EM/0245
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 398 participants (estimated)
- Lead sponsor
- NHS FifeOther government
- Collaborators
- Royal College of Emergency Medicine
- Study start
- 3 Feb 2025 (estimated)
- Primary completion
- 18 Mar 2025 (estimated)
- Study completion
- 18 Mar 2025 (estimated)
- First posted
- 23 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 11 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- Patients aged 10 and under.
- Patients with distress caused by a physical condition, relieved by appropriate treatment.
- Delirium, unless caused by a mental health- or substance-related disorder.
- Patients with alcohol intoxication alone, without other evidence of harmful use of alcohol and without evidence of psychological distress.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine CareAlso: Standard CareThis study involves no change in clinical care and no study specific interventions for participants. | Behavioural | – |
Primary outcome
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.
9 secondary outcomes
Proportion of patients physically in ED who meet inclusion criteria at any one time
Time frame: 7 days
Comparison with coding data
Time frame: 7 days
Admission rate
Time frame: 7 days
Length of stay
Time frame: 30 days
Specialist mental health or addictions input in ED
Time frame: 7 days
Specialist referrals from ED
Time frame: 7 days
7-day and 30-day follow-up
Time frame: 30 days
Clinician Confidence Scale
Time frame: 7 days
Resource Availability Scale
Time frame: 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Background: PubMed 38340282European Taskforce on Geriatric Emergency Medicine (ETGEM) collaborators. Prevalence of Frailty in European Emergency Departments (FEED): an international flash mob study. Eur Geriatr Med. 2024 Apr;15(2):463-470. doi: 10.1007/s41999-023-00926-3. Epub 2024 Feb 10.
- Background: PubMed 37945311McLatchie R, Reed MJ, Freeman N, Parker RA, Wilson S, Goodacre S, Cowan A, Boyle J, Clarke B, Clarke E; DAShED investigators. Diagnosis of Acute Aortic Syndrome in the Emergency Department (DAShED) study: an observational cohort study of people attending the emergency department with symptoms consistent with acute aortic syndrome. Emerg Med J. 2024 Feb 20;41(3):136-144. doi: 10.1136/emermed-2023-213266.
- Background: PubMed 38015745Reed MJ, Karuranga S, Kearns D, Alawiye S, Clarke B, Mockel M, Karamercan M, Janssens K, Riesgo LG, Torrecilla FM, Golea A, Fernandez Cejas JA, Lupan-Muresan EM, Zaimi E, Nuernberger A, Rennet O, Skjaerbaek C, Polyzogopoulou E, Imecz J, Groff P, Camilleri R, Cimpoesu D, Jovic M, Miro O, Anderson R, Laribi S; SEED investigators. Management of syncope in the Emergency Department: a European prospective cohort study (SEED). Eur J Emerg Med. 2024 Apr 1;31(2):136-146. doi: 10.1097/MEJ.0000000000001101. Epub 2023 Nov 27.
- Background: PubMed 33302905Odejimi O, Bagchi D, Tadros G. Typology of psychiatric emergency services in the United Kingdom: a narrative literature review. BMC Psychiatry. 2020 Dec 10;20(1):587. doi: 10.1186/s12888-020-02983-5.
- BackgroundScottish Government (2017) Mental Health Strategy: 2017-2027. Crown Copyright. Available at: https://www.gov.scot/binaries/content/documents/govscot/publications/strategy-plan/2017/03/mental-health-strategy-2017-2027/documents/00516047-pdf/00516047-pdf/govscot%3Adocument/00516047.pdf
- Background: PubMed 27120350Barratt H, Rojas-Garcia A, Clarke K, Moore A, Whittington C, Stockton S, Thomas J, Pilling S, Raine R. Epidemiology of Mental Health Attendances at Emergency Departments: Systematic Review and Meta-Analysis. PLoS One. 2016 Apr 27;11(4):e0154449. doi: 10.1371/journal.pone.0154449. eCollection 2016.
- Background: PubMed 33154100Baracaia S, McNulty D, Baldwin S, Mytton J, Evison F, Raine R, Giacco D, Hutchings A, Barratt H. Mental health in hospital emergency departments: cross-sectional analysis of attendances in England 2013/2014. Emerg Med J. 2020 Dec;37(12):744-751. doi: 10.1136/emermed-2019-209105. Epub 2020 Nov 5.
- BackgroundRoyal College of Emergency Medicine (2022) James Lind Alliance Emergency Medicine Priority Setting Partnership Refresh 2022. Available at: https://rcem.ac.uk/research-priorities/
- Background: PubMed 29231128Digel Vandyk A, Young L, MacPhee C, Gillis K. Exploring the Experiences of Persons Who Frequently Visit the Emergency Department for Mental Health-Related Reasons. Qual Health Res. 2018 Mar;28(4):587-599. doi: 10.1177/1049732317746382. Epub 2017 Dec 12.
- Background: PubMed 17348963Clarke DE, Dusome D, Hughes L. Emergency department from the mental health client's perspective. Int J Ment Health Nurs. 2007 Apr;16(2):126-31. doi: 10.1111/j.1447-0349.2007.00455.x.
- BackgroundRoyal College of Emergency Medicine (2022) RCEM Acute Insight Series: Mental Health Emergency Care. Available at: https://rcem.ac.uk/wp-content/uploads/2022/09/RCEM-Acute-Insight-Series-Mental-Health-Emergency-Care.pdf
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Health and Substance Use (Drugs, Alcohol), run by NHS Fife at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rajendra Raman, MBBChir (+447803814111, rajendra.raman@nhs.scot), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion fo ED attendance related to issues of mental health, substance use or psychological distress (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06655467, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2024.