Suicide prevention for Emergency Department attendees with substance misuse
| ISRCTN | ISRCTN42939142 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN42939142 |
| IRAS number | 288891 |
| Secondary identifying numbers | IRAS 288891 |
- Submission date
- 12/04/2023
- Registration date
- 14/04/2023
- Last edited
- 14/04/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Research has shown that brief interventions may reduce the risk of suicide in people who present to a hospital emergency department (ED) after self-harm. However, while people with a substance use disorder (including alcohol) are at higher risk of suicide compared with people without, it is not known whether brief interventions reduce the risk of suicide or self-harm among this group. The research team have developed a brief telephone-based intervention that is designed to help people who present to ED after self-harm, and who have a substance use disorder. The main aim of this study is to test the feasibility and acceptability of the intervention.
Who can participate?
Individuals over the age of 18 years who have attended a hospital emergency department following a suicide attempt or act of self-harm and who have been using drugs and or alcohol
What does the study involve?
Participants complete a short set of questionnaires and participate in weekly telephone calls with liaison psychiatry staff over a 1-month period
What are the possible benefits and risks of participating?
By taking part in the intervention, patients receive follow-up support (delivered by telephone). The research team believes that the proposed study methods pose low to no risk for this patient group whose risks often remain high without any additional treatment intervention. All sessions of the intervention will be carried out by liaison psychiatry staff, who are clinically skilled and experienced in assessing and treating this patient population.
Where is the study run from?
University of Bristol (UK)
When is the study starting and how long is it expected to run for?
January 2020 to June 2022
Who is funding the study?
Bristol and Weston Hospitals Charity (UK)
Who is the main contact?
Prof. Paul Moran, paul.moran@bristol.ac.uk
Contact information
Principal Investigator
Bristol Medical School
University of Bristol
Bristol
BS8 2BN
United Kingdom
 ORCID ID |
0000-0002-9257-8699 |
|---|---|
| Phone | +44 (0)117 33 14027 |
| paul.moran@bristol.ac.uk |
Study information
| Study design | Non-randomized mixed-methods feasibility study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case series |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Suicide prevention care for Emergency Department attendees presenting with self-harm and concurrent substance misuse |
| Study acronym | CONNECT |
| Study objectives | This study is assessing the acceptability, feasibility and safety of a brief intervention for people who present to hospital with self-harm and who have a history of drug and/or alcohol misuse |
| Ethics approval(s) | Approved 10/01/2021, South West - Frenchay Research Ethics Committee (Temple Quay House, 2 The Square, Bristol, BS1 6PN, UK; +44 (0)207 104 8379; frenchay.rec@hra.nhs.uk), ref: 20/SW/0188 |
| Health condition(s) or problem(s) studied | Prevention of suicide among hospital attenders presenting with self-harm and substance use |
| Intervention | This is a feasibility study of a new brief intervention for people who attend ED with self-harm and who have a history of substance misuse. The study incorporates the delivery of the intervention with a sample of patient participants, and interviews with staff and patients following the completion of treatment, to gather their views about their experiences of delivering/receiving treatment. Staff training: The study CI will train liaison psychiatry staff to deliver the intervention. A training session lasting approximately 90 minutes will be conducted at each hospital site: this will include familiarising staff with the study, the treatment manual and locally specific SOPs. Recruitment of patients: The research team will aim to recruit a convenience sample of up to 40 patients over a 12-month period. Eligible patients will be identified by liaison psychiatry (LP) staff during routine psychosocial assessments conducted in ED and will be asked whether they would like to take part. If patients wish to take part, LP staff will verbally explain the study to them, provide them with a participant information sheet, and take their written consent. At the point of recruitment, LP staff will record the patient's contact details, to enable the delivery of the follow-up sessions of the intervention, which will be delivered by telephone. They will explain the arrangements for follow-up sessions to the patient. Intervention delivery: The intervention will be implemented with up to 40 patients. Following the patient's first presentation to ED, treatment will be comprised of weekly telephone sessions, delivered by LP staff. The first follow-up session will take place between 24-72 hours after the patient's ED attendance. Subsequent follow-up calls will be delivered by LP staff approximately once a week for up to 1 month, with each session usually lasting up to 30 minutes. Collection of quantitative outcome data: In order to assess the acceptability and feasibility of the intervention, the research team will determine its uptake, retention and delivery. The research team will record details about the number of sessions offered to patients, the number of sessions attended, and staff adherence to the treatment protocol. LP staff delivering the intervention will also record quantitative data on patient outcomes. This data will be collected at baseline and then upon completion of the final telephone follow-up session. Staff will collect the following brief, pragmatic outcome measures, and will record these using the REDCap (Research Electronic Data Capture) system, which has been approved for use by the University of Bristol Medical School: 1. Suicidal ideation (COLUMBIA questionnaire) 2. Self-harm frequency (Self-report questions based on the CASE study (Madge et al. 2008) 3. Depression (PHQ-9) 4. Anxiety (GAD-7) 5. Substance use (DUDIT) 6. Quality of life (EQ-5D 5L) Collection of qualitative data: The research team will conduct qualitative interviews with a purposive sample of up to 15 patients, about their experiences of receiving intervention treatment and of participating in the study. Each patient will take part in one interview. Interviews will take place following the completion of treatment and will be conducted by the study manager, by telephone. The research team will invite all staff involved in the delivery of the intervention to take part in an interview. Each staff member will take part in one interview. Interviews will take place when the delivery of intervention treatment is complete and will be conducted by the study manager, by telephone or online. |
| Intervention type | Other |
| Primary outcome measure | Recruitment rate is recorded as the number of eligible participants who consent to participate in the study by 12 months |
| Secondary outcome measures | 1. Depression is measured using the Patient Health Questionnaire-9 (PHQ-9) at baseline and at the final session of intervention delivery 2. Anxiety is measured using the Generalised Anxiety Disorders Assessment (GAD-7) at baseline and at the final session of intervention delivery 3. Quality of life is measured using the EQ-5D-5L at baseline and at the final session of intervention delivery |
| Overall study start date | 01/01/2020 |
| Completion date | 29/06/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 40 |
| Total final enrolment | 24 |
| Key inclusion criteria | 1. Aged >18 years 2. Presenting to hospital emergency department following a suicide attempt or act of self-harm 3. Harmful use of alcohol and /or regular illicit unprescribed psychoactive substance use |
| Key exclusion criteria | 1. Unable to give informed consent 2. Unable to speak English fluently enough to participate in procedures |
| Date of first enrolment | 03/05/2021 |
| Date of final enrolment | 30/05/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Marlborough Street
Bristol
BS2 8HW
United Kingdom
Westbury-on-trym
Bristol
BS10 5NB
United Kingdom
Sponsor information
University/education
1 Cathedral Square
Bristol
BS1 5DD
England
United Kingdom
| Phone | +44 (0)1173940177 |
|---|---|
| research-governance@bristol.ac.uk | |
| Website | http://bristol.ac.uk/ |
"ROR" |
https://ror.org/0524sp257 |
Funders
Funder type
Charity
No information available
Results and Publications
| Intention to publish date | 31/05/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Final report submitted to the funder (Bristol and Weston Hospitals Charity) |
| IPD sharing plan | The quantitative dataset generated and analysed during the current study are not expected to be made available because we did not seek consent from participants to share their data outside the research team. A copy of the final report will be made available on reasonable request to the Chief Investigator and with the agreement of the funder. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
14/04/2023: Trial's existence confirmed by the South West - Frenchay Research Ethics Committee.
