Mental health Mental and Behavioural Disorders
Conditions
Interventions
This study will be a 6-month cluster randomised feasibility trial comparing usual practice (individuals contact organisational support services unprompted) to EMS-SHIELD. Preliminary findings suggest
Sponsors
South Western Ambulance Service NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participant is willing and able to give informed consent for participation in the study. 2. Aged 18 years or above. 3. HCPC registered paramedic employed by South Western Ambulance Service NHS Foundation Trust (SWASFT) with their base station registered as one of the four ambulance stations chosen to participate in this trial. 4. Based primarily (50% shifts or more) at participating ambulance station.
Exclusion criteria
Exclusion criteria: 1. Non-paramedic (including student paramedic) 2. Prior participation in preparatory focus groups
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The feasibility of the approach to inform the design of a future definitive trial: 1. Feasibility outcomes (measured at baseline, within 4-6 weeks, and 3-months post-randomisation): 1.1. Recruitment rate (percentage of eligible paramedics recruited) 1.2. Retention rate (percentage retained at follow-up points) 1.3. Data collection feasibility (completion rates for questionnaire measures) 1.4. Time needed to collect and analyse data 1.5. Adherence to the EMS-SHIELD intervention by facilitators (fidelity checklists to completed by the facilitators - including any reasons for session interruption, e.g., major incident) 2. Acceptability outcomes (measured at baseline, within 4-6 weeks, and 3-months post-randomisation and via process evaluation interviews for select participants): 2.1. Attendance rates (session participation) 2.2. Session ratings (intervention satisfaction) 2.3. Intervention experience 2.4. Self-report Theoretical Framework of Acceptability (TFA) questionnaire (all participants) 2.5. Process evaluation qualitative interviews (subset of participants) | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured at baseline within 4-6 weeks, and 3 months post-randomisation: The secondary objectives of this study aim to inform sample size calculations and estimate statistical quantities for health economic outcomes for a larger definitive trial of the intervention versus treatment-as-usual (TAU) by collecting the following data: 1. Participant-focussed questionnaires: 1.1. Attitude towards help-seeking short form 1.2. Perceived Organisational Support 1.3. PTSD checklist (PCL-5) 1.4. Trauma exposure checklist (LEC-5) 1.5. World Health Organization-Five Well-Being Index (WHO-5) 2. Health economic questionnaires: 2.1. Health-related Quality-of-Life (HRQoL) EQ-5D-5 2.2. Mental health specific Recovering Quality of Life (ReQoL-10) 2.3. Intervention e.g., frontline backfill, preparation and post session time 2.4. Other resource use/costs e.g., using a modified (with PPI/E support) Client Service Receipt Inventory form at the 3-month post-randomisation time point, to capture participants’ use of health and social care (e.g., GP visits; medications), travel time to/from health treatments/visits, as well as any time off work, and all associated costs. We will also evaluate whether the following progression criteria have been met, prior to planning a future definitive trial: Intervention: 1. Feasibility measure: sign up four EMS stations, including =50% recruited by eligible staff at each site. 2. Acceptability measure: =60% of consenting paramedics attend allotted IMPACT sessions Trial methods: 1. Feasibility measures: =75% of participants complete data collection and changes in participant well-being will yield trends in the predicted direction (improves). 2. Acceptability measures: qualitative process evaluation findings include intent to continue use of EMS-SHIELD approach and perceived appropriateness for organisational practice. | — |
Countries
England, United Kingdom
Outcome results
None listed