Written information providing first aid advice for patients presenting to the Emergency Department

ISRCTN	ISRCTN29784348
DOI	https://doi.org/10.1186/ISRCTN29784348
Protocol serial number	Version 1.1
Sponsor	Sheffield Teaching Hospitals NHS Trust (UK)
Funder	British Red Cross (UK)

Submission date: 10/02/2014
Registration date: 20/03/2014
Last edited: 08/03/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Injury, Occupational Diseases, Poisoning

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Emergency Department (ED) attendances are an excellent opportunity for education interventions. A variety of written information is given to patients in EDs. There is some evidence of this working well in other areas but it is unproven in first aid. The study seeks to question if there is an improvement in confidence in the first aid treatment of injuries if patients are given written information while in the ED.

Who can participate?
Adult patients coming to the ED with limb injuries, wounds and head injuries

What does the study involve?
Patients are randomly allocated to one of two groups: the intervention or the control group. Intervention group patients will be asked to complete two questionnaires: first, in person in the ED while waiting to be seen by a doctor or nurse practitioner, and second, 4 weeks later a questionnaire is completed by phone. Control group patients receive normal care.

What are the possible benefits and risks of participating?
The possible benefit to participants would be an improved confidence in managing first aid problems. There is minimal risk to the patients. The questionnaire is designed to be simple and take very little time. Research team members will not have clinical commitments while recruiting patients so ED staffing levels will not be affected. Should a patient be identified as in significant distress or pain, the researchers will inform the clinical staff responsible in preference to completing the study consent and survey. During the follow-up questionnaire, should clinical advice be sought by the patient, they will be directed to their own GP, out of hours services, or ED. This is because the research team may not be familiar with giving clinical advice by phone, and the inability to generate medical documentation from these discussions. Should any complaint be raised by the patient during follow-up questioning, the patient will be directed to the Patient Advice Liaison Service.

Where is the study run from?
The ED at the Northern General Hospital, Sheffield (UK) and the Minor Injuries Unit at the Royal Hallamshire Hospital, Sheffield (UK)

When is the study starting and how long is it expected to run for?
It is due to recruit in March-April 2014 with follow-up questionnaires in April-May 2014 and records checked for re-attendances to the ED in June-July 2014

Who is funding the study?
The British Red Cross (UK)

Who is the main contact?
Dr David Pallot
d.pallot@sheffield.ac.uk

Contact information

Prof Suzanne Mason
Scientific

Health Services Research
School of Health and Related Research
Regent Court
30 Regent Street
Sheffield
S1 4DA
United Kingdom

Phone	+44 (0)114 2220694
Email	s.mason@sheffield.ac.uk

Study information

Primary study design	Interventional
Study design	Single-centre randomised controlled interventional trial questionnaire study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Written information providing first aid advice for patients presenting to the Emergency Department: a randomised controlled trial
Study objectives	Giving written first aid information will result in an improvement of patients' confidence in managing injuries in future. This may lead to better self-care and potentially even fewer attendances to the Emergency Department.
Ethics approval(s)	NRES Committee East of England - Cambridge South, 28/02/2014, REC ref: 14/EE/0072
Health condition(s) or problem(s) studied	Minor injuries: wounds, limb injuries, and head injuries
Intervention	Patients will be randomised in clusters by the day they attend the ED to either the intervention arm or the control arm. The intervention group will receive an additional information leaflet giving information on first aid for the injury they have sustained; this will be in addition to normal care which would not be altered. The control group will receive all normal care, including any other verbal or written information they would normally receive about the after-care for their injury. Both arms will be followed up at 4 weeks by telephone. ED records will be checked at 3 months for reattendances for both arms.
Intervention type	Other
Primary outcome measure(s)	Confidence in first aid management if the patient were to suffer the an injury again, assessed at baseline and follow-up
Key secondary outcome measure(s)	1. Confidence of first aid management to someone else. Confidence in first aid will be measured on a scale of 0 to 10 with 0 being 'Not confident' and 10 being 'Very confident' with half measures being accepted. 2. Improvement in the correct knowledge of first aid. Correct knowledge of first aid will be assessed based on an answer to an open question; answers will be marked correct if key words or phrases are used in the absence of any treatments which would be harmful. 3. How useful the written information was rated. Use of the material will be assessed using a series of yes/no questions and asking them to rate its usefulness on a scale of 0 ('not useful') to 10 ('very useful'). 4. The use of other first aid information; related and unrelated reattendances to the Emergency Department within 3 months. The reattendance outcomes will be measured at 3 months by reviewing ED records at that time. Most outcomes will be measured during the patients' attendance to the ED by a researcher in person, and at 4 weeks by telephone. Questionnaires will be used.
Completion date	01/08/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	248
Key inclusion criteria	1. Presenting to the Emergency Department at the Northern General Hospital, or Minor Injury Unit at the Royal Hallamshire Hospital during the study period between 9am and 8pm. 2. Book in to reception with the presenting complaint of a head injury, limb injury, or wound between the hours of 9am and 8pm during the study period.
Key exclusion criteria	1. Patients who do not themselves read English 2. Patients who are unable to consent 3. Patients who are resident in a care home 4. Patients with self-inflicted injuries 5. Patients with serious injury requiring immediate resuscitation or treatment 6. Patients over the age of 65 with suspected fractured neck of femur 7. Healthcare professionals
Date of first enrolment	01/03/2014
Date of final enrolment	30/04/2014

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Northern General Hospital

Sheffield Teaching Hospitals NHS Foundation Trust
Herries Road
Sheffield
S5 7AU
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
IPD sharing plan	The datasets generated during and analysed during the current study are not expected to be made available due to lack of consent of the participants (the study took place before recent guidelines about data sharing, and participants were informed that their data would be kept confidential).

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Abstract results	abstract	01/12/2015		No	No
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

08/03/2018: Publication reference, publication and dissemination plan and IPD sharing statement added.