Condition category
Injury, Occupational Diseases, Poisoning
Date applied
10/02/2014
Date assigned
20/03/2014
Last edited
02/07/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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 can participate.

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Suzanne Mason

ORCID ID

Contact details

Health Services Research
School of Health and Related Research
Regent Court
30 Regent Street
Sheffield
S1 4DA
United Kingdom
+44 (0)114 2220694
s.mason@sheffield.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Version 1.1

Study information

Scientific title

Written information providing first aid advice for patients presenting to the Emergency Department: A randomised controlled trial

Acronym

Study hypothesis

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

NRES Committee East of England - Cambridge South, 28/02/2014, REC ref: 14/EE/0072

Study design

Single-centre randomised controlled interventional trial questionnaire study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Patient information can be found at https://docs.google.com/file/d/0BxEofEMwq3fNQVVDZkJoMUk2ZzA/edit?pli=1

Condition

Minor injuries: Wounds, limb injuries, and head injuries

Intervention

Written information with first aid information.

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

Phase

Not Applicable

Drug names

Primary outcome measures

Change between baseline assessment and follow-up assessment of confidence in first aid management if the patient were to suffer the an injury again.

Secondary outcome measures

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.

Overall trial start date

01/03/2014

Overall trial end date

01/08/2014

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

248

Participant 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. Health care professionals

Recruitment start date

01/03/2014

Recruitment end date

30/04/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Health Services Research
Sheffield
S1 4DA
United Kingdom

Sponsor information

Organisation

Sheffield Teaching Hospitals NHS Trust (UK)

Sponsor details

Clinical Research Office Sheffield
11 Broomfield Road
Sheffield
S10 2SE
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.sheffieldclinicalresearch.org/clinical-research-office

Funders

Funder type

Charity

Funder name

British Red Cross (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes