Clinical trial NCT03881982: A Novel Electronic Method of Collecting Pain Scores in the Emergency Department
Official title: Patient Input Monitoring of Pain in the Emergency Room: Novel Electronic Log (PIMPERNEL). A Randomised Controlled Trial of an Electronic Pain Score Display in Adults in the Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Acute
Lead sponsor: University of Leicester
Sponsor class: OTHER
First posted: 2019-03-20
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Can a novel electronic display of pain be successfully used in the emergency department and does it (1) change analgesic prescription and (2) change amount of pain experienced? Pain is a common symptom in emergency care. As patients are seldom reassessed, staff may not be aware of pain. Currently, members of nursing or medical staff need to ask patients about their pain and record it manually using a visual analogue scale from 0-10.

The new electronic display uses buttons to represent a pain scale from 0 (no pain) to 10 (worst pain). Patients will select the number that best corresponds to their pain every 15 minutes. In the experimental group, the score will be displayed on a screen. In the control group, the score will not be displayed. The investigators will compare the overall amount of pain in both groups, and will look at their pain management (painkillers prescribed). The investigators will also ask patients and staff for their opinions on the display.

The study will include adult patients in the emergency department at Leicester Royal Infirmary with an initial pain score of 5 or more who are able to make a decision about whether to participate. Participants will also need to be likely to stay in the hospital for more than 2 hours to allow the investigators to gather enough useful data. The study will recruit 200 participants. If the study can demonstrate that the monitor is acceptable to patients and staff and results in improved pain management, it is a low cost intervention which could be widely implemented within the NHS. It also has the potential for being used in other areas such as surgical wards. The investigators have previously found that 300-400 patients per week in the department have moderate to severe pain and might therefore benefit from this monitor.


Eligibility criteria: Inclusion Criteria:

* adult (18 years and over)
* underlying condition giving rise to significant pain (initial VAS pain score of 5 or more)
* likely to be staying in the hospital for at least 2 hours
* willing and able to give informed consent
* able to understand and speak a good level of English

Exclusion Criteria:

* children (under 18 years)
* patients not willing to undergo routine care (analgesic treatment)
* patients who do not have capacity to consent
* patients who are unwilling or unable to give informed consent
* prisoners
* patients who cannot understand the study information in English
* currently participating in another clinical trial as far as can be determined from information available at the time of assessment
* patients who have a physical or visual disability which will prevent them from holding or using the pain display

Primary outcomes:
measure: Pain reported by the patient:11 point numerical pain scale
timeFrame: Up to 6 hours
Secondary outcomes:
measure: Proportion of possible scores recorded by patients
timeFrame: Up to 6 hours
measure: Comparison of pain recorded on the display (closest minute) with verbal pain assessment at 2 and 4 hours
timeFrame: Up to 6 hours
measure: Understanding the pattern of pain (shape of the curve of pain scores) over the time of the ED stay
timeFrame: Up to 6 hours
measure: Recording time to second dose of analgesia and whether there is a pattern to this
timeFrame: Up to 6 hours
measure: Use of analgesia in intervention and control groups (dose, time prescribed, time administered and name)
timeFrame: Up to 6 hours
measure: Opinion of patients
timeFrame: Up to 6 hours
measure: Opinion of staff (including their opinion of whether patients press the button for reasons other than pain)
timeFrame: Up to 6 hours
measure: Opinion of researchers regarding any likely stratification needs
timeFrame: Up to 6 hours
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary
state: Leicestershire
Study officials:
affiliation: University of Leicester
name: Timothy J Coats, Prof
role: PRINCIPAL_INVESTIGATOR
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