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A Novel Electronic Method of Collecting Pain Scores in the Emergency Department (PIMPERNEL)

Primary Purpose

Pain, Acute

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
PIMPERNEL Novel Electronic Log: Pain display can be seen
PIMPERNEL Novel Electronic Log: Pain display is hidden
Sponsored by
University of Leicester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pain, Acute

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Leicester Royal Infirmary

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

PIMPERNEL Novel Electronic Log - intervention

PIMPERNEL Novel Electronic Log - control

Arm Description

The display is an electronic version of the 11 point NRS. An audible 'beep' every 15 minutes prompts the patient to record their pain level. The display measures 122mm x 30mm x 15mm. Through a wireless connection, the data from the display are transmitted to a display unit (a Nexus tablet).

The display is an electronic version of the 11 point NRS. An audible 'beep' every 15 minutes prompts the patient to record their pain level. The display measures 122mm x 30mm x 15mm. Through a wireless connection, the data from the display are transmitted to a display unit (a Nexus tablet).

Outcomes

Primary Outcome Measures

Pain reported by the patient:11 point numerical pain scale
Data collected from the display using the 11 point numerical pain scale. The area under the curve will be compared between the intervention and control groups. The Numerical Rating Scale is a scale from 0-10 (whole numbers only, where 0 represents 'no pain' and 10 represents 'worst pain ever').

Secondary Outcome Measures

Proportion of possible scores recorded by patients
Comparison of pain recorded on the display (closest minute) with verbal pain assessment at 2 and 4 hours
The scores recorded by the participants at 2 and 4 hours into their hospital stay will be compared with the scores recorded by nursing staff in the electronic record. The 11 point numerical rating scale is used for both measurements. The Numerical Rating Scale is a scale from 0-10 (whole numbers only, where 0 represents 'no pain' and 10 represents 'worst pain ever').
Understanding the pattern of pain (shape of the curve of pain scores) over the time of the ED stay
Recording time to second dose of analgesia and whether there is a pattern to this
Use of analgesia in intervention and control groups (dose, time prescribed, time administered and name)
The dose, time prescribed, time administered and name of analgesia given pre-hospital and whilst in hospital will be recorded and a comparison made between the groups. This is a feasibility study only so exact outcome depends upon what data can be collected.
Opinion of patients
Uses a short (4 question) questionnaire designed for this study. Questions on ease of use, whether the monitor is a good idea, whether participants would use it again in the future and whether it improved their experience as a patient, plus a comments box. Questions: 1) How easy was it to use the pain monitor? (very easy, easy, no opinion, difficult, very difficult) 2) I think that the pain monitor is a good idea (strongly agree, agree, no opinion, disagree, strongly disagree) 3) I would use the monitor again in the future (strongly agree, agree, no opinion, disagree, strongly disagree) 4) The pain monitor improved my experience as a patient (strongly agree, agree, no opinion, disagree, strongly disagree)
Opinion of staff (including their opinion of whether patients press the button for reasons other than pain)
Short (4 question) questionnaire designed for the study. Questions on whether the display is practical to use in the Emergency Department, whether they think it is a good idea, whether it is likely to improve the patient experience and whether a patient used the display to get their attention for a reason other than pain. Also has a comments box. Questions: 1) The pain display is practical to use in the Emergency Department (strongly agree, agree, no opinion, disagree, strongly disagree) 2) I think that the pain display is a good idea (strongly agree, agree, no opinion, disagree, strongly disagree) 3) The pain display is likely to improve the patient experience (strongly agree, agree, no opinion, disagree, strongly disagree) 4) A patient used the pain display to get my attention for a reason other than pain (yes, not sure, no)
Opinion of researchers regarding any likely stratification needs
Subjective opinion of researchers having completed the study on whether stratification would be required in future studies. No specific measurement used.

Full Information

First Posted
January 28, 2019
Last Updated
January 29, 2020
Sponsor
University of Leicester
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1. Study Identification

Unique Protocol Identification Number
NCT03881982
Brief Title
A Novel Electronic Method of Collecting Pain Scores in the Emergency Department
Acronym
PIMPERNEL
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

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
August 3, 2017 (Actual)
Primary Completion Date
July 31, 2019 (Actual)
Study Completion Date
July 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Leicester

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PIMPERNEL Novel Electronic Log - intervention
Arm Type
Experimental
Arm Description
The display is an electronic version of the 11 point NRS. An audible 'beep' every 15 minutes prompts the patient to record their pain level. The display measures 122mm x 30mm x 15mm. Through a wireless connection, the data from the display are transmitted to a display unit (a Nexus tablet).
Arm Title
PIMPERNEL Novel Electronic Log - control
Arm Type
Other
Arm Description
The display is an electronic version of the 11 point NRS. An audible 'beep' every 15 minutes prompts the patient to record their pain level. The display measures 122mm x 30mm x 15mm. Through a wireless connection, the data from the display are transmitted to a display unit (a Nexus tablet).
Intervention Type
Other
Intervention Name(s)
PIMPERNEL Novel Electronic Log: Pain display can be seen
Intervention Description
Pain scores are displayed on the screen when the participant presses the corresponding button
Intervention Type
Other
Intervention Name(s)
PIMPERNEL Novel Electronic Log: Pain display is hidden
Intervention Description
Participants press the buttons to record their pain score but the score is not on display (the screen is turned backwards).
Primary Outcome Measure Information:
Title
Pain reported by the patient:11 point numerical pain scale
Description
Data collected from the display using the 11 point numerical pain scale. The area under the curve will be compared between the intervention and control groups. The Numerical Rating Scale is a scale from 0-10 (whole numbers only, where 0 represents 'no pain' and 10 represents 'worst pain ever').
Time Frame
Up to 6 hours
Secondary Outcome Measure Information:
Title
Proportion of possible scores recorded by patients
Time Frame
Up to 6 hours
Title
Comparison of pain recorded on the display (closest minute) with verbal pain assessment at 2 and 4 hours
Description
The scores recorded by the participants at 2 and 4 hours into their hospital stay will be compared with the scores recorded by nursing staff in the electronic record. The 11 point numerical rating scale is used for both measurements. The Numerical Rating Scale is a scale from 0-10 (whole numbers only, where 0 represents 'no pain' and 10 represents 'worst pain ever').
Time Frame
Up to 6 hours
Title
Understanding the pattern of pain (shape of the curve of pain scores) over the time of the ED stay
Time Frame
Up to 6 hours
Title
Recording time to second dose of analgesia and whether there is a pattern to this
Time Frame
Up to 6 hours
Title
Use of analgesia in intervention and control groups (dose, time prescribed, time administered and name)
Description
The dose, time prescribed, time administered and name of analgesia given pre-hospital and whilst in hospital will be recorded and a comparison made between the groups. This is a feasibility study only so exact outcome depends upon what data can be collected.
Time Frame
Up to 6 hours
Title
Opinion of patients
Description
Uses a short (4 question) questionnaire designed for this study. Questions on ease of use, whether the monitor is a good idea, whether participants would use it again in the future and whether it improved their experience as a patient, plus a comments box. Questions: 1) How easy was it to use the pain monitor? (very easy, easy, no opinion, difficult, very difficult) 2) I think that the pain monitor is a good idea (strongly agree, agree, no opinion, disagree, strongly disagree) 3) I would use the monitor again in the future (strongly agree, agree, no opinion, disagree, strongly disagree) 4) The pain monitor improved my experience as a patient (strongly agree, agree, no opinion, disagree, strongly disagree)
Time Frame
Up to 6 hours
Title
Opinion of staff (including their opinion of whether patients press the button for reasons other than pain)
Description
Short (4 question) questionnaire designed for the study. Questions on whether the display is practical to use in the Emergency Department, whether they think it is a good idea, whether it is likely to improve the patient experience and whether a patient used the display to get their attention for a reason other than pain. Also has a comments box. Questions: 1) The pain display is practical to use in the Emergency Department (strongly agree, agree, no opinion, disagree, strongly disagree) 2) I think that the pain display is a good idea (strongly agree, agree, no opinion, disagree, strongly disagree) 3) The pain display is likely to improve the patient experience (strongly agree, agree, no opinion, disagree, strongly disagree) 4) A patient used the pain display to get my attention for a reason other than pain (yes, not sure, no)
Time Frame
Up to 6 hours
Title
Opinion of researchers regarding any likely stratification needs
Description
Subjective opinion of researchers having completed the study on whether stratification would be required in future studies. No specific measurement used.
Time Frame
Up to 6 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy J Coats, Prof
Organizational Affiliation
University of Leicester
Official's Role
Principal Investigator
Facility Information:
Facility Name
Leicester Royal Infirmary
City
Leicester
State/Province
Leicestershire
ZIP/Postal Code
LE1 5WW
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We are collecting feasibility data only in this trial.
Citations:
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A Novel Electronic Method of Collecting Pain Scores in the Emergency Department

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