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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03881982
Recruitment Status : Completed
First Posted : March 20, 2019
Last Update Posted : January 30, 2020
Sponsor:
Information provided by (Responsible Party):
University of Leicester

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.


Condition or disease Intervention/treatment Phase
Pain, Acute Other: PIMPERNEL Novel Electronic Log: Pain display can be seen Other: PIMPERNEL Novel Electronic Log: Pain display is hidden Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : August 3, 2017
Actual Primary Completion Date : July 31, 2019
Actual Study Completion Date : July 31, 2019

Arm Intervention/treatment
Experimental: PIMPERNEL Novel Electronic Log - intervention

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).

Other: PIMPERNEL Novel Electronic Log: Pain display can be seen
Pain scores are displayed on the screen when the participant presses the corresponding button

PIMPERNEL Novel Electronic Log - control

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).

Other: PIMPERNEL Novel Electronic Log: Pain display is hidden
Participants press the buttons to record their pain score but the score is not on display (the screen is turned backwards).




Primary Outcome Measures :
  1. Pain reported by the patient:11 point numerical pain scale [ Time Frame: Up to 6 hours ]
    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 :
  1. Proportion of possible scores recorded by patients [ Time Frame: Up to 6 hours ]
  2. Comparison of pain recorded on the display (closest minute) with verbal pain assessment at 2 and 4 hours [ Time Frame: Up to 6 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').

  3. 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 ]
  4. Recording time to second dose of analgesia and whether there is a pattern to this [ Time Frame: Up to 6 hours ]
  5. Use of analgesia in intervention and control groups (dose, time prescribed, time administered and name) [ Time Frame: Up to 6 hours ]
    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.

  6. Opinion of patients [ Time Frame: Up to 6 hours ]

    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)


  7. Opinion of staff (including their opinion of whether patients press the button for reasons other than pain) [ Time Frame: Up to 6 hours ]

    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)


  8. Opinion of researchers regarding any likely stratification needs [ Time Frame: Up to 6 hours ]
    Subjective opinion of researchers having completed the study on whether stratification would be required in future studies. No specific measurement used.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03881982


Locations
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United Kingdom
Leicester Royal Infirmary
Leicester, Leicestershire, United Kingdom, LE1 5WW
Sponsors and Collaborators
University of Leicester
Investigators
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Principal Investigator: Timothy J Coats, Prof University of Leicester
Publications:
France J, Smith S, Smith L. The College of Emergency Medicine Best Practice Guideline: Management of Pain in Adults. 2014.

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Responsible Party: University of Leicester
ClinicalTrials.gov Identifier: NCT03881982    
Other Study ID Numbers: 0588
IRAS 210798 ( Other Identifier: IRAS )
First Posted: March 20, 2019    Key Record Dates
Last Update Posted: January 30, 2020
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We are collecting feasibility data only in this trial.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Emergencies
Acute Pain
Disease Attributes
Pathologic Processes
Pain
Neurologic Manifestations