This study has two objectives. First, to evaluate the measurement properties (construct validity, internal consistency, and responsiveness) of five different PROMs in the ED. These PROMs include the Quality of Recovery (QoR-15) scale, the Brief Pain…
ID
Source
Brief title
Condition
- General system disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
- Other intervention
N.a.
Outcome measures
Primary outcome
<p>For objective 1: NRS, APS-POQ-RED, BPI-SF, EQ-5D-5L, OBAS, QoR-15, and Patient Global Impression of Change (PGIC) and satisfaction.<br>For objective 2: Time to complete PROM, time to discuss PROM with healthcare professional, an overview of facilitators and barriers for implementation of PROMs in the ED, usability and experience from surveys.</p>
Secondary outcome
<p>Not applicable</p>
Background summary
Pain is the most common reason for patients to visit the Emergency Department (ED). It significantly impacts patients’ well-being and physical function and is often undertreated, which can lead to chronic pain. Existing tools to assess pain in the ED are limited, and relying solely on pain intensity scores may be problematic for appropriate treatment of pain. Pain intensity scores do not capture the individual’s overall comfort or their need for additional treatment, as pain tolerance varies widely between patients. To ensure effective care, there is a need for valid and reliable Patient-Reported Outcome Measures (PROMs) that consider the multidimensional nature of pain, focusing on biopsychological aspects rather than just numerical scores.
Study objective
This study has two objectives. First, to evaluate the measurement properties (construct validity, internal consistency, and responsiveness) of five different PROMs in the ED. These PROMs include the Quality of Recovery (QoR-15) scale, the Brief Pain Inventory (BPI), the APS-POQ-RED questionnaire, health-related quality of life with EQ-5D-5L, and the Overall Benefit of Analgesia Score (OBAS).
Secondly, we will evaluate the feasibility and usability of implementing these PROMs in the context of acute pain management in the Emergency Department (ED). By feasibility, we refer to aspects such as the ease of administration, the time required for completion, staff and patient acceptability, and the integration of these tools into routine clinical workflows. Based on the feasibility in combination with the measurement properties, the best PROMs will be selected for use in the ED.
Study design
A multicenter prospective cohort study will be conducted in seven EDs across the Netherlands, including three university medical centers and four regional hospitals.
Intervention
APS-POQ-RED, BPI-SF, EQ-5D-5L, OBAS, QoR-15
Study burden and risks
Questionnaires will be given to patients at 3 moments in time: at the end of their ED visit, after 24 hours and after 7 days. The last two will be send by email. Filling out the questionnaires takes roughly 15 minutes per moment in time, thus 45 minutes in total.
There is no risk in participation of this study.
A Top
Albunisdreef 2
Leiden 2333ZA
Netherlands
071 526 9111
optimized_SEH@lumc.nl
A Top
Albunisdreef 2
Leiden 2333ZA
Netherlands
071 526 9111
optimized_SEH@lumc.nl
Listed location countries
Age
Inclusion criteria
- Adult patients ≥ 18years
- NRS or VAS for pain of 4/10 or greater (at arrival to the ED)
- Acute pain for less than 6 weeks
- Informed consent obtained.
Exclusion criteria
-Intoxicated with alcohol or drugs.
- Self-inflicted injury.
- Cognitive impairment
- Unable to give consent.
- Triaged into the most urgent category (Manchester Triage System or Dutch Triage Standard)
Design
Recruitment
Medical products/devices used
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Research portal | NL-009249 |