Nurse-led Pain Management in Adult ICU

NCT05488834 | Completed DMC

• 1 other identifier: KingAbdulazizMC
• Study Type: interventional
• Target: 880
• Locations: 1 country
• Sites: 1

Brief Summary

This project is about implementing a pain scale, the Critical Care Pain Observation Tool (CPOT), in ICU settings at King Abdullah Medical City to evaluate its impact on nurse pain assessment and management. Pain is considered as a significant problem in ICU and the literature shows that 50% of patients in ICU suffer moderate to severe pain and up to 70% of patients experience undetected pain while in ICU. The CPOT is an evidence-based intervention to assess pain among non-verbal patients in ICU settings. A stepped-Wedge Randomised trial will be used to implement the CPOT in 8 ICU in King Abduullah Medical City. Patient chart audits and a survey of ICU nurses will be conducted post implementation.

Conditions

Pain Management

Keywords

pain; ICU; critical care; nurses; pain assessment; CPOT

Outcome Measures

Primary Outcomes (1)

• Number of documented pain assessments per 24-hour period

  How many times pain is documented and reassessed then charted in the medical file for a non-verbal patient over a 24 hour period.

  6 months

Secondary Outcomes (6)

• Level of sedation and analgesia

  6 months

• Length of intubation (LOI)

  6 months

• ICU stay

  6 months

• Acceptability

  6 months

• Appropriateness

  6 months

Study Arms (1)

Intensive care units

OTHER

The unit will be subject to the intervention. Data will be collected from all 8 units in the control phase of this study. Units will then be randomised in blocks to the intervention.

Other: Critical-Care Pain Observation Tool

Interventions

Critical-Care Pain Observation Tool OTHER

The Critical Care Pain Observation Tool (CPOT) was created to help assess pain in critically ill patients who were unable to self-report pain. The CPOT instrument evaluates facial expression, body movement, muscle tension, and compliance with ventilator or vocalisation to evaluate an individual's pain. The total score ranges from 0 to 8, where 8 is the worst pain. Patients are observed for 60 seconds while resting and during nociceptive procedures such as turning or wound dressings to detect any change in behaviour that could indicate pain. Further, the patient must be observed before and at the peak of analgesia medications administered to evaluate pain treatment effectiveness.

Also known as: CPOT

Intensive care units

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient's who are 18 years and above
• Patients must be discharged from ICU

You may not qualify if:

• \- Patient's who are on muscle relaxants
• Nurses survey
• Working in ICU
• Understand English language

Sponsors & Collaborators

• King Abdulaziz Medical City: lead
• Newcastle University: collaborator
• Qassim University: collaborator

Study Sites (1)

King Abdulaziz Medical City

Riyadh, Saudi Arabia

Location

Related Publications (1)

• Alotni MA, Sim J, Chu G, Guilhermino M, Barker D, Szwec S, Fernandez R. Impact of implementing the critical-care pain observation tool in the adult intensive care unit: A nonrandomised stepped-wedge trial. Aust Crit Care. 2025 Mar;38(2):101129. doi: 10.1016/j.aucc.2024.09.014. Epub 2024 Nov 2.

  PMID: 39489653 DERIVED

MeSH Terms

Conditions

Agnosia; Pain

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: A stepped-wedge cluster randomised trial will be used to roll-out the implementation of CPOT (intervention) in a random sequence across groups. When the study starts, all groups will not be exposed to the intervention (control group). The groups are randomised and switched to the intervention at a predetermined moment. At the beginning of the trial, every two ICUs will be clustered in one group, so four groups will be formed. The study will be conducted over six months. In the first month (month 1), all groups will be in the control period, and then at month 2, the intervention will be implemented to the first group over one month, while the other three groups are in the control arm.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student

Model Details: A hybrid effectiveness-implementation design will be used in this study. This study will use type (III) hybrid effectiveness implementation strategy. The Critical Care Pain Observation Tool (CPOT) is a pain scale tool used to assess pain in critically ill patients who are incapable of reporting pain. CPOT will be implemented in the eight adult ICUs, and at the same time, data will be collected to measure the intervention's effectiveness.

Study Record Dates

• First Submitted: June 14, 2021
• First Posted: August 5, 2022
• Study Start: February 1, 2022
• Primary Completion: June 30, 2022
• Study Completion: July 1, 2022
• Last Updated: August 5, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)