Nurse-led Pain Management in Adult ICU

Nurse-led Pain Management in Adult ICU; A Randomised Stepped-Wedge Hybrid Effectiveness Trial

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.

Study Overview

• Status: Completed
• Conditions: Pain Management
• Intervention / Treatment: Other: Critical-Care Pain Observation Tool

Detailed Description

This project is about implementing a pain scale, Critical Care Pain Observation Tool (CPOT), in 8 adult ICUs in King Abdullah Medical City to evaluate the impact on nurse pain assessment and management.

The literature shows that pain is perceived to be one of the most concerning issues in ICU and that 50% of patients in the ICU suffer moderate to severe pain. In addition, 70% of patients have undetected pain while admitted to ICU. Evidence-based guidelines suggest that CPOT is the most reliable and efficient pain scale tool for non-verbal patients in ICUs, and it is recommended in countries such as the USA, Canada, Australia and New Zealand. The literature suggests that CPOT has a positive impact on frequency of pain assessment.

A Stepped-Wedge Randomised trial will be used to implement the CPOT and at the same time assess the effectiveness of CPOT on pain assessment frequency and management. Patient charts will be audited, and a survey of nurses will be undertaken post CPOT implementation to assess the CPOT acceptability, appropriateness and feasibility.

• Study Type: Interventional
• Enrollment (Actual): 880
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Riyadh, Saudi Arabia
    • King Abdulaziz Medical City

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Patient chart audits

Inclusion Criteria:

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

Exclusion criteria:

- Patient's who are on muscle relaxants

Nurses survey

Inclusion criteria

• Working in ICU
• Understand English language

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

OTHER: Intensive care units; 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; 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.; Other Names: CPOT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of sedation and analgesia	Measurement of the amount of sedation and analgesics administered to patients. For opioids such as Morphine, the Morphine equivalent units (MME) will be used to standardise the level of analgesia given per day. Other opioids will be equalised to Morphine using this formula: MME/day = Dosage X Doses per day X MME conversion Factor (Sinha et al., 2017).	6 months
Length of intubation (LOI)	The LOI is the total time a patient was intubated and invasively ventilated.	6 months
ICU stay	The ICU stay is the total time in days that the patient was been admitted to the ICU.	6 months
Acceptability	To measure the acceptability of the CPOT intervention, the candidate will apply the post-intervention survey and measure how acceptable the CPOT is to nurses working in the ICUs.	6 months
Appropriateness	To measure the perceived fit, compatibility or relevance of the CPOT intervention to nurses working in the ICUs using the post-intervention survey.	6 months
Feasibility in nursing practice	To measure how feasible it is to implement the CPOT intervention within the ICUs using the post-intervention survey	6 months

Collaborators and Investigators

• Sponsor: King Abdulaziz Medical City
• Collaborators: Newcastle University; Qassim University

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2022
• Primary Completion (ACTUAL): June 30, 2022
• Study Completion (ACTUAL): July 1, 2022

Study Registration Dates

• First Submitted: June 14, 2021
• First Submitted That Met QC Criteria: August 3, 2022
• First Posted (ACTUAL): August 5, 2022

Study Record Updates

• Last Update Posted (ACTUAL): August 5, 2022
• Last Update Submitted That Met QC Criteria: August 3, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: pain; critical care; pain assessment; ICU; nurses; CPOT
• Other Study ID Numbers: KingAbdulazizMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No