Nurse-led Pain Management in Adult ICU

Not Applicable

Completed

• Conditions: Pain Management
• Interventions: Other: Critical-Care Pain Observation Tool

• Registration Number: NCT05488834
• Lead Sponsor: King Abdulaziz Medical City

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.

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 Timeline

• Study First Submitted: 2021-06-14
• Study Start: 2022-02-01
• Primary Completion: 2022-06-30
• Study Completion: 2022-07-01
• Status Verified: 2022-08
• Study First Submitted QC: 2022-08-03
• Last Update Submitted: 2022-08-03
• Study First Posted: 2022-08-05
• Last Update Posted: 2022-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 880

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Intensive care units	Critical-Care Pain Observation Tool	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.

Primary Outcome Measures

Name	Time	Method
Number of documented pain assessments per 24-hour period	6 months	How many times pain is documented and reassessed then charted in the medical file for a non-verbal patient over a 24 hour period.

Secondary Outcome Measures

Name	Time	Method
Level of sedation and analgesia	6 months	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).
Length of intubation (LOI)	6 months	The LOI is the total time a patient was intubated and invasively ventilated.
Appropriateness	6 months	To measure the perceived fit, compatibility or relevance of the CPOT intervention to nurses working in the ICUs using the post-intervention survey.
ICU stay	6 months	The ICU stay is the total time in days that the patient was been admitted to the ICU.
Acceptability	6 months	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.
Feasibility in nursing practice	6 months	To measure how feasible it is to implement the CPOT intervention within the ICUs using the post-intervention survey

Trial Locations

Locations (1)

King Abdulaziz Medical City; 🇸🇦 Riyadh, Saudi Arabia