Nurse-led Pain Management in Adult ICU

Pain Management Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05488834
• Other study ID #: KingAbdulazizMC
• Status: Completed
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: July 1, 2022

Study information

• Verified date: August 2022
• Source: King Abdulaziz Medical City
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 880
• Est. completion date: July 1, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain Management

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.

Locations

Country	Name	City	State
Saudi Arabia	King Abdulaziz Medical City	Riyadh

Sponsors (3)

Lead Sponsor	Collaborator
King Abdulaziz Medical City	Newcastle University, Qassim University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Length of intubation (LOI)	The LOI is the total time a patient was intubated and invasively ventilated.	6 months
Secondary	ICU stay	The ICU stay is the total time in days that the patient was been admitted to the ICU.	6 months
Secondary	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
Secondary	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
Secondary	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