Clinical trial NCT05488834: Nurse-led Pain Management in Adult ICU
Official title: Nurse-led Pain Management in Adult ICU; A Randomised Stepped-Wedge Hybrid Effectiveness Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain Management
Keywords: pain
ICU
critical care
nurses
pain assessment
CPOT
Lead sponsor: King Abdulaziz Medical City
Sponsor class: OTHER_GOV
Collaborators: name: Newcastle University
name: Qassim University
First posted: 2022-08-05
Enrollment: 880
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of documented pain assessments per 24-hour period
timeFrame: 6 months
Secondary outcomes:
measure: Level of sedation and analgesia
timeFrame: 6 months
measure: Length of intubation (LOI)
timeFrame: 6 months
measure: ICU stay
timeFrame: 6 months
measure: Acceptability
timeFrame: 6 months
measure: Appropriateness
timeFrame: 6 months
measure: Feasibility in nursing practice
timeFrame: 6 months
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Abdulaziz Medical City
Study officials:
References: