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Nurse-led Pain Management in Adult ICU

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05488834
Enrollment
880
Registered
2022-08-05
Start date
2022-02-01
Completion date
2022-07-01
Last updated
2022-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain Management

Keywords

pain, ICU, critical care, nurses, pain assessment, CPOT

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.

Interventions

OTHERCritical-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.

Sponsors

Newcastle University
CollaboratorOTHER
Qassim University
CollaboratorOTHER
King Abdulaziz Medical City
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Masking description

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.

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Number of documented pain assessments per 24-hour period6 monthsHow many times pain is documented and reassessed then charted in the medical file for a non-verbal patient over a 24 hour period.

Secondary

MeasureTime frameDescription
Length of intubation (LOI)6 monthsThe LOI is the total time a patient was intubated and invasively ventilated.
ICU stay6 monthsThe ICU stay is the total time in days that the patient was been admitted to the ICU.
Level of sedation and analgesia6 monthsMeasurement 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).
Appropriateness6 monthsTo measure the perceived fit, compatibility or relevance of the CPOT intervention to nurses working in the ICUs using the post-intervention survey.
Feasibility in nursing practice6 monthsTo measure how feasible it is to implement the CPOT intervention within the ICUs using the post-intervention survey
Acceptability6 monthsTo 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.

Countries

Saudi Arabia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026