Nurse-led Pain Management in Adult ICU

Sponsor
King Abdulaziz Medical City (Other)
Overall Status
Completed
CT.gov ID
NCT05488834
Collaborator
Newcastle University (Other), Qassim University (Other)
880
1
1
4.9
178.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Critical-Care Pain Observation Tool
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
880 participants
Allocation:
N/A
Intervention Model:
Sequential Assignment
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.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.
Masking:
None (Open Label)
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.
Primary Purpose:
Supportive Care
Official Title:
Nurse-led Pain Management in Adult ICU; A Randomised Stepped-Wedge Hybrid Effectiveness Trial
Actual Study Start Date :
Feb 1, 2022
Actual Primary Completion Date :
Jun 30, 2022
Actual Study Completion Date :
Jul 1, 2022

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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).

    2. Length of intubation (LOI) [6 months]

      The LOI is the total time a patient was intubated and invasively ventilated.

    3. ICU stay [6 months]

      The ICU stay is the total time in days that the patient was been admitted to the ICU.

    4. 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.

    5. 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.

    6. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 King Abdulaziz Medical City Riyadh Saudi Arabia

    Sponsors and Collaborators

    • King Abdulaziz Medical City
    • Newcastle University
    • Qassim University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Majid Alotni, PhD student, Newcastle University
    ClinicalTrials.gov Identifier:
    NCT05488834
    Other Study ID Numbers:
    • KingAbdulazizMC
    First Posted:
    Aug 5, 2022
    Last Update Posted:
    Aug 5, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Majid Alotni, PhD student, Newcastle University

    Study Results

    No Results Posted as of Aug 5, 2022