NCT05373641

Brief Summary

The aim of the study is to find out how pain nursing documentation audit and educational feedback effect to RN's pain nursing documentation, the average level of pain nursing documentation knowledge of unit RN's, patient satisfaction of pain management and number of pain nursing incident reports. In addition, how background variables are related to the pain nursing documentation. Research hypothesis: Pain nursing documentation audit and educational feedback increased RNs' pain nursing documentation and knowledge, patient satisfaction to pain management and effect to number of pain nursing incident reports.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2022

Completed
10 days until next milestone

Study Start

First participant enrolled

March 4, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 13, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

October 25, 2023

Status Verified

November 1, 2022

Enrollment Period

9 months

First QC Date

February 22, 2022

Last Update Submit

October 23, 2023

Conditions

Keywords

RNPain nursingPain assessmentPain managementPain documentationAudit and feedbackEducationRandomized Controlled TrialNursing sensitive qualityNursing sensitive outcomes

Outcome Measures

Primary Outcomes (2)

  • Change in RNs' pain documentation

    MEASUREMENT TOOL: Structured audit frame to evaluate pain assessment and management documentation. UNIT OF MEASURE: Information is collected as follows from EHR 1. Patient pain documented in the care chart 2. Patient need for pain management documented 3. Patient pain management goal documented 4. Patient pain assessment 5. Patient pain assessment in the previous 24 hours 6. Patient pain 7. Use of pain assessment tool 8. Non-pharmacological methods 9. Pharmacological interventions 10. Intervention (pharmacological or non-pharmacological effect assessment) Multiple measurements are aggregated to achieve one declared value as follows: First, each evaluated area results in 0 (not fulfilled) or 1 point (fulfilled). Second, the points are summed. Third, the sum is transformed to a 0-100 scale and reported as a single value reflecting pain documentation quality.

    Baseline (T0), month 1 (T1), month 2 (T2), month 3 (T3), month 4 (T4), month 5 (T5) month 6 (T6), month 7 (T7), month 8 (T8)

  • Change in RNs' pain knowledge

    Pain knowledge questionnaire used in three time points

    Baseline (T0), month 3 (T3), month (T7)

Secondary Outcomes (2)

  • Change in patient satisfaction of pain management

    Before intervention (T0), month 3 (T3), month 6 (T6), month 8 (T8)

  • Change in number of pain nursing incident reports

    Before intervention (T0), month 8 (T8)

Study Arms (2)

Pain documentation audit and repeated feedback

EXPERIMENTAL

Pain documentation audit and repeted feedback

Other: Repeated feedbackOther: Pain documentation audit

Pain documentation audit

ACTIVE COMPARATOR

Pain documentation audit

Other: Pain documentation audit

Interventions

Repeated feedback monthly based on previous month pain documentation audit results.

Pain documentation audit and repeated feedback

Monthly pain documentation audit

Pain documentation auditPain documentation audit and repeated feedback

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Registered nurses (RN) who work at the Kuopio University Hospital in units of which patients potentially require pain management.

You may not qualify if:

  • Professionals other than RN
  • RN who do not use pain management strategies in their work

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kuopio University Hospital

Kuopio, Finland

Location

Related Publications (1)

  • Grommi S, Voutilainen A, Vaajoki A, Kankkunen P. Effects of Repeated Feedback on Pain Documentation: A Cluster Randomized Trial. Pain Manag Nurs. 2025 Jun;26(3):336-343. doi: 10.1016/j.pmn.2024.12.021. Epub 2025 Jan 30.

MeSH Terms

Conditions

PainAgnosia

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Units serve as a statistical units. Number of units 30, number of individual participants 800-1000.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2022

First Posted

May 13, 2022

Study Start

March 4, 2022

Primary Completion

November 30, 2022

Study Completion

December 31, 2022

Last Updated

October 25, 2023

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations