NCT05244928

Brief Summary

Medication administration events have the potential to cause patient harm. Frequency of medication administration events in the ambulance services is less known. Effective teamwork has been described as paramount for providing safe and effective patient care in the high-risk ambulance environment. "Team Strategies and Tools to Enhance Performance and Patient Safety®" is an evidence-based team training program released from the Agency for Healthcare Research and Quality. The aims of the study are: (1) to advance the knowledge of medication administration process in the ambulance services, and (2) to study the impact of a team training program on medication administration events, teamwork, and patient safety culture. To address the overall aims, the following research objectives will guide the study: Pre-study: To analyse and validate the psychometric properties of the Norwegian version of the Teamwork Perception Questionnaire for use in an ambulance service. Studies:

  1. 1.To determine the frequency of medication administration events in an ambulance service.
  2. 2.To describe the medication administration process in an ambulance service according to the "Systems Engineering Initiative for Patient Safety model".
  3. 3.To identify the impact of a team training program on the frequency of medication administration events in an ambulance service.
  4. 4.To explore ambulance professionals' experiences of teamwork before and after the implementation of a team training program and their experiences with the program.
  5. 5.To compare ambulance professionals' perceptions of teamwork and patient safety culture before and after implementation of a team training program.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
131

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

Typical duration 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

January 19, 2022

Completed
5 days until next milestone

Study Start

First participant enrolled

January 24, 2022

Completed
24 days until next milestone

First Posted

Study publicly available on registry

February 17, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
Last Updated

October 6, 2025

Status Verified

March 1, 2024

Enrollment Period

2 years

First QC Date

January 19, 2022

Last Update Submit

September 30, 2025

Conditions

Keywords

Patient safetyTeam trainingMedication administrationAmbulance servicesHuman factors

Outcome Measures

Primary Outcomes (5)

  • Testing the psychometric properties of the Teamwork Perception Questionnaire

    The questionnaire will be digitally distributed to approximately 500 ambulance personnel in a hospital trust. Each items are scored on a five-point scale. The survey will be carried out for 14 days in February, and 14 days in August 2022.

    4 weeks

  • The perception of patient safety culture and teamwork.

    To measure the ambulance personnel's perception of patient safety culture and teamwork, the Prehospital Survey on Patient Safety Culture (five point-scale) and the Teamwork Perception Questionnaire (five point-scale), will be carried out at three times in each cluster (one time before and two times after the intervention) In cluster 1, the survey will be carried out for 14 days in January/February 2022, 14 days in June 2022 and 14 days in January 2023. In cluster 2, the survey will be carried out for 14 days in August 2022, 14 days in January 2023 and 14 days in August 2023.

    3 month

  • The frequency of medication administration in ambulance service

    The frequency of medication administration will be assed by a retrospective review of approximately 500 electronic patient journals before the intervention. An interim analysis will be conducted after the this review to determine the final number of necessary review of electronic patient journals after the intervention. The journals will be collected for a 6-month period prior to the intervention and a 12-month period after the end of the intervention in both clusters.

    18 month

  • Description of the medication administration process.

    Qualitative data from partly participants observations, approximately 10 individual interviews of ambulance professionals and supplemented by local guidelines.

    3 month

  • The experiences of teamwork and the team training program before and after the intervention.

    Qualitative data from from four focus group interviews before and after the intervention in each cluster.

    4 days

Secondary Outcomes (1)

  • Association between medication administration, team training and patient safety culture

    21 month

Study Arms (2)

Cluster 1.

EXPERIMENTAL

The clusters will be formed from two ambulance stations (Approximately 50 participants).

Other: The team training program "Team Strategies and Tools to Enhance Performance and Patient Safety®"

Cluster 2.

EXPERIMENTAL

The clusters will be formed from five ambulance stations (Approximately 70 participants).

Other: The team training program "Team Strategies and Tools to Enhance Performance and Patient Safety®"

Interventions

"Team Strategies and Tools to Enhance Performance and Patient Safety®" is a team training program consisting of an evidence-based set of tools designed to develop teamwork skills with the goal of improving quality in healthcare services and providing safer patient care. In this study, selected tools from the "Team Strategies and Tools to Enhance Performance and Patient Safety®" curriculum have been chosen for implementation over a 4-month period together with a general emphasis on the key principles: communication, leadership, situation monitoring and mutual support. A full day introduction will be held to mark the start of the intervention and each successive month will have a focus on a single key principle with associated tools. A quasi-experimental, pre- post design, provides the framework for the intervention of the team training program in two clusters including seven ambulance stations, in total.

Cluster 1.Cluster 2.

Eligibility Criteria

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

You may qualify if:

  • Ambulance professionals employed in the ambulance services

You may not qualify if:

  • Under 18 years of age
  • EPJs for patients who are transported or treated within the assigned areas
  • Patient which receives medication (Oxygen, or clear fluid intravenously, by inhalation, intramuscularly, intraosseous, per os, sublingually, or intranasally)
  • Missing and/or incomplete data.
  • Ambulance professionals employed in the ambulance services
  • Under 18 years of age
  • Student and apprentices
  • Ambulance professionals and apprentices participating in the "Team Strategies and Tools to Enhance Performance and Patient Safety®" intervention
  • Ambulance professionals on long-term leave
  • Under 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Innlandet Hospital Trust

Brumunddal, 2381, Norway

Location

Related Publications (3)

  • Myhr K, Ballangrud R, Porthun J, Sollid SJM, Vifladt A. Medication administration errors in a Norwegian ambulance service: a quasi-experimental study on the impact of a team training program. Scand J Trauma Resusc Emerg Med. 2026 Jan 24. doi: 10.1186/s13049-026-01560-1. Online ahead of print.

  • Myhr K, Ballangrud R, Aase K, Vifladt A. Ambulance professionals' experiences of teamwork in the context of a team training programme - a qualitative study. BMC Emerg Med. 2024 Jul 2;24(1):108. doi: 10.1186/s12873-024-01018-6.

  • Vifladt A, Ballangrud R, Myhr K, Grusd E, Porthun J, Maehlum PA, Aase K, Sollid SJM, Odberg KR. Team training program's impact on medication administration, teamwork and patient safety culture in an ambulance service (TEAM-AMB): a longitudinal multimethod study protocol. BMJ Open. 2023 Jan 20;13(1):e067006. doi: 10.1136/bmjopen-2022-067006.

MeSH Terms

Interventions

Patient Safety

Intervention Hierarchy (Ancestors)

SafetyAccident PreventionAccidentsPublic HealthEnvironment and Public Health

Study Officials

  • Ingeborg Hartz, PhD

    Sykehuset Innlandet HF

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Model Details: A quasi-experimental, pre- post design, imply the framework for how the "Team Strategies and Tools to Enhance Performance and Patient Safety®" intervention will be introduced in the two clusters. To ease the logistics need for training and the implementation, two clusters will be formed from seven ambulance stations within the same organization. The order in which the two clusters will undergo the intervention will be randomized. The intervention will be introduced for one cluster in February 2022, and for the other cluster in September 2022.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2022

First Posted

February 17, 2022

Study Start

January 24, 2022

Primary Completion

January 31, 2024

Study Completion

January 31, 2024

Last Updated

October 6, 2025

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations