- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05244928
Team Training and Medication Administration in an Ambulance Service (TEAM-AMB)
Team Training and Medication Administration in an Ambulance Service. A Study of a Team Training Interventions' Impact on Medication Administration, Teamwork, and Patient Safety Culture.
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:
- To determine the frequency of medication administration events in an ambulance service.
- To describe the medication administration process in an ambulance service according to the "Systems Engineering Initiative for Patient Safety model".
- To identify the impact of a team training program on the frequency of medication administration events in an ambulance service.
- To explore ambulance professionals' experiences of teamwork before and after the implementation of a team training program and their experiences with the program.
- To compare ambulance professionals' perceptions of teamwork and patient safety culture before and after implementation of a team training program.
Post-study: To study the association between medication administration events and team training and patient safety culture in an ambulance service.
A quasi-experimental, pre- and post-design, provides the framework for the intervention of the team training program in two clusters including seven ambulance stations, in total.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Brumunddal, Norway, 2381
- Innlandet Hospital Trust
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion criteria pre-study
- Ambulance professionals employed in the ambulance services
Exclusion criteria pre-study
- Under 18 years of age
Inclusion criteria study 1 and 3
- 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)
Exclusion criteria study 1 and 3
- Missing and/or incomplete data.
Inclusion criteria study 2
- Ambulance professionals employed in the ambulance services
Exclusion criteria study 2
- Under 18 years of age
- Student and apprentices
Inclusion criteria study 4 and 5
- Ambulance professionals and apprentices participating in the "Team Strategies and Tools to Enhance Performance and Patient Safety®" intervention
Exclusion criteria study 4 and 5
- Ambulance professionals on long-term leave
- Under 18 years of age
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cluster 1.
The clusters will be formed from two ambulance stations (Approximately 50 participants).
|
"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. |
|
Experimental: Cluster 2.
The clusters will be formed from five ambulance stations (Approximately 70 participants).
|
"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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Testing the psychometric properties of the Teamwork Perception Questionnaire
Time Frame: 4 weeks
|
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.
Time Frame: 3 month
|
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
Time Frame: 18 month
|
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.
Time Frame: 3 month
|
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.
Time Frame: 4 days
|
Qualitative data from from four focus group interviews before and after the intervention in each cluster.
|
4 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Association between medication administration, team training and patient safety culture
Time Frame: 21 month
|
The study include data from the primary outcome measures 2 and 3.
|
21 month
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Ingeborg Hartz, PhD, Sykehuset Innlandet HF
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16797830
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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