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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05244928
Other study ID # 16797830
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 24, 2022
Est. completion date January 31, 2024

Study information

Verified date March 2024
Source Sykehuset Innlandet HF
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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. To determine the frequency of medication administration events in an ambulance service. 2. To describe the medication administration process in an ambulance service according to the "Systems Engineering Initiative for Patient Safety model". 3. To identify the impact of a team training program on the frequency of medication administration events in an ambulance service. 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. 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 stepped wedge cluster randomized controlled trial provides the framework for the intervention of the team training program in two clusters including seven ambulance stations, in total.


Recruitment information / eligibility

Status Completed
Enrollment 131
Est. completion date January 31, 2024
Est. primary completion date January 31, 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
The team training program "Team Strategies and Tools to Enhance Performance and Patient Safety®"
"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 stepped wedge cluster randomized controlled trial provides the framework for the intervention of the team training program in two clusters including seven ambulance stations, in total.

Locations

Country Name City State
Norway Innlandet Hospital Trust Brumunddal

Sponsors (2)

Lead Sponsor Collaborator
Sykehuset Innlandet HF Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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 Association between medication administration, team training and patient safety culture The study include data from the primary outcome measures 2 and 3. 21 month
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