Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06388356
Status:
COMPLETED
Last Update Posted:
2024-06-18
First Post:
2024-04-19
Brief Title:
Patients Informational Privacy in Prehospital Emergency Care - Educational Intervention Study for the Paramedics
Sponsor:
Eini Koskimies
Organization:
University of Turku
Study Overview
Official Title:
Patients Informational Privacy in Prehospital Emergency Care A Quasi-experimental Intervention Study
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main goal of this educational intervention study about patients informational privacy IP is to evaluate the effect of the educational intervention into the paramedics knowledge and attitude regarding patients IP The study also investigates the usability and the feasibility of the educational intervention
The main questions it aims to answer are
1 What is the effect of the educational intervention on the
1 theoretical knowledge of paramedics regarding IP
2 the paramedics attitude towards patients IP
2 What is the usability and feasibility of the intervention being evaluated according to the respondents
The main questions it aims to answer are
1 What is the effect of the educational intervention on the
1 theoretical knowledge of paramedics regarding IP
2 the paramedics attitude towards patients IP
2 What is the usability and feasibility of the intervention being evaluated according to the respondents
Detailed Description:
The focus of this research is informational privacy IP in prehospital emergency care PEC The aim of this research is to improve the paramedics knowledge of the patients IP through an educational intervention In addition the educational intervention aims to impact positively to the paramedics attitude towards patients IP The primary outcome of this research is the paramedics knowledge about IP and the secondary outcome is the possible change in paramedics attitude towards IP
As a research method a quasi-experimental research design with pre- and post-test with a comparison group is used Sampling is purposive Study is conducted in Finland Advanced or basic support level paramedics working in two of the Finlands 21 rescue departments providing emergency medical services EMS in two of the wellbeing services counties in Finland is being recruited These specific target rescue departments have been selected because of their similarity Participants must also meet the separately defined inclusion criteria
A simple random allocation is conducted to divide the rescue departments into intervention n 50 approximately and control n50 approximately group Blinding is not conducted Both the researcher and the participants will be aware about the result of the allocation
The educational intervention is a self-study online course on Koulumaali Moodle platform about patients IP in PEC It includes three separate modules approximately 30 min long module I the meaning and significance of IP and its protection module II legislation regarding IP and its protection in healthcare and module III breaches of informational privacy and its protection in PEC Each module contains theoretical sections as well as case-exercises and tests that allow participants to test their own skills
The effectiveness of the educational intervention the main and secondary outcomes will be evaluated by the Knowledge and attitude towards patients informational privacy KAPIP - instrument developed by the researcher measuring the paramedics subjective and actual objective theoretical knowledge about patients IP as well as paramedics attitude towards IP In usability and feasibility evaluation two separate questionnaires will be used First usability of the developed educational intervention will be measured by using the System Usability Scale SUS or more precisely its Finnish version The general feasibility of the educational intervention will be evaluated by using already existing questionnaire containing five structured items and three open ended questions Permissions for the use of the already existing questionnaires has been received
The research starts by recruiting the participants by email An email is sent by separate contact persons from the target organizations to all the paramedics working in the target rescue departments in which they will be informed about the study and how to take part in it if they meet the inclusion criteria presented in the information email In addition a privacy notice will be given Possibility for further questions is also provided In the information email targeted only for the participants in the intervention group more precise description about performing the actual educational intervention is described
Whether a paramedic is willing to participate to the study shehe will be asked to answer the electronic survey KAPIP-instrument to conduct the first measurement pretest M0 Link for the survey is provided in the information email Informed consent and request for the email is placed at the beginning of the survey Giving consent and email address is mandatory and controlled Four weeks are set aside for the recruiting and the first measurement pretest M0
The educational intervention will start right after the recruitment and first measurement The intervention group will perform the educational intervention The comparison group will not perform the educational intervention and will continue to work as normal standard according to the organizations instructions Participants in the intervention group will receive instructions for completing the educational intervention from the contact person researcher will inform the contact person regarding the participants to whom the instruction about the intervention execution needs to be sent In total the participants in the intervention group will have four weeks time to complete independently the educational intervention Participants can execute the module according to their own schedule The module does not have to be completed in one session and it can interrupt and resume the educational intervention later and continue at the same point However the modules need to be completed in certain order by following the numerical order from first to third The educational intervention proceeds so that one of the modules is always open at a time Participants can evaluate their performance through tests and case exercises The participant receives a mark of approval for the tests and case exercises performed automatically If the respondent does not complete the modules shehe will not be able to advance to the next module Previously performed modules will be inactivated This controls the correct and equal completion of the educational intervention Researcher will monitor the participants execution and data regarding the execution times and how they perform the tasks will be collected from the Koulumaali platform through Koulumaali activity monitoring The last module of the educational intervention also includes the data collection regarding the participants perceptions about the usability and feasibility of the educational intervention
The second measurement post-test M1 phase starts right after the time 4 weeks for the educational intervention execution has ended Participants in control- and intervention group will receive an email from the target organizations contact persons where they are asked to complete the same KAPIP-instrument within four weeks
In the Evaluation phase of the intervention the collected data is described and analysed Apropriate statistical methods will be used descriptive statistics frequencies proportions mean the standard deviation meadians with lower and upper quantile and statistical tests suitable for the data linear mixed modes for repeated measures having group time and group by time interaction in the model In addition cluster structure will be taken into account Significance level of 005 two-tailed will be used and 95 confidence intervals will be calculated Also correlation analyses can be performed
The research follows good scientific practice An ethical approval is applied from The Ethics Committee for Health Care Division at the University of Turku and permissions for the study are applied from the target organizations
Participants will be fully informed about the study and its phases in a separate information letters In addition to the information letters participants will be informed more precisely about the collection processing reporting and storing of data in the privacy statement form All the collected data will be handled with appropriate manners and only by the research team including statisticians and possible research assistant Only personal information necessary for the research will be collected The personal datasensitive information collected will be removed and coded with separate ID numbers before the data analysis pseudonymization Results will be reported in a way that it is not possible to identify individual respondents from the data From the ethical point of view it is also worth nothing that the subjects are not representing particularly vulnerable group and they are taking part to the study voluntarily Participation in research does not deviate from the principle of informed consent
A separate data management plan has been conducted by using the DMPTuuli tool In addition a separate privacy notice informs respondents about the processing of their personal data Both of these documents have been approved by The Ethics Committee for Health Care Division at the University of Turku
As a research method a quasi-experimental research design with pre- and post-test with a comparison group is used Sampling is purposive Study is conducted in Finland Advanced or basic support level paramedics working in two of the Finlands 21 rescue departments providing emergency medical services EMS in two of the wellbeing services counties in Finland is being recruited These specific target rescue departments have been selected because of their similarity Participants must also meet the separately defined inclusion criteria
A simple random allocation is conducted to divide the rescue departments into intervention n 50 approximately and control n50 approximately group Blinding is not conducted Both the researcher and the participants will be aware about the result of the allocation
The educational intervention is a self-study online course on Koulumaali Moodle platform about patients IP in PEC It includes three separate modules approximately 30 min long module I the meaning and significance of IP and its protection module II legislation regarding IP and its protection in healthcare and module III breaches of informational privacy and its protection in PEC Each module contains theoretical sections as well as case-exercises and tests that allow participants to test their own skills
The effectiveness of the educational intervention the main and secondary outcomes will be evaluated by the Knowledge and attitude towards patients informational privacy KAPIP - instrument developed by the researcher measuring the paramedics subjective and actual objective theoretical knowledge about patients IP as well as paramedics attitude towards IP In usability and feasibility evaluation two separate questionnaires will be used First usability of the developed educational intervention will be measured by using the System Usability Scale SUS or more precisely its Finnish version The general feasibility of the educational intervention will be evaluated by using already existing questionnaire containing five structured items and three open ended questions Permissions for the use of the already existing questionnaires has been received
The research starts by recruiting the participants by email An email is sent by separate contact persons from the target organizations to all the paramedics working in the target rescue departments in which they will be informed about the study and how to take part in it if they meet the inclusion criteria presented in the information email In addition a privacy notice will be given Possibility for further questions is also provided In the information email targeted only for the participants in the intervention group more precise description about performing the actual educational intervention is described
Whether a paramedic is willing to participate to the study shehe will be asked to answer the electronic survey KAPIP-instrument to conduct the first measurement pretest M0 Link for the survey is provided in the information email Informed consent and request for the email is placed at the beginning of the survey Giving consent and email address is mandatory and controlled Four weeks are set aside for the recruiting and the first measurement pretest M0
The educational intervention will start right after the recruitment and first measurement The intervention group will perform the educational intervention The comparison group will not perform the educational intervention and will continue to work as normal standard according to the organizations instructions Participants in the intervention group will receive instructions for completing the educational intervention from the contact person researcher will inform the contact person regarding the participants to whom the instruction about the intervention execution needs to be sent In total the participants in the intervention group will have four weeks time to complete independently the educational intervention Participants can execute the module according to their own schedule The module does not have to be completed in one session and it can interrupt and resume the educational intervention later and continue at the same point However the modules need to be completed in certain order by following the numerical order from first to third The educational intervention proceeds so that one of the modules is always open at a time Participants can evaluate their performance through tests and case exercises The participant receives a mark of approval for the tests and case exercises performed automatically If the respondent does not complete the modules shehe will not be able to advance to the next module Previously performed modules will be inactivated This controls the correct and equal completion of the educational intervention Researcher will monitor the participants execution and data regarding the execution times and how they perform the tasks will be collected from the Koulumaali platform through Koulumaali activity monitoring The last module of the educational intervention also includes the data collection regarding the participants perceptions about the usability and feasibility of the educational intervention
The second measurement post-test M1 phase starts right after the time 4 weeks for the educational intervention execution has ended Participants in control- and intervention group will receive an email from the target organizations contact persons where they are asked to complete the same KAPIP-instrument within four weeks
In the Evaluation phase of the intervention the collected data is described and analysed Apropriate statistical methods will be used descriptive statistics frequencies proportions mean the standard deviation meadians with lower and upper quantile and statistical tests suitable for the data linear mixed modes for repeated measures having group time and group by time interaction in the model In addition cluster structure will be taken into account Significance level of 005 two-tailed will be used and 95 confidence intervals will be calculated Also correlation analyses can be performed
The research follows good scientific practice An ethical approval is applied from The Ethics Committee for Health Care Division at the University of Turku and permissions for the study are applied from the target organizations
Participants will be fully informed about the study and its phases in a separate information letters In addition to the information letters participants will be informed more precisely about the collection processing reporting and storing of data in the privacy statement form All the collected data will be handled with appropriate manners and only by the research team including statisticians and possible research assistant Only personal information necessary for the research will be collected The personal datasensitive information collected will be removed and coded with separate ID numbers before the data analysis pseudonymization Results will be reported in a way that it is not possible to identify individual respondents from the data From the ethical point of view it is also worth nothing that the subjects are not representing particularly vulnerable group and they are taking part to the study voluntarily Participation in research does not deviate from the principle of informed consent
A separate data management plan has been conducted by using the DMPTuuli tool In addition a separate privacy notice informs respondents about the processing of their personal data Both of these documents have been approved by The Ethics Committee for Health Care Division at the University of Turku
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None