Clinical trial NCT06388356: Patient's Informational Privacy in Prehospital Emergency Care - Educational Intervention Study for the Paramedics
Official title: Patient's Informational Privacy in Prehospital Emergency Care: A Quasi-experimental Intervention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knowledge
Attitude of Health Personnel
Keywords: Informational privacy, confidentiality,
Lead sponsor: University of Turku
Sponsor class: OTHER
First posted: 2024-04-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups, intervention and control group. Only intervention group is receiveing the intervention.
Primary purpose: BASIC_SCIENCE

Brief summary: The main goal of this educational intervention study about patient's informational privacy (IP) is to evaluate the effect of the educational intervention into the paramedics' knowledge and attitude regarding patient's 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 patient's 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 patient's IP through an educational intervention. In addition, the educational intervention aims to impact positively to the paramedics' attitude towards patient's 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 Finland's 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 (n=50 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 patient's 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 patient's 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 she/he 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 organization's 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, she/he 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 0.05 (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 data/sensitive 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.

Eligibility criteria: Inclusion Criteria:

* Participating paramedic has a degree in healthcare or is in the process of completing a health care degree.
* Participating paramedics is working as an ALS (advanced life support) or BLS (basic life support) level paramedic in one of the two target rescue departments during the entire time of the data collection.
* Participant is capable to understand Finnish.

Exclusion Criteria:

-

Primary outcomes:
measure: Paramedics' knowledge about patient's informational privacy
timeFrame: Measurements are conducted during two different time frame: first measurement before the educational intervention taking up to 4 weeks. Second measurement after educational intervention taking up to 4 weeks.
Secondary outcomes:
measure: paramedics' attitude towards patient's informational privacy.
timeFrame: Measurements are conducted during two different time frame: first measurement before the educational intervention taking up to 4 weeks. Second measurement after educational intervention taking up to 4 weeks.
Other outcomes:
Locations:
city: Turku
country: Finland
facility: University of Turku
Study officials:
affiliation: University of Turku
name: Eini Koskimies, Doctoral researcher
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brooke, J. (2013). SUS: A Retrospective. Journal of Usability Studies, 8(2), 29- 40. Brooke, J. (1996). SUS: a 'quick and dirty' usability scale. In: Usability evaluation in industry (Jordan PW, Thomas B, Weerdmeester BA, McClelland AL ed.), Taylor and Francis, London, pp. 189- 194.