Staff AttitudePREPARENCT04709926
Paramedic Experiences and Perceptions of Training for Participation in Research: the PREPARE Study
An observational study of Staff Attitude, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The investigators are currently conducting a research study, called PRESTO, in the pre-hospital environment where the investigators are asking paramedics to talk to patients about participating in the research study, interpret a heart tracing (or ECG), take a blood sample and record some study specific information. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Staff Attitude
- What is being tested?
- Survey and Interview (optional)
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Sep 2020to 25 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Staff employed by one of the four ambulance services that were involved in the PRESTO study Paramedics that either did or did not complete the PRESTO training package are eligible to take part as we would like to get opinions from both groups.
Who may be able to join
- Staff that are employed by one of the four ambulance services involved in the PRESTO study
Who cannot join
- Staff that are not employed by one of the four ambulance services involved in the PRESTO study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Manchester University Hospitals NHS Foundation Trust
Manchester, M13 WL
About this study
The investigators are currently conducting a research study, called PRESTO, in the pre-hospital environment where the investigators are asking paramedics to talk to patients about participating in the research study, interpret a heart tracing (or ECG), take a blood sample and record some study specific information. Apart from ECG interpretation, these are activities that the paramedics would not normally do and so the investigators had to provide training in order to ensure that these activities were carried out to the same standard across the four ambulance services that were involved, all of who have different working practices.
In order to do this, the investigators provided a training package based around four subject areas - blood sample collection, heart tracing interpretation, background to the study and the importance of conducting the study activities to a high standard (called Research Fundamentals). These were presented to the paramedics either as online training or in a face-to-face session. There has been a mixed response to both the uptake in training across the four ambulance services and the engagement from paramedics in following PRESTO with a potential participant.
Read more
As more research is being done in the pre-hospital environment the investigators feel that it would be beneficial to try to find out why paramedics may or may not have taken part in the PRESTO training. To do this the investigators will be sending out a survey to each of the four ambulance services which will contain questions around whether the paramedics thought the training package for PRESTO was suitable, whether the paramedics felt confident following PRESTO with a potential participant after the training and what the paramedics think the main barriers are to participating in research. Up to 30 paramedics will also be approached to participate in an interview, which will explore these ideas further.
This should allow the investigators to identify potential barriers that prevent paramedics from taking part in training for research studies. It should also allow the investigators to offer insight to future researchers about the type of training that should be provided for paramedics for a research study and how it should be delivered.
- Conditions
- Staff Attitude
- Being tested
- Survey, Interview (optional)
- Keywords
- PRESTO study, Research training, Paramedics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
Paramedics will complete a 5 minute survey that is asking for their opinions on why they did or did not take part in the PRESTO training package and also why they think paramedics might not engage with research training in general.
Interview (optional)Other
Paramedics will also be given the option to participate in a 1hr interview to explore the questions asked in the survey in more detail.
| Study group | Role | What they receive |
|---|---|---|
| Paramedics that were eligible to take part in the PRESTO study | Paramedics that are employed by one of the four Ambulance Services involved in the PRESTO study and were eligible to complete the training provided by Manchester University NHS Foundation Trust to take part in the PRESTO study. Receives: Other: Survey; Other: Interview (optional) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Paramedic views on research training via survey
Survey will be used to collect answers on paramedics' views of training for research studies
Measured: For the study duration, an average of 5 months
Paramedic views on research training via interview (optional)
Interview will be used to collect answers on paramedics' views of training for research studies
Measured: For the study duration, an average of 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start9 Sep 2020
- Primary completion25 Oct 2022
- Study completion25 Oct 2022
Why it stopped: Capacity issues within team after pandemic \& unable to progress with the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Staff AttitudeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manchester University NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04709926
- Sponsor's protocol ID
- B00686
- Acronym
- PREPARE
- Status last verified
- Oct 2022
- First submitted
- 16 Jan 2020
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paramedic Experiences and Perceptions of Training for Participation in Research: the PREPARE Study
- ClinicalTrials.gov ID
- NCT04709926
- Acronym / sponsor ID
- PREPARE / B00686
- Conditions
- Staff Attitude
- Keywords
- PRESTO study, Research training, Paramedics
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Capacity issues within team after pandemic \& unable to progress with the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Manchester University NHS Foundation TrustOther government
- Study start
- 9 Sep 2020 (actual)
- Primary completion
- 25 Oct 2022 (actual)
- Study completion
- 25 Oct 2022 (actual)
- First posted
- 14 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators are currently conducting a research study, called PRESTO, in the pre-hospital environment where the investigators are asking paramedics to talk to patients about participating in the research study, interpret a heart tracing (or ECG), take a blood sample and record some study specific information. Apart from ECG interpretation, these are activities that the paramedics would not normally do and so the investigators had to provide training in order to ensure that these activities were carried out to the same standard across the four ambulance services that were involved, all of who have different working practices.
In order to do this, the investigators provided a training package based around four subject areas - blood sample collection, heart tracing interpretation, background to the study and the importance of conducting the study activities to a high standard (called Research Fundamentals). These were presented to the paramedics either as online training or in a face-to-face session. There has been a mixed response to both the uptake in training across the four ambulance services and the engagement from paramedics in following PRESTO with a potential participant.
As more research is being done in the pre-hospital environment the investigators feel that it would be beneficial to try to find out why paramedics may or may not have taken part in the PRESTO training. To do this the investigators will be sending out a survey to each of the four ambulance services which will contain questions around whether the paramedics thought the training package for PRESTO was suitable, whether the paramedics felt confident following PRESTO with a potential participant after the training and what the paramedics think the main barriers are to participating in research. Up to 30 paramedics will also be approached to participate in an interview, which will explore these ideas further.
This should allow the investigators to identify potential barriers that prevent paramedics from taking part in training for research studies. It should also allow the investigators to offer insight to future researchers about the type of training that should be provided for paramedics for a research study and how it should be delivered.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paramedics that were eligible to take part in the PRESTO study | – | Other: Survey, Other: Interview (optional)Paramedics that are employed by one of the four Ambulance Services involved in the PRESTO study and were eligible to complete the training provided by Manchester University NHS Foundation Trust to take part in the PRESTO study. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Staff employed by one of the four ambulance services that were involved in the PRESTO study Paramedics that either did or did not complete the PRESTO training package are eligible to take part as we would like to get opinions from both groups.
Key inclusion criteria (1 listed)
- Staff that are employed by one of the four ambulance services involved in the PRESTO study
Key exclusion criteria (1 listed)
- Staff that are not employed by one of the four ambulance services involved in the PRESTO study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurveyParamedics will complete a 5 minute survey that is asking for their opinions on why they did or did not take part in the PRESTO training package and also why they think paramedics might not engage with research training in general. | Other | Paramedics that were eligible to take part in the PRESTO study |
| Interview (optional)Paramedics will also be given the option to participate in a 1hr interview to explore the questions asked in the survey in more detail. | Other | Paramedics that were eligible to take part in the PRESTO study |
Primary outcome
Paramedic views on research training via survey
Time frame: For the study duration, an average of 5 months
Survey will be used to collect answers on paramedics' views of training for research studies
Paramedic views on research training via interview (optional)
Time frame: For the study duration, an average of 5 months
Interview will be used to collect answers on paramedics' views of training for research studies
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Staff Attitude, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Paramedic views on research training via survey (time frame: For the study duration, an average of 5 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2022.