Risk ReductionNCT02510196
Assessment of Skill Retention in Clinical Practice
A study testing reminder in people with Risk Reduction, run by Hadassah Medical Organization.
Trial summary
Teaching program population: Participants in Hadassah Ein Kerem ultrasound training day - Anesthesia residents Exclusion criteria: Refusal to participate, insufficient understanding of written English used in the questionnaires Stage 1 - training The aims and requirements of the teaching program will be explained to… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Risk Reduction
- What is being tested?
- reminder
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Feb 2016
- Phase
- Interventional
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Practicing anesthesiologists of all levels at Hadassah Ein Kerem hospital
Who cannot join
- Unwillingness to complete questionnaire, poor English comprehension
About this study
Teaching program population: Participants in Hadassah Ein Kerem ultrasound training day - Anesthesia residents Exclusion criteria: Refusal to participate, insufficient understanding of written English used in the questionnaires
Stage 1 - training The aims and requirements of the teaching program will be explained to the participants at the start of the workshop. All participants will be given a sticker with a number and a questionnaire numbered about current ultrasound practice which is numbered according to participant number to allow for blinding. Anyone not wishing to participate can either remove their sticker or not return the questionnaire at the end of the session. The number on the questionnaire correlated to participant number. This will be recorded against the participant name to allow for further follow up. All participants will rotate normally throughout the sessions. At the end of the neuraxial session participants will be scored by the session leader according to their ability to adequately carry out the procedure. Scores will be correlated to participant number.
Read more
Stage 2 - assessment of skill retention
Following the training day participants will randomly be allocated into two groups. One group will receive regular reminders to use ultrasound for all neuraxial anesthesias they perform in the OR or labor ward. They will be reminded on a regular basis that ultrasound is a new tool to assist them in performing neuraxial ultrasound. The other group with be allowed to continue with their regular practice and will not receive reminders to use ultrasound for neuraxial anesthesia insertion. Two months after the initial training day all participants with be observed performing neuraxial anesthesia and re-assesed according to the original scoring system. Each participant will be assessed 3 times over a 6 month period.
- Conditions
- Risk Reduction
- Being tested
- reminder
- Medical subject headings
- Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reminderBehavioural
| Study group | Role | What they receive |
|---|---|---|
| reminder | Active comparator | participants in this group will be reminded to use ultrasound for neuraxial anesthesia on a regular basis Receives: Behavioral: reminder |
| control | No intervention | participants in this group will not be reminded to use ultrasound for neuraxial anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasound Performance on a model
ability of participants to perform neuraxial ultrasound will be assessed at 2 monthly intervals
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2015 (estimated)
- Study startApr 2015
- Primary completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Risk ReductionStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02510196
- Sponsor's protocol ID
- 0036-13-HMO
- Status last verified
- Feb 2015
- First submitted
- 10 Jun 2015
- Last updated
- 29 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Skill Retention in Clinical Practice
- ClinicalTrials.gov ID
- NCT02510196
- Acronym / sponsor ID
- 0036-13-HMO
- Conditions
- Risk Reduction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Feb 2016 (estimated)
- First posted
- 29 Jul 2015 (estimated)
- 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.
Teaching program population: Participants in Hadassah Ein Kerem ultrasound training day - Anesthesia residents Exclusion criteria: Refusal to participate, insufficient understanding of written English used in the questionnaires
Stage 1 - training The aims and requirements of the teaching program will be explained to the participants at the start of the workshop. All participants will be given a sticker with a number and a questionnaire numbered about current ultrasound practice which is numbered according to participant number to allow for blinding. Anyone not wishing to participate can either remove their sticker or not return the questionnaire at the end of the session. The number on the questionnaire correlated to participant number. This will be recorded against the participant name to allow for further follow up. All participants will rotate normally throughout the sessions. At the end of the neuraxial session participants will be scored by the session leader according to their ability to adequately carry out the procedure. Scores will be correlated to participant number.
Stage 2 - assessment of skill retention
Following the training day participants will randomly be allocated into two groups. One group will receive regular reminders to use ultrasound for all neuraxial anesthesias they perform in the OR or labor ward. They will be reminded on a regular basis that ultrasound is a new tool to assist them in performing neuraxial ultrasound. The other group with be allowed to continue with their regular practice and will not receive reminders to use ultrasound for neuraxial anesthesia insertion. Two months after the initial training day all participants with be observed performing neuraxial anesthesia and re-assesed according to the original scoring system. Each participant will be assessed 3 times over a 6 month period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| reminder | Active comparator | Behavioral: reminderparticipants in this group will be reminded to use ultrasound for neuraxial anesthesia on a regular basis |
| control | No intervention | –participants in this group will not be reminded to use ultrasound for neuraxial anesthesia |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Practicing anesthesiologists of all levels at Hadassah Ein Kerem hospital
Key exclusion criteria (1 listed)
- Unwillingness to complete questionnaire, poor English comprehension
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 |
|---|---|---|
| reminder | Behavioural | reminder |
Primary outcome
Ultrasound Performance on a model
Time frame: 1 year
ability of participants to perform neuraxial ultrasound will be assessed at 2 monthly intervals
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2015.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing reminder in people with Risk Reduction, run by Hadassah Medical Organization.
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: status not confirmed, as of the sponsor's last update on 29 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Ultrasound Performance on a model (time frame: 1 year). 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 29 Jul 2015.