Plain Abdominal RadiographyNCT04116294
Using a Computer-assisted Prescription to Decrease Inappropriate Use of Plain Abdominal Radiography in Emergency Department
A study testing Computer-assisted prescription in people with Plain Abdominal Radiography, run by Christophe Fehlmann at 2 sites in Switzerland.
Trial summary
The aim of this study is to assess whether a computer-assisted prescription allows a reduction of the overall number of inappropriate PAR in emergency departments. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Plain Abdominal Radiography
- What is being tested?
- Computer-assisted prescription
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 1 Nov 2019to 30 Apr 2020
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients aged 16 or more with a PAR.
Who cannot join
- Refusal to participate
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites, 2 recruiting
- Recruiting
Hôpitaux Universitaires de Geneve
Geneva, 1205
Christophe A Fehlmann, MD, 15149435717, christophe.fehlmann@hcuge.ch
- Recruiting
Hôpital de La Tour
Meyrin, 1217
Omar Kherad, MD, MPH, omar.kherad@latour.ch
About this study
The aim of this study is to assess whether a computer-assisted prescription allows a reduction of the overall number of inappropriate PAR in emergency departments.
- Conditions
- Plain Abdominal Radiography
- Being tested
- Computer-assisted prescription
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer-assisted prescriptionOther
The intervention is based on a computer-assisted prescription: when a PAR will be ordered, an alert will arise and explain the recognized indications for this examination and ask a confirmation for the prescription. This is a non-blocking system: physicians will be able to prescribe PAR even if the PAR is not appropriate.
| Study group | Role | What they receive |
|---|---|---|
| Before | No intervention | Standard of care for informatic prescription. |
| After | Active comparator | Computer-assisted prescription for radiological procedure Receives: Other: Computer-assisted prescription |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of plain abdominal radiopraphy (PAR) with an inappropriate indication
4 indications are considered as appropriate : (1) foreign body suspicion, (2) checking after contrast injection, (3) catheter checking and (4) follow-up of urolithiasis. Order for PAR will be independantly reviewed by blinded assessors.
Measured: Same ED consultation (or max 24 hours)
Secondary outcomes (1)
Incidence of additional radiological examination (CT, US, IRM) after the PAR
Measured: Same ED consultation (or max 24 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2019
- Study start1 Nov 2019
- Primary completion30 Apr 2020 (estimated)
- Study completion30 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plain Abdominal RadiographyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Before after. During the before period, standard of care. During the after period, computer-assisted prescription for plain abdominal radiography (reminding the indication for this procedure).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Christophe Fehlmann
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Christophe Fehlmann, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04116294
- Sponsor's protocol ID
- 2018-02142
- Other IDs
- 2018
- Status last verified
- Nov 2019
- First submitted
- 30 Sep 2019
- Last updated
- 26 Nov 2019
- 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 26 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using a Computer-assisted Prescription to Decrease Inappropriate Use of Plain Abdominal Radiography in Emergency Department
- ClinicalTrials.gov ID
- NCT04116294
- Acronym / sponsor ID
- 2018-02142
- Conditions
- Plain Abdominal Radiography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Christophe FehlmannUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 30 Apr 2020 (estimated)
- Study completion
- 30 Apr 2020 (estimated)
- First posted
- 4 Oct 2019 (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 aim of this study is to assess whether a computer-assisted prescription allows a reduction of the overall number of inappropriate PAR in emergency departments.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Before after. During the before period, standard of care. During the after period, computer-assisted prescription for plain abdominal radiography (reminding the indication for this procedure).
| Arm | Type | Receives |
|---|---|---|
| Before | No intervention | –Standard of care for informatic prescription. |
| After | Active comparator | Other: Computer-assisted prescriptionComputer-assisted prescription for radiological procedure |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 16 or more with a PAR.
Key exclusion criteria (1 listed)
- Refusal to participate
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 |
|---|---|---|
| Computer-assisted prescriptionThe intervention is based on a computer-assisted prescription: when a PAR will be ordered, an alert will arise and explain the recognized indications for this examination and ask a confirmation for the prescription. This is a non-blocking system: physicians will be able to prescribe PAR even if the PAR is not appropriate. | Other | After |
Primary outcome
Incidence of plain abdominal radiopraphy (PAR) with an inappropriate indication
Time frame: Same ED consultation (or max 24 hours)
4 indications are considered as appropriate : (1) foreign body suspicion, (2) checking after contrast injection, (3) catheter checking and (4) follow-up of urolithiasis. Order for PAR will be independantly reviewed by blinded assessors.
1 secondary outcome
Incidence of additional radiological examination (CT, US, IRM) after the PAR
Time frame: Same ED consultation (or max 24 hours)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2019.
- Individual participant dataSharing planned: No
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer-assisted prescription in people with Plain Abdominal Radiography, run by Christophe Fehlmann at 2 sites in Switzerland.
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 26 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christophe Christophe, MD (+15149435717, Christophe.Fehlmann@hcuge.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of plain abdominal radiopraphy (PAR) with an inappropriate indication (time frame: Same ED consultation (or max 24 hours)). 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 26 Nov 2019.