Continuity of CareNCT02001467
The Effects of Simulation-based Ultrasound Training on Continuity of Care in Managing Pre-mature Onset of Labor
A study testing Simulation-based training in people with Continuity of Care, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Simulation-based training lead to improvements in learning compared to no intervention but little is known of the effects on organizational improvements that are relevant to patient care. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Continuity of Care
- What is being tested?
- Simulation-based training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2013to Oct 2014
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All midwives who are taking shift on the maternity ward
Who cannot join
- Any prior ultrasound training and planned maternity leave.
Trial locations and contacts
1 site in 1 country.
About this study
Simulation-based training lead to improvements in learning compared to no intervention but little is known of the effects on organizational improvements that are relevant to patient care. This study focused on the effects of training midwives in performing cervical ultrasound scans on continuity of care when managing pregnant women with symptoms of premature onset of labor. Our hypothesis is that simulation-based training can be used to decrease the number of shifts in primary responsible health care practitioner as midwives that are trained in cervical ultrasound scans may manage the patient encounter without engaging a second practitioner (i.e. an obstetrician).
Read the detailed description
Pregnant women with symptoms of premature onset of labor are typically managed by midwives and obstetricians but shifts in responsibility in patient care may result in lack of continuity of care. This may, in turn, result in threats to patient safety and delays in initiation of treatment due to long wait times.
This study examined the effects of simulation-based ultrasound training on the management of women with symptoms of pre-mature onset of labor. 12 midwives were randomized to simulation-based ultrasound training focusing on cervical assessment or no training (controls). The midwives in the intervention group were trained to an expert criterion on a high-fidelity transvaginal ultrasound simulator. Once this level was attained, they continued clinical training until proficiency in performing cervical scans independently. Proficiency was determined using a previously validated assessment instrument (the Objective Structured Assessment of Ultrasound Skills) and by sending in pictures for the Fetal Medicine Foundation certification programme.
The number of responsible health care practitioners providing care for pregnant women with acute onset of symptoms of premature onset of labor is registered along with time from arrival at the hospital to medical assessment and treatment is commenced. Differences between patients treated by the two groups of midwives are compared over a period of 6 months. During this period all patients with symptoms of premature onset of labor are included, of which only a small proportion are admitted for further examinations and treatment. The vast majority are expected to be scheduled for ambulatory follow-up.
- Conditions
- Continuity of Care
- Being tested
- Simulation-based training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulation-based trainingOther
Also called Simulation-based training on a high-fidelity ultrasound simulator (Scantrainer, Medaphor) and subsequently on a low-fidelity mannequin (BluePhantom, CAE).
| Study group | Role | What they receive |
|---|---|---|
| Simulation-based training | Active comparator | Simulation-based training to an expert criterion followed by clinical training until proficiency and certification. Receives: Other: Simulation-based training |
| Control | No intervention | No training is provided the control group participants. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuity of care
Continuity of care is evaluated by registering the number of health care practitioners involved in patient management.
Measured: Patients will be followed untill discharge from the hospital, which is expected to be an average of 6 hours
Secondary outcomes (1)
Wait times
Wait times for pregnant women with symptoms of premature onset of labor are registered and compared between the two groups of midwives, who are responsible for the initial patient care and -contact.
Measured: An average of 6 hours is expected.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionSep 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Continuity of CareStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin G. Tolsgaard, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Martin G Tolsgaard, MD, PhD, Principal investigator, CEKU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02001467
- Sponsor's protocol ID
- H-4-2013-FSP 10
- Other IDs
- H-4-2013-FSP 10
- Status last verified
- May 2015
- First submitted
- 21 Nov 2013
- Last updated
- 5 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Simulation-based Ultrasound Training on Continuity of Care in Managing Pre-mature Onset of Labor
- ClinicalTrials.gov ID
- NCT02001467
- Acronym / sponsor ID
- H-4-2013-FSP 10
- Conditions
- Continuity of Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 5 Dec 2013 (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.
Simulation-based training lead to improvements in learning compared to no intervention but little is known of the effects on organizational improvements that are relevant to patient care. This study focused on the effects of training midwives in performing cervical ultrasound scans on continuity of care when managing pregnant women with symptoms of premature onset of labor. Our hypothesis is that simulation-based training can be used to decrease the number of shifts in primary responsible health care practitioner as midwives that are trained in cervical ultrasound scans may manage the patient encounter without engaging a second practitioner (i.e. an obstetrician).
Detailed description
Pregnant women with symptoms of premature onset of labor are typically managed by midwives and obstetricians but shifts in responsibility in patient care may result in lack of continuity of care. This may, in turn, result in threats to patient safety and delays in initiation of treatment due to long wait times.
This study examined the effects of simulation-based ultrasound training on the management of women with symptoms of pre-mature onset of labor. 12 midwives were randomized to simulation-based ultrasound training focusing on cervical assessment or no training (controls). The midwives in the intervention group were trained to an expert criterion on a high-fidelity transvaginal ultrasound simulator. Once this level was attained, they continued clinical training until proficiency in performing cervical scans independently. Proficiency was determined using a previously validated assessment instrument (the Objective Structured Assessment of Ultrasound Skills) and by sending in pictures for the Fetal Medicine Foundation certification programme.
The number of responsible health care practitioners providing care for pregnant women with acute onset of symptoms of premature onset of labor is registered along with time from arrival at the hospital to medical assessment and treatment is commenced. Differences between patients treated by the two groups of midwives are compared over a period of 6 months. During this period all patients with symptoms of premature onset of labor are included, of which only a small proportion are admitted for further examinations and treatment. The vast majority are expected to be scheduled for ambulatory follow-up.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simulation-based training | Active comparator | Other: Simulation-based trainingSimulation-based training to an expert criterion followed by clinical training until proficiency and certification. |
| Control | No intervention | –No training is provided the control group participants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All midwives who are taking shift on the maternity ward
Key exclusion criteria (1 listed)
- Any prior ultrasound training and planned maternity leave.
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 |
|---|---|---|
| Simulation-based trainingAlso: Simulation-based training on a high-fidelity ultrasound simulator (Scantrainer, Medaphor) and subsequently on a low-fidelity mannequin (BluePhantom, CAE). | Other | Simulation-based training |
Primary outcome
Continuity of care
Time frame: Patients will be followed untill discharge from the hospital, which is expected to be an average of 6 hours
Continuity of care is evaluated by registering the number of health care practitioners involved in patient management.
1 secondary outcome
Wait times
Time frame: An average of 6 hours is expected.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 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.
Martin G Tolsgaard, MD, PhD principal investigator
CEKU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simulation-based training in people with Continuity of Care, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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: finished, as of the sponsor's last update on 5 May 2015. 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 Denmark. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Continuity of care (time frame: Patients will be followed untill discharge from the hospital, which is expected to be an average of 6 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 5 May 2015.