The Effects of Simulation-based Ultrasound Training on Continuity of Care in Managing Pre-mature Onset of Labor

Continuity of Care Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02001467
• Other study ID #: H-4-2013-FSP 10
• Secondary ID: H-4-2013-FSP 10
• Status: Completed
• Phase: N/A
• First received: November 21, 2013
• Last updated: May 4, 2015
• Start date: November 2013
• Est. completion date: October 2014

Study information

• Verified date: May 2015
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Regional Ethical Committee for the Capital Region
• Study type: Interventional

Clinical 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. 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: October 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

All midwives who are taking shift on the maternity ward

Exclusion Criteria:

Any prior ultrasound training and planned maternity leave.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Continuity of Care

Intervention

Other:
• Simulation-based training

Locations

Country	Name	City	State
Denmark	Nordsjællands Hospital	Hillerød	Capital Region

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Continuity of care	Continuity of care is evaluated by registering the number of health care practitioners involved in patient management.	Patients will be followed untill discharge from the hospital, which is expected to be an average of 6 hours	Yes
Secondary	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.	An average of 6 hours is expected.	Yes