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

NCT ID: NCT02001467

Last Updated: 2015-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2014-10-31

Brief 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).

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Simulation-based training

Simulation-based training to an expert criterion followed by clinical training until proficiency and certification.

Group Type: ACTIVE_COMPARATOR

Simulation-based training

Intervention Type: OTHER

Control

No training is provided the control group participants.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Simulation-based training

Intervention Type: OTHER

Other Intervention Names

Simulation-based training on a high-fidelity ultrasound simulator (Scantrainer, Medaphor) and subsequently on a low-fidelity mannequin (BluePhantom, CAE).

Eligibility Criteria

Inclusion Criteria

All midwives who are taking shift on the maternity ward

Exclusion Criteria

Any prior ultrasound training and planned maternity leave.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Martin G. Tolsgaard

MD, PhD, postdoctoral fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Martin G Tolsgaard, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CEKU

Locations

Nordsjællands Hospital

Hillerød, Capital Region, Denmark

Countries

Denmark

Other Identifiers

H-4-2013-FSP 10

Identifier Type: OTHER

Identifier Source: secondary_id

H-4-2013-FSP 10

Identifier Type: -

Identifier Source: org_study_id