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

NCT02001467 | Completed

• 1 other identifier: H-4-2013-FSP 10
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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).

Conditions

Continuity of Care

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Wait times

  An average of 6 hours is expected.

Study Arms (2)

Simulation-based training

ACTIVE COMPARATOR

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

Other: Simulation-based training

Control

NO INTERVENTION

No training is provided the control group participants.

Interventions

Simulation-based training OTHER

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

Simulation-based training

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All midwives who are taking shift on the maternity ward

You may not qualify if:

• Any prior ultrasound training and planned maternity leave.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Nordsjællands Hospital

Hillerød, Capital Region, 3400, Denmark

Location

Study Officials

• Martin G Tolsgaard, MD, PhD

  CEKU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, postdoctoral fellow

Study Record Dates

• First Submitted: November 21, 2013
• First Posted: December 5, 2013
• Study Start: November 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: October 1, 2014
• Last Updated: May 5, 2015

Record last verified: 2015-05

Locations

DK (1)