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

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).

Study Overview

• Status: Completed
• Conditions: Continuity of Care
• Intervention / Treatment: Other: Simulation-based training

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Capital Region
    • Hillerød, Capital Region, Denmark, 3400
      • Nordsjællands Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

All midwives who are taking shift on the maternity ward

Exclusion Criteria:

Any prior ultrasound training and planned maternity leave.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Simulation-based training; Simulation-based training to an expert criterion followed by clinical training until proficiency and certification.	Other: Simulation-based training; Other Names: Simulation-based training on a high-fidelity ultrasound simulator (Scantrainer, Medaphor) and subsequently on a low-fidelity mannequin (BluePhantom, CAE).
NO_INTERVENTION: Control; No training is provided the control group participants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Investigators: Principal Investigator: Martin G Tolsgaard, MD, PhD, CEKU

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (ACTUAL): September 1, 2014
• Study Completion (ACTUAL): October 1, 2014

Study Registration Dates

• First Submitted: November 21, 2013
• First Submitted That Met QC Criteria: December 4, 2013
• First Posted (ESTIMATE): December 5, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): May 5, 2015
• Last Update Submitted That Met QC Criteria: May 4, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: H-4-2013-FSP 10 (OTHER: Regional Ethical Committee of the Capital Region, Denmark)