Evaluation of the PelvicSim Simulator for Training in Intrauterine Device Insertions

NCT02220205 | Completed Results

• 1 other identifier: 2014P-000106
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Intrauterine devices (IUDs) are a very effective, long-acting method of contraception. In order to make them accessible to women, health care providers must be trained to insert them. Physicians, physician assistant, and nurse practitioners often learn how to do so by first learning about IUDs, then practicing on a model that the IUD manufacturer provides. Educators have recently been using more sophisticated models to teach clinical skills such as surgical procedures. We are investigating whether these models may be more useful in teaching IUD insertion.

Conditions

Contraceptive Devices, Intrauterine; Education, Medical

Keywords

IUD; training; simulation

Outcome Measures

Primary Outcomes (1)

• Insertion Score Before and Immediately After Initial Practice (Same Day), and 3 Months After Initial Practice

  Participants were filmed performing 3 IUD insertions each, for three IUDs available in the US. They then practiced on an assigned simulator for 30 minutes, and were re-recorded immediately afterwards. Three months after initial practice, they returned and performed the insertions again. Sets of insertions were scored using a checklist. Participants earned up to 86 points for performing various elements of IUC insertion correctly: sounding the uterus (14 points), and loading as well as inserting the copper device (24 points), levonorgestrel 52mg device (26 points), and levonorgestrel 13.5mg device (22 points). Higher scores were better.

  Before and immediately after initial practice on assigned simulator (same day), and three months after initial practice

Secondary Outcomes (1)

• Percent Change in Comfort Placing IUDs From Pre- to Post-insertion

  Baseline to three months

Study Arms (2)

PelvicSim

ACTIVE COMPARATOR

Participants randomized to this arm practice IUD insertion on the PelvicSim for 30 minutes.

Other: PelvicSim

Manufacturer model

PLACEBO COMPARATOR

Participants randomized to this arm practice IUD insertion on models provided by the IUD manufacturer for 30 minutes.

Device: Manufacturer model

Interventions

PelvicSim OTHER

PelvicSim

Manufacturer model DEVICE

Manufacturer model

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• First-year residents in obstetrics and gynecology or family medicine, or student in physician assistant or nurse practitioner training programs
• Trainees who have performed \<5 intrauterine device insertions
• Trainees who plan to provide intrauterine devices in their clinical practice

You may not qualify if:

• None

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Limitations and Caveats

Participants directed their own practice time. An investigator answered questions but did not provide other feedback unless specifically asked.

Results Point of Contact

• Title: Siripanth Nippita
• Organization: Beth Israel Deaconess Medical Center

snippita@bidmc.harvard.edu

617-667-4165

Study Officials

• Siripanth Nippita, MD, MS

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor in Obstetrics, Gynecology and Reproductive Biology

Study Record Dates

• First Submitted: August 14, 2014
• First Posted: August 19, 2014
• Study Start: April 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: May 24, 2017
• Results First Posted: May 24, 2017

Record last verified: 2017-04

Locations

US (1)