Contraceptive Devices, Intrauterine, Education, Medical
Conditions
Keywords
IUD, training, simulation
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.
Interventions
OTHERPelvicSim
DEVICEManufacturer model
Sponsors
Beth Israel Deaconess Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insertion Score Before and Immediately After Initial Practice (Same Day), and 3 Months After Initial Practice | Before and immediately after initial practice on assigned simulator (same day), and three 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Comfort Placing IUDs From Pre- to Post-insertion | Baseline to three months | Participants were given questionnaires at the initial study visit and at a three-month follow-up visit that assessed their comfort with IUD insertion using a modified Likert scale. |
Countries
United States
Participant flow
Pre-assignment details
One participant voluntarily withdrew from the study due to time constraints which precluded completion of the study visit. Therefore, 60 participants enrolled and were randomized, and 59 completed the study.
Participants by arm
| Arm | Count |
|---|---|
| PelvicSim Participants randomized to this arm practice IUD insertion on the PelvicSim for 30 minutes.
PelvicSim | 29 |
| Manufacturer Model Participants randomized to this arm practice IUD insertion on models provided by the IUD manufacturer for 30 minutes.
Manufacturer model | 30 |
| Total | 59 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | PelvicSim | Manufacturer Model | Total |
|---|---|---|---|
| Age, Continuous | 26 years | 28 years | 27 years |
| Occupation Intern | 8 participants | 12 participants | 20 participants |
| Occupation Nurse practitioner student | 21 participants | 18 participants | 39 participants |
| Prior IUD insertions performed 0 | 23 exams | 28 exams | 51 exams |
| Prior IUD insertions performed >=1 | 6 exams | 2 exams | 8 exams |
| Prior pelvic exams 0 | 10 exams | 5 exams | 15 exams |
| Prior pelvic exams >10 | 7 exams | 9 exams | 16 exams |
| Prior pelvic exams 1-5 | 10 exams | 10 exams | 20 exams |
| Prior pelvic exams 6-10 | 2 exams | 6 exams | 8 exams |
| Region of Enrollment United States | 29 participants | 30 participants | 59 participants |
| Sex: Female, Male Female | 27 Participants | 26 Participants | 53 Participants |
| Sex: Female, Male Male | 2 Participants | 4 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 29 | 0 / 30 |
| serious Total, serious adverse events | 0 / 29 | 0 / 30 |
Outcome results
Primary
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.
Time frame: Before and immediately after initial practice on assigned simulator (same day), and three months after initial practice
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| PelvicSim | Insertion Score Before and Immediately After Initial Practice (Same Day), and 3 Months After Initial Practice | Pre-simulation | 61.5 Percent of tasks performed correctly |
| PelvicSim | Insertion Score Before and Immediately After Initial Practice (Same Day), and 3 Months After Initial Practice | Post-simulation | 82.5 Percent of tasks performed correctly |
| PelvicSim | Insertion Score Before and Immediately After Initial Practice (Same Day), and 3 Months After Initial Practice | Three month visit | 65.5 Percent of tasks performed correctly |
| Manufacturer Model | Insertion Score Before and Immediately After Initial Practice (Same Day), and 3 Months After Initial Practice | Pre-simulation | 67.5 Percent of tasks performed correctly |
| Manufacturer Model | Insertion Score Before and Immediately After Initial Practice (Same Day), and 3 Months After Initial Practice | Post-simulation | 83 Percent of tasks performed correctly |
| Manufacturer Model | Insertion Score Before and Immediately After Initial Practice (Same Day), and 3 Months After Initial Practice | Three month visit | 67.5 Percent of tasks performed correctly |
Secondary
Percent Change in Comfort Placing IUDs From Pre- to Post-insertion
Participants were given questionnaires at the initial study visit and at a three-month follow-up visit that assessed their comfort with IUD insertion using a modified Likert scale.
Time frame: Baseline to three months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PelvicSim | Percent Change in Comfort Placing IUDs From Pre- to Post-insertion | Copper IUD | 89.3 Percent change in comfort |
| PelvicSim | Percent Change in Comfort Placing IUDs From Pre- to Post-insertion | 52mg levonorgestrel IUD | 92.9 Percent change in comfort |
| PelvicSim | Percent Change in Comfort Placing IUDs From Pre- to Post-insertion | 13.5mg levonorgestrel IUD | 89.3 Percent change in comfort |
| Manufacturer Model | Percent Change in Comfort Placing IUDs From Pre- to Post-insertion | Copper IUD | 96.7 Percent change in comfort |
| Manufacturer Model | Percent Change in Comfort Placing IUDs From Pre- to Post-insertion | 52mg levonorgestrel IUD | 100 Percent change in comfort |
| Manufacturer Model | Percent Change in Comfort Placing IUDs From Pre- to Post-insertion | 13.5mg levonorgestrel IUD | 100 Percent change in comfort |