Contraception, Contraception Behavior
Conditions
Brief summary
Many female adolescents using the pediatric emergency department (ED) are at higher risk for unintended pregnancy. This is a significant public health issue and hormonal contraception is the mainstay of prevention. Many barriers to hormonal contraception exist and other studies have demonstrated that referral from the ED for hormonal contraception leads to poor follow up. This study will be a pilot study to assess the feasibility of initiating hormonal contraception in the pediatric ED.
Detailed description
This study will assess the feasibility of initiating hormonal contraception in the pediatric ED. Currently, all 15-21-year-old patients receiving care in our ED are asked to complete an adolescent heath questionnaire to identify risk-factors for sexually transmitted infections (STIs). Sexually active female patients who indicate on this questionnaire they are not currently using hormonal contraception will be eligible for participation in this study. Potential participants will be screened using the EMR and eligible patients will be approached. Consent will be obtained from adults directly and from a parent or guardian for minors that have one present. For minors that present without a parent or guardian, assent only with be obtained from the minor. Participants will be randomized into two groups, an intervention group and a control group. Participants in both groups will be given tablet computer and, through a software application on the tablet, answer questions electronically about their background, medical history, and contraceptive preferences. They will then be shown a video that provides an overview of hormonal contraceptive options. Depending on the participants medical history and contraceptive preferences, they may be offered more in-depth educational videos about specific types of hormonal contraception for which they are eligible (e.g. pill, transdermal patch, intravaginal ring, injection, and implant). Once they have completed watching the videos, participants in the intervention group will have the option of initiating one of the offered forms of birth control during the ED visit. They will only be offered medications considered low risk and for which they do not have any medical contraindications. Urine pregnancy testing will be done before any method is given. They will be able to start any contraceptive method from among those offered after their screening. Participants in the control group will be offered outpatient referral to initiate contraception, the current standard of care in our ED. All patients in both arms of the study will be given referral/follow up options for further contraceptive care. All participants in this study will then be followed up at 1, 3, 6, and 12 months to determine continuation of contraception practices, follow up practices, satisfaction, and pregnancy rates.
Interventions
DIAGNOSTIC_TESTIntervention Group
The electronic application will collect screening health information and contraceptive preferences about the participant. Then, using branch logic, decide which contraceptive options the participant would qualify for based on health history answers. Contraceptive choices being offered include the contraceptive implant, injection, pill, patch, or ring. They will then be able to watch videos about methods they are eligible for. The participant can then decide if they would like to start a medication they qualify for in the ED.
OTHERControl Group
The electronic application will collect screening health information and contraceptive preferences about the participant. Then, using branch logic, decide which contraceptive options the participant would qualify for based on health history answers. This includes the contraceptive implant, injection, pill, patch, or ring. They will then be able to watch videos about methods they are eligible for. Participants will then be given follow up information on outpatient locations where they can receive these contraceptive methods.
Sponsors
Merck Sharp & Dohme LLC
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Feasibility trial
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 21 Years
Healthy volunteers
Yes
Inclusion criteria
* Female patients, 15-21 years old that present to the SLCH pediatric ED * Report history of vaginal sex on the ED routine screening questionnaire * Not currently using hormonal contraception
Exclusion criteria
* Pregnant * Currently using hormonal contraception * Foster care * Non-English speaking * Chief complaint of psychiatric concern, physical abuse or sexual abuse * Triage acuity level 1 or 2 as they are likely to be too ill to participate * Those with history of stroke, venous thromboembolism, actively being treated for cancer, or who have an organ transplant * Too ill to participate as determined by the pediatric ED health care provider (attending physician or advanced practice nurse) * Already participated in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Initiation of contraception in the ED using the electronic application | 12 months | The proportion of enrolled patients that initiate contraception when offered same-day (intervention arm) compared to those that initiate contraception at follow up (the control arm) at 3 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Delivery process related outcomes #2 | At initial encounter. | Subject length of stay defined by arrival time to disposition (admit or discharge) from ED. |
| Delivery process related outcomes #3 | At initial encounter and at follow up at 3, 6, and 12 months. | Patient experience and satisfaction survey both directly after program and at follow up at 3, 6, and 12 months. Likert 5 point scale will be used with the following rating options strongly agree, agree, no opinion, disagree, or strongly disagree. Data will be stored in original language and in a numerical scale, with a range of 1 to 5 with 5 for the question being better experience/satisfaction. Following completion of enrollment, all data will be aggregated and analyzed to determine mean and standard deviation of all questions. |
| Delivery process related outcomes #1 | At initial encounter. | Total length of time of the intervention beginning after consent and ending with provision of contraception, contraceptive script, or declining initiation of contraception. |
| Contraceptive continuation | At 3,6, and 12 months. | Percentage of participants that are using hormonal contraception in the intervention group as compared to the control group at 1, 3, 6 and 12 months. |
| Pregnancy rates | 12 months. | The number of participants that become pregnant within 12 months in the intervention group verses the control group. |
| Delivery process related outcomes #4 | At initial encounter. | Providers (doctors and nurses) experience and satisfaction survey for initial visit in ED. Likert 5 point scale will be used with the following rating options strongly agree, agree, no opinion, disagree, or strongly disagree. Data will be stored in original language and in a numerical scale, with a range of 1 to 5 with 5 for the question being better experience/satisfaction. Following completion of enrollment, all data will be aggregated and analyzed to determine mean and standard deviation of all questions. |
Countries
United States
Outcome results
None listed