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| ID | Type | Description | Link |
|---|---|---|---|
| 5R21HD095096-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Children's Mercy Hospital Kansas City | OTHER |
| University of Pittsburgh | OTHER |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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This multi-site study is employing a brief contraception counseling intervention in the Emergency Department (ED) to shed light on factors that affect decision making as well as barriers and facilitators to conception initiation in the Emergency Department (ED) setting. The overarching goal of the study is to reduce unintended pregnancy among females ages 15 to 18 who present to the Emergency Department (ED).
This study is a prospective cohort study involving females who present to one of two emergency departments (ED) between the ages of 16 and 18, who are at risk of unintended pregnancy.
Our primary objective is to assess intention to initiate contraception ("high"=very/somewhat likely vs "low"=unsure/not likely/definitely not on Likert scale survey) among females aged 15 to 18 years who receive emergency department-based contraceptive counseling.
Our secondary objectives are as follows:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Counseling Intervention | Experimental | All participants will receive contraception counseling by study Advanced Practice Providers (APPs) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Contraception Counseling | Behavioral | Each participant will receive a 10 minute confidential contraception counseling session with an APP in the Emergency Department |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intention to Initiate Contraception | Intention to initiate contraception at Emergency Department (ED) or follow-up visit from survey responses | up to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Contraceptive Care Referral Completion | Participants completed a referral visit for any contraception care | up to 8 weeks |
| Initiation of Contraception | Participant has started contraception as evidenced by electronic medical record view and follow-up phone calls or surveys |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Unique Themes Affecting Decision-Making | Semistructured interviews were conducted and analyzed using grounded theory to elucidate the factors that affect decision-making around contraception initiation. Only a subset of enrolled adolescents participated in interviews which were optional (28 participants). Factors were based on a theoretical framework called eTPB, the ecologically expanded theory of planned behavior, relying on attitudes, subjective norms, community, health care and perceived behavioral control factors to explain behavior. Interview analysis yielded the following factors: concerns about contraception side effects and safety, previous experiences with contraception, reasons for using contraception, peer, family and partner influence, social media, pregnancy rates, and access to contraception eduction, provider encounters, confidence in contraception decision making and knowledge, and the ED session characteristics; all of the above factors corresponded with a construct from eTPB. |
Inclusion Criteria:
Exclusion Criteria:
APPs: [no age limit]] Have been working in ED 6 months
Individuals who identify as females and are at risk of getting pregnant.
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| Name | Affiliation | Role |
|---|---|---|
| Cynthia J Mollen, MD, MSCE | Children's Hospital of Philadelphia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Mercy Hospital | Kansas City | Missouri | 64108 | United States | ||
| Children's Hospital of Philadelphia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Hoffman SD, Maynard RA. Kids having kids: Economic costs & social consequences of teen pregnancy. The Urban Institute; 2008. | ||
| Background | Teen Childbearing Cost Taxpayers $9.4 Billion in 2010 [press release]. 2013. | ||
| 25535265 | Background | Miller E, Goldstein S, McCauley HL, Jones KA, Dick RN, Jetton J, Silverman JG, Blackburn S, Monasterio E, James L, Tancredi DJ. A school health center intervention for abusive adolescent relationships: a cluster RCT. Pediatrics. 2015 Jan;135(1):76-85. doi: 10.1542/peds.2014-2471. Epub 2014 Dec 22. | |
| Background | Guttmacher Institute. Adolescent pregnancy and its outcomes across countries. Fact Sheet; August 2015. https://www.guttmacher.org/fact-sheet/adolescent-pregnancy-and-its-outcomes-across-countries; accessed January 12, 2018. | ||
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Only the site PIs and team will have access to study data.
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Adolescents and APPs were enrolled from Emergency Departments of two geographically distinct urban pediatric hospitals.
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| ID | Title | Description |
|---|---|---|
| FG000 | Contraception Counseling in ED | APPs administer contraception counseling to adolescents. Adolescents complete survey and follow up data, and APP completes feasibility data. |
| FG001 | APP Contraception Counseling Training | APPs are trained to conduct a brief contraception counseling session with adolescents in the ED. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
96 participants were assessed at baseline, received the adolescent counseling intervention and completed outcome information. Please note, no baseline measures were collected for the APP participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Adolescent Counseling Intervention | All adolescent participants will receive contraception counseling. Contraception Counseling: Each participant will receive a 10 minute confidential contraception counseling session with an Advanced Practice Provider(APP) in the Emergency Department Please note, no baseline measures were collected for APP participants. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Please note, no baseline measures were collected for APP participants. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Intention to Initiate Contraception | Intention to initiate contraception at Emergency Department (ED) or follow-up visit from survey responses | Those who reported "high intention" to initiate contraception | Posted | Count of Participants | Participants | up to 8 weeks |
|
|
Up to eight weeks
Up to eight weeks after the index ED visit participants were contacted by text message to complete a follow-up survey assessing referral completion and contraception initiation.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Counseling Intervention | All participants will receive contraception counseling. Contraception Counseling: Each participant will receive a 10 minute confidential contraception counseling session with an Advanced Practice Provider in the Emergency Department |
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Coronavirus (COVID) 19 occurred during the study recruitment period and impacted the duration of time needed to reach our recruitment goals, and our ability to reach our initial recruitment goals. The sample size was recalculated to establish a suitable reduced sample size achievable within the confines of the study enrollment period and study budget.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Cynthia Mollen | Children's Hospital of Philadelphia | 2153701217 | mollenc@chop.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 23, 2019 | Oct 3, 2019 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Advanced Practice Providers | Jun 11, 2019 | Oct 3, 2019 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Patients | Sep 9, 2019 | Oct 3, 2019 | ICF_002.pdf |
Not provided
| ID | Term |
|---|---|
| D003268 | Contraception Behavior |
| ID | Term |
|---|---|
| D043762 | Reproductive Behavior |
| D001519 | Behavior |
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Contraception counseling will occur for all adolescent participants and APPs will be enrolled to conduct counseling. The number of participants enrolled includes the final number of participants including adolescent and APPs.
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| up to 12 weeks |
| up to 12 weeks |
| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
| 27595471 |
| Background |
| Lindberg L, Santelli J, Desai S. Understanding the Decline in Adolescent Fertility in the United States, 2007-2012. J Adolesc Health. 2016 Nov;59(5):577-583. doi: 10.1016/j.jadohealth.2016.06.024. Epub 2016 Aug 29. |
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| 23528510 | Background | Mollen CJ, Miller MK, Hayes KL, Barg FK. Knowledge, attitudes, and beliefs about emergency contraception: a survey of female adolescents seeking care in the emergency department. Pediatr Emerg Care. 2013 Apr;29(4):469-74. doi: 10.1097/PEC.0b013e31828a3249. |
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| 21676058 | Background | Miller MK, Plantz DM, Dowd MD, Mollen CJ, Reed J, Vaughn L, Gold MA. Pediatric emergency health care providers' knowledge, attitudes, and experiences regarding emergency contraception. Acad Emerg Med. 2011 Jun;18(6):605-12. doi: 10.1111/j.1553-2712.2011.01079.x. |
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| Background | Office of Disease Prevention and Health Promotion. Healthy People 2020. https://www.healthypeople.gov/2020/topics-objectives/topic/family-planning/objectives; Accessed December 12, 2017. |
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| BG001 |
| APP Contraception Counseling Training |
All adolescent participants will receive contraception counseling. Contraception Counseling: Each participant will receive a 10 minute confidential contraception counseling session with an Advanced Practice Provider(APP) in the Emergency Department Please note, no baseline measures were collected for APP participants. |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | Please note, no baseline measures were collected for APP participants. | Mean | Full Range | years |
|
| Sex: Female, Male | Please note, no baseline measures were collected for APP participants. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Please note, no baseline measures were collected for APP participants. | Count of Participants | Participants |
|
| Region of Enrollment | Three of participants enrolled initially were not included in study analysis due to enrollment eligibility errors or having not received contraception counseling. Among the 96 participants remaining who completed study measures and were included in analysis, 45 were enrolled at cmh (site 2). Please note, no baseline measures were collected for APP participants. | Count of Participants | Participants |
|
| Participants |
|
|
| Secondary | Contraceptive Care Referral Completion | Participants completed a referral visit for any contraception care | Posted | Count of Participants | Participants | up to 8 weeks |
|
|
|
| Secondary | Initiation of Contraception | Participant has started contraception as evidenced by electronic medical record view and follow-up phone calls or surveys | Posted | Count of Participants | Participants | up to 12 weeks |
|
|
|
| Other Pre-specified | Number of Unique Themes Affecting Decision-Making | Semistructured interviews were conducted and analyzed using grounded theory to elucidate the factors that affect decision-making around contraception initiation. Only a subset of enrolled adolescents participated in interviews which were optional (28 participants). Factors were based on a theoretical framework called eTPB, the ecologically expanded theory of planned behavior, relying on attitudes, subjective norms, community, health care and perceived behavioral control factors to explain behavior. Interview analysis yielded the following factors: concerns about contraception side effects and safety, previous experiences with contraception, reasons for using contraception, peer, family and partner influence, social media, pregnancy rates, and access to contraception eduction, provider encounters, confidence in contraception decision making and knowledge, and the ED session characteristics; all of the above factors corresponded with a construct from eTPB. | The total number of unique themes for all participants was reported based on qualitative analysis. 28 adolescents participated in interviews out of the total number of adolescents enrolled in the study. This portion of the study was optional. | Posted | Number | themes | up to 12 weeks |
|
|
|
| 0 |
| 99 |
| 0 |
| 99 |
| 0 |
| 99 |
| EG001 | APP Contraception Counseling Training | APPs are trained to conduct a brief contraception counseling session with adolescents in the ED. | 0 | 27 | 0 | 27 | 0 | 27 |
Not provided
Not provided