Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1K23HD096060-01 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
Not provided
Not provided
Not provided
Not provided
This study will determine the feasibility, acceptability, and potential efficacy of an emergency department-based pregnancy prevention intervention targeting sexually active adolescent female emergency department patients.
Emergency Departments (ED) care for 15 million adolescents each year. Adolescents who use the ED are at particularly high risk of unintended pregnancy. To date, no intervention has successfully increased contraception use among this high risk, hard-to-reach ED population.
In this study, the investigators will conduct a pilot randomized controlled trial of a user-informed, theory-based, personalized, interactive, pregnancy prevention text messaging intervention (Dr. Erica) to determine its feasibility, acceptability and potential efficacy. The investigators hypothesize that high risk adolescent female ED patients who receive Dr. Erica will more often initiate contraceptives than those females who receive standard discharge instructions alone.
At baseline and follow-up assessment at 3 months, participants will provide information regarding effective contraception initiation, any contraception at last intercourse, follow up with reproductive preventive health services, and contraception self-efficacy.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention arm | Experimental | The intervention consists of a brief contraception educational video and then the 10-week texting intervention which consists of 30 automated, personalized and interactive texting algorithms (3 texts per week). |
|
| Control arm | No Intervention | Patients randomized to the control arm will receive the current standard discharge instructions provided in the investigator's ED. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dr. Erica | Behavioral | The 10 week texting intervention contains the follow characteristics to increase engagement: (1) Dr. ERICA (Emergency Room Interventions to Improve the Care of Adolescents): The persona and brand of the intervention is Dr. Erica, a relatable, empathetic, straightforward and reliable female doctor; (2) Personalization: Information collected at baseline will be incorporated into each individualized program; (3) Interactivity: The majority of text message algorithms contain 3-4 two-way automated messaging conversations. (4) Feedback loops: The investigators will collect feedback from participants to prompt action; (5) Visual stimuli: Texts include emojis, memes, and other visual stimuli, similar to current teen texting behaviors; (6) Social media: The investigators designed sexual health comic strips posted as an Instagram story; (7) Links and role modeling: Texts contain links to testimonials, influencers, and evidence-based websites. |
| Measure | Description | Time Frame |
|---|---|---|
| Potential Efficacy: Effective Contraception Initiation Rates [Time Frame: Enrollment, 12 Weeks Post-enrollment (2 Weeks Post Close of Intervention)] | Initiation of effective contraception will be considered positive if participant self-reports initiation of effective contraception at follow up (telephone or online survey). An "effective" form of contraception (as defined by the World Health Organization) includes the following:
| 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility: Percentage of Refusal | Percentage of eligible participants who refused | Baseline |
| Feasibility: Opt Outs Measured Via Mobile Platform | Percentage of enrolled participants in the intervention group who texted to stop receiving messages. |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory Efficacy Outcome: Number of Participants Who Followed up for Preventative Reproductive Care | Participants who reported they did not go to the Columbia Family Planning Clinic over the past 3 months and answered "yes" to the question: "Over the past 3 months, have you seen a doctor for medical care?" In this Outcome, "preventative reproductive care" is defined as any visit to a doctor for the purposes of reproductive health. |
Inclusion Criteria:
Exclusion Criteria:
Female adolescent emergency department patients
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lauren S. Chernick, MD, MSc | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Morgan Stanley Children's Hospital Emergency Department | New York | New York | 10032 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Arm | The intervention consists of a brief contraception educational video and then the 10-week texting intervention which consists of 30 automated, personalized and interactive texting algorithms (3 texts per week). Dr. Erica: The 10 week texting intervention contains the follow characteristics to increase engagement: (1) Dr. ERICA (Emergency Room Interventions to Improve the Care of Adolescents): The persona and brand of the intervention is Dr. Erica, a relatable, empathetic, straightforward and reliable female doctor; (2) Personalization: Information collected at baseline will be incorporated into each individualized program; (3) Interactivity: The majority of text message algorithms contain 3-4 two-way automated messaging conversations. (4) Feedback loops: The investigators will collect feedback from participants to prompt action; (5) Visual stimuli: Texts include emojis, memes, and other visual stimuli, similar to current teen texting behaviors; (6) Social media: The investigators designed sexual health comic strips posted as an Instagram story; (7) Links and role modeling: Texts contain links to testimonials, influencers, and evidence-based websites. |
| FG001 | Control Arm | Patients randomized to the control arm will receive the current standard discharge instructions provided in the investigator's ED. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Arm | Dr. Erica consists of two parts-a digital ED-based brief intervention and multimedia text messaging. |
| BG001 | Control Arm | Those randomized to usual care received an introductory text message to ensure texting capabilities for follow-up. No other edu- cation was provided outside usual care in the ED. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of 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 | Potential Efficacy: Effective Contraception Initiation Rates [Time Frame: Enrollment, 12 Weeks Post-enrollment (2 Weeks Post Close of Intervention)] | Initiation of effective contraception will be considered positive if participant self-reports initiation of effective contraception at follow up (telephone or online survey). An "effective" form of contraception (as defined by the World Health Organization) includes the following:
| Only participants who provided self-report updates at the 3 months follow up mark were included in the analysis. | Posted | Count of Participants | Participants | 3 months |
|
1 year
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Arm | The intervention consists of a brief contraception educational video and then the 10-week texting intervention which consists of 30 automated, personalized and interactive texting algorithms (3 texts per week). Dr. Erica: The 10 week texting intervention contains the follow characteristics to increase engagement: (1) Dr. ERICA (Emergency Room Interventions to Improve the Care of Adolescents): The persona and brand of the intervention is Dr. Erica, a relatable, empathetic, straightforward and reliable female doctor; (2) Personalization: Information collected at baseline will be incorporated into each individualized program; (3) Interactivity: The majority of text message algorithms contain 3-4 two-way automated messaging conversations. (4) Feedback loops: The investigators will collect feedback from participants to prompt action; (5) Visual stimuli: Texts include emojis, memes, and other visual stimuli, similar to current teen texting behaviors; (6) Social media: The investigators designed sexual health comic strips posted as an Instagram story; (7) Links and role modeling: Texts contain links to testimonials, influencers, and evidence-based websites. |
Not provided
Not provided
First, this study was conducted at a single center and represents a predominantly Hispanic population. Second, our intervention was available in only English. Third, participants did not respond to all follow-up questions, which may have affected our findings.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lauren Chernick | Columbia University | 2123056628 | lc2243@columbia.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 | Jan 8, 2019 | Sep 27, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 1, 2020 | Jul 9, 2024 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D043762 | Reproductive Behavior |
| D012725 | Sexual Behavior |
| D000294 | Adolescent Behavior |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
A randomized controlled trial with two arms
Not provided
Not provided
The outcome assessor will be blinded to study enrollment arm.
|
| 3 months |
| Number of Enrolled Participants Who do Not Complete Follow up | Measurement of the feasibility of Dr. Erica among adolescent female users | 3 months |
| Acceptability: Satisfaction With the Intervention Measured Via Online or Telephone Survey | Percentage of participants in the intervention group who followed up and answered that they like the program and would recommend it to friends | 3 months |
| Any Sex Over the Past 3 Months | Self-report of any over the past 3 months. | 1 year |
| 3 months |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG001 | Control Arm | Patients randomized to the control arm will receive the current standard discharge instructions provided in the investigator's ED. |
|
|
| Secondary | Feasibility: Percentage of Refusal | Percentage of eligible participants who refused | Includes those who were eligible for enrollment who were screened for study participation. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Secondary | Feasibility: Opt Outs Measured Via Mobile Platform | Percentage of enrolled participants in the intervention group who texted to stop receiving messages. | Posted | Count of Participants | Participants | 3 months |
|
|
|
| Secondary | Number of Enrolled Participants Who do Not Complete Follow up | Measurement of the feasibility of Dr. Erica among adolescent female users | Includes the total number of participants randomized to each arm, regardless of follow up completion. | Posted | Count of Participants | Participants | 3 months |
|
|
|
| Secondary | Acceptability: Satisfaction With the Intervention Measured Via Online or Telephone Survey | Percentage of participants in the intervention group who followed up and answered that they like the program and would recommend it to friends | Includes all participants in the intervention arm who completed the required follow up post-intervention. | Posted | Count of Participants | Participants | 3 months |
|
|
|
| Secondary | Any Sex Over the Past 3 Months | Self-report of any over the past 3 months. | Includes participants in each arm who completed the follow-up post-intervention. | Posted | Count of Participants | Participants | 1 year |
|
|
|
| Other Pre-specified | Exploratory Efficacy Outcome: Number of Participants Who Followed up for Preventative Reproductive Care | Participants who reported they did not go to the Columbia Family Planning Clinic over the past 3 months and answered "yes" to the question: "Over the past 3 months, have you seen a doctor for medical care?" In this Outcome, "preventative reproductive care" is defined as any visit to a doctor for the purposes of reproductive health. | This population answered "yes" or "no" the question prompted by Dr. Erica: "Over the past 3 months, have you been to the Columbia Family Planning Clinic?" | Posted | Count of Participants | Participants | 3 months |
|
|
|
| 0 |
| 72 |
| 0 |
| 72 |
| 0 |
| 72 |
| EG001 | Control Arm | Patients randomized to the control arm will receive the current standard discharge instructions provided in the investigator's ED. | 0 | 74 | 0 | 74 | 0 | 74 |
Not provided
Not provided