Back to resultsA Pilot Study Using Text Messaging to Communicate With Adolescent Females in the Pediatric Emergency Department (T2I)
Primary Purpose
Pregnancy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Text Messaging Intervention
Standard Referral
Sponsored by
About this trial
This is an interventional prevention trial for Pregnancy focused on measuring Pregnancy, Pregnancy, unplanned, Reproductive behavior, Pregnancy in Adolescence, Text messaging
Eligibility Criteria
Inclusion Criteria:
- Aged 14-19 years
- Sexually active with males in the past three months
- Presenting to the ED for a reproductive health complaint.
Exclusion Criteria:
- Presently pregnant
- Too ill for participation per the attending physician
- Cognitively impaired
- In foster care or a ward of the state
- Does not speak English or Spanish
- Does not own a cellular or mobile phone with text messaging capabilities
- Used contraception at last intercourse and/or is currently using any "highly effective" or "effective" form of contraception (as defined by the World Health Organization)
- Does not live in Manhattan or the Bronx
Sites / Locations
- Morgan Stanley Children's Hospital Emergency Department
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Text Messaging Intervention
Standard Referral
Arm Description
Patients in the text messaging group will receive educational and motivational text messages.
Patients in the standard referral arm will receive paper based information about the Family Planning Clinic.
Outcomes
Primary Outcome Measures
Initiation of highly effective contraception, as defined by the World Health Organization.
We will be assessing contraception initiation rates based on electronic medical record review and telephone call follow up.
Secondary Outcome Measures
Patient visits to Family Planning Clinic
We assess Family Planning Clinic visits using our electronic medical records.
Follow up for contraceptive counseling to a doctor or nurse
We will be asking patients during our phone call follow if they have had contraceptive counseling with any healthcare professional. We will also be looking through electronic medical records for documentation of contraceptive counseling such as by ICD-9 coding or a physician's/nurse's note.
Change in pregnancy intentions
We will compare pregnancy intentions elicited from the answers provided in the baseline questionnaire to those reported on the telephone follow up for both study arms.
Full Information
NCT ID
NCT02093884
First Posted
March 19, 2014
Last Updated
January 18, 2017
Sponsor
Columbia University
Collaborators
Society of Family Planning
1. Study Identification
Unique Protocol Identification Number
NCT02093884
Brief Title
A Pilot Study Using Text Messaging to Communicate With Adolescent Females in the Pediatric Emergency Department
Acronym
T2I
Official Title
Texting 2 Initiate: A Pilot Study Using Text Messaging to Communicate With Adolescent Females in the Pediatric Emergency Department (T2I)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
January 2014 (Actual)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
Society of Family Planning
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study is to develop and test an emergency department (ED)-based intervention which uses text messages to facilitate contraception initiation.
Detailed Description
Our hypothesis is that adolescent females at high pregnancy risk who receive text message reminders and motivational messages that promote contraception and referral to the Family Planning Clinic are more likely to start effective contraception than those who receive standard paper-based referral to the Family Planning Clinic alone.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy
Keywords
Pregnancy, Pregnancy, unplanned, Reproductive behavior, Pregnancy in Adolescence, Text messaging
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Text Messaging Intervention
Arm Type
Experimental
Arm Description
Patients in the text messaging group will receive educational and motivational text messages.
Arm Title
Standard Referral
Arm Type
Active Comparator
Arm Description
Patients in the standard referral arm will receive paper based information about the Family Planning Clinic.
Intervention Type
Other
Intervention Name(s)
Text Messaging Intervention
Intervention Type
Other
Intervention Name(s)
Standard Referral
Primary Outcome Measure Information:
Title
Initiation of highly effective contraception, as defined by the World Health Organization.
Description
We will be assessing contraception initiation rates based on electronic medical record review and telephone call follow up.
Time Frame
3 months after initial enrollment
Secondary Outcome Measure Information:
Title
Patient visits to Family Planning Clinic
Description
We assess Family Planning Clinic visits using our electronic medical records.
Time Frame
3 months after initial enrollment
Title
Follow up for contraceptive counseling to a doctor or nurse
Description
We will be asking patients during our phone call follow if they have had contraceptive counseling with any healthcare professional. We will also be looking through electronic medical records for documentation of contraceptive counseling such as by ICD-9 coding or a physician's/nurse's note.
Time Frame
3 months after initial enrollment
Title
Change in pregnancy intentions
Description
We will compare pregnancy intentions elicited from the answers provided in the baseline questionnaire to those reported on the telephone follow up for both study arms.
Time Frame
3 months after initial enrollment
Other Pre-specified Outcome Measures:
Title
Text messaging intervention safety
Description
Safety will be assessed during the telephone follow up.
Time Frame
3 months after initial enrollment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged 14-19 years
Sexually active with males in the past three months
Presenting to the ED for a reproductive health complaint.
Exclusion Criteria:
Presently pregnant
Too ill for participation per the attending physician
Cognitively impaired
In foster care or a ward of the state
Does not speak English or Spanish
Does not own a cellular or mobile phone with text messaging capabilities
Used contraception at last intercourse and/or is currently using any "highly effective" or "effective" form of contraception (as defined by the World Health Organization)
Does not live in Manhattan or the Bronx
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lauren Chernick, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Morgan Stanley Children's Hospital Emergency Department
City
Manhattan
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32779730
Citation
Palmer MJ, Henschke N, Villanueva G, Maayan N, Bergman H, Glenton C, Lewin S, Fonhus MS, Tamrat T, Mehl GL, Free C. Targeted client communication via mobile devices for improving sexual and reproductive health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013680. doi: 10.1002/14651858.CD013680.
Results Reference
derived
Learn more about this trial
A Pilot Study Using Text Messaging to Communicate With Adolescent Females in the Pediatric Emergency Department
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