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A Pilot Study Using Text Messaging to Communicate With Adolescent Females in the Pediatric Emergency Department (T2I)

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ClinicalTrials.gov Identifier: NCT02093884
Recruitment Status : Completed
First Posted : March 21, 2014
Last Update Posted : January 20, 2017
Sponsor:
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
Lauren S. Chernick, Columbia University

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.

Condition or disease Intervention/treatment
Pregnancy Other: Text Messaging Intervention Other: Standard Referral

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Texting 2 Initiate: A Pilot Study Using Text Messaging to Communicate With Adolescent Females in the Pediatric Emergency Department (T2I)
Actual Study Start Date : January 2014
Primary Completion Date : March 2015
Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Text Messaging Intervention
Patients in the text messaging group will receive educational and motivational text messages.
Other: Text Messaging Intervention
Active Comparator: Standard Referral
Patients in the standard referral arm will receive paper based information about the Family Planning Clinic.
Other: Standard Referral



Primary Outcome Measures :
  1. Initiation of highly effective contraception, as defined by the World Health Organization. [ Time Frame: 3 months after initial enrollment ]
    We will be assessing contraception initiation rates based on electronic medical record review and telephone call follow up.


Secondary Outcome Measures :
  1. Patient visits to Family Planning Clinic [ Time Frame: 3 months after initial enrollment ]
    We assess Family Planning Clinic visits using our electronic medical records.

  2. Follow up for contraceptive counseling to a doctor or nurse [ Time Frame: 3 months after initial enrollment ]
    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.

  3. Change in pregnancy intentions [ Time Frame: 3 months after initial enrollment ]
    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.


Other Outcome Measures:
  1. Text messaging intervention safety [ Time Frame: 3 months after initial enrollment ]
    Safety will be assessed during the telephone follow up.



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Ages Eligible for Study:   14 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02093884


Locations
United States, New York
Morgan Stanley Children's Hospital Emergency Department
Manhattan, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Society of Family Planning
Investigators
Principal Investigator: Lauren Chernick, MD Columbia University

Responsible Party: Lauren S. Chernick, Assistant Professor of Pediatrics, Columbia University
ClinicalTrials.gov Identifier: NCT02093884     History of Changes
Other Study ID Numbers: AAAM3457
First Posted: March 21, 2014    Key Record Dates
Last Update Posted: January 20, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Lauren S. Chernick, Columbia University:
Pregnancy
Pregnancy, unplanned
Reproductive behavior
Pregnancy in Adolescence
Text messaging

Additional relevant MeSH terms:
Emergencies
Disease Attributes
Pathologic Processes