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

January 18, 2017 updated by: Lauren S. Chernick, Columbia University

Texting 2 Initiate: A Pilot Study Using Text Messaging to Communicate With Adolescent Females in the Pediatric Emergency Department (T2I)

The objective of this study is to develop and test an emergency department (ED)-based intervention which uses text messages to facilitate contraception initiation.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New York
      • Manhattan, New York, United States, 10032
        • Morgan Stanley Children's Hospital Emergency Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months after initial enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient visits to Family Planning Clinic
Time Frame: 3 months after initial enrollment
We assess Family Planning Clinic visits using our electronic medical records.
3 months after initial enrollment
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 months after initial enrollment
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.
3 months after initial enrollment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Text messaging intervention safety
Time Frame: 3 months after initial enrollment
Safety will be assessed during the telephone follow up.
3 months after initial enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Lauren Chernick, MD, Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2014

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

March 19, 2014

First Submitted That Met QC Criteria

March 19, 2014

First Posted (Estimate)

March 21, 2014

Study Record Updates

Last Update Posted (Estimate)

January 20, 2017

Last Update Submitted That Met QC Criteria

January 18, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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