Meaningful Use of Technology to Improve Health Care Delivery

NCT ID: NCT01641380

Last Updated: 2021-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2017-09-01

Brief Summary

While there have been major declines in teenage pregnancy around the country, Baltimore, Maryland has continued to experience increases over the last several years. Access and adherence to contraception has been found to be a major contributor to declines in teen pregnancy worldwide. The aim of this proof of concept pilot project is to determine preliminary efficacy of the DepoText Intervention. We will randomize urban adolescent girls who have elected Depo-Provera for ongoing contraception to receive either standard counseling and clinic appointment reminders or a text messaging (DepoTEXT) follow-up intervention. Participants in the DepoTEXT intervention will receive reminders for clinic visits and encouraging messages each month for STI prevention. The primary outcome is the preliminary efficacy for improving appointment adherence.

Detailed Description

Aims:

The aim of this proof of concept pilot project is to determine the feasibility and acceptability of a text messaging reminder system for communicating with urban adolescents using Depo-Provera for long-acting contraception. We will randomize urban adolescent girls who have elected Depo-Provera for ongoing contraception to receive either standard counseling and clinic appointment reminders or a text messaging (DepoTEXT) follow-up intervention. Participants in the DepoTEXT intervention will receive reminders for clinic visits and encouraging messages each month for STI prevention. The primary outcome is the preliminary efficacy for improving appointment adherence. Secondary measures include patient responsiveness to text messages and acceptability/satisfaction with this approach.

Setting and Participants:

This research study will be conducted in the Johns Hopkins Harriet Lane Clinic located Baltimore, Maryland. As noted above, Baltimore currently has rates of teen pregnancy that are significantly higher than statewide rates.5, 6 The United States Census estimates that there are 47,710 adolescents between the ages of 15-19 years in Baltimore. 7 Using 2007 Youth Risk Behavior Survey estimates, approximately 35,829 youth in this age group are having sexual intercourse and 13,302 are not using condoms for either STI or pregnancy prevention. 20 The current rise in birth rates to teens in urban Baltimore has prompted a joint initiative involving the mayor's office, Baltimore City Health Department, Urban Health Institute, and Healthy Teen Network.21

The Harriet Lane Clinic located in East Baltimore primarily serves low-income African American families from the neighboring communities. Adolescents and young adults in East Baltimore have high rates of pregnancy and STIs. During the 1st 12-months of funding of the Johns Hopkins Harriet Lane Teen Clinic's Title X Program, the majority of clients were females aged 15 to 25 years (83%), uninsured (52%), and minors seeking confidential services (50%). The program provides sexual/reproductive health services to young persons who are uninsured, underinsured and seeking confidential services. More than 80% of patients served by the clinic participate in a Medicaid Managed Care Organization. While there are approximately 250 individuals on the Depo-Provera logs, the Harriet Lane Clinic currently has more than 100 active users, but adherence to scheduled Depo-Provera appointments remains a problem despite access to care through our clinical site.

Recruitment:

Adolescent girls 13-21 who have 1) elected Depo-Provera for long-acting contraception and 2) have an active cell phone for their personal use will be asked by the adolescent nurse case manager and/or research staff at 1) routine clinical visits and 2) through telephone outreach if they would be willing to participate in a quality improvement intervention that involved random assignment to the text messaging intervention that reminds them of their next Depo-Provera visit via text message or the standard clinic reminders via phone.

All recruitment will take place in the confines of their private room during their routine clinical visits for family planning or via phone at the preferred contact number listed by the patient. The same degree of privacy will be afforded as during the clinical visit or during routine follow-up phone calls.

Randomization & Blinding As noted in the above schematic, adolescents who agree to participate will be randomized to the intervention or control arms at the time of enrollment. A computer-generated randomization sequence for block randomization (5 units) will be employed. Ordered envelopes will be generated for each enrollment packet to guide the research staff regarding group assignment.

Interventions All adolescents will receive care from the Harriet Lane Adolescent Medicine Clinic according to the existing clinical protocol. During "Depo visits" patients receive a nursing assessment, medical assessment if indicated, counseling, and if all is well their next injection, an appointment card with the date of the next injection. Patients are also offered automatic clinic reminders via their home phone. All adolescents in the study will complete a baseline interview and brief follow-up interview at each visit based on the standard interviews conducted by staff at each Depo-Provera visit. Adolescents who are enrolled by phone will be asked the questions via phone and then interviewed at the next visit.

In addition to standard of care and brief study interviews, adolescents in the Depo-TEXT intervention will be provided with online enrollment in the Compliance for Life® (CFL) system through iReminder) to receive a welcome Message 24 hrs after enrollment, appointment reminders prior to 3 month injection cycles, monthly health reminders (condom use, weight control on Depo-Provera, side effect management, 6-month STD testing reminder, call for text replies to reschedule missed appointments.) Intervention participants will receive standard of care for those enrolled in the Depo-Provera clinical program through which a nurse case manager responds to self-activated queries for assistance and missed clinic appointments.

Patients will be followed for adherence for 2-3 Depo-Provera injection cycles depending on the time of enrollment.

Human subjects Protections:

All participants will provide informed oral consent and/or via phone and will be informed that their participation in the study will have no effect on subsequent medical care. All patient data will be kept confidential and secure by using subject ID numbers, electronic collection of survey information and storage on secure servers with password protection for access. All research team members on this project have been educated in the protection of human research participants and the treatment of protected health information as evidenced by completion of their institutional compliance courses. Research assistants have completed the compliance courses as a part of their staff training. We are also using an established provider of global, secure and regulatory HIPAA compliant patient communication solutions to healthcare and biopharmaceutical research sectors to engage adolescents using SMS technology.

Conditions

Contraceptive Behavior

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Control

Adolescents in the Control Arm received standard of care. They continue to receive the DepoProvera injections through scheduled appointment, but would not receive a call from the nurse case manager regarding DepoProvera appointments until they have missed their scheduled DepoProvera appointment.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Text Messaging Intervention

Adolescents in the intervention arm receive text message reminders for appointments and positive sexual health messages regarding use of DepoProvera in between scheduled appointments. They are encouraged to seek care for assistance with obtaining condoms and/or if they are having problems with the medication.

Group Type: EXPERIMENTAL

Text Messaging Intervention

Intervention Type: BEHAVIORAL

1. Online enrollment in the Compliance for Life® (CFL) system through iReminder)

2. Welcome Message 24 hrs after enrollment

3. Appointment Reminder prior to 3 month injection cycles

4. Monthly health reminders i. Condom use ii. Weight control iii. Side Effect Management 5.6-month STD testing reminder

6.Call for missed appointment or no reply to appointment reminder (or other text message)

Interventions

Text Messaging Intervention

1. Online enrollment in the Compliance for Life® (CFL) system through iReminder)

2. Welcome Message 24 hrs after enrollment

3. Appointment Reminder prior to 3 month injection cycles

4. Monthly health reminders i. Condom use ii. Weight control iii. Side Effect Management 5.6-month STD testing reminder

6.Call for missed appointment or no reply to appointment reminder (or other text message)

Intervention Type: BEHAVIORAL

Other Intervention Names

Compliance for Life®

Eligibility Criteria

Inclusion Criteria

• Selected Depo-Provera for ongoing contraception
• Have a cell phone with text messaging capacity for personal use, and
• Agree to be randomized

Exclusion Criteria

• Adolescent girls using other forms of contraception
• Adolescents who do not have a cell phone w/ text messaging capability for personal use

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

The Thomas Wilson Sanitarium for Children of Baltimore City

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maria Trent, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins School of Medicine

Locations

Johns Hopkins Children's Center

Baltimore, Maryland, United States

Countries

United States

Related Links

http://trials.johnshopkins.edu/studyData.cfm?sdUUID=591B710E-D80A-1D0A-C128FF733488EB93

Registration link on Johns Hopkins ICTR Trials Registry

Other Identifiers

NA_00043284

Identifier Type: -

Identifier Source: org_study_id