Study of the Implementation of Telehealth-Supported LARC Provision in School-Based Health Centers

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 13 to 22 years
• Women only
• Healthy volunteers accepted
• Child, Adult

Study population: Based on SBHC clinical data from the full academic year (2018-19), it is estimated that, over the 12 month cohort there will be 113 telehealth consultations, defined as a visit in which an appointment is scheduled to initiate a LARC methods (Aim 1), and 102 LARC insertions (Aim 2). The SBHC patient population, as a whole, is 69% Hispanic and 26% Black (not mutually exclusive), with an average age of 16 years.

Trial locations and contacts

1 site in 1 country.

About this study

Official title: A Prospective Observational Study of the Implementation of Telehealth-Supported LARC Provision in School-Based Health Centers

Conditions

Long Acting Reversible Contraception, Contraception Behavior

Being tested

Telehealth-supported LARC provision

Keywords

LARC

Medical subject headings

Contraception Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Telehealth-supported LARC provisionBehavioural

  Also called LARC method

  Provision of LARC in routine care will include a hybrid model of telehealth-supported long-acting reversible contraception (LARC) service provision in a network of 6 school-based health centers (SBHCs) in New York City that serve adolescents and young adult high school students age 13-22 years (hereafter referred to as "adolescents").

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Number of Telehealth and Non-Telehealth LARC Device Initiations Within the SBHC Network

   Among all patients who had a visit for contraceptive counseling, quantify the number of telehealth LARC consultations and LARC initiations overall, and compare by LARC type (contraceptive implant vs. IUD) using data collected from patient interviews.

   Measured: Up to 20 months

2. Percentage of Patients Reported Being Satisfied With Telehealth-supported Care

   A qualitative interview and a quantitative survey will be used to assess LARC patients' experience and satisfaction with telehealth-supported care. Patients will be assessed by investigator as satisfied or not satisfied based on their responses.

   Measured: Up to 20 months

3. LARC Continuation Rate Over a Follow-up Period Among LARC Initiators Within the SBHC Network Following Implementation of Telehealth-supported LARC Provision

   Using EHR data for all patients who initiated LARC, investigator will use Kaplan-Meier survival curves to assess LARC discontinuation overall. Continuation rate will be expressed as a percentage at 6 months post-initiation, and using Kaplan-Meier curves to model discontinuation.

   Measured: At 6 months post LARC initiation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted12 Apr 2021
2. Study start20 Apr 2021
3. Primary completion31 Dec 2022
4. Study completion31 Dec 2022

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
• Other trials for Long Acting Reversible ContraceptionStudies of the same condition, open and under way.
• More trials run by Columbia UniversityThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.