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

NCT04840836 | Completed Results

• 1 other identifier: AAAT6596
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective observational cohort study that will include SBHC patients at the 6 participating SBHCs who receive a reproductive health visit as part of their care in a setting where telehealth-supported care is available. Information will be collected during patient interviews in the follow-up observation period regarding LARC initiation, satisfaction and continuation. Aim 1. Quantify uptake of LARC (contraceptive implant, IUD) within the SBHC network following implementation of telehealth-supported LARC provision. Aim 2: Describe the implementation of telehealth-supported long-acting reversible contraception (LARC) service provision in school-based health centers (SBHCs) using mixed methods. Aim 3: Quantify LARC continuation, as in absolute continuation rate 12 months post-initiation, with analyses also examining continuation at 6 months follow-up period, among LARC initiators within the SBHC network following implementation of telehealth-supported LARC provision. Aim 4: Compare continuation rates across dimensions of telehealth experience.

Conditions

Long Acting Reversible Contraception; Contraception Behavior

Keywords

LARC

Outcome Measures

Primary Outcomes (3)

• 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.

  Up to 20 months

• 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.

  Up to 20 months

• 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.

  At 6 months post LARC initiation

Other Outcomes (1)

• Continuation Rate Across Dimensions of Telehealth Experience

  Up to 20 months

Study Arms (1)

Telehealth-supported LARC provision

Patients who receive care at the SBHC provide informed consent for care, as well as record review for quality assurance purposes. Analyses will include female patients who have a "reproductive health visit," which includes contraceptive counseling, contraceptive management, or contraceptive method initiation, during the study period. Patients who have a telehealth consultation with a SBHC medical provider for LARC services (conservatively estimated n=113) will be considered enrolled patients once the data are extracted from the electronic health record (EHR) system.

Behavioral: Telehealth-supported LARC provision

Interventions

Telehealth-supported LARC provision BEHAVIORAL

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").

Also known as: LARC method

Telehealth-supported LARC provision

Eligibility Criteria

• Age: 13 Years - 22 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

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.

You may qualify if:

• an enrolled patient at the participating SBHC
• age 13-22 years
• female
• had a visit at the SBHC during the study period that is coded as a "reproductive health visit" including contraceptive counseling, contraceptive management, and contraceptive method initiation

You may not qualify if:

• are younger than age 13 years
• are older than age 22
• are not an enrolled patient of the participating SBHCs
• did not initiate a LARC method
• are a person without a uterus
• are unable to read, speak, and understand either English or Spanish

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Contraception Behavior

Condition Hierarchy (Ancestors)

Reproductive Behavior; Behavior

Results Point of Contact

• Title: Samantha Garbers, PhD, Principal Investigator
• Organization: Columbia University

svg2108@cumc.columbia.edu

212-305-0123

Study Officials

• Samantha Garbers, PhD

  Associate Professor of Population & Family Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2021
• First Posted: April 12, 2021
• Study Start: April 20, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: June 22, 2025
• Results First Posted: June 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)