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

Contraception Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04840836
• Other study ID #: AAAT6596
• Status: Active, not recruiting
• Start date: April 20, 2021
• Est. completion date: May 2023

Study information

• Verified date: July 2022
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a prospective observational cohort study that will include SBHC patients at the 6 participating SBHCs who receive a telehealth reproductive health visit as part of their care. 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.

Description:

Long acting reversible contraceptives (LARCs) are safe and effective for adolescents, but low rates of use among this population and early discontinuation due to method dissatisfaction limits their potential to reduce unintended pregnancy. Reducing barriers for obtaining LARCs by adolescents who want to use them is key in reducing risk of unintended pregnancy. Data will be collected from patients who are receiving same-day LARC as a part of their normal care via telehealth services in school-based health centers (SBHCs). This implementation model, therefore, has the potential for replication and scale-up with wide reach. The findings from this study, given the SBHC setting, have the potential to inform and improve LARC service delivery for adolescents far beyond New York City and the SBHC setting.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 113
• Est. completion date: May 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 13 Years to 22 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria (specifically for Aims 2 and 3):

• 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

Related Conditions & MeSH terms

• Contraception Behavior
• Long Acting Reversible Contraception

Intervention

Behavioral:
• Telehealth-supported LARC provision
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").

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uptake of LARC (contraceptive implant, IUD) within the SBHC network following implementation of telehealth-supported LARC provision	Among all patients who had a telehealth visit for contraceptive counseling, quantify the number/rate 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 2 years
Primary	Proportion 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 2 years
Primary	Change in 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, and Cox proportional hazard models to compare LARC continuation by LARC type. Continuation rates will be expressed both as rates at 6 months and 12 months post-initiation, and using Kaplan-Meier curves to model discontinuation.	At 6 months and 12 months post LARC initiation
Primary	Continuation rate across dimensions of telehealth experience	Merging electronic health record (EHR) data on method continuation with baseline survey data on the telehealth experience, we will compare, using Cox proportional hazard models, continuation (overall and within LARC type): by telehealth experience (e.g. satisfaction with telehealth).	Up to 2 years