Trial Outcomes & Findings for Study of the Implementation of Telehealth-Supported LARC Provision in School-Based Health Centers (NCT NCT04840836)

Last Updated: 2025-06-22

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

75 participants

Primary outcome timeframe

Up to 20 months

Results posted on

2025-06-22

Participant Flow

Unit of analysis: device initiations

Participant milestones

Participant milestones
Measure	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 will be considered enrolled patients once the data are extracted from the EHR. 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").
Overall Study STARTED	75 77
Overall Study COMPLETED	75 77
Overall Study NOT COMPLETED	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Telehealth-supported LARC Provision n=75 Participants 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 EHR. 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").
Age, Continuous	16.65 years n=93 Participants
Sex: Female, Male Female	75 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	33 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	32 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	11 Participants n=93 Participants
Race (NIH/OMB) White	7 Participants n=93 Participants
Race (NIH/OMB) More than one race	26 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	31 Participants n=93 Participants
Region of Enrollment United States	75 participants n=93 Participants

PRIMARY outcome

Timeframe: Up to 20 months

Outcome measures

Outcome measures
Measure	Telehealth-supported LARC Provision n=77 device initiations 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 will be considered enrolled patients once the data are extracted from the EHR. 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").
Number of Telehealth and Non-Telehealth LARC Device Initiations Within the SBHC Network Telehealth visit	4 device initiations
Number of Telehealth and Non-Telehealth LARC Device Initiations Within the SBHC Network No telehealth visit	73 device initiations

PRIMARY outcome

Timeframe: Up to 20 months

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.

Outcome measures

Outcome measures
Measure	Telehealth-supported LARC Provision n=45 Device initiator survey respondent 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 will be considered enrolled patients once the data are extracted from the EHR. 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").
Percentage of Patients Reported Being Satisfied With Telehealth-supported Care Very satisfied with post-initiation visit	33 Device initiator survey respondent
Percentage of Patients Reported Being Satisfied With Telehealth-supported Care Somewhat satisfied with post-initiation visit	3 Device initiator survey respondent
Percentage of Patients Reported Being Satisfied With Telehealth-supported Care Somewhat dissatisfied with post-initiation visit	0 Device initiator survey respondent
Percentage of Patients Reported Being Satisfied With Telehealth-supported Care Very dissatisfied with post-initiation visit	0 Device initiator survey respondent
Percentage of Patients Reported Being Satisfied With Telehealth-supported Care Did not respond	9 Device initiator survey respondent

PRIMARY outcome

Timeframe: At 6 months post LARC initiation

Population: Only distinct initiators are included in this analysis. The 2 patients who initiated more than one LARC method were only counted once here; one patient had two IUD insertions, the other had IUD followed by contraceptive implant. The patient is included with their initial method in this analysis.

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.

Outcome measures

Outcome measures
Measure	Telehealth-supported LARC Provision n=75 device initiations 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 will be considered enrolled patients once the data are extracted from the EHR. 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").
LARC Continuation Rate Over a Follow-up Period Among LARC Initiators Within the SBHC Network Following Implementation of Telehealth-supported LARC Provision Overall	79.3 percent Interval 69.0 to 91.1
LARC Continuation Rate Over a Follow-up Period Among LARC Initiators Within the SBHC Network Following Implementation of Telehealth-supported LARC Provision Contraceptive implant	80.7 percent Interval 68.7 to 94.8
LARC Continuation Rate Over a Follow-up Period Among LARC Initiators Within the SBHC Network Following Implementation of Telehealth-supported LARC Provision IUD	76.7 percent Interval 59.1 to 99.6

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 20 months

Population: Due to low number of LARC initiations, there was insufficient statistic power to detect differences in continuation. The data therefore cannot be analyzed.

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).

Outcome measures

Outcome data not reported

Adverse Events

Telehealth-supported LARC Provision

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Samantha Garbers, PhD, Principal Investigator

Columbia University

Phone: 212-305-0123

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place