Clinical trial NCT04840836: Study of the Implementation of Telehealth-Supported LARC Provision in School-Based Health Centers
Official title: A Prospective Observational Study of the Implementation of Telehealth-Supported LARC Provision in School-Based Health Centers
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Long Acting Reversible Contraception
Contraception Behavior
Keywords: LARC
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2021-04-12
Enrollment: 113
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Uptake of LARC (contraceptive implant, IUD) within the SBHC network following implementation of telehealth-supported LARC provision
timeFrame: Up to 2 years
measure: Proportion of patients reported being satisfied with telehealth-supported care
timeFrame: Up to 2 years
measure: Change in LARC continuation rate over a follow-up period among LARC initiators within the SBHC network following implementation of telehealth-supported LARC provision
timeFrame: At 6 months and 12 months post LARC initiation
measure: Continuation rate across dimensions of telehealth experience
timeFrame: Up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Associate Professor of Population & Family Health
name: Samantha Garbers, PhD
role: PRINCIPAL_INVESTIGATOR
References: