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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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"). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 20 months |
Inclusion Criteria:
Exclusion Criteria (specifically for Aims 2 and 3):
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Samantha Garbers, PhD | Associate Professor of Population & Family Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Irving Medical Center | New York | New York | 10032 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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"). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 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"). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Units | device initiations | Up to 20 months | device initiations | device initiations |
|
Up to 20 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 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"). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Samantha Garbers, PhD, Principal Investigator | Columbia University | 212-305-0123 | svg2108@cumc.columbia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 5, 2024 | May 19, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003268 | Contraception Behavior |
| ID | Term |
|---|---|
| D043762 | Reproductive Behavior |
| D001519 | Behavior |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | 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. | Posted | Count of Units | Device initiator survey respondent | Up to 20 months | Device initiator survey respondent | Device initiator survey respondent |
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| Primary | 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. | 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. | Posted | Median | 95% Confidence Interval | percent | At 6 months post LARC initiation | device initiations | device initiations |
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| Other Pre-specified | 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). | Due to low number of LARC initiations, there was insufficient statistic power to detect differences in continuation. The data therefore cannot be analyzed. | Posted | Up to 20 months |
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| 0 |
| 75 |
| 0 |
| 75 |
| 0 |
| 75 |
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| Very dissatisfied with post-initiation visit |
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| Did not respond |
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| Contraceptive implant |
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| IUD |
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