Contraception Behavior, Long Acting Reversible Contraception
Conditions
Keywords
LARC
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.
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.
Interventions
BEHAVIORALTelehealth-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).
Sponsors
Columbia University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
13 Years to 22 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Telehealth and Non-Telehealth LARC Device Initiations Within the SBHC Network | Up to 20 months | 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. |
| Percentage of Patients Reported Being Satisfied With Telehealth-supported Care | 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. |
| LARC Continuation Rate Over a Follow-up Period Among LARC Initiators Within the SBHC Network Following Implementation of Telehealth-supported LARC Provision | At 6 months post LARC initiation | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Continuation Rate Across Dimensions of Telehealth Experience | Up to 20 months | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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). | 75 |
| Total | 75 |
Baseline characteristics
| Characteristic | Telehealth-supported LARC Provision |
|---|---|
| Age, Continuous | 16.65 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 33 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 32 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants |
| Race (NIH/OMB) More than one race | 26 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 31 Participants |
| Race (NIH/OMB) White | 7 Participants |
| Region of Enrollment United States | 75 participants |
| Sex: Female, Male Female | 75 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 75 |
| other Total, other adverse events | 0 / 75 |
| serious Total, serious adverse events | 0 / 75 |
Outcome results
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Telehealth-supported LARC Provision | 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 |
| Telehealth-supported LARC Provision | 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 |
| Telehealth-supported LARC Provision | 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 |
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.
Time frame: Up to 20 months
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Telehealth-supported LARC Provision | Number of Telehealth and Non-Telehealth LARC Device Initiations Within the SBHC Network | Telehealth visit | 4 device initiations |
| Telehealth-supported LARC Provision | Number of Telehealth and Non-Telehealth LARC Device Initiations Within the SBHC Network | No telehealth visit | 73 device initiations |
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.
Time frame: Up to 20 months
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Telehealth-supported LARC Provision | Percentage of Patients Reported Being Satisfied With Telehealth-supported Care | Very satisfied with post-initiation visit | 33 Device initiator survey respondent |
| Telehealth-supported LARC Provision | Percentage of Patients Reported Being Satisfied With Telehealth-supported Care | Somewhat satisfied with post-initiation visit | 3 Device initiator survey respondent |
| Telehealth-supported LARC Provision | Percentage of Patients Reported Being Satisfied With Telehealth-supported Care | Somewhat dissatisfied with post-initiation visit | 0 Device initiator survey respondent |
| Telehealth-supported LARC Provision | Percentage of Patients Reported Being Satisfied With Telehealth-supported Care | Very dissatisfied with post-initiation visit | 0 Device initiator survey respondent |
| Telehealth-supported LARC Provision | Percentage of Patients Reported Being Satisfied With Telehealth-supported Care | Did not respond | 9 Device initiator survey respondent |
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).
Time frame: 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.