This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Study of the Implementation of Telehealth-Supported LARC Provision in School-Based Health Centers (NCT04840836), a registered phase not stated study. The primary outcome is Number of Telehealth and Non-Telehealth LARC Device Initiations Within the SBHC Network.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04840836 |
| Phase | Phase not stated |
| Condition | Long Acting Reversible Contraception, Contraception Behavior |
| Allocation | Not Stated |
| Design model | Not Stated |
| Masking | Not Stated |
| Enrollment | 75 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Columbia University |
| Results posted | Yes |
2. Clinical Question
Population
Patients receiving reproductive health care at participating school-based health centers (SBHCs), in a setting where telehealth-supported care is available. The study description focuses on patients with a reproductive health visit, including contraceptive counseling or management. The registry record lists 75 enrolled participants.
Intervention
Telehealth-supported provision of long-acting reversible contraception (LARC), including contraceptive implants and intrauterine devices (IUDs). The study examines service implementation as well as LARC consultations, initiation, satisfaction and continuation.
Comparator
The primary outcome title refers to telehealth and non-telehealth LARC device initiations within the SBHC network, and the description also proposes comparisons by LARC type. This is not a randomized comparison, and the registry warns that the arms are not a like-for-like control comparison.
Primary question
How many telehealth consultations and LARC initiations occur within the SBHC network, and how do initiation counts vary by telehealth status and device type? The primary outcome covers up to 20 months. The registry record does not report the observed counts or a numerical comparison.
The study also sets out questions about implementation, continuation after initiation, and whether continuation differs across dimensions of telehealth experience. Its stated aims include absolute continuation at 12 months and examination of continuation at 6 months. These are study objectives, not results: outcome values are not reported in the registry record. The central question is therefore descriptive and implementation-focused, rather than a test of whether telehealth is superior to a randomized control condition.
3. Trial Design
This is a prospective observational cohort study of telehealth-supported LARC provision in school-based health centers. The registry describes six participating SBHCs and an enrolled population of 75. Columbia University is listed as the sponsor. The study is marked completed; its recorded start date is 2021-04-20 and its primary completion date is 2022-12-31.
Patients receive care in a setting where telehealth-supported care is available. The study description says information is collected during patient interviews in a follow-up observation period, including information about LARC initiation, satisfaction and continuation. It also describes record review for quality assurance purposes. The planned analyses include patients with a reproductive health visit, such as contraceptive counseling or management. The precise eligibility criteria and the exact definition of each analysis population are not reported in the registry record.
The intervention is described as behavioral and is named telehealth-supported LARC provision. The record identifies contraceptive implants and IUDs as the LARC types of interest. Because allocation is not stated and the study is observational, differences between people receiving telehealth and non-telehealth care cannot be read as randomized treatment effects. The registry explicitly cautions that the arms are not a like-for-like control comparison.
The stated aims cover uptake, implementation, continuation, and comparisons of continuation across dimensions of telehealth experience. The primary outcome is a count of consultations and device initiations over up to 20 months. The registry record does not report a statistical analysis plan, an allocation procedure, or a rationale for the enrollment target. Those details should not be inferred from the prospective design or from the fact that the study is complete.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Telehealth-supported LARC Provision |
|---|---|
| STARTED | 75 |
| COMPLETED | 75 |
| NOT COMPLETED | 0 |
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Telehealth-supported LARC Provision |
|---|---|---|
| Participants analysed | 75 | |
| Age, Continuous | years | 16.65 (14 to 21) |
| Sex: Female, Male: Female | Participants | 75 |
| Sex: Female, Male: Male | Participants | 0 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 33 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 10 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 32 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 11 |
| Race (NIH/OMB): White | Participants | 7 |
| Race (NIH/OMB): More than one race | Participants | 26 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 31 |
| Region of Enrollment: United States | participants | 75 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Telehealth and Non-Telehealth LARC Device Initiations Within the SBHC Network, measured over Up to 20 months.
| Element | Registry entry |
|---|---|
| Result type | Count Of Units |
| Measure of spread | not applicable |
| Unit | device initiations |
| Endpoint classification | not reduced to a single comparison |
The primary outcome is the number of telehealth and non-telehealth LARC device initiations within the SBHC network. Its description says the study will quantify telehealth LARC consultations and initiations overall among patients seen for contraceptive counseling, and compare initiation counts by LARC type: contraceptive implant versus IUD. The stated timeframe is up to 20 months.
A count outcome is useful for describing service activity: it can characterize how often consultations and device initiations occur in the participating network. It does not, by itself, describe the proportion of eligible patients who initiated a device, nor does it establish why an initiation occurred. Those interpretations would require relevant denominators and analysis details, which are not reported in the registry record.
The outcome title distinguishes telehealth and non-telehealth initiations, but the study is observational and the registry says the groups are not like-for-like controls. Therefore, a difference in counts would be descriptive and could reflect differences in who received each type of care or in the circumstances of care, rather than an isolated effect of telehealth. The registry record does not report the observed counts or a numerical comparison.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry describes a completed prospective observational cohort study with enrollment of 75 in a network of six SBHCs. Its primary outcome is a count of telehealth and non-telehealth LARC initiations, alongside telehealth consultations, over up to 20 months. However, it does not report the resulting counts, an estimate of a difference, or an uncertainty interval. The primary outcome therefore cannot be numerically interpreted from the registry record.
The aims extend beyond initiation. They include describing implementation, examining continuation among LARC initiators, and comparing continuation across dimensions of telehealth experience. Continuation is described at 12 months after initiation, with examination also at 6 months. Those statements define intended questions and time points; they do not establish that follow-up was complete or report continuation results. Satisfaction is also mentioned as information collected during follow-up, but no satisfaction result is reported in the registry record.
Any comparison between telehealth and non-telehealth care requires particular caution. The record does not describe random allocation and explicitly warns that the arms are not a like-for-like control comparison. In general, observational groups can differ in participant characteristics, care needs, access, or other circumstances. Without adjustment details and measured results, a group contrast cannot be separated from those possible differences. No adjusted estimate or analysis method is reported in the registry record.
The study can be understood as an investigation of service uptake and implementation in participating school-based health centers, not as a randomized efficacy comparison. A count of initiations would indicate service activity in the observed network, but would not alone reveal the fraction of eligible patients initiating LARC, the experience of patients who did not initiate, or the causal effect of telehealth. The registry record does not report the denominators needed to interpret initiation as a rate.
The record lists no analysis entries. It also gives no numerical results for the primary outcome or the stated continuation aims. Consequently, no conclusion about the magnitude, precision, or direction of an observed effect can be drawn from the registry record. The completed status and enrollment figure describe the study's administrative progress, not its findings.
9. Statistical Methods Explained
A count outcome records how many events of interest occur in a defined population and observation period. In this study, the events are LARC consultations and device initiations, with attention to telehealth status and device type. Counts can describe workload or uptake in a service network, but they need context: the size and characteristics of the population under observation, the period each person was observed, and the rules used to count events. The registry gives a timeframe of up to 20 months but does not report the detailed counting rules or the denominators used for rate calculations.
What does an observational comparison mean?
In a randomized study, allocation is used to create comparison groups by a defined procedure. Here, the registry describes a prospective observational cohort and does not state an allocation procedure. It also cautions that the arms are not a like-for-like control comparison. In general, people receiving telehealth and non-telehealth care may differ in ways that affect service use or outcomes. A raw difference between groups would therefore be an association in the observed care setting, not necessarily an effect caused by telehealth.
Statistical adjustment can sometimes account for measured differences between groups, but it cannot automatically remove differences that were not measured or were not adequately represented in the model. The registry record does not report whether adjustment was planned or performed, which variables might have been considered, or how any adjusted comparison was estimated. No adjusted result is reported.
Why can count data need specialized methods?
General statistical explanation: count outcomes are often analyzed with models suited to nonnegative event counts. A simple count model may assume that the variability is closely tied to the average count. In practice, counts can vary more than that assumption allows, a feature called over-dispersion. Ignoring over-dispersion can make uncertainty appear smaller than it is. Counts can also vary with the time each person is observed or with the size of the population at risk, so analysts may need to account for exposure time or use a rate model when the design and data support it.
These are general considerations, not a description of methods used in this study. The registry record does not name a count model, report a dispersion estimate, or explain whether observation time was handled in the analysis. It also does not provide the distribution of counts, so it is not possible to judge which count method would be appropriate from the registry record alone.
How should uncertainty be understood?
General statistical explanation: an estimate describes the value observed in a sample, while a confidence interval expresses the range of values compatible with the data under the method's assumptions. A narrow interval indicates greater precision than a wide interval; neither guarantees that the model assumptions are correct. The registry record does not report an estimate or confidence interval for the primary outcome. It also does not report a p-value or a model-based comparison.
The registry includes a planning illustration based on an observed effect and describes assumptions of two-sided significance level 0.05, equal allocation between two arms, and a normal approximation. It says that the effect to detect is a stated fraction of the observed effect, and that time-to-event illustrations give total events while other illustrations give participants per arm. These are planning assumptions, not evidence of observed power. No resulting planning values or effect magnitude are reported in the registry record. The record also does not say that these assumptions were part of the study's original design.
What can the continuation aims tell readers?
The study description identifies continuation after LARC initiation as an aim, including continuation at 12 months and examination at 6 months. Continuation is a follow-up outcome among initiators, and its interpretation depends on a clear definition of continuation, the timing and completeness of follow-up, and how people lost to follow-up are handled. Those analytic details and the observed continuation results are not reported in the registry record.
The record also says that continuation rates are to be compared across dimensions of telehealth experience. Such comparisons may involve groups defined by reported experiences, but the record does not specify those dimensions or the analysis method. Without those definitions and results, the aim cannot be interpreted as a particular statistical contrast.
10. Multiplicity, Missing Data and Analysis Populations
The study lists several aims: uptake, implementation, continuation, and comparisons of continuation across dimensions of telehealth experience. Considering multiple outcomes or comparisons can increase the chance of finding an apparently notable result by chance if no suitable approach is planned. General approaches include prespecifying a primary contrast or adjusting inference across a defined family of tests. The registry record does not report a multiplicity strategy, a hierarchy among secondary outcomes, or a statistical analysis plan. It lists no analysis entries, so no test results or multiplicity adjustments are available to assess.
The registry does not report how missing interview data, incomplete follow-up, or loss to follow-up were handled. This is relevant to continuation outcomes because the aims concern follow-up after initiation. If follow-up is incomplete, the observed outcomes may not represent all initiators; the direction and extent of any resulting bias depend on why information is missing. The record does not provide follow-up completion figures or a missing-data method.
The description refers to patients with reproductive health visits and to LARC initiators for continuation analyses, but it does not give full analysis-population definitions. It is therefore not reported in the registry record whether all enrolled participants contributed to every outcome, how eligibility for each analysis was determined, or whether any participants were excluded from particular analyses. The record does not report an intention-to-treat population, and the observational design does not establish that such a population was used.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Telehealth-supported LARC Provision | 0 | 75 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Telehealth-supported LARC Provision | 0 of 75 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Telehealth-supported LARC Provision | 0 of 75 |
The registry safety figures list 75 people at risk in the telehealth-supported LARC provision group. It records zero serious adverse events, zero other adverse events, and zero deaths for that group. The registry record does not list serious adverse event terms.
These are the recorded figures, not proof that no adverse events occurred outside the reporting process or observation period. The record does not describe the safety surveillance procedures, the observation window for these figures, the event definitions, or how complete the reporting was. It also does not provide a safety comparison with a randomized control group. Since the study is observational and the registry cautions that the arms are not like-for-like controls, the safety figures should be read as descriptive registry entries rather than comparative evidence.
The record separately lists 75 at risk for the other adverse-event category. The figures should not be added together: the registry does not explain whether the categories represent separate populations or overlapping safety reporting. No further safety interpretation is reported in the registry record.
12. What the Result Does, and Does Not, Mean
The study addresses a practical service question: how telehealth-supported LARC provision is implemented in school-based health centers and what consultation and initiation activity is recorded in the network. Its prospective observational design also sets out to examine continuation among initiators and patient satisfaction. The registry record establishes the intended outcomes and the study setting, but it does not report the observed primary counts or continuation results.
Accordingly, the record does not establish whether telehealth-supported provision increased or decreased initiation, whether continuation differed by telehealth experience, or how precisely any such comparison was estimated. It also does not establish that telehealth caused any observed difference. The nonrandomized comparison and explicit warning about non-equivalent arms mean that any future contrast would need to be interpreted in light of differences between the groups and the analysis used.
A service count is not the same as an initiation rate among eligible patients. To interpret uptake as a proportion or rate, readers would need relevant denominators and a clear observation period for each person. The registry gives a primary timeframe of up to 20 months but does not report those denominators or the observed counts. Nor does the count alone describe satisfaction, access, or reasons for choosing a method.
The study's completed status indicates its administrative status, not that all intended results are available in the registry record. The enrollment figure likewise does not show how many participants contributed to each outcome. Conclusions should remain limited to the stated design and the data actually recorded: the registry identifies a descriptive implementation study and its aims, while numerical effectiveness, precision, and follow-up findings are not reported in the registry record.
13. Why This Trial Matters Statistically
Statistically, this study illustrates why the design and the estimand—the quantity a study is intended to describe or estimate—matter as much as the name of an outcome. A count of consultations or device initiations addresses service activity in a defined network. It is not interchangeable with a rate among eligible patients or a causal treatment effect. Interpreting a count requires clarity about the population, event definition, observation period, and denominator.
The study also makes the distinction between implementation research and randomized comparative research important. The registry describes care delivered in an observational setting, and it warns that the telehealth and non-telehealth arms are not like-for-like controls. A descriptive comparison can still be informative about how services operate, but causal claims require stronger support than a difference in observed counts alone.
Follow-up outcomes add further statistical questions. Continuation is assessed among people who initiated LARC, and interpreting that outcome depends on who remains observable and how missing follow-up is handled. The registry record states continuation aims at 12 months and 6 months but does not report the corresponding results or handling of missing data. Those omissions limit precision and interpretation, rather than changing what the study set out to examine.
The registry record is therefore useful for identifying the outcome structure and its boundaries. It does not provide enough reported analysis to quantify uptake, assess uncertainty, or compare continuation. Keeping those distinctions clear prevents a study's aims, design, and status from being mistaken for findings.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The registry record does not report the observed primary counts, the numerical comparisons, confidence intervals, or p-values. It therefore does not permit assessment of the size or precision of the primary outcome. It also does not report numerical findings for continuation or satisfaction, despite describing these as study interests.
The observational design limits causal interpretation, and the registry explicitly states that the arms are not a like-for-like control comparison. Allocation is not stated. The record does not report adjustment methods or information about participant differences between telehealth and non-telehealth care. The number of participating SBHCs is six, but site-specific results or methods for accounting for differences among centers are not reported.
The record does not give detailed eligibility criteria, counting rules, denominators, or observation-time distributions. It does not report follow-up completion, missing-data handling, outcome definitions for continuation, or the dimensions used to compare telehealth experience. The statistical analysis plan and multiplicity approach are also not reported in the registry record.
Finally, the enrollment figure does not establish the number contributing to each endpoint, and the completed status does not fill in the missing results. The registry record does not report a sample-size justification or indicate whether the planning illustration reflects the study's original design. These limitations concern what can be learned from the registry record; they do not establish that unreported procedures were absent from the study itself.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Study of the Implementation of Telehealth-Supported LARC Provision in School-Based Health Centers — NCT04840836.
- Registry record last updated 2025-06-22; status last verified 2025-06.
- Results first posted 2025-06-22.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
NCT04840836 is a completed prospective observational study sponsored by Columbia University, titled “Study of the Implementation of Telehealth-Supported LARC Provision in School-Based Health Centers.” The registry lists enrollment of 75 and six participating SBHCs. The recorded start date is 2021-04-20, and the primary completion date is 2022-12-31.
The primary outcome is the number of telehealth and non-telehealth LARC device initiations in the network, with telehealth consultations and comparisons by implant versus IUD also described. The primary timeframe is up to 20 months. Other aims include implementation and LARC continuation at 12 months, with examination at 6 months, among initiators.
The registry record does not report the primary counts, continuation results, statistical analyses, or confidence intervals. It cautions that the observational arms are not like-for-like controls.