Reporting and Analysis

The project described is supported by Grant Number 1C1CMS331351-01-00 from the Department of Health and Human Services, Centers for Medicare & Medicaid Services. The contents of this document are solely the responsibility of the authors and do not necessarily represent the official views of the U.S. Department of Health and Human Services or any of its agencies

Study Design

Health outcome, healthcare. and cost savings will be assessed in the form of a quasi-experimental design. Randomized controlled trials (RCT) are considered the most rigorous research design and the gold standard when testing the effectiveness of an intervention.(21) Randomized controlled trials are not always practical to implement in some clinical and administrative settings. Some telehealth administrators may not want their patients randomly assigned to a control group when the program's interest is to use the technology as much as possible.(22)

In addition, RCT includes highly motivated and carefully selected patients based on strict inclusion and exclusion criteria, and these patients are not usually representative of the mix of patients seen in community-based health care settings, threatening the external validity and generalizability of the study.(22) However, regression to the mean and selection bias are two important statistical issues that need to be considered along with feasibility in rural settings when designing a telehealth study.

Some authors recommended quasi-experimental study designs, which usually do not involve random assignment of subjects to the intervention. Pre- and post-test designs are threatened by the Hawthorne effect. Other approaches to obtain comparison samples are case control studies where intervention group outcomes are compared with those of a usual-care group.

We selected the control group design to show that telehealth can provide equal to superior outcomes for neurosurgical emergency patients while lowering cost and improving health care quality. Our control group design will have two groups: the telehealth group and the usual-care group. To keep the randomization process simple and feasible for small community hospitals, we will randomize based on providers. Most rural hospitals are staffed for some period of time by locum tenens, which contributes to a high turnover rate of employees.

In our recruitment process we will focus on health care providers who have a long-term history of working in their communities. They will be trained in using telehealth in their daily practice. We will not train locum tenens. We will train half of the ER staff if there are no locum tenens providing ER coverage. With this approach we will be able to collect data on a control as well as on an intervention group without disrupting the hectic flow of an ER and while still gathering data on patients with similar backgrounds and from a similar environment, which will eliminate selection bias. Patients are randomly assigned to ER providers, which will also limit the selection bias. As the study progresses and HCPs get to know about he impact of the THS, we will need to ensure that subjects/patients who are in the ER for a neurosurgical emergency are not preferentially assigned to providers with telehealth experience (and as the study progresses).

All adult patients the provider feels he cannot manage without neurosurgical specialty consultation will be included in the study. The current practice is to call the physician access line at UNMH and speak with the neurosurgeon on call. The usual-care group will continue this practice; the telehealth group will use the telehealth interface to triage patients.