Sustainable Methods, Algorithms, and Research Tools for Delivering Optimal Care Study (SMART DOCS)

SMART DOCS is a randomized comparative clinical trial designed to evaluate a new approach of outpatient medical care. In current sleep medicine practice, a consultation lasting one hour or less is allotted for the assessment, diagnosis, planning, and implementation of sleep disorders among patients and their health care provider. Patients are expected to convey their complex medical history and relevant symptoms, while clinicians must effectively and appropriately diagnose and create a treatment plan in this given period of time.

New technology for home-based diagnostic testing and electronic access to diagnostic results and outcomes provides functional advantages to the delivery of healthcare in an outpatient setting. The project was designed to compare the traditional diagnostic and treatment medical outpatient approach to a patient-centered outcomes and coordinated-care management (PCCM) approach for sleep medicine. New or refined methods, algorithms, and tools were expected to improve clinical practice and the patient's experience of care. The specific aim of this study was to determine whether a new patient-centered outcomes and coordinated-care management (PCCM) approach for sleep medicine provides better care and improves the health of patients compared to a conventional diagnostic/treatment outpatient medical care (CONV) approach.

Patients were randomized to one of two arms; Conventional Diagnostic/Treatment Outpatient Medical Care (CONV) and Patient-Centered Outcomes and Coordinated-Care Management (PCCM). Randomization was conducted using a permuted block design. Each new patient consecutively seen at the Stanford Sleep Medicine Center and each patient seen at Stanford Sleep Clinic in Primary Care who were suspected of having a new sleep disorder were informed about the study. The patient was notified that the study was a randomized trial and he or she could be assigned to either the CONV or PCCM arms. The patient was also apprised that he or she was consenting to grant access all clinical data collected during his or her evaluation and treatment to the research team. If the patient agreed to participate, informed consent was obtained. He or she was then randomized to one of the study arms in order to diagnose and treat his or her sleep disorder.