Insomnia Clinical Trial
Official title:
Sustainable Methods, Algorithms, and Research Tools for Delivering Optimal Care Study (SMART DOCS)
Sustainable Methods, Algorithms, and Research Tools for Delivering Optimal Care Study (SMART DOCS) was designed to develop and evaluate a new approach (patient-centered outcomes and coordinated-care management [PCCM]) for the diagnosis and treatment of sleep disorders. Specialized and pertinent information and resources regarding sleep disorder management were developed and made available through an online portal, allowing patients to make informed health care decisions, and providers to assist patients in achieving what they feel are the most important goals regarding their care. Half of participants were randomized into the conventional diagnosis and treatment (CONV) arm and the other half into the patient-centered outcomes and coordinated-care management (PCCM) arm. Validated objective and subjective assessment measures were administered at intervals throughout a 13 month participation period in both the CONV and PCCM arms to determine whether the new PCCM approach for sleep medicine results in increased patient satisfaction, quality of care, and improved health outcomes. Qualifying participants were 18 years of age or older and presenting with a new sleep disorder. Patients received no monetary compensation.
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.
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