Sustainable Methods, Algorithms, and Research Tools for Delivering Optimal Care Study

2014-09-25 15:08:22 | BioPortfolio


Sustainable Methods, Algorithms, and Research Tools for Delivering Optimal Care Study (SMART DOCS) will 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 will be 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 will be 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 will be 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 participant will be 18 years of age or older, presenting with a new sleep disorder. Patients will be enrolled for 13 months and will receive 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 proposed project challenges and seeks 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 are expected to improve clinical practice and the patient's experience of care. The specific aim of this study is 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 will be randomized to one of two arms; Conventional Diagnostic/Treatment Outpatient Medical Care (CONV) and Patient-Centered Outcomes and Coordinated-Care Management (PCCM). Randomization will be conducted using a permuted block design. Each new patient consecutively seen at the Stanford Sleep Medicine Center and each patient seen at Stanford Primary Care who is suspected of having a new sleep disorder will be informed about the study. The patient will be notified that the study is a randomized trial and he or she could be assigned to either the CONV or PCCM arms. The patient will also be apprised that he or she will be consenting to grant access all clinical data collected during his or her evaluation and treatment. If the patient agrees to participate, informed consent will be obtained. He or she is then randomized to one of the study arms in order to diagnose and treat his or her sleep disorder.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research


Obstructive Sleep Apnea of Adult


CONV care for the diagnosis and treatment of sleep disorders, PCCM for the diagnosis and treatment of sleep disorders


Stanford Sleep Clinic, Stanford University Center for Sleep Science and Medicine
Redwood City
United States




Stanford University

Results (where available)

View Results


Published on BioPortfolio: 2014-09-25T15:08:22-0400

Clinical Trials [5403 Associated Clinical Trials listed on BioPortfolio]

Clinical Evaluation of a Wearable Sleep Diagnosis Technology

The primary endpoint is to evaluate the sensitivities and specificities for diagnosis of sleep apnoea of a wearable sleep diagnosis technology vs. existing gold standard.

Home Diagnosis and Treatment of Obstructive Sleep Apnea

Obstructive Sleep Apnea (OSA) is a common and underrecognised condition. The diagnosis of OSA is typically made after an in-lab polysomnography (PSG) which requires an overnight stay in a ...

Validation of Sleep Apnea Diagnosis Device

Obstructive sleep apnea (OSA) is common and largely underdiagnosed disease. The standard method for the diagnosis of OSA is a complete night polysomnography (PSG). Simple methods for OSA d...

Sleep Apnea : Diagnosis and Monitoring

This prospective study aims to evaluate a new medical screening method to detect and discriminate sleep apnea-hypopnea events. A new device called ApneaBand will be tested to propose a new...

Domiciliary Diagnosis and Follow up in Obstructive Apnoea Syndrome

The aim of the investigators study was to evaluate the effectiveness of a home programme (diagnosis and follow-up) in patients with Obstructive Sleep Apnea (OSA) syndrome treated with CPAP...

PubMed Articles [36515 Associated PubMed Articles listed on BioPortfolio]

Obstructive Sleep Apnea in Posttraumatic Stress Disorder Comorbid With Mood Disorder: Significantly Higher Incidence Than in Either Diagnosis Alone.

To examine the correlations between obstructive sleep apnea (OSA) and psychiatric disorders such as major depressive disorder (MDD), posttraumatic stress disorder (PTSD), or bipolar disorder (BD) and ...

"In Medical School, You Get Far More Training on Medical Stuff than Developmental Stuff": Perspectives on ASD from Ontario Physicians.

This study investigated the knowledge and perceived competence of Ontario physicians regarding the diagnosis and treatment of ASDs. Previous research demonstrates that many physicians would like more ...

Diagnosis and perioperative management in pediatric sleep-disordered breathing.

Sleep-disordered breathing has a prevalence of 12% in the pediatric population. It represents a spectrum of disorders encompassing abnormalities of the upper airway that lead to sleep disruption, incl...

Timely diagnosis and treatment of sleep apnea reduce cardiovascular sequelae in patients with myocardial infarction.

The present study aimed to test if the temporal sequence between sleep apnea (SA) diagnosis and incident myocardial infarction (MI) was associated with the long-term mortality and cardiovascular event...

Performance of point-of-care birth HIV testing in primary health care clinics: An observational cohort study.

Failure to timely diagnose HIV in infants is a major barrier for scaling-up paediatric antiretroviral treatment (ART). WHO recommends birth testing for earlier diagnosis and to improve test coverage, ...

Medical and Biotech [MESH] Definitions

A medical specialty concerned with the diagnosis and treatment of SLEEP DISORDERS and their causes.

Conditions characterized by disturbances of usual sleep patterns or behaviors. Sleep disorders may be divided into three major categories: DYSSOMNIAS (i.e. disorders characterized by insomnia or hypersomnia), PARASOMNIAS (abnormal sleep behaviors), and sleep disorders secondary to medical or psychiatric disorders. (From Thorpy, Sleep Disorders Medicine, 1994, p187)

A system for classifying patient care by relating common characteristics such as diagnosis, treatment, and age to an expected consumption of hospital resources and length of stay. Its purpose is to provide a framework for specifying case mix and to reduce hospital costs and reimbursements and it forms the cornerstone of the prospective payment system.

Dyssomnias (i.e., insomnias or hypersomnias) associated with dysfunction of internal sleep mechanisms or secondary to a sleep-related medical disorder (e.g., sleep apnea, post-traumatic sleep disorders, etc.). (From Thorpy, Sleep Disorders Medicine, 1994, p187)

Movements or behaviors associated with sleep, sleep stages, or partial arousals from sleep that may impair sleep maintenance. Parasomnias are generally divided into four groups: arousal disorders, sleep-wake transition disorders, parasomnias of REM sleep, and nonspecific parasomnias. (From Thorpy, Sleep Disorders Medicine, 1994, p191)

More From BioPortfolio on "Sustainable Methods, Algorithms, and Research Tools for Delivering Optimal Care Study"

Quick Search


Relevant Topics

Pulmonary relating to or associated with the lungs eg Asthma, chronic bronchitis, emphysema, COPD, Cystic Fibrosis, Influenza,  Lung Cancer, Pneumonia, Pulmonary Arterial Hypertension, Sleep Disorders etc Follow and track Lung Cancer News ...

Sleep Disorders
Sleep disorders disrupt sleep during the night, or cause sleepiness during the day, caused by physiological or psychological factors. The common ones include snoring and sleep apnea, insomnia, parasomnias, sleep paralysis, restless legs syndrome, circa...

Searches Linking to this Trial