Clinical trial NCT02037438: Sustainable Methods, Algorithms, and Research Tools for Delivering Optimal Care Study
Official title: Sustainable Methods, Algorithms, and Research Tools for Delivering Optimal Care Study (SMART DOCS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea of Adult
Insomnia
Circadian Rhythm Sleep Disorder
Sleep Related Movement Disorders
Narcolepsy and Hypersomnia
Parasomnia
Keywords: Clinical sleep medicine
New methodology for healthcare delivery
Diagnosis and treatment of sleep disorders
Electronic health records
Clinical informatics
Evidence-based comparative effectiveness research
Sleep specialists
Primary care providers
Allied health professionals
Patient-centered care
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2014-01-16
Enrollment: 1836
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 18 years of age and older
* New clinical outpatient presenting signs and/or symptoms of a sleep disorder

Exclusion Criteria:

* None

Primary outcomes:
measure: Change in CGCAHPS Global Rating After 12 Months
timeFrame: 12 months
measure: Change in SF-36 Version 2 Health Survey Vitality Score After 12 Months
timeFrame: 12 months
Secondary outcomes:
measure: Change in CGCAHPS Provider Communication After 12 Months
timeFrame: 12 months
measure: Change in CGCAHPS Health Information Technology Measure #1 After 12 Months
timeFrame: 12 months
measure: Change in CGCAHPS Health Information Technology Measure #3 After 12 Months
timeFrame: 12 months
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: Stanford Sleep Clinic, Stanford University Center for Sleep Science and Medicine
state: California
Study officials:
affiliation: Stanford University
name: Clete A Kushida, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kushida CA, Nichols DA, Holmes TH, Miller R, Griffin K, Cardell CY, Hyde PR, Cohen E, Manber R, Walsh JK. SMART DOCS: a new patient-centered outcomes and coordinated-care management approach for the future practice of sleep medicine. Sleep. 2015 Feb 1;38(2):315-26. doi: 10.5665/sleep.4422.