Trial record 16 of 40 for:    "Sleep Disorders, Circadian Rhythm"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT02037438
First received: January 14, 2014
Last updated: September 5, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Obstructive Sleep Apnea of Adult
Insomnia
Circadian Rhythm Sleep Disorder, Unspecified Type
Restless Legs Syndrome
Narcolepsy and Hypersomnia
Other: CONV care for the diagnosis and treatment of sleep disorders
Other: PCCM for the diagnosis and treatment of sleep disorders

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Sustainable Methods, Algorithms, and Research Tools for Delivering Optimal Care Study (SMART DOCS)

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • CGCAHPS global rating [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Improved healthcare as measured by the global rating of the provider from the Consumer Assessment of Healthcare Providers and Systems Clinician and Group Survey (CGCAHPS)

  • SF-36 Version 2 Health Survey vitality score [ Time Frame: Baseline, 12 months ] [ Designated as safety issue: No ]
    Improved health as measured by the vitality scale score of the Short Form-36 (SF-36) Version 2 Health Survey


Secondary Outcome Measures:
  • CGCAHPS provider communication [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Communication of provider as measured by the Consumer Assessment of Healthcare Providers and Systems Clinician and Group Survey (CGCAHPS)

  • CGCAHPS Health Information Technology item set [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Effectiveness of technology as measured by the Health Information Technology item set of the Consumer Assessment of Healthcare Providers and Systems Clinician and Group Survey (CGCAHPS)

  • SF-36 Version 2 Health Survey QALYs [ Time Frame: Baseline, 12 months ] [ Designated as safety issue: No ]
    Quality Adjusted Life Years (QALYs) as measured by Short Form-36 (SF-36) Version 2 Health Survey

  • FOSQ-10 score [ Time Frame: Baseline, 12 months ] [ Designated as safety issue: No ]
    Functional Outcomes of Sleep Questionnaire-10 (FOSQ-10) score

  • SF-36 Version 2 Health Survey physical health score [ Time Frame: Baseline, 12 months ] [ Designated as safety issue: No ]
    Physical health quality as measured by the SF-36 Version 2 Health Survey

  • ESS total score [ Time Frame: Baseline, 12 months ] [ Designated as safety issue: No ]
    Disease-specific outcomes as measured by the Epworth Sleepiness Scale (ESS) total score

  • ISI total score [ Time Frame: Baseline, 12 months ] [ Designated as safety issue: No ]
    Disease-specific outcomes as measured by the Insomnia Severity Index (ISI) score

  • IRLS score [ Time Frame: Baseline, 12 months ] [ Designated as safety issue: No ]
    Disease-specific outcomes as measured by the International Restless Legs Syndrome Rating Scale (IRLS) score

  • Costs [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Analysis of costs over study duration


Estimated Enrollment: 1506
Study Start Date: January 2014
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CONV
Conventional (CONV) care for the diagnosis and treatment of sleep disorders
Other: CONV care for the diagnosis and treatment of sleep disorders
The Conventional (CONV) intervention will utilize standard-of-care diagnostic and treatment procedures for new patients with sleep disorders at the Stanford Sleep Medicine Center
Experimental: PCCM
Patient-Centered Outcomes and Coordinated Care Management (PCCM) for the diagnosis and treatment of sleep disorders
Other: PCCM for the diagnosis and treatment of sleep disorders
The Patient-Centered Outcomes and Coordinated Care Management (PCCM) intervention will follow a new methodology for the diagnosis and treatment of sleep disorders. It also incorporates the utilization of a web-based interactive portal that provides specific and relevant information and resources for patients, health care providers, and allied health professionals. The portal is designed to facilitate informed health care decisions among patients and health care providers through improved access to medical data and enhanced communications.

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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02037438

Contacts
Contact: Elyse Cohen, RN, BSN 650-721-7574 eacohen@stanford.edu

Locations
United States, California
Stanford Sleep Clinic, Stanford University Center for Sleep Science and Medicine Recruiting
Redwood City, California, United States, 94063
Principal Investigator: Clete A. Kushida, M.D., Ph.D.         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Clete A Kushida, M.D., Ph.D. Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT02037438     History of Changes
Other Study ID Numbers: CE-12-11-4137, SPO #: 105981
Study First Received: January 14, 2014
Last Updated: September 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
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

Additional relevant MeSH terms:
Sleep Disorders, Circadian Rhythm
Sleep Apnea, Obstructive
Restless Legs Syndrome
Sleep Disorders
Parasomnias
Narcolepsy
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Nervous System Diseases
Mental Disorders
Neurologic Manifestations
Signs and Symptoms
Disorders of Excessive Somnolence
Chronobiology Disorders
Occupational Diseases

ClinicalTrials.gov processed this record on October 16, 2014