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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02037438
Recruitment Status : Completed
First Posted : January 16, 2014
Results First Posted : March 4, 2019
Last Update Posted : March 4, 2019
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Clete A. Kushida, Stanford University

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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea of Adult Insomnia Circadian Rhythm Sleep Disorder Sleep Related Movement Disorders Narcolepsy and Hypersomnia Parasomnia Other: CONV care for the diagnosis and treatment of sleep disorders Other: PCCM for the diagnosis and treatment of sleep disorders Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1836 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Sustainable Methods, Algorithms, and Research Tools for Delivering Optimal Care Study (SMART DOCS)
Study Start Date : January 2014
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Disorders

Arm Intervention/treatment
Active Comparator: CONV Arm
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 utilized standard-of-care diagnostic and treatment procedures for new patients with sleep disorders at the Stanford Sleep Medicine Center

Experimental: PCCM ARM
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 implemented new methodologies 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 was designed to facilitate informed health care decisions among patients and health care providers through improved access to medical data and enhanced communications.




Primary Outcome Measures :
  1. Change in CGCAHPS Global Rating After 12 Months [ Time Frame: 12 months ]
    Global rating of the provider from the Consumer Assessment of Healthcare Providers and Systems Clinician and Group Survey (CGCAHPS) compared between the two arms at end of study (12 months). The global rating instructions specify: "Using any number from 0 to 10, where 0 is the worst provider possible, and 10 is the best provider possible, what number would you use to rate this provider?"

  2. Change in SF-36 Version 2 Health Survey Vitality Score After 12 Months [ Time Frame: 12 months ]
    The vitality scale score of the Short Form-36 (SF-36) Version 2 Health Survey was compared at the end-of study (12 months) and was derived from the following four questions: "How much of the time during the past 4 weeks… Did you feel full of life?" "Did you have a lot of energy?" "Did you feel worn out?" "Did you feel tired?" The possible responses and point values were: all of the time (1), most of the time (2), some of the time (3), a little of the time (4), and none of the time (5). The scale is transformed to a 0-100 scale, with the lower the score indicating more disability.


Secondary Outcome Measures :
  1. Change in CGCAHPS Provider Communication After 12 Months [ Time Frame: 12 months ]
    Communication of provider as measured by the Consumer Assessment of Healthcare Providers and Systems Clinician and Group Survey (CGCAHPS). This comprised "How Well Providers (or Doctors) Communicate with Patients" The ratings for the following four questions were averaged for each participant: "In the last 12 months, how often did this provider explain things in a way that was easy to understand?" "In the last 12 months, how often did this provider listen carefully to you?" "In the last 12 months, how often did this provider show respect for what you had to say?" "In the last 12 months, how often did this provider spend enough time with you?" The responses and point values were: never (1), sometimes (2), usually (3), and always (4).

  2. Change in CGCAHPS Health Information Technology Measure #1 After 12 Months [ Time Frame: 12 months ]
    Helpfulness of Provider's Use of Computers During a Visit (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]). This included composite measures of helpfulness of provider's use of computers during a visit. The ratings for the following two questions were averaged for each participant: "During your visits in the last 12 months, was this provider's use of a computer or handheld device helpful to you?" The point values for the responses were: yes, definitely (1), yes, somewhat (2), and no (3). "During your visits in the last 12 months, did this provider's use of a computer or handheld device make it harder or easier for you to talk with him or her?" The point values for the responses were: easier (1), not harder or easier (2), harder (3).

  3. Change in CGCAHPS Health Information Technology Measure #3 After 12 Months [ Time Frame: 12 months ]
    Helpfulness of Provider's Website in Giving Patient Information About Patient's Care and Tests (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]). This included composite measures of helpfulness of provider's website in giving information about care and tests. The ratings for the following four questions were averaged for each participant: "In the last 12 months, how often was it easy to find these lab or other test results on the website?" "In the last 12 months, how often were these lab or other test results put on the website as soon as you needed them?" "In the last 12 months, how often were these lab or other test results presented in a way that was easy to understand?" "In the last 12 months, how often were the visit notes easy to understand?" The responses and point values were: never (1), sometimes (2), usually (3), and always (4).



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02037438


Locations
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United States, California
Stanford Sleep Clinic, Stanford University Center for Sleep Science and Medicine
Redwood City, California, United States, 94063
Sponsors and Collaborators
Stanford University
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Clete A Kushida, M.D., Ph.D. Stanford University

Publications:
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Responsible Party: Clete A. Kushida, Principle Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT02037438    
Other Study ID Numbers: CE-12-11-4137
SPO #: 105981 ( Other Identifier: Stanford Sponsored Project Number )
First Posted: January 16, 2014    Key Record Dates
Results First Posted: March 4, 2019
Last Update Posted: March 4, 2019
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified data will be shared with other researchers; these data will be available after April 2017
Keywords provided by Clete A. Kushida, 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:
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Sleep Apnea, Obstructive
Sleep Wake Disorders
Parasomnias
Movement Disorders
Narcolepsy
Disorders of Excessive Somnolence
Sleep Disorders, Circadian Rhythm
Disease
Pathologic Processes
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Nervous System Diseases
Mental Disorders
Neurologic Manifestations
Signs and Symptoms
Central Nervous System Diseases
Chronobiology Disorders
Occupational Diseases