Obstructive Sleep Apnea of AdultSMART DOCSNCT02037438
Sustainable Methods, Algorithms, and Research Tools for Delivering Optimal Care Study
A study testing CONV care for the diagnosis and treatment of sleep disorders and PCCM for the diagnosis and treatment of sleep disorders in people with Obstructive Sleep Apnea of Adult and Insomnia, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea of Adult, Insomnia, Circadian Rhythm Sleep Disorder
- What is being tested?
- CONV care for the diagnosis and treatment of sleep disorders and PCCM for the diagnosis and treatment of sleep disorders
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,836 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to May 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age and older
- New clinical outpatient presenting signs and/or symptoms of a sleep disorder
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Sleep Clinic, Stanford University Center for Sleep Science and Medicine
Redwood City, California, 94063
About this study
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.
Read the 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.
- Conditions
- Obstructive Sleep Apnea of Adult, Insomnia, Circadian Rhythm Sleep Disorder, Sleep Related Movement Disorders, Narcolepsy and Hypersomnia, Parasomnia
- Being tested
- CONV care for the diagnosis and treatment of sleep disorders, PCCM for the diagnosis and treatment of sleep disorders
- 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
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Sleep Disorders, Circadian Rhythm, Narcolepsy, Disorders of Excessive Somnolence, Parasomnias, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CONV care for the diagnosis and treatment of sleep disordersOther
The Conventional (CONV) intervention utilized standard-of-care diagnostic and treatment procedures for new patients with sleep disorders at the Stanford Sleep Medicine Center
PCCM for the diagnosis and treatment of sleep disordersOther
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.
| Study group | Role | What they receive |
|---|---|---|
| CONV Arm | Active comparator | Conventional (CONV) care for the diagnosis and treatment of sleep disorders Receives: Other: CONV care for the diagnosis and treatment of sleep disorders |
| PCCM ARM | Experimental | Patient-Centered Outcomes and Coordinated Care Management (PCCM) for the diagnosis and treatment of sleep disorders Receives: Other: PCCM for the diagnosis and treatment of sleep disorders |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in CGCAHPS Global Rating After 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?"
Measured: 12 months
Change in SF-36 Version 2 Health Survey Vitality Score After 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.
Measured: 12 months
Secondary outcomes (3)
Change in CGCAHPS Provider Communication After 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).
Measured: 12 months
Change in CGCAHPS Health Information Technology Measure #1 After 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).
Measured: 12 months
Change in CGCAHPS Health Information Technology Measure #3 After 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).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep Apnea of AdultStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,836 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Clete A. Kushida, Stanford University
- Investigators
- Clete A Kushida, M.D., Ph.D., Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02037438
- Sponsor's protocol ID
- CE-12-11-4137
- Other IDs
- SPO #: 105981
- Acronym
- SMART DOCS
- Status last verified
- Nov 2018
- First submitted
- 14 Jan 2014
- Last updated
- 4 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: De-identified data will be shared with other researchers; these data will be available after April 2017
Publications
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.
PubMed 25409112
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sustainable Methods, Algorithms, and Research Tools for Delivering Optimal Care Study (SMART DOCS)
- ClinicalTrials.gov ID
- NCT02037438
- Acronym / sponsor ID
- SMART DOCS / CE-12-11-4137
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,836 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- Jan 2014
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 16 Jan 2014 (estimated)
- Results
- Posted 4 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CONV Arm | Active comparator | Other: CONV care for the diagnosis and treatment of sleep disordersConventional (CONV) care for the diagnosis and treatment of sleep disorders |
| PCCM ARM | Experimental | Other: PCCM for the diagnosis and treatment of sleep disordersPatient-Centered Outcomes and Coordinated Care Management (PCCM) for the diagnosis and treatment of sleep disorders |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years of age and older
- New clinical outpatient presenting signs and/or symptoms of a sleep disorder
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CONV care for the diagnosis and treatment of sleep disordersThe Conventional (CONV) intervention utilized standard-of-care diagnostic and treatment procedures for new patients with sleep disorders at the Stanford Sleep Medicine Center | Other | CONV Arm |
| PCCM for the diagnosis and treatment of sleep disordersThe 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. | Other | PCCM ARM |
Primary outcome
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?"
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.
3 secondary outcomes
Change in CGCAHPS Provider Communication After 12 Months
Time frame: 12 months
Change in CGCAHPS Health Information Technology Measure #1 After 12 Months
Time frame: 12 months
Change in CGCAHPS Health Information Technology Measure #3 After 12 Months
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25409112Kushida 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.
- Individual participant dataSharing planned: Yes. De-identified data will be shared with other researchers; these data will be available after April 2017
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clete A Kushida, M.D., Ph.D. principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CONV care for the diagnosis and treatment of sleep disorders and PCCM for the diagnosis and treatment of sleep disorders in people with Obstructive Sleep Apnea of Adult and Insomnia, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in CGCAHPS Global Rating After 12 Months (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02037438, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2019.