Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02037438
Acronym
SMART DOCS
Enrollment
1836
Registered
2014-01-16
Start date
2014-01-31
Completion date
2016-05-31
Last updated
2019-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Circadian Rhythm Sleep Disorder, Insomnia, Narcolepsy and Hypersomnia, Obstructive Sleep Apnea of Adult, Parasomnia, Sleep Related Movement 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

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.

Interventions

OTHERCONV 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

OTHERPCCM 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.

Sponsors

Patient-Centered Outcomes Research Institute
CollaboratorOTHER
Stanford University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Change in CGCAHPS Global Rating After 12 Months12 monthsGlobal 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 Months12 monthsThe 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

MeasureTime frameDescription
Change in CGCAHPS Provider Communication After 12 Months12 monthsCommunication 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).
Change in CGCAHPS Health Information Technology Measure #1 After 12 Months12 monthsHelpfulness 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).
Change in CGCAHPS Health Information Technology Measure #3 After 12 Months12 monthsHelpfulness 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).

Countries

United States

Participant flow

Participants by arm

ArmCount
CONV Arm
Conventional (CONV) care for the diagnosis and treatment of sleep disorders 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
920
PCCM ARM
Patient-Centered Outcomes and Coordinated Care Management (PCCM) for the diagnosis and treatment of sleep disorders 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.
916
Total1,836

Baseline characteristics

CharacteristicCONV ArmTotalPCCM ARM
Age, Continuous51.1 years
STANDARD_DEVIATION 15.6
50.1 years
STANDARD_DEVIATION 15.32
49.1 years
STANDARD_DEVIATION 14.98
Ethnicity (NIH/OMB)
Hispanic or Latino
89 Participants186 Participants97 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
814 Participants1622 Participants808 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
17 Participants28 Participants11 Participants
Race (NIH/OMB)
American Indian or Alaska Native
11 Participants19 Participants8 Participants
Race (NIH/OMB)
Asian
146 Participants249 Participants103 Participants
Race (NIH/OMB)
Black or African American
32 Participants55 Participants23 Participants
Race (NIH/OMB)
More than one race
105 Participants193 Participants88 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
8 Participants16 Participants8 Participants
Race (NIH/OMB)
Unknown or Not Reported
11 Participants20 Participants9 Participants
Race (NIH/OMB)
White
607 Participants1284 Participants677 Participants
Region of Enrollment
United States
920 participants1836 participants916 participants
Sex: Female, Male
Female
396 Participants797 Participants401 Participants
Sex: Female, Male
Male
524 Participants1039 Participants515 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
30 / 15823 / 172

Outcome results

Primary

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?

Time frame: 12 months

Population: Although 1135 participants (574 CONV, 561 PCCM) completed at least one of the primary outcome measures, 546 CONV and 535 PCCM participant data were acceptable for statistical analysis for this outcome measure.

ArmMeasureValue (MEAN)Dispersion
CONV ArmChange in CGCAHPS Global Rating After 12 Months8.32 units on a scaleStandard Deviation 1.973
PCCM ARMChange in CGCAHPS Global Rating After 12 Months8.45 units on a scaleStandard Deviation 1.65
p-value: 0.687see Comments
Primary

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.

Time frame: 12 months

Population: Although 1135 participants (574 CONV, 561 PCCM) completed at least one of the primary outcome measures, 540 CONV and 539 PCCM participant data were acceptable for statistical analysis for this outcome measure.

ArmMeasureValue (MEAN)Dispersion
CONV ArmChange in SF-36 Version 2 Health Survey Vitality Score After 12 Months48.0 units on a scaleStandard Deviation 10.84
PCCM ARMChange in SF-36 Version 2 Health Survey Vitality Score After 12 Months47.1 units on a scaleStandard Deviation 11.19
p-value: 0.989see Comments
Secondary

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).

Time frame: 12 months

Population: Although 1135 participants (574 CONV, 561 PCCM) completed at least one of the primary outcome measures, 423 CONV and 426 PCCM participant data were acceptable for statistical analysis for this outcome measure.

ArmMeasureValue (MEAN)Dispersion
CONV ArmChange in CGCAHPS Health Information Technology Measure #1 After 12 Months2.03 units on a scaleStandard Deviation 0.378
PCCM ARMChange in CGCAHPS Health Information Technology Measure #1 After 12 Months2.06 units on a scaleStandard Deviation 0.356
p-value: 0.468see Comments
Secondary

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).

Time frame: 12 months

Population: Although 1135 participants (574 CONV, 561 PCCM) completed at least one of the primary outcome measures, 268 CONV and 270 PCCM participant data were acceptable for statistical analysis for this outcome measure.

ArmMeasureValue (MEAN)Dispersion
CONV ArmChange in CGCAHPS Health Information Technology Measure #3 After 12 Months3.31 units on a scaleStandard Deviation 0.787
PCCM ARMChange in CGCAHPS Health Information Technology Measure #3 After 12 Months3.30 units on a scaleStandard Deviation 0.771
p-value: 0.003see Comments
Secondary

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).

Time frame: 12 months

Population: Although 1135 participants (574 CONV, 561 PCCM) completed at least one of the primary outcome measures, 530 CONV and 525 PCCM participant data were acceptable for statistical analysis for this outcome measure.

ArmMeasureValue (MEAN)Dispersion
CONV ArmChange in CGCAHPS Provider Communication After 12 Months3.59 units on a scaleStandard Deviation 0.655
PCCM ARMChange in CGCAHPS Provider Communication After 12 Months3.64 units on a scaleStandard Deviation 0.551
p-value: 0.417see Comments

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026