NCT02037438

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,836

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

January 14, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 16, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

March 4, 2019

Completed
Last Updated

March 4, 2019

Status Verified

November 1, 2018

Enrollment Period

2.3 years

First QC Date

January 14, 2014

Results QC Date

December 1, 2016

Last Update Submit

November 2, 2018

Conditions

Obstructive Sleep Apnea of AdultInsomniaCircadian Rhythm Sleep DisorderSleep Related Movement DisordersNarcolepsy and HypersomniaParasomnia

Keywords

Clinical sleep medicineNew methodology for healthcare deliveryDiagnosis and treatment of sleep disordersElectronic health recordsClinical informaticsEvidence-based comparative effectiveness researchSleep specialistsPrimary care providersAllied health professionalsPatient-centered care

Outcome Measures

Primary Outcomes (2)

  • 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?"

    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.

    12 months

Secondary Outcomes (3)

  • Change in CGCAHPS Provider Communication After 12 Months

    12 months

  • Change in CGCAHPS Health Information Technology Measure #1 After 12 Months

    12 months

  • Change in CGCAHPS Health Information Technology Measure #3 After 12 Months

    12 months

Study Arms (2)

CONV Arm

ACTIVE COMPARATOR

Conventional (CONV) care for the diagnosis and treatment of sleep disorders

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

Other: PCCM for the diagnosis and treatment of sleep disorders

Interventions

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

CONV Arm
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.

PCCM ARM

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford Sleep Clinic, Stanford University Center for Sleep Science and Medicine

Redwood City, California, 94063, United States

Location

Related Publications (1)

  • 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.

    PMID: 25409112BACKGROUND

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersSleep Disorders, Circadian RhythmNarcolepsyDisorders of Excessive SomnolenceParasomniasDisease

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersChronobiology DisordersOccupational DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Clete Kushida
Organization
Stanford University
clete@stanford.edu
650-721-7560

Study Officials

  • Clete A Kushida, M.D., Ph.D.

    Stanford University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

January 14, 2014

First Posted

January 16, 2014

Study Start

January 1, 2014

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

March 4, 2019

Results First Posted

March 4, 2019

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will share

De-identified data will be shared with other researchers; these data will be available after April 2017

Locations

US(1)