N/A
Completed N=1,836
Sustainable Methods, Algorithms, and Research Tools for Delivering Optimal Care Study
Obstructive Sleep Apnea of Adult · Insomnia · Circadian Rhythm Sleep Disorder · Sleep Related Movement Disorders
Source: ClinicalTrials.gov NCT02037438 ↗
Enrolled (actual)
1,836
Serious AEs
16.1%
Results posted
Mar 2019
Primary outcomePrimary: Change in CGCAHPS Global Rating After 12 Months — 8.32; 8.45 units on a scale — p=0.687
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in CGCAHPS Global Rating After 12 Months |
8.32; 8.45 | 0.687 |
| PRIMARY Change in SF-36 Version 2 Health Survey Vitality Score After 12 Months |
48.0; 47.1 | 0.989 |
| SECONDARY Change in CGCAHPS Provider Communication After 12 Months |
3.59; 3.64 | 0.417 |
| SECONDARY Change in CGCAHPS Health Information Technology Measure #1 After 12 Months |
2.03; 2.06 | 0.468 |
| SECONDARY Change in CGCAHPS Health Information Technology Measure #3 After 12 Months |
3.31; 3.30 | 0.003 sig |
Eligibility Criteria
Inclusion Criteria
- 18 years of age and older
- New clinical outpatient presenting signs and/or symptoms of a sleep disorder
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT02037438). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.