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

• Sponsor: Stanford University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02037438
• Collaborator: Patient-Centered Outcomes Research Institute (Other)
• Enrollment: 1,836
• Location: 1
• Arms: 2
• Duration (Months): 28
• Patients Per Site Per Month: 65.7

Study Details

Study Description

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	N/A

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

• Study Type: Interventional
• 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: Jan 1, 2014
• Actual Primary Completion Date: May 1, 2016
• Actual Study Completion Date: May 1, 2016

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Change in CGCAHPS Global Rating After 12 Months [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 [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 [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 [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 [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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

• Principal Investigator: Clete A Kushida, M.D., Ph.D., Stanford University

Study Documents (Full-Text)

None provided.

More Information

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.

• Responsible Party: Clete A. Kushida, Principle Investigator, Stanford University
• ClinicalTrials.gov Identifier: NCT02037438
• Other Study ID Numbers: CE-12-11-4137; SPO #: 105981
• First Posted: Jan 16, 2014
• Last Update Posted: Mar 4, 2019
• Last Verified: Nov 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Clete A. Kushida, Principle Investigator, 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: Sleep Apnea, Obstructive; Sleep Wake Disorders; Parasomnias; Movement Disorders; Narcolepsy; Disorders of Excessive Somnolence; Sleep Disorders, Circadian Rhythm; Disease

Study Results

Participant Flow

Arm/Group Title	CONV Arm	PCCM ARM
Arm/Group Description	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	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.
Period Title: Overall Study
STARTED	920	916
COMPLETED	574	561
NOT COMPLETED	346	355

Baseline Characteristics

Arm/Group Title	CONV Arm	PCCM ARM	Total
Arm/Group Description	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	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.	Total of all reporting groups
Overall Participants	920	916	1836
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	51.1 (15.60)	49.1 (14.98)	50.1 (15.32)
Sex: Female, Male (Count of Participants)
Female	396 43%	401 43.8%	797 43.4%
Male	524 57%	515 56.2%	1039 56.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	89 9.7%	97 10.6%	186 10.1%
Not Hispanic or Latino	814 88.5%	808 88.2%	1622 88.3%
Unknown or Not Reported	17 1.8%	11 1.2%	28 1.5%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	11 1.2%	8 0.9%	19 1%
Asian	146 15.9%	103 11.2%	249 13.6%
Native Hawaiian or Other Pacific Islander	8 0.9%	8 0.9%	16 0.9%
Black or African American	32 3.5%	23 2.5%	55 3%
White	607 66%	677 73.9%	1284 69.9%
More than one race	105 11.4%	88 9.6%	193 10.5%
Unknown or Not Reported	11 1.2%	9 1%	20 1.1%
Region of Enrollment (participants) [Number]
United States	920 100%	916 100%	1836 100%

Outcome Measures

1. Primary Outcome

Title	Change in CGCAHPS Global Rating After 12 Months
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	CONV Arm	PCCM ARM
Arm/Group Description	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	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.
Measure Participants	546	535
Mean (Standard Deviation) [units on a scale]	8.32 (1.973)	8.45 (1.650)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CONV Arm, PCCM ARM
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.687
	Comments
	Method	see Comments
	Comments	Finite-Mixture Models with Fixed Effects for Providers
Method of Estimation	Estimation Parameter	Provider-Effect Adjusted Difference
	Estimated Value	0.03
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.075
	Estimation Comments

2. Primary Outcome

Title	Change in SF-36 Version 2 Health Survey Vitality Score After 12 Months
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	CONV Arm	PCCM ARM
Arm/Group Description	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	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.
Measure Participants	540	539
Mean (Standard Deviation) [units on a scale]	48.0 (10.84)	47.1 (11.19)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CONV Arm, PCCM ARM
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.989
	Comments
	Method	see Comments
	Comments	Heteroscedasticity-Consistent Linear Regression with Fixed Effects for Providers and Baseline Covariate
Method of Estimation	Estimation Parameter	Provider-Effect Adjusted Difference
	Estimated Value	-0.007
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.539
	Estimation Comments

3. Secondary Outcome

Title	Change in CGCAHPS Provider Communication After 12 Months
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	CONV Arm	PCCM ARM
Arm/Group Description	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	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.
Measure Participants	530	525
Mean (Standard Deviation) [units on a scale]	3.59 (0.655)	3.64 (0.551)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CONV Arm, PCCM ARM
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.417
	Comments
	Method	see Comments
	Comments	Finite-Mixture Models with Fixed Effects for Providers
Method of Estimation	Estimation Parameter	Provider-Effect Adjusted Difference
	Estimated Value	0.114
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.141
	Estimation Comments

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	CONV Arm	PCCM ARM
Arm/Group Description	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	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.
Measure Participants	423	426
Mean (Standard Deviation) [units on a scale]	2.03 (0.378)	2.06 (0.356)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CONV Arm, PCCM ARM
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.468
	Comments
	Method	see Comments
	Comments	Finite-Mixture Models with Fixed Effects for Providers
Method of Estimation	Estimation Parameter	Provider-Effect Adjusted Difference
	Estimated Value	0.057
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.078
	Estimation Comments

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	CONV Arm	PCCM ARM
Arm/Group Description	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	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.
Measure Participants	268	270
Mean (Standard Deviation) [units on a scale]	3.31 (0.787)	3.30 (0.771)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CONV Arm, PCCM ARM
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.003
	Comments
	Method	see Comments
	Comments	Finite-Mixture Models with Fixed Effects for Providers
Method of Estimation	Estimation Parameter	Provider-Effect Adjusted Difference
	Estimated Value	0.177
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.061
	Estimation Comments

Adverse Events

Time Frame	1 year
Adverse Event Reporting Description	Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.
Arm/Group Title	CONV Arm		PCCM ARM
Arm/Group Description	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		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.
All Cause Mortality
	CONV Arm		PCCM ARM
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	CONV Arm		PCCM ARM
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	30/158 (19%)		23/172 (13.4%)
Cardiac disorders
Hospital Admissions	1/158 (0.6%)		0/172 (0%)
Surgeries/Procedures	3/158 (1.9%)		4/172 (2.3%)
Deaths	2/158 (1.3%)		0/172 (0%)
Endocrine disorders
Surgeries/Procedures	1/158 (0.6%)		0/172 (0%)
Deaths	1/158 (0.6%)		0/172 (0%)
Gastrointestinal disorders
Emergency Department Visits	1/158 (0.6%)		0/172 (0%)
Hospital Admissions	0/158 (0%)		1/172 (0.6%)
Surgeries/Procedures	1/158 (0.6%)		3/172 (1.7%)
General disorders
Emergency Department Visits	0/158 (0%)		1/172 (0.6%)
Surgeries/Procedures	0/158 (0%)		2/172 (1.2%)
Musculoskeletal and connective tissue disorders
Emergency Department Visits	0/158 (0%)		1/172 (0.6%)
Surgeries/Procedures	4/158 (2.5%)		4/172 (2.3%)
Accidents	2/158 (1.3%)		1/172 (0.6%)
Nervous system disorders
Emergency Department Visits	1/158 (0.6%)		1/172 (0.6%)
Hospital Admissions	2/158 (1.3%)		0/172 (0%)
Deaths	0/158 (0%)		1/172 (0.6%)
Psychiatric disorders
Emergency Department Visits	1/158 (0.6%)		0/172 (0%)
Hospital Admissions	1/158 (0.6%)		0/172 (0%)
Renal and urinary disorders
Emergency Department Visits	1/158 (0.6%)		0/172 (0%)
Surgeries/Procedures	1/158 (0.6%)		2/172 (1.2%)
Respiratory, thoracic and mediastinal disorders
Hospital Admissions	2/158 (1.3%)		0/172 (0%)
Surgeries/Procedures	4/158 (2.5%)		1/172 (0.6%)
Deaths	1/158 (0.6%)		0/172 (0%)
Skin and subcutaneous tissue disorders
Hospital Admissions	0/158 (0%)		1/172 (0.6%)
Other (Not Including Serious) Adverse Events
	CONV Arm		PCCM ARM
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.