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Impact of Automated Education and Follow-up Mechanisms on Patient Engagement (EmmiUSleep)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02279901
Recruitment Status : Completed
First Posted : October 31, 2014
Last Update Posted : March 6, 2017
Sponsor:
Collaborator:
ResMed
Information provided by (Responsible Party):
Dennis Hwang, MD, Kaiser Permanente

Brief Summary:

The primary and well-known challenge with continuous positive airway pressure (CPAP) is the incomplete adherence of patients to this therapy. Successfully improving CPAP use is likely through emphasizing patient education regarding the risks associated with obstructive sleep apnea (OSA), potential benefits of therapy, teaching techniques to acclimate to CPAP, and providing a system of accountability through a follow-up process. With the changing landscape of healthcare reimbursement which emphasizes achieving positive clinical outcomes, discovering more automated and self-directed methods of educating and follow-up is needed.

The investigators plan to investigate the impact of adjunct Web education and automated follow-up on CPAP use and other measurements of patient engagement. The specific aims of this pilot study are as follows:

  1. Assess impact of Telemedicine mechanisms on CPAP use 3 months after initiating therapy in comparison to usual standard of care.
  2. Assess impact of Telemedicine mechanisms on functional outcomes and parameters of healthcare utilization at 3 months after initiation of therapy in comparison to usual standard of care.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Behavioral: Telemedicine Education Behavioral: IVR Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1873 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Health Services Research
Official Title: Impact of Interactive Web-Based Education and Interactive Voice Response (Automated Follow-up) Programs on CPAP Adherence for the Treatment of Obstructive Sleep Apnea
Study Start Date : November 2014
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
No Intervention: Traditional
Patients will attend a 1 hour OSA Class where OSA education is provided and home sleep testing is set up. These patients return the next day for individual appointments where study is scored and test results are discussed with patient. If study is consistent with OSA based on AHI4% at least 5/hour, patients undergo a 1 week autoCPAP trial. During this week, wireless remote monitoring is performed and troubleshooting is provided via telephone if problems with CPAP use are identified. The autoCPAP is returned during an individual visit, and CPAP is ordered for long-term use based on trial results and patient feedback. Patients are scheduled a 3 month follow-up appointment but are also instructed to call their sleep center case manager prior to that visit if there are problems with CPAP use.
Experimental: Telemedicine Education Pathway
Patients follow our usual workflow as outlined in the Traditional Pathway. In addition, patients are emailed a link to view the Emmi OSA program within 2 weeks prior to their initial OSA class. If the patient tests positive for OSA and agrees to an autoCPAP trial, the patient is emailed a link to view the Emmi CPAP program. These patients are also scheduled for a 3 month follow-up visit to check CPAP usage.
Behavioral: Telemedicine Education

Emmi Solutions produces Web-based, simple to understand, healthcare related educational programs. These programs are interactive sessions that last about 15 minutes, educating patients on the risk of OSA and assisting in preparing patients for procedures. Two such programs will be sent to patients at preset intervals over the duration of the study:

  1. OSA program
  2. CPAP program

Links to each of these programs are emailed to the patient and date of birth needs to be verified before the program will start. The programs ask the patient for feedback at regular intervals and provide opportunities throughout to make notes or write down questions that can be later printed. These programs are already approved for clinical use within Kaiser Permanente which has a contract with the vendor.

Other Name: Emmi

Experimental: Telemedicine IVR Pathway
Patients follow our usual workflow as outlined in the Traditional Pathway. Additionally, if CPAP is ordered for long-term therapy, the patient is enrolled into an IVR protocol that automatically analyzes the patient's CPAP use. If specific provider-defined thresholds are met, the platform will automatically deliver feedback messages to the patient (phone call, text messaging, or email) with the intention of encouraging better CPAP use. Patients are instructed to contact the sleep center for any issues with their therapy. This platform also includes a method for patients to track their own usage online. Automated messaging mechanism will be active for 3 months after CPAP is ordered, after which the messaging will stop. These patients are also scheduled for a 3 month follow-up visit.
Behavioral: IVR

Interactive Voice Response (IVR) is a protocol in which automated messages are delivered via e-mail, text or phone to patients to provide feedback regarding their CPAP use, intended to improve therapy adherence. The basic protocol involves the use of CPAP devices that wirelessly send usage data to a cloud platform. Automated algorithms will assess the usage data and send messages to the patient when there is suboptimal usage or excessive leak, or to provide encouragement for successful use.

Specifically, we will use CPAP devices with built-in modems which will send usage data via cellular network to cloud-based platforms that will automatically analyze the usage data and send the automated messages. Patients also can track their own therapy information through the platform.

Other Names:
  • U-Sleep
  • Interactive Voice Response

Experimental: Telemedicine Both Pathway
Patients follow our usual workflow as outlined in the Traditional Pathway. In addition, patients are provided both Emmi education programs and IVR follow-up as previously outlined. These patients are also scheduled for a 3 month follow-up.
Behavioral: Telemedicine Education

Emmi Solutions produces Web-based, simple to understand, healthcare related educational programs. These programs are interactive sessions that last about 15 minutes, educating patients on the risk of OSA and assisting in preparing patients for procedures. Two such programs will be sent to patients at preset intervals over the duration of the study:

  1. OSA program
  2. CPAP program

Links to each of these programs are emailed to the patient and date of birth needs to be verified before the program will start. The programs ask the patient for feedback at regular intervals and provide opportunities throughout to make notes or write down questions that can be later printed. These programs are already approved for clinical use within Kaiser Permanente which has a contract with the vendor.

Other Name: Emmi

Behavioral: IVR

Interactive Voice Response (IVR) is a protocol in which automated messages are delivered via e-mail, text or phone to patients to provide feedback regarding their CPAP use, intended to improve therapy adherence. The basic protocol involves the use of CPAP devices that wirelessly send usage data to a cloud platform. Automated algorithms will assess the usage data and send messages to the patient when there is suboptimal usage or excessive leak, or to provide encouragement for successful use.

Specifically, we will use CPAP devices with built-in modems which will send usage data via cellular network to cloud-based platforms that will automatically analyze the usage data and send the automated messages. Patients also can track their own therapy information through the platform.

Other Names:
  • U-Sleep
  • Interactive Voice Response




Primary Outcome Measures :
  1. Average hours of CPAP use per night: experimental pathway vs. traditional pathway [ Time Frame: 3 months ]
    Difference in 3 month CPAP use (hours per night) between each telemedicine (experimental) pathway compared to the traditional (control) pathway


Secondary Outcome Measures :
  1. Average hours of CPAP use per night: experimental pathway vs. experimental pathway [ Time Frame: 3 months ]
    Difference in 3 month CPAP use (hours per night) between each telemedicine pathway (experimental) as compared to other telemedicine (experimental) pathways

  2. ESS (Epworth Sleepiness Score) [ Time Frame: 3 months ]
    Difference in 3 month change in ESS among pathways

  3. FOSQ-10 (Functional Outcomes of Sleep Questionnaire - 10 Questions) [ Time Frame: 3 months ]
    Difference in 3 month change in FOSQ-10 among pathways

  4. Adherence to provider encounters [ Time Frame: 3 months ]
    Difference in encounter no-show rates and percentage of moderate-severe OSA patients that agree to long-term CPAP therapy among pathways

  5. Healthcare utilization [ Time Frame: 3 months ]
    Difference in measures of healthcare utilization (e.g. number of provider encounters, primary care visits, number of patient pharmaceutical prescription fills) among pathways



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical suspicion of obstructive sleep apnea (OSA)
  • Appropriate for home sleep testing
  • No prior use of CPAP or other therapies for OSA

Exclusion Criteria:

  • Commercial drivers
  • Complex sleep disorders (e.g. CSA)
  • No DME (durable medical equipment) insurance coverage
  • Declines CPAP therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02279901


Locations
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United States, California
Sleep Center; Fontana Medical Center, Kaiser Permanente
Fontana, California, United States, 92335
Sponsors and Collaborators
Kaiser Permanente
ResMed
Investigators
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Principal Investigator: Dennis Hwang, MD Kaiser Permanente

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dennis Hwang, MD, MD, Kaiser Permanente
ClinicalTrials.gov Identifier: NCT02279901    
Other Study ID Numbers: KaiserPermanente
ASMF #104-SR-13 ( Other Grant/Funding Number: American Sleep Medicine Foundation )
First Posted: October 31, 2014    Key Record Dates
Last Update Posted: March 6, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: This study has been conducted solely within Kaiser Permanente, and it is unnecessary to release IPD to external sources or organizations.
Keywords provided by Dennis Hwang, MD, Kaiser Permanente:
Obstructive Sleep Apnea
CPAP
Continuous positive airway pressure
CPAP compliance
Telemedicine
Automated response mechanisms
Patient engagement
OSA
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases