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

NCT02279901 | Completed

• 2 other identifiers: KaiserPermanenteASMF #104-SR-13
• Study Type: interventional
• Target: 1,873
• Locations: 1 country
• Sites: 1

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. 1.Assess impact of Telemedicine mechanisms on CPAP use 3 months after initiating therapy in comparison to usual standard of care.
2. 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.

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive Sleep Apnea; CPAP; Continuous positive airway pressure; CPAP compliance; Telemedicine; Automated response mechanisms; Patient engagement; OSA

Outcome Measures

Primary Outcomes (1)

• Average hours of CPAP use per night: experimental pathway vs. traditional pathway

  Difference in 3 month CPAP use (hours per night) between each telemedicine (experimental) pathway compared to the traditional (control) pathway

  3 months

Secondary Outcomes (5)

• Average hours of CPAP use per night: experimental pathway vs. experimental pathway

  3 months

• ESS (Epworth Sleepiness Score)

  3 months

• FOSQ-10 (Functional Outcomes of Sleep Questionnaire - 10 Questions)

  3 months

• Adherence to provider encounters

  3 months

• Healthcare utilization

  3 months

Study Arms (4)

Traditional

NO INTERVENTION

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.

Telemedicine Education Pathway

EXPERIMENTAL

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

Telemedicine IVR Pathway

EXPERIMENTAL

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

Telemedicine Both Pathway

EXPERIMENTAL

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; Behavioral: IVR

Interventions

Telemedicine Education BEHAVIORAL

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.

Also known as: Emmi

Telemedicine Both Pathway; Telemedicine Education Pathway

IVR BEHAVIORAL

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.

Also known as: U-Sleep, Interactive Voice Response

Telemedicine Both Pathway; Telemedicine IVR Pathway

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Kaiser Permanente: lead
• ResMed: collaborator

Study Sites (1)

Sleep Center; Fontana Medical Center, Kaiser Permanente

Fontana, California, 92335, United States

Location

Related Publications (5)

• Young T, Palta M, Dempsey J, Skatrud J, Weber S, Badr S. The occurrence of sleep-disordered breathing among middle-aged adults. N Engl J Med. 1993 Apr 29;328(17):1230-5. doi: 10.1056/NEJM199304293281704.

  PMID: 8464434 BACKGROUND

• The Economic Cost of Sleep Disorders in Australia. Sleep Health Foundation. Deloitte Access Economics. 2010.

  BACKGROUND

• Fox N, Hirsch-Allen AJ, Goodfellow E, Wenner J, Fleetham J, Ryan CF, Kwiatkowska M, Ayas NT. The impact of a telemedicine monitoring system on positive airway pressure adherence in patients with obstructive sleep apnea: a randomized controlled trial. Sleep. 2012 Apr 1;35(4):477-81. doi: 10.5665/sleep.1728.

  PMID: 22467985 BACKGROUND

• Hwang, Dennis. Pathway to Progress: Kaiser Permanente rethinks its sleep center delivery care model. Sleep Review Magazine. October 2012.

  BACKGROUND

• Hwang D, Chang JW, Benjafield AV, Crocker ME, Kelly C, Becker KA, Kim JB, Woodrum RR, Liang J, Derose SF. Effect of Telemedicine Education and Telemonitoring on Continuous Positive Airway Pressure Adherence. The Tele-OSA Randomized Trial. Am J Respir Crit Care Med. 2018 Jan 1;197(1):117-126. doi: 10.1164/rccm.201703-0582OC.

  PMID: 28858567 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Patient Participation

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Dennis Hwang, MD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 28, 2014
• First Posted: October 31, 2014
• Study Start: November 1, 2014
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: March 6, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)