Enabling Sleep Apnea Patient-Centered Care Via an Internet Intervention (California)

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Summary:

Obstructive sleep apnea syndrome (OSA) is a common type of sleep apnea and is caused by obstruction of the airway. Treatment is with a continuous positive airway pressure (CPAP) flow generator, a machine used at night by patients to create positive pressure of air via a facemask or nasal pillow in order to keep the airway open. Adherence to this treatment is typically poor: while CPAP should be used throughout a night of sleep, use is typically on the order of 3 to 5 hours. It has been found that if proper CPAP use is established from the beginning, users are more likely to be adherent with the treatment. In order to improve adherence to CPAP use, this project developed an Internet portal integrated with a telemetry treatment device designed to provide new users of CPAP with access to their clinical data, educational materials, and support. The CPAP machine was able to wirelessly upload data to the portal so that patient-use information could be viewed by both the patient and the provider. Data collected included adherence to CPAP use, the amount of air leaking around the mask or pillow, and the number of apnea episodes per hour.

The main objectives of this project were to:

  • Examine the effect of the myCPAP intervention compared to usual care on the patient’s experience of the quality of patient-centered, collaborative care (as measured by the Patient Assessment of Chronic Illness Care and the modified Consumer Assessment of Healthcare Providers and Systems Clinician & Group Survey).
  • Examine the effect of the myCPAP Internet intervention compared to usual care on level of CPAP adherence.
  • Examine the effect of myCPAP, compared to usual care, on obstructive sleep apnea outcomes (e.g., OSA symptoms and OSA-specific health-related quality of life).

The project was evaluated with a randomized clinical trial comparing the intervention group, called myCPAP, to a usual care group. The key measurement was the amount of time CPAP was used at the pressure prescribed by the clinician. The patients in the myCPAP group had a statistically significant higher rate of nearly an hour of CPAP adherence at 2 months compared with the usual care group. At 4 months the intervention group remained higher than the usual care group, although the difference was not statistically significant. The two groups did not differ on the number of outcomes measured, which included sleepiness, depressive symptoms, vigilance, and OSA-related quality of life. The project team felt that this indicated that an increase of an hour of CPAP use was not enough time to impact these measures.

Enabling Sleep Apnea Patient-Centered Care Via an Internet Intervention - 2011

Summary Highlights

  • Principal Investigator: 
  • Funding Mechanism: 
    RFA: HS07-007: Ambulatory Safety and Quality Program: Enabling Patient-Centered Care through Health Information Technology (PCC)
  • Grant Number: 
    R18 HS 017246
  • Project Period: 
    September 2007 - August 2011
  • AHRQ Funding Amount: 
    $1,155,062
  • PDF Version: 
    (PDF, 171.46 KB)

Summary: Continuous positive airway pressure (CPAP) is the therapy providers use most often to treat Obstructive sleep apnea (OSA) syndrome. Poor adherence to CPAP therapy is well-documented. This project developed an integrated remote monitoring device and Internet-based portal for patients with OSA who are prescribed CPAP treatment. The project evaluated the intervention's effect on patients' experience of care, CPAP adherence, and OSA outcomes.

OSA syndrome is a common condition that is treated with a CPAP flow generator, a machine that blows air at a physician-prescribed pressure into a facemask or nasal pillow. The Restraxx Data Center (RDC), composed of the Restraxx wireless module, affixes to and transmits data from the CPAP flow generator, and the server/database, which houses the data and restricts access to authorized health care professionals.

The objectively-measured adherence data from the RDC was transmitted to both patient and provider and used as the central outcome measure to evaluate the intervention. The provider portal contained information including adherence, volume of air leak, and number of apneas and hypopneas per hour. With this information, the provider continuously monitored the patient's progress and made ongoing decisions to support the patient and/or alter his or her treatment plan.

The team organized the data provided by the RDC into user-friendly pieces of information that are provided to the patient through the Internet Positive Airway Pressure (i-PAP) patient portal. The portal included a learning center with information on sleep apnea and the CPAP device, charts that provided objectively-measured adherence and efficacy data, self-tracked changes in weight, sleepiness, physical activity, and other user-defined factors over time. The learning center also contained self-assessment materials (including research surveys) an interactive troubleshooting guide, and cleaning instructions.

The research team conducted a randomized controlled clinical trial to evaluate the effects of the interactive portion of the CPAP treatment. Both the usual care group and the i-PAP patients were provided with CPAP devices and education materials on OSA. The trial evaluated the effect of having the Internetbased portal to facilitate the flow of information and communication between providers and patients in addition to the CPAP device. The team evaluated whether and how the i-PAP intervention affected OSArelated outcomes, CPAP adherence, patient-centeredness of care, patient assessment of and satisfaction with care, and patient activation. In addition, the team examined indicators such as use of the Web site and the frequency and nature of clinical contacts to understand the reasons behind any effects.

Specific Aims:

  • Examine the effect of the i-PAP intervention compared to usual care on the patient's experience of the quality of patient-centered, collaborative care. (Achieved)
  • Examine the effect of the i-PAP Internet intervention compared to usual care on the level of CPAP adherence. (Achieved)
  • Examine the effect of i-PAP compared to usual care on OSA outcomes. (Achieved)
  • Perform a basic cost analysis of the i-PAP intervention compared to usual care, applying a micro-cost methodology of measuring the quantity of inputs used in the production of care and the unit cost of each. (Achieved)

2011 Activities: Data were aggregated and transferred from Excel to SPSS. Scoring and data value checking were completed; scoring algorithms for questionnaires had been completed previously. Data analysis and manuscript development continued during this period.

Due to delays stemming from following up with the project subjects, the project team used a 12-month no-cost extension. The team used this time to finish data analysis. As last self-reported in the AHRQ Research Reporting System, project progress was on track and project budget spending was on target. The project was completed in August 2011.

Impact and Findings: The main finding of the study was that the i-CPAP intervention resulted in higher adherence relative to the usual care group. This difference was almost 1 hour per night. However, the difference of 1 hour per night did not appear to make a difference in the measured OSA symptoms between the interventional groups.

The key advantage of the i-CPAP intervention was the availability of resources important to the patient, including the learning center, the troubleshooting guide, and the data tracking. In the development of the i-CPAP intervention, the project was not able to execute certain functions due to privacy and confidentiality concerns related to local policies. These functions included: 1) setting up an e-mail contact system between patient and provider; 2) setting up a forum or bulletin board for enrolled participants; and 3) allowing for greater tracking possibilities. Health-related behavior change is in large part susceptible to several key behavioral change techniques, including goal-setting, self-monitoring, peer support, and increased selfefficacy. It may be that in omitting peer support, the intervention lost a potentially efficacious component. In a previous study by this research team, a group self-management program with peer support as one of its core components had a slightly larger effect. The key advantage of the i-CPAP intervention is its ability to provide OSA patients with the information they need when they need it, which is consistent with a patient-centered, collaborative care approach. The i-CPAP intervention provides the core of future interventional efforts using this technology.

Target Population: Adults

Strategic Goal: Develop and disseminate health IT evidence and evidence-based tools to support patient- centered care, the coordination of care across transitions in care settings, and the electronic exchange of health information to improve quality of care.

Business Goal: Implementation and Use

Enabling Sleep Apnea Patient-Centered Care Via an Internet Intervention - 2010

Summary Highlights

  • Principal Investigator: 
  • Funding Mechanism: 
    RFA: HS07-007: Ambulatory Safety and Quality Program: Enabling Patient-Centered Care through Health Information Technology (PCC)
  • Grant Number: 
    R18 HS 017246
  • Project Period: 
    September 2007 – August 2011, Including No-Cost Extension
  • AHRQ Funding Amount: 
    $1,155,062
  • PDF Version: 
    (PDF, 357.74 KB)


Target Population: Adults

Summary: Poor treatment adherence with continuous positive airway pressure (CPAP) therapy is well-documented. This project develops an integrated remote monitoring device and Internet-based portal for patients with obstructive sleep apnea syndrome (OSA) who are prescribed CPAP treatment. The project will evaluate the intervention’s effect on patients’ experience of care, CPAP adherence, and OSA outcomes. Poor treatment adherence with continuous positive airway pressure (CPAP) therapy is well-documented. This project develops an integrated remote monitoring device and Internet-based portal for patients with obstructive sleep apnea syndrome (OSA) who are prescribed CPAP treatment. The project will evaluate the intervention’s effect on patients’ experience of care, CPAP adherence, and OSA outcomes.

OSA is a common sleep apnea and is caused by obstruction of the airway. It is treated with a CPAP flow generator, a machine that blows air at a physician-prescribed pressure into a facemask or nasal pillow. The team used the ResMed-developed Restraxx Data Center (RDC), a Web site that obtains data from the CPAP flow generator via a wireless monitoring module that affixes directly to the CPAP unit. The objectively-measured adherence data from the RDC will be transmitted to both patient and provider and used as the central outcome measure to evaluate the intervention. The provider portal contains information including adherence, amount of air leaking, and number of apneas or hypopneas per hour. With this information, the provider can continuously monitor the patient’s progress and make ongoing decisions about how to support the patient and/or alter his or her treatment plan.

The team organizes the data provided by the RDC into user-friendly pieces of information which are then provided to the patient through the Internet Positive Airway Pressure (i-PAP) patient portal. In addition, the portal contains tailored measures that patients can observe and allows them to add self-defined measures. The portal has a learning center with information on sleep apnea and the CPAP device, charts that provide objectively-measured adherence and efficacy data, self-tracked changes in weight, sleepiness, physical activity, and other user-defined factors over time. The learning center also contains self-assessment materials, including research surveys and a journal for self-documentation, a message board with a support network for CPAP users, and links to external sources of information on sleep apnea.

The project will conduct a randomized controlled clinical trial to evaluate the effects of the interactive portion of the CPAP treatment. Both the usual care group and the i-PAP patients will be provided with CPAP devices and education materials on OSA. The trial will evaluate the effect of having the Internet-based portal to facilitate the flow of information and communication between providers and patients in addition to the CPAP device. The team will evaluate whether and how the i-PAP intervention affects OSA-related outcomes, CPAP adherence, patient-centeredness of care, patient assessment of and satisfaction with care, and patient activation. In addition, the team will examine indicators such as use of the Web site and frequencies and the nature of clinical contacts to understand the reasons behind any effects.

Specific Aims:
  • Examine the effect of the i-PAP intervention compared to usual care on the patient’s experience of the quality of patient-centered, collaborative care. (Ongoing)
  • Examine the effect of the i-PAP Internet intervention compared to usual care on the level of CPAP adherence. (Ongoing)
  • Examine the effect of i-PAP compared to usual care on OSA outcomes. (Ongoing)
  • Perform a basic cost analysis of the i-PAP intervention compared to usual care, applying a micro-cost methodology of measuring the quantity of inputs used in the production of care and the unit cost of each. (Ongoing)

2010 Activities: The project online assessments were created and subjected to extensive validation procedures to ensure that the paper version of the questionnaire be accurately portrayed in the Web-based version. The validation procedures included verification of each item, the allowable responses, the flow and order of the questions within the questionnaire, the accuracy of the changes in items across baseline, post-intervention, followup visits, and troubleshooting of any problems when the test subjects took practice versions of the online testing. Online questionnaires were improved in several ways: font size was increased for readability; “hit” zones were enlarged to make response selection easier; online questionnaires were divided into two parts to allow a sense of completion for those who might find the survey lengthy; and an added progress bar at the top of the page for those wished to monitor relative time until completion. Once the online surveys were created, they were integrated to the Web site for patients, and a research administration page was created to allow project staff to track participants who were due to complete surveys and those who already completed them.

The basic flow of recruitment, enrollment, and intervention, along with assessments, are firmly in place. The Web site design is essentially complete. The team continues to consider adding functionality to the Web site in two areas and continues to review and update troubleshooting guide.

The team continued to work on cleaning the CPAP data. For various reasons some research participants ended up with more than one data download, so the team combined the excel files so there was one file per subject. The project had 210 CPAP data downloads at the time of the last report, 14 of which needed to have the data aggregated. Hand manipulation was required and double-checks were integrated into the process. In addition, the team attempted to reduce the higher-than-expected rates of uncompleted data on the questionnaire. Efforts to schedule more in-office appointments and maintain better contact helped maintain a 20 percent or higher questionnaire completeness rate.

Grantee’s Most Recent Self-Reported Quarterly Status (as of December 2010): Project progress is mostly on track. Budget spending is roughly on target.

Preliminary Impact and Findings: A review of sleep apnea and CPAP Web sites identified more than 90 Web sites. The team coded 49 of them for descriptive and evaluative variables. The project team is reviewing the information for type of interactivity. Fewer than five Web sites had any interactive content and only one had graphical interactive content. Patients who engaged in the clinical aspect of the project are not as compliant with the Web-based assessment as would have been expected. The study team is expecting to implement strategies to improve the 25 percent attrition rates.

This project successfully developed a trigger that had a higher predictive value than those used in previous studies. A final important finding is that previously, diagnostic error in primary care has focused on cancer. Data from this study however, indicates that there is a range of common conditions in which diagnostic errors occur.

Several manuscripts and book chapters were initiated and are expected to be published in 2011.

Strategic Goal: Develop and disseminate health IT evidence and evidence-based tools to support patient-centered care, the coordination of care across transitions in care settings, and the electronic exchange of health information to improve quality of care.

Business Goal: Implementation and Use

Enabling Sleep Apnea Patient-Centered Care Via an Internet Intervention - Final Report

Citation:
Stepnowsky C. Enabling Sleep Apnea Patient-Centered Care Via an Internet Intervention - Final Report. (Prepared by the Veterans Medical Research Foundation under Grant No. R18 HS017246). Rockville, MD: Agency for Healthcare Research and Quality, 2012. (PDF, 287.67 KB)

The findings and conclusions in this document are those of the author(s), who are responsible for its content, and do not necessarily represent the views of AHRQ. No statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services.
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