Predictive Analytics and Peer-Driven Intervention for Guideline-based Care for Sleep Apnea

November 15, 2017 updated by: Sairam Parthasarathy, University of Arizona

Obstructive sleep apnea (OSA) is a prevalent condition that affects 7 to 12% of the US population and is characterized by repetitive collapse of the upper airway during sleep. Continuous positive airway pressure (CPAP) has been shown to be highly effective in the treatment of OSA, however, adherence is poor with up to 54% of patients being non-adherent to CPAP therapy by Medicare criteria, which has been attributed to inadequate patient education and support for CPAP therapy.

Poor treatment adherence in patients with OSA can lead to adverse health consequences, poor quality of life, and patient dissatisfaction. Poor treatment adherence may be due to lack of sufficient patient education, time delays in delivery of care, lack of adequate healthcare coordination, or difficulty accessing various healthcare providers across a front desk which serves as a "healthcare bottle-neck". Better efficiency in healthcare delivery, with greater connectivity through knowledgeable and trained peer volunteers and cheap cell-phones integrated by a smart telephone exchange may alleviate some of the care and communication burden faced by the healthcare system. Specifically, such community health education volunteers ("peer-buddies") who are experienced in managing their OSA may be able to impart knowledge and confidence to a recently diagnosed patient in a much more personalized manner than that of a group therapy session.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

OSA affects 7 to 12% of the US population and is an independent risk factor for several clinical consequences such as systemic hypertension, cardiovascular disease, stroke, reduced HR-QOL, increased all-cause mortality, and motor vehicle accidents due to sleepiness. However, OSA and other sleep disorders are woefully underdiagnosed because of time constraints at the PCP's office. Such poor CPAP adherence is associated with increased risk for fatal and non-fatal cardiovascular events. CPAP therapy has been associated with up to 3-fold reduction in fatal and non-fatal cardiovascular events in both on-treatment analysis of RCTs and observational studies. CPAP therapy is associated with 7-fold reduction in sleepiness-related accidents. The overarching aim of this proposal is to institute a multi-level strategy aimed at improving guideline based care for OSA in populations with health disparities.

The overarching aim of the program of research is to eventually institute a multi-level strategy with interventions aimed at both providers and patients in order to improve guideline based care for OSA in populations with health disparities. Specifically, in order to address the under-diagnosis of OSA, an electronic health record (EHR) based predictive analytics system will be implemented. A similar EHR-based alert system with reflex order sets for initiating testing for OSA that the investigators have developed will enable PCPs to effectively diagnose and treat OSA. It was found that in a nationally representative dataset of ~220,000 patients, lower neighborhood income was associated with lower CPAP adherence. Considering the time and access-related barriers in the PCP office, it is believed that such socioeconomic status (SES) related differences in CPAP adherence needs to be addressed by culturally-competent peer educators (such as promotors) with OSA serving as "peer-buddies". In a recent multi-site RCT, it was found that CPAP adherence and patient satisfaction was improved by peer-driven intervention through an interactive voice response system (PDI-IVR; PCORI-IHS-1306-02505), whereby the peers shared their experiences with CPAP naïve patients and educated them about OSA and risks of CPAP nonadherence. Whether PDI-IVR can improve adherence in underserved population in low resource clinics is unclear. In this proposal, 110 CPAP naïve patients and 35 experienced peer-buddies will be recruited in from a large healthcare system that provides care for an underserved population with an excess burden of sleep disorders (Medicaid and dual-eligible Medicare beneficiaries). This study will address health disparities in the diagnosis and treatment of OSA using a patient-level educational intervention (PDI-IVR system) targeting patients and thereby promote health equity. This proposal will also inform future studies by gathering additional data on the effect of PDI-IVR on adherence to sleep study testing and CPAP adherence in an underserved population in low resource clinics.

Specific Aim #1: To test a peer-driven intervention with interactive voice response (PDI-IVR) system to improve adherence to sleep study testing in a lower socioeconomic population.

Hypothesis #1: A PDI-IVR support system will lead to greater adherence to sleep study testing in patients with OSA when compared to patients receiving conventional education.

Specific Aim #2: To test a peer-driven intervention with interactive voice response (PDI-IVR) system to improve CPAP treatment adherence in a lower socioeconomic population.

Hypothesis #2: A PDI-IVR support system will lead to greater adherence to CPAP therapy in patients with OSA when compared to patients receiving conventional education.

Study Type

Interventional

Enrollment (Anticipated)

145

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85721
        • University of Arizona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria for Subject:

  • Referral for sleep study testing for possible OSA
  • Medicaid and dual-eligible Medicare beneficiaries
  • Household income in the bottom national quartile of household median income

Inclusion Criteria for Peer Buddy:

  • Adherent to CPAP therapy (greater than or equal to 4 hours per night of CPAP use)
  • Willing to meet with peer-buddy on 2-4 occasions in-person
  • Has a cell phone or other reliable telephone line
  • Willing to undergo one-two training and orientation session(s) and pass a subsequent mock patient interaction

Exclusion Criteria for Subject:

  • Central sleep apnea (CSA)
  • Participation in another intervention-based research study
  • Patient's primary care provider refuses patient participation for medical instability

Exclusion Criteria for Peer Buddy:

  • Central sleep apnea (CSA)
  • Participation in another intervention-based research study
  • Patient's primary care provider refuses patient participation for medical instability
  • Major depression or other major psychiatric illness
  • Shift-worker or frequent out of town traveler

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Peer-buddy system
Will meet with peer-buddy who will help with them with CPAP usage. Also will receive standard of care CPAP educational training
Other: Peer-Buddy System

2-4 30-minute in person sessions with Peer Buddy (2 before and 2 after receiving CPAP)

Standard of care CPAP educational training

8-10 phone conversations with Peer Buddy over 3 month period

Subsequent 3 months use of phone system to contact Peer Buddy as needed
Active Comparator: Usual Care
Will receive educational material at the same frequency that those in the experimental arm. Will also receive standard of care CPAP educational training.
Other: Usual Care

Standard of care CPAP educational training

Educational Brochures and DVD videos mailed to participants (12 times)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients undergoing sleep study testing
Time Frame: Baseline
Difference between the proportion of patients in the peer-buddy arm from the proportion of patients in the conventional educational arm that follow-through and undergo sleep study testing.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CPAP Adherence downloads
Time Frame: Day 30, Day 90, and Day 180
All CPAP devices have internal adherence monitoring which can be downloaded using a computer cable, smart card, SD chip or wireless transmission. The objective, adherence information as 'mask-on' time for 6 months, number of nights used, cumulative hours used, average hours of CPAP use per night, and average number of hours per day of CPAP use will be derived. The proportion of days in which CPAP use was at least 4 hr (Medicare criterion) will also be utilized. Change in CPAP adherence over time will be assessed.
Day 30, Day 90, and Day 180

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Outcomes of Sleep Questionnaire (FOSQ)
Time Frame: Baseline, Day 90, and Day 180
A condition-specific functional status measure designed to evaluate the impact of disorders of excessive sleepiness on activities of daily living. Lower global scores are associated with greater dysfunction. FOSQ has good to excellent test-retest reproducibility, internal consistency, with discriminate validity between those seeking medical attention for sleep disorders compared to normal subjects. Change in FOSQ over time will be assessed.
Baseline, Day 90, and Day 180
Epworth Sleepiness Scale
Time Frame: Baseline, Day 90, and Day 180
This scale measure daytime sleepiness. A measure of sleepiness that is administered as 8-item questionnaire of situational sleepiness on a 3-point scale. The sum of the points will yield the Epworth score which ranges from 0 to 24 and is essentially the sum of the scores for each of the 8-items that are scored from a range of 0 to 3. An Epworth Sleepiness Score that is greater than 10 is considered to signify excessive daytime sleepiness with a score of 24 signifying with worst possible score. The change in ESS over time will be measured.
Baseline, Day 90, and Day 180
Systolic Blood Pressure
Time Frame: Baseline, Day 90, and Day 180
Measured by experienced staff following international guidelines. Change in blood pressure over time will be assessed.
Baseline, Day 90, and Day 180
Diastolic blood pressure
Time Frame: Baseline, Day 90, and Day 180
Measured by experienced staff following international guidelines. Change in blood pressure over time will be assessed.
Baseline, Day 90, and Day 180
Body Mass Index (BMI)
Time Frame: Baseline, Day 90, and Day 180
A measure of body fat based on height and weight. Change in BMI over time will be assessed.
Baseline, Day 90, and Day 180

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arizona

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 17, 2017

Primary Completion (Anticipated)

October 11, 2018

Study Completion (Anticipated)

October 11, 2018

Study Registration Dates

First Submitted

November 13, 2017

First Submitted That Met QC Criteria

November 15, 2017

First Posted (Actual)

November 17, 2017

Study Record Updates

Last Update Posted (Actual)

November 17, 2017

Last Update Submitted That Met QC Criteria

November 15, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1709834717
  • 1R56HL138377-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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