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

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ClinicalTrials.gov Identifier: NCT03345524
Recruitment Status : Not yet recruiting
First Posted : November 17, 2017
Last Update Posted : November 17, 2017
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Sairam Parthasarathy, University of Arizona

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Other: Peer-Buddy System Other: Usual Care Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 145 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Controlled Trial
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Will be blinded to subjects group assignment
Primary Purpose: Supportive Care
Official Title: Predictive Analytics and Peer-Driven Intervention for Guideline-based Care for Sleep Apnea
Estimated Study Start Date : November 17, 2017
Estimated Primary Completion Date : October 11, 2018
Estimated Study Completion Date : October 11, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

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)





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03345524


Contacts
Contact: Sairam Parthasarathy, MD 520-626-6109 sparthasarathy@deptofmed.arizona.edu

Locations
United States, Arizona
University of Arizona Recruiting
Tucson, Arizona, United States, 85721
Contact: Sairam Parthasarathy, MD    520-626-6109    sparthasarathy@deptofmed.arizona.edu   
Contact: Chris Morton    520-626-8457    cjmorton@email.arizona.edu   
Sponsors and Collaborators
University of Arizona
National Heart, Lung, and Blood Institute (NHLBI)

Publications:

Responsible Party: Sairam Parthasarathy, Professor of Medicine, University of Arizona
ClinicalTrials.gov Identifier: NCT03345524     History of Changes
Other Study ID Numbers: 1709834717
1R56HL138377-01 ( U.S. NIH Grant/Contract )
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sairam Parthasarathy, University of Arizona:
Obstructive Sleep Apnea
OSA
Peer-Buddies
CPAP
CPAP Adherence

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases