Predictive Analytics and Peer-Driven Intervention for Guideline-based Care for Sleep Apnea
NCT ID: NCT03345524
Last Updated: 2017-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
145 participants
INTERVENTIONAL
2017-11-17
2018-10-11
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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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
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
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.
Usual Care
Standard of care CPAP educational training
Educational Brochures and DVD videos mailed to participants (12 times)
Interventions
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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
Usual Care
Standard of care CPAP educational training
Educational Brochures and DVD videos mailed to participants (12 times)
Eligibility Criteria
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Inclusion Criteria
* Medicaid and dual-eligible Medicare beneficiaries
* Household income in the bottom national quartile of household median income
* 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
* Participation in another intervention-based research study
* Patient's primary care provider refuses patient participation for medical instability
* 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
21 Years
85 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
University of Arizona
OTHER
Responsible Party
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Sairam Parthasarathy
Professor of Medicine
Locations
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University of Arizona
Tucson, Arizona, United States
Countries
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Central Contacts
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Facility Contacts
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Sairam Parthasarathy, MD
Role: primary
Chris Morton
Role: backup
References
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Punjabi NM, Caffo BS, Goodwin JL, Gottlieb DJ, Newman AB, O'Connor GT, Rapoport DM, Redline S, Resnick HE, Robbins JA, Shahar E, Unruh ML, Samet JM. Sleep-disordered breathing and mortality: a prospective cohort study. PLoS Med. 2009 Aug;6(8):e1000132. doi: 10.1371/journal.pmed.1000132. Epub 2009 Aug 18.
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Mulgrew AT, Nasvadi G, Butt A, Cheema R, Fox N, Fleetham JA, Ryan CF, Cooper P, Ayas NT. Risk and severity of motor vehicle crashes in patients with obstructive sleep apnoea/hypopnoea. Thorax. 2008 Jun;63(6):536-41. doi: 10.1136/thx.2007.085464. Epub 2008 Jan 30.
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Other Identifiers
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1709834717
Identifier Type: -
Identifier Source: org_study_id