Predictive Analytics and Peer-Driven Intervention for Guideline-based Care for Sleep Apnea
Primary Purpose
Obstructive Sleep Apnea
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Peer-Buddy System
Usual Care
Sponsored by
About this trial
This is an interventional supportive care trial for Obstructive Sleep Apnea focused on measuring Obstructive Sleep Apnea, OSA, Peer-Buddies, CPAP, CPAP Adherence
Eligibility 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
Sites / Locations
- University of Arizona
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Peer-buddy system
Usual Care
Arm Description
Will meet with peer-buddy who will help with them with CPAP usage. Also will receive standard of care CPAP educational training
Will receive educational material at the same frequency that those in the experimental arm. Will also receive standard of care CPAP educational training.
Outcomes
Primary Outcome Measures
Proportion of patients undergoing sleep study testing
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
CPAP Adherence downloads
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.
Full Information
NCT ID
NCT03345524
First Posted
November 13, 2017
Last Updated
November 15, 2017
Sponsor
University of Arizona
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT03345524
Brief Title
Predictive Analytics and Peer-Driven Intervention for Guideline-based Care for Sleep Apnea
Official Title
Predictive Analytics and Peer-Driven Intervention for Guideline-based Care for Sleep Apnea
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 17, 2017 (Anticipated)
Primary Completion Date
October 11, 2018 (Anticipated)
Study Completion Date
October 11, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Arizona
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
Obstructive Sleep Apnea, OSA, Peer-Buddies, CPAP, CPAP Adherence
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial
Masking
InvestigatorOutcomes Assessor
Masking Description
Will be blinded to subjects group assignment
Allocation
Randomized
Enrollment
145 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Peer-buddy system
Arm Type
Experimental
Arm Description
Will meet with peer-buddy who will help with them with CPAP usage. Also will receive standard of care CPAP educational training
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Will receive educational material at the same frequency that those in the experimental arm. Will also receive standard of care CPAP educational training.
Intervention Type
Other
Intervention Name(s)
Peer-Buddy System
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
Standard of care CPAP educational training
Educational Brochures and DVD videos mailed to participants (12 times)
Primary Outcome Measure Information:
Title
Proportion of patients undergoing sleep study testing
Description
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.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
CPAP Adherence downloads
Description
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.
Time Frame
Day 30, Day 90, and Day 180
Other Pre-specified Outcome Measures:
Title
Functional Outcomes of Sleep Questionnaire (FOSQ)
Description
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.
Time Frame
Baseline, Day 90, and Day 180
Title
Epworth Sleepiness Scale
Description
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.
Time Frame
Baseline, Day 90, and Day 180
Title
Systolic Blood Pressure
Description
Measured by experienced staff following international guidelines. Change in blood pressure over time will be assessed.
Time Frame
Baseline, Day 90, and Day 180
Title
Diastolic blood pressure
Description
Measured by experienced staff following international guidelines. Change in blood pressure over time will be assessed.
Time Frame
Baseline, Day 90, and Day 180
Title
Body Mass Index (BMI)
Description
A measure of body fat based on height and weight. Change in BMI over time will be assessed.
Time Frame
Baseline, Day 90, and Day 180
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sairam Parthasarathy, MD
Phone
520-626-6109
Email
sparthasarathy@deptofmed.arizona.edu
Facility Information:
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85721
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sairam Parthasarathy, MD
Phone
520-626-6109
Email
sparthasarathy@deptofmed.arizona.edu
First Name & Middle Initial & Last Name & Degree
Chris Morton
Phone
520-626-8457
Email
cjmorton@email.arizona.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
18250205
Citation
Punjabi NM. The epidemiology of adult obstructive sleep apnea. Proc Am Thorac Soc. 2008 Feb 15;5(2):136-43. doi: 10.1513/pats.200709-155MG.
Results Reference
background
PubMed Identifier
22618924
Citation
Marin JM, Agusti A, Villar I, Forner M, Nieto D, Carrizo SJ, Barbe F, Vicente E, Wei Y, Nieto FJ, Jelic S. Association between treated and untreated obstructive sleep apnea and risk of hypertension. JAMA. 2012 May 23;307(20):2169-76. doi: 10.1001/jama.2012.3418.
Results Reference
background
PubMed Identifier
10805822
Citation
Peppard PE, Young T, Palta M, Skatrud J. Prospective study of the association between sleep-disordered breathing and hypertension. N Engl J Med. 2000 May 11;342(19):1378-84. doi: 10.1056/NEJM200005113421901.
Results Reference
background
PubMed Identifier
10770144
Citation
Nieto FJ, Young TB, Lind BK, Shahar E, Samet JM, Redline S, D'Agostino RB, Newman AB, Lebowitz MD, Pickering TG. Association of sleep-disordered breathing, sleep apnea, and hypertension in a large community-based study. Sleep Heart Health Study. JAMA. 2000 Apr 12;283(14):1829-36. doi: 10.1001/jama.283.14.1829. Erratum In: JAMA 2002 Oct 23-30;288(16):1985.
Results Reference
background
PubMed Identifier
16641120
Citation
Peker Y, Carlson J, Hedner J. Increased incidence of coronary artery disease in sleep apnoea: a long-term follow-up. Eur Respir J. 2006 Sep;28(3):596-602. doi: 10.1183/09031936.06.00107805. Epub 2006 Apr 26.
Results Reference
background
PubMed Identifier
11751180
Citation
Leung RS, Bradley TD. Sleep apnea and cardiovascular disease. Am J Respir Crit Care Med. 2001 Dec 15;164(12):2147-65. doi: 10.1164/ajrccm.164.12.2107045. No abstract available.
Results Reference
background
PubMed Identifier
19131443
Citation
Yumino D, Wang H, Floras JS, Newton GE, Mak S, Ruttanaumpawan P, Parker JD, Bradley TD. Relationship between sleep apnoea and mortality in patients with ischaemic heart failure. Heart. 2009 May;95(10):819-24. doi: 10.1136/hrt.2008.160952. Epub 2009 Jan 8.
Results Reference
background
PubMed Identifier
16282178
Citation
Yaggi HK, Concato J, Kernan WN, Lichtman JH, Brass LM, Mohsenin V. Obstructive sleep apnea as a risk factor for stroke and death. N Engl J Med. 2005 Nov 10;353(19):2034-41. doi: 10.1056/NEJMoa043104.
Results Reference
background
PubMed Identifier
12531049
Citation
Weaver TE. Outcome measurement in sleep medicine practice and research. Part 1: assessment of symptoms, subjective and objective daytime sleepiness, health-related quality of life and functional status. Sleep Med Rev. 2001 Apr;5(2):103-128. doi: 10.1053/smrv.2001.0152.
Results Reference
background
PubMed Identifier
19688045
Citation
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.
Results Reference
background
PubMed Identifier
15788497
Citation
Gami AS, Howard DE, Olson EJ, Somers VK. Day-night pattern of sudden death in obstructive sleep apnea. N Engl J Med. 2005 Mar 24;352(12):1206-14. doi: 10.1056/NEJMoa041832.
Results Reference
background
PubMed Identifier
10080847
Citation
Teran-Santos J, Jimenez-Gomez A, Cordero-Guevara J. The association between sleep apnea and the risk of traffic accidents. Cooperative Group Burgos-Santander. N Engl J Med. 1999 Mar 18;340(11):847-51. doi: 10.1056/NEJM199903183401104.
Results Reference
background
PubMed Identifier
18234904
Citation
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.
Results Reference
background
PubMed Identifier
20339144
Citation
Redline S, Yenokyan G, Gottlieb DJ, Shahar E, O'Connor GT, Resnick HE, Diener-West M, Sanders MH, Wolf PA, Geraghty EM, Ali T, Lebowitz M, Punjabi NM. Obstructive sleep apnea-hypopnea and incident stroke: the sleep heart health study. Am J Respir Crit Care Med. 2010 Jul 15;182(2):269-77. doi: 10.1164/rccm.200911-1746OC. Epub 2010 Mar 25.
Results Reference
background
PubMed Identifier
11898119
Citation
Rahaghi F, Basner RC. Delayed Diagnosis of Obstructive Sleep Apnea: Don't Ask, Don't Tell. Sleep Breath. 1999;3(4):119-124. doi: 10.1007/s11325-999-0119-z.
Results Reference
background
PubMed Identifier
24931392
Citation
Flygare J, Parthasarathy S. Narcolepsy: let the patient's voice awaken us! Am J Med. 2015 Jan;128(1):10-3. doi: 10.1016/j.amjmed.2014.05.037. Epub 2014 Jun 12.
Results Reference
background
PubMed Identifier
27571048
Citation
McEvoy RD, Antic NA, Heeley E, Luo Y, Ou Q, Zhang X, Mediano O, Chen R, Drager LF, Liu Z, Chen G, Du B, McArdle N, Mukherjee S, Tripathi M, Billot L, Li Q, Lorenzi-Filho G, Barbe F, Redline S, Wang J, Arima H, Neal B, White DP, Grunstein RR, Zhong N, Anderson CS; SAVE Investigators and Coordinators. CPAP for Prevention of Cardiovascular Events in Obstructive Sleep Apnea. N Engl J Med. 2016 Sep 8;375(10):919-31. doi: 10.1056/NEJMoa1606599. Epub 2016 Aug 28.
Results Reference
background
PubMed Identifier
18250209
Citation
Weaver TE, Grunstein RR. Adherence to continuous positive airway pressure therapy: the challenge to effective treatment. Proc Am Thorac Soc. 2008 Feb 15;5(2):173-8. doi: 10.1513/pats.200708-119MG.
Results Reference
background
PubMed Identifier
22983957
Citation
Martinez-Garcia MA, Campos-Rodriguez F, Catalan-Serra P, Soler-Cataluna JJ, Almeida-Gonzalez C, De la Cruz Moron I, Duran-Cantolla J, Montserrat JM. Cardiovascular mortality in obstructive sleep apnea in the elderly: role of long-term continuous positive airway pressure treatment: a prospective observational study. Am J Respir Crit Care Med. 2012 Nov 1;186(9):909-16. doi: 10.1164/rccm.201203-0448OC. Epub 2012 Sep 13.
Results Reference
background
PubMed Identifier
15781100
Citation
Marin JM, Carrizo SJ, Vicente E, Agusti AG. Long-term cardiovascular outcomes in men with obstructive sleep apnoea-hypopnoea with or without treatment with continuous positive airway pressure: an observational study. Lancet. 2005 Mar 19-25;365(9464):1046-53. doi: 10.1016/S0140-6736(05)71141-7.
Results Reference
background
PubMed Identifier
20656940
Citation
Javaheri S, Caref EB, Chen E, Tong KB, Abraham WT. Sleep apnea testing and outcomes in a large cohort of Medicare beneficiaries with newly diagnosed heart failure. Am J Respir Crit Care Med. 2011 Feb 15;183(4):539-46. doi: 10.1164/rccm.201003-0406OC. Epub 2010 Jul 23.
Results Reference
background
PubMed Identifier
10712333
Citation
Findley L, Smith C, Hooper J, Dineen M, Suratt PM. Treatment with nasal CPAP decreases automobile accidents in patients with sleep apnea. Am J Respir Crit Care Med. 2000 Mar;161(3 Pt 1):857-9. doi: 10.1164/ajrccm.161.3.9812154.
Results Reference
background
PubMed Identifier
21061860
Citation
Tregear S, Reston J, Schoelles K, Phillips B. Continuous positive airway pressure reduces risk of motor vehicle crash among drivers with obstructive sleep apnea: systematic review and meta-analysis. Sleep. 2010 Oct;33(10):1373-80. doi: 10.1093/sleep/33.10.1373.
Results Reference
background
Learn more about this trial
Predictive Analytics and Peer-Driven Intervention for Guideline-based Care for Sleep Apnea
We'll reach out to this number within 24 hrs