Clinical trial NCT05419323: Direct Referral for Apnea Monitoring
Official title: Improving Access to Sleep Apnea Care: A Pragmatic Study of New Consultation Models
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obstructive Sleep Apnea (OSA)
Keywords: sleep apnea syndromes
polysomnography
home sleep apnea testing
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: San Francisco Veterans Affairs Medical Center
First posted: 2022-06-15
Enrollment: 2413
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will include patients referred for new OSA evaluations at Sleep Medicine clinics at the 3 VA study sites. Participants will be identified via a review of their medical records by the PIs (study physicians) after they are referred for OSA evaluations at the 3 study sites.

Brief summary: The primary objective of this project is to compare a health care delivery model, Direct Referral for Apnea Monitoring (DREAM), with initial in-person (Traditional) clinic appointments for Veterans at risk for obstructive sleep apnea (OSA). A secondary objective is to determine the negative predictive value (NPV) of home sleep apnea testing (HSAT).

Detailed description: Patients referred to one of 3 participating VA sleep medicine clinics (San Francisco VA, VA Portland or VA Pittsburgh) for OSA will be assigned either to the Traditional clinical pathway (which might include an initial encounter with a sleep care provider through in-person visits, telephone clinics, or video conferencing) or the DREAM pathway which will omit the initial encounter with a care provider. After a clinician conducts a chart review of medical records, patients in the DREAM pathway will be referred for sleep testing. All patients will be tracked from the time of referral until 90-days past the initiation of treatment. To determine the NPV of HSAT, results of sleep tests will be compared for patients who undergo both HSAT and polysomnographic (PSG) procedures. Concurrent PSG and HSAT studies will be done at Portland, Pittsburgh, and San Francisco.

Eligibility criteria: Inclusion Criteria:

Age 18 years Agrees to be seen by a VA sleep program Reason for referral to sleep clinic: New OSA Evaluation

Exclusion Criteria:

Age \< 18 years Declines to be seen by a VA sleep program Reason for referral to sleep clinic: anything other than a new OSA evaluation

Primary outcomes:
measure: Time from referral
timeFrame: 1 year
measure: PAP adherence
timeFrame: 1 year
measure: AHI scores
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco VA Medical Center, San Francisco, CA
state: California
city: Portland
country: United States
facility: VA Portland Health Care System, Portland, OR
state: Oregon
city: Pittsburgh
country: United States
facility: VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
state: Pennsylvania
Study officials:
affiliation: San Francisco VA Medical Center, San Francisco, CA
name: Kathleen Fumiko Sarmiento, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Folmer RL, Smith CJ, Boudreau EA, Hickok AW, Totten AM, Kaul B, Stepnowsky CJ, Whooley MA, Sarmiento KF. Prevalence and management of sleep disorders in the Veterans Health Administration. Sleep Med Rev. 2020 Dec;54:101358. doi: 10.1016/j.smrv.2020.101358. Epub 2020 Jul 20.
citation: Sarmiento KF, Boudreau EA, Smith CJ, Kaul B, Johnson N, Folmer RL. Effects of Computer-Based Documentation Procedures on Health Care Workload Assessment and Resource Allocation: An Example From VA Sleep Medicine Programs. Fed Pract. 2020 Aug;37(8):368-374. doi: 10.12788/fp.0023.
citation: Chang YHA, Folmer RL, Shasha B, Shea JA, Sarmiento K, Stepnowsky CJ, Lim D, Pack A, Kuna ST. Barriers and facilitators to the implementation of a novel web-based sleep apnea management platform. Sleep. 2021 Apr 9;44(4):zsaa243. doi: 10.1093/sleep/zsaa243.
citation: Atwood CW, Boudreau EA, Folmer RL, Kuna ST, Pineda L, Reichert J, Sarmiento K, Thompson W, Whooley M, Zhang N, Yarbrough WC. 1170 Trends in Sleep Apnea Testing Among Veterans Participating in a Rural Health-Focused Telesleep Medicine Program. [Abstract]. Sleep Medicine Reviews. 2020 Apr 1; 43(Supplement 1):A447.
citation: Salinsky M, Evrard C, Joos S, Boudreau E. Utility of mental health and sleep screening questionnaires for patients admitted to a seizure monitoring unit. Epilepsy Behav. 2021 Oct;123:108237. doi: 10.1016/j.yebeh.2021.108237. Epub 2021 Aug 7.
citation: Sarmiento K, Kuna S, Boudreau EA, Atwood C, Pineda L, Thompson W, Zeidler M, Fields B, Uzzaman A, Totten A, Smith C, Folmer RL, Williams K, Zhang N, Whooley M. VHA's TeleSleep Program improves rural Veteran access to sleep care through expansion of telehealth networks. [Abstract]. Sleep. 2021 May 3; 44(Suppl 2):A317-A318.
citation: Folmer RL, Boudreau EA, Atwood CW, Smith CJ, Totten AM, Tock JL, Chilakamarri P, Sarmiento KF. Study protocol to assess de-implementation of the initial provider encounter for diagnosis and treatment of obstructive sleep apnea: the DREAM (Direct Referral for Apnea Monitoring) Project. BMC Pulm Med. 2022 Apr 2;22(1):123. doi: 10.1186/s12890-022-01899-y.
citation: Atwood W, Smith C, Totten A, Boudreau EA, Sarmiento K, Hahn Z, Folmer RL, Tock J, Hotchkiss J. Good Sleep Care: Geospatial Optimization of Distant Sleep Care in the VA. [Abstract]. Sleep. 2022 Jun 1; 45(Suppl 1):A164.
citation: Folmer RL, Smith CJ, Boudreau EA, Totten AM, Chilakamarri P, Atwood CW, Sarmiento KF. Sleep disorders among rural Veterans: Relative prevalence, comorbidities, and comparisons with urban Veterans. J Rural Health. 2023 Jun;39(3):582-594. doi: 10.1111/jrh.12722. Epub 2022 Nov 5.
citation: Chun VS, Whooley MA, Williams K, Zhang N, Zeidler MR, Atwood CW, Folmer RL, Totten AM, Smith CJ, Boudreau EA, Reichert JM, Sarmiento KF. Veterans Health Administration TeleSleep Enterprise-Wide Initiative 2017-2020: bringing sleep care to our nation's veterans. J Clin Sleep Med. 2023 May 1;19(5):913-923. doi: 10.5664/jcsm.10488.
citation: Hahn Z, Hotchkiss J, Atwood C, Smith C, Totten A, Boudreau E, Folmer R, Chilakamarri P, Whooley M, Sarmiento K. Travel Burden as a Measure of Healthcare Access and the Impact of Telehealth within the Veterans Health Administration. J Gen Intern Med. 2023 Jul;38(Suppl 3):805-813. doi: 10.1007/s11606-023-08125-3. Epub 2023 Jun 20.
citation: Folmer RL. Unresolved Issues Associated with Transcranial Magnetic Stimulation (TMS) Treatment of Chronic Tinnitus. J Clin Med. 2023 Jul 12;12(14):4648. doi: 10.3390/jcm12144648.
citation: Mazzotti DR, Haendel MA, McMurry JA, Smith CJ, Buysse DJ, Roenneberg T, Penzel T, Purcell S, Redline S, Zhang Y, Merikangas KR, Menetski JP, Mullington J, Boudreau E. Sleep and circadian informatics data harmonization: a workshop report from the Sleep Research Society and Sleep Research Network. Sleep. 2022 Jun 13;45(6):zsac002. doi: 10.1093/sleep/zsac002.
citation: Belkora JK, Ortiz DeBoque L, Folmer RL, Totten AM, Williams K, Whooley MA, Boudreau E, Atwood CW, Zeidler M, Rezayat T, Chilakamarri P, Sarmiento KF. Sustainment of the TeleSleep program for rural veterans. Front Health Serv. 2023 Nov 10;3:1214071. doi: 10.3389/frhs.2023.1214071. eCollection 2023.
citation: Atwood C, Boudreau EA, Sarmiento K, Williams K, Totten A, Folmer RL, Wholey M. 1058 Experience of VA Telesleep Medicine Following the COVID Pandemic. [Abstract]. Sleep. 2024 May 1; 47(Suppl 1):A454-A455.