Sleep Apnea Intervention for Stroke
(ASAP Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byJason Sico, MD MHS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: VA Office of Research and Development

No Placebo Group

Trial Summary

What is the purpose of this trial?Effectively identifying and treating risk factors for ischemic stroke and transient ischemic attack (TIA) is important to patients, their family members, and healthcare systems. While obstructive sleep apnea (OSA) is a known risk factor for stroke and TIA that is present in more than 70% of stroke/TIA survivors, testing for OSA is infrequently performed for patients and within healthcare systems. The Addressing Sleep Apnea Post-Stroke/TIA (ASAP) study intends to improve rates of guideline-recommended OSA testing and treatment through local quality improvement initiatives (QI) conducted within and across 6 VA Medical Centers. ASAP will also determine the impact of these local QI initiatives on rates of OSA diagnosis, OSA treatment, recurrent vascular events, and hospital readmissions.

Eligibility Criteria

This trial is for patients who've had a stroke or TIA (mini-stroke) and haven't been diagnosed with sleep apnea. Participating facilities must admit over 50 such cases yearly and have dedicated staff for system redesign. Patients in palliative care, unable to use PAP therapy, or with contraindications to PAP are excluded.

Inclusion Criteria

My care facility admits over 50 stroke/TIA patients yearly and has staff for system redesign.

I have had a stroke or TIA and have not been diagnosed with sleep apnea.

Chosen sites must be diverse in terms of geography and sleep infrastructure

Exclusion Criteria

My care facility admits fewer than 50 stroke/TIA patients yearly and lacks dedicated staff for system redesign.

I am not in hospice care and can use PAP therapy without issues like facial injuries or trouble clearing secretions.

Participant Groups

The ASAP study tests a Quality Improvement Protocol aimed at increasing the diagnosis and treatment of obstructive sleep apnea (OSA) in stroke/TIA survivors across six VA Medical Centers, evaluating its effect on OSA management and recurrence of vascular events.

3Treatment groups

Experimental Treatment

Group I: Active implementation - Wave 3 (Fifth and Sixth Sites)Experimental Treatment1 Intervention

This four-year stepped-wedge evaluation includes a total of 6 sites. Active implementation is initiated in 3 waves, each of which includes 2 sites. The project involves two phases at each of the 6 sites: a variable number of 7-month data periods during baseline period (three 7-month periods for Wave 1 sites, four 7-month data periods for Wave 2 sites, five 7-month data periods for Wave 3 sites), three 7-month data periods in active implementation phase for each wave. Wave 1 and Wave 2 sites will also each have one 7-month period of sustainability. The stepped-wedge design allows for 6 mutually exclusive, 7-month data periods. The baseline data period is the time prior to the date of the baseline site visit. The active implementation data period extends 21 months after the site visit. The stepped-wedge design allows site-level estimates of proportions on six different cross-sectional samples. Investigators will have repeated information on each site. "Arm" 3 corresponds to Wave 3.

Group II: Active implementation - Wave 2 (Third and Fourth Sites)Experimental Treatment1 Intervention

Group III: Active implementation - Wave 1 (First and Second Sites)Experimental Treatment1 Intervention