Addressing Sleep Apnea Post-Stroke/TIA

Not Applicable

Active, not recruiting

• Conditions: Ischemic Stroke; Transient Ischemic Attack (TIA); Obstructive Sleep Apnea

• Registration Number: NCT04322162
• Lead Sponsor: VA Office of Research and Development

Brief Summary

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.

Detailed Description

Approximately 11,000 Veterans present to a VAMC annually with an acute ischemic stroke or TIA. The cornerstone of secondary stroke/TIA prevention includes delivering timely, guideline-concordant vascular risk factor management. Over the past decade, OSA has been recognized as a potent, underdiagnosed, and inadequately treated cerebrovascular risk factor. OSA is very common among patients with stroke/TIA with a prevalence of 60-80%. Despite being highly prevalent, 70-80% of patients with OSA are neither diagnosed nor treated. Untreated OSA has been associated with poor outcomes among patients with cerebrovascular disease including higher mortality and worse functional status. The mainstay of OSA therapy is positive airway pressure (PAP). PAP reduces recurrent vascular events, improves neurological symptoms and functional status among stroke/TIA patients with OSA. The evidence favoring neurological recovery is strongest when interventions are applied early post-stroke/TIA. Guidelines recommend diagnosing and treating OSA for stroke and TIA patients; however, within VHA, very few stroke or TIA patients receive OSA screening. This guideline recommendation was informed in part by clinical trials utilizing an acute OSA assessment protocol developed and implemented by the investigators' group. To address the observed gap in care, the investigators propose a Hybrid Type I, randomized, stepped-wedge trial at 6 VAMCs to increase the rate of timely, guideline-concordant diagnosis and treatment of OSA among Veterans with ischemic stroke/TIA and thereby reduce recurrent vascular events and hospital readmissions. The investigators will identify matched control sites for each ASAP implementation site to examine temporal trends in outcomes among non-intervention sites. For example, the investigators will use administrative data to examine the use of polysomnography across stroke/TIA patients in the VA system and compare changes in matched controls versus the intervention sites on the diagnostic rate. The same adjustment approach will be used for ASAP intervention sites and for control sites.

Study Timeline

• Study First Submitted: 2020-03-24
• Study First Submitted QC: 2020-03-24
• Study First Posted: 2020-03-26
• Study Start: 2020-04-02
• Primary Completion: 2023-09-30
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-10
• Last Update Posted: 2024-04-12
• Study Completion: 2024-07-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

As recruitment was at the facility-level, an ASAP a VAMCS had to have >50 stroke/TIA admissions per year and have at least 1.0 FTE staff dedicated to systems redesign

• The sites were chosen because they are diverse in terms of geography and sleep infrastructure

  • Local site investigators and their care teams will identify patients eligible for the QI intervention, specifically patients with ischemic stroke/TIA without a prior diagnosis of OSA

Exclusion Criteria

• VAMCs were excluded if they had <=50 stroke/TIA admissions per year and did not have at least 1.0 FTE staff dedicated to systems redesign

• Local site investigators and their care teams will prioritize the protection of patients from harm and use their clinical expertise in identifying patients who would not be candidates for PAP therapy

  • e.g., palliative care/hospice, inability to use PAP therapy [e.g., orofacial injury], or contraindication to PAP [e.g., inability to clear secretions]

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Facility-level OSA diagnostic rate	30-day	PSG completion or initiation of auto-PAP within 30 days of presentation for the index stroke or TIA

Secondary Outcome Measures

Name	Time	Method
Facility-level treatment rate (Positive airway pressure and non-positive airway pressure treatments)	30-day	PAP or non-PAP treatment initiation within 30 days of presentation to the facility. For this outcome, the denominator will be patients diagnosed with OSA. Patients with a prior diagnosis of sleep apnea and those who die within 7 days of presentation will be excluded. Because the denominator in this secondary effectiveness measure includes the patients who are diagnosed with OSA, it is variable and depends on the primary effectiveness outcome of diagnostic rate.
Facility-level treatment rate	30-day	PAP initiation within 30 days of presentation to the facility. For this outcome, the denominator will be patients diagnosed with OSA. Patients with a prior diagnosis of sleep apnea and those who die within 7 days of presentation will be excluded. Because the denominator in this secondary effectiveness measure includes the patients who are diagnosed with OSA, it is variable and depends on the primary effectiveness outcome of diagnostic rate.
Facility-level all-cause readmission rate	90-day	Includes an inpatient admission for any cause at either a VA or non-VA acute care facility.
Facility-level recurrent vascular event rate	90-day	Stroke, myocardial infarction (MI), acute coronary syndrome (ACS), hospitalization for congestive heart failure (CHF), and all-cause mortality. The recurrent vascular event rate is measured from the day of presentation (e.g., to the Emergency Department) which may be the same as or prior to the day of admission.

Trial Locations

Locations (2)

VA Connecticut Healthcare System West Haven Campus, West Haven, CT; 🇺🇸 West Haven, Connecticut, United States

Richard L. Roudebush VA Medical Center, Indianapolis, IN; 🇺🇸 Indianapolis, Indiana, United States