Addressing Sleep Apnea Post-Stroke/TIA (ASAP)

VA Office of Research and Development

Status: Active, not recruiting

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

Treatments: Other: ASAP Intervention Quality Improvement Protocol

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT04322162

IIR 16-211

1I01HX002324-01A2 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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]

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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6 participants in 3 patient groups

Active implementation - Wave 1 (First and Second Sites)

Experimental group

Description:

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" 1 corresponds to Wave 1.

Treatment:

Other: ASAP Intervention Quality Improvement Protocol

Active implementation - Wave 2 (Third and Fourth Sites)

Experimental group

Description:

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" 2 corresponds to Wave 2.

Treatment:

Other: ASAP Intervention Quality Improvement Protocol

Active implementation - Wave 3 (Fifth and Sixth Sites)

Experimental group

Description:

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.

Treatment:

Other: ASAP Intervention Quality Improvement Protocol