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Sleep Apnea Intervention for Stroke (ASAP Trial)

N/A
Waitlist Available
Led By Jason Sico, MD MHS
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
VAMCs with <=50 stroke/TIA admissions per year and without at least 1.0 FTE staff dedicated to systems redesign are excluded
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured throughout active implementation and sustainability periods
Awards & highlights
No Placebo-Only Group

Summary

This trial will improve rates of testing and treating for obstructive sleep apnea (OSA) in stroke and TIA patients, which will in turn improve patient outcomes and reduce hospital readmissions.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial focuses on improving healthcare practices rather than testing drugs, it does not directly involve medication side effects. However, any interventions as part of quality improvement may carry risks which will be monitored by the healthcare team.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My care facility admits fewer than 50 stroke/TIA patients yearly and lacks dedicated staff for system redesign.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90-day
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90-day for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Facility-level OSA diagnostic rate
Secondary study objectives
Facility-level all-cause readmission rate
Facility-level recurrent vascular event rate
Facility-level treatment rate
+1 more
Other study objectives
Audit and Feedback
External Facilitation
Implementation Outcome - Adaptation
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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
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.
Group III: Active implementation - Wave 1 (First and Second 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" 1 corresponds to Wave 1.

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Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,664 Previous Clinical Trials
3,765,660 Total Patients Enrolled
86 Trials studying Stroke
6,872 Patients Enrolled for Stroke
Jason Sico, MD MHSPrincipal InvestigatorVA Connecticut Healthcare System West Haven Campus, West Haven, CT
Dawn M. Bravata, MDPrincipal InvestigatorRichard L. Roudebush VA Medical Center, Indianapolis, IN
3 Previous Clinical Trials
2,628 Total Patients Enrolled
2 Trials studying Stroke
2,517 Patients Enrolled for Stroke
Jason Jonathon Sico, MD MHSPrincipal InvestigatorVA Connecticut Healthcare System West Haven Campus, West Haven, CT

Media Library

ASAP Intervention Quality Improvement Protocol Clinical Trial Eligibility Overview. Trial Name: NCT04322162 — N/A
Stroke Research Study Groups: Active implementation - Wave 2 (Third and Fourth Sites), Active implementation - Wave 3 (Fifth and Sixth Sites), Active implementation - Wave 1 (First and Second Sites)
Stroke Clinical Trial 2023: ASAP Intervention Quality Improvement Protocol Highlights & Side Effects. Trial Name: NCT04322162 — N/A
ASAP Intervention Quality Improvement Protocol 2023 Treatment Timeline for Medical Study. Trial Name: NCT04322162 — N/A
~1 spots leftby Dec 2025
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