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Ischemic StrokeASAPNCT04322162

Addressing Sleep Apnea Post-Stroke/TIA

A study testing ASAP Intervention Quality Improvement Protocol in people with Ischemic Stroke and Transient Ischemic Attack (TIA), run by VA Office of Research and Development at 2 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ASAP Intervention Quality Improvement Protocol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
2 sitesUnited States
Study dates
2 Apr 2020to 31 Jul 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

2 sites in 1 country.

United States2 sites

  • Richard L. Roudebush VA Medical Center, Indianapolis, IN

    Indianapolis, Indiana, 46202-2884

  • VA Connecticut Healthcare System West Haven Campus, West Haven, CT

    West Haven, Connecticut, 06516-2770

Other trials in United States

About this study

Official title: Addressing Sleep Apnea Post-Stroke (ASAP)

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.

Read the 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.

Being tested
ASAP Intervention Quality Improvement Protocol
Keywords
Ischemic stroke, Transient ischemic attack (TIA), Stepped-wedge trial, Implementation Science, Hybrid Type I, Quality Improvement, Systems Redesign, Champion, External Facilitation, Audit and feedback, Local Adaptation, Obstructive Sleep Apnea, Polysomnography, Sustainability, Business-case
Medical subject headings
Ischemic Stroke, Ischemic Attack, Transient, Sleep Apnea, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ASAP Intervention Quality Improvement ProtocolOther

    The intervention program includes: (1) a systems redesign Virtual Collaborative, and; (2) data monitoring and is designed to aid each of the 6 participating VAMCs in developing, implementing, and evaluating the implementation of an acute OSA testing and treatment protocol for ischemic stroke/TIA patients. The sites will choose a diagnostic strategy (i.e., unattended polysomnography [PSG]/home sleep test [HST], in-laboratory PSG, direct to auto-titrating [auto]-PAP) and a therapeutic strategy (i.e., in-laboratory PAP titration, auto-PAP). The intervention will employ 3 implementation strategies: (1) local adaptation; (2) external facilitation, and; (3) audit and feedback.

Study groups in NCT04322162
Study groupRoleWhat they receive
Active implementation - Wave 1 (First and Second Sites)ExperimentalThis 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.
Receives: Other: ASAP Intervention Quality Improvement Protocol
Active implementation - Wave 2 (Third and Fourth Sites)ExperimentalThis 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.
Receives: Other: ASAP Intervention Quality Improvement Protocol
Active implementation - Wave 3 (Fifth and Sixth Sites)ExperimentalThis 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.
Receives: Other: ASAP Intervention Quality Improvement Protocol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Facility-level OSA diagnostic rate

    PSG completion or initiation of auto-PAP within 30 days of presentation for the index stroke or TIA

    Measured: 30-day

Secondary outcomes (4)

  1. Facility-level treatment rate

    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.

    Measured: 30-day

  2. Facility-level recurrent vascular event rate

    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.

    Measured: 90-day

  3. Facility-level all-cause readmission rate

    Includes an inpatient admission for any cause at either a VA or non-VA acute care facility.

    Measured: 90-day

  4. Facility-level treatment rate (Positive airway pressure and non-positive airway pressure treatments)

    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.

    Measured: 30-day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Mar 2020
  2. Study start2 Apr 2020
  3. Primary completion30 Sep 2023
  4. Study completion31 Jul 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04322162
Sponsor's protocol ID
IIR 16-211
Other IDs
1I01HX002324-01A2
Acronym
ASAP
Status last verified
Apr 2024
First submitted
24 Mar 2020
Last updated
12 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Diaz MM, Hu X, Fenton BT, Kimuli I, Lee A, Lindsey H, Bigelow JK, Maiser S, Altalib HH, Sico JJ. Prevalence of and characteristics associated with in-hospital mortality in a Ugandan neurology ward. BMC Neurol. 2020 Jan 31;20(1):42. doi: 10.1186/s12883-020-1627-5.

    PubMed 32005185

  • Sico JJ, Sarwal A, Benish SM, Busis NA, Cohen BH, Das RR, Finsilver S, Halperin JJ, Kelly AG, Meunier L, Phipps MS, Thirumala PD, Villanueva R, von Gaudecker J, Bennett A, Shenoy AM. Quality improvement in neurology: Neurology Outcomes Quality Measurement Set. Neurology. 2020 Jun 2;94(22):982-990. doi: 10.1212/WNL.0000000000009525. Epub 2020 May 12. No abstract available.

    PubMed 32398356

  • Patel K, Nussbaum E, Sico J, Merchant N. Atypical case of Miller-Fisher syndrome presenting with severe dysphagia and weight loss. BMJ Case Rep. 2020 May 27;13(5):e234316. doi: 10.1136/bcr-2020-234316.

    PubMed 32467120

  • Arling G, Perkins A, Myers LJ, Sico JJ, Bravata DM. Blood Pressure Trajectories and Outcomes for Veterans Presenting at VA Medical Centers with a Stroke or Transient Ischemic Attack. Am J Med. 2022 Jul;135(7):889-896.e1. doi: 10.1016/j.amjmed.2022.02.012. Epub 2022 Mar 12.

    PubMed 35292287

  • Miech EJ, Perkins AJ, Zhang Y, Myers LJ, Sico JJ, Daggy J, Bravata DM. Pairing regression and configurational analysis in health services research: modelling outcomes in an observational cohort using a split-sample design. BMJ Open. 2022 Jun 7;12(6):e061469. doi: 10.1136/bmjopen-2022-061469.

    PubMed 35672067

  • Sico JJ, Koo BB, Perkins AJ, Burrone L, Sexson A, Myers LJ, Taylor S, Yarbrough WC, Daggy JK, Miech EJ, Bravata DM. Impact of the coronavirus disease-2019 pandemic on Veterans Health Administration Sleep Services. SAGE Open Med. 2023 May 3;11:20503121231169388. doi: 10.1177/20503121231169388. eCollection 2023.

    PubMed 37152838

  • Waddell KJ, Myers LJ, Perkins AJ, Sico JJ, Sexson A, Burrone L, Taylor S, Koo B, Daggy JK, Bravata DM. Development and validation of a model predicting mild stroke severity on admission using electronic health record data. J Stroke Cerebrovasc Dis. 2023 Sep;32(9):107255. doi: 10.1016/j.jstrokecerebrovasdis.2023.107255. Epub 2023 Jul 18.

    PubMed 37473533

  • Rattray NA, Miech EJ, Bravata DM, Story KM, Myers LJ, Koo BB, Burrone L, Sexson A, Taylor SE, Perkins AJ, Daggy J, Sico JJ. Difference-making factors in implementing a quality improvement program for sleep apnea in stroke/TIA patients. Implement Sci Commun. 2026 Apr 17;7(1):109. doi: 10.1186/s43058-026-00944-9.

    PubMed 41998761

  • Ding Q, Sico JJ, Perkins AJ, Myers LJ, Daggy JK, Sexson A, Taylor SE, Burrone L, Waddell K, Bravata DM. Trends in the use of sodium-glucose cotransporter-2 inhibitors and glucagon-like peptide-1 receptor agonists among ischemic stroke patients. Cardiovasc Diabetol Endocrinol Rep. 2026 Mar 10;12(1):11. doi: 10.1186/s40842-026-00280-w.

    PubMed 41803896

  • Bravata DM, Perkins AJ, Myers LJ, Daggy JK, Sexson A, Taylor SE, Burrone L, Koo BB, Miech EJ, Rattray N, Story KM, Waddell KJ, Ding QP, Sico JJ; ASAP Investigators Group. Quality Improvement Intervention to Increase Sleep Apnea Diagnostic Testing After Stroke and Transient Ischemic Attack: A Cluster Randomized Trial. JAMA Netw Open. 2025 Nov 3;8(11):e2543385. doi: 10.1001/jamanetworkopen.2025.43385.

    PubMed 41236739

  • Bravata DM, Myers LJ, Perkins AJ, Sexson AE, Daggy JK, Taylor SE, Burrone L, Koo BB, Miech EJ, Rattray NA, Story KM, Waddell K, Ding Q, Sico JJ. Addressing sleep apnea post-stroke and transient ischemic attack (ASAP) clinical trial design features: Inclusion of usual care control sites and electronic health record data validation. Contemp Clin Trials. 2025 Dec;159:108135. doi: 10.1016/j.cct.2025.108135. Epub 2025 Oct 30.

    PubMed 41173184

Questions about this trial

What is this clinical trial studying?

A study testing ASAP Intervention Quality Improvement Protocol in people with Ischemic Stroke and Transient Ischemic Attack (TIA), run by VA Office of Research and Development at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Facility-level OSA diagnostic rate (time frame: 30-day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04322162, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2024.

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Addressing Sleep Apnea Post-Stroke/TIA (NCT04322162) | AzTrials