NCT04322162

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 26, 2020

Completed
7 days until next milestone

Study Start

First participant enrolled

April 2, 2020

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

April 12, 2024

Status Verified

April 1, 2024

Enrollment Period

3.5 years

First QC Date

March 24, 2020

Last Update Submit

April 10, 2024

Conditions

Ischemic StrokeTransient Ischemic Attack (TIA)Obstructive Sleep Apnea

Keywords

Ischemic strokeTransient ischemic attack (TIA)Stepped-wedge trialImplementation ScienceHybrid Type IQuality ImprovementSystems RedesignChampionExternal FacilitationAudit and feedbackLocal AdaptationObstructive Sleep ApneaPolysomnographySustainabilityBusiness-case

Outcome Measures

Primary Outcomes (1)

  • Facility-level OSA diagnostic rate

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

    30-day

Secondary Outcomes (4)

  • Facility-level treatment rate

    30-day

  • Facility-level recurrent vascular event rate

    90-day

  • Facility-level all-cause readmission rate

    90-day

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

    30-day

Other Outcomes (5)

  • Implementation Outcome - Adaptation

    Measured throughout active implementation and sustainability periods

  • External Facilitation

    Measured throughout active implementation and sustainability periods

  • Audit and Feedback

    Measured throughout active implementation and sustainability periods

  • +2 more other outcomes

Study Arms (3)

Active implementation - Wave 1 (First and Second Sites)

EXPERIMENTAL

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.

Other: ASAP Intervention Quality Improvement Protocol

Active implementation - Wave 2 (Third and Fourth Sites)

EXPERIMENTAL

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.

Other: ASAP Intervention Quality Improvement Protocol

Active implementation - Wave 3 (Fifth and Sixth Sites)

EXPERIMENTAL

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.

Other: ASAP Intervention Quality Improvement Protocol

Interventions

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.

Active implementation - Wave 1 (First and Second Sites)Active implementation - Wave 2 (Third and Fourth Sites)Active implementation - Wave 3 (Fifth and Sixth Sites)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 \[e.g., inability to clear secretions\]

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

West Haven, Connecticut, 06516-2770, United States

Location

Richard L. Roudebush VA Medical Center, Indianapolis, IN

Indianapolis, Indiana, 46202-2884, United States

Location

Related Publications (9)

  • 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.

    PMID: 32005185RESULT

  • 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.

    PMID: 32398356RESULT

  • 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.

    PMID: 32467120RESULT

  • 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.

    PMID: 35292287RESULT

  • 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.

    PMID: 35672067RESULT

  • 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.

    PMID: 37152838RESULT

  • 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.

    PMID: 37473533RESULT

  • 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.

    PMID: 41236739DERIVED

  • 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.

    PMID: 41173184DERIVED

MeSH Terms

Conditions

Ischemic StrokeIschemic Attack, TransientSleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBrain IschemiaSleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake Disorders

Study Officials

  • Jason Jonathon Sico, MD MHS

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

    PRINCIPAL INVESTIGATOR

  • Dawn M. Bravata, MD

    Richard L. Roudebush VA Medical Center, Indianapolis, IN

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SEQUENTIAL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2020

First Posted

March 26, 2020

Study Start

April 2, 2020

Primary Completion

September 30, 2023

Study Completion

July 31, 2024

Last Updated

April 12, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

US(2)