Back to resultsAddressing Sleep Apnea Post-Stroke/TIA (ASAP)
Primary Purpose
Ischemic Stroke, Transient Ischemic Attack (TIA), Obstructive Sleep Apnea
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ASAP Intervention Quality Improvement Protocol
Sponsored by
About this trial
This is an interventional health services research trial for Ischemic Stroke focused on measuring 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
Eligibility Criteria
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]
Sites / Locations
- VA Connecticut Healthcare System West Haven Campus, West Haven, CT
- Richard L. Roudebush VA Medical Center, Indianapolis, IN
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Active implementation - Wave 1 (First and Second Sites)
Active implementation - Wave 2 (Third and Fourth Sites)
Active implementation - Wave 3 (Fifth and Sixth Sites)
Arm 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.
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.
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.
Outcomes
Primary Outcome Measures
Facility-level OSA diagnostic rate
PSG completion or initiation of auto-PAP within 30 days of presentation for the index stroke or TIA
Secondary Outcome Measures
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.
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.
Facility-level all-cause readmission rate
Includes an inpatient admission for any cause at either a VA or non-VA acute care facility.
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.
Full Information
NCT ID
NCT04322162
First Posted
March 24, 2020
Last Updated
April 3, 2023
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT04322162
Brief Title
Addressing Sleep Apnea Post-Stroke/TIA
Acronym
ASAP
Official Title
Addressing Sleep Apnea Post-Stroke (ASAP)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 2, 2020 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke, Transient Ischemic Attack (TIA), Obstructive Sleep Apnea
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
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active implementation - Wave 1 (First and Second Sites)
Arm Type
Experimental
Arm 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.
Arm Title
Active implementation - Wave 2 (Third and Fourth Sites)
Arm Type
Experimental
Arm 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.
Arm Title
Active implementation - Wave 3 (Fifth and Sixth Sites)
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
ASAP Intervention Quality Improvement Protocol
Intervention Description
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.
Primary Outcome Measure Information:
Title
Facility-level OSA diagnostic rate
Description
PSG completion or initiation of auto-PAP within 30 days of presentation for the index stroke or TIA
Time Frame
30-day
Secondary Outcome Measure Information:
Title
Facility-level treatment rate
Description
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.
Time Frame
30-day
Title
Facility-level recurrent vascular event rate
Description
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.
Time Frame
90-day
Title
Facility-level all-cause readmission rate
Description
Includes an inpatient admission for any cause at either a VA or non-VA acute care facility.
Time Frame
90-day
Title
Facility-level treatment rate (Positive airway pressure and non-positive airway pressure treatments)
Description
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.
Time Frame
30-day
Other Pre-specified Outcome Measures:
Title
Implementation Outcome - Adaptation
Description
Information regarding implementation of acute OSA diagnosis and treatment approaches will be collected at each site on an ongoing basis during brief phone calls every month between the local RA and/or local champion with members of the ASAP implementation team using the "local adaptation real-time tracking system" developed by a team of VA investigators. Local adaptations will also be recorded by local RAs in response to the monthly site assessments.
Time Frame
Measured throughout active implementation and sustainability periods
Title
External Facilitation
Description
External facilitation changes over time based on the needs of the team. However, the core elements of relationship-building, methods training, communication, facilitating team-based problem solving, and monitoring performance over time will be preserved through external facilitation from a Lean Six Sigma Black belt experienced in stroke QI work and ASAP investigators experienced in implementation of post-stroke/TIA OSA programs. External facilitation activities will be recorded and will later be classified by type of contact, topic, and dose/duration.
Time Frame
Measured throughout active implementation and sustainability periods
Title
Audit and Feedback
Description
To support the sites' use of data, the local teams will receive explicit training in team-based reflecting & evaluating, goal-setting, and planning. Meeting as a group, local teams will be encouraged to formally ask and answer questions like: "How are we doing?" "Are we where we want to be?" "What performance goals do we want to set as targets?" "What do we need to do to achieve our goals?" "How will we know how far or how close we are to hitting our targets?." Data usage will be monitored by the web-based data platform known as the ASAP "hub."
Time Frame
Measured throughout active implementation and sustainability periods
Title
Sustainability - mixed methods analysis
Description
The sustainability analysis will include: a comparison of the change in the diagnostic rate from the baseline data period to the sustainability period. This will be obtained from the multilevel models as described for the Aim 1 analysis. The investigators will explore whether sites that use HST as their primary diagnostic approach, that continue to actively review their audit and feedback data, and that have champions who continue to engage with systems redesign demonstrate the greatest program sustainability.
Time Frame
Measured throughout sustainability period
Title
Sustainability - Program Sustainability Assessment Tool (PSAT)
Description
Those agreeing to participate will receive a link to complete the Program Sustainability Assessment Tool (PSAT), an online tool which allows users to: (1) understand factors associated with sustainability; (2) assess the sustainability of a program; (3) review their sustainability report, and; (4) develop an action plan to enhance the chances of programmatic sustainability. This tool assesses the facility's overall capacity for sustainability and across the specific domains of: environmental support, funding stability, partnerships, organizational capacity, program adaptation, communications, and strategic planning. Reports are generated by this tool, ranking the facility from 1 (little to no extent) to 7 (to a great extent) and provides guidance on what areas can be addressed to maximize sustainability.
Time Frame
Measured prior to and at the end of active implementation period and at the end of the sustainability period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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]
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Jonathon Sico, MD MHS
Organizational Affiliation
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dawn M. Bravata, MD
Organizational Affiliation
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516-2770
Country
United States
Facility Name
Richard L. Roudebush VA Medical Center, Indianapolis, IN
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-2803
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32005185
Citation
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.
Results Reference
result
PubMed Identifier
32398356
Citation
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.
Results Reference
result
PubMed Identifier
32467120
Citation
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.
Results Reference
result
PubMed Identifier
35292287
Citation
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. Erratum In: Am J Med. 2023 Feb;136(2):215.
Results Reference
result
PubMed Identifier
35672067
Citation
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.
Results Reference
result
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Addressing Sleep Apnea Post-Stroke/TIA
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