Addressing Sleep Apnea Post-Stroke/TIA

Obstructive Sleep Apnea Clinical Trial

— ASAP  

Official title:

Addressing Sleep Apnea Post-Stroke (ASAP)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04322162
• Other study ID #: IIR 16-211
• Secondary ID: 1I01HX002324-01A
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 2, 2020
• Est. completion date: July 31, 2024

Study information

• Verified date: April 2024
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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, 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 6
• Est. completion date: July 31, 2024
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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]

Related Conditions & MeSH terms

• Apnea
• Ischemia
• Ischemic Attack, Transient
• Ischemic Stroke
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Stroke
• Transient Ischemic Attack (TIA)

Intervention

Other:
• ASAP Intervention Quality Improvement Protocol
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.

Locations

Country	Name	City	State
United States	Richard L. Roudebush VA Medical Center, Indianapolis, IN	Indianapolis	Indiana
United States	VA Connecticut Healthcare System West Haven Campus, West Haven, CT	West Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View 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 — View 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):e0614 — View 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. — View Citation

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;11:205031212311 — View 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 — View Citation

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 S — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Implementation Outcome - Adaptation	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.	Measured throughout active implementation and sustainability periods
Other	External Facilitation	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.	Measured throughout active implementation and sustainability periods
Other	Audit and Feedback	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."	Measured throughout active implementation and sustainability periods
Other	Sustainability - mixed methods analysis	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.	Measured throughout sustainability period
Other	Sustainability - Program Sustainability Assessment Tool (PSAT)	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.	Measured prior to and at the end of active implementation period and at the end of the sustainability period
Primary	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	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.	30-day
Secondary	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.	90-day
Secondary	Facility-level all-cause readmission rate	Includes an inpatient admission for any cause at either a VA or non-VA acute care facility.	90-day
Secondary	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.	30-day