MARC KOWALKOWSKI, PhD
Atrium Health

Sepsis survivors experience high morbidity and mortality, and healthcare systems lack effective strategies to address patient needs after hospital discharge. The Sepsis Transition and Recovery (STAR) program is a navigator-led, telehealth-based multicomponent strategy to provide proactive care coordination and monitoring of high-risk patients using evidence-driven, post-sepsis care tasks. The purpose of this study is to evaluate the effectiveness of STAR to improve outcomes for sepsis patients and to examine contextual factors that influence STAR implementation.

This study uses a hybrid type I effectiveness-implementation design to concurrently test clinical effectiveness and gather implementation data. The effectiveness evaluation is a two-arm, pragmatic, stepped-wedge cluster randomized controlled trial at eight hospitals in North Carolina comparing clinical outcomes between sepsis survivors who receive Usual Care versus care delivered through STAR. Each hospital begins in a Usual Care control phase and transitions to STAR in a randomly assigned sequence (one every four months). During months that a hospital is allocated to Usual Care, all eligible patients will receive usual care. Once a hospital transitions to STAR, all eligible patients will receive STAR during their hospitalization and extending through 90 days from discharge. STAR includes centrally located nurse navigators using telephonic counseling and electronic health record-based support to facilitate best-practice post-sepsis care strategies including post-discharge review of medications, evaluation for new impairments or symptoms, monitoring existing comorbidities, and palliative care referral when appropriate. Adults admitted with suspected sepsis, defined by clinical criteria for infection and organ failure, are included. Planned enrollment is 4032 patients during a 36-month period; as of March 26, 999 (25%) patients have been enrolled, which is on target. The primary effectiveness outcome is the composite of all-cause hospital readmission or mortality within 90 days of discharge. We are conducting an implementation determinants evaluation conceptually guided by the Consolidated Framework for Implementation Research (CFIR) before, during, and after STAR implementation. To increase policy impact, we are also conducting a prospective economic evaluation to provide an understanding of the resource implications of the STAR program intervention on post-sepsis health benefits and costs.

This pragmatic evaluation will test the effectiveness of STAR to reduce combined hospital readmissions and mortality, while identifying key implementation factors. Results will provide practical information to advance understanding of how to integrate post-sepsis management across care settings and facilitate implementation, dissemination, and sustained utilization of best-practice post-sepsis management strategies in other heterogeneous healthcare delivery systems.

AMANDA GLICKMAN, MD
University of Colorado Anschutz Medical Campus

Early goals of care conversations are recommended by the National Academy of Medicine, preferred by patients and families, and associated with less aggressive medical care at end of life, earlier hospice referral, and better caregiver bereavement adjustment. Conversations aim to explore and establish patients’ underlying values and priorities to guide decisions about specific medical interventions in the present and future. Despite the VA’s intent to increase early conversations in the outpatient setting by implementing the National Center for Ethics in Health Care’s Life Sustaining Treatment Decisions Initiative (LSTDI) in 2017, the majority of conversations still take place in the inpatient setting near end of life, when patients may be critically ill and unable to fully participate. Thus, further implementation strategies are needed. Using a sequential multiple assignment randomized trial (SMART) design, various adaptive strategies will be compared to better understand whether low- or high-intensity patient-facing and/or clinician-facing strategies improve conversations. This will help health care systems decide which approaches to use.

Study sites include the VA Eastern Colorado, Greater Los Angeles, and Palo Alto Health Care Systems. Advance practice outpatient clinicians with low rates of documented conversations who care for ?15 veterans with cancer, heart failure, COPD, interstitial lung disease, dementia, or end-stage renal or liver disease in the top 10th percentile for risk of hospitalization or death will be eligible for randomization.

This study employs a cluster (clinician-level randomization) SMART design. The primary outcome is number of documented conversations, measured 6 and 12 months after initial randomization. In stage 1, clinicians will receive written materials and one-time training. Their patients will be randomized to no patient strategy or a letter directing them to an interactive website to prepare for conversations. After 6 months, in stage 2, clinicians in either group who do not respond (<4 notes completed) will receive in-person team facilitation and lists of patients potentially appropriate for a conversation. Clinicians’ patients will be randomized to receive the letter or the letter with follow-up phone calls. Clinician and patient implementation strategy success or failure will be evaluated through surveys and semi-structured interviews. Data will be analyzed using quantitative and qualitative methods.

This study will help determine whether an implementation strategy requiring fewer resources could be effective, and to learn what sequence of strategies is effective overall and for specific patients, clinicians, or sites. Increasing goals of care conversations in the outpatient setting, earlier in the course of serious illness while the patient has decision making capacity and prior to a health crisis, will better align medical care with Veterans’ values.

LILA J. FINNEY RUTTEN, PhD
Mayo Clinic

Despite the availability of an effective and safe vaccine, the human papillomavirus (HPV) causes nearly 36,000 cancers each year in the U.S. HPV vaccination rates remain well below public health goals. Our team is conducting a pragmatic trial with process evaluation to evaluate a multilevel intervention to improve clinician recommendations of the HPV vaccine and increase HPV vaccination rates.

Our trial is being conducted in six Mayo Clinic primary care practices in southeastern Minnesota that employ salaried pediatricians, family physicians, and advanced practice providers. Children aged 11 and 12 years empaneled to the participating practices who in the previous calendar month became due for a dose of the HPV vaccine are eligible.

We are conducting a stepped wedge cluster randomized trial with a factorial design to evaluate the independent and combined impact of parent reminder-recall letters and provider audit-and-feedback interventions on HPV vaccination rates. The audit and feedback reports sent to clinicians on a monthly basis include a web address and QR code to access a strong recommendations toolkit that teaches evidence-based methods for offering strong recommendations and addressing vaccine hesitancy. Following a 12-month baseline assessment, sites were block randomized to the interventions in three subsequent steps, each 12 months in duration to account for seasonal variation in vaccination. During the baseline period, we collected baseline vaccination rates and developed and refined our intervention materials based on feedback from focus groups involving parents of children in our target age group and clinicians who care for patients in the target age group. Throughout the trial we are conducting a process evaluation which involves mailing questionnaires to parents to evaluate their awareness of and response to the reminder-recall intervention and to assess their attitudes and beliefs about HPV vaccination. The process evaluation also includes sending electronic questionnaires to all participating healthcare providers to assess their exposure to and experience with receipt of the monthly audit-and-feedback reports. We initiated step 3 of our pragmatic trial in September of 2020; all six clinical practices are now receiving at least one of the two interventions.

Critical improvements were made to the intervention materials based on feedback from parents and from key stakeholders in the clinical practice. Ongoing assessment of implementation outcomes through process evaluation efforts will provide insight into intervention fidelity and individual, provider, and clinic-level factors that may be associated with observed outcomes. Results of this pragmatic trial and process evaluation will quantify the impact of these practice- and provider-level interventions on HPV vaccination rates and will provide guidance on the factors associated.