Abstract
BackgroundVirtual Learning Collaboratives (VLC), learning communities focused on a common purpose, are used frequently in healthcare settings to implement best practices. Yet, there is limited research testing the effectiveness of this approach compared to other implementation strategies. This study evaluates the effectiveness of a VLC compared to Technical Assistance (TA) among community oncology practices implementing ENABLE (Educate, Nurture, Advise, Before Life Ends), an evidence-based, early palliative care telehealth, psycho-educational intervention for patients with newly diagnosed advanced cancer and their caregivers.MethodsUsing Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) and Proctor’s Implementation Outcomes Frameworks, this two-arm hybrid type-III cluster-randomized controlled trial (RCT) will compare two implementation strategies, VLC versus TA, among the 48 National Cancer Institute Community Oncology Research Program (NCORP) practice clusters that have not historically provided palliative care to all patients with advanced cancer. Three cohorts of practice clusters will be randomized to the study arms. Each practice cluster will recruit 15–27 patients and a family caregiver to participate in ENABLE. The primary study outcome is ENABLE uptake (patient level), i.e., the proportion of eligible patients who complete the ENABLE program (receive a palliative care assessment and complete the six ENABLE sessions over 12 weeks). The secondary outcome is overall program implementation (practice cluster level), as measured by the General Organizational Index at baseline, 6, and 12 months. Exploratory aims assess patient and caregiver mood and quality of life outcomes at baseline, 12, and 24 weeks. Practice cluster randomization will seek to keep the proportion of rural practices, practice sizes, and minority patients seen within each practice balanced across the two study arms.DiscussionThis study will advance the field of implementation science by evaluating VLC effectiveness, a commonly used but understudied, implementation strategy. The study will advance the field of palliative care by building the capacity and infrastructure to implement an early palliative care program in community oncology practices.Trial registrationClinicaltrials.gov. NCT04062552; Pre-results. Registered: August 20, 2019. https://clinicaltrials.gov/ct2/show/NCT04062552?term=NCT04062552&draw=2&rank=1
Highlights
Due to the benefits of early palliative care (EPC) in randomized controlled trials [1,2,3], the American Society of Clinical Oncology recommends “ ... combined standard oncology care and palliative care ... early in the course of illness for any patient with metastatic cancer and/or high symptom burden” [4] (p.881)
Which strategy would be most effective for the widespread implementation of ENABLE in community oncology practices is unclear. To address these gaps in implementation science and palliative care, we developed a cluster randomized controlled trial (RCT) that compares Virtual Learning Collaboratives (VLC) to Technical Assistance (TA) for implementing ENABLE in community oncology practices
This study will provide a direct comparison between the VLC and TA strategies to determine if VLC is a superior method to facilitate implementation of the evidence-based ENABLE program in community-based oncology practices
Summary
Background and rationale Due to the benefits of early palliative care (EPC) in randomized controlled trials [1,2,3], the American Society of Clinical Oncology recommends “ ... combined standard oncology care and palliative care ... early in the course of illness for any patient with metastatic cancer and/or high symptom burden” [4] (p.881). An effective implementation strategy to address implementation barriers (e.g., lack of knowledge about evidence-based EPC, insufficient infrastructure) is needed to equip oncology practices to develop the skills to implement and sustain ENABLE. It is unclear which strategy would be most successful in assisting implementation. This study evaluates the effectiveness of a VLC compared to Technical Assistance (TA) among community oncology practices implementing ENABLE (Educate, Nurture, Advise, Before Life Ends), an evidence-based, early palliative care telehealth, psycho-educational intervention for patients with newly diagnosed advanced cancer and their caregivers
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