A cluster randomized controlled trial comparing Virtual Learning Collaborative and Technical Assistance strategies to implement an early palliative care program for patients with advanced cancer and their caregivers: a study protocol

Abstract

Background Virtual 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. Methods Using 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. Discussion This 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 registration Clinicaltrials.gov. NCT04062552; Pre-results. Registered: August 20, 2019. https://clinicaltrials.gov/ct2/show/NCT04062552?term=NCT04062552&draw=2&rank=1

Learning Collaboratives: a Strategy for Quality Improvement and Implementation in Behavioral Health

“…Multiple reviews in health care and the field of dissemination and implementation science have shown that passive implementation strategies (e.g., distributing published or printed recommendations) and even traditional training strategies (e.g., workshops, lectures) are not effective in changing provider behavior and/or implementing evidence-based practices. [37][38][39] Moreover, using a single implementation strategy to foster practice change is less effective, in general, than multi-component strategies. [40][41][42] As is highlighted in Table 1, a learning collaborative is a multi-component strategy.…”

Feasibility and Application of Cluster Nursing to the Care of Patients with Acute Oncology

“…The main guiding basis of intensive care is evidence-based medicine, and nursing staff can achieve good care by communicating with patients, can provide patients with more valuable care, can achieve targeted care, and can improve patient outcomes by integrating various elements, and after care, the quality of patient survival is significantly improved and the risk of patient infection is significantly reduced [ 24 ]. Oncology via patients with high psychological stress and loss of confidence in life and the application of the PICC catheter approach to intravenous infusion, where foreign bodies are implanted in the patient's body, can lead to physical discomfort symptoms, which disturbs the patient's life and aggravates anxiety [ 25 ]. By providing health education and psychological intervention to the patients, the nursing staff helped to relieve the patients' anxiety and depression and speed up the time of disappearing symptoms.…”

Design and management considerations for control groups in hybrid effectiveness-implementation trials: Narrative review & case studies

“…Figure 1 depicts how publications were assessed and selected for inclusion in the review. 17 had an "A vs. A+" structure (9,(11)(12)(13)(14)(15)(16)(17)(18)(19)(20)(21)(22)(23)(24)(25)(26), 26 had an "A vs. B" structure (8, 27-51) and 2 had unique structures that did not fall into the two defined categories (52,53).…”