ABSTRACT
This study protocol describes the conceptual framework, design, and methods being employed to evaluate the implementation of the Transitional Care Model (TCM) as part of a randomized controlled trial. The trial, designed to examine the health and cost outcomes of at-risk hospitalized older adults, is being conducted in the context of the COVID-19 pandemic. This parallel study is guided by the Practical, Robust, Implementation and Sustainability Model (PRISM) and uses a fixed, mixed methods convergent parallel design to identify challenges encountered by participating hospitals and post-acute and community-based providers that impact the implementation of the TCM with fidelity, strategies implemented to address those challenges and the relationships between challenges, strategies, and rates of fidelity to TCM's core components over time. Prior to the study's launch and throughout its implementation, qualitative and quantitative data related to COVID and non-COVID challenges are being collected via surveys and meetings with healthcare system staff. Strategies implemented to address challenges and fidelity to TCM's core components are also being assessed. Analyses of quantitative (established metrics to evaluate TCM's core components) and qualitative data (barriers and facilitators to implementation) are being conducted independently. These datasets are then merged and interpreted together. General linear and mixed effects modeling using all merged data and patients' socio-demographic and social determinants of health characteristics, will be used to examine relationships between key variables and fidelity rates. Implications of study findings in the context of COVID-19 and future research opportunities are suggested. Trial registration: ClinicalTrials.gov Identifier: NCT04212962.
Subject(s)
COVID-19 , Transitional Care , Humans , Aged , Pandemics , Delivery of Health Care , Randomized Controlled Trials as TopicABSTRACT
The COVID-19 pandemic caused significant disruptions for people and institutions across healthcare settings. Clinical trials are an important research tool to test interventions in real-world healthcare settings and provide high quality evidence that supports older adults’ longevity and wellness. Clinical trialists must consider how to account for unpredictable and ever-changing environmental contexts. The COVID-19 pandemic is a specific example of a changing context that impacted all stages of the clinical trials process from planning, to administration, and outcomes. Reflecting on ways clinical trialists navigated their studies during the COVID-19 pandemic may unlock opportunities to design flexible clinical trials that meet the needs of older adults in real-world environments. This symposium highlights five clinical trials for older adults that occurred during the COVID-19 pandemic. Dr. Carpenter will discuss lessons learned in implementing a palliative care intervention in nursing homes. Brianna Morgan will describe the pivots needed to complete a clinical trial testing an advance care planning website for nursing home residents with dementia. Dr. Nuckols will describe obstacles and opportunities to implementing a randomized controlled trial on hospital nursing units, including implications for medication safety. Dr. Pevnick will highlight barriers and facilitators to implementing a pharmacist-led intervention to reduce hospital readmissions. Dr. Stark will share novel procedures for conducting clinical trials in the community that reduce burden for older adult participants while maintaining fidelity. Presenters will address practice transformations that researchers can bring forward to design flexible clinical trials that meet the needs of older adults in different healthcare contexts.
ABSTRACT
We partnered with a national for-profit nursing home (NH) organization to test the acceptability and use of an advance care planning (ACP) website for people living with dementia using a randomized controlled trial (RCT) design. Concurrently, the COVID-19 pandemic disproportionately impacted NHs and halted in-person research. We will present challenges, opportunities, and adaptations in site engagement, recruitment, and data collection. Initially, NHs were overwhelmed by pandemic efforts and research staff were unable to enter sites. We capitalized on time and available resources by beta-testing the website in a comparable population and designing surveys to elicit COVID-19’s impact on ACP. Once able, NH staff took on recruitment and data collection efforts intended for research staff. We supported NHs by pivoting to remote data collection, providing technology on site, and offering flexible communication. Flexibility is key in supporting site engagement, recruitment, and data collection and has implications for designing pragmatic RCTs.
ABSTRACT
Randomized clinical trials (RCTs) have demonstrated that the multicomponent Transitional Care Model (TCM), an advanced practice registered nurse-led, team-based, care management strategy improves outcomes for older adults transitioning from hospital to home. However, healthcare systems’ adoption of the model has been limited. A multi-system, replication RCT (MIRROR-TCM) enrolling older adults hospitalized with heart failure, chronic obstructive pulmonary disease or pneumonia began in February 2020 just as the outbreak of COVID-19 in the U.S. dramatically changed the healthcare and research landscape. The goal of this qualitative descriptive study is to explore the impact of COVID-19 on fidelity to the TCM intervention during this clinical trial. Using directed content analysis, recorded monthly meetings with health system leaders and staff were coded to identify challenges and strategies to maintaining fidelity to the intervention in the context of the pandemic. Analyses showed that COVID-19 impacted all 10 TCM components. The components with the most challenges were delivering services from hospital-to-home due to quarantining, restrictive facility policies, lack of personal protective equipment and limited telehealth availability;coordinating care due reduced availability of services, and screening at risk individuals because of fewer eligible patients. Strategies for addressing challenges included: exploring alternatives (e.g., increasing reliance on telehealth, expanding study eligibility), building and engaging networks (e.g., direct outreach to skilled nursing facility staff) and anticipating needs (e.g., preparing for shorter hospital stays). Findings highlight the importance of monitoring the contextual challenges to implementing an evidence-based intervention and actively engaging partners in identifying strategies to achieve fidelity.