The study protocol to evaluate implementation of the transitional care model in four U.S. healthcare systems during the Covid-19 pandemic.

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.

MIRROR-TCM: Multisite Replication of a Randomized Controlled Trial - Transitional Care Model.

In the U.S., older adults hospitalized with acute episodes of chronic conditions often are rehospitalized within 30 days of discharge. Numerous studies reveal that poor management of the complex needs of this population remains the norm. METHODS: This prospective, intent-to-treat, randomized controlled trial (RCT) will assess the effects of replicating the rigorously studied Transitional Care Model (TCM) in four U.S. healthcare systems. The TCM is an advanced practice registered nurse led, team-based, care management intervention that supports older adults throughout vulnerable care episodes that span hospital to home. This RCT will compare health and economic outcomes demonstrated by at-risk older adults hospitalized with heart failure, chronic obstructive pulmonary disease or pneumonia randomized to receive usual discharge planning (control group, N = 800) to those observed by a similar group of older adults randomized to receive the TCM protocol (N = 800). The primary outcome is number of rehospitalizations at 12 months post-discharge, with secondary resource use outcomes measured at multiple intervals. Patient experience with care, health and quality of life outcomes will be assessed at 90 days post-discharge. DISCUSSION: Based on health and economic benefits demonstrated in multiple NIH funded RCTs, the study team hypothesizes that the intervention group, both within and across participating health systems, will have decreased acute care resource use and costs at 12 months and better ratings of the care experience and health and quality of life through 90 days post-discharge compared to the control group. The impact of COVID-19 on implementation of this study also is discussed.

Meeting the Transitional Care Needs of Older Adults with COVID-19.

Older adults with COVID-19 who survive hospitalizations and return to their homes confront substantial health challenges and an unpredictable future. While understanding of the unique needs of COVID-19 survivors is developing, components of the evidence-based Transitional Care Model provide a framework for taking a more immediate, holistic response to caring for these individuals as they moved back into the community. These components include: increasing screening, building trusting relationships, improving patient engagement, promoting collaboration across care teams, undertaking symptom management, increasing family caregiver care/education, coordinating health and social services, and improving care continuity. Evidence generated from rigorous testing of these components reveal the need for federal and state policy solutions to support the following: employment/redeployment of nurses, social workers, and community health workers; training and reimbursement of family caregivers; widespread access to research-based transitional care tools; and coordinated local efforts to address structural barriers to effective transitions. Immediate action on these policy options is necessary to more effectively address the complex issues facing these older adults and their family caregivers who are counting on our care system for essential support.