Design and methods of an adaptive trial to test comparative effectiveness of readmission reduction approaches following infection and sepsis hospitalizations (ACCOMPLISH).

Background: The months following hospitalization for sepsis and lower respiratory tract infection can often be very difficult for patients. Many will have subsequent clinical deterioration, which for some requires hospital readmission while, for others, transition to hospice care may be more appropriate. Unfortunately, there is a lack of high-quality evidence regarding how best to support patients in this period. Remote patient monitoring (RPM) technology can allow patients to remain at home yet be monitored for early signs of clinical deterioration. However, what should be monitored, and how any response should be coordinated, is unclear. We designed a pragmatic adaptive randomized clinical trial to determine the effect of four post-discharge RPM strategies comprising low vs. high intensity monitoring and standard versus enhanced care team response on 90-day hospital readmission rates. Methods: Adults admitted to the hospital with sepsis or lower respiratory tract infection (index admission) are recruited and randomized to usual care (structured telephonic support [STS]) or one of four post-discharge RPM care models in addition to STS. The primary outcome is home days, a composite endpoint of 90-day mortality and the number of days a patient spends at home within 90 days after discharge to home from the index admission. Hospital readmissions will be measured primarily by health insurance claims data. Secondary endpoints, such as functional status and health-related quality of life, will be measured at baseline and 90 days. An adaptive randomization process is run quarterly, improving patients' chances to be randomized to the highest-performing intervention arms. Discussion: The study evaluates different post-discharge monitoring and workforce strategies to increase home days. With a large, representative sample and pragmatic adaptive study design, this research aims to deliver key insights into effective remote discharge monitoring technology and workforce deployment, benefiting patients, providers, and payers. Trial registration: This trial is registered at clinicaltrials.gov (NCT04829188). https://clinicaltrials.gov/study/NCT04829188. Date of registration: January 4, 2021.