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Background: New patient-centered models of care are needed to individualize care and reduce high-cost care, including emergency department (ED) visits and hospitalizations for low- and intermediate-acuity conditions that could be managed outside the hospital setting. Community paramedics (CPs) have advanced training in low- and high-acuity care and are equipped to manage a wide range of health conditions, deliver patient education, and address social determinants of health in the home setting. The objective of this trial is to evaluate the effectiveness and implementation of the Care Anywhere with Community Paramedics (CACP) program with respect to shortening and preventing acute care utilization., Methods: This is a pragmatic, hybrid type 1, two-group, parallel-arm, 1:1 randomized clinical trial of CACP versus usual care that includes formative evaluation methods and assessment of implementation outcomes. It is being conducted in two sites in the US Midwest, which include small metropolitan areas and rural areas. Eligible patients are ≥ 18 years old; referred from an outpatient, ED, or hospital setting; clinically appropriate for ambulatory care with CP support; and residing within CP service areas of the referral sites. Aim 1 uses formative data collection with key clinical stakeholders and rapid qualitative analysis to identify potential facilitators/barriers to implementation and refine workflows in the 3-month period before trial enrollment commences (i.e., pre-implementation). Aim 2 uses mixed methods to evaluate CACP effectiveness, compared to usual care, by the number of days spent alive outside of the ED or hospital during the first 30 days following randomization (primary outcome), as well as self-reported quality of life and treatment burden, emergency medical services use, ED visits, hospitalizations, skilled nursing facility utilization, and adverse events (secondary outcomes). Implementation outcomes will be measured using the RE-AIM framework and include an assessment of perceived sustainability and metrics on equity in implementation. Aim 3 uses qualitative methods to understand patient, CP, and health care team perceptions of the intervention and recommendations for further refinement. In an effort to conduct a rigorous evaluation but also speed translation to practice, the planned duration of the trial is 15 months from the study launch to the end of enrollment., Discussion: This study will provide robust and timely evidence for the effectiveness of the CACP program, which may pave the way for large-scale implementation. Implementation outcomes will inform any needed refinements and best practices for scale-up and sustainability., Trial Registration: ClinicalTrials.gov NCT05232799. Registered on 10 February 2022., (© 2023. The Author(s).)

From March 1981 to June 1989, 44 patients with locally recurrent, previously irradiated adenocarcinoma of the breast were treated with hyperthermia and irradiation. Treatment sites were chest wall (35) or nodal (nine), with an average tumor area of 29.44 cm2 (range 0.16 to 252 cm2) prior to treatment. Concurrent radiation doses varied from 16 to 56 Gy (mean = 29.4 Gy). Externally applied microwave hyperthermia was given twice weekly, aiming at 43 degrees C for 60 min. Evaluation at one month post treatment revealed 41% complete response (CR), 23% partial response (PR), and 36% no response (NR), and 67% of patients with a CR sustained that response for greater than 12 months. Tumors heated to a mean thermal dose (equivalent-minutes at 42.5 degrees C) greater than 50 had a 53% CR rate, significantly better than the 14% CR rate observed in patients whose tumors received a mean thermal dose less than 50. Among patients with tumors less than or equal to 6 cm2 in area, 65% achieved CR, significantly better than the 26% CR rate noted for patients with tumors greater than 6 cm2 in area. Only four patients (7.4%) experienced complications: one developed a catheter-related infection, two had ulcerated infections, and one had a severe blister. In summary, higher thermal doses delivered and smaller tumor areas were associated with more favorable tumor responses.