||1UM1CA233033-01 Interpret this number
||Mayo Clinic Rochester
||Enhanced, Ehr-Facilitated Cancer Symptom Control (E2C2) Pragmatic Clinical Trial
Cancer and its treatment engender disabling symptoms that are frequently undertreated, and associated with
needlessly increased healthcare utilization, non-adherence to oncologic treatments, and reduced survival. The
key to addressing this damaging situation lies in reliably detecting symptoms and providing evidence-based
care. Of note, the National Academy of Medicine has identified systematic screening with patient reported
outcomes (PROs) as critical, not only to symptom control, but also to enhancing the patient centricity and
effectiveness of cancer care in general. Unfortunately, experience has shown that simply presenting PRO data
to over-loaded, treatment-focused clinicians has minimal or no impact on the outcomes of patients with many
diseases, including cancer. On the other hand, providing these data to mid-level providers and entrusting them
to initiate, monitor and adapt individually tailored symptom management plans has proven robustly effective in
the control of cancer-related and other symptoms. However, the high resource requirements of this approach
have heretofore limited its dissemination and scalability. Encouragingly, such resource intense care is not
always required for meaningfully benefit, as attested by the effectiveness of interventions that provide patients
experiencing mild or moderate with self-management education. This application recognizes the need for both
low- and high-touch approaches to cancer symptom control and proposes the Enhanced, EHR-facilitated
Cancer Symptom Control (E2C2) pragmatic clinical trial to test a bundled intervention that leverages EHR
interface and clinical decision support functionalities to operationalize the population-level implementation of an
approach that automatically triages symptomatic patients to low-touch automated self-management (Level 1),
or high-touch nurse care management (Level 2), both validated, depending on PRO scores, as well as patient
and clinical factors. The E2C2 intervention will target Sleep disturbance, Pain, Anxiety, Depression, and
Energy deficit/fatigue, the SPADE pentad which represents the most prevalent and potentially treatable group
of overlapping cancer symptoms. To rigorously assess the effectiveness of discrete E2C2 intervention
components, we will initially test a Stage 1 Symptom Control Bundle for 12 months, after which we will add
a Stage 2 Implementation Bundle. The trial's stepped wedge design will randomize the order of E2C2
implementation among 21 clusters. Clusters will be defined at the level of the cancer care team, and will be
randomized to one of five different tranches to receive the intervention at staggered 6 month intervals.
Outcomes will include SPADE symptom scores (primary), physical function, social participation, quality of life,
distress, healthcare utilization, adherence to cancer treatment, and vital status which will be collected for 9-12
months during each trial phase; pre-E2C2, Stage 1 and Stage 2. A multi-stakeholder, mixed methods
approach will be used to comprehensively assess the impact of the Stage 2 Implementation Bundle, as well as
both Stages' impact on rurally-based and elderly patients, groups prone to disparities in symptom control.
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