Trial Summary

Too many older Americans with advanced cancer die every year receiving aggressive interventions at the end of life that do not reflect their values, goals, and preferences. Advance Care Planning (ACP) is the most consistent modifiable factor associated with better end-of-life communication and goal-concordant care. However, clinicians often do not possess the communication skills needed for high-quality ACP conversations and patients are often unable to imagine their options for medical care to make informed decisions.

To address this gap, we have developed a Comprehensive ACP Program that combines two well-tested, evidence-based, and complementary interventions: clinician communication skills training and patient video decision aids. This inclusive ACP approach treats patients and clinicians as equal stakeholders providing both with the communication skills and tools needed to optimally make informed decisions before the toughest choices arise. We have shown the efficacy of the elements of the Comprehensive ACP intervention in several small randomized controlled trials for older patients with cancer. The overall objective of this proposal is to conduct a pragmatic stepped wedge cluster randomized trial (SW-CRT) in three large health care systems: Duke Health, the Mayo Clinic, and Northwell Health.

During the first UG3 year, we will establish the organization, processes, and infrastructure necessary to develop all aspects of a pragmatic SW-CRT of the intervention for 4,500 patients over 65 with advanced cancer and pilot test the study protocol in one oncology clinic in each system (Aim 1). During the four years of the UH3 stage, we will conduct a SW-CRT in 36 oncology clinics in the three systems and evaluate the effectiveness of the intervention by comparing the following outcomes: 1. Advance care plans completion; 2. Medical orders for resuscitation preferences; 3. Palliative care consultations; and 4. Hospice use (Aim 2). We will use established electronic health record systems at each health system to obtain outcomes. We hypothesize that a higher proportion of patients in the intervention phase (vs. control) will: complete advance care plans (primary trial outcome), have documented electronic medical orders for resuscitation preferences, be seen in palliative care consultations, and enroll in hospice. We will also characterize detailed patient-centered outcomes in a subgroup of 450 patients, including video declarations of individual preferences (Aim 3). Clinician communication training along with video decision support is a practical, evidence-based, and innovative approach to uniformly provide robust ACP. This work has the potential to improve the quality of care provided to millions of older Americans with cancer.

NIH Project Information