Low-touch, team-based care for co-morbidity management in cancer patients: the ONE TEAM randomized controlled trial

Leah L Zullig,Susan Dent,Michaela A Dinan,Terry Hyslop,Kacey Clayton-Stiglbauer,Brittany M Griffin,Benjamin Neely,Lynda Owen,Theresa Coles,Renee A V Avecilla,S Yousuf Zafar,Kevin C Oeffinger,Linda Sutton,Rebecca A Shelby,Nishant P Shah,Mohammad Shahsahebi,Kevin Shah,Bryce B Reeve

doi:10.1186/s12875-021-01569-8

Abstract

BackgroundAs treatments for cancer have improved, more people are surviving cancer. However, compared to people without a history of cancer, cancer survivors are more likely to die of cardiovascular disease (CVD). Increased risk for CVD-related mortality among cancer survivors is partially due to lack of medication adherence and problems that exist in care coordination between cancer specialists, primary care physicians, and cardiologists.Methods/DesignThe Onco-primary care networking to support TEAM-based care (ONE TEAM) study is an 18-month cluster-randomized controlled trial with clustering at the primary care clinic level. ONE TEAM compares the provision of the iGuide intervention to patients and primary care providers versus an education-only control. For phase 1, at the patient level, the intervention includes video vignettes and a live webinar; provider-level interventions include electronic health records-based communication and case-based webinars. Participants will be enrolled from across North Carolina one of their first visits with a cancer specialist (e.g., surgeon, radiation or medical oncologist). We use a sequential multiple assignment randomized trial (SMART) design.Outcomes (measured at the patient level) will include Healthcare Effectiveness Data and Information Set (HEDIS) quality measures of management of three CVD comorbidities using laboratory testing (glycated hemoglobin [A1c], lipid profile) and blood pressure measurements; (2) medication adherence assessed pharmacy refill data using Proportion of Days Covered (PDC); and (3) patient-provider communication (Patient-Centered Communication in Cancer Care, PCC-Ca-36).Primary care clinics in the intervention arm will be considered non-responders if 90% or more of their participating patients do not meet the modified HEDIS quality metrics at the 6-month measurement, assessed once the first enrollee from each practice reaches the 12-month mark. Non-responders will be re-randomized to either continue to receive the iGuide 1 intervention, or to receive the iGuide 2 intervention, which includes tailored videos for participants and specialist consults with primary care providers.DiscussionAs the population of cancer survivors grows, ONE TEAM will contribute to closing the CVD outcomes gap among cancer survivors by optimizing and integrating cancer care and primary care teams. ONE TEAM is designed so that it will be possible for others to emulate and implement at scale.Trial registrationThis study (NCT04258813) was registered in clinicaltrals.gov on February 6, 2020.

Highlights

As treatments for cancer have improved, more people are surviving cancer
Primary care clinics in the intervention arm will be considered non-responders if 90% or more of their participat‐ ing patients do not meet the modified Healthcare Effectiveness Data and Information Set (HEDIS) quality metrics at the 6-month measurement, assessed once the first enrollee from each practice reaches the 12-month mark
As the population of cancer survivors grows, ONE Onco-primary care networking to support TEAM-based care (TEAM) will contribute to closing the cardiovascular disease (CVD) outcomes gap among cancer survivors by optimizing and integrating cancer care and primary care teams

Summary

Introduction

Compared to people without a history of cancer, cancer survivors are more likely to die of cardiovascular disease (CVD). Increased risk for CVD-related mortality among cancer survivors is partially due to lack of medication adherence and problems that exist in care coordination between cancer specialists, primary care physicians, and cardiologists. 70% of cancer survivors have cardiovascular disease (CVD) risk factors (e.g., comorbidities such as hypertension and diabetes) that require comprehensive care [2, 3]. Effective management of CVD risk is essential for reducing mortality among a growing population of cancer survivors. Due to the intensity of tests and treatments during diagnosis and survivorship, existing models of care generally do not integrate primary care or cardiology in patients with established CVD throughout patients’ cancer treatment continuum. There is often disengagement by primary care providers during the active phase of cancer therapy, and they may or may not be reengaged after therapy is complete

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