Accountability for Cancer Care Through Undoing Racism and Equity (ACCURE)

University of North Carolina (UNC)

Status: Completed

Conditions: Breast Cancer; Lung Cancer

Treatments: Other: Usual Care by Cancer Center Care Team; Other: ACCURE Navigator

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01954641

5R01CA150980-02 (U.S. NIH Grant/Contract)

11-1474

Details and patient eligibility

About

Purpose: African American cancer patients, as compared to their White counterparts, continue to initiate treatment later and remain less apt to undergo complete treatment; fueling worse treatment outcomes including shorter survival. The concepts of "transparency" and "accountability," as mechanisms of systems change have been applied for decades by anti-racism organizations to civil rights and social change. Yet, the application of these concepts to health systems' change and unequal treatment has rarely been done. The Greensboro Health Disparities Collaborative and two Cancer Centers have joined together to specify structures built into cancer care systems that make cancer care vulnerable to institutional racism and investigate how they can be changed to reduce racial inequity in quality and completion of treatment for Stage 1-2 breast and lung cancer patients.

Participants: White and African American patients with first diagnosis of Stage 1-2 breast and lung cancer, with intention to treat, and their cancer care staff at 2 cancer centers. The 2 cancer centers are Cone Health Cancer Center (CHCC) in Greensboro, North Carolina and the University of Pittsburgh Medical Center (UPMC) Hillman Comprehensive Cancer Center in Pittsburgh, Pennsylvania.

Procedures (methods): Using a 5-year interrupted time-series, with an embedded randomized control trial (RCT) study design, we will test the effectiveness of the ACCURE intervention components. Having received Institutional Review Board approval for Phase 1, we completed a 5-year, retrospective review of de-identified Electronic Medical Record data to establish a baseline of repeated outcome measures, convening of an expert committee to design the intervention, and design of the real-time, electronic breast and lung cancer registry coupled with dummy testing of the registry system.

The randomized trial will compare patients who receive usual care to those who receive visits and calls from a trained ACCURE Navigator, who is well versed in issues specific to breast and lung cancer and trained to serve as a two-way communication bridge to optimize the cancer care system's accountability and transparency for equity in quality of care. Given unintended, but likely variation in implementation of the ACCURE intervention by the two Cancer Centers (at our two research sites), 6 elements of implementation and their potential effect on outcomes will be documented through a process evaluation.

Full description

The ACCURE Interventions include:

1. Quality Improvement / Race specific feedback for providers regarding breast and lung surgery and adjuvant treatments.
2. A real time registry with automated electronic health record feeds that provides warning signs if milestones in cancer care have not been met or if patients miss scheduled appointments
3. Health Equity Training for cancer center staff at quarterly intervals
4. Accure Navigation (based on special training regarding trust, culturally appropriate communication, and Kleinman's Patient Model of Illness)
5. Additional efforts will be made to collect information on symptoms and side effect management from patients and medical charts.

Enrollment: 300 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• White or African American patients aged 18 or older
• Recently received a first diagnosis of stage 1 or 2 breast or lung cancer
• Patient plans to initiate oncology treatment with curative intent

Exclusion criteria

• Have cognitive impairments or limited English proficiency that would preclude their ability to comprehend survey questions

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 2 patient groups

ACCURE Navigator

Experimental group

Description:

For those patients assigned to the ACCURE Navigator, the ACCURE Real-Time Registry is programmed to automatically alert the Navigator when a patient misses a scheduled treatment appointment and to require the Navigator to include details as to how she addressed and resolved that missed appointment, ensuring the ACCURE Navigator's proactive approach to addressing such issues. In addition, a warning message will be produced if no follow-up appointments or procedures are scheduled within 21 days of the index visit.

Treatment:

Other: ACCURE Navigator

Usual Care by Cancer Center Care Team

Active Comparator group

Description:

A list of registry warnings about all patients enrolled in the study will be delivered securely to a designated representative at the clinic.

Treatment:

Other: Usual Care by Cancer Center Care Team