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

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Partnership Project, Inc.
Cone Health System Cancer Center
University of Pittsburgh
North Carolina Translational and Clinical Sciences Institute
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01954641
First received: September 19, 2013
Last updated: April 20, 2016
Last verified: April 2016
  Purpose

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.


Condition Intervention
Breast Cancer
Lung Cancer
Other: ACCURE Navigator
Other: Usual Care by Cancer Center Care Team

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Accountability for Cancer Care Through Undoing Racism and Equity

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Lung Cancer - Lung Resection Surgery within 4 months of diagnosis or stereotactic radiation Breast Cancer - Completion of surgery, radiation if surgery is breast conserving, and adjuvant chemotherapy (when indicated) within 6 months of diagnosis [ Time Frame: Chart review 6 to 8 months after patient enrollment and continuous Electronic Health Record (EHR) downloads into the real time registry for the 3 years of follow up. ]
    Changes in race-specific proportions of quality and completion of breast and lung cancer treatment. Will examine the influence of Quality Improvement/race-specific feedback and the real time registry compared to historical controls using an interrupted time series analysis and will compare the ACCURE Navigator component to Usual Care control groups (the randomized portion of the study).


Secondary Outcome Measures:
  • Adherence to scheduled appointments [ Time Frame: Continuous downloads of Electronic Health Record (EHR) data into the real time registry for the 3 years of follow up or death or study withdrawal - whichever comes first. ]
    Will count completed appointments over scheduled appointments and look at the influence that the ACCURE Navigator has on adherence throughout the study period


Other Outcome Measures:
  • Patient satisfaction with communication [ Time Frame: Will be assessed by survey every 6 months for 3 years post enrollment or until death or study withdrawal, whichever comes first. ]
    Will examine the influence of the navigator on patient perceptions of communication

  • Trust [ Time Frame: Will be assessed by survey every 6 months for 3 years post enrollment or until death or study withdrawal, whichever comes first. ]
    Will examine the influence of the ACCURE navigator on measures of Trust of the provider and health care system

  • Functional Status [ Time Frame: Will be assessed by survey every 3 months in year one then every 6 months in years 2 and 3 or until death or study withdrawal, whichever comes first. ]
    Will assess functional status via survey and compare the various treatment modalities over time (as well as incomplete treatment).


Estimated Enrollment: 300
Study Start Date: April 2013
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ACCURE Navigator
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.
Other: ACCURE Navigator
The ACCURE Real-Time Registry will automatically alert the ACCURE Navigator to follow a schedule of patient-interactions. The Navigator has been trained to employ the "teachback" method of patient education as appropriate per encounter. For instance: (1) initial face-to-face interaction, after the patient's first visit with the oncologist; (2) telephone call 3 business days after the initial visit; (3) contact the patient 10-21 days after the initial visit; and (4) after treatment has begun, contacting the patient every 8 weeks.It is projected that 50% of the staff will attend the Healthcare Equity Training (HET) and Booster Sessions.
Active Comparator: Usual Care by Cancer Center Care Team
A list of registry warnings about all patients enrolled in the study will be delivered securely to a designated representative at the clinic.
Other: Usual Care by Cancer Center Care Team
The Usual Care group will receive the support and care that is usually given to patients at their designated cancer center.

Detailed 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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01954641

Locations
United States, North Carolina
Cone Health, Regional Cancer Center
Greensboro, North Carolina, United States, 27401
United States, Pennsylvania
University of Pittsburgh Medical Center, Hillman Comprehensive Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Cancer Institute (NCI)
Partnership Project, Inc.
Cone Health System Cancer Center
University of Pittsburgh
North Carolina Translational and Clinical Sciences Institute
Investigators
Principal Investigator: Eugenia Eng, MPH, DrPH University of North Carolina, Chapel Hill
Principal Investigator: Samuel Cykert, MD University of North Carolina, Chapel Hill
  More Information

Additional Information:
Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01954641     History of Changes
Other Study ID Numbers: 11-1474
5R01CA150980-02 ( US NIH Grant/Contract Award Number )
Study First Received: September 19, 2013
Last Updated: April 20, 2016
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by University of North Carolina, Chapel Hill:
breast cancer
lung cancer
cancer treatments
racial inequity
health systems change
transparency
accountability

Additional relevant MeSH terms:
Isotretinoin
Dermatologic Agents

ClinicalTrials.gov processed this record on May 25, 2017