Intervention IP-073: A System-Based Intervention to Reduce Black-White Disparities in the Treatment of Early Stage Lung Cancer

Summary

This system-based intervention is a five-year pragmatic trial performed at five cancer centers where Black and White patients were randomized into intervention or control groups to reduce lung cancer treatment disparities. The intervention uses real-time digital warnings, accountability through race-specific quality improvement, and enhanced communication through navigators trained on race-related barriers to treatment. Findings show Black‐White treatment gap reduced and there was improved care for patients of both races.

Overview

Intervention Details

Intervention was Primarily Driven, Led, or Managed by:

Both Community and Academic/Clinical Researchers

Citations:

  • Cykert S, Eng E, Walker P, Manning MA, Robertson LB, Arya R, Jones NS, Heron DE. A system-based intervention to reduce Black-White disparities in the treatment of early stage lung cancer: A pragmatic trial at five cancer centers. Cancer medicine. 2019 Mar;8(3):1095-1102. Epub 2019 Feb 4. PubMedExternal Web Site Policy PubMed CentralExternal Web Site Policy DOIExternal Web Site Policy
Adaptation of Another Research-based Intervention:

Yes

Name of Original Intervention:

A tracking and feedback registry to reduce racial disparities in breast cancer care.

Name of Original Intervention Author:

Nina Bickell, Icahn Mount Sinai School of Medicine, nina.bickell@mssm.edu

URL to original Intervention:

N/A

Citations:

  • Bickell NA, Shastri K, Fei K, Oluwole S, Godfrey H, Hiotis K, Srinivasan A, Guth AA. A tracking and feedback registry to reduce racial disparities in breast cancer care. Journal of the National Cancer Institute. 2008 Dec 3;100(23):1717-23. Epub 2008 Nov 25. PubMedExternal Web Site Policy PubMed CentralExternal Web Site Policy DOIExternal Web Site Policy
Intervention Primary Outcomes were comparable to the original:

Yes

Contact Information

Primary Contact Name:

Samuel Cykert

Primary Contact Affiliation:

UNC School of Medicine

Intervention URL:

https://onlinelibrary.wiley.com/doi/10.1002/cam4.2005

Primary Contact Email:

samuel_cykert@med.unc.edu

Primary Contact Phone Number:

919-448-6748

Results

Evaluations and Assessments

Were Any of the Following Assessments Conducted (Economic Evaluation, Needs Assessment, Process Evaluation)?:

No

Demographic and Implementation Description

Socio-demographics / Population Characteristics

Community Type:

Unspecified

Other Populations with Health Disparities:

Unspecified

Gender Identity:

Female, Male

Sexual Orientation:

Unspecified

Geographic Location:

North Carolina, Pennsylvania, South Carolina

Socio-Economic Status:

Low SES, Middle SES, High SES

Minority Health and Health Disparities Research Framework

Levels of Influence
Individual Interpersonal Community Societal
Determinant Types Biological
Behavioral
Physical / Built Environment
Sociocultural Environment
Health Care System

Community Involvement

The community's role in different areas of the Intervention (Choices are "No Role", "Participation", and "Leadership"):

Design:

Participation

Dissemination:

Participation

Evaluation:

Participation

Implementation:

Participation

Outreach:

Participation

Planning :

Participation

Recruitment:

Participation

Sustainability:

Participation

Characteristics and Implementation

Conceptual Framework

Intervention Theory:

Theories of Organization Change (e.g. Dimensions of Organizational Change, Stage Theory, Interorganization Relations Theory, Community Coalition Action Theory), The People’s Institute for Survival and Beyond (PISAB) Undoing Racism™ framework was used as a conceptual model for medical care. The model uses transparency in measuring system effects and accountability to implement system change as key concepts.

Intervention Framework:

None

Implementation

Intervention Study Design:

Quasi-Experimental (does not require random assignment, but requires a comparison/control group with pre and post intervention outcome assessments)

Targeted Intervention Sample Size:

360

Actual Intervention Sample Size:

3798

Start Year:

2013

End Year:

2017

Intervention Exposures

Duration of Intervention/How Long it Lasted:

10-12 months

Frequency of Intervention Delivery:

The 3798 sample was intervention (360) plus control (3438). Real-time registry system was continuous to generate alerts for missed appointments and milestones; Race-specific QI sessions for care completion/quarterly; Navigation communication/monthly.

Number of Sessions/Meetings/Visits/Interactions:

More than 10 Sessions

Average Length of Each Session/Meeting/Visit/Interaction:

Less than 1 Hour

Format of Delivery:

Group (e.g. Community leaders), Individual

Highest Reading Level of Intervention Materials Provided to Participants:

Grade 4-5

Adaptations and Modifications

Modification Details

Explanation
Content

Adding Elements, Tailoring, None

In the Bickell study (published 2008), the breast cancer patient registry was filled out manually - research personnel had to review medical records and call various specialty offers to fill out the dates and types of treatments for each patient then had to verbally communicate, mostly by phone, to the practice to suggest that a treatment was omitted or incomplete. Given that our study occurred after Congress passed the HITECH act and essentially all cancer centers had adopted electronic health records (EHRs), we could actually upload data from the various EHRs and program algorithms to generate automated warnings for appointments missed and milestones that were not reached. These warnings could then be downloaded by the navigators on a daily basis then the clinical team was informed about inertia or the patient was contacted for missed appointments to ascertain barriers and ensure that these barriers were addressed, and the next appointment could be kept.

Context

Population

Early stage ("curable") non-small cell lung cancer patients were the target population rather than breast cancer patients.

Implementation

Delivery, Duration, Study Design

The real time registry was not the lone intervention. We added navigation and quarterly, QI audit and feedback on treatment completion according to race. These components met our community partners' requirements for enhanced communication and accountability, respectively. Also, our navigators pro-actively contacted patients at least once a month over the course of one year.

Organization

Availability of Staffing / Technology / Space

See explanation of modifications to content. In addition, all participating clinical settings had password protected access to our real time registry system.

Providers

None

Clinical specialties of participants were different given the change in cancer type.

Stages of Occurrence

Implementation, Planning/Pre-implementation/Pilot, Sustainability

We knew from the beginning that given the relatively large population of lung cancer patients at participating systems, that a system reliant on manual entry would not be broadly usable or sustainable. Therefore, our plan from the beginning was to use automation. Implementation was modified based on clinic workflows and community advice on how to communicate to patients who were initially equivocal about the study. Because the major functions of the registry and the data obtained for the accountability - audit and feedback - part of the study were largely automated, we knew that re: long term diffusion and implementation of the work that the intervention would be sustainable.

Impact, Lessons, Components

Intervention Impact:

Not only did completion of lung cancer care improve for Black patients and care become more equitable relative to White patients, but completion of cancer care for White patients also markedly improved by using a system-based approach to real time transparency, accountability, and enhanced communication.

Lessons Learned

Key Lessons Learned and/or Things That Could be Changed or Done Differently:

To remedy institutional-level bias: Work with affected communities through a system-level lens to help determine appropriate measures and interventions, measure serial outcomes according to race (or other disadvantages) and apply interventions in real time using automation of available EHR data.

Insights Gained During Implementation

Insight Category Insight Description
Cost of Implementing or Sustaining Programming needed to build the real time, warning system for 5 cancer centers for stages I and II, non-small cell lung cancer including salary and benefits (9 months, one full-time programmer) was approximately $110,000 then $11,000 were yearly maintenance. Navigator training cost about $500 each.
Logistics Navigators met patients face to face at initial visits then second face to face visits were used to build rapport. Monthly check-ins were pro-active to maintain this rapport. Quarterly feedback meetings for clinicians were better attended if we used scheduled standing meetings instead of new ones.
Administrative Resources Racial equity efforts could be led by either an established navigation program or cancer quality improvement program. Disparities/Equity expertise should be included in the administrative structure of these programs.
Equipment / Technologies Because of multiple EHRs at study institutions, we programmed an umbrella system for the real time warning system at the UNC Sheps Center that was password protected and accessed at the individual sites. However, this programming can be done within an EHR. One participant has done this in Epic.
Training / Technical Assistance Navigators were trained using the Racial Equity Institute's Phase I Training then the concepts were applied by doing role plays with input from community advisors. Note that navigators were both Black and White and given the training, there was no difference in success rates.
Staffing Navigators were able to support 30 to 70 patients in active treatment using a proactive approach. Maintenance and periodic quality checking of the real time warning system required a 0.1 FTE of a programmer.
Recruitment The initial, patient recruitment scripts were edited and tailored by community partners. In early recruitment, we experienced some "soft" refusals. When this issue was presented to our community partners, their advice about removing time pressure from the decision with thoughtful follow-up worked.

Intervention Components

Intervention Has Multiple Components:

Yes

Assessed Each Unique Contribution:

No

Products, Materials, and Funding

Product/Material/Tools

Tailored For Language Language(s) if other than English Material
Outreach/Recruitment Tools

Informed Consent Form

No

Attachment available for request at the bottom of the page.

Participant Educational Tools

Brochures/Factsheets/Pamphlets

No

Attachment available for request at the bottom of the page.

Brochures/Factsheets/Pamphlets

No

Attachment available for request at the bottom of the page.

Brochures/Factsheets/Pamphlets

No

Attachment available for request at the bottom of the page.

Brochures/Factsheets/Pamphlets

No

Attachment available for request at the bottom of the page.

Measurement Tools

Non-Standardized Instruments/Surveys/Questionnaires

No

Attachment available for request at the bottom of the page.

Non-Standardized Instruments/Surveys/Questionnaires

No

Attachment available for request at the bottom of the page.

Implementation Materials and Products

Material
Implementation/Delivery Materials

These are case examples used for role play training of navigators.

Attachment available for request at the bottom of the page.

Intervention implementation guidelines

Attachment available for request at the bottom of the page.

Intervention implementation guidelines

Attachment available for request at the bottom of the page.

Implementation/Output Materials
No Implementation/Output Materials provided.

Articles Related to Submitted Intervention

Article
Reports/Monographs
No Reports/Monographs provided.
Additional Articles

Evaluation

https://ascopubs.org/doi/abs/10.1200/jco.21.01745 

Qualitative findings

https://doi.org/10.1177/15248399221136534 

Materials Available for Request

  • Patient_Consent_Form_FINAL3.docx
  • Lung cancer decision aid pneumonectomy bad health.docx
  • Lung cancer decision aid pneumonectomy good health_10-3-11clean.docx
  • Lung cancer decision aid stage 1_10-3-11clean.docx
  • Lung cancer decision aid stage 2_10-3-11clean.docx
  • Patient questionnaire_December 2011.doc
  • Pt satisfaction Q for 6mos and 12 mos.docx
  • Nav Role PLay.docx
  • Communication Flow Straw Man 5-29-12.docx
  • Navigation Engagement Protocol.docx