Improving Cancer Screening and Follow-up in Community Health Centers

This is an implementation science study that examines implementation of a single intervention and the development of practice-level implementation strategies to facilitate implementation of the intervention.

Study Overview

• Status: Completed
• Conditions: Breast Cancer Screening; Implementation; Colorectal Cancer Screening
• Intervention / Treatment: Other: Practice-Level Implementation Strategies

Detailed Description

The research team has a strong partnership with Azara Healthcare, which provides a population management platform to 325 community health centers (CHCs) in 30 US states. This platform, the Data Reporting and Visualization System (DRVS), allows for population- and patient-level tracking and data visualization. Individual CHCs can customize DRVS by using different functionalities that track specific conditions or care gaps. The aim of this study is to pilot test an implementation intervention to integrate new DRVS tools into practice and assess its impact on timely screening and follow-up in health centers based on availability of patient navigators. This is a small, pre-post design pilot test in which the research team will implement screening tools and practice facilitation over a 4-month period and examine rates of screening referrals, screening completion, and diagnostic resolution. The research team will select up to 4 CHCs to participate (two with patient navigation for cancer screening care and two without patient navigation). The CHCs will be selected from among those who use the DRVS system and express interest in the study. As agreed on by sites, the decision to participate in the intervention will be made at the site-level through collaboration with facility leadership and state primary care associations. The intervention is a practice-level clinical strategy that consists of routine care. Participants will be CHC staff whose duties include helping patients to complete cancer screening and follow-up of abnormal tests as well as CHC patients who experience a clinical encounter as a result of use of the tools. As part of the usual DRVS tool roll-out, Azara will provide staff with 1.5 hours of training on use of the new DRVS tools. The research team anticipates using facilitation as an implementation strategy to troubleshoot intervention workflows and to troubleshoot intervention workflows and monitor implementation. However, the team will be evaluating CHC barriers to implementation and may use alternative implementation strategies if warranted. The CHC staff member who interacts with the DRVS in relation to cancer screening will then, as part of the study, participate in 6 hours of facilitation over 4 months to troubleshoot intervention workflows and monitor implementation. The CHC staff who participate in the implementation will be asked to participate in one follow-up, virtual interview. The research team will use coded data to examine the impact of the tools on patient screening outcomes. The team will not have access to the codes that would allow identification (as will be specified in the data use agreement [DUA] with Azara).

The human-subjects research aspect of this project consists of an evaluation of the implementation intervention with up to 3 staff and 2 patients per CHC via one-hour interviews. The CHC staff whose duties include use of the DRVS tools for cancer screening will participate in a semi-structured interview (up to 60 minutes) to assess their experience with the intervention and ideas for further improvements. Patients who interact with the clinic because of the CHCs use of the tools will also participate in a semi-structured interview (up to 60 minutes) to assess their experiences. The CHCs that agree to participate in the study will be informed at the time of their agreement that staff that use the screening tools and patients who have a clinical encounter because of use of the screening tools will be asked to participate in interviews to assess their experience with the tools. Following completion of the pilot intervention test period, the research team will send the designated staff or patient an email invitation to participate in the interview. The email will include a description of the study purpose. Interview questions for staff will cover the use of tools by asking participants to describe how the tools are integrated into their daily practice, as well as perceived barriers and facilitators to using the tools and strategies to overcome barriers. Interview questions for patient participants will cover their experiences with the follow-up and support provided by the CHC staff related to closing their screening gaps. Interviews will be conducted via zoom or the participant's preferred platform. A research assistant will sit in on the interviews to take notes. Interviews will be audio-recorded, and recordings will be saved on a secure HSPH drive. Participants' involvement is complete after the interview.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Mississippi
    • Biloxi, Mississippi, United States, 39530
      • Coastal Family Health Center, Inc.
  • South Carolina
    • Hartsville, South Carolina, United States, 29550
      • CareSouth Carolina, Inc.
  • Wisconsin
    • Appleton, Wisconsin, United States, 54913
      • Partnership Community Health Center, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• To participate, individuals must be over the age of 18 and employed at a participating Community Health Center.

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: All Pilot Sites; All community health centers participating in the study will implement the new population health management tools utilizing tailored implementation strategies

Other: Practice-Level Implementation Strategies; The intervention is implementation of new population health management tools that may better leverage patient navigation and other staff resources to ensure timely abnormal follow up of breast and colorectal cancer screening. The research team will work with CHCs to select implementation strategies that will best facilitate integration of the new tools into practice. The team will use electronic health record data (analyzed at the population level) to determine the impact of the new tools on screening outcomes and qualitative data from up to 3 staff and 2 patients per CHC to evaluate integration of the tools into practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of open orders for FIT screening	Measured from electronic health record	4 months
Number of open orders for mammography screening	Measured from electronic health record	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to diagnostic resolution among those with abnormal FIT tests	Measured from electronic health record	4 months
Time to diagnostic resolution among those with abnormal mammograms	Measured from electronic health record	4 months
Feasibility of Implementation Strategies	Assessed via Qualitative Interviews	4 months
Acceptability of Implementation Strategies	Assessed via Qualitative Interviews	4 months
Appropriateness of Implementation Strategies	Assessed via Qualitative Interviews	4 months

Collaborators and Investigators

• Sponsor: Harvard School of Public Health (HSPH)
• Collaborators: National Cancer Institute (NCI); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Karen M Emmons, PhD, Harvard School of Public Health (HSPH)

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2023
• Primary Completion (Actual): January 4, 2024
• Study Completion (Actual): January 4, 2024

Study Registration Dates

• First Submitted: January 6, 2023
• First Submitted That Met QC Criteria: February 19, 2023
• First Posted (Actual): March 6, 2023

Study Record Updates

• Last Update Posted (Estimated): January 26, 2024
• Last Update Submitted That Met QC Criteria: January 25, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Colorectal cancer screening; Implementation science; Breast cancer screening; Abnormal screening followup
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 20-1456; R03CA256233-01 (U.S. NIH Grant/Contract); 3P50CA244433-01S2 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported here, after de-identification (text, tables, figures, and appendices). Upon request and appropriate approvals.
• IPD Sharing Time Frame: Transcripts with no identifiers will be stored on the Harvard Chan shared drive for 7 years. Audio files will be deleted at the end of the study period (expected to be November 2022).
• IPD Sharing Access Criteria: Outside investigators will need an approved concept proposal to analyze study data and spend the requisite time with study staff to learn about the data elements needed to conduct the proposed analysis. With the assistance from the study's analytic team, s/he will draft a detailed analysis plan and present to the core group of co-investigators. The discussion at this meeting ensures adequate knowledge of the data, and the presenter gains much insight into how the analysis can be most useful and how it relates to previous analyses. Once the plan is approved by this group, it must also be approved by the CHCs that provide the de-identified data. Following approval by the appropriate IRBs and confirmation that it meets HIPAA requirements, s/he may sign a DUA to use a secure, de-identified dataset to complete only the approved analyses and write the manuscript(s) offsite. A formal data analysis plan application and DUA are available. Requests should be directed to jdaly@hsph.harvard.edu.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No