Clinical trial NCT05756725: Improving Cancer Screening and Follow-up in Community Health Centers
Official title: Improving Cancer Screening and Follow-up in Community Health Centers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Screening
Colorectal Cancer Screening
Implementation
Keywords: Implementation science
Breast cancer screening
Colorectal cancer screening
Abnormal screening followup
Lead sponsor: Harvard School of Public Health (HSPH)
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
First posted: 2023-03-06
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None

Primary outcomes:
measure: Number of open orders for FIT screening
timeFrame: 4 months
measure: Number of open orders for mammography screening
timeFrame: 4 months
Secondary outcomes:
measure: Time to diagnostic resolution among those with abnormal FIT tests
timeFrame: 4 months
measure: Time to diagnostic resolution among those with abnormal mammograms
timeFrame: 4 months
measure: Feasibility of Implementation Strategies
timeFrame: 4 months
measure: Acceptability of Implementation Strategies
timeFrame: 4 months
measure: Appropriateness of Implementation Strategies
timeFrame: 4 months
Other outcomes:
Locations:
city: Biloxi
country: United States
facility: Coastal Family Health Center, Inc.
state: Mississippi
city: Hartsville
country: United States
facility: CareSouth Carolina, Inc.
state: South Carolina
city: Appleton
country: United States
facility: Partnership Community Health Center, Inc.
state: Wisconsin
Study officials:
affiliation: Harvard School of Public Health (HSPH)
name: Karen M Emmons, PhD
role: PRINCIPAL_INVESTIGATOR
References: