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.
Inclusion Criteria
- To participate, individuals must be over the age of 18 and employed at a participating Community Health Center.
Exclusion Criteria
- None
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05756725.
Locations matching your search criteria
United States
Mississippi
Biloxi
South Carolina
Hartsville
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.
Trial PhaseNo phase specified
Trial Typescreening
Lead OrganizationHarvard School of Public Health (HSPH)
Principal InvestigatorKaren M. Emmons
- Primary ID20-1456
- Secondary IDsNCI-2023-07378, 3P50CA244433-01S2, R03CA256233-01
- ClinicalTrials.gov IDNCT05756725