Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05756725 |
| Other study ID # |
20-1456 |
| Secondary ID |
R03CA256233-013P |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 25, 2023 |
| Est. completion date |
January 4, 2024 |
Study information
| Verified date |
January 2024 |
| Source |
Harvard School of Public Health (HSPH) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
