AzTrials
AzTrials

Breast Cancer ScreeningNCT05756725

Improving Cancer Screening and Follow-up in Community Health Centers

A study testing Practice-Level Implementation Strategies in people with Breast Cancer Screening and Colorectal Cancer Screening, run by Harvard School of Public Health (HSPH) at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Practice-Level Implementation Strategies
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
3 sitesUnited States
Study dates
25 Jul 2023to 4 Jan 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • None

Trial locations and contacts

3 sites in 1 country.

United States3 sites
  • Partnership Community Health Center, Inc.

    Appleton, Wisconsin, 54913

  • Coastal Family Health Center, Inc.

    Biloxi, Mississippi, 39530

  • CareSouth Carolina, Inc.

    Hartsville, South Carolina, 29550

Other trials in United States

About this study

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.

Read the 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.

Being tested
Practice-Level Implementation Strategies
Keywords
Implementation science, Breast cancer screening, Colorectal cancer screening, Abnormal screening followup

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Practice-Level Implementation StrategiesOther

    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.

Study groups in NCT05756725
Study groupRoleWhat they receive
All Pilot SitesOtherAll community health centers participating in the study will implement the new population health management tools utilizing tailored implementation strategies
Receives: Other: Practice-Level Implementation Strategies

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of open orders for FIT screening

    Measured from electronic health record

    Measured: 4 months

  2. Number of open orders for mammography screening

    Measured from electronic health record

    Measured: 4 months

Secondary outcomes (5)
  1. Time to diagnostic resolution among those with abnormal FIT tests

    Measured from electronic health record

    Measured: 4 months

  2. Time to diagnostic resolution among those with abnormal mammograms

    Measured from electronic health record

    Measured: 4 months

  3. Feasibility of Implementation Strategies

    Assessed via Qualitative Interviews

    Measured: 4 months

  4. Acceptability of Implementation Strategies

    Assessed via Qualitative Interviews

    Measured: 4 months

  5. Appropriateness of Implementation Strategies

    Assessed via Qualitative Interviews

    Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2023
  2. Study start25 Jul 2023
  3. Primary completion4 Jan 2024
  4. Study completion4 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05756725
Sponsor's protocol ID
20-1456
Other IDs
R03CA256233-01, 3P50CA244433-01S2
Status last verified
Jan 2024
First submitted
6 Jan 2023
Last updated
26 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data that underlie the results reported here, after de-identification (text, tables, figures, and appendices). Upon request and appropriate approvals.

Questions about this trial

What is this clinical trial studying?

A study testing Practice-Level Implementation Strategies in people with Breast Cancer Screening and Colorectal Cancer Screening, run by Harvard School of Public Health (HSPH) at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of open orders for FIT screening (time frame: 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2024.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in