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.
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
- Conditions the study is for
- Breast Cancer Screening, Colorectal Cancer Screening, Implementation
- 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
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 group | Role | What they receive |
|---|---|---|
| All Pilot Sites | Other | All 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.
Number of open orders for FIT screening
Measured from electronic health record
Measured: 4 months
Number of open orders for mammography screening
Measured from electronic health record
Measured: 4 months
Secondary outcomes (5)
Time to diagnostic resolution among those with abnormal FIT tests
Measured from electronic health record
Measured: 4 months
Time to diagnostic resolution among those with abnormal mammograms
Measured from electronic health record
Measured: 4 months
Feasibility of Implementation Strategies
Assessed via Qualitative Interviews
Measured: 4 months
Acceptability of Implementation Strategies
Assessed via Qualitative Interviews
Measured: 4 months
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.
- First posted6 Mar 2023
- Study start25 Jul 2023
- Primary completion4 Jan 2024
- Study completion4 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer ScreeningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Karen Emmons, Harvard School of Public Health (HSPH)
- Investigators
- Karen M Emmons, PhD, Principal investigator, Harvard School of Public Health (HSPH)
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.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Cancer Screening and Follow-up in Community Health Centers
- ClinicalTrials.gov ID
- NCT05756725
- Acronym / sponsor ID
- 20-1456
- Keywords
- Implementation science, Breast cancer screening, Colorectal cancer screening, Abnormal screening followup
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- 25 Jul 2023 (actual)
- Primary completion
- 4 Jan 2024 (actual)
- Study completion
- 4 Jan 2024 (actual)
- First posted
- 6 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Pilot Sites | Other | Other: Practice-Level Implementation StrategiesAll community health centers participating in the study will implement the new population health management tools utilizing tailored implementation strategies |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- To participate, individuals must be over the age of 18 and employed at a participating Community Health Center.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Practice-Level Implementation StrategiesThe 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. | Other | All Pilot Sites |
Primary outcome
Number of open orders for FIT screening
Time frame: 4 months
Measured from electronic health record
Number of open orders for mammography screening
Time frame: 4 months
Measured from electronic health record
5 secondary outcomes
Time to diagnostic resolution among those with abnormal FIT tests
Time frame: 4 months
Time to diagnostic resolution among those with abnormal mammograms
Time frame: 4 months
Feasibility of Implementation Strategies
Time frame: 4 months
Acceptability of Implementation Strategies
Time frame: 4 months
Appropriateness of Implementation Strategies
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2024.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported here, after de-identification (text, tables, figures, and appendices). Upon request and appropriate approvals.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen M Emmons, PhD principal investigator
Harvard School of Public Health (HSPH)
3 sites in 1 country: see every site and its status.
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.