NCT05756725

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 6, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

July 25, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 4, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 4, 2024

Completed
Last Updated

January 26, 2024

Status Verified

January 1, 2024

Enrollment Period

5 months

First QC Date

January 6, 2023

Last Update Submit

January 25, 2024

Conditions

Breast Cancer ScreeningColorectal Cancer ScreeningImplementation

Keywords

Implementation scienceBreast cancer screeningColorectal cancer screeningAbnormal screening followup

Outcome Measures

Primary Outcomes (2)

  • Number of open orders for FIT screening

    Measured from electronic health record

    4 months

  • Number of open orders for mammography screening

    Measured from electronic health record

    4 months

Secondary Outcomes (5)

  • Time to diagnostic resolution among those with abnormal FIT tests

    4 months

  • Time to diagnostic resolution among those with abnormal mammograms

    4 months

  • Feasibility of Implementation Strategies

    4 months

  • Acceptability of Implementation Strategies

    4 months

  • Appropriateness of Implementation Strategies

    4 months

Study Arms (1)

All Pilot Sites

OTHER

All community health centers participating in the study will implement the new population health management tools utilizing tailored implementation strategies

Other: Practice-Level Implementation Strategies

Interventions

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.

All Pilot Sites

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Coastal Family Health Center, Inc.

Biloxi, Mississippi, 39530, United States

Location

CareSouth Carolina, Inc.

Hartsville, South Carolina, 29550, United States

Location

Partnership Community Health Center, Inc.

Appleton, Wisconsin, 54913, United States

Location

Study Officials

  • Karen M Emmons, PhD

    Harvard School of Public Health (HSPH)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Social and Behavioral Sciences

Study Record Dates

First Submitted

January 6, 2023

First Posted

March 6, 2023

Study Start

July 25, 2023

Primary Completion

January 4, 2024

Study Completion

January 4, 2024

Last Updated

January 26, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will share

Individual participant data that underlie the results reported here, after de-identification (text, tables, figures, and appendices). Upon request and appropriate approvals.

Time Frame
Transcripts with no identifiers will be stored on the Harvard Chan shared drive for 7 years. Audio files will be deleted at the end of the study period (expected to be November 2022).
Access Criteria
Outside investigators will need an approved concept proposal to analyze study data and spend the requisite time with study staff to learn about the data elements needed to conduct the proposed analysis. With the assistance from the study's analytic team, s/he will draft a detailed analysis plan and present to the core group of co-investigators. The discussion at this meeting ensures adequate knowledge of the data, and the presenter gains much insight into how the analysis can be most useful and how it relates to previous analyses. Once the plan is approved by this group, it must also be approved by the CHCs that provide the de-identified data. Following approval by the appropriate IRBs and confirmation that it meets HIPAA requirements, s/he may sign a DUA to use a secure, de-identified dataset to complete only the approved analyses and write the manuscript(s) offsite. A formal data analysis plan application and DUA are available. Requests should be directed to jdaly@hsph.harvard.edu.

Locations

US(3)