Technology-Based Cancer Screening Intervention

NCT ID: NCT04535492

Last Updated: 2023-05-11

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-04
• Study Completion Date: 2022-06-30

Brief Summary

The primary purpose of this research study is to contribute to generalized knowledge on how to increase screening for patients at risk of missing their recommended cancer preventive care by using a newly developed predictive model and analytic tool to improve shared decision-making for these patients. The goal of the clinical trial is to evaluate (prove) the effectiveness of this shared-decision making support tool developed in EPIC on the rate of recommended cancer screening in practice. It contributes to knowledge on what specific methods can increase patient adherence to recommended preventive care and reduce disparities.

Detailed Description

Patients seen at primary care practices, who have been pre-determined to have unmet screening requirements and have received standard of care with a QI tool, will be asked to complete an optional questionnaire electronically through a patient portal or via a link sent by text within a week of their visit, based on their preference. Only those who have indicated they agree to be contacted for research purposes will be contacted. Surveys will be distributed through REDCap so no identifying information will be contained in the answers. REDCap is a free, HIPAA compliant interface for building and managing online databases. Additionally, surveys will be sent via mail if the patient cannot be reached electronically. Survey responses received through the mail will not include any identifying information. Pre-paid return envelopes will be provided to preserve anonymity. Although a small proportion of South Carolina's population are primary Spanish speakers (about 4%), to be inclusive we want to ensure all materials are available in Spanish. To remove barriers to participation, those needing physical, hearing, and visual assistance will be able to review and complete documents at the time of their clinic visit with the assistance of trained study personnel. Invitations will continue to be sent out until 100 total patient responses are received per practice in the pragmatic trial, or 50 per practice in the pilot. Clinicians will also receive a survey to assess the tool. Recruitment for clinicians surveys will be done via email sent by the practice managers to the providers who have agreed to use the QI tool. Clinician assessments will be delivered electronically via a link delivery by email or text, or sent by mail, based on clinician preference. Respondents will be reimbursed for their time and effort. These assessments will be anonymous. Survey participation will be coded in order to provide compensation. Since data will be identified only by code numbers (participant IDs) the master list of those codes will be kept physically separate from the collected data.

Conditions

Colorectal Cancer; Lung Cancer; Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Colorectal Cancer Screening Recommended

The USPSTF recommends screening for colorectal cancer starting at age 50 years and continuing until age 75 years.

Group Type: OTHER

Decision Making Support Tool

Intervention Type: BEHAVIORAL

Primary care practices randomized in a stepped wedge cluster design will implement a newly developed predictive model and analytic tool to improve shared decision-making for patients.

Lung Cancer Screening Recommended

The USPSTF recommends annual screening for lung cancer with low-dose computed tomography (LDCT) in adults ages 50 to 80 years who have a 20 pack-year smoking history and currently smoke or have quit within the past 15 years.

Group Type: OTHER

Decision Making Support Tool

Intervention Type: BEHAVIORAL

Primary care practices randomized in a stepped wedge cluster design will implement a newly developed predictive model and analytic tool to improve shared decision-making for patients.

Breast Cancer Screening Recommended

The USPSTF recommends biennial screening mammography for women aged 50 to 74 years.

Group Type: OTHER

Decision Making Support Tool

Intervention Type: BEHAVIORAL

Primary care practices randomized in a stepped wedge cluster design will implement a newly developed predictive model and analytic tool to improve shared decision-making for patients.

Interventions

Decision Making Support Tool

Primary care practices randomized in a stepped wedge cluster design will implement a newly developed predictive model and analytic tool to improve shared decision-making for patients.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

Colorectal Cancer Screening:

Lung Cancer Screening:

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Vanessa Diaz

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vanessa Diaz, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

Other Identifiers

1R61AG068951

Identifier Type: NIH

Identifier Source: secondary_id

View Link

00101494

Identifier Type: -

Identifier Source: org_study_id