A Patient Reminder and Self-Referral Via Online Patient Portals and Text Messaging to Improve Adherence to Breast Cancer Screening

NCT05526872 | Completed

• 4 other identifiers: STUDY00004618NCI-2022-06810RAD5676-22P30CA138292
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial evaluates the patient reminders and self-referrals via online patient portals and text messaging (PReVenT) intervention for improving adherence to breast cancer screening. Though no doctor referral is required for mammography, adherence to screening mammograms remains low. Barriers to screening mammography can include things like forgetfulness, low motivation, high cost, or lack of knowledge. Patient reminders and self-scheduling assistance may overcome some of these barriers by increasing patients' awareness, motivating them to schedule their mammogram, and improving access by removing the need for a healthcare provider to order the exam. The PReVenT intervention uses online and text-message based patient-reminders and self-referral assistance to increase adherence to breast cancer screening.

Conditions

Breast Carcinoma

Outcome Measures

Primary Outcomes (5)

• Completion of Screening Mammogram-Adherence Rate

  Assessed with self-reported surveys and electronic medical record data extraction. Will use chi-square tests and/or two-sample Z-tests for proportions to compare adherence rates between study arms. Fisher's exact test will be considered where necessary.

  Within 6 months after enrollment

• Completion of Screening Mammogram-Regression Modeling

  Assessed with self-reported surveys and electronic medical record data extraction.Will perform a multivariable logistic regression modeling to compare screening mammogram completion rates between the intervention and control arms while controlling for prior adherence behavior and sociodemographic variables.

  Within 6 months after enrollment

• Patient Satisfaction-Qualitative

  Will use a mixed-methods approach using surveys and qualitative interviews to evaluate patient satisfaction with the intervention features, online portal and short message service usability i.e., opening the portal message, clicking the embedded link, and replying to the short message service. the patient satisfaction survey measure the following: I prefer to get care in person or over the phone instead of using online patient portals, where 1= Strongly Disagree, 2=Disagree, 3= Unsure, 4= Agree, 5= Strongly Agree, 6= Not Applicable. I rarely use online patient portals because I hardly ever need Emory Healthcare services, where 1= Strongly Disagree, 2=Disagree, 3= Unsure, 4= Agree, 5= Strongly Agree, 6= Not Applicable.It was difficult to register for Emory's online patient portal, where 1= Strongly Disagree, 2=Disagree, 3= Unsure, 4= Agree, 5= Strongly Agree, 6= Not Applicable.

  At 6 months

• Patient Satisfaction-Quantitative

  Will use a mixed-methods approach using chi-square tests and/or two-sample Z-tests for proportions to compare adherence rates between study arms. Fisher's exact test will be considered where necessary.

  At 6 months

• Assistance with Self-Referral Scheduling

  Will use a mixed-methods approach using surveys and qualitative interviews. Arm I patients will receive a single portal message reminder followed by a single text message reminder with an embedded link to receive a callback to get assistance with self-referral screening mammogram scheduling.The survey measures the following:I only became aware that I was due for screening mammography after I received Emory's online patient portal reminder, where 1= Strongly Disagree, 2=Disagree, 3= Unsure, 4= Agree, 5= Strongly Agree, 6= Not Applicable.I only became aware that I was due for screening mammography after I received Emory's text message reminder, where 1= Strongly Disagree, 2=Disagree, 3= Unsure, 4= Agree, 5= Strongly Agree, 6= Not Applicable.I was more willing to schedule a screening mammography after receiving Emory's online patient portal reminder, where1= Strongly Disagree, 2=Disagree, 3= Unsure, 4= Agree, 5= Strongly Agree, 6= Not Applicable.

  At 6 months

Study Arms (2)

Arm I (PReVenT intervention)

EXPERIMENTAL

Participants receive usual care as well as a portal message reminder to schedule a SM and a callback link if they need assistance. Participants who have not or do not schedule their SM at the time of the first reminder receive a reminder text-message one week later with a link to receive assistance with scheduling.

Other: Best Practice; Other: Interview; Other: Planned Notification; Other: Survey Administration

Arm II (enhanced usual care)

ACTIVE COMPARATOR

Participants receive usual care as well as portal and text messages one week apart with educational materials about healthy eating.

Other: Best Practice; Behavioral: Health Education; Other: Interview; Other: Survey Administration

Interventions

Best Practice OTHER

Receive usual care

Also known as: standard of care, standard therapy

Arm I (PReVenT intervention); Arm II (enhanced usual care)

Health Education BEHAVIORAL

Receive educational materials

Arm II (enhanced usual care)

Interview OTHER

Ancillary studies

Arm I (PReVenT intervention); Arm II (enhanced usual care)

Planned Notification OTHER

Receive planned reminders to schedule mammogram

Also known as: PlannedNotification

Arm I (PReVenT intervention)

Survey Administration OTHER

Ancillary studies

Arm I (PReVenT intervention); Arm II (enhanced usual care)

Eligibility Criteria

• Age: 50 Years - 74 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged 50-74 years
• Active online patient portal account
• Mobile phone number listed in the electronic medical record (EMR)
• At least one primary care visit in our healthcare system between 2015 and 2021
• No screening mammography performed in our healthcare system in the last 2 years

You may not qualify if:

• Because of limited research team and patient portal language at this time, non-English speaking patient will be excluded
• Personal history of breast cancer or prior mastectomy
• Participants who already have an upcoming SM scheduled within or outside of Emory Healthcare
• Patients who had a screening mammography at an outside facility within the prior 2 years
• Patients with severe comorbidities at the time of the study (in palliative care or hospitalized at the time of the study)
• Participants who are cognitively impaired or have with history of Alzheimer's disease or dementia

Sponsors & Collaborators

• Emory University: lead
• National Cancer Institute (NCI): collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Emory University/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Practice Guidelines as Topic; Standard of Care; Interviews as Topic

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health

Study Officials

• Patricia Balthazar, MD,CIIP

  Emory University Hospital/Winship Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be blinded to their study arm.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 31, 2022
• First Posted: September 2, 2022
• Study Start: September 5, 2022
• Primary Completion: March 31, 2024
• Study Completion: June 1, 2024
• Last Updated: June 4, 2024

Record last verified: 2024-06

Locations

US (1)