Breast Carcinoma
Conditions
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.
Detailed description
PRIMARY OBJECTIVES; I. Compare the screening mammogram (SM) completion rates between PReVenT and enhanced usual care (EUC) arms at 6 months. II. Describe patient's experience with the PReVenT intervention using mixed methods stratified by completion of SM. OUTLINE: Participants are randomized to 1 of 2 arms. ARM I: 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. ARM II: Participants receive usual care as well as portal and text messages one week apart with educational materials about healthy eating. After completion of study, patients are followed up at 6 months.
Interventions
OTHERBest Practice
Receive usual care
BEHAVIORALHealth Education
Receive educational materials
OTHERInterview
Ancillary studies
OTHERPlanned Notification
Receive planned reminders to schedule mammogram
OTHERSurvey Administration
Ancillary studies
Sponsors
National Cancer Institute (NCI)
National Institutes of Health (NIH)
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Subject)
Masking description
Participants will be blinded to their study arm.
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 74 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Completion of Screening Mammogram-Adherence Rate | Within 6 months after enrollment | 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. |
| Completion of Screening Mammogram-Regression Modeling | Within 6 months after enrollment | 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. |
| Patient Satisfaction-Qualitative | At 6 months | 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. |
| Patient Satisfaction-Quantitative | At 6 months | 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. |
| Assistance with Self-Referral Scheduling | At 6 months | 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. |
Countries
United States
Outcome results
None listed