A Patient Reminder and Self-Referral Via Online Patient Portals and Text Messaging to Improve Adherence to Breast Cancer Screening (PReVenT)
Patient Reminders and Self-Referrals Via Online Patient Portals and Text Messaging (PReVenT) to Improve Adherence to Breast Cancer Screening
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Georgia
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Atlanta, Georgia, United States, 30322
- Emory University/Winship Cancer Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Arm I (PReVenT intervention)
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.
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Receive usual care
Other Names:
Ancillary studies
Ancillary studies
Receive planned reminders to schedule mammogram
Other Names:
|
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Active Comparator: Arm II (enhanced usual care)
Participants receive usual care as well as portal and text messages one week apart with educational materials about healthy eating.
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Receive usual care
Other Names:
Ancillary studies
Ancillary studies
Receive educational materials
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Completion of Screening Mammogram-Adherence Rate
Time Frame: 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.
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Within 6 months after enrollment
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Completion of Screening Mammogram-Regression Modeling
Time Frame: Within 6 months after enrollment
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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.
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Within 6 months after enrollment
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Patient Satisfaction-Qualitative
Time Frame: At 6 months
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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
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Patient Satisfaction-Quantitative
Time Frame: At 6 months
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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.
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At 6 months
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Assistance with Self-Referral Scheduling
Time Frame: At 6 months
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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.
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At 6 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Patricia Balthazar, MD,CIIP, Emory University Hospital/Winship Cancer Institute
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00004618 (Other Identifier: Emory University Hospital/Winship Cancer Institute)
- P30CA138292 (U.S. NIH Grant/Contract)
- NCI-2022-06810 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- RAD5676-22 (Other Identifier: Emory University Hospital/Winship Cancer Institute)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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