Back to resultsA Patient Reminder and Self-Referral Via Online Patient Portals and Text Messaging to Improve Adherence to Breast Cancer Screening (PReVenT)
Primary Purpose
Breast Carcinoma
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Best Practice
Health Education
Interview
Planned Notification
Survey Administration
Sponsored by
About this trial
This is an interventional screening trial for Breast Carcinoma
Eligibility Criteria
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
Sites / Locations
- Emory University/Winship Cancer Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Arm I (PReVenT intervention)
Arm II (enhanced usual care)
Arm Description
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.
Participants receive usual care as well as portal and text messages one week apart with educational materials about healthy eating.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05526872
First Posted
August 31, 2022
Last Updated
May 8, 2023
Sponsor
Emory University
Collaborators
National Cancer Institute (NCI), National Institutes of Health (NIH)
1. Study Identification
Unique Protocol Identification Number
NCT05526872
Brief Title
A Patient Reminder and Self-Referral Via Online Patient Portals and Text Messaging to Improve Adherence to Breast Cancer Screening
Acronym
PReVenT
Official Title
Patient Reminders and Self-Referrals Via Online Patient Portals and Text Messaging (PReVenT) to Improve Adherence to Breast Cancer Screening
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 5, 2022 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
March 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
National Cancer Institute (NCI), National Institutes of Health (NIH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Carcinoma
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Participants will be blinded to their study arm.
Allocation
Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm I (PReVenT intervention)
Arm Type
Experimental
Arm Description
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 Title
Arm II (enhanced usual care)
Arm Type
Active Comparator
Arm Description
Participants receive usual care as well as portal and text messages one week apart with educational materials about healthy eating.
Intervention Type
Other
Intervention Name(s)
Best Practice
Other Intervention Name(s)
standard of care, standard therapy
Intervention Description
Receive usual care
Intervention Type
Behavioral
Intervention Name(s)
Health Education
Intervention Description
Receive educational materials
Intervention Type
Other
Intervention Name(s)
Interview
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Planned Notification
Other Intervention Name(s)
PlannedNotification
Intervention Description
Receive planned reminders to schedule mammogram
Intervention Type
Other
Intervention Name(s)
Survey Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Completion of Screening Mammogram-Adherence Rate
Description
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.
Time Frame
Within 6 months after enrollment
Title
Completion of Screening Mammogram-Regression Modeling
Description
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.
Time Frame
Within 6 months after enrollment
Title
Patient Satisfaction-Qualitative
Description
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.
Time Frame
At 6 months
Title
Patient Satisfaction-Quantitative
Description
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.
Time Frame
At 6 months
Title
Assistance with Self-Referral Scheduling
Description
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.
Time Frame
At 6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia Balthazar, MD,CIIP
Organizational Affiliation
Emory University Hospital/Winship Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University/Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Patient Reminder and Self-Referral Via Online Patient Portals and Text Messaging to Improve Adherence to Breast Cancer Screening
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