Text Message-Based Nudges Prior to Primary Care Visits to Increase Care Gap Closure
Primary Purpose
Pneumonia, Pneumococcal, Diabetes Mellitus, Breast Cancer
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Text message nudge
Sponsored by
About this trial
This is an interventional health services research trial for Pneumonia, Pneumococcal
Eligibility Criteria
Inclusion Criteria: Age 18 or older Have documented consent to communicate electronically Have a visit scheduled with a primary care practice Have at least one open care gap among those in the intervention Exclusion Criteria: No phone number on file to send text messages
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Usual Care
Text Message Group
Arm Description
This is a group will serve as usual care and have no intervention during the study period
This group of primary care practices will be randomized to have the text message intervention
Outcomes
Primary Outcome Measures
Care gap order rate
The proportion of open care gaps that have a test or treatment ordered to address them
Secondary Outcome Measures
Full Information
NCT ID
NCT05799976
First Posted
March 22, 2023
Last Updated
August 30, 2023
Sponsor
Ascension South East Michigan
1. Study Identification
Unique Protocol Identification Number
NCT05799976
Brief Title
Text Message-Based Nudges Prior to Primary Care Visits to Increase Care Gap Closure
Official Title
A Pragmatic Randomized Intervention Using Text Messages Prior to Primary Care Visits to Encourage Care Gap Closure: The PRIME Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
February 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ascension South East Michigan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Primary care visits are a key aspect of clinical care focused on helping patients to close care gaps related to preventive care such as vaccination, diabetes testing, statin therapy and cancer screening. However, less than 50% of care gaps are closed during these visits and new approaches are needed to prime patients for a discussion during these visits. In this study, the study team will evaluate a health system initiative that uses text messaging to patients in days preceding a primary care visit to prime patients to be amenable to ordering of vaccination, diabetes testing, cancer screening, and statin prescribing.
Detailed Description
The United States Preventive Services Task Force has recommended tests and treatments for vaccination, diabetes testing, statin therapy, and cancer screening. These preventive services have been demonstrated to reduce illness and improve quality of care. Yet, more than 50% of open care gaps go unaddressed during primary care visits.
Nudges are subtle changes to the way information is framed or choices are offered that can have a significant impact on behavior. In a previous randomized clinical trial, text messages sent to patients prior to primary care visits increased vaccination by up to 11% relative to control. The most effective message told patients the influenza vaccine was "reserved for you," and sent two text messages to patients in the 3 days preceding a primary care appointment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Pneumococcal, Diabetes Mellitus, Breast Cancer, Colorectal Cancer
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study will use a randomized clinical trial to evaluate a health system initiative to improve care gap closure. We will randomly assign primary care practices that use AthenaClinicals electronic health record at the following locations at Ascension's health system: Alabama-Birmingham, Kansas-Wichita, Tennessee-Nashville, Texas-Austin, and Texas-Waco. These practices will have the opportunity to opt-out from the program before randomization occurs.
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
This is a group will serve as usual care and have no intervention during the study period
Arm Title
Text Message Group
Arm Type
Experimental
Arm Description
This group of primary care practices will be randomized to have the text message intervention
Intervention Type
Behavioral
Intervention Name(s)
Text message nudge
Intervention Description
The text message nudge will be sent to patients 3 days and 1 day prior to a visit with the primary care practices and notify them of up to 3 care gaps based on electronic health record data. Care gaps will be selected based on availability and ranked in this order: influenza vaccination, pneumococcal vaccination, breast cancer screening, colorectal cancer screening, hemoglobin A1 testing, or statin therapy.
Primary Outcome Measure Information:
Title
Care gap order rate
Description
The proportion of open care gaps that have a test or treatment ordered to address them
Time Frame
By the end of the day of the primary care visit
Other Pre-specified Outcome Measures:
Title
Care gap completion rate
Description
The proportion of open care gaps that have a test or treatment completed to address them. Exploratory and only if data is available
Time Frame
Within 3 months of the primary care visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 18 or older
Have documented consent to communicate electronically
Have a visit scheduled with a primary care practice
Have at least one open care gap among those in the intervention
Exclusion Criteria:
No phone number on file to send text messages
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mitesh Patel, MD
Phone
646-580-2416
Email
mitesh.patel3@ascension.org
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Has patient information that we are not approved to share
Citations:
PubMed Identifier
33926993
Citation
Milkman KL, Patel MS, Gandhi L, Graci HN, Gromet DM, Ho H, Kay JS, Lee TW, Akinola M, Beshears J, Bogard JE, Buttenheim A, Chabris CF, Chapman GB, Choi JJ, Dai H, Fox CR, Goren A, Hilchey MD, Hmurovic J, John LK, Karlan D, Kim M, Laibson D, Lamberton C, Madrian BC, Meyer MN, Modanu M, Nam J, Rogers T, Rondina R, Saccardo S, Shermohammed M, Soman D, Sparks J, Warren C, Weber M, Berman R, Evans CN, Snider CK, Tsukayama E, Van den Bulte C, Volpp KG, Duckworth AL. A megastudy of text-based nudges encouraging patients to get vaccinated at an upcoming doctor's appointment. Proc Natl Acad Sci U S A. 2021 May 18;118(20):e2101165118. doi: 10.1073/pnas.2101165118.
Results Reference
background
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Text Message-Based Nudges Prior to Primary Care Visits to Increase Care Gap Closure
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