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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
Ascension South East Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Pneumonia, Pneumococcal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    March 22, 2023
    Last Updated
    August 30, 2023
    Sponsor
    Ascension South East Michigan
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    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
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    Text Message-Based Nudges Prior to Primary Care Visits to Increase Care Gap Closure

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