Text Message-Based Nudges Prior to Primary Care Visits to Increase Care Gap Closure

A Pragmatic Randomized Intervention Using Text Messages Prior to Primary Care Visits to Encourage Care Gap Closure: The PRIME Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus; Breast Cancer; Colorectal Cancer; Pneumonia, Pneumococcal
• Intervention / Treatment: Behavioral: Text message nudge

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.

• Study Type: Interventional
• Enrollment (Actual): 29334
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63134
      • Ascension

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care; This is a group will serve as usual care and have no intervention during the study period
Experimental: Text Message Group; This group of primary care practices will be randomized to have the text message intervention	Behavioral: Text message nudge; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Care gap order rate	The proportion of open care gaps that have a test or treatment ordered to address them	By the end of the day of the primary care visit

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Care gap completion rate	The proportion of open care gaps that have a test or treatment completed to address them. Exploratory and only if data is available	Within 3 months of the primary care visit

Collaborators and Investigators

• Sponsor: Mitesh Patel
• Investigators: Principal Investigator: Mitesh Patel, MD, Principal Investigator

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2023
• Primary Completion (Actual): November 9, 2023
• Study Completion (Actual): February 9, 2024

Study Registration Dates

• First Submitted: March 22, 2023
• First Submitted That Met QC Criteria: April 4, 2023
• First Posted (Actual): April 5, 2023

Study Record Updates

• Last Update Posted (Actual): April 25, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia; Lung Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; Pneumonia, Bacterial; Pneumococcal Infections; Pneumonia, Pneumococcal
• Other Study ID Numbers: RIN20230039

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Has patient information that we are not approved to share

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No