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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05799976
• Other study ID #: RIN20230039
• Status: Completed
• Phase: N/A
• Start date: September 5, 2023
• Est. completion date: February 9, 2024

Study information

• Verified date: April 2024
• Source: Ascension Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29334
• Est. completion date: February 9, 2024
• Est. primary completion date: November 9, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Colorectal Cancer
• Diabetes Mellitus
• Pneumonia, Pneumococcal

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.

Locations

Country	Name	City	State
United States	Ascension	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Mitesh Patel

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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