NCT05799976

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29,334

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 5, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

September 5, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 9, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 9, 2024

Completed
Last Updated

April 25, 2024

Status Verified

April 1, 2024

Enrollment Period

2 months

First QC Date

March 22, 2023

Last Update Submit

April 24, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Care gap completion rate

    Within 3 months of the primary care visit

Study Arms (2)

Usual Care

NO INTERVENTION

This is a group will serve as usual care and have no intervention during the study period

Text Message Group

EXPERIMENTAL

This group of primary care practices will be randomized to have the text message intervention

Behavioral: Text message nudge

Interventions

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.

Text Message Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • No phone number on file to send text messages

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ascension

St Louis, Missouri, 63134, United States

Location

Related Publications (2)

  • 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.

    PMID: 33926993BACKGROUND
  • Patel MS, Aloia TA, Shoemaker AG, Fakih MG, Masoudi FA, Smith L, Rosenzweig E, Chaiyachati KH, Conrad BN, Bandreddi J, Fogel RI. A Digital Care Plan Nudge to Improve Primary Care Outcomes. NEJM Evid. 2025 Jun;4(6):EVIDoa2400419. doi: 10.1056/EVIDoa2400419. Epub 2025 May 27.

MeSH Terms

Conditions

Pneumonia, PneumococcalDiabetes MellitusBreast NeoplasmsColorectal Neoplasms

Condition Hierarchy (Ancestors)

Pneumococcal InfectionsStreptococcal InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsPneumonia, BacterialPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Mitesh Patel, MD

    Principal Investigator

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR INVESTIGATOR
PI Title
VP, Ascension

Study Record Dates

First Submitted

March 22, 2023

First Posted

April 5, 2023

Study Start

September 5, 2023

Primary Completion

November 9, 2023

Study Completion

February 9, 2024

Last Updated

April 25, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Has patient information that we are not approved to share

Locations