Preventive Reminder Ordering AssistanCe Via Texting for Improved Visit Encounters

NCT07636187 | Not Yet Recruiting

• 1 other identifier: 859571
• Study Type: interventional
• Target: 16,416
• Locations: 1 country
• Sites: 1

Brief Summary

A substantial portion of the United States population remains overdue for key screenings, despite availability and insurance coverage of preventive health services. Barriers for completion and remaining up to date with screening include patients not remaining actively engaged with their care team, time constraints during office visits, and operational strain. This project aims to implement and evaluate a primary care visit-based program that harmonizes multiple preventive health and chronic disease management care gaps, reduces staff burden, and improves ordering and subsequent patient follow through on completion of overdue care gaps. In this study, we will evaluate nudges to clinicians and patients to help increase screening completion for multiple care gaps identified as high priority by primary care, including imaging (Mammogram, DEXA) and labs (Diabetes Management (Hemoglobin A1C, Basic Metabolic Panel, and Urine Microalbumin), Hepatitis C, and Lipids). This will be a 6 month, stepped-wedge, pragmatic trial conducted at Penn Medicine.

Conditions

Behavior, Health

Keywords

EHR Nudge; Behavioral Economics; Preventive Health

Outcome Measures

Primary Outcomes (3)

• Mammogram Screening Completion (3 months)

  The primary outcome is the proportion of patients overdue who complete a mammogram within 3 months after the first eligible primary care visit.

  Within 3 months after first eligible primary care visit.

• Hepatitis C Screening Completion (3 months)

  The primary outcome is the proportion of patients overdue who complete Hepatitis C screening within 3 months after the first eligible primary care visit.

  Within 3 months after first eligible primary care visit.

• Lipids Screening Completion (3 months)

  The primary outcome is the proportion of patients overdue who complete lipids screening within 3 months after the first eligible primary care visit.

  Within 3 months after first eligible primary care visit.

Secondary Outcomes (11)

• DEXA Screening Completion (3 months)

  Within 3 months after the first eligible primary care visit.

• Hemoglobin A1C Screening Completion (3 months)

  Within 3 months after the first eligible primary care visit.

• Basic Metabolic Panel Screening Completion (3 months)

  Within 3 months after the first eligible primary care visit.

• Urine Microalbumin Screening Completion (3 months)

  Within 3 months after the first eligible primary care visit.

• Mammogram Screening Completion (6 months)

  Within 6 months after the first eligible primary care visit.

Study Arms (2)

Control Condition

NO INTERVENTION

During the control condition, clinics will receive standard of care.

Active Intervention

EXPERIMENTAL

During the active intervention, clinics will receive both clinician and patient facing nudges. Patient nudges will be pre- and post-visit text message reminders about their overdue care gaps. Clinician nudges will be default pended orders for overdue care gaps and an EHR Smart Data Element communication banner notifying the provider that a pre-visit reminder was sent to the patient and that orders have been pended for their review.

Behavioral: Pre-visit and post-visit patient messaging; Behavioral: Default pended order; Behavioral: EHR communication

Interventions

Default pended order BEHAVIORAL

The default pended orders will be automatically placed into the patient's primary care visit encounter via a custom Epic extension for each included care gap (mammogram, DEXA, hemoglobin A1C, basic metabolic panel, urine microalbumin, lipids, and Hepatitis C) that the patient is overdue for according to their Health Maintenance status. Clinical staff will have the option of signing the order or dismissing it if they deem it inappropriate for a given patient.

Active Intervention

EHR communication BEHAVIORAL

An electronic health record (EHR) communication will be visible to the provider and entire care team during the visit encounter. This smart data element (SDE) communication will display in the patient's EHR encounter as a section in pre-charting, check-in, and rooming, and will notify the clinician and care team that a pre-visit communication was sent to the patient regarding their overdue status for their preventive care imaging and/or labs.

Active Intervention

Pre-visit and post-visit patient messaging BEHAVIORAL

The patient nudges will be delivered by a series of one to three text messages. Patients will receive the pre-visit text message 2 days prior to their scheduled primary care visit. This message will remind them that they are overdue for their preventive care imaging and/or labs and encourage them to speak with their provider about screening completion during their upcoming appointment. All patients who complete their primary care visit and whose provider signed at least one of their pended orders will be sent post-visit text messages 7 and 14 days after completion, if they have not yet scheduled or completed their overdue labs and/or imaging. The messages delivered at 7 and 14 days will remind patients that appointments for lab and imaging are available for them and provide phone number(s) to call for scheduling and a link to complete scheduling online. Patients will also have the option to engage with a bi-directional support menu via text message.

Active Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients must meet the following criteria to be eligible:
• years or older
• A scheduled new or return (non-urgent/sick) primary care visit at one of the study practices
• Overdue for at least one of the included care gaps according to Health Maintenance: Mammogram, DEXA, Hemoglobin A1C, Basic Metabolic Panel, Urine Microalbumin, Lipids, Hepatitis C
• Last eligible office visit was greater than or equal to 3 months ago

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania Health System

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Shivan Mehta

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shivan Mehta

CONTACT

215-898-9807; shivan.mehta@pennmedicine.upenn.edu

Caitlin Brophy

CONTACT

Caitlin.Brophy@pennmedicine.upenn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Innovation Officer, Associate Professor of Medicine

Model Details: In a cluster randomized stepped wedge design, units are randomized to a particular time period at which to switch from the control condition to the active intervention. After the intervention is activated by a unit (e.g., a clinic), it remains active throughout the remainder of the trial. The first period serves as a baseline with all clinics following the control condition. In the last period of the trial, all clinics are implementing the active intervention. PROACTIVE will consist of six 4-week periods including the baseline period (i.e., the control condition). Prior to study launch, 24 participating clinics will be randomized to one of the remaining five periods (i.e., periods 2 through 6). The randomization will be stratified by clinic type, defined as community (employed by health system) or academic (part of medical school department).

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: June 9, 2026
• Study Start: June 8, 2026
• Primary Completion (Estimated): February 23, 2027
• Study Completion (Estimated): May 23, 2027
• Last Updated: June 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)