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Enrolling by invitation NCT07636187

Preventive Reminder Ordering AssistanCe Via Texting for Improved Visit Encounters

No phase Interventional Behavior, Health

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pre-visit and post-visit patient messaging, Default pended order, EHR communication.
Who it may be relevant to
Registry conditions: Behavior, Health. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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, the investigators 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.

Detailed description

A substantial portion of the United States population remains overdue for preventive care screenings, despite availability of health services. This gap in care persists due to both patient and clinician facing barriers. Patients may not always remain actively engaged with their care team, while clinicians are impacted by time constraints and the complexity of managing multiple care tasks during visits. One population health strategy to address these barriers is visit-based nudges, which is anchored around office visits and uses methods such as pre-visit texting to patients and pended orders for clinicians. In a previous study aimed at improving influenza vaccination rates, pre-visit texting and automated pended orders used within an office visit increased vaccination rates by 5 percentage points. Another prior study, aimed at improving mammogram completion, utilized pended orders and post-visit texting to increase screening rates by 5 percentage points at six months for intervention patients. Both studies have demonstrated the impact of leveraging multiple nudges to both patients and clinicians and have highlighted the need to integrate these aspects into one large scalable program to create a cohesive patient experience. Building upon this prior work and in collaboration with primary care, the investigators propose to develop and evaluate an integrated visit-based preventive health program with nudges to both clinicians and patients using a stepped wedge design, with the goal of implementing this system across primary care practices.

Interventions

  • Behavioral Pre-visit and post-visit patient messaging
    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 order
  • Behavioral Default pended order
    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.
  • Behavioral EHR communication
    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.

Primary outcome measures

  • Mammogram Screening Completion (3 months) [Time frame: Within 3 months after first eligible primary care visit.]
  • Hepatitis C Screening Completion (3 months) [Time frame: Within 3 months after first eligible primary care visit.]
  • Lipids Screening Completion (3 months) [Time frame: Within 3 months after first eligible primary care visit.]
Secondary outcome measures (11)
  • DEXA Screening Completion (3 months) [Time frame: Within 3 months after the first eligible primary care visit.]
  • Hemoglobin A1C Screening Completion (3 months) [Time frame: Within 3 months after the first eligible primary care visit.]
  • Basic Metabolic Panel Screening Completion (3 months) [Time frame: Within 3 months after the first eligible primary care visit.]
  • Urine Microalbumin Screening Completion (3 months) [Time frame: Within 3 months after the first eligible primary care visit.]
  • Mammogram Screening Completion (6 months) [Time frame: Within 6 months after the first eligible primary care visit.]
  • Hepatitis C Screening Completion (6 months) [Time frame: Within 6 months after the first eligible primary care visit.]
  • Lipids Screening Completion (6 months) [Time frame: Within 6 months after the first eligible primary care visit.]
  • DEXA Screening Completion (6 months) [Time frame: Within 6 months after the first eligible primary care visit.]
  • Hemoglobin A1C Screening Completion (6 months) [Time frame: Within 6 months after the first eligible primary care visit.]
  • Basic Metabolic Panel Screening Completion (6 months) [Time frame: Within 6 months after the first eligible primary care visit.]
  • Urine Microalbumin Screening Completion (6 months) [Time frame: Within 6 months after the first eligible primary care visit.]

Eligibility criteria

Inclusion criteria

All patients must meet the following criteria to be eligible:

  • 18 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

Exclusion criteria

As this trial is integrated with routine clinical operations, there will be no exclusion criteria. However, for each care gap independently, we will exclude all patient visits throughout the remaining trial duration after the patient's first eligible office visit within the trial duration. In other words, each patient will contribute data from at most one eligible office visit.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Sequential
Masking
Double blind
Primary purpose
Health services research

Study locations

United States · 1 center
  • University of Pennsylvania Health System — Philadelphia

Identifiers

NCT: NCT07636187 · 859571

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗